Software Technology for “Apparatus for filling a drug-eluting medical device by capillary action using a catheter”

Medical Device – Justin Peterson, James Mitchell, Abby S Pandya, Nate Glucklich, Joseph Berglund, Ya Guo, Medtronic Vascular Inc

Abstract for “Apparatus for filling a drug-eluting medical device by capillary action using a catheter”

“Methods for filling a therapeutic drug or substance within a hollow wire that forms an stent are described. The fluid drug formulation is contained within the chamber in which the stent is placed. The chamber must be filled to the vapor-liquid equilibrium level of the solvent during filling. A portion of the stent should be placed in contact with the fluid formulation to fill it. The hollow wire will then act as a capillary, filling the lumen with the fluid formulation. Once the fluid drug formulation has been fully infused, the stent can be pulled out so that it is no longer in direct contact. To evaporate solvents from the fluid drug formulation, the solvent vapor pressure in the chamber is decreased. The fluid drug formulation may be transferred into the stent by means of a wicking device.

Background for “Apparatus for filling a drug-eluting medical device by capillary action using a catheter”

“Drug-eluting medical devices that are implantable are very useful because they can provide structural support and medical treatment to the area where they are placed. Drug-eluting devices have been used to prevent the development of restenosis in the coronary arteries. Anti-inflammatory drugs such as those that block local invasion/activation or monocyte activation may be administered by drug-eluting devices. This prevents the release of growth factors that could trigger VSMC proliferation. Antiproliferative compounds, such as chemotherapy and sirolimus, can also be anti-restenotic. Anti-restenotic uses can also be made for other drugs, such as antithrombotics and anti-oxidants, platelet-aggregation inhibitors, cytostatic agents, and anti-thrombotics.

“Drug-eluting medical device may be covered with a polymeric material that is then impregnated in a drug or combination of drugs. The drug is released from the plastic material once the device is placed at the target site. The drug is released through diffusion through a layer of polymer of a biostable or biodegradable material.

“Drug-impregnated polymer coats are limited in terms of the drug delivery. This is due to the limitations of the polymer coating’s ability to carry and the size the medical device. It is also difficult to control the rate at which polymer coatings elute drugs.

“Accordingly drug-eluting medical equipment that allow increased amounts of a drug delivery by the medical device and allow for improved control over the drug’s elution rate and better methods of making such medical devices are required. Co-pending U.S. Patent Application Publication No. 2011/0008405, filed Jul. 9, 2009, U.S. Provisional Application Number. Provisional Application No. Provisional Application No. Provisional Application No. 61/244.050, filed Sep. 20, 2009. Also co-pending U.S. Patent Application Publication Number. Each of these documents, which are incorporated herein in its entirety, describe methods for creating drug-eluting catheters with hollow wires. Hollow wire drug-eluting devices can have similar elution curves to those with the therapeutic substance placed in a polymer on their surface. Hollow wire drug-eluting devices can achieve similar elution curves to those with drug-polymer-coated stents. They are expected to be clinically effective and safer than the polymer-coated stents. A variety of elution curves are possible with drug-eluting hollow wires. Some applications, like coronary stents have a very small diameter hollow wire lumen that can be filled with drug or therapeutic substance. It is usually less than 0.0015 inches, making it difficult to fill the lumen. It is therefore necessary to develop improved methods and apparatus for filling the lumen of a hollow wire stent.

“Embodiments are directed at methods and apparatus for filling fluid drug formulations within a lumenal area of a hollowwire having a plurality side openings along its length that form a drug-eluting device with a plurality side drug delivery openings. An embodiment of this invention consists of a hollow wire with a plurality side openings that is placed in a first chamber. The apparatus also includes a valve that is positioned between the first and second chambers. This valve houses a wicking mechanism that is in direct contact with a fluid drug formulation. The valve is closed so that the first and second chambers are not in fluid communications. The valve should be opened so that the first and second chambers are in fluid communication. The solvent vapor saturation of the first and second chambers is reached or close to solvent vapor saturation. The wicking mechanism within the second chamber is placed in contact with a portion of the stent so that at least one side opening is in contact the wicking. The selected portion of stent remains in contact with wicking elements until the lumenal space created by hollow wire is filled via capillary action through at least one side opening that is in contact with wicking. The stent can be retracted so that it is not in direct contact with the wicking mechanism and remains within the first chamber. The valve is closed so that the first and second chambers are not in fluid communication. Additionally, the solvent vapor pressure in this chamber is decreased to evaporate any solvent in the fluid drug formulation.

“In another embodiment, a stent made from hollow wire with a plurality side openings is placed inside a chamber that houses the fluid drug formulation. The fluid drug formulation is in the chamber at the vapor-liquid equilibrium. One portion of the stent is placed in contact with the fluid formulation so that at least one side opening is in contact. The fluid drug formula and the selected section of the stent are kept in contact until the lumenal space created by the hollow wire has been filled with the fluid formulation through capillary action via at least one side opening that is in direct contact with the fluid. The fluid drug formulation may be transferred into the stent by means of a wicking device.

“BRIEF DESCRIPTION DES DRAWINGS”

The following description of embodiments of the invention, as illustrated in the accompanying illustrations, will reveal the above and other advantages and features of the invention. These accompanying drawings are included in the specification and constitute a part thereof. They further explain the principles of invention and allow a skilled person to make and use this invention. These drawings are not scaled.

“FIG. “FIG.

“FIG. 2A is a cross sectional view taken along the line 2A-2A in FIG. 1.”

“FIG. 2B is a sectional look taken along line 2B-2B at the end of the hollow wire in FIG. 1.”

“FIG. 2C is an end-view taken along line 2C-2C in FIG. 1”

“FIG. “FIG. 1. A fluid drug formulation by capillary action.

“FIGS. “FIGS. 3. The flow chart of FIG. 3 is performed in an apparatus with upper and lower chambers. In these chambers, the stents are brought into contact via a wicking device with the fluid drug formulation.

“FIGS. 8A-8B show an example of a stent suspension device that holds the plurality of Stents in place during the capillary-filling procedure. 4A-7.”

“FIGS. 9A-9B show another example of a stent suspension mechanism, which holds or secures the plurality stents during the capillary filling process described in FIGS. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIGS. 12A-12B show another example of a stent suspension mechanism that holds or secures the plurality stents during the capillary filling process described in FIGS. 4A-7.”

“FIGS. 13A-13B show another embodiment of a suspension device that holds the plurality of Stents in place during the capillary-filling procedure. 4A-7.”

“FIGS. 13C-13D show another embodiment of a suspension device that holds the plurality of Stents in place during the capillary-filling procedure. 4A-7.”

“FIGS. 14A-14B show another embodiment of a suspension device that holds the plurality of Stents in place during the capillary filling process described in FIGS. 4A-7.”

“FIGS. FIGS. 15A-15B show another example of a stent suspension mechanism that holds or secures the plurality stents during the capillary filling process described in FIGS. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIGS. 18A-18B show another example of a stent suspension mechanism, which holds or secures the plurality stents during the capillary filling process described in FIGS. 4A-7.”

“FIGS. FIGS. 18C-18D show another example of a stent suspension mechanism that holds or secures the plurality stents during the capillary filling process described in FIGS. 4A-7.”

“FIGS. 19A-19D show another example of a stent suspension mechanism, which holds or secures the plurality stents during the capillary filling process described in FIGS. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIGS. 21-21A is another example of a stent suspension mechanism that holds or secures the plurality stents during the capillary filling process described in FIGS. 4A-7.”

“FIGS. 22A-22C show another embodiment of a suspension device that holds the plurality of Stents in place during the capillary-filling procedure. 4A-7.”

“FIGS. FIGS. 23A-B show an example of a wicking mechanism that controls the transfer of a fluid formulation to a catheter during the capillary filling process described in FIGS. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIGS. FIGS. 27A-27B show another example of a wicking mechanism that controls the transfer of a fluid formulation to a catheter during the capillary filling process described in FIGS. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIGS. 31A-31B show another embodiment of a means for controlling the transfer of fluid drug formulations to stents during capillary filling procedures described in FIGS. 4A-7.”

“FIGS. 32A-32B are another example of a wicking mechanism that controls the transfer of a fluid formulation to a catheter during the capillary filling process described in FIGS. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIGS. 36A-36C are another example of a wicking mechanism that minimizes the contact surface between each stent & the fluid drug formula in order to control the transfer of a fluid medication to a catheter during the capillary filling process described in FIGS. 4A-7.”

“FIGS. 37A-37C are another example of a wicking mechanism that minimizes the contact surface between each stent & the fluid drug formula in order to control the transfer of a fluid medication to a catheter during the capillary filling process described in FIGS. 4A-7.”

“FIGS. 38A to 38B show another embodiment of a Wicking Mean, which reduces the contact area between the stents and the fluid formulation. This is done to prevent fluid formulations from being transferred to the stents during the capillary filling process described in FIGS. 4A-7.”

“FIG. 39 is a schematic illustration showing an apparatus with upper and lower chambers that can be used to perform the flow chart in FIG. 3. The stents are directly in contact with the fluid drug formulation, without the aid of a wicking device.

“Specific embodiments are described in the following with reference to the figures. Like reference numbers indicate identical elements or functionally related elements. The terms “distal” and “proximal” are interchangeable. The terms?distal? und?proximal? are used in the following description to refer to a position or direction relative to the treating clinician. These terms refer to a direction or position relative to the treating physician. ?Distal? Alternatively,?distally? are in a distant position from or in a direction from the clinician. ?Proximal? ?Proximal? are in close proximity to or in the direction of the clinician. Self-expanding is also a term. The term “self-expanding” is also used in this description. It means that structures can be shaped or formed using a material that can have a mechanical memory to allow it to change from a compressed delivery configuration to an expanded deployment configuration. A few examples of self-expanding materials that are not limited to stainless steel include a pseudo-elastic material such as a nickel-titanium alloy or nitinol or various polymers or a so called super alloy. This may have a base metal made up of nickel, cobalt or chromium. Thermal treatment can impart mechanical memory to wires or stent structures to create spring tempers in stainless steel or set shape memories in susceptible metal alloys, such as nitinol. Many polymers can be made with shape memory properties and may be used in the embodiments. These polymers include polynorborene (trans-polyisoprene), polynorborene (oligo caprylactone copolymer), polyurethane (polyurethane) and styrenebutadiene (styrene-butadiene). Poly L-D Lactic copolymer (oligo caprylactone polyolymer) and poly cyclooctine may be used in combination with other shape-memory polymers.

The following description is only an example and does not limit the invention. The drug eluting devices described herein can be used in the treatment of blood vessels, such as the renal, carotid, and coronary arteries. They may also be used to treat any other body passageways that are deemed necessary. Particularly, drug-eluting stents containing a therapeutic substance are designed to be deployed at different treatment sites in the patient. These include vascular (e.g. coronary vascular and peripheral vascular) stents as well as urinary stents. There is no intent to be bound by any implied or explicit theory in the technical background, summary, or detailed description.

“Hollow Wire Drug Eliminating Stent”

FIGS. 1-2C. Stent 100 is made from a hollow wire or strut 102. Also known as a stent, or hollow core stent, it can be described as follows: Hollow wire 102 is defined as a lumen or luminanal space 103. It can be formed either before or after it has been shaped into the desired stent pattern. A hollow wire stent is, in other words, one made from hollow wire. A straight hollow wire that is shaped into a desired shape or a stent made from any suitable manufacturing process that results in a tubular part formed into a desired pattern. The tubular component must have a lumen (or lumenal space) that extends continuously through it. As illustrated in FIG. FIG. 2C) that runs from the first tip or end 105 to the second tip or end 107 of the stent 100. As shown in FIG. 1. The methods of filling a drug in a stent according to embodiments hereof aren’t limited to stents with the pattern shown in FIG. 1. The methods described herein allow for the loading of drugs into stents made from any suitable pattern. U.S. Pat. stents are also available in patterns. No. No. No. No. No. No. No. No. No. No.

“As illustrated in FIG. 2A: Hollow wire 102 allows for a therapeutic drug or substance 112 to be placed within the lumen or lumenal spaces 103 of hollowwire 102. FIG. 103 shows lumen 103 as being filled uniformly with therapeutic substance or drug 112. 2A shows that lumen 103 is filled with therapeutic substance or drug 112 in FIG. Lumen 103 can extend continuously from a first end (114) to a second ending (114). Hollow wire 102. While hollow wire 102 appears to have a circular cross section, hollow wire102 could be rectangular or elliptical in cross-section. Hollow wire 102 can have a wall thickness of 0.0004 inch to 0.005 inches with an inner or lumen size ID ranging between 0.0005 and 0.02 inch. Hollow wire 102 used to form stent 100 can be made of a metallic material to provide artificial radial support for the wall tissue. This includes stainless steel, nickel?titanium (nitinol), and nickel-cobalt alloy such as MP35N. It may also include cobalt-chromium or tantalum, titanium. Hypotubes, which are hollow metal tubes with a smaller diameter than the ones used for making hypodermic needles, can be used to make hollow wire 102. Hollow wire 102 can also be made from non-metallic materials, such as polymeric material. The polymeric material could be biodegradable and bioresorbable so that stent 100 is absorbed by the body, after it has been used to restore patency to lumens and/or deliver drugs.

“Hollow wire102 also includes drug-delivery side ports or ports 104 that are distributed along its length to allow therapeutic substance or drug 112 release from lumen103. Side openings104 can be placed only on the generally straight segments (106, 108, and 108) of stent 100 or both segments 106, 106, and crowns108 of stent100. Side openings 104 can be sized or shaped to reduce the elution of drug 112 from catheter 100. Side openings 104 can be slits, or holes with any cross-section, including, but not limited, circular, oval and rectangular. Side openings 104 of a larger size allow for a faster rate of elution. Smaller side openings, 104 on the other hand, are more efficient. You can also vary the size or quantity of side openings (104) along stent100 to adjust the amount and/or speed of drug 112 being eluted at different parts of stent100. Side openings 104 can be from 5-30 mm in width or length, but this is not a limitation. Side openings 104 can be placed only on the outwardly facing surface 116 of the stent 100. FIG. 2. Only on the inwardly facing surface 118 of the stent 100.

“In different embodiments, a variety of therapeutic agents or drugs can be used as the elutabletherapeutic substance or drug 112 in lumen103 of hollow wire102. The pharmaceutically effective amount will depend, ultimately, on the condition being treated, the nature and composition of the therapeutic agent, the tissue in which it is introduced, etc. One of ordinary skill can see that hollow wire 102 may contain one or more therapeutic drugs. The therapeutic substance or drug 112 that is delivered to the site of stenotic lesions can be any type of drug that dissolves the plaque material, anti-thrombotic, anti-proliferative, or anti-platelet drug. TPA, heparin and urokinase are some examples of such drugs. The stent 100 can be used to deliver any medication to the interior and walls of a vessel, including anti-thrombotic, antiproliferative, anti?inflammatory, anti?migratory, anti?migratory, anti?migratory, anti?thrombotic, anti?proliferative, anti?migratory, agents affecting extracellular mat production and organization, antineoplastic, anti?mitotic agents and anesthetics agents, antineoplastic, anti?mitotic, vascular growth inhibitors, vasodilating, cholesterol-lowering, vasodilating, and other endogenous vasoactive vasoactive vasoactive vasoactive vasoactive vasoactive vasoactive vasoactive vale

“Stent 100, in accordance with the embodiments hereof is filled with therapeutic substance 112 before it is inserted into the body. To load into hollow wire 102 lumen 103, therapeutic substance or drug 112 can be mixed with a solvent/dispersant. The therapeutic substance or drug 112 may also be mixed with an excipient that aids with elution to load into lumen 103 of hollowwire 102. Fluid drug formulation is the term used hereinafter. may be used to refer generally to therapeutic substance or drug 112, a solvent or dispersion medium, and any excipients/additives/modifiers added thereto. One embodiment of therapeutic substance or drug 112 is mixed in a solvent or solvent combination before being loaded into hollow wire 101. A solution is a mixture that contains therapeutic substance or drug 112 in a solvent. A high-capacity solvent is an organic solvent with a high ability to dissolve therapeutic substance 112. A high capacity is defined herein as the ability to dissolve therapeutic substance 112 at concentrations greater that 500 mg per milliliter. High-capacity drug dissolving solvents are available for sirolimus (THF), dichloromethane, di-chloromethane and chloroform. To aid in drug elution, the solution may also contain an excipient. In one embodiment, an excipient may be a surfactant such as but not limited to sorbitan fatty acid esters such as sorbitan monooleate and sorbitan monolaurate, polysorbates such as polysorbate 20, polysorbate 60, and polysorbate 80, cyclodextrins such as 2-hydroxypropyl-beta-cyclodextrin and 2,6-di-O-methyl-beta-cyclodextrin, sodium dodecyl sulfate, octyl glucoside, and low molecular weight poly(ethylene glycol)s. In another embodiment, an excipient may be a hydrophilic agent such as but not limited to salts such as sodium chloride and other materials such as urea, citric acid, and ascorbic acid. Another embodiment may include a stabilizer, such as butylated hydrotoluene. A low-capacity solvent may also be used depending on the drug load. It is known for its lower solubility of drug 112. A low capacity solvent is one that can dissolve therapeutic substance or drug 112. Its concentrations are typically below 500 mg per milliliter solvent. Examples of low capacity drug dissolving solvents for sirolimus and similar substances include but are not limited to methanol, ethanol, propanol, acetonitrile, ethyl lactate, acetone, and solvent mixtures like tetrahydrofuran/water (9:1 weight ratio). Once a solution has been loaded into stent 100 the therapeutic substance, drug, or other substance, can be precipitated from the solution. The majority of the solvent and any nonsolvent may be removed from hollow wire 102 so that only the therapeutic substance, drug 112, or therapeutic substance, 112 and any excipients are left to enter the body.

“In another embodiment, the therapeutic substance or drug 112 can be mixed with a dispersion media as a suspension before being loaded into hollow wire 102. A slurry/suspension formulation does not dissolve therapeutic substance or drug 112, but instead disperses as solid particulate in dispersion medium. This refers to a continuous liquid medium within which the solid particles are distributed. Dispersion mediums that are unable to dissolve therapeutic substances or drugs 112 will vary depending on their properties. Water, hexane and other simple alkanes are suitable dispersions mediums that cannot dissolve sirolimus. To aid in suspension or stabilization, certain excipients, suspension agents, surfactants and/or other additives/modifiers may be added to the drug suspension to increase the surface lubricity and/or disperse drug particles. Surfactants are used to prevent therapeutic substance 112 from floating or sinking to bottom of dispersion medium. Examples of surfactants include but are not limited to sorbitan fatty acid esters such as sorbitan monooleate and sorbitan monolaurate, polysorbates such as polysorbate 20, polysorbate 60, and polysorbate 80, and cyclodextrins such as 2-hydroxypropyl-beta-cyclodextrin and 2,6-di-O-methyl-beta-cyclodextrin. One embodiment of the invention involves the target amount of therapeutic substance/drug 112 suspended in the dispersion media and the appropriate additive/modifier being added on a 0.001-10 wt% basis to the total formulation. In addition, an excipient such as urea or 2,6-di-O-methyl-beta-cylcodextrin may be added to the slurry/suspension in order to assist in drug elution.”

“Open ends 114, 114? The wire 102 can be sealed or closed before or after the drug has been loaded within lumen103, as shown in FIG. 2B is shown along line 2B-2B in FIG. 1. Once placed in the body at the desired place, stent 100 can be deployed for permanent or temporal implantation in the lumen. This allows therapeutic substance 112 to escape from lumen103 via side openings 104.

“Filling Process Via Capillary Action

“Embodiments hereof refer to the use capillary action for filling lumen 103 hollow wire 102. Capillary action is the ability for liquids to flow in narrow spaces, without the aid of external forces such as gravity. The only requirement for stent 100 to have at least one side hole is to submerge or expose it to a fluid formulation or to a submerged or exposed means to wick fluid drug formulation. The fluid drug formulation will then travel through lumen103 of hollow wire102 via the exposed/submerged holes 104 to fill or load the entire length lumen103 by capillary action. Inter-molecular attraction forces between the fluid drug formula and hollow wire 101 cause capillary action. If lumen 103 is small enough, the combination of surface tension 102 and adhesive forces between the fluid and hollow wires 102 lift the liquid drug formulation to fill the hollow wire. Capillary action fills stents 100. This allows for a faster filling process. It can be used to batch fill multiple stents within a short time. Filling stents 100 by capillary action decreases variability in drug loads and makes drug filling easier and more predictable. Fluid drug formulation is uniformly filled or deposited within lumen103 hollow wire 101. After solvent/dispersion media extraction, lumen103 hollow wire 102 has uniform drug content.

“More particularly, FIG. 3. This is a flowchart of a procedure for filling lumen 100 with a fluid formulation 432 by capillary action. FIG. FIGS. 4A-7 are schematic illustrations of an apparatus, 420 that can be used to perform the steps of FIG. 3. FIGS. FIGS. 4A-7 show an embodiment where a wicking device controls the fluid drug formulation’s transfer into lumen103. FIG. 39 is an embodiment where the stents directly touch fluid drug formulation to fill lumen103. FIGS. 100 show stents 100 as straight tubular structures. This is for illustration purposes only. 4A-7, although one of ordinary skill will understand that stents100 are hollow wires shaped into desired stent patterns as described in FIG. 1. Apparatus 422, which includes an upper chamber 422 that houses a manifold, or stent suspension mechanism 428 and an open container 431 that contains a liquid or solvent 433, and a second chamber 424 that houses a wicking mean 430 that comes in contact with fluid formulation 432. This fluid includes therapeutic substance or drugs 112, and a valve 426 that is located between the upper chamber 422 & lower chamber 424. Fluid drug formulation 432 contains the same solvent contained in reservoir 431. Valve 426 can alternate between an open configuration where the first and second chambers are in fluid contact and a closed configuration where the first and second chambers are not in fluid connection. A plurality 100 stents are loaded onto the stent suspension mechanism 428. This holds or suspends them in position during the capillary filling process, as shown in FIG. 301A. 3. Stent suspension means 428 can suspend stents 100 vertically as shown in FIG. 4A or 100 may be suspended in a horizontal orientation, as shown in FIG. 4B. The stent suspension means 428 can be used to move the plurality 100 stents between the upper and lower chambers 422, 442. Capillary filling procedures according to embodiment may be easily scaled as batch processes. The stents 100 can be loaded onto the stent suspension means 428. This is hollow wire 102 that has been previously shaped into desired waveforms and formed into cylindrical Stent 100, as shown in FIG. 1. Alternately, capillary filling may be done on straight hollow wires before shaping or forming hollowwire 102 into desired shape and subsequent stent configuration. In one embodiment, stent suspension 428 holds the stents 100 in position by slightly increasing the inner diameter of stents. This increases friction between the suspension 428 and the stents. It also minimizes unwanted movement.

Refer to FIG. 4A and/or FIG. 4A and/or FIG. The interior of upper chamber 422 is connected to a pressure source 434 or heat source 435. Another embodiment, not shown, connects a pressure source 434 or heat source 435 to the interior lower chamber 424. This depends on the volume and mass differences between these chambers. To remove any solvent vapor remaining in the upper chamber, pressure source 434 must be used before placing stents 100 in upper chamber 422. The stent suspension means 428 holding the stents 100 is completed. Next, the pressure source 434 is turned off to allow solvent vapor into upper chamber 422. 3. Once evaporation is stopped or sufficiently slowed down, valve 426 can be opened so that the upper and lower chambers 422, 442, are exposed and in fluid communication. 3. As shown in FIG. 5. To reach solvent saturation or near solvent saturation, both the upper and lower chambers 422, 442, are required. 3. To put it another way, the solvent 433 fluid drug formulation 432 requires both the upper and lower chambers 422, 432, to reach the solvent-liquid equilibrium. Vapor-liquid equilibrium refers to the state or condition in which liquid and vapor are in equilibrium. If liquid and vapor can be kept in close contact for sufficient time, such an equilibrium can be achieved in a closed area. The term “near the liquid-vapor equilibrium” is used herein. or ?near solvent vapor saturation? Includes pressure rates from?5 torr/min up to?5 torr/min. This range of pressure rates is considered to be very slow and almost negligible. The filling process can be done within this range without precipitation of therapeutic substance 112 within hollow wire 102 lumen 103. The preferred embodiment of this invention is that the filling process takes place when the pressure rate is between?2 andrr/min and 2 torr/min. The step of allowing the evaporation to stop in the upper chamber 422 or sufficiently slow before opening valve 426 reduces the rate at which the fluid drug formulation 432 evaporates within the lower chamber 424. This ensures that the formulation concentration doesn’t change.

There are many ways to decrease the time it takes to reach solvent saturation in chambers 422, 424. This will allow for faster processing and increase throughput. One embodiment creates a large area to decrease the time it takes to achieve vapor saturation. An embodiment may allow for large surface areas to be created by using ultrasonic spraynozzles to atomize droplets in the upper or lower chamber 422, 424. Another way to create a large area is to provide wicking means (430) with a large area, as illustrated in FIGS. 4A-7 to increase the surface area for the solvent to evaporate. You can also reduce the time it takes to reach vapor saturation by raising the temperature of solvent/dispersion medium. Heat source 435, which may alternatively be found within the second lower chamber 424, may be used to regulate fluid drug formulation 432’s temperature. Solvent vapor pressure is often highly dependent on temperature. Convection of gas across the solvent surface may reduce the time it takes to reach vapor saturation. A fan 499 could be used in the upper chamber 422 for convection across reservoir 431, which contains solvent 433. The solvent 433 reservoir 431 supplies the solvent vapor necessary to reach solvent saturation. These methods can be used in combination or individually to reduce the time it takes to reach solvent saturation in chambers 422, 424.

“Once both chambers 422 and 424 have reached or are close to solvent vapor saturation, capillary Filling can be initiated by moving the stents 100 into contact or submerging into wicking devices 430 as shown at step 301E in FIG. 3. 6. Wicking means 430 comes in contact with fluid formulation 432 to control the transfer of the fluid medication into lumens 103 and 102 of stent 100. One embodiment of wicking is 430, which is an open-celled sponge or foam made from polyurethane. However, there are many other wicking methods. Stents 100 can be pushed onto or into wicking elements 430, deforming wicking elements 430. As the wicking mechanism deforms, wicking mean 430 transfers fluid drug formula 432 from the lower chamber 424 to submerged holes 104 of stent100. Lumen 103 hollow wire 102 is filled with surface tension driving fluid formulation 432 through stent lumen. Until the length of lumen103 is filled via capillary force forces as shown in FIG. 3. The vapor-liquid equilibrium of the solvent 433 is maintained in the chambers 422, 424 during the filling step. This ensures that the therapeutic substance or drug 112 does not evaporate.

“FIGS. “FIGS. Only a small portion of each stent with at least one port or side hole 104 can be submerged into wicking materials 430. So, only a small amount of the wires 102 and 100’s exterior surfaces are exposed to fluid drug formulation. Most of the exterior surface of hollow wires of stents is not exposed to fluid drug formulation. FIG. FIG. 6A corresponds with FIG. 4A shows FIG. Only a tip 107 is submerged into wicking materials 430 when a stent 100 has been held vertically. This means that only one side hole (104) is in contact with the wicking material 430 and is exposed to fluid drug formulation 432. In one embodiment, about 0.3mm of each stent’s length is exposed to the wicking mechanism. FIG. FIG. 6B corresponds with FIG. 4B is the FIG. Horizontally, a longitudinal segment or strip 611 is placed along the outer surface of each stent 100. It is then submerged into wicking materials 430 so that at least one side hole (104) is in contact to wicking substances 430. Fluid drug formulation 432 is then exposed. No matter how the stents 100 may be oriented, fluid drug formula 432 can pass through hole(s), 104 on hollow wire (102), that is in contact with wicking mean 430. FIG. 6C shows only a small portion of hollow wire102 with a side hole104 that is submerged into wicking medium 430. Fluid drug formulation 432 creates a concave meniscus in lumen 103 hollow wire 102. Fluid drug formulation 432 is pulled by adhesive forces until enough fluid drug formula 432 is present for gravitational forces and to overcome intermolecular forces between hollow wire 102 and fluid drug preparation 432 or the advancing liquid column completely fills in the lumen. “The height h for a column fluid drug formulation 432 is determined using”

“h = 2 ? ?cos? ? ? ? g ? r

“where ? What is the liquid-air tension (force/unit)? The contact angle is? The density of fluid drug formula 432 (mass/volume), the local gravitational force strength (force/unit weight) and the radius hollow wire 102 (length) are the values. Fluid drug formulation 432 is not able to leak or exit from non-submersed holes and ports 104 along the length of the catheter. This is due to the intermolecular forces and nature of capillary filling.

Refer to FIG. 7. Stents 100 are pulled out or retracted so that they are not in direct contact with wicking devices 430. As stents are pulled out of wicking methods 430, wicking method 430 removes excess fluid medication 432 from wires 102 and 100 so that stents100 are completely free of drug residue. Stents 100 have fluid drug formulation 432 within the lumen 103 hollow wire 102. The capillary action filling process ends with the extraction of the solvent or dispersion media of fluid drug formula 432 from the lumenal spaces. This results in stents 100 being filled with the drug and a stent 100 containing the primarily therapeutic substance or drugs 112 and one or several excipients to be eluted into stent 100. Particularly, the stents 100 are pulled into the upper chamber 422, which remains at or close to the vapor-liquid equilibrium for solvent 433, as shown by FIG. 301G. 3. The valve 426 is closed so that the chambers 422 and 424 no longer communicate fluidly, as shown in FIG. 301H. 3. 7. To prevent fluid drug formula 432 from vaporizing, valve 426 is shut off. Additional stents can be filled with the same fluid formulation without any concentration changes. The solvent vapor pressure in the upper chamber 422 can then be reduced to ambient pressure by venting it, as shown in FIG. 301I. 3. The solvent vapor pressure in the upper chamber is decreased and hollow wire 102’s lumen 103 is opened. This causes the solvent of drug formulation 432 to evaporate, precipitating its constituents. Once the solvent or dispersion media has been removed from lumen103, the therapeutic substance or drug 112 will fill at least a portion lumen103. Apparatus 420 may be used to remove stens 100.

“Means to Hold Stents”

“FIGS. 8A-22B show several embodiments of the stent suspension mechanism 428 that holds or secures the plurality stents during the capillary filling process as described in FIGS. 4A-7. The stented suspension means 428 has several functions. It holds one or more stents so that only a small portion of the stents 100 is exposed to fluid drug formulation 432. Additionally, stent suspension mean 428 can be configured to simultaneously hold multiple stents 100 so that the batch size for a capillary filling process is easily scalable. The stent suspension mechanism holds 100 stents in place. It does this by expanding the inner diameter and elastically deforming the stents. This increases friction and minimizes unwanted movement. Stents 100 can be placed on stent suspension mechanism 428. Alternatively, stents 100 can be secured in an array (not illustrated) with a number of wells that are sized to hold them. The array can be placed in the first or upper chamber 422 in apparatus 420. It is designed to hold stents100 stationary, while stent suspension mean 428 are used to hold stents100 in place during filling. FIGS. 100 shows stents 100 as straight tubular structures. This is only for illustration. 8A-22B, but it is clear to anyone with ordinary skill in art that stents100 are hollow wires that have been shaped into desired stent patterns as described previously in FIG. 1. The stent suspension devices described in FIGS. 8A-22B show stent 100 held in a vertical orientation, but can be modified to hold it in a horizontal orientation. Refer to FIG. 4B.”

“FIGS. 8A and 8B show a stent suspension mechanism 828. It includes a header 836 that is shown in the figure and a carousel 836. A mandrel wire 85 for holding a 100-pound stent in place during the capillary filling process described in FIGS. 4A-7. 4A-7. The header or carousel 836, a flat sheet-like part, has at least one hole 837 or passageway 837 through it to allow passage of mandrel 85. Mandrel wire 85 is an elongated part with a first end of 840 that is fixed above header 836 and a 2nd end 842 that can be moved relative to the header 836. Mandrelwire 850 runs through a tubular component, or shaft 815 that is attached or coupled to header 836 so that a lumen is aligned and a passageway 837. Mandrelwire 850 runs through the lumen 815. It has both its first and second ends 842, which extend out from a top or one end. To allow a loop 838 of mandrelwire 850 to extend from a second or lower end of shaft 815, the second end 842 may be advanced. Based on the position of loop 838 relative to shaft 815, it becomes larger or smaller. As shown in FIG. 8, stent 100 is placed over shaft 815. Mandrel wire 85 is contained within the shaft. 8A. After stent 100 has been in place, the second end 842 should be moved towards header or carousel 836, in a?downward’ direction. Direction, indicated by directional Arrow 839, towards Stent 100 to expose loop 828 from shaft 815. To increase or decrease the diameter of Loop 838 so that it abuts or is opposed to the inner diameter of Stent 100 as shown in FIG. 8B. 8B. Loop 838 is made from elastic materials, such as Nitinol and spring steel.

“FIGS. 9A-9B show another embodiment of a suspension mechanism 928. It includes a header 936 and a carousel 936. A loop 938 is used to hold a stent 100 in position during the capillary filling process described in FIGS. 4A-7. 4A-7. The header or carousel is a flat sheet-like component with a loop or U-shaped component 938 attached to it. It has a first and second ends 940 of loop 938 that are both attached or bonded together to the header or carousel. A push-pull rod/wire 944 has a first and middle end that are connected to loop 938. The second end 948 extends through the passageway or hole 937 created through header/carousel 936. To adjust the diameter or size of loop 938, second end 948 may be pulled or pushed relative to header 936 or carousel 936. As shown in FIG. 9, the second end 948 (or push-pull wire 944) is used to create a small loop 938 with a diameter that is within the confines of stent 100. 9A. After being in place, the second end 948 (push-pull wire 944) is moved in an “upward?” direction. Direction relative to the header or carousel 936 is indicated by directional Arrow 941. It is away from stent100 that loop 938 bows outwards. The diameter of loop 938 increases or decreases when push-pull wire 944 is moved, as shown in FIG. 9B. FIG. 9B shows the larger and expanded loop 938. 9B grabs onto the inner circle of stent100 and, in one embodiment, may slightly increase the inner circle of stent100 to increase friction between the stent100 and the stent suspension means 928. This will minimize unwanted movement of the stent100. Loop 938 is made from elastic materials, such as Nitinol and spring steel. FIGS. FIGS. 9A-9B show a single loop for grasping onto the inner diameters of stents 100 and 100, but one or more loops can be attached to the loops and placed equally around the inner diameters of stents 100 to grab stents 100 in a circumferential fashion.”

“FIG. “FIG. 4A-7. 4A-7. The header or carousel 1036, which is generally a flat sheet-like component is attached or coupled to the carousel or header 1036 at the first end 1051. Mandrel 10050 is a tubular solid component with an outer diameter that is smaller than that of stent100. Therefore, mandrel 10050 fits within stent100 so that a second end 1053 from mandrel 10050 extends inside stent100. Mandrel 1050 has a slot or passageway 1052 through which a removable dowel rod 1054 is able to extend through passageway 1052 as well. Dowel rod 1054 is longer than mandrel 1005. This means that dowel rod 1054’s ends extend beyond the outer diameter 1050. Dowel rod 1054’s diameter is small enough to pass through the openings in stent 100, which are formed between the series generally sinusoidal waves. Stent 100 hangs from dowel rod 1004, which is held in place due to interference between dowel rod 1054 and hollow wire 102. Slip fit or spring-release mechanisms (not shown), may be used to connect dowel rod 1054 and the mandrel 1050. This allows dowel rod 1054 out of the mandrel through the openings in the stent. Mandrel 1050 and dowel rod 1054 can be made of any material that is compatible with organic solvents, including aluminum, stainless steel, and select polymers like delrin or polystyrene. Another embodiment, not shown, may use tabs or similar structures to attach to mandrel1050. These tabs will extend perpendicularly to the longitudinal axis 100 and pass through the openings in the stent.

“FIG. “FIG. 11. illustrates another embodiment for a stent suspension mechanism 1128. It includes a header 1136 or carousel 1136. A portion of this figure is shown. Also, there’s a mandrel 1150 that holds a stent 100 in position during the capillary filling process described in FIGS. 4A-7. 4A-7. The header or carousel 136 is a flat-sheet-like component. A first end 1151 is attached to the header or carousel 136. Mandrel 1150, a tubular solid component, has male threads 1155 forming on its exterior surface. The male threads have an outer diameter that is roughly equal or slightly larger than the inner diameter stent 100. The male threads 1155 grip the inner diameter 100 of stent 100 like a wood ordrywall screw. The male threads 1155 can be made from steel and may be integrated on the mandrel 1150, or may be an individual component that is coupled to it.

“FIGS. 12A-12B show another embodiment of a suspension mechanism 1228. It includes a header 1236 or carousel 1236. A portion of the figure is shown. Also, there is a mandrel 1250 that holds a stent 100 in position during the capillary filling process described in FIGS. 4A-7. 4A-7. A header or carousel 1236, a flat sheet-like component with at least one hole 1237 drilled through it to allow passage of a portion mandrel 1250, is called a header or carousel. Mandrel 1250 consists of two concentric tubes, or shafts: an outer tube 1256 with a lumen 1257 and an inner tube 1258 that can be slidably mounted inside a lumen 1256. The outer tube 1256’s first end 1262 is connected to the header or carousel 1206, and inner tube (1258) is longer than outer tube (1256). This means that an inner tube 1265 extends beyond outer tube 1256’s first end 1262 and passes through passageway 1237. A second end 1264 from inner tube 1258 extends beyond outer tube 1256’s second end 1263. A cylindrical braided wire tubular component 1260 has a first and second ends 1259, 1263 of outer tube 1256, and 1261 to inner tube 1258. Inner tube 1258 can be pulled or pushed relative to outer tube 1256 in order to adjust the size of braided components 1260. Operation: The second end 1265 is used to extend or lengthen braided components 1260. This allows the inner diameter of the stent 100 to be within the braided component’s 1260 diameter. FIG. 12A. 12A. Direction toward the header or carousel 1236 is indicated by directional Arrow 1241. This will cause braided component 1260 radially to expand. The inner tube 1258 is moved relative to the outer tube 1256, causing braided components 1260’s diameter to expand or contract until braided part 1260 is opposed to or in conflict with stent 100. FIG. 12B. The braided, larger component 1260 grabs onto the inner circumference of stent100. In one embodiment, it may slightly expand the inner circumference of stent100 to increase friction between the stent100 and the stent suspension means 1228. This will minimize unwanted movement of the stent100. Inner tube 1258 is moved in a?downward? direction relative to outer tube 1256 to release stent 100. To release stent 100 in a?downward? direction, inner tube 1258 is moved relative to outer tube 1256 in an?downward? direction. This will allow braided component 1260 to be extended longitudinally back to the position illustrated in FIG. 12A. 12A.

“FIGS. 13A-13B show another embodiment of a suspension mechanism 1328. It includes a header 1336 or carousel 1336. A portion of this figure is shown. There’s also a mandrel 1350 that holds a stent 100 in position during the capillary filling process described in FIGS. 4A-7. While only one mandrel 1350 has been shown, one of ordinary skill will understand that multiple mandrels can be attached to the header or carousel 1336 in order to accommodate a plurality stents 100. A header or carousel 1336, a flat sheet-like component, has at least one hole 1337 drilled through it to allow passage of a portion mandrel 1350. Mandrel 130 includes two concentric tubes, or shafts, that pass through passageway 1337 in header or carousel 13.36. An outer tube 1356, and an inner tube 1358 are mounted slidingly to extend through the lumen 1357 created by outer tube 1356. Inner tube 1358 has a length that is greater than outer tube 13.56. A first end 1365 extends beyond outer tube 1362 and a second ending 1364 extends beyond outer tube 1305. The outer tube 1356 could be a Nitinol tube. The second end 1363 (outer tube 1356) includes a plurality fingers, which is similar to a collet. The inner tube 1358’s second end 1364 is flared or bulbous, which means that its outer diameter is larger than the rest. Inner tube 1356’s inner tube 1358 has an outer diameter that is larger than its inner diameter. Inner tube 1358 can be pulled or pushed relative to outer tube 135 to allow the fingers at second end 1363 of outertube 1356 to be radially deployed. As shown in FIG. 13, the second end of inner tube 1358 should be positioned so that the bulbous end 1364 of innertube 1358 does not come in direct contact with fingers formed at second end 1363. 13A. Once stent 100 has been placed in the desired position, inner tube 1358’s second end 1364 is moved in an “upward” direction. Direction toward the header or carousel 1336. The direction is indicated by the directional arrow 1341. To move the second end 1364 from inner tube 1358 away from stent100, the bulbous second 1364 of innertube 1358 will contact the fingers on the second end 1363 in outer tube 1356. Bulbous inner tube 1358’s second end 1364 radially extends or spreads the fingers on outer tube 1356’s second end 1363 until they grab onto the inner diameter of the stent 100, as shown in FIG. 13B. 13B. In one embodiment, the deployed fingers may increase the inner diameter of the stent100 to increase friction between the stent 100 & stent suspension means1328. This will minimize unwanted movement of the stent100.

“FIGS. 13C-13D show another embodiment of a suspension means 1328C. It includes a header or carousel 1336. A portion of this figure is shown. There’s also a mandrel 1350C to hold a stent 100 in position during the capillary filling process described in FIGS. 4A-7. While only one mandrel 1350 has been shown, one of ordinary skill will understand that multiple mandrels can be attached to the header or carousel 1336 in order to accommodate a plurality stents 100. As shown in FIG. 13A. A header or carousel 1336, a flat-sheet-like component with at least one hole 1337 drilled through it to allow passage of a portion 1350C of mandrel 1350C. Mandrel 130C includes two concentric shafts or tubes that pass through passageway 1337C. An outer tube 1356C, and an inner tube 1358C are attached to slideably extend through the lumen 1357C. The outer tube 1356C could be a Nitinol tube, while the second end 1363C is an outer tube 1356C that includes a plurality fingers similar to a collet. This embodiment is different from the FIGS. 13A-B, fingers at the second end 1363C on outer tube 1356C can be bent or curved inwardly toward inner tube 1358C. The inner diameter of outer tube 1306C and inner tube 1358C is slightly smaller than that of 1364C. Inner tube 1358C can be pulled or pushed relative to outer tube 1306C in order to radially release the fingers at second end 1363C. As shown in FIG. 13, the second end of inner tube 1358C must be positioned so that the inner tube 1364C’s second end is not in direct contact with fingers formed at outer tube 1356C’s second end 1363C. 13C. After stent 100 has been placed in the desired position, the second end 1364C (internal tube 1358C) is moved in a “downward” direction. Direction towards header or carousel1336 as indicated by the directional arrow 1341C. The second end 1364C is moved in a?downward? direction. This causes the second end 1364C inner tube 1358C contact with fingers formed at second end 1363C outer tube 1356C. The second end 1364C (inner tube 1358C) straightens or spreads the fingers on the outer tube 1356C’s second end 1363C, until they grab onto the inner diameter of the stent 100. FIG. 13D. 13D. In one embodiment, the deployed fingers may increase the inner diameter of the stent 100 in order to increase friction between the stent 100 & stent suspension means1328C. This will reduce unwanted movement of the stent100.

“FIGS. 14A-14B show another embodiment of a suspension means 1428. It includes a header 1436 or carousel 1436. A portion of this figure is shown. There’s also a mandrel 1450 that holds a stent 100 in position during the capillary filling process described in FIGS. 4A-7. 4A-7. A header or carousel 1436, a flat sheet-like component, has at least one hole 1437 through it to allow passage of a portion mandrel 1450. Mandrel 1450 consists of two concentric tubes, or shafts, that pass through passageway 1437 of header or carousel. It also includes a retractable outertube 1466 and an innertube 1458 that can be slidably mounted so it extends through the lumen 1457 created by outer tube 1466. The inner tube 1458 could be a Nitinol tube. A second end 1463 from inner tube 1458 contains a plurality self-expanding fingers similar to a collet. The outer diameter of outer tube 1466 is less than that of stent 100. Operation: stent 100 is placed over outer tube 1466. This radially restricts fingers at second end 1463 and mandrel 1405, as shown in FIG. 14A. The outer tube 1466 can be moved in an “upward” direction. The outer tube 1466 may be moved in an?upward? direction towards the header or carousel, 1436. This will expose the fingers at second end 1463 and 1450. 14B. One embodiment allows the deployed fingers to slightly increase the inner diameter of the stent 100 in order to increase friction between the stent 100 & stent suspension means 1428. This will minimize unwanted movement of the stent100. To retract or constrain the fingers at the second end 1463, mandrel 1405, outer tube 1466 can be moved downwards to resume the configuration as shown in FIG. 14A.”

“FIGS. “FIGS. 4A-7. While only one mandrel 1550 has been shown, it is clear that multiple mandrels can be attached or coupled to the header or carousel for accommodating a plurality stents 100. A flat, sheet-like component with at least one hole 1537 or passageway 1536 through it is called header or carousel. Mandrel 1502 is a hollow shaft, or tube with a hole 1517 in its sidewall. A first end 1562 is connected to header 1536. The Nitinol wire 1568 has a first and second ends 1569A and 1569B. It extends through passageway 1507 of header 1536 and through the lumen 1550. This exits from the hole 1517 in the mandrel. 15A. The second end 1569B is connected to the second end 1563 in mandrel 1505. Operation: Stent 100 is placed over mandrel 1505. Once stent 100 has been placed in the desired position, tension on wire 1568 can be released. Helical Nitinol Wire 1568 will self-expand and radially expand to the shape it was designed to. The helical windings of wire 1568 grab onto the inner diameter or against stent100 as shown in FIG. 15B. The wire 1568 can be pulled back to the position in FIG. 15A: Retract the wire into the lumen 1550. This will reduce the diameter of the helical winds of wire 1568. One embodiment of the deployed helical winds of helical Nitinolwire 1568 may slightly increase the inner diameter to stent100 to increase friction between stent100 and stent suspension mean 1528 to reduce unwanted movement of the stent100.

“FIG. “FIG. 4A-7. While only one tubular component 1672 has been shown, one of ordinary skill will understand that multiple tubular components can be coupled to header 1636 for accommodating a plurality stents 100. The header or carousel 1636 component is generally a flat sheet-like one. The lumen, or passageway 1674, of tubular component 1672 has a diameter slightly larger than that of stent 100. The first open end 1671 is attached to header 1636 or carousel 1636. A second open end 1673 is located adjacent to or near a wicking device 1630. Lumen 1674 is fluidly connected to a vacuum source 1670. The lumen of tubular part 1672 is in fluid communication with a vacuum source 1670. As such, the stent 100 can be adjusted to move towards or away the 1630 wicking mechanism. After stent 100 has been filled, vacuum source 1670 may be used to apply suction to pull stent 100 away form wicking mechanism 1630. A cylindrical plug 1675 can be placed within the inner diameter stent 100 in order to reduce air passage.

“FIG. “FIG. 4A-7. While only one balloon 1776 has been shown, one of ordinary skill will understand that multiple balloons can be attached to the header or carousel 1736 in order to accommodate a plurality 100. The header or carousel1736 is a flat-sheet-like component. A first end 1777 is attached to or coupled to the carousel or header 1736. Balloon 1776 can be cylindrical or tubular-shaped, and the interior 1779 is in fluid communication to an inflation source 1778. Before inflation, balloon 1776 had an outer diameter that fit within stent 100. After stent 100 has been placed as desired, balloon 1776 can be inflated via inflation source 1778. As shown in FIG. phantom, balloon 1776 expands or inflates until its outer surface is in opposition to or abuts against stent 100’s inner diameter. 17. Inflated balloon 1776 grabs onto the inner circle of stent100. One embodiment may slightly increase the inner circle of stent100 to increase friction between the stent 100 & stent suspension means 1728, to reduce unwanted movement of stent100. Examples of materials that can be used to make balloon 1776 are polyethylene terephthalate, polyethylene (PET), nylon, nylon blendeds, polyurethanes and polyesters.

“FIGS. 18A-18B show another embodiment of a suspension means 1828. It includes a header 1836 or carousel 1836. A portion of this figure is shown. Also, there’s a mandrel 1850 that holds a stent 100 in position during the capillary filling process described in FIGS. 4A-7. While only one mandrel 1850 has been shown, one of ordinary skill will understand that multiple mandrels can be coupled to a header or carousel1836 for accommodating a plurality stents 100. A header or carousel 1836, a flat sheet-like component with at least one slot 1837 allowing passage of a portion mandrel 1850 through, is generally flat. Two adjacent pins or shafts make up mandrel 1850. One is a stationary pin 1880 that connects to header 1836 or carousel1836, and the other is a movable pin 1881 that extends through slot 1837 or carousel1836 1836. To retain stent 100, the second movable pin may be moved or shifted laterally. Particularly, the second movable pin is mounted in a block 1821 over the header carousel1836. A compression spring 1819 extends between the block and header. As shown in FIG. 18, the compression spring 1819 exerts a force which tends to move second pin 1881 away form the stationary pin 1880. 18B. Operation: A force 1841 is applied externally, i.e. an operator presses on block 1821 to compress spring 1819. This causes second movable pin (1881) to shift or move within slot 1837. It then becomes relatively close to the stationary pin (1880, as shown in FIG. 18A. The stent 100 is placed on both the movable pin 1881 and stationary pin 1880, with the first pin 1880 touching the inner surface of stent 100. Once stent 100 has been placed in the desired position, force 1841 can be removed. Spring 1819 then resumes its normal configuration. Second pin 1881 is moved laterally away from stationary pint1880 as shown in FIG. 18B. 18B. The pins 1880 and 1881 touch the inner diameters of stent 100 in opposing places.”

“FIGS. 18C-18D show another embodiment of a suspension means 1828C. It includes a header 1836C or carousel 1836C. A portion of this figure is shown. Also, there’s a mandrel 1850C to hold a stent 100 in position during the capillary filling process described in FIGS. 4A-7. While only one mandrel 1850C has been shown, one of ordinary skill will understand that multiple mandrels can be attached to the header or carousel1836 for accommodating multiple stents 100. A flat sheet-like component known as a header or carousel 1836C has at least one slot 1837C that allows for passage of a portion mandrel 1850C. Mandrel 1850C consists of two adjacent pins or shafts. A first stationary pin 1880C is coupled to header 1836C, and a second movable Pin 1881C extends through slot 1837C in header 1836C. To retain stent 100, the second movable pin 1881C can be moved or shifted laterally. Particularly, the second movable pin is 1881C mounted in a block 1821C over the header carousel1836C with a compression Spring 1819C running between the block and header. The compression spring 1819C exerts a force on the second pin 1881C to move it toward the stationary pin (1880C), as illustrated in FIG. 18D. Operation: A force 1841C can be applied externally, i.e. an operator presses on block 1821C to compress spring 1819C. This will cause second movable pin (1881C) to shift or move within slot 1837C. It will then space out from stationary pin (1880C), as shown in FIG. 18C. The 100-pound stent is placed between the movable pin 1881C and the stationary pin 1880C, with the first pin 1880C touching the inner surface of stent 100. Once stent 100 has been placed in the desired position, force 1841C can be removed. Spring 1819C then resumes its normal configuration and laterally moves second pin (1881C) toward stationary pint (1880C), as shown in FIG. 18D. The movable pin 1881C is moved towards the stationary pin 1880C. This causes the stent 100’s outer diameter or surface to come into contact with the pin 1881C.

“FIGS. 19A-19D show another example of a suspension means 1928. It includes a header 1936 or carousel 1936. A portion of the figure is shown. Also, there’s a mandrel 1950 that holds a stent 100 in position during the capillary filling process described in FIGS. 4A-7. While only one mandrel 1950 has been shown, one of ordinary skill will understand that multiple mandrels can be coupled to a header or carousel 1936 in order to accommodate a plurality stents 100. A header or carousel 1936 is a flat sheet-like component that has at least one slot or passageway 1937. This allows for passage of a portion 1950 or a collet 1982. Collet 1982 has a tapered, frustoconical exterior and a lumen (or hole) 1925 that extends therethrough. It is slightly larger than the outer diameter of stent100. Multiple cuts 1923 can be made at the end of collet in the sidewall to form jaws 1982A-B and 1983C. Mandrel 1950 has an outer diameter slightly larger than that of stent 100 and extends through lumen 1995 of collet822. As shown in FIGS. 19A-19B. The collet 1982 allows adjacent jaws to spread out by cutting 1923. After stent 100 has been placed in the desired position, collet can be moved in an “upward” direction. Direction toward header or carousel 36, indicated by directional Arrow 1441. Move away from stent100 until the outer edge of the collet touches the edge of passageway 37 of header 1936. If the outer diameter for collet 1982 exceeds the diameter of passageway 37, passageway 1937 applies an inner radial force to the collet, and squeezes or moves the jaws 1982A-B, 1983C as shown in FIGS. 19C-19D. To effectively clamp or capture the stent 100 between collet 1992’s inner surface and mandrel 1950’s exterior surface, the lumen 1925 of colet 1982 is reduced.

“FIG. “FIG. 20 illustrates another embodiment a stent suspension mechanism 2028. It includes a header 2036, which is a part of the figure, and an 2050 that holds a 100-pound stent in place during the capillary filling process described in FIGS. 4A-7. 4A-7. The header or carousel is a flat-sheet-like component. A first end 2062 is attached to header 2036. Mandrel 2050 has a bumpy or wavy exterior surface that is adjacent to at most a second end 2063. Mandrel 2050’s bumpy or wavy exterior surface is created by circumferential bands or ribs 2083 with a larger outer diameter than the rest of mandrel2050. In an interference or friction fit, the bumpy or wavy exterior of mandrel 20050 meets the inner diameter of stent 100. Mandrel 2050 can be made from 3 series stainless or any other material that is resistant to oxidation and corrosion and is non-dissolvable and not affected by harsh chemicals. Another embodiment, mandrel 2050, may have an exterior that meets the inner diameter of the stent 100 in an interference- or friction fit. The tip of the slip fit mandrel can include a chamfer or taper or be substantially flat to improve the fit with the stent. Another embodiment, not shown, may use a tubular shaft/rod as a mandrel. The stent suspension means could be made up of one or more springs/coiled wires that are offset from one another and form a tubular rod. Tubular mandrels are formed by springs or coiled cables that meet against the inner diameter 100 of the stent. This creates an interference or friction fit.

“FIGS. 21-21A show another embodiment of a suspension mechanism 2128. It includes a header 2136 or carousel 2136. A portion of the figure is shown. Also, there is a mandrel 2150 that holds a stent 100 in position during the capillary filling process described in FIGS. 4A-7. FIG. FIG. 21A shows a top view. 21 with header 2136 removed. While only one mandrel 2150 has been shown, one of ordinary skill will understand that multiple mandrels can be connected to header or carousel 2136 for accommodating multiple stents 100. Header 2136 or carousel 2136 is a flat-sheet-like component. A first end 2162 of mandrel 2150 is connected to header 2136 or carousel 2236. The outer diameter of the first end portion 2162 in mandrel 2150 is smaller than that of the second end portion 2163 in mandrel 2150. In an interference or friction fit, the outer diameter of the second end portion 2163 (mandrel 2150) abuts against that of stent 100. Stent 100 can be placed over mandrel 2150 by sliding up mandrel 2150 until the end 105. The narrower second end portion 2163 is passed by stent 100 and is placed over narrower mandrel 2150. The stationary spring leaf 2184, or cantilevered spring arm 2184, is located adjacent to the first end 2162 of mandrel 2150 and contacts and abuts against the end 105. The stent 100 may feel an upward force when it is placed into the wicking components 430 and 424. This may result in the stent slipping up the mandrel 2150. Spring arm 2184 counters any upward forces caused by the interaction between the stent and the wicking components 430. It exerts a downward force on stent 100 if spring arms 2184 are deflected from their neutral position as shown in FIG. 21. Spring arm 2184 presses stent 100 into wicking components for uniform loading during filling when multiple stents exist.”

“FIGS. 22A-22C show another embodiment of a suspension means 2228. It includes a header 2236, which is a part of the figure, and a 2236 carousel 2236. A mandrel 22250 holds a stent 100 in position during the capillary filling process described in FIGS. 4A-7. FIG. FIG. 22C is a sectional image taken along line C?C of FIG. 22B. 22B. Although one mandrel is shown, one of ordinary skill will understand that multiple mandrels can be coupled to header/carousel 2236 to accommodate a plurality stents 100. Header 2236 or carousel is a flat-sheet-like component. A first end 2262 from mandrel 22250 is connected to header 2236. As shown in FIG. 22A. Once the stent 100 has been placed in its desired position, spring-loaded arm 2285 pushes it against mandrel 2325 as shown in FIGS. 22B and 22C are used to capture or sandwich stent 100 between arm 2185 and the exterior of mandrel 22255. Arm 2285 moves or rotates via a spring 2286 or pivot 2287.

“Means to Wicking Fluid Drug Formulation.”

“FIGS. FIGS. 23-33 show several examples of wicking mechanisms 430 that are in contact with fluid formulation 432 to control the transfer of fluid drug formulation 432 into lumen 3 of hollow wire 102 during capillary filling as described in FIGS. 4A-7. ?Wicking means? As used herein, a medium or component which acts or functions in moving or conveying fluid drug formulation 432 through capillary action within the second or lower chamber 424 into hollow wire 103. The wicking mechanism 430 controls the transfer of the fluid drug formula. In some embodiments, the wicking device also removes any excess fluid drug composition from hollow wire 102 of the stent 100 after the stent 100 has been removed from the wicking apparatus. The excess removal function performed by wicking mechanism 430 does not require additional processing or cleaning to remove drug residue from the exterior surfaces hollow wire 102. Wicking means 430 should have several properties or characteristics, such as that it doesn’t degrade or add contaminants to fluid drug formula 432, it is inert within fluid drug formula 432 and it does not cause phase separations within fluid drug preparation 432. It is also usable and/or steady for several days and/or weeks.

“As mentioned previously, wicking refers to 430 being an open-celled sponge made of polyurethane. To improve the sponge’s efficiency and reduce fill weight variability further, a variety of characteristics or properties can be changed. These include the chemical structure of the sponge as well as the hydrophilicity, the sponge’s density, the compression modulus, the shape or dimensions, and the sponge’s pore size. Hydrophilicity and pore sizes are directly related to fluid affinity and capillary action. Optimizing these properties will allow the sponge to clean hollow wire 102 better than stent 100. The sponge’s compression modulus allows for controlled amounts of the stent to contact the wicking mechanisms. The sponge can be placed in contact with side holes (104 of stent100) while the exterior surface of hollow wire (102 of stent100) is limited.

“An alternative to a sponge-wicking mechanism, the wicking method may be a component or surface between the stents 432 and the fluid formulation 432. It makes contact with the fluid formulation 432 during capillary filling. This allows for control of fluid drug formula 432’s transfer into lumen 103 of hollowwire 102. 4A-7. FIGS. 4A-7 show stents 100 as straight tubular structures. 23-33, although one of ordinary skill will understand that stents100 are hollow wires shaped into desired stent patterns as described in FIG. 1. FIG. 23 illustrates an example. FIG. 23 shows a section of the lower chamber or second chamber 424 that has a portion containing a stent 100, which is lowered to touch a wicking device 2330. Wicking means 2330 refers to a flexible membrane or sheet which is placed over a fluid drug formulation 432 contained within a container 2327, second chamber 424. One embodiment of wicking is a continuous filament polyester fibre sheet of material or a purity wiping. Two concentric tubes control the configuration or position of wicking mean 2330. One is an outer stationary tube 2388A, and one is an inner movable tube (2388B). The tubes 2388A and 2388B can be rectangular or cylindrical in cross-section. The wicking means 2330 drapes or extends over the top of outer stationary tubes 2388A. It is secured over outer stationary tubes 2388A by an O-ring 2329 made of an inert substance like Teflon. Another embodiment of wicking means 2330 is held in place by a clamp over outer stationary tube 238A. In operation, wicking mean 2330 is draped above outer stationary tube 2388A so that the center of the wicking mechanism contacts fluid drug formulation 432 contained within container 2327. FIG. 23A. 23A. After filling is completed, stent 100 can be raised with inner movable tub 2388B. Inner movable tube 238B is raised by an electromotive force from an EMF source. This pushes wicking mechanism 2330 upwards to a second configuration, in which deformable sheets are not in direct contact with fluid drug formulation 432 contained within container 2327. 23B. 23B. After the excess fluid drug formula 432 has been drained, the electromotive forces are removed and the inner movable tube 2388B is lowered back to FIG. 23A.”

“FIG. “FIG. 4A-7. FIG. FIG. 24 shows a section of the lower chamber or second chamber 424 that has a portion containing a stent 100, which is lowered to touch a 2430 wicking mechanism. Wicking means 2430 refers to mesh material that is placed within the second chamber 424’s layer of fluid drug formula 432. End 107 of stent100 is brought into contact with Wicking means 2430. The mesh material buckles and deforms to allow contact between stent100 and the fluid drug formulation 432. After 100 stents have been filled, 100 stents are removed from contact with the wicking mean 2430. During the retraction of the stents 100 the mesh material for wicking means 2430 returns to its original form and pulls or removes any excess fluid drug formulation from the exterior surface of the stents 100. The mesh material of wicking is 2430 includes, but is not limited to, nylon, polypropylene or rubber.

“FIG. “FIG. 4A-7. FIG. FIG. 25 shows a section of second chamber 424 that has a portion containing a stent 100, which is lowered to touch a 2530 wicking mechanism. Wicking means 2530 refers to flocked or texture material that is placed within the second chamber 424. The flocked, textured sheet may contain VELCRO or cotton and can be VELCRO or cellulose. The textured material buckles when it comes into contact with wicking medium 2530 at the end 107. This allows fluid drug formulation 432 to contact stent 100. After 100 stents have been filled, 100 stents are removed from contact with wicking 2530. During the retraction of the stents 100 the textured material 2530 of wicking means 2530 returns back to its original form and pulls or removes excess fluid medication formulation from the exterior surfaces hollow wires 102 of the stents 100.”

“FIG. “FIG. 26 is an alternative embodiment of the wicking mechanism that acts as an intermediate surface or component to fluid drug formulation 432. This allows for control of fluid drug formulation 432’s transfer into lumen 103 hollow wire 102. 4A-7. FIG. FIG. 26 shows a section of second chamber 424 that has a portion containing a stent 100, which is lowered by a wicking device 2630. Wicking means 2630 refers to a layer of PEG gel or immiscible fluid that is separated from the fluid drug formulation 432 when it is poured into second chamber 424. End 107 is passed through wicking mechanism 2630, until the stents 100 come in contact with the fluid drug formulation 432. After the stents have been filled, the stents are pulled back through wicking 2630. The cellulose, PEG gel or immiscible fluid may pull or remove excess fluid from the exterior surfaces 100 of stents 100 during retraction.

“FIGS. “FIGS. 4A-7. FIGS. FIGS. 27A-27B show a section of second chamber 424 that has a portion containing a stent 100 which is lowered to touch a wicking mechanism 2730. Wicking means 2730 refers to a number of hypotubes and cylindrical microchannels that are contained in the second chamber 424’s layer of fluid drug formula 432. The hypotubes are made of material that is subject to magnetic or electrical field changes. From the end of 2730, stent 100 is placed in the hypotubes. The layer of fluid drug formulation 432 is between 107 and 100. Each application will have a different set of hypotube sizes and heights. The filling steps of hypotubes of the wicking means 2730 are performed in the first or vertical orientation as shown in FIG. 27A allows fluid drug formulation 432 through the hypotube lumens by capillary action. Fluid drug formulation 432 passes up the hypotubes via wicking means 2730. Fluid drug formulation 432 then comes in contact with the end 107 of the stent 100. This allows the hollow wire 102 of the stent 100 to fill via capillary. To fill the hypotubes by capillary action, the fluid drug formulation must only be submerged in the liquid. After the stents 100 are filled, an electric field or magnetic field is used to move hypotubes of the wicking means 2730 into a horizontal orientation. FIG. FIG. 27B shows that fluid drug formulation 432 is not in direct contact with stent 100. Filling the stent via capillary actions is stopped. The fluid transfer properties of fluid 100 and fluid drug formula 432 can be altered by changing the orientation of hypotubes ofwicking 2730. Hypotubes can transfer fluid drug formulation 432 from stent 100 in their vertical orientation. In their horizontal orientation, capillary action stops and fluid affinity is modified to make cleaning hollow wire 102 easier.

“FIG. “FIG. 4A-7. FIG. FIG. 28 shows a section of the lower chamber or second chamber 424 that has a portion containing a stent 100, which is lowered to touch a 2830 wicking mechanism. Wicking means 2830 refers to a cellulose column that is placed within the second chamber 424 and extends beyond or past a layer fluid drug formulation 432. The end 107 of the stent100 is placed in contact with a side surface 2830 of wicking mean 2830. This acts as a conduit or bridge between stent100 and fluid drug formula 432 to transfer fluid drug formulation to catheter 100. Alternately, the end 107 of stent 100 can be placed in contact with a top surface 2830 of wicking mean. To control the surface energy properties of the filling process, the cellulose column reduces the contact area between the stents 100 & fluid drug formulation 432. For embodiments where the stent contacts the fluid formulation directly, it is important to control the fluid’s surface energy properties so that it has the highest affinity for hollow wire 102 lumen 103. This allows the fluid to be more receptive to hollow wire 102 exterior surfaces.

“Similar To FIG. 28, FIG. 28 FIG. 4A-7. FIG. FIG. 29 shows a section of the lower chamber or second chamber 424 that has a portion containing a stent 100, which is lowered to touch a 2930 wicking mechanism. Wicking means 2930 refers to a fiber/filament, or a plurality or parallel of woven fibers/filaments that are placed within or extend beyond the second chamber 424’s fluid drug formulation 432. End 107 is brought into contact with the top surface of wicking mean 2930 so that wicking mean 2930 is directly in contact with wire 102’s opening or hole. Wicking means 2930 transfers fluid formulation 432 from stent 100. It also minimizes the area between stents100 and fluid formulation 432 in order to control the surface energy properties of the filling process. Another embodiment of wicking is a plug made from cotton or a similar fibrous material.

“In FIGS. 28 and 29 show the cellulose column/fibers positioned within, and beyond, a layer 432 of fluid drug formulation 424. As shown in FIG. A wicking device 3030 can be extended from the end 107 at stent 100. It may then be dipped into or lowered into a layer 432 of fluid drug formulation. FIG. FIG. 30 shows a section of the lower chamber or second chamber 424 that has a portion containing a stent 100, which is lowered to make contact with wicking mechanism 3030. Wicking mean 3030 could be a cellulose extension or a fiber/filament that contains a plurality or parallel fibers/filaments or a plug made of cotton. Wicking means 3030 connects to end 107 on stent100. Then, stent100 is dropped within the second chamber 424 until the bottom surface of wicking mean 3030 comes into contact with fluid drug formula 432. Wicking is 3030. It transfers fluid drug formula 432 to the stent100 and reduces the contact area between the stent 100 & fluid drug formulation 432 in order to control the surface energy properties of the filling process.

“FIGS. 31A-31B show another example of the wicking mechanism. An intermediate surface or component is placed in contact with fluid formulation 432 to control the transfer of fluid drug formula 432 into lumen 332 of hollow wire 102, as described in FIGS. 4A-7. FIGS. FIGS. 31A-31B show a section of the lower or second chamber 424 that has a portion containing a stent 100, which is lowered to contact a 3130A, 3130B wicking mechanism. Wicking means 3130A refers to a flat, generally solid or impervious substrate that is in contact with an HE heating element. Wicking mean 3130B refers to a porous substrate or open-celled substrate that is in contact with an HE heating element. FIG. 31A: Fluid drug formulation 432 is applied to the impervious wicking surface 3130A. Fluid drug formulation 432 is spread over the top of wicking mean 3130A. It thereby extends to or reaches stent 100, which is also placed on the top of wicking mean 3130A. FIG. 31B: The stent 100 is brought in contact with the porous wicking mean 3130B’s top, which is in direct contact with the fluid drug formula 432 and passes the fluid drug formulation to its stent. After filling is completed, the heating element heats the wicking elements 3130A and 3130B to adjust the surface tension. The surface tension forces between fluid formulation 432 and the stent 100 is weakened when wicking mean 3130A and 3130B are heated. This prevents the fluid formulation from adhering between wicking methods 3130A and 3130B. Temperature changes of wicking mean 3130A,3130B alter surface tension/affinity properties and control transfer of fluid drug formulation 432 to lumen 103 hollow wire 102 during capillary filling.

Summary for “Apparatus for filling a drug-eluting medical device by capillary action using a catheter”

“Drug-eluting medical devices that are implantable are very useful because they can provide structural support and medical treatment to the area where they are placed. Drug-eluting devices have been used to prevent the development of restenosis in the coronary arteries. Anti-inflammatory drugs such as those that block local invasion/activation or monocyte activation may be administered by drug-eluting devices. This prevents the release of growth factors that could trigger VSMC proliferation. Antiproliferative compounds, such as chemotherapy and sirolimus, can also be anti-restenotic. Anti-restenotic uses can also be made for other drugs, such as antithrombotics and anti-oxidants, platelet-aggregation inhibitors, cytostatic agents, and anti-thrombotics.

“Drug-eluting medical device may be covered with a polymeric material that is then impregnated in a drug or combination of drugs. The drug is released from the plastic material once the device is placed at the target site. The drug is released through diffusion through a layer of polymer of a biostable or biodegradable material.

“Drug-impregnated polymer coats are limited in terms of the drug delivery. This is due to the limitations of the polymer coating’s ability to carry and the size the medical device. It is also difficult to control the rate at which polymer coatings elute drugs.

“Accordingly drug-eluting medical equipment that allow increased amounts of a drug delivery by the medical device and allow for improved control over the drug’s elution rate and better methods of making such medical devices are required. Co-pending U.S. Patent Application Publication No. 2011/0008405, filed Jul. 9, 2009, U.S. Provisional Application Number. Provisional Application No. Provisional Application No. Provisional Application No. 61/244.050, filed Sep. 20, 2009. Also co-pending U.S. Patent Application Publication Number. Each of these documents, which are incorporated herein in its entirety, describe methods for creating drug-eluting catheters with hollow wires. Hollow wire drug-eluting devices can have similar elution curves to those with the therapeutic substance placed in a polymer on their surface. Hollow wire drug-eluting devices can achieve similar elution curves to those with drug-polymer-coated stents. They are expected to be clinically effective and safer than the polymer-coated stents. A variety of elution curves are possible with drug-eluting hollow wires. Some applications, like coronary stents have a very small diameter hollow wire lumen that can be filled with drug or therapeutic substance. It is usually less than 0.0015 inches, making it difficult to fill the lumen. It is therefore necessary to develop improved methods and apparatus for filling the lumen of a hollow wire stent.

“Embodiments are directed at methods and apparatus for filling fluid drug formulations within a lumenal area of a hollowwire having a plurality side openings along its length that form a drug-eluting device with a plurality side drug delivery openings. An embodiment of this invention consists of a hollow wire with a plurality side openings that is placed in a first chamber. The apparatus also includes a valve that is positioned between the first and second chambers. This valve houses a wicking mechanism that is in direct contact with a fluid drug formulation. The valve is closed so that the first and second chambers are not in fluid communications. The valve should be opened so that the first and second chambers are in fluid communication. The solvent vapor saturation of the first and second chambers is reached or close to solvent vapor saturation. The wicking mechanism within the second chamber is placed in contact with a portion of the stent so that at least one side opening is in contact the wicking. The selected portion of stent remains in contact with wicking elements until the lumenal space created by hollow wire is filled via capillary action through at least one side opening that is in contact with wicking. The stent can be retracted so that it is not in direct contact with the wicking mechanism and remains within the first chamber. The valve is closed so that the first and second chambers are not in fluid communication. Additionally, the solvent vapor pressure in this chamber is decreased to evaporate any solvent in the fluid drug formulation.

“In another embodiment, a stent made from hollow wire with a plurality side openings is placed inside a chamber that houses the fluid drug formulation. The fluid drug formulation is in the chamber at the vapor-liquid equilibrium. One portion of the stent is placed in contact with the fluid formulation so that at least one side opening is in contact. The fluid drug formula and the selected section of the stent are kept in contact until the lumenal space created by the hollow wire has been filled with the fluid formulation through capillary action via at least one side opening that is in direct contact with the fluid. The fluid drug formulation may be transferred into the stent by means of a wicking device.

“BRIEF DESCRIPTION DES DRAWINGS”

The following description of embodiments of the invention, as illustrated in the accompanying illustrations, will reveal the above and other advantages and features of the invention. These accompanying drawings are included in the specification and constitute a part thereof. They further explain the principles of invention and allow a skilled person to make and use this invention. These drawings are not scaled.

“FIG. “FIG.

“FIG. 2A is a cross sectional view taken along the line 2A-2A in FIG. 1.”

“FIG. 2B is a sectional look taken along line 2B-2B at the end of the hollow wire in FIG. 1.”

“FIG. 2C is an end-view taken along line 2C-2C in FIG. 1”

“FIG. “FIG. 1. A fluid drug formulation by capillary action.

“FIGS. “FIGS. 3. The flow chart of FIG. 3 is performed in an apparatus with upper and lower chambers. In these chambers, the stents are brought into contact via a wicking device with the fluid drug formulation.

“FIGS. 8A-8B show an example of a stent suspension device that holds the plurality of Stents in place during the capillary-filling procedure. 4A-7.”

“FIGS. 9A-9B show another example of a stent suspension mechanism, which holds or secures the plurality stents during the capillary filling process described in FIGS. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIGS. 12A-12B show another example of a stent suspension mechanism that holds or secures the plurality stents during the capillary filling process described in FIGS. 4A-7.”

“FIGS. 13A-13B show another embodiment of a suspension device that holds the plurality of Stents in place during the capillary-filling procedure. 4A-7.”

“FIGS. 13C-13D show another embodiment of a suspension device that holds the plurality of Stents in place during the capillary-filling procedure. 4A-7.”

“FIGS. 14A-14B show another embodiment of a suspension device that holds the plurality of Stents in place during the capillary filling process described in FIGS. 4A-7.”

“FIGS. FIGS. 15A-15B show another example of a stent suspension mechanism that holds or secures the plurality stents during the capillary filling process described in FIGS. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIGS. 18A-18B show another example of a stent suspension mechanism, which holds or secures the plurality stents during the capillary filling process described in FIGS. 4A-7.”

“FIGS. FIGS. 18C-18D show another example of a stent suspension mechanism that holds or secures the plurality stents during the capillary filling process described in FIGS. 4A-7.”

“FIGS. 19A-19D show another example of a stent suspension mechanism, which holds or secures the plurality stents during the capillary filling process described in FIGS. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIGS. 21-21A is another example of a stent suspension mechanism that holds or secures the plurality stents during the capillary filling process described in FIGS. 4A-7.”

“FIGS. 22A-22C show another embodiment of a suspension device that holds the plurality of Stents in place during the capillary-filling procedure. 4A-7.”

“FIGS. FIGS. 23A-B show an example of a wicking mechanism that controls the transfer of a fluid formulation to a catheter during the capillary filling process described in FIGS. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIGS. FIGS. 27A-27B show another example of a wicking mechanism that controls the transfer of a fluid formulation to a catheter during the capillary filling process described in FIGS. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIGS. 31A-31B show another embodiment of a means for controlling the transfer of fluid drug formulations to stents during capillary filling procedures described in FIGS. 4A-7.”

“FIGS. 32A-32B are another example of a wicking mechanism that controls the transfer of a fluid formulation to a catheter during the capillary filling process described in FIGS. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIG. “FIG. 4A-7.”

“FIGS. 36A-36C are another example of a wicking mechanism that minimizes the contact surface between each stent & the fluid drug formula in order to control the transfer of a fluid medication to a catheter during the capillary filling process described in FIGS. 4A-7.”

“FIGS. 37A-37C are another example of a wicking mechanism that minimizes the contact surface between each stent & the fluid drug formula in order to control the transfer of a fluid medication to a catheter during the capillary filling process described in FIGS. 4A-7.”

“FIGS. 38A to 38B show another embodiment of a Wicking Mean, which reduces the contact area between the stents and the fluid formulation. This is done to prevent fluid formulations from being transferred to the stents during the capillary filling process described in FIGS. 4A-7.”

“FIG. 39 is a schematic illustration showing an apparatus with upper and lower chambers that can be used to perform the flow chart in FIG. 3. The stents are directly in contact with the fluid drug formulation, without the aid of a wicking device.

“Specific embodiments are described in the following with reference to the figures. Like reference numbers indicate identical elements or functionally related elements. The terms “distal” and “proximal” are interchangeable. The terms?distal? und?proximal? are used in the following description to refer to a position or direction relative to the treating clinician. These terms refer to a direction or position relative to the treating physician. ?Distal? Alternatively,?distally? are in a distant position from or in a direction from the clinician. ?Proximal? ?Proximal? are in close proximity to or in the direction of the clinician. Self-expanding is also a term. The term “self-expanding” is also used in this description. It means that structures can be shaped or formed using a material that can have a mechanical memory to allow it to change from a compressed delivery configuration to an expanded deployment configuration. A few examples of self-expanding materials that are not limited to stainless steel include a pseudo-elastic material such as a nickel-titanium alloy or nitinol or various polymers or a so called super alloy. This may have a base metal made up of nickel, cobalt or chromium. Thermal treatment can impart mechanical memory to wires or stent structures to create spring tempers in stainless steel or set shape memories in susceptible metal alloys, such as nitinol. Many polymers can be made with shape memory properties and may be used in the embodiments. These polymers include polynorborene (trans-polyisoprene), polynorborene (oligo caprylactone copolymer), polyurethane (polyurethane) and styrenebutadiene (styrene-butadiene). Poly L-D Lactic copolymer (oligo caprylactone polyolymer) and poly cyclooctine may be used in combination with other shape-memory polymers.

The following description is only an example and does not limit the invention. The drug eluting devices described herein can be used in the treatment of blood vessels, such as the renal, carotid, and coronary arteries. They may also be used to treat any other body passageways that are deemed necessary. Particularly, drug-eluting stents containing a therapeutic substance are designed to be deployed at different treatment sites in the patient. These include vascular (e.g. coronary vascular and peripheral vascular) stents as well as urinary stents. There is no intent to be bound by any implied or explicit theory in the technical background, summary, or detailed description.

“Hollow Wire Drug Eliminating Stent”

FIGS. 1-2C. Stent 100 is made from a hollow wire or strut 102. Also known as a stent, or hollow core stent, it can be described as follows: Hollow wire 102 is defined as a lumen or luminanal space 103. It can be formed either before or after it has been shaped into the desired stent pattern. A hollow wire stent is, in other words, one made from hollow wire. A straight hollow wire that is shaped into a desired shape or a stent made from any suitable manufacturing process that results in a tubular part formed into a desired pattern. The tubular component must have a lumen (or lumenal space) that extends continuously through it. As illustrated in FIG. FIG. 2C) that runs from the first tip or end 105 to the second tip or end 107 of the stent 100. As shown in FIG. 1. The methods of filling a drug in a stent according to embodiments hereof aren’t limited to stents with the pattern shown in FIG. 1. The methods described herein allow for the loading of drugs into stents made from any suitable pattern. U.S. Pat. stents are also available in patterns. No. No. No. No. No. No. No. No. No. No.

“As illustrated in FIG. 2A: Hollow wire 102 allows for a therapeutic drug or substance 112 to be placed within the lumen or lumenal spaces 103 of hollowwire 102. FIG. 103 shows lumen 103 as being filled uniformly with therapeutic substance or drug 112. 2A shows that lumen 103 is filled with therapeutic substance or drug 112 in FIG. Lumen 103 can extend continuously from a first end (114) to a second ending (114). Hollow wire 102. While hollow wire 102 appears to have a circular cross section, hollow wire102 could be rectangular or elliptical in cross-section. Hollow wire 102 can have a wall thickness of 0.0004 inch to 0.005 inches with an inner or lumen size ID ranging between 0.0005 and 0.02 inch. Hollow wire 102 used to form stent 100 can be made of a metallic material to provide artificial radial support for the wall tissue. This includes stainless steel, nickel?titanium (nitinol), and nickel-cobalt alloy such as MP35N. It may also include cobalt-chromium or tantalum, titanium. Hypotubes, which are hollow metal tubes with a smaller diameter than the ones used for making hypodermic needles, can be used to make hollow wire 102. Hollow wire 102 can also be made from non-metallic materials, such as polymeric material. The polymeric material could be biodegradable and bioresorbable so that stent 100 is absorbed by the body, after it has been used to restore patency to lumens and/or deliver drugs.

“Hollow wire102 also includes drug-delivery side ports or ports 104 that are distributed along its length to allow therapeutic substance or drug 112 release from lumen103. Side openings104 can be placed only on the generally straight segments (106, 108, and 108) of stent 100 or both segments 106, 106, and crowns108 of stent100. Side openings 104 can be sized or shaped to reduce the elution of drug 112 from catheter 100. Side openings 104 can be slits, or holes with any cross-section, including, but not limited, circular, oval and rectangular. Side openings 104 of a larger size allow for a faster rate of elution. Smaller side openings, 104 on the other hand, are more efficient. You can also vary the size or quantity of side openings (104) along stent100 to adjust the amount and/or speed of drug 112 being eluted at different parts of stent100. Side openings 104 can be from 5-30 mm in width or length, but this is not a limitation. Side openings 104 can be placed only on the outwardly facing surface 116 of the stent 100. FIG. 2. Only on the inwardly facing surface 118 of the stent 100.

“In different embodiments, a variety of therapeutic agents or drugs can be used as the elutabletherapeutic substance or drug 112 in lumen103 of hollow wire102. The pharmaceutically effective amount will depend, ultimately, on the condition being treated, the nature and composition of the therapeutic agent, the tissue in which it is introduced, etc. One of ordinary skill can see that hollow wire 102 may contain one or more therapeutic drugs. The therapeutic substance or drug 112 that is delivered to the site of stenotic lesions can be any type of drug that dissolves the plaque material, anti-thrombotic, anti-proliferative, or anti-platelet drug. TPA, heparin and urokinase are some examples of such drugs. The stent 100 can be used to deliver any medication to the interior and walls of a vessel, including anti-thrombotic, antiproliferative, anti?inflammatory, anti?migratory, anti?migratory, anti?migratory, anti?thrombotic, anti?proliferative, anti?migratory, agents affecting extracellular mat production and organization, antineoplastic, anti?mitotic agents and anesthetics agents, antineoplastic, anti?mitotic, vascular growth inhibitors, vasodilating, cholesterol-lowering, vasodilating, and other endogenous vasoactive vasoactive vasoactive vasoactive vasoactive vasoactive vasoactive vasoactive vale

“Stent 100, in accordance with the embodiments hereof is filled with therapeutic substance 112 before it is inserted into the body. To load into hollow wire 102 lumen 103, therapeutic substance or drug 112 can be mixed with a solvent/dispersant. The therapeutic substance or drug 112 may also be mixed with an excipient that aids with elution to load into lumen 103 of hollowwire 102. Fluid drug formulation is the term used hereinafter. may be used to refer generally to therapeutic substance or drug 112, a solvent or dispersion medium, and any excipients/additives/modifiers added thereto. One embodiment of therapeutic substance or drug 112 is mixed in a solvent or solvent combination before being loaded into hollow wire 101. A solution is a mixture that contains therapeutic substance or drug 112 in a solvent. A high-capacity solvent is an organic solvent with a high ability to dissolve therapeutic substance 112. A high capacity is defined herein as the ability to dissolve therapeutic substance 112 at concentrations greater that 500 mg per milliliter. High-capacity drug dissolving solvents are available for sirolimus (THF), dichloromethane, di-chloromethane and chloroform. To aid in drug elution, the solution may also contain an excipient. In one embodiment, an excipient may be a surfactant such as but not limited to sorbitan fatty acid esters such as sorbitan monooleate and sorbitan monolaurate, polysorbates such as polysorbate 20, polysorbate 60, and polysorbate 80, cyclodextrins such as 2-hydroxypropyl-beta-cyclodextrin and 2,6-di-O-methyl-beta-cyclodextrin, sodium dodecyl sulfate, octyl glucoside, and low molecular weight poly(ethylene glycol)s. In another embodiment, an excipient may be a hydrophilic agent such as but not limited to salts such as sodium chloride and other materials such as urea, citric acid, and ascorbic acid. Another embodiment may include a stabilizer, such as butylated hydrotoluene. A low-capacity solvent may also be used depending on the drug load. It is known for its lower solubility of drug 112. A low capacity solvent is one that can dissolve therapeutic substance or drug 112. Its concentrations are typically below 500 mg per milliliter solvent. Examples of low capacity drug dissolving solvents for sirolimus and similar substances include but are not limited to methanol, ethanol, propanol, acetonitrile, ethyl lactate, acetone, and solvent mixtures like tetrahydrofuran/water (9:1 weight ratio). Once a solution has been loaded into stent 100 the therapeutic substance, drug, or other substance, can be precipitated from the solution. The majority of the solvent and any nonsolvent may be removed from hollow wire 102 so that only the therapeutic substance, drug 112, or therapeutic substance, 112 and any excipients are left to enter the body.

“In another embodiment, the therapeutic substance or drug 112 can be mixed with a dispersion media as a suspension before being loaded into hollow wire 102. A slurry/suspension formulation does not dissolve therapeutic substance or drug 112, but instead disperses as solid particulate in dispersion medium. This refers to a continuous liquid medium within which the solid particles are distributed. Dispersion mediums that are unable to dissolve therapeutic substances or drugs 112 will vary depending on their properties. Water, hexane and other simple alkanes are suitable dispersions mediums that cannot dissolve sirolimus. To aid in suspension or stabilization, certain excipients, suspension agents, surfactants and/or other additives/modifiers may be added to the drug suspension to increase the surface lubricity and/or disperse drug particles. Surfactants are used to prevent therapeutic substance 112 from floating or sinking to bottom of dispersion medium. Examples of surfactants include but are not limited to sorbitan fatty acid esters such as sorbitan monooleate and sorbitan monolaurate, polysorbates such as polysorbate 20, polysorbate 60, and polysorbate 80, and cyclodextrins such as 2-hydroxypropyl-beta-cyclodextrin and 2,6-di-O-methyl-beta-cyclodextrin. One embodiment of the invention involves the target amount of therapeutic substance/drug 112 suspended in the dispersion media and the appropriate additive/modifier being added on a 0.001-10 wt% basis to the total formulation. In addition, an excipient such as urea or 2,6-di-O-methyl-beta-cylcodextrin may be added to the slurry/suspension in order to assist in drug elution.”

“Open ends 114, 114? The wire 102 can be sealed or closed before or after the drug has been loaded within lumen103, as shown in FIG. 2B is shown along line 2B-2B in FIG. 1. Once placed in the body at the desired place, stent 100 can be deployed for permanent or temporal implantation in the lumen. This allows therapeutic substance 112 to escape from lumen103 via side openings 104.

“Filling Process Via Capillary Action

“Embodiments hereof refer to the use capillary action for filling lumen 103 hollow wire 102. Capillary action is the ability for liquids to flow in narrow spaces, without the aid of external forces such as gravity. The only requirement for stent 100 to have at least one side hole is to submerge or expose it to a fluid formulation or to a submerged or exposed means to wick fluid drug formulation. The fluid drug formulation will then travel through lumen103 of hollow wire102 via the exposed/submerged holes 104 to fill or load the entire length lumen103 by capillary action. Inter-molecular attraction forces between the fluid drug formula and hollow wire 101 cause capillary action. If lumen 103 is small enough, the combination of surface tension 102 and adhesive forces between the fluid and hollow wires 102 lift the liquid drug formulation to fill the hollow wire. Capillary action fills stents 100. This allows for a faster filling process. It can be used to batch fill multiple stents within a short time. Filling stents 100 by capillary action decreases variability in drug loads and makes drug filling easier and more predictable. Fluid drug formulation is uniformly filled or deposited within lumen103 hollow wire 101. After solvent/dispersion media extraction, lumen103 hollow wire 102 has uniform drug content.

“More particularly, FIG. 3. This is a flowchart of a procedure for filling lumen 100 with a fluid formulation 432 by capillary action. FIG. FIGS. 4A-7 are schematic illustrations of an apparatus, 420 that can be used to perform the steps of FIG. 3. FIGS. FIGS. 4A-7 show an embodiment where a wicking device controls the fluid drug formulation’s transfer into lumen103. FIG. 39 is an embodiment where the stents directly touch fluid drug formulation to fill lumen103. FIGS. 100 show stents 100 as straight tubular structures. This is for illustration purposes only. 4A-7, although one of ordinary skill will understand that stents100 are hollow wires shaped into desired stent patterns as described in FIG. 1. Apparatus 422, which includes an upper chamber 422 that houses a manifold, or stent suspension mechanism 428 and an open container 431 that contains a liquid or solvent 433, and a second chamber 424 that houses a wicking mean 430 that comes in contact with fluid formulation 432. This fluid includes therapeutic substance or drugs 112, and a valve 426 that is located between the upper chamber 422 & lower chamber 424. Fluid drug formulation 432 contains the same solvent contained in reservoir 431. Valve 426 can alternate between an open configuration where the first and second chambers are in fluid contact and a closed configuration where the first and second chambers are not in fluid connection. A plurality 100 stents are loaded onto the stent suspension mechanism 428. This holds or suspends them in position during the capillary filling process, as shown in FIG. 301A. 3. Stent suspension means 428 can suspend stents 100 vertically as shown in FIG. 4A or 100 may be suspended in a horizontal orientation, as shown in FIG. 4B. The stent suspension means 428 can be used to move the plurality 100 stents between the upper and lower chambers 422, 442. Capillary filling procedures according to embodiment may be easily scaled as batch processes. The stents 100 can be loaded onto the stent suspension means 428. This is hollow wire 102 that has been previously shaped into desired waveforms and formed into cylindrical Stent 100, as shown in FIG. 1. Alternately, capillary filling may be done on straight hollow wires before shaping or forming hollowwire 102 into desired shape and subsequent stent configuration. In one embodiment, stent suspension 428 holds the stents 100 in position by slightly increasing the inner diameter of stents. This increases friction between the suspension 428 and the stents. It also minimizes unwanted movement.

Refer to FIG. 4A and/or FIG. 4A and/or FIG. The interior of upper chamber 422 is connected to a pressure source 434 or heat source 435. Another embodiment, not shown, connects a pressure source 434 or heat source 435 to the interior lower chamber 424. This depends on the volume and mass differences between these chambers. To remove any solvent vapor remaining in the upper chamber, pressure source 434 must be used before placing stents 100 in upper chamber 422. The stent suspension means 428 holding the stents 100 is completed. Next, the pressure source 434 is turned off to allow solvent vapor into upper chamber 422. 3. Once evaporation is stopped or sufficiently slowed down, valve 426 can be opened so that the upper and lower chambers 422, 442, are exposed and in fluid communication. 3. As shown in FIG. 5. To reach solvent saturation or near solvent saturation, both the upper and lower chambers 422, 442, are required. 3. To put it another way, the solvent 433 fluid drug formulation 432 requires both the upper and lower chambers 422, 432, to reach the solvent-liquid equilibrium. Vapor-liquid equilibrium refers to the state or condition in which liquid and vapor are in equilibrium. If liquid and vapor can be kept in close contact for sufficient time, such an equilibrium can be achieved in a closed area. The term “near the liquid-vapor equilibrium” is used herein. or ?near solvent vapor saturation? Includes pressure rates from?5 torr/min up to?5 torr/min. This range of pressure rates is considered to be very slow and almost negligible. The filling process can be done within this range without precipitation of therapeutic substance 112 within hollow wire 102 lumen 103. The preferred embodiment of this invention is that the filling process takes place when the pressure rate is between?2 andrr/min and 2 torr/min. The step of allowing the evaporation to stop in the upper chamber 422 or sufficiently slow before opening valve 426 reduces the rate at which the fluid drug formulation 432 evaporates within the lower chamber 424. This ensures that the formulation concentration doesn’t change.

There are many ways to decrease the time it takes to reach solvent saturation in chambers 422, 424. This will allow for faster processing and increase throughput. One embodiment creates a large area to decrease the time it takes to achieve vapor saturation. An embodiment may allow for large surface areas to be created by using ultrasonic spraynozzles to atomize droplets in the upper or lower chamber 422, 424. Another way to create a large area is to provide wicking means (430) with a large area, as illustrated in FIGS. 4A-7 to increase the surface area for the solvent to evaporate. You can also reduce the time it takes to reach vapor saturation by raising the temperature of solvent/dispersion medium. Heat source 435, which may alternatively be found within the second lower chamber 424, may be used to regulate fluid drug formulation 432’s temperature. Solvent vapor pressure is often highly dependent on temperature. Convection of gas across the solvent surface may reduce the time it takes to reach vapor saturation. A fan 499 could be used in the upper chamber 422 for convection across reservoir 431, which contains solvent 433. The solvent 433 reservoir 431 supplies the solvent vapor necessary to reach solvent saturation. These methods can be used in combination or individually to reduce the time it takes to reach solvent saturation in chambers 422, 424.

“Once both chambers 422 and 424 have reached or are close to solvent vapor saturation, capillary Filling can be initiated by moving the stents 100 into contact or submerging into wicking devices 430 as shown at step 301E in FIG. 3. 6. Wicking means 430 comes in contact with fluid formulation 432 to control the transfer of the fluid medication into lumens 103 and 102 of stent 100. One embodiment of wicking is 430, which is an open-celled sponge or foam made from polyurethane. However, there are many other wicking methods. Stents 100 can be pushed onto or into wicking elements 430, deforming wicking elements 430. As the wicking mechanism deforms, wicking mean 430 transfers fluid drug formula 432 from the lower chamber 424 to submerged holes 104 of stent100. Lumen 103 hollow wire 102 is filled with surface tension driving fluid formulation 432 through stent lumen. Until the length of lumen103 is filled via capillary force forces as shown in FIG. 3. The vapor-liquid equilibrium of the solvent 433 is maintained in the chambers 422, 424 during the filling step. This ensures that the therapeutic substance or drug 112 does not evaporate.

“FIGS. “FIGS. Only a small portion of each stent with at least one port or side hole 104 can be submerged into wicking materials 430. So, only a small amount of the wires 102 and 100’s exterior surfaces are exposed to fluid drug formulation. Most of the exterior surface of hollow wires of stents is not exposed to fluid drug formulation. FIG. FIG. 6A corresponds with FIG. 4A shows FIG. Only a tip 107 is submerged into wicking materials 430 when a stent 100 has been held vertically. This means that only one side hole (104) is in contact with the wicking material 430 and is exposed to fluid drug formulation 432. In one embodiment, about 0.3mm of each stent’s length is exposed to the wicking mechanism. FIG. FIG. 6B corresponds with FIG. 4B is the FIG. Horizontally, a longitudinal segment or strip 611 is placed along the outer surface of each stent 100. It is then submerged into wicking materials 430 so that at least one side hole (104) is in contact to wicking substances 430. Fluid drug formulation 432 is then exposed. No matter how the stents 100 may be oriented, fluid drug formula 432 can pass through hole(s), 104 on hollow wire (102), that is in contact with wicking mean 430. FIG. 6C shows only a small portion of hollow wire102 with a side hole104 that is submerged into wicking medium 430. Fluid drug formulation 432 creates a concave meniscus in lumen 103 hollow wire 102. Fluid drug formulation 432 is pulled by adhesive forces until enough fluid drug formula 432 is present for gravitational forces and to overcome intermolecular forces between hollow wire 102 and fluid drug preparation 432 or the advancing liquid column completely fills in the lumen. “The height h for a column fluid drug formulation 432 is determined using”

“h = 2 ? ?cos? ? ? ? g ? r

“where ? What is the liquid-air tension (force/unit)? The contact angle is? The density of fluid drug formula 432 (mass/volume), the local gravitational force strength (force/unit weight) and the radius hollow wire 102 (length) are the values. Fluid drug formulation 432 is not able to leak or exit from non-submersed holes and ports 104 along the length of the catheter. This is due to the intermolecular forces and nature of capillary filling.

Refer to FIG. 7. Stents 100 are pulled out or retracted so that they are not in direct contact with wicking devices 430. As stents are pulled out of wicking methods 430, wicking method 430 removes excess fluid medication 432 from wires 102 and 100 so that stents100 are completely free of drug residue. Stents 100 have fluid drug formulation 432 within the lumen 103 hollow wire 102. The capillary action filling process ends with the extraction of the solvent or dispersion media of fluid drug formula 432 from the lumenal spaces. This results in stents 100 being filled with the drug and a stent 100 containing the primarily therapeutic substance or drugs 112 and one or several excipients to be eluted into stent 100. Particularly, the stents 100 are pulled into the upper chamber 422, which remains at or close to the vapor-liquid equilibrium for solvent 433, as shown by FIG. 301G. 3. The valve 426 is closed so that the chambers 422 and 424 no longer communicate fluidly, as shown in FIG. 301H. 3. 7. To prevent fluid drug formula 432 from vaporizing, valve 426 is shut off. Additional stents can be filled with the same fluid formulation without any concentration changes. The solvent vapor pressure in the upper chamber 422 can then be reduced to ambient pressure by venting it, as shown in FIG. 301I. 3. The solvent vapor pressure in the upper chamber is decreased and hollow wire 102’s lumen 103 is opened. This causes the solvent of drug formulation 432 to evaporate, precipitating its constituents. Once the solvent or dispersion media has been removed from lumen103, the therapeutic substance or drug 112 will fill at least a portion lumen103. Apparatus 420 may be used to remove stens 100.

“Means to Hold Stents”

“FIGS. 8A-22B show several embodiments of the stent suspension mechanism 428 that holds or secures the plurality stents during the capillary filling process as described in FIGS. 4A-7. The stented suspension means 428 has several functions. It holds one or more stents so that only a small portion of the stents 100 is exposed to fluid drug formulation 432. Additionally, stent suspension mean 428 can be configured to simultaneously hold multiple stents 100 so that the batch size for a capillary filling process is easily scalable. The stent suspension mechanism holds 100 stents in place. It does this by expanding the inner diameter and elastically deforming the stents. This increases friction and minimizes unwanted movement. Stents 100 can be placed on stent suspension mechanism 428. Alternatively, stents 100 can be secured in an array (not illustrated) with a number of wells that are sized to hold them. The array can be placed in the first or upper chamber 422 in apparatus 420. It is designed to hold stents100 stationary, while stent suspension mean 428 are used to hold stents100 in place during filling. FIGS. 100 shows stents 100 as straight tubular structures. This is only for illustration. 8A-22B, but it is clear to anyone with ordinary skill in art that stents100 are hollow wires that have been shaped into desired stent patterns as described previously in FIG. 1. The stent suspension devices described in FIGS. 8A-22B show stent 100 held in a vertical orientation, but can be modified to hold it in a horizontal orientation. Refer to FIG. 4B.”

“FIGS. 8A and 8B show a stent suspension mechanism 828. It includes a header 836 that is shown in the figure and a carousel 836. A mandrel wire 85 for holding a 100-pound stent in place during the capillary filling process described in FIGS. 4A-7. 4A-7. The header or carousel 836, a flat sheet-like part, has at least one hole 837 or passageway 837 through it to allow passage of mandrel 85. Mandrel wire 85 is an elongated part with a first end of 840 that is fixed above header 836 and a 2nd end 842 that can be moved relative to the header 836. Mandrelwire 850 runs through a tubular component, or shaft 815 that is attached or coupled to header 836 so that a lumen is aligned and a passageway 837. Mandrelwire 850 runs through the lumen 815. It has both its first and second ends 842, which extend out from a top or one end. To allow a loop 838 of mandrelwire 850 to extend from a second or lower end of shaft 815, the second end 842 may be advanced. Based on the position of loop 838 relative to shaft 815, it becomes larger or smaller. As shown in FIG. 8, stent 100 is placed over shaft 815. Mandrel wire 85 is contained within the shaft. 8A. After stent 100 has been in place, the second end 842 should be moved towards header or carousel 836, in a?downward’ direction. Direction, indicated by directional Arrow 839, towards Stent 100 to expose loop 828 from shaft 815. To increase or decrease the diameter of Loop 838 so that it abuts or is opposed to the inner diameter of Stent 100 as shown in FIG. 8B. 8B. Loop 838 is made from elastic materials, such as Nitinol and spring steel.

“FIGS. 9A-9B show another embodiment of a suspension mechanism 928. It includes a header 936 and a carousel 936. A loop 938 is used to hold a stent 100 in position during the capillary filling process described in FIGS. 4A-7. 4A-7. The header or carousel is a flat sheet-like component with a loop or U-shaped component 938 attached to it. It has a first and second ends 940 of loop 938 that are both attached or bonded together to the header or carousel. A push-pull rod/wire 944 has a first and middle end that are connected to loop 938. The second end 948 extends through the passageway or hole 937 created through header/carousel 936. To adjust the diameter or size of loop 938, second end 948 may be pulled or pushed relative to header 936 or carousel 936. As shown in FIG. 9, the second end 948 (or push-pull wire 944) is used to create a small loop 938 with a diameter that is within the confines of stent 100. 9A. After being in place, the second end 948 (push-pull wire 944) is moved in an “upward?” direction. Direction relative to the header or carousel 936 is indicated by directional Arrow 941. It is away from stent100 that loop 938 bows outwards. The diameter of loop 938 increases or decreases when push-pull wire 944 is moved, as shown in FIG. 9B. FIG. 9B shows the larger and expanded loop 938. 9B grabs onto the inner circle of stent100 and, in one embodiment, may slightly increase the inner circle of stent100 to increase friction between the stent100 and the stent suspension means 928. This will minimize unwanted movement of the stent100. Loop 938 is made from elastic materials, such as Nitinol and spring steel. FIGS. FIGS. 9A-9B show a single loop for grasping onto the inner diameters of stents 100 and 100, but one or more loops can be attached to the loops and placed equally around the inner diameters of stents 100 to grab stents 100 in a circumferential fashion.”

“FIG. “FIG. 4A-7. 4A-7. The header or carousel 1036, which is generally a flat sheet-like component is attached or coupled to the carousel or header 1036 at the first end 1051. Mandrel 10050 is a tubular solid component with an outer diameter that is smaller than that of stent100. Therefore, mandrel 10050 fits within stent100 so that a second end 1053 from mandrel 10050 extends inside stent100. Mandrel 1050 has a slot or passageway 1052 through which a removable dowel rod 1054 is able to extend through passageway 1052 as well. Dowel rod 1054 is longer than mandrel 1005. This means that dowel rod 1054’s ends extend beyond the outer diameter 1050. Dowel rod 1054’s diameter is small enough to pass through the openings in stent 100, which are formed between the series generally sinusoidal waves. Stent 100 hangs from dowel rod 1004, which is held in place due to interference between dowel rod 1054 and hollow wire 102. Slip fit or spring-release mechanisms (not shown), may be used to connect dowel rod 1054 and the mandrel 1050. This allows dowel rod 1054 out of the mandrel through the openings in the stent. Mandrel 1050 and dowel rod 1054 can be made of any material that is compatible with organic solvents, including aluminum, stainless steel, and select polymers like delrin or polystyrene. Another embodiment, not shown, may use tabs or similar structures to attach to mandrel1050. These tabs will extend perpendicularly to the longitudinal axis 100 and pass through the openings in the stent.

“FIG. “FIG. 11. illustrates another embodiment for a stent suspension mechanism 1128. It includes a header 1136 or carousel 1136. A portion of this figure is shown. Also, there’s a mandrel 1150 that holds a stent 100 in position during the capillary filling process described in FIGS. 4A-7. 4A-7. The header or carousel 136 is a flat-sheet-like component. A first end 1151 is attached to the header or carousel 136. Mandrel 1150, a tubular solid component, has male threads 1155 forming on its exterior surface. The male threads have an outer diameter that is roughly equal or slightly larger than the inner diameter stent 100. The male threads 1155 grip the inner diameter 100 of stent 100 like a wood ordrywall screw. The male threads 1155 can be made from steel and may be integrated on the mandrel 1150, or may be an individual component that is coupled to it.

“FIGS. 12A-12B show another embodiment of a suspension mechanism 1228. It includes a header 1236 or carousel 1236. A portion of the figure is shown. Also, there is a mandrel 1250 that holds a stent 100 in position during the capillary filling process described in FIGS. 4A-7. 4A-7. A header or carousel 1236, a flat sheet-like component with at least one hole 1237 drilled through it to allow passage of a portion mandrel 1250, is called a header or carousel. Mandrel 1250 consists of two concentric tubes, or shafts: an outer tube 1256 with a lumen 1257 and an inner tube 1258 that can be slidably mounted inside a lumen 1256. The outer tube 1256’s first end 1262 is connected to the header or carousel 1206, and inner tube (1258) is longer than outer tube (1256). This means that an inner tube 1265 extends beyond outer tube 1256’s first end 1262 and passes through passageway 1237. A second end 1264 from inner tube 1258 extends beyond outer tube 1256’s second end 1263. A cylindrical braided wire tubular component 1260 has a first and second ends 1259, 1263 of outer tube 1256, and 1261 to inner tube 1258. Inner tube 1258 can be pulled or pushed relative to outer tube 1256 in order to adjust the size of braided components 1260. Operation: The second end 1265 is used to extend or lengthen braided components 1260. This allows the inner diameter of the stent 100 to be within the braided component’s 1260 diameter. FIG. 12A. 12A. Direction toward the header or carousel 1236 is indicated by directional Arrow 1241. This will cause braided component 1260 radially to expand. The inner tube 1258 is moved relative to the outer tube 1256, causing braided components 1260’s diameter to expand or contract until braided part 1260 is opposed to or in conflict with stent 100. FIG. 12B. The braided, larger component 1260 grabs onto the inner circumference of stent100. In one embodiment, it may slightly expand the inner circumference of stent100 to increase friction between the stent100 and the stent suspension means 1228. This will minimize unwanted movement of the stent100. Inner tube 1258 is moved in a?downward? direction relative to outer tube 1256 to release stent 100. To release stent 100 in a?downward? direction, inner tube 1258 is moved relative to outer tube 1256 in an?downward? direction. This will allow braided component 1260 to be extended longitudinally back to the position illustrated in FIG. 12A. 12A.

“FIGS. 13A-13B show another embodiment of a suspension mechanism 1328. It includes a header 1336 or carousel 1336. A portion of this figure is shown. There’s also a mandrel 1350 that holds a stent 100 in position during the capillary filling process described in FIGS. 4A-7. While only one mandrel 1350 has been shown, one of ordinary skill will understand that multiple mandrels can be attached to the header or carousel 1336 in order to accommodate a plurality stents 100. A header or carousel 1336, a flat sheet-like component, has at least one hole 1337 drilled through it to allow passage of a portion mandrel 1350. Mandrel 130 includes two concentric tubes, or shafts, that pass through passageway 1337 in header or carousel 13.36. An outer tube 1356, and an inner tube 1358 are mounted slidingly to extend through the lumen 1357 created by outer tube 1356. Inner tube 1358 has a length that is greater than outer tube 13.56. A first end 1365 extends beyond outer tube 1362 and a second ending 1364 extends beyond outer tube 1305. The outer tube 1356 could be a Nitinol tube. The second end 1363 (outer tube 1356) includes a plurality fingers, which is similar to a collet. The inner tube 1358’s second end 1364 is flared or bulbous, which means that its outer diameter is larger than the rest. Inner tube 1356’s inner tube 1358 has an outer diameter that is larger than its inner diameter. Inner tube 1358 can be pulled or pushed relative to outer tube 135 to allow the fingers at second end 1363 of outertube 1356 to be radially deployed. As shown in FIG. 13, the second end of inner tube 1358 should be positioned so that the bulbous end 1364 of innertube 1358 does not come in direct contact with fingers formed at second end 1363. 13A. Once stent 100 has been placed in the desired position, inner tube 1358’s second end 1364 is moved in an “upward” direction. Direction toward the header or carousel 1336. The direction is indicated by the directional arrow 1341. To move the second end 1364 from inner tube 1358 away from stent100, the bulbous second 1364 of innertube 1358 will contact the fingers on the second end 1363 in outer tube 1356. Bulbous inner tube 1358’s second end 1364 radially extends or spreads the fingers on outer tube 1356’s second end 1363 until they grab onto the inner diameter of the stent 100, as shown in FIG. 13B. 13B. In one embodiment, the deployed fingers may increase the inner diameter of the stent100 to increase friction between the stent 100 & stent suspension means1328. This will minimize unwanted movement of the stent100.

“FIGS. 13C-13D show another embodiment of a suspension means 1328C. It includes a header or carousel 1336. A portion of this figure is shown. There’s also a mandrel 1350C to hold a stent 100 in position during the capillary filling process described in FIGS. 4A-7. While only one mandrel 1350 has been shown, one of ordinary skill will understand that multiple mandrels can be attached to the header or carousel 1336 in order to accommodate a plurality stents 100. As shown in FIG. 13A. A header or carousel 1336, a flat-sheet-like component with at least one hole 1337 drilled through it to allow passage of a portion 1350C of mandrel 1350C. Mandrel 130C includes two concentric shafts or tubes that pass through passageway 1337C. An outer tube 1356C, and an inner tube 1358C are attached to slideably extend through the lumen 1357C. The outer tube 1356C could be a Nitinol tube, while the second end 1363C is an outer tube 1356C that includes a plurality fingers similar to a collet. This embodiment is different from the FIGS. 13A-B, fingers at the second end 1363C on outer tube 1356C can be bent or curved inwardly toward inner tube 1358C. The inner diameter of outer tube 1306C and inner tube 1358C is slightly smaller than that of 1364C. Inner tube 1358C can be pulled or pushed relative to outer tube 1306C in order to radially release the fingers at second end 1363C. As shown in FIG. 13, the second end of inner tube 1358C must be positioned so that the inner tube 1364C’s second end is not in direct contact with fingers formed at outer tube 1356C’s second end 1363C. 13C. After stent 100 has been placed in the desired position, the second end 1364C (internal tube 1358C) is moved in a “downward” direction. Direction towards header or carousel1336 as indicated by the directional arrow 1341C. The second end 1364C is moved in a?downward? direction. This causes the second end 1364C inner tube 1358C contact with fingers formed at second end 1363C outer tube 1356C. The second end 1364C (inner tube 1358C) straightens or spreads the fingers on the outer tube 1356C’s second end 1363C, until they grab onto the inner diameter of the stent 100. FIG. 13D. 13D. In one embodiment, the deployed fingers may increase the inner diameter of the stent 100 in order to increase friction between the stent 100 & stent suspension means1328C. This will reduce unwanted movement of the stent100.

“FIGS. 14A-14B show another embodiment of a suspension means 1428. It includes a header 1436 or carousel 1436. A portion of this figure is shown. There’s also a mandrel 1450 that holds a stent 100 in position during the capillary filling process described in FIGS. 4A-7. 4A-7. A header or carousel 1436, a flat sheet-like component, has at least one hole 1437 through it to allow passage of a portion mandrel 1450. Mandrel 1450 consists of two concentric tubes, or shafts, that pass through passageway 1437 of header or carousel. It also includes a retractable outertube 1466 and an innertube 1458 that can be slidably mounted so it extends through the lumen 1457 created by outer tube 1466. The inner tube 1458 could be a Nitinol tube. A second end 1463 from inner tube 1458 contains a plurality self-expanding fingers similar to a collet. The outer diameter of outer tube 1466 is less than that of stent 100. Operation: stent 100 is placed over outer tube 1466. This radially restricts fingers at second end 1463 and mandrel 1405, as shown in FIG. 14A. The outer tube 1466 can be moved in an “upward” direction. The outer tube 1466 may be moved in an?upward? direction towards the header or carousel, 1436. This will expose the fingers at second end 1463 and 1450. 14B. One embodiment allows the deployed fingers to slightly increase the inner diameter of the stent 100 in order to increase friction between the stent 100 & stent suspension means 1428. This will minimize unwanted movement of the stent100. To retract or constrain the fingers at the second end 1463, mandrel 1405, outer tube 1466 can be moved downwards to resume the configuration as shown in FIG. 14A.”

“FIGS. “FIGS. 4A-7. While only one mandrel 1550 has been shown, it is clear that multiple mandrels can be attached or coupled to the header or carousel for accommodating a plurality stents 100. A flat, sheet-like component with at least one hole 1537 or passageway 1536 through it is called header or carousel. Mandrel 1502 is a hollow shaft, or tube with a hole 1517 in its sidewall. A first end 1562 is connected to header 1536. The Nitinol wire 1568 has a first and second ends 1569A and 1569B. It extends through passageway 1507 of header 1536 and through the lumen 1550. This exits from the hole 1517 in the mandrel. 15A. The second end 1569B is connected to the second end 1563 in mandrel 1505. Operation: Stent 100 is placed over mandrel 1505. Once stent 100 has been placed in the desired position, tension on wire 1568 can be released. Helical Nitinol Wire 1568 will self-expand and radially expand to the shape it was designed to. The helical windings of wire 1568 grab onto the inner diameter or against stent100 as shown in FIG. 15B. The wire 1568 can be pulled back to the position in FIG. 15A: Retract the wire into the lumen 1550. This will reduce the diameter of the helical winds of wire 1568. One embodiment of the deployed helical winds of helical Nitinolwire 1568 may slightly increase the inner diameter to stent100 to increase friction between stent100 and stent suspension mean 1528 to reduce unwanted movement of the stent100.

“FIG. “FIG. 4A-7. While only one tubular component 1672 has been shown, one of ordinary skill will understand that multiple tubular components can be coupled to header 1636 for accommodating a plurality stents 100. The header or carousel 1636 component is generally a flat sheet-like one. The lumen, or passageway 1674, of tubular component 1672 has a diameter slightly larger than that of stent 100. The first open end 1671 is attached to header 1636 or carousel 1636. A second open end 1673 is located adjacent to or near a wicking device 1630. Lumen 1674 is fluidly connected to a vacuum source 1670. The lumen of tubular part 1672 is in fluid communication with a vacuum source 1670. As such, the stent 100 can be adjusted to move towards or away the 1630 wicking mechanism. After stent 100 has been filled, vacuum source 1670 may be used to apply suction to pull stent 100 away form wicking mechanism 1630. A cylindrical plug 1675 can be placed within the inner diameter stent 100 in order to reduce air passage.

“FIG. “FIG. 4A-7. While only one balloon 1776 has been shown, one of ordinary skill will understand that multiple balloons can be attached to the header or carousel 1736 in order to accommodate a plurality 100. The header or carousel1736 is a flat-sheet-like component. A first end 1777 is attached to or coupled to the carousel or header 1736. Balloon 1776 can be cylindrical or tubular-shaped, and the interior 1779 is in fluid communication to an inflation source 1778. Before inflation, balloon 1776 had an outer diameter that fit within stent 100. After stent 100 has been placed as desired, balloon 1776 can be inflated via inflation source 1778. As shown in FIG. phantom, balloon 1776 expands or inflates until its outer surface is in opposition to or abuts against stent 100’s inner diameter. 17. Inflated balloon 1776 grabs onto the inner circle of stent100. One embodiment may slightly increase the inner circle of stent100 to increase friction between the stent 100 & stent suspension means 1728, to reduce unwanted movement of stent100. Examples of materials that can be used to make balloon 1776 are polyethylene terephthalate, polyethylene (PET), nylon, nylon blendeds, polyurethanes and polyesters.

“FIGS. 18A-18B show another embodiment of a suspension means 1828. It includes a header 1836 or carousel 1836. A portion of this figure is shown. Also, there’s a mandrel 1850 that holds a stent 100 in position during the capillary filling process described in FIGS. 4A-7. While only one mandrel 1850 has been shown, one of ordinary skill will understand that multiple mandrels can be coupled to a header or carousel1836 for accommodating a plurality stents 100. A header or carousel 1836, a flat sheet-like component with at least one slot 1837 allowing passage of a portion mandrel 1850 through, is generally flat. Two adjacent pins or shafts make up mandrel 1850. One is a stationary pin 1880 that connects to header 1836 or carousel1836, and the other is a movable pin 1881 that extends through slot 1837 or carousel1836 1836. To retain stent 100, the second movable pin may be moved or shifted laterally. Particularly, the second movable pin is mounted in a block 1821 over the header carousel1836. A compression spring 1819 extends between the block and header. As shown in FIG. 18, the compression spring 1819 exerts a force which tends to move second pin 1881 away form the stationary pin 1880. 18B. Operation: A force 1841 is applied externally, i.e. an operator presses on block 1821 to compress spring 1819. This causes second movable pin (1881) to shift or move within slot 1837. It then becomes relatively close to the stationary pin (1880, as shown in FIG. 18A. The stent 100 is placed on both the movable pin 1881 and stationary pin 1880, with the first pin 1880 touching the inner surface of stent 100. Once stent 100 has been placed in the desired position, force 1841 can be removed. Spring 1819 then resumes its normal configuration. Second pin 1881 is moved laterally away from stationary pint1880 as shown in FIG. 18B. 18B. The pins 1880 and 1881 touch the inner diameters of stent 100 in opposing places.”

“FIGS. 18C-18D show another embodiment of a suspension means 1828C. It includes a header 1836C or carousel 1836C. A portion of this figure is shown. Also, there’s a mandrel 1850C to hold a stent 100 in position during the capillary filling process described in FIGS. 4A-7. While only one mandrel 1850C has been shown, one of ordinary skill will understand that multiple mandrels can be attached to the header or carousel1836 for accommodating multiple stents 100. A flat sheet-like component known as a header or carousel 1836C has at least one slot 1837C that allows for passage of a portion mandrel 1850C. Mandrel 1850C consists of two adjacent pins or shafts. A first stationary pin 1880C is coupled to header 1836C, and a second movable Pin 1881C extends through slot 1837C in header 1836C. To retain stent 100, the second movable pin 1881C can be moved or shifted laterally. Particularly, the second movable pin is 1881C mounted in a block 1821C over the header carousel1836C with a compression Spring 1819C running between the block and header. The compression spring 1819C exerts a force on the second pin 1881C to move it toward the stationary pin (1880C), as illustrated in FIG. 18D. Operation: A force 1841C can be applied externally, i.e. an operator presses on block 1821C to compress spring 1819C. This will cause second movable pin (1881C) to shift or move within slot 1837C. It will then space out from stationary pin (1880C), as shown in FIG. 18C. The 100-pound stent is placed between the movable pin 1881C and the stationary pin 1880C, with the first pin 1880C touching the inner surface of stent 100. Once stent 100 has been placed in the desired position, force 1841C can be removed. Spring 1819C then resumes its normal configuration and laterally moves second pin (1881C) toward stationary pint (1880C), as shown in FIG. 18D. The movable pin 1881C is moved towards the stationary pin 1880C. This causes the stent 100’s outer diameter or surface to come into contact with the pin 1881C.

“FIGS. 19A-19D show another example of a suspension means 1928. It includes a header 1936 or carousel 1936. A portion of the figure is shown. Also, there’s a mandrel 1950 that holds a stent 100 in position during the capillary filling process described in FIGS. 4A-7. While only one mandrel 1950 has been shown, one of ordinary skill will understand that multiple mandrels can be coupled to a header or carousel 1936 in order to accommodate a plurality stents 100. A header or carousel 1936 is a flat sheet-like component that has at least one slot or passageway 1937. This allows for passage of a portion 1950 or a collet 1982. Collet 1982 has a tapered, frustoconical exterior and a lumen (or hole) 1925 that extends therethrough. It is slightly larger than the outer diameter of stent100. Multiple cuts 1923 can be made at the end of collet in the sidewall to form jaws 1982A-B and 1983C. Mandrel 1950 has an outer diameter slightly larger than that of stent 100 and extends through lumen 1995 of collet822. As shown in FIGS. 19A-19B. The collet 1982 allows adjacent jaws to spread out by cutting 1923. After stent 100 has been placed in the desired position, collet can be moved in an “upward” direction. Direction toward header or carousel 36, indicated by directional Arrow 1441. Move away from stent100 until the outer edge of the collet touches the edge of passageway 37 of header 1936. If the outer diameter for collet 1982 exceeds the diameter of passageway 37, passageway 1937 applies an inner radial force to the collet, and squeezes or moves the jaws 1982A-B, 1983C as shown in FIGS. 19C-19D. To effectively clamp or capture the stent 100 between collet 1992’s inner surface and mandrel 1950’s exterior surface, the lumen 1925 of colet 1982 is reduced.

“FIG. “FIG. 20 illustrates another embodiment a stent suspension mechanism 2028. It includes a header 2036, which is a part of the figure, and an 2050 that holds a 100-pound stent in place during the capillary filling process described in FIGS. 4A-7. 4A-7. The header or carousel is a flat-sheet-like component. A first end 2062 is attached to header 2036. Mandrel 2050 has a bumpy or wavy exterior surface that is adjacent to at most a second end 2063. Mandrel 2050’s bumpy or wavy exterior surface is created by circumferential bands or ribs 2083 with a larger outer diameter than the rest of mandrel2050. In an interference or friction fit, the bumpy or wavy exterior of mandrel 20050 meets the inner diameter of stent 100. Mandrel 2050 can be made from 3 series stainless or any other material that is resistant to oxidation and corrosion and is non-dissolvable and not affected by harsh chemicals. Another embodiment, mandrel 2050, may have an exterior that meets the inner diameter of the stent 100 in an interference- or friction fit. The tip of the slip fit mandrel can include a chamfer or taper or be substantially flat to improve the fit with the stent. Another embodiment, not shown, may use a tubular shaft/rod as a mandrel. The stent suspension means could be made up of one or more springs/coiled wires that are offset from one another and form a tubular rod. Tubular mandrels are formed by springs or coiled cables that meet against the inner diameter 100 of the stent. This creates an interference or friction fit.

“FIGS. 21-21A show another embodiment of a suspension mechanism 2128. It includes a header 2136 or carousel 2136. A portion of the figure is shown. Also, there is a mandrel 2150 that holds a stent 100 in position during the capillary filling process described in FIGS. 4A-7. FIG. FIG. 21A shows a top view. 21 with header 2136 removed. While only one mandrel 2150 has been shown, one of ordinary skill will understand that multiple mandrels can be connected to header or carousel 2136 for accommodating multiple stents 100. Header 2136 or carousel 2136 is a flat-sheet-like component. A first end 2162 of mandrel 2150 is connected to header 2136 or carousel 2236. The outer diameter of the first end portion 2162 in mandrel 2150 is smaller than that of the second end portion 2163 in mandrel 2150. In an interference or friction fit, the outer diameter of the second end portion 2163 (mandrel 2150) abuts against that of stent 100. Stent 100 can be placed over mandrel 2150 by sliding up mandrel 2150 until the end 105. The narrower second end portion 2163 is passed by stent 100 and is placed over narrower mandrel 2150. The stationary spring leaf 2184, or cantilevered spring arm 2184, is located adjacent to the first end 2162 of mandrel 2150 and contacts and abuts against the end 105. The stent 100 may feel an upward force when it is placed into the wicking components 430 and 424. This may result in the stent slipping up the mandrel 2150. Spring arm 2184 counters any upward forces caused by the interaction between the stent and the wicking components 430. It exerts a downward force on stent 100 if spring arms 2184 are deflected from their neutral position as shown in FIG. 21. Spring arm 2184 presses stent 100 into wicking components for uniform loading during filling when multiple stents exist.”

“FIGS. 22A-22C show another embodiment of a suspension means 2228. It includes a header 2236, which is a part of the figure, and a 2236 carousel 2236. A mandrel 22250 holds a stent 100 in position during the capillary filling process described in FIGS. 4A-7. FIG. FIG. 22C is a sectional image taken along line C?C of FIG. 22B. 22B. Although one mandrel is shown, one of ordinary skill will understand that multiple mandrels can be coupled to header/carousel 2236 to accommodate a plurality stents 100. Header 2236 or carousel is a flat-sheet-like component. A first end 2262 from mandrel 22250 is connected to header 2236. As shown in FIG. 22A. Once the stent 100 has been placed in its desired position, spring-loaded arm 2285 pushes it against mandrel 2325 as shown in FIGS. 22B and 22C are used to capture or sandwich stent 100 between arm 2185 and the exterior of mandrel 22255. Arm 2285 moves or rotates via a spring 2286 or pivot 2287.

“Means to Wicking Fluid Drug Formulation.”

“FIGS. FIGS. 23-33 show several examples of wicking mechanisms 430 that are in contact with fluid formulation 432 to control the transfer of fluid drug formulation 432 into lumen 3 of hollow wire 102 during capillary filling as described in FIGS. 4A-7. ?Wicking means? As used herein, a medium or component which acts or functions in moving or conveying fluid drug formulation 432 through capillary action within the second or lower chamber 424 into hollow wire 103. The wicking mechanism 430 controls the transfer of the fluid drug formula. In some embodiments, the wicking device also removes any excess fluid drug composition from hollow wire 102 of the stent 100 after the stent 100 has been removed from the wicking apparatus. The excess removal function performed by wicking mechanism 430 does not require additional processing or cleaning to remove drug residue from the exterior surfaces hollow wire 102. Wicking means 430 should have several properties or characteristics, such as that it doesn’t degrade or add contaminants to fluid drug formula 432, it is inert within fluid drug formula 432 and it does not cause phase separations within fluid drug preparation 432. It is also usable and/or steady for several days and/or weeks.

“As mentioned previously, wicking refers to 430 being an open-celled sponge made of polyurethane. To improve the sponge’s efficiency and reduce fill weight variability further, a variety of characteristics or properties can be changed. These include the chemical structure of the sponge as well as the hydrophilicity, the sponge’s density, the compression modulus, the shape or dimensions, and the sponge’s pore size. Hydrophilicity and pore sizes are directly related to fluid affinity and capillary action. Optimizing these properties will allow the sponge to clean hollow wire 102 better than stent 100. The sponge’s compression modulus allows for controlled amounts of the stent to contact the wicking mechanisms. The sponge can be placed in contact with side holes (104 of stent100) while the exterior surface of hollow wire (102 of stent100) is limited.

“An alternative to a sponge-wicking mechanism, the wicking method may be a component or surface between the stents 432 and the fluid formulation 432. It makes contact with the fluid formulation 432 during capillary filling. This allows for control of fluid drug formula 432’s transfer into lumen 103 of hollowwire 102. 4A-7. FIGS. 4A-7 show stents 100 as straight tubular structures. 23-33, although one of ordinary skill will understand that stents100 are hollow wires shaped into desired stent patterns as described in FIG. 1. FIG. 23 illustrates an example. FIG. 23 shows a section of the lower chamber or second chamber 424 that has a portion containing a stent 100, which is lowered to touch a wicking device 2330. Wicking means 2330 refers to a flexible membrane or sheet which is placed over a fluid drug formulation 432 contained within a container 2327, second chamber 424. One embodiment of wicking is a continuous filament polyester fibre sheet of material or a purity wiping. Two concentric tubes control the configuration or position of wicking mean 2330. One is an outer stationary tube 2388A, and one is an inner movable tube (2388B). The tubes 2388A and 2388B can be rectangular or cylindrical in cross-section. The wicking means 2330 drapes or extends over the top of outer stationary tubes 2388A. It is secured over outer stationary tubes 2388A by an O-ring 2329 made of an inert substance like Teflon. Another embodiment of wicking means 2330 is held in place by a clamp over outer stationary tube 238A. In operation, wicking mean 2330 is draped above outer stationary tube 2388A so that the center of the wicking mechanism contacts fluid drug formulation 432 contained within container 2327. FIG. 23A. 23A. After filling is completed, stent 100 can be raised with inner movable tub 2388B. Inner movable tube 238B is raised by an electromotive force from an EMF source. This pushes wicking mechanism 2330 upwards to a second configuration, in which deformable sheets are not in direct contact with fluid drug formulation 432 contained within container 2327. 23B. 23B. After the excess fluid drug formula 432 has been drained, the electromotive forces are removed and the inner movable tube 2388B is lowered back to FIG. 23A.”

“FIG. “FIG. 4A-7. FIG. FIG. 24 shows a section of the lower chamber or second chamber 424 that has a portion containing a stent 100, which is lowered to touch a 2430 wicking mechanism. Wicking means 2430 refers to mesh material that is placed within the second chamber 424’s layer of fluid drug formula 432. End 107 of stent100 is brought into contact with Wicking means 2430. The mesh material buckles and deforms to allow contact between stent100 and the fluid drug formulation 432. After 100 stents have been filled, 100 stents are removed from contact with the wicking mean 2430. During the retraction of the stents 100 the mesh material for wicking means 2430 returns to its original form and pulls or removes any excess fluid drug formulation from the exterior surface of the stents 100. The mesh material of wicking is 2430 includes, but is not limited to, nylon, polypropylene or rubber.

“FIG. “FIG. 4A-7. FIG. FIG. 25 shows a section of second chamber 424 that has a portion containing a stent 100, which is lowered to touch a 2530 wicking mechanism. Wicking means 2530 refers to flocked or texture material that is placed within the second chamber 424. The flocked, textured sheet may contain VELCRO or cotton and can be VELCRO or cellulose. The textured material buckles when it comes into contact with wicking medium 2530 at the end 107. This allows fluid drug formulation 432 to contact stent 100. After 100 stents have been filled, 100 stents are removed from contact with wicking 2530. During the retraction of the stents 100 the textured material 2530 of wicking means 2530 returns back to its original form and pulls or removes excess fluid medication formulation from the exterior surfaces hollow wires 102 of the stents 100.”

“FIG. “FIG. 26 is an alternative embodiment of the wicking mechanism that acts as an intermediate surface or component to fluid drug formulation 432. This allows for control of fluid drug formulation 432’s transfer into lumen 103 hollow wire 102. 4A-7. FIG. FIG. 26 shows a section of second chamber 424 that has a portion containing a stent 100, which is lowered by a wicking device 2630. Wicking means 2630 refers to a layer of PEG gel or immiscible fluid that is separated from the fluid drug formulation 432 when it is poured into second chamber 424. End 107 is passed through wicking mechanism 2630, until the stents 100 come in contact with the fluid drug formulation 432. After the stents have been filled, the stents are pulled back through wicking 2630. The cellulose, PEG gel or immiscible fluid may pull or remove excess fluid from the exterior surfaces 100 of stents 100 during retraction.

“FIGS. “FIGS. 4A-7. FIGS. FIGS. 27A-27B show a section of second chamber 424 that has a portion containing a stent 100 which is lowered to touch a wicking mechanism 2730. Wicking means 2730 refers to a number of hypotubes and cylindrical microchannels that are contained in the second chamber 424’s layer of fluid drug formula 432. The hypotubes are made of material that is subject to magnetic or electrical field changes. From the end of 2730, stent 100 is placed in the hypotubes. The layer of fluid drug formulation 432 is between 107 and 100. Each application will have a different set of hypotube sizes and heights. The filling steps of hypotubes of the wicking means 2730 are performed in the first or vertical orientation as shown in FIG. 27A allows fluid drug formulation 432 through the hypotube lumens by capillary action. Fluid drug formulation 432 passes up the hypotubes via wicking means 2730. Fluid drug formulation 432 then comes in contact with the end 107 of the stent 100. This allows the hollow wire 102 of the stent 100 to fill via capillary. To fill the hypotubes by capillary action, the fluid drug formulation must only be submerged in the liquid. After the stents 100 are filled, an electric field or magnetic field is used to move hypotubes of the wicking means 2730 into a horizontal orientation. FIG. FIG. 27B shows that fluid drug formulation 432 is not in direct contact with stent 100. Filling the stent via capillary actions is stopped. The fluid transfer properties of fluid 100 and fluid drug formula 432 can be altered by changing the orientation of hypotubes ofwicking 2730. Hypotubes can transfer fluid drug formulation 432 from stent 100 in their vertical orientation. In their horizontal orientation, capillary action stops and fluid affinity is modified to make cleaning hollow wire 102 easier.

“FIG. “FIG. 4A-7. FIG. FIG. 28 shows a section of the lower chamber or second chamber 424 that has a portion containing a stent 100, which is lowered to touch a 2830 wicking mechanism. Wicking means 2830 refers to a cellulose column that is placed within the second chamber 424 and extends beyond or past a layer fluid drug formulation 432. The end 107 of the stent100 is placed in contact with a side surface 2830 of wicking mean 2830. This acts as a conduit or bridge between stent100 and fluid drug formula 432 to transfer fluid drug formulation to catheter 100. Alternately, the end 107 of stent 100 can be placed in contact with a top surface 2830 of wicking mean. To control the surface energy properties of the filling process, the cellulose column reduces the contact area between the stents 100 & fluid drug formulation 432. For embodiments where the stent contacts the fluid formulation directly, it is important to control the fluid’s surface energy properties so that it has the highest affinity for hollow wire 102 lumen 103. This allows the fluid to be more receptive to hollow wire 102 exterior surfaces.

“Similar To FIG. 28, FIG. 28 FIG. 4A-7. FIG. FIG. 29 shows a section of the lower chamber or second chamber 424 that has a portion containing a stent 100, which is lowered to touch a 2930 wicking mechanism. Wicking means 2930 refers to a fiber/filament, or a plurality or parallel of woven fibers/filaments that are placed within or extend beyond the second chamber 424’s fluid drug formulation 432. End 107 is brought into contact with the top surface of wicking mean 2930 so that wicking mean 2930 is directly in contact with wire 102’s opening or hole. Wicking means 2930 transfers fluid formulation 432 from stent 100. It also minimizes the area between stents100 and fluid formulation 432 in order to control the surface energy properties of the filling process. Another embodiment of wicking is a plug made from cotton or a similar fibrous material.

“In FIGS. 28 and 29 show the cellulose column/fibers positioned within, and beyond, a layer 432 of fluid drug formulation 424. As shown in FIG. A wicking device 3030 can be extended from the end 107 at stent 100. It may then be dipped into or lowered into a layer 432 of fluid drug formulation. FIG. FIG. 30 shows a section of the lower chamber or second chamber 424 that has a portion containing a stent 100, which is lowered to make contact with wicking mechanism 3030. Wicking mean 3030 could be a cellulose extension or a fiber/filament that contains a plurality or parallel fibers/filaments or a plug made of cotton. Wicking means 3030 connects to end 107 on stent100. Then, stent100 is dropped within the second chamber 424 until the bottom surface of wicking mean 3030 comes into contact with fluid drug formula 432. Wicking is 3030. It transfers fluid drug formula 432 to the stent100 and reduces the contact area between the stent 100 & fluid drug formulation 432 in order to control the surface energy properties of the filling process.

“FIGS. 31A-31B show another example of the wicking mechanism. An intermediate surface or component is placed in contact with fluid formulation 432 to control the transfer of fluid drug formula 432 into lumen 332 of hollow wire 102, as described in FIGS. 4A-7. FIGS. FIGS. 31A-31B show a section of the lower or second chamber 424 that has a portion containing a stent 100, which is lowered to contact a 3130A, 3130B wicking mechanism. Wicking means 3130A refers to a flat, generally solid or impervious substrate that is in contact with an HE heating element. Wicking mean 3130B refers to a porous substrate or open-celled substrate that is in contact with an HE heating element. FIG. 31A: Fluid drug formulation 432 is applied to the impervious wicking surface 3130A. Fluid drug formulation 432 is spread over the top of wicking mean 3130A. It thereby extends to or reaches stent 100, which is also placed on the top of wicking mean 3130A. FIG. 31B: The stent 100 is brought in contact with the porous wicking mean 3130B’s top, which is in direct contact with the fluid drug formula 432 and passes the fluid drug formulation to its stent. After filling is completed, the heating element heats the wicking elements 3130A and 3130B to adjust the surface tension. The surface tension forces between fluid formulation 432 and the stent 100 is weakened when wicking mean 3130A and 3130B are heated. This prevents the fluid formulation from adhering between wicking methods 3130A and 3130B. Temperature changes of wicking mean 3130A,3130B alter surface tension/affinity properties and control transfer of fluid drug formulation 432 to lumen 103 hollow wire 102 during capillary filling.

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What is a software medical device?

The FDA can refer to software functions that include ” Software As a Medical Device” and “Software in a Medical Device(SiMD)”, which are software functions that are integral to (embedded in a) a medical device.

Section 201(h),?21 U.S.C. 321(h),(1) defines a medical device to be?an apparatus, implements, machine, contrivances, implant, in vitro regulator, or other similar or related articles, as well as a component or accessory. . . (b) is intended for diagnosis or treatment of disease or other conditions in humans or animals. (c) Is intended to alter the structure or function of human bodies or animals. To be considered a medical device, and thus subject to FDA regulation, the software must meet at least one of these criteria:

• It must be used in diagnosing and treating patients.
• It must not be designed to alter the structure or function of the body.

If your software is designed to be used by healthcare professionals to diagnose, treat, or manage patient information in hospitals, the FDA will likely consider such software to be medical devices that are subject to regulatory review.

Is Your Software a Medical Device?

FDA’s current oversight, which puts more emphasis on the functionality of the software than the platform, will ensure that FDA does not regulate medical devices with functionality that could be dangerous to patient safety. Examples of Device Software and Mobile Medical Apps FDA is focused on

• Software functions that aid patients with diagnosed mental disorders (e.g., depression, anxiety, and post-traumatic stress disorder (PTSD), etc.) by providing “Skill of the Day”, a behavioral technique, or audio messages, that the user can access when they are experiencing anxiety.
• Software functions that offer periodic reminders, motivational guidance, and educational information to patients who are recovering from addiction or smokers trying to quit;
• Software functions that use GPS location data to alert asthmatics when they are near high-risk locations (substance abusers), or to alert them of potential environmental conditions that could cause symptoms.
• Software that uses video and games to encourage patients to exercise at home.
• Software functions that prompt users to choose which herb or drug they wish to take simultaneously. They also provide information about interactions and give a summary of the type of interaction reported.
• Software functions that take into account patient characteristics, such as gender, age, and risk factors, to offer patient-specific counseling, screening, and prevention recommendations from established and well-respected authorities.
• Software functions that use a list of common symptoms and signs to give advice about when to see a doctor and what to do next.
• Software functions that help users to navigate through a questionnaire about symptoms and to make a recommendation on the best type of healthcare facility for them.
• These mobile apps allow users to make pre-specified nurse calls or emergency calls using broadband or cell phone technology.
• Apps that allow patients or caregivers to send emergency notifications to first responders via mobile phones
• Software that tracks medications and provides user-configured reminders to improve medication adherence.
• Software functions that give patients access to their health information. This includes historical trending and comparisons of vital signs (e.g. body temperature, heart rate or blood pressure).
• Software functions that display trends in personal healthcare incidents (e.g. hospitalization rates or alert notification rate)
• Software functions allow users to electronically or manually enter blood pressure data, and to share it via e-mail, track it and trend it, and upload it to an electronic or personal health record.
• Apps that offer mobile apps for tracking and reminders about oral health or tools to track users suffering from gum disease.
• Apps that offer mobile guidance and tools for prediabetes patients;
• Apps that allow users to display images and other messages on their mobile devices, which can be used by substance abusers who want to quit addictive behaviors.
• Software functions that provide drug interaction and safety information (side effects and drug interactions, active ingredient, active ingredient) in a report based upon demographic data (age and gender), current diagnosis (current medications), and clinical information (current treatment).
• Software functions that allow the surgeon to determine the best intraocular lens powers for the patient and the axis of implantation. This information is based on the surgeon’s inputs (e.g., expected surgically induced astigmatism and patient’s axial length, preoperative corneal astigmatism etc.).
• Software, usually mobile apps, converts a mobile platform into a regulated medical device.
• Software that connects with a mobile platform via a sensor or lead to measure and display electrical signals from the heart (electrocardiograph; ECG).
• Software that attaches a sensor or other tools to the mobile platform to view, record and analyze eye movements to diagnose balance disorders
• Software that collects information about potential donors and transmits it to a blood collection facility. This software determines if a donor is eligible to collect blood or other components.
• Software that connects to an existing device type in order to control its operation, function, or energy source.
• Software that alters or disables the functions of an infusion pump
• Software that controls the inflation or deflation of a blood pressure cuff
• Software that calibrates hearing aids and assesses sound intensity characteristics and electroacoustic frequency of hearing aids.

What does it mean if your software/SaaS is classified as a medical device?

SaaS founders need to be aware of the compliance risks that medical devices pose. Data breaches are one of the biggest risks. Medical devices often contain sensitive patient data, which is why they are subject to strict regulations. This data could lead to devastating consequences if it were to become unprotected. SaaS companies who develop medical devices need to take extra precautions to ensure their products are safe.

So who needs to apply for FDA clearance? The FDA defines a ?mobile medical app manufacturer? is any person or entity who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components. This term does not include persons who exclusively distribute mobile medical apps without engaging in manufacturing functions; examples of such distributors may include the app stores.

Software As Medical Device Patenting Considerations

The good news is that investors like medical device companies which have double exclusivity obtained through FDA and US Patent and Trademark Office (USPTO) approvals. As such, the exit point for many medical device companies is an acquisition by cash rich medical public companies. This approach enables medical devices to skip the large and risky go-to-market (GTM) spend and work required to put products in the hands of consumers.

Now that we have discussed the FDA review process, we will discuss IP issues for software medical device companies. Typically, IP includes Patents, Trademarks, Copyrights, and Trade secrets. All of these topics matter and should be considered carefully. However, we will concentrate on patents to demonstrate how careless drafting and lack of planning can lead to problems, namely unplanned disclosures of your design that can then be used as prior art against your patent application.

In general, you should file patent application(s) as soon as practicable to get the earliest priority dates. This will help you when you talk to investors, FDA consultants, prototyping firms, and government agencies, among others. Compliance or other documents filed with any government agency may be considered disclosure to third parties and could make the document public. In general, disclosures to third parties or public availability of an invention trigger a one year statutory bar during which you must file your patent application. Failure to file your application within the required time frame could result in you losing your right to protect your invention.

The information from your FDA application may find its way into FDA databases, including DeNovo, PMA and 510k databases and FDA summaries of orders, decisions, and other documents on products and devices currently being evaluated by the FDA. Your detailed information may be gleaned from Freedom of Information Act requests on your application. This risk mandates that you patent your invention quickly.

When you patent your medical device invention, have a global picture of FDA regulatory framework when you draft your patent application. Be mindful of whether your software/SaaS application discusses the diagnosing and treating patients or affecting the structure or function of the body and add language to indicate that such description in the patent application relates to only one embodiment and not to other embodiments. That way you have flexibility in subsequent discussions with the FDA if you want to avoid classification of your software/SaaS/software as a medical device. In this way, if you wish to avoid FDA registration and oversight, you have the flexibility to do so.

An experienced attorney can assist you in navigating the regulatory landscape and ensure that you comply with all applicable laws. This area of law is complex and constantly changing. It is important that you seek legal advice if you have any questions about whether or not your software should be registered with FDA.

Patent PC is an intellectual property and business law firm that was built to speed startups. We have internally developed AI tools to assist our patent workflow and to guide us in navigating through government agencies. Our business and patent lawyers are experienced in software, SaaS, and medical device technology. For a flat fee, we offer legal services to startups, businesses, and intellectual property. Our lawyers do not have to track time as there is no hourly billing and no charges for calls or emails. We just focus on getting you the best legal work for your needs.

Our expertise ranges from advising established businesses on regulatory and intellectual property issues to helping startups in their early years. Our lawyers are familiar with helping entrepreneurs and fast-moving companies in need of legal advice regarding company formation, liability, equity issuing, venture financing, IP asset security, infringement resolution, litigation, and equity issuance. For a confidential consultation, contact us at 800-234-3032 or make an appointment here.