Software Technology for “Method for fabricating implantable medical device from a polymer coupon that has been bonded to a rigid substrate.”

Medical Device – John Janik, Robert Brindley, Edward Chia-Ning Tang, Stryker Corp

Abstract for “Method for fabricating implantable medical device from a polymer coupon that has been bonded to a rigid substrate.”

A single coupon of polymer is all that is required to create a medical device. The coupon is initially bonded to a hard substrate. To ensure that the coupon has an even height across its surface, heat, force and suction can be applied selectively. After the polymer coupon has been bonded, the medical device components are attached to it. The coupon is then shaped to make the individual devices. The rigid backing is then removed from the sections that have been shaped. The medical devices are made up of the sections that have been lifted from the rigid backing.

Background for “Method for fabricating implantable medical device from a polymer coupon that has been bonded to a rigid substrate.”

There is a growing interest in articles of manufacture that have one or more layers supporting layers made from thin film polymers. What is a thin film polymer? A thin film polymer is a polymer with a thickness less than 1 mm. This polymer is a good substrate, or carrier layer, on which electrically-conductive traces can form. This polymer is thin enough in cross-section to allow for mounting of electrical, mechanical and electromechanical components. This polymer has another advantage: it can support components and conductors but is flexible. This polymer can be used as a substrate to support components and conductors that may be required by the assembly’s intended purpose.

An implantable medical device is one example of such an article. These devices can be implanted in a living organism, whether it is a human or a species, to provide diagnostic or therapeutic purposes. An electrode array is one example of such a device. An electrode array is a device that has multiple exposed electrodes mounted on a frame or carrier. The array also includes conductors that act as the components of the array. They are used to source or sink currents from individual electrodes. The actual components that supply current to the array are mounted to some electrode arrays. The array is intended to be inserted against living tissue, such as a human. The array is designed to allow current flow through tissue. The following therapeutic purposes have been suggested or used to select current flow through a patient: pain management, cardiac arrhythmia correction, appetite suppression, control of incontinence, and overriding damaged neurological connections that have caused loss of muscle control and/or loss feeling. Another use of these arrays is to monitor electrical impulses generated in the brain. The array’s electrodes transmit signals that are representative of these electrical impulses, to other components. These signals may be used by the array components to control devices that they are connected. These devices can include exoskeleton units with mechanical power that move an individual, as well as robotic linkages and artificial speech generation.

“The Applicant?s Assignee?s FOLDABLE and IMPLANTABLE Electrode ARRAY ASSEMBLY, AND TOOL FOR IMPLANTING THE SAME, PCT Pub. WO 2009/11942 A2, U.S. patent application Ser. No. No. Pub. No. No. No. No. Pub. No. No. These publications generally include an electrode array, also known as a carrier, made from elastic material. These frames are used to hold the electrodes. These disclosures use Nitinol as a nickel-titanium alloy to make the frames. These frames are conductive and it is necessary that the electrodes be formed over electrically insulating layer. It may be possible to apply parylene C to the elastic Nitinol carrier to make this material the insulating support. According to these documents, it is possible to apply multiple layers of parylene. Once cured, each layer serves as the substrate for one or more conductor components. The layers of parylene closest to the elastic carrier are cured and serve as support layers for conductors. The outer layers of parylene have two purposes. These layers are the electrically insulating outer skin of the array. The support layer that the array electrodes are made is usually at least one of these layers.

“Parylene is an excellent electrical insulator. It bonds well with superelastic materials like Nitinol and is flexible once it has cured. It also accepts metal layers that have been selectively etched to create conductors or electrodes. These desirable properties are ideal for an insulating coating that forms part of an implantable array. Parylene is not suitable for use as an insulating layer in an implantable electrode array. Parylene is able to absorb large amounts of water. A body fluid surrounds an electrode array that has been implanted in living tissue. These fluids are primarily made up of water. Because parylene is known to absorb water, it is possible that these fluids could become absorbed into the electrode array’s parylene layers. Once the fluid is absorbed into parylene, it can cause the insulating layers to separate from the layers to which they are bonded. The array can then be broken or malfunctioned due to this delamination.

“There is a growing interest in the formation of insulating layers from polymers other than parylene. A liquid crystal polymer is an alternative material that can be used in an electrode array to form an electrically insulating coating. Like parylene this polymer has excellent bonding properties and is flexible when bonded. It also accepts metal layers. A liquid crystal polymer absorbs less water than parylene. Implanted in a living organism, the LCP insulation layer or layers of an array of electrodes absorb minimal amounts of body fluid and are therefore less likely to delaminate.

“The Assignee has been incorporated by reference PCT Pub. No. No. After the array is partially assembled, the liquid polymer is applied to it and left to cure. This assembly method has been proven to be costly. Implantable electrode arrays can be made with liquid crystal polymer layers. The LCP is already in sheet form.

However, it is difficult to make electrode arrays using LCP that has been cured. The reason is that the sheets, when they are applied to the frame or another layer on which they are bonded, often sit unevenly over the underlying surfaces. It is difficult, if it is not impossible, to apply the LCP insulation layers in a way that maintains the bond between the insulating and conductive layers.

This invention is about a novel and useful method for fabricating implantable medical devices. It includes one or more layers of support layers that are a thin, biocompatible film made from a polymer. This method can be used to create a device that provides diagnostic information and/or therapeutic effects. This method allows the fabrication of a device with a substrate, intermediate, or support layer of polymer of a thickness of at least 1 mm.

An electrode array that is designed to be implanted into living tissue can be made according to this invention.

“Accordingly to the invention, the thin film of polymer on which the components are to be made is first applied to a backing. An adhesive is first applied to the backing where the polymer film will be bound in order to accomplish this task. The backing is then covered with 64-plymer film. After the coupon has been applied to the backing, pressure must be applied to it while the assembly is kept at an elevated temperature and below the ambient pressure. The pressure guarantees the bonding between the film and the adhesive coating on its backing. The film must be maintained at an elevated height relative to the backing.

The coupon is attached with the components that provide the intended therapeutic effect or diagnostic. This attachment process may include the selective etching of portions of the coupon in some versions, but not all. You can attach conductive components to coupons by applying layers of metal to the coupon’s exposed face. This metal can be used to make conductors. To form an array of electrodes, the coupon is filled with spaced-apart sections of metal. Sometimes, metal can be deposited through previously created openings in the coupon during the application of metal. These openings can be used to pass metal through the coupon’s insulating layers.

“Also, other components may be bonded to exposed faces of the polymer. These components can include integrated circuits and electrical components. You can mount support members to the coupon. These support members are structural components that give the coupon at least some rigidity. These support members can be made from materials that are plastically malleable, such as metal frames or plastic. These support materials can also be made from materials with some elastic properties, such as Nitinol frame members.

“The section of the polymer film is bent to form a support layer for the device. This can be done mechanically or electronically. This process is often performed before the removal of the backing.

“In some inventions, one coupon may be attached to another coupon. Inverting one of your backed coupons will cause the coupon’s exposed side to be directed at the second coupon’s exposed side. The coupons are then bonded together using thermal compression bonding. After bonding the coupons, the backing of one coupon is removed. This partially finished assembly may have a new LCP layer that is backed.

“As a result of the above processes the work piece under assembly is composed of plural LCP coupon that have been bonded together. These layers are sandwiched with conductors, structural members, and other electrical components.

“Some components can be attached to the exposed side of the outermost LCP Coupon once the multi-layer assembly has been formed. The associated backing is removed from the bottommost coupon. The coupons that don’t form the assembly can be separated from the layers that make it.

This invention allows you to create components from cured sections of thin film polymer, such as liquid crystal polymer (LCP) films. The backing is attached to the film so that the film rises substantially above the backing. The surface of the polymer coupon’s film is flat and smooth. This improves the chances that the entire assembly (the polymer coupon as well as the components attached to it) will be structurally sound. This invention also allows for the bonding of two layers of polymer. This invention also allows for the fabrication of assemblies made from layers of thin polymer films. This multi-layer assembly may contain components that can be used to provide diagnostic information or therapeutic effects.

Another feature of the invention is the ability to shape and process multiple sections of one backed polymer coupon at once. Each section of a coupon can be made to have the same features as a separate assembly. Individual sections can have electrical components or structural components applied to them. Each section of a coupon can be used to create sections for separate assemblies. This invention allows for batch processing of thin polymer films so that each section of the coupon can be used to create layers of finished assemblies.

This method allows the coupon to be removed from the backing. The adhesive that holds the coupon to it is dissolved. The adhesive has been dissolved and the attached components and polymer are free from any mechanical stress. This stress can be eliminated in the same way that it could cause damage to either the polymer support layer, or to any component(s) attached.

“The methods of this method may be used together. Or, the invention can be used in isolation.

“I. “I.

“FIGS. “FIGS. This is an electrode array, and it will be referred to as such throughout this document. The electrode array 50 contains a number 52 spaced apart. The invention’s illustrated embodiment shows the electrodes 52 arranged in a row-by-column pattern. Many electrode arrays 50 made using this method have at least 10 electrodes. Other electrode arrays made according to the invention include 20 or 40 electrodes. Each electrode in the illustrated embodiment of the invention is rectangularly shaped. The function of the array 50 can affect the size and shape 52 of the electrodes. In some embodiments of the invention, an electrode can have a width of 10mm, 5mm, or 2mm. An individual electrode 52 can be as long as 40 mm, 20 mm, 10 mm, or even 5 mm.

“Array 50″ also contains a number control modules 54 (one seen in FIG. 2. Each control module 54 can be connected to one or several electrodes 52. Each control module 54 can be used as an ASIC (application specific integrated circuit). The circuit contains components that can source/sink current to the electrodes 52. FIG. FIG. 2. The control module 54 is shown below the electrode 52 to which it is associated.”

“Conductors 56, 58 (one each) extend from control modules 54. The conductors 56, 58 and 60 are connected to a cable that runs from the electrode array assembly 50’s proximal end. (Here ?proximal? It is located at the bottom 50 of FIG. 1. ?Distal? It refers to the end of FIG. 1.) The individual conductors within cable 60 are not illustrated. The cable 60 is connected to the implantable device controller (IDC 62). The power source for currents between the 42 electrodes is contained in the IDC 62. IDC 62 also includes a controller that generates instructions to indicate which electrodes 52 are to be flown. The present invention does not include the IDC 62 structure.

“Electrode array assembly 50 has a base of 66 which is the most proximal part of the assembly. Nine rows of 52 electrodes are located ahead of base 66. Each row of 52 electrodes is spaced longitudinally from the row or rows that follow. The spacing between rows is usually between 0.5 to 10 mm. The illustrated embodiment of the invention shows six electrodes 52 per row. The array 50 is designed so that each of the four inner electrodes 52 are seated on a rectangularly shaped tab (68). The array 50 is divided on three sides by each electrode-carrying tab68. Two I-shaped slots 70 are interleaved between each row of electrodes 52. The perimeters of the tabs 68 are thus defined by each slot 70. Some versions of the invention have slots 70 that are designed so that each tab (measurement along the longitudinal axis 50) has a length of between 0.5 and 5 mm. This length is often between 2 and 4 millimeters. Each tab 68 is measured along the axis perpendicular the longitudinal axis 50 in FIG. 2) between 0.25 and 2 mm. This width can be found in many versions of the invention. It is usually between 0.5 and 1 mm. Each slot 70 measures approximately 75 microns in distance. The array 50 has two columns of I-shaped slots 70. The two slots 70 are located in each row of 52 electrodes. They are separated laterally from one another and align laterally with each other.

“Immediately ahead of the distalmost row of electrodes 52 array 50, is formed a head 74. Head 74 is located at the distal end of array 50. The arcuately shaped head 74 has a leading edge. This arc forms the leading edge and is located along the array’s longitudinal axis. The front edge of the head 74 has been shaped so that it extends distally from the distal end.

“Array head 74 has two slots 76. The slots 74 are opposite sides and symmetrical relative to the array’s longitudinal axis. Each slot 76 is made up of a number sections. Each slot 76 is composed of a base section (78) that runs parallel to the array’s longitudinal axis and laterally offset from it. Particularly, each slot base section is registered with one of the separate rows of slots 70. Each slot section 76’s most forward part opens into a primary opening. The primary opening 80 generally looks like a triangle. The distal end of head 74 is where the opening 80’s most acute apex is located. Each slot 76 has a distal-directed extension 82. Each distal extension (82) extends forward from 80, the slot primary opening. Each slot distal extension curves distally towards the array 50 from the associated slot primary opening 80. The slot distal extensions 82 curve toward each other but do not connect.

FIG. 2. Frame 88 is embedded in the electrode array 50. Frame 88 is made from superelastic materials. A superelastic material is material which, after being subjected a significant amount of rolling, folding, or bending strain, returns to its original shape. The frame 88 in one version of the invention is made from Nitinol, a nickel-titanium alloy. As seen best in FIG. FIG. 4 shows frame 88, which is made from one piece of Nitinol. It is designed to have a proximal tail 90. Frame 88 also features a 130-degree head that is located forward of the tail 90. From the frame tail 90, three parallel-spaced bridges 114 and 116 are located towards the frame head 130.

Frame tail 90 is composed of two beams 92, 112 that run perpendicularly to array 40. Beam 92 is the proximal beam and the shorter one. Beam 112, which is distal to beam 92, is longer and more proximal than beam 92. Both beams 92 & 112 are centered along the array’s longitudinal axis 40. Between beams 92 to 112. There are many additional beams. Between beams 92 to 112. are two beams 96, 102. Beams 96, 102 and 104 are perpendicular with beams 92 to 112 and run along parallel to frame 88’s longitudinal axis. A beam 94, another beam, extends distally from beam 96 to beam 112. A beam 104 extends distally and outwardly from the side of beam 101 to the adjacent beam 112. The beam 104 that extends outwardly from beam 102 to the adjacent end of beam 112. is located forward from beam 102, from which beams 104 and 96 extend. Beam 106 is parallel to beam 92, and extends between beams 95 and 102. Beam 106 runs perpendicularly to beam 102, at the same location as beam 102, from which beams 104 and 102 extend distally ahead.

“Bridges 112, 116, and 118 extend distally to the forward of beam 112. Bridge 116 is centered on the longitudinal axis for frame 88. Bridges 114, 118 and 116 are spaced symmetrically in relation to bridge 116. Three-sided tabs 120 are located outwardly from bridges 112, 116, and 118. Frame 88 is designed so that tabs 120 have major directions that run parallel to the frame’s longitudinal axis. Tabs 120 are organized in pairs. A tab 120 that extends outwardly beyond a bridge 114 or 116 is joined by a laterally aligned 120 that extends outwardly past the opposite side of the bridge. Tabs 120 also have the added feature that tabs extend outwardly beyond one bridge 114-116-118. The tabs 120 extend outwardly to the sections laterally adjacent to the bridges 120. Frame 88 is constructed such that the tabs 120 are placed in rows. In the illustrated version, each row has six tabs. Tabs 120 are spaced longitudinally apart.

“Some versions of the invention are shaped so that the tabs120 have a length of approximately 0.5 to 4.0 mm. The width of the tabs 120 is the distance that the tab extends from the associated bridge 114 or 116. It can be between approximately 0.5 to 2.0 mm. Each row of tabs 50 in frame 88 are spaced approximately 0.5-4.0 mm from each row of laterally adjacent ones. Frame 88 is also shaped in such a way that any tab 120 that extends from the center-located bridge 116 is separated from any adjacent tab that extends from bridges 114 or118. This separation is usually a minimum 100 microns.

Frame 88 is further shaped so that each tab 120 has a rectangular opening in the center. The tab openings 122 have their major axes at the same level as the tabs 120. Each of the openings 122 has been sized to accommodate a control module 54. The tabs 120 that extend from the bridges 114 or 118’s outer edges have tapered rear and front sections. These sections are perpendicular with the longitudinal axis of a frame. These sections (unidentified) taper so that the tab 120’s length decreases slightly when it extends beyond the bridge 114 and 118 to which the tab is attached. The tab corners (corners not known) are rounded at the edges.

“Several rectangularly shaped beams (124), also part of frame88, link bridges 114 to 116 to 118. Frame 88 is designed so that a beam of 124 runs between bridges 114 and 116 while a beam of 124 extends from bridge 116 to bridge 118. A beam of 124 can be found between bridges 116 and 118. The beams 124 have been arranged so that a pair if laterally adjacent beams are located in front and behind all other tabs 120. The pair of beams 124-6 are immediately in front of the tabs 120’s most proximal row. The illustrated version of this invention shows nine rows of tabs. There are therefore 18 pairs of beams that are laterally adjacent. Each beam 124 is measured in width. This refers to the distance parallel with the longitudinal axis of frame 88. It is usually 2.0 mm, but more often it is 0.5 mm.

“As mentioned above, the tabs 120 that extend from bridge 116 are separated from adjacent tabs 120 integral to bridges 114 or 118. The tabs 120 are separated longitudinally from the inter-bridge beams 124. There are I-shaped slots (123) around the tabs 120, which can be found between bridges 112 and 116 as well as between bridges 126-7 and 118. As we have seen, the primary void for each slot 123 is the void for one of the array slots 70. Each frame slot 123 is therefore substantially the same shape as an array slot 70. Each frame slot 123 is approximately 25 microns larger than an array slot70.

Frame head 130 is designed to have slots 132 and 130. Each slot 132’s void is the primary space of an array slot 76. Each slot 132 is therefore the same shape as the associated array slot 76.

“Returning back to FIG. “Returning to FIG. 2 it is clear that two layers of liquid crystal plastic (LCP), insulating material, are placed around the opposing surfaces of frame.88. LCP layer 136 is placed over the passive side 88 of the frame and the control modules 54 within the frame. (The ?passive? (The?passive? side of the array/frame corresponds to the side where the electrodes 52 are located. The?active? The?active? Seite of the array/frame is where the electrodes 52 are located. LCP layer 136’s outer surface acts as the passive side of the array 50. LCP layer 138 is the first intermediate LCP and is placed over frame 88. The passive side of LCP layer 138, which is not placed against frame 88 or control modules 54, is covered by layer 136. Layer 140 is the second intermediate LCP and is placed over layer 138’s active side. Layer 142 is the third intermediate LCP and is placed over layer 140. Layer 144 is an active side LCP layer that is placed on the active side of layer 140. LCP layer 144’s outer surface functions as the active side exposed front of the array 50.”

“The active side LCP layer144 contains the electrodes 52. The second intermediate LCP layer 140 contains one layer of conductors, specifically 56. The third intermediate LCP layer 142 contains a second layer of conductors. Specifically, conductors 56. Vias 146 are formed between control modules 54, 56 and LCP intermediate layer. They extend through this layer. Vias 148 are formed between the control modules 54, and conductors 56 and extend through LCP intermediate layer 138 and 140. The electrical connections between control module 54, and conductors 56, and 58 are provided by the vias 146, 148. Plural vias 150 are formed within and extend through intermediate LCP layer 138, 140, and 142. Each via 150 is an electrical connection between the control module 54 and the electrode 52 to which it is associated.

“II. “II. Method of Assembly”

“The assembly and assembly of the plural electrode array 50, or the batch assembly of plural arrays 50 starts with the fabrication of plural frames. 88 The frame 88 is made by cutting a section of the material to which it will be formed. This sheet is called a coupon 160 (see FIG. 3. The described invention coupon 160 is made from Nitinol. It has a thickness of between 25 and 100 microns. Frame coupon 160 is 10 microns thicker than the heights of control modules 54, which are located in frames 88.

“Using chemical etch processes, sections of coupon 160 are removed in order to create a number of through openings. To prevent them from being removed, coupon sections that will remain in the frame are masking prior to the etching. These openings are defined by the etching process and include through openings that both define the outer perimeter of plural frames (88) as well as the structural characteristics of each frame. A slot 162 is shown in FIG. 4. The slot 162’s width varies around the perimeter of the associated frame 88 to determine the outer shape of this frame. Slot 162 has a narrow width where the tab 120 extends from one of bridges 114 and 118. Slot 162 is adjacent to the tab-free sections of bridges 112 and 118. It has a wider width.

“In this etching stage, each slot 162 has been formed so that the frame 88 is not completely separated from the coupon’s surrounding portion. Instead, the slot 162 can be broken up into sections using a variety of retaining tabs 164. Each tab 164 (one shown in FIG. 4A) is between the frame (one in FIG. FIG. 4A shows only one tab 164, but typically multiple tabs 164 extend between frames 88 and 160. Two tabs 164 are present in the described embodiment of the invention. The tabs 164 are located opposite the longitudinal center axis (88) of the frame with which they are associated.

“In some embodiments of the invention, plural-etching or other materials removal processes are performed to the coupon 160 in order for the frames 88 to be defined. The plural etching process is used to shape the coupon 160 so that its tabs 164 are less thick than the remaining coupon 160. These plural etching procedures are used in some versions of the invention to make the tabs 164 thicker than the portions of coupon 160 that have not been removed.

“Oxide is applied to the coupons that form the frames 88 after the Nitinol coupon 160 has been shaped. First, you must mask off any portions of the coupon 160 that are not intended to function as array frames. The mask is usually a photo-resisting resin. The coupon is then placed in a chamber, and the silicon oxide is applied to the unmasked area. The plasma enhanced chemicalvapor deposition process is used to deposit the oxide. As shown in FIG. 5. In FIGS. 163 and 163, the silicon oxide coating is shown. 5, 15, and 15 have a thickness of between 1000 and 10,000 Angstroms. Some versions of the invention have the coating thicknesses ranging from 1,500 to 4000 Angstroms.

The coupon 160 can be shaped to form the frames 88. If the array 50 is intended for use over tissue that isn’t planar, this processing may be performed. Frames that are still part of coupon 160 are bent permanently so that they approximate the contour of the tissue to be applied with assembly arrays 50. If arrays 50 are to be applied over the spinal cord then each frame 88 should be shaped so that on one side its longitudinal axis the frame curves out from the plane of coupon 160. The frames 88 that extend beyond the coupon 160 are not illustrated.

You can frame shape by pressing the coupon 160 between opposing dies. The attached frames 88 can be bent by the die’s geometric features. After the frames 88 have been pressed into the desired shape, heat is used to set the frames. Heat can be generated by heaters within the individual dies, external heaters, or heat transfer from the liquid around the dies. The carriers are able to bend and heat simultaneously the frame 88 in the desired manner, and can undergo plastic deformation.

“A coupon for LCP, coupon 176. First seen in FIG. 8 is designed to identify the plural passive side LCP layers (136), to which the frames are bonded. FIG. FIG. 6 shows the process. It starts with placing a backing 172 onto a vacuum chuck 170. A vacuum chuck is an object, such as a wafer, that can be held by a vacuum drawn and that can spin. As discussed below, this particular vacuum chuck 170 can be rotated at speeds of up to 10,000 RPM. Backing 172 is made from a rigid material that can withstand the above described processing steps without cracking. Backing 172 is a silicon wafer in one form of the invention. It has a shape similar to a circle, with a section at one end. Backing 172 can have a width of 150 mm or a thickness of 500 nm.

“Once backing 170 has been positioned on chuck 170 a adhesive 174 can be evenly applied to the backing’s exposed face, as shown in FIG. 7. Backing 172 uses one such adhesive. It is made from a mixture of phthalic acidide and ethanediol, which is sold under the trade name CRYSTALBOND by electron Microscopy Services, Hatfield, Pa., USA. After the adhesive 176 has been applied to backing 172, it is important to rotate chuck 170 so that the adhesive 176 is properly applied. For approximately 10 seconds, chuck 170 rotates at approximately 500 RPM. The adhesive is spread over the entire backing by rotating chuck 170, and then backing 172 and adhesive 173. Chuck 170 can be rotated at speeds between 1,000 and 3,000 RPM for about 5 to 20 seconds. The adhesive 174 is evenly distributed over the entire backing by rotating the backing 172. These spins are done at room temperature. The backing 172’s exposed surface is covered with adhesive 174. This layer is about 1 to 5 microns thick. The adhesive 174 is applied over backing 172 to reduce variation of thickness by less than 1%.

After adhesive 174 has been evenly spread on backing 172, the backing can be seated on a press-chuck 175 as shown in FIG. 8 blocks.

“After backing 172 has been transferred to the press adhesive 174 is applied backing 172. The LCP coupon 176 is then applied to the adhesive’s exposed surface as shown in FIG. 8. Coupon 176 has a thickness 50 microns. LCP coupon 176 is shaped in a way that approximates backing 172. Coupon 176 has an area greater than that of layers 136, which is the support layer that the coupon was designed to form. The surface area of coupon 176 is also smaller than that of backing 172. LCP coupon 176 is specifically shaped so that the coupon’s outer perimeter is approximately 5-50 microns inwardly of the backing 172. This difference in surface area is illustrated in the drawings.

“As also shown by FIG. 8 – A glass plate 178 is placed over the LCP coupon 175. Plate 178 is between 0.5 and 3.0 cm thick. Glass plate 178 has an area so that it extends beyond both the coupon 178 and backing 172. Particularly, although not visible in FIGS. 8. and 9. Plate 178 extends at most 0.5 cm beyond backing 172. Two of the clamps 180 shown extend from the glass coupon’s exposed surface to press chuck 175. Glass plate 178 is held by clamps 180 to hold it in place. The clamped assembly can then be transferred to a bond chamber 182, where the pressure can be controlled. FIG. FIG. 9. Bond chamber 182 is represented in the background rectangle.”

“Clamps 180 have been removed. The LCP coupon 176 is removed from glass plate 178. Press chuck 175. The backing adhesive-LCP coupon assembly has been lifted. (Steps are not illustrated). FIG. As shown in FIG. 11., the LCP Coupon 176 is now securely attached to the backing172 by adhesive174. 11. The outer surface of coupon 176 has a uniform height over its backing 172 due to the heat and vacuum pressing. This is the “uniform height” It is understood that the height at which the LCP coupon 176 is placed above backing 172 is not uniformly distributed by less than 5%, and more often 1.5%.

LCP coupon 176 can now be added to the code. In a series of steps, it can be bent into plural array passive side LCP layers. This process involves removing portions of coupon 176. The photo resist is first applied to the coupons 176 that do not have slots. The unmasked parts of the LCP coupon can then be removed using an oxygen plasma reactive Ion etching process (O2 PlasmaRIE). The remaining coupons 176 are then stripped of any mask material. These steps are done while coupon 176 is still bonded to backing 172. These processes resulted in coupon 176 appearing as shown in FIG. 12. This Figure LCP coupon looks substantially the same as it did in FIG. 11. As shown in FIG. 12 shows two of the slots shown in FIG. Each of the LCP coupon 176 slots becomes a section of one the slots 70 or 76 that extends through the array 50. For example, slots 184 and 186 are sections of one tab 68-defining slot 70. It will be apparent that the array 50 will be constructed between slots 184-186.

“In the next set of steps, the frame coupon 160 will be bonded to the LCP coupon coupon 176’s exposed face. This surface is exposed to oxygen plasma in preparation for bonding. This is done in a vacuum chamber. The LCP coupon’s surface is roughened by the oxygen plasma. The exposure lasts approximately 20 minutes.

Frame coupon 160 is placed over the LCP Coupon 176 once the surface has been roughened. The frame coupon 160 is positioned so that frame coupon slots 123, 132 and 176 are in registration with the LCP coupon. FIG. 15 where the parallel sections of the one frame coupon I-slots123 are in registration over those LCP coupon slots184 and186. FIG. FIG. 13 shows the extent to that the outer margin of LCP coupon176 is inwardly receded from back 172. FIG. 160 shows the extent to the which the outer edge of frame coupon 160 is inwardly receded from the LCP coupon’s outer perimeter. These are only illustrations.

“Once frames 88 have been bonded to LCP coupon176, the sections 160 of the frame coupon 160 that are not part of the frames can be lifted from the LCP coupon176. This is done by first mechanically serving tabs 164 (FIG. 4) from the frames. Manually removing the remaining coupon 160 from the LCP coupon 175.

“The partially assembled arrays are created by the removal of remnants of the frame coupon 160 and the LCP coupon176. 14, 15. The plural frames 88 are bonded with the LCP coupon176. FIG. FIG. 15. This is a section of 88. More particularly, FIG. FIG. 15 shows a cross-section through one tab 120 adjacent beams, 124 in a single frame. It is seen that the tab opening 122 is placed over an underside section of the frame, which forms LCP coupon 175. Each of the LCP coupons slots 184 and186 are located between the frames tab 120 and the adjacent beam 124, due to the location of the frames 88 on LCP coupon176.

“As shown in FIG. 16. The next step in batch assembly of electrode arrays 50 will be the placement of control modules 54 into the tab openings. 122 The control modules 54 are electrically protected by the oxide coating 163, which is placed around the frames’ window-defining edges 88.

“Prior the first intermediate LCP layer, LCP layers layers 138, being applied on the frames 88. These layers 138 were fabricated with a LCP coupon coupon 196 in FIG. 17. LCP coupon number 196 is made from the same material that LCP coupon number 176. LCP coupon number 196 has a thickness between 75 and 150 microns. LCP coupon number 196 can be processed by placing coupon 196 on a backing. Backing 192 is in FIG. 17. Layer 194, an adhesive layer holds LCP coupon 696 to backing 192. LCP coupon number 196 is attached to backing 192 using the same process as LCP coupon number 176. These process steps won’t be repeated. These process steps can be used to obtain the LCP coupons 224 to 244 and 266 to, respectively backings 220, 234 and 262.

“After LCP coupon number 196 has been attached to backing 192,” plural recesses 198 will be formed in coupon 196. Each recess of 198 doesn’t extend through coupon 196. Each recess 198 is confined to the coupon’s outer surface and extends inwardly to a depth that is at least equal to the thicknesses of the frames 88. LCP coupon 196 creates recesses 198 by first masking the coupons 196 that do not contain the recesses. The recesses can then be formed using the oxygen plasma RIE method in the unmasked areas of the coupon 196. The aluminum mask can then be removed. As seen best in FIG. FIG. 21 shows that each recess has an outline that is identical to the shape of the frame. Each recess 196 is equal in size to the area of the recess 88. The depth of recesses 196 is at minimum equal to the thicknesses of frames 88.

After recesses 198 have been formed in LCP coupon 196 the coupon is then subject to a second oxygen plasma RIE treatment. The etching process creates a variety of openings. FIG. 19 shows these openings. 19 extends from the base recesses 198 all the way to the end of the LCP Coupon 196. Many of these openings can be represented by slots 202 or 210 in FIGS. 19, 21 and 212, respectively, in FIG. 21. These slots 202 to 210 are part of the array slots 70, 76 after they have been assembled. Specifically, the slots 202 and 220 are two different sections of one of the array I slots 70. Each slot 212 is a part the array slot 76.

“In the LCP coupon number 196, another set of openings is formed, through bores 209, 206, and 208. Each through bore 204 has a circular cross section with a diameter between 5 and 1000 microns, and sometimes 50 to 250 microns.

FIG. 20. Bores 204,206, and 208 are used to deposit metal, such as gold. This gold is deposited in one step. First, a thin layer (approximately 500 Angstroms) of titanium is applied using a sputtering process that covers the entire coupon 196. The titanium bonds to the LCP coupon number 196’s inner cylindrical walls, which define the bores of 204,206 and 208. The titanium layer is then covered with a gold layer of approximately 1000 Angstroms. This layer is applied to the entire coupon 196 by sputtering. This titanium layer is first applied, as titanium adheres well both to LCP and gold.

“Once the thin layer of gold has been applied, gold can then be plated in bores 204-206 and 208. This plating is done by masking the coupon so that only bores 204-66 and 208 are visible. An electroplating process is used to apply the gold so that the bore can be filed. The previously applied gold acts as a seed layer, to which the electroplated golden bonds. The mask layer that was gold-covered is removed. The remaining coupon is then removed from the thin layers covered in titanium and gold.

The metal in bores204 acts as an array via 146 between control module 56 and conductor 56. Bores 206’s metal cores function as sections of array vias148 that run between the control module 56 and the conductor 58. Bores 208’s metal cores function as sections of array vias 150 between the control module 54, and the overlying electro 52. FIG. FIG. 20 shows these cores of metal identified by the vias they become.

LCP coupon 196 is now available by adding the via-forming metallic. FIGS. 20 and 21. The coupon 196 contains a number recesses, namely 198. Each recess 198 can receive a frame 88. There are a number of slots, 202, 210, and 212 that extend from the base of each recess, 198, through polymer to the opposing face of coupon 196, which is bonded to the adhesive layer 194. These slots correspond to the sections of the array slots. Each pair of slots 202, 210 belongs to one of the array I slots 70. The slots 212 and 76 are located in the array head. FIG. 2 shows plural metal columns. 21 is represented by a black dot. It extends from the base of the recess 198 to face of coupon 196.

“Once LCP coupon number 196 has been formed to delineate the plural LCP intermediate layers, 138, the coupon number 196, attached to backing 192, is inverted (step non shown). The LCP coupon number 176 is inverted and the inverted coupon 196 is placed in registration. FIG. 22. The two coupons 176 & 196 are aligned so each recess of coupon 196 is registered over the one in frame 88.

FIG. 23. The frames 88 and control modules 54, which were previously installed in the frames, are now seated in the recesses. 198 The outer surfaces of LCP coupon 176 and 196 meet. You should know that the LCP coupons 176 and 196 have via forming metal columns. These metal columns sit over the bond pads 54. (Control module bond pad not illustrated.)

“Inverting LCP coupon number 196 and positioning coupon 196 over coupon 171 should be a reminder that coupon 196 is in fact positioning coupon 196.

The coupons are joined by a thermally-induced pressure bond after the LCP coupons 176 & 196 have been pressed together. The LCP from the opposing coupons 176 and196 becomes semi-liquid, and the two together form a unitary structure. These plural LCP coupons and the plural array LCP layers are shown as separate layers to aid understanding of the invention.

“Once the assembly has been removed from the oven it will appear as shown in FIG. 24. Between the LCP coupons 176-196, the control modules 54 and frames88 are embedded. LCP coupon176, the coupon forming layers 136, remains bonded to backing132. This coupon extends through vias 146-148 and 150.

“An LCP coupon, coupon 224, in FIG. 25 is designed to form the plural intermediate LCP layers 140. Coupon 224 is between 10 and 50 microns thick. To secure coupon 224 to its backing (backing 220 in FIG.), the previously mentioned bonding steps are used. 25. It can be seen here that adhesive layer 222 holds LCP coupon 220 to backing 223. LCP coupon number 224 has a thickness between 10 and 50 microns. LCP coupon 224, after it has been thermally compressed bonded to the backing 220, is not shown. This drawing would be identical to FIG. 17 shows LCP coupon number 196 after it has been press bonded to backing 192. This drawing is therefore omitted.

LCP coupon 224, bonded to backing192, a series 228 grooves (one shown) is etched on the coupon’s exposed face. Grooves 228 were formed using the LCP coupon 224. Grooves 228 can be formed by using the same etching steps that were used to create recesses 198 and 196 in LCP coupon 269. The grooves 228 have a depth of 5-15 microns relative the LCP coupon 224. Grooves 228 are generally rectangular in cross-sectional shape.

“LCP coupon number 224” can also be shaped to create a variety of openings as shown in FIG. 26. Slots are a type of LCP coupon opening. They are represented by slots 226 or 234. These slots are segments of the array slots 70-76. Coupon slots 226 and 234, respectively, are different sections of what when the array 50 has been assembled. The I-shaped slot 70 is also one of these I-shaped slots. LCP coupon coupon 224 slot sections 226 and 234 are almost identical to the sections 202, 210 and 226 of LCP coupon.196.

“The second type openings in LCP coupon 224, are those through which conductors forming sections vias 148 or 150 extend. FIG. FIG. 26 shows these openings through bores 231 and 223. The through bores 223 and 232 are analogues to the bores 206, 208, formed in LCP coupon number 196. Bores 230, 232, and 208 have the same cross sectional dimensions and shape as bores 296, 208, respectively.

“In a series, the metal is first placed in bores 230-232, and then in grooves 228, in a sequence of steps. Initialy, a gold seed layer and a titanium adhesion are placed over the entire coupon 224. These layers are the same thickness as those described previously. A photo resist mask is then placed on top of the LCP coupon 224. Only the bores 230 & 232 are left exposed by the mask. Bores 230, 232 are then filled with gold using an electroplating process. This is followed by the removal of the first mask. Coupon 224 is then covered with a second mask. The outlines of grooves 228 are left exposed by this mask. The coupon 224 then goes through a second electroplating step. This is where gold is used to fill in the grooves 228. After this electroplating process is complete, the mask, underlying gold and titanium layers will be removed. It is important to understand that the first electroplating process is to ensure that the gold rises above the bores 230 & 232. To ensure that the exposed face on the LCP coupon 226 is uniformly plated with the gold, the second electroplating is done.

“As a result of the selective plating coupon 224, it appears as in FIGS. 27, 28. The grooves are 228 in the gold. These are known as conductors 56. Bores 230 and 223 are used to store gold cores. These cores are section of vias 148 or 150 and are identified by their identification. FIG. FIG. 28 shows the exposed face LCP coupon 224. LCP coupon coupon 224’s face is planar as it will meet LCP coupon coupon 196’s exposed planar face. The LCP coupon 224’s face is marked with 236 dashed lines. These lines represent the boundaries of individual LCP intermediate sections 140 that will be formed by different sections. There are three main branches of conductor 56 within each section of LCP coupon 224. Each boarder defines a specific section. The branches extend from the trunk conductor, not illustrated, but formed on the LCP coupon 224. Each primary branch has a number of secondary branch conductors. Plural pairs of dots are also shown within the sections of LCP coupon 224. These dots are the heads of partially formed vias 148 & 150.

Once LCP coupon number 224 has been fabricated, the coupon is inverted. LCP coupon is placed over LCP coupon number 196. LCP Coupon is placed so that LCP Coupon 224 slot sections 226 & 234 are registered with LCP Coupon 196 slot sections 209 and 210; conductors56 are in registration over vias146; via sections 146 & 150 of LCP Coupon 224, and in registration with LCP coupons 176. LCP coupon coupon 224 is bonded to LCP coupons 176 using the same process. Illustrations of these steps should not be repeated as they are almost identical to those used to bond LCP coupon 161.

LCP coupon 228 is bonded to LCP coupon 193. After that, backing 220 can be removed from coupon 224. To remove backing 220 from coupon 196, follow the same steps as for backing 192. These steps are completed and a number 50 partially assembled electrode arrays 50 can be disposed of on backing 172. FIG. FIG. 29 shows a portion 50 of this array. Control module 54 is located in the frame tab 120. The tab 120 and the adjacent beams 122 are placed between LCP coupons176 and 196 which, respectively, form layers 136, and 138. LCP coupon 194 is used to dispose of the LCP coupon 224. It forms plural second intermediate LCP layers 140.

FIG. 244 shows an LCP coupon 244. The LCP coupon 244, as shown in FIG. 30, is then processed to create plural third intermediate LCP layer 142. LCP coupon 24 has a thickness that is similar to coupon 224. Initially. LCP coupon 244 is bonded with a backing 240 by following the previously mentioned LCP-to?backing bonding procedures. Although not illustrated, the end result is identical to the backing and LCP coupon assemblies of FIG. 17. Layer 242 is a layer of adhesive that holds coupon 244 and backing 240.

“Plural grooves 248, one of which is shown in FIG. 30 are then formed in LCP Coupon 244. Grooves 248, which are integral to LCP coupon 244, have a cross-sectional geometry similar to grooves 228. They also share the same width and depth dimensions. Grooves 248 refer to the void spaces within the LCP coupon 244 where the metal forming array conductors (58) can be deposited. In LCP coupon 244, the grooves 248 are formed at the locations where conductors 58 must be present.

“Once grooves 248 form in LCP coupon 244, plural openings are illustrated best in FIG. 31 are found in the coupon. These are called slots. These are slots that run through an individual array and are sections of the slots 70 or 76. FIG. 31 are shown with slot sections 246 & 252 illustrated in FIG. Sections 246 and 252 represent portions of an I-shaped slot 70 that runs through the array.

Bores 250 are the other type of openings that can be formed in LCP coupon 244, as shown. Bores 250 are used to receive metal deposits that, after forming the arrays 50, become portions of vias 150.

Once the coupon has been opened, the metal can be deposited in the grooves 248, and the bores 250. You can use the same steps to deposit metal into grooves 228 and bores 230 and 223 of LCP coupon 224, as well as in bores 250 and 248 of LCP coupon 228. FIG. shows the results of depositing this metal. 32. The conductors 58 will work as metal that is deposited in grooves 248, and the metal that is identified as such is 248. The metal cores formed in bores 250 are the same as sections of vias 150 and are therefore identified as such.”

Once LCP coupon 244 has been fabricated, the coupon is inverted. LCP coupon 244 should be placed over LCP coupon 224. LCP Coupon 244 is placed so that LCP Coupon 224 Slot Sections 246 and 252 and conductors58 are registered over vias148; via sections 256 off LCP Coupon 244 and via sections 238 in LCP Coupon 224. To bond LCP coupon 244 and LCP coupon 224, the same steps are used. The steps for positioning and bonding LCP Coupon 196 are almost identical to those described previously. These steps are not repeated.

The backing 240 can then be lifted off LCP coupon 244 by following the previously described backing lifting off process. The partially assembled electrode arrays 50 are still bonded to backing172. FIG. FIG. 33 shows that the partially assembled electrode arrays include an LCP layer, which is not present in FIG. 29. The LCP coupon 244, which is the third intermediate LCP layer 142, is now disposed of over coupon 224. This coupon forms the second intermediate LCP layer 140. The conductors 58, and portions of 150 are embedded in the LCP layers.

FIG. 266) shows an LCP coupon. 34 is designed to create the plural active side LCP layer 144. Coupon 266 must be at least 50 microns thick. Coupon 266, which is used to process coupons, must be first bonded to the backing 262 using adhesive layer 264.

“Once the LCP coupon 266, which is attached to backing 262, is secured, plural rectangularly shaped recesses or openings are created in the coupon, as shown in FIG. 34. These openings and recesses are created in multiple oxygen plasma RIE processes. The coupon 266 is formed by a first oxygen reactive ion engraving process. Slots are created to allow the coupon to extend fully through the coupon. FIG. 34 of these slots are represented in FIG. After assembly 50 of each array, the through slots 276 and 270 become sections of slots 70 and 76 which extend through the array. Rectangular recesses 272, shown in the first etching, are made using LCP coupon 266, Each recess 272 serves as the void space in which, in a later step, the metal that will form the base pad for each electrode 52, is deposited. The second etching process creates recesses 272 that are identical in shape and dimension to array electrodes 52. Recesses 276 have a depth of about 5-40 microns. Through openings 274 are formed by the third oxygen plasma RIE. These openings extend downwardly from the base of recesses 270. Each through opening 274 is circular in cross-section and has a diameter between 10 and 300 microns. The base of each through opening 274 is the recess 266, from which the opening extends to face 266.

The metal is then placed in recesses 272 or openings 274 to create the electrodes 52. The masking of coupon 266 is an initial step. Only the through openings 274 of the coupon are left unmasked. The sputtering process then deposits the iridium into the through openings 274. However, the iridium isn’t deposited in full to fill all of the openings 274. The iridium is only partially filled by the coupon 266 that was disposed against backing 262. Each opening 274 is only partially filled. The 5-10 microns in the top of each opening 274 are not filled. While the mask is still in place, titanium can be sputter-deposited on the coupon 266, to fill the remaining openings 274 Each through opening contains a column made of metal. The lower part is iridium and the upper is titanium. Each one of these metal columns can be considered an integral button 282 to the electrode 52. FIG. FIG. 35 shows an electrode, but the plural metal layers that make each button 282 is not illustrated.

The first mask can be removed once the electrode buttons 282 have been formed. The entire LCP coupon 266 is covered with a titanium adhesion layer of approximately 500 Angstroms. The titanium layer is then covered with a gold seed layer of approximately the same thickness. The coupon 266 is then covered with a second mask. The only parts of the coupon 266 that are left exposed by the second layer of masking are the recesses 272. The recesses are then filled with gold by electroplating the LCP coupon 266, which is made of gold. “The mask, as well as the titanium and gold that were underneath it, are removed.”

“The electrodes 52 can now be considered fabricated after the mask has been removed. FIG. 35. The electrode has a gold base pad 288, and the recess LCP coupon contains the recess 272. The base pad is covered by the LCP, which runs through the base pad and the exposed face 266 of the polymer coupon 266, where there are many buttons 282. The electrode 52’s exposed surfaces are formed by the exposed faces of the iridium cores. Because iridium provides an excellent interface against living tissue, buttons are made with iridium faces. Because titanium adheres well with iridium liquid crystal polymer, gold and gold, the buttons 282 have titanium sections.

FIG. 36. FIG. FIG. The coupon 266’s face is planar. The coupon 266 has many slots. FIG. FIG. 36 shows only two sections of slot, the sections 270 and 276, respectively. These slots are made into sections of the array slots 70-76 after the fabrication of the array 50. The exposed surfaces of electrode base pads 280 are visible on LCP coupon 266, which is also visible from the exposed face.

After the LCP coupon 266 has been shaped and the metal layers have been deposited, the coupon 266, is bonded to LCP coupon 224. LCP coupon 266 is positioned above LCP coupon 224. LCP coupon 266 should be positioned against LCP Coupon 224 so that LCP coupon 224’s gold base pad 280 for each electrode 52 is placed against the face of the complimentary via 150. LCP coupon 266, which is bonded to LCP Coupon 224 via the thermal induced compression bonding procedure, is now completed. Vias 150 bond to LCP coupon 266 by thermal induced compression bonding process. The backing 262 can then be lifted from LCP coupon 266, using the previously described backing lifting off process. This stage of the assembly of plural electrode arrays 50 is when an array in cross-section would appear in the assembled form depicted in FIG. 2.”

The plural electrode arrays 50 are still bonded to backing 172. Each of the 50 arrays are a part of a laminate structure made by the LCP coupons 176 to 196, 224, 244 or 266. To separate the arrays and the surrounding laminate sections from the backing 172 before removing them, LCP laminate cuts are made. This is done by a press.

“Once arrays 50 have been defined on backing 172, the arrays can be removed from backing and the surrounding remnant LCP lamination. The backing adhesive 174 is then removed from the backing. This is done by following the previously mentioned backing liftoff process. The arrays are then dried and cleaned before being tested for their functionality.

“Post-manufacture of the electrode array assembly 50, there are substantial portions that consist of the stacked layers LCP film layers 136 to 138 and 140 to 142 to 144, which are stacked one upon the other. These layers do not contain any electrical components, conductors, or support members. These LCP film laminations make up the body of the array, which extends from frame 88. This body can be thought of as membranes that extend beyond the section of the array where the frame 88 is embedded. Referring to FIG. Returning to FIG. 1A, there are two such membranes. Membras 302 is the LCP film laminate section that extends between longitudinally adjacent frame tabs 120, which extend outwardly beyond frame bridges 114 or 118. FIG. FIG. Other membranes, such as membranes 304 extend into the rectangular spaces between bridges 114-116, 118, and beams 124.

“Also, while it is not obvious, it should be noted that the frames slots 123 and 132 have LCP layers 136 or 140 which overlap by at least 25 microns. These LCP layers cover all exposed edges of frame 88.”

Summary for “Method for fabricating implantable medical device from a polymer coupon that has been bonded to a rigid substrate.”

There is a growing interest in articles of manufacture that have one or more layers supporting layers made from thin film polymers. What is a thin film polymer? A thin film polymer is a polymer with a thickness less than 1 mm. This polymer is a good substrate, or carrier layer, on which electrically-conductive traces can form. This polymer is thin enough in cross-section to allow for mounting of electrical, mechanical and electromechanical components. This polymer has another advantage: it can support components and conductors but is flexible. This polymer can be used as a substrate to support components and conductors that may be required by the assembly’s intended purpose.

An implantable medical device is one example of such an article. These devices can be implanted in a living organism, whether it is a human or a species, to provide diagnostic or therapeutic purposes. An electrode array is one example of such a device. An electrode array is a device that has multiple exposed electrodes mounted on a frame or carrier. The array also includes conductors that act as the components of the array. They are used to source or sink currents from individual electrodes. The actual components that supply current to the array are mounted to some electrode arrays. The array is intended to be inserted against living tissue, such as a human. The array is designed to allow current flow through tissue. The following therapeutic purposes have been suggested or used to select current flow through a patient: pain management, cardiac arrhythmia correction, appetite suppression, control of incontinence, and overriding damaged neurological connections that have caused loss of muscle control and/or loss feeling. Another use of these arrays is to monitor electrical impulses generated in the brain. The array’s electrodes transmit signals that are representative of these electrical impulses, to other components. These signals may be used by the array components to control devices that they are connected. These devices can include exoskeleton units with mechanical power that move an individual, as well as robotic linkages and artificial speech generation.

“The Applicant?s Assignee?s FOLDABLE and IMPLANTABLE Electrode ARRAY ASSEMBLY, AND TOOL FOR IMPLANTING THE SAME, PCT Pub. WO 2009/11942 A2, U.S. patent application Ser. No. No. Pub. No. No. No. No. Pub. No. No. These publications generally include an electrode array, also known as a carrier, made from elastic material. These frames are used to hold the electrodes. These disclosures use Nitinol as a nickel-titanium alloy to make the frames. These frames are conductive and it is necessary that the electrodes be formed over electrically insulating layer. It may be possible to apply parylene C to the elastic Nitinol carrier to make this material the insulating support. According to these documents, it is possible to apply multiple layers of parylene. Once cured, each layer serves as the substrate for one or more conductor components. The layers of parylene closest to the elastic carrier are cured and serve as support layers for conductors. The outer layers of parylene have two purposes. These layers are the electrically insulating outer skin of the array. The support layer that the array electrodes are made is usually at least one of these layers.

“Parylene is an excellent electrical insulator. It bonds well with superelastic materials like Nitinol and is flexible once it has cured. It also accepts metal layers that have been selectively etched to create conductors or electrodes. These desirable properties are ideal for an insulating coating that forms part of an implantable array. Parylene is not suitable for use as an insulating layer in an implantable electrode array. Parylene is able to absorb large amounts of water. A body fluid surrounds an electrode array that has been implanted in living tissue. These fluids are primarily made up of water. Because parylene is known to absorb water, it is possible that these fluids could become absorbed into the electrode array’s parylene layers. Once the fluid is absorbed into parylene, it can cause the insulating layers to separate from the layers to which they are bonded. The array can then be broken or malfunctioned due to this delamination.

“There is a growing interest in the formation of insulating layers from polymers other than parylene. A liquid crystal polymer is an alternative material that can be used in an electrode array to form an electrically insulating coating. Like parylene this polymer has excellent bonding properties and is flexible when bonded. It also accepts metal layers. A liquid crystal polymer absorbs less water than parylene. Implanted in a living organism, the LCP insulation layer or layers of an array of electrodes absorb minimal amounts of body fluid and are therefore less likely to delaminate.

“The Assignee has been incorporated by reference PCT Pub. No. No. After the array is partially assembled, the liquid polymer is applied to it and left to cure. This assembly method has been proven to be costly. Implantable electrode arrays can be made with liquid crystal polymer layers. The LCP is already in sheet form.

However, it is difficult to make electrode arrays using LCP that has been cured. The reason is that the sheets, when they are applied to the frame or another layer on which they are bonded, often sit unevenly over the underlying surfaces. It is difficult, if it is not impossible, to apply the LCP insulation layers in a way that maintains the bond between the insulating and conductive layers.

This invention is about a novel and useful method for fabricating implantable medical devices. It includes one or more layers of support layers that are a thin, biocompatible film made from a polymer. This method can be used to create a device that provides diagnostic information and/or therapeutic effects. This method allows the fabrication of a device with a substrate, intermediate, or support layer of polymer of a thickness of at least 1 mm.

An electrode array that is designed to be implanted into living tissue can be made according to this invention.

“Accordingly to the invention, the thin film of polymer on which the components are to be made is first applied to a backing. An adhesive is first applied to the backing where the polymer film will be bound in order to accomplish this task. The backing is then covered with 64-plymer film. After the coupon has been applied to the backing, pressure must be applied to it while the assembly is kept at an elevated temperature and below the ambient pressure. The pressure guarantees the bonding between the film and the adhesive coating on its backing. The film must be maintained at an elevated height relative to the backing.

The coupon is attached with the components that provide the intended therapeutic effect or diagnostic. This attachment process may include the selective etching of portions of the coupon in some versions, but not all. You can attach conductive components to coupons by applying layers of metal to the coupon’s exposed face. This metal can be used to make conductors. To form an array of electrodes, the coupon is filled with spaced-apart sections of metal. Sometimes, metal can be deposited through previously created openings in the coupon during the application of metal. These openings can be used to pass metal through the coupon’s insulating layers.

“Also, other components may be bonded to exposed faces of the polymer. These components can include integrated circuits and electrical components. You can mount support members to the coupon. These support members are structural components that give the coupon at least some rigidity. These support members can be made from materials that are plastically malleable, such as metal frames or plastic. These support materials can also be made from materials with some elastic properties, such as Nitinol frame members.

“The section of the polymer film is bent to form a support layer for the device. This can be done mechanically or electronically. This process is often performed before the removal of the backing.

“In some inventions, one coupon may be attached to another coupon. Inverting one of your backed coupons will cause the coupon’s exposed side to be directed at the second coupon’s exposed side. The coupons are then bonded together using thermal compression bonding. After bonding the coupons, the backing of one coupon is removed. This partially finished assembly may have a new LCP layer that is backed.

“As a result of the above processes the work piece under assembly is composed of plural LCP coupon that have been bonded together. These layers are sandwiched with conductors, structural members, and other electrical components.

“Some components can be attached to the exposed side of the outermost LCP Coupon once the multi-layer assembly has been formed. The associated backing is removed from the bottommost coupon. The coupons that don’t form the assembly can be separated from the layers that make it.

This invention allows you to create components from cured sections of thin film polymer, such as liquid crystal polymer (LCP) films. The backing is attached to the film so that the film rises substantially above the backing. The surface of the polymer coupon’s film is flat and smooth. This improves the chances that the entire assembly (the polymer coupon as well as the components attached to it) will be structurally sound. This invention also allows for the bonding of two layers of polymer. This invention also allows for the fabrication of assemblies made from layers of thin polymer films. This multi-layer assembly may contain components that can be used to provide diagnostic information or therapeutic effects.

Another feature of the invention is the ability to shape and process multiple sections of one backed polymer coupon at once. Each section of a coupon can be made to have the same features as a separate assembly. Individual sections can have electrical components or structural components applied to them. Each section of a coupon can be used to create sections for separate assemblies. This invention allows for batch processing of thin polymer films so that each section of the coupon can be used to create layers of finished assemblies.

This method allows the coupon to be removed from the backing. The adhesive that holds the coupon to it is dissolved. The adhesive has been dissolved and the attached components and polymer are free from any mechanical stress. This stress can be eliminated in the same way that it could cause damage to either the polymer support layer, or to any component(s) attached.

“The methods of this method may be used together. Or, the invention can be used in isolation.

“I. “I.

“FIGS. “FIGS. This is an electrode array, and it will be referred to as such throughout this document. The electrode array 50 contains a number 52 spaced apart. The invention’s illustrated embodiment shows the electrodes 52 arranged in a row-by-column pattern. Many electrode arrays 50 made using this method have at least 10 electrodes. Other electrode arrays made according to the invention include 20 or 40 electrodes. Each electrode in the illustrated embodiment of the invention is rectangularly shaped. The function of the array 50 can affect the size and shape 52 of the electrodes. In some embodiments of the invention, an electrode can have a width of 10mm, 5mm, or 2mm. An individual electrode 52 can be as long as 40 mm, 20 mm, 10 mm, or even 5 mm.

“Array 50″ also contains a number control modules 54 (one seen in FIG. 2. Each control module 54 can be connected to one or several electrodes 52. Each control module 54 can be used as an ASIC (application specific integrated circuit). The circuit contains components that can source/sink current to the electrodes 52. FIG. FIG. 2. The control module 54 is shown below the electrode 52 to which it is associated.”

“Conductors 56, 58 (one each) extend from control modules 54. The conductors 56, 58 and 60 are connected to a cable that runs from the electrode array assembly 50’s proximal end. (Here ?proximal? It is located at the bottom 50 of FIG. 1. ?Distal? It refers to the end of FIG. 1.) The individual conductors within cable 60 are not illustrated. The cable 60 is connected to the implantable device controller (IDC 62). The power source for currents between the 42 electrodes is contained in the IDC 62. IDC 62 also includes a controller that generates instructions to indicate which electrodes 52 are to be flown. The present invention does not include the IDC 62 structure.

“Electrode array assembly 50 has a base of 66 which is the most proximal part of the assembly. Nine rows of 52 electrodes are located ahead of base 66. Each row of 52 electrodes is spaced longitudinally from the row or rows that follow. The spacing between rows is usually between 0.5 to 10 mm. The illustrated embodiment of the invention shows six electrodes 52 per row. The array 50 is designed so that each of the four inner electrodes 52 are seated on a rectangularly shaped tab (68). The array 50 is divided on three sides by each electrode-carrying tab68. Two I-shaped slots 70 are interleaved between each row of electrodes 52. The perimeters of the tabs 68 are thus defined by each slot 70. Some versions of the invention have slots 70 that are designed so that each tab (measurement along the longitudinal axis 50) has a length of between 0.5 and 5 mm. This length is often between 2 and 4 millimeters. Each tab 68 is measured along the axis perpendicular the longitudinal axis 50 in FIG. 2) between 0.25 and 2 mm. This width can be found in many versions of the invention. It is usually between 0.5 and 1 mm. Each slot 70 measures approximately 75 microns in distance. The array 50 has two columns of I-shaped slots 70. The two slots 70 are located in each row of 52 electrodes. They are separated laterally from one another and align laterally with each other.

“Immediately ahead of the distalmost row of electrodes 52 array 50, is formed a head 74. Head 74 is located at the distal end of array 50. The arcuately shaped head 74 has a leading edge. This arc forms the leading edge and is located along the array’s longitudinal axis. The front edge of the head 74 has been shaped so that it extends distally from the distal end.

“Array head 74 has two slots 76. The slots 74 are opposite sides and symmetrical relative to the array’s longitudinal axis. Each slot 76 is made up of a number sections. Each slot 76 is composed of a base section (78) that runs parallel to the array’s longitudinal axis and laterally offset from it. Particularly, each slot base section is registered with one of the separate rows of slots 70. Each slot section 76’s most forward part opens into a primary opening. The primary opening 80 generally looks like a triangle. The distal end of head 74 is where the opening 80’s most acute apex is located. Each slot 76 has a distal-directed extension 82. Each distal extension (82) extends forward from 80, the slot primary opening. Each slot distal extension curves distally towards the array 50 from the associated slot primary opening 80. The slot distal extensions 82 curve toward each other but do not connect.

FIG. 2. Frame 88 is embedded in the electrode array 50. Frame 88 is made from superelastic materials. A superelastic material is material which, after being subjected a significant amount of rolling, folding, or bending strain, returns to its original shape. The frame 88 in one version of the invention is made from Nitinol, a nickel-titanium alloy. As seen best in FIG. FIG. 4 shows frame 88, which is made from one piece of Nitinol. It is designed to have a proximal tail 90. Frame 88 also features a 130-degree head that is located forward of the tail 90. From the frame tail 90, three parallel-spaced bridges 114 and 116 are located towards the frame head 130.

Frame tail 90 is composed of two beams 92, 112 that run perpendicularly to array 40. Beam 92 is the proximal beam and the shorter one. Beam 112, which is distal to beam 92, is longer and more proximal than beam 92. Both beams 92 & 112 are centered along the array’s longitudinal axis 40. Between beams 92 to 112. There are many additional beams. Between beams 92 to 112. are two beams 96, 102. Beams 96, 102 and 104 are perpendicular with beams 92 to 112 and run along parallel to frame 88’s longitudinal axis. A beam 94, another beam, extends distally from beam 96 to beam 112. A beam 104 extends distally and outwardly from the side of beam 101 to the adjacent beam 112. The beam 104 that extends outwardly from beam 102 to the adjacent end of beam 112. is located forward from beam 102, from which beams 104 and 96 extend. Beam 106 is parallel to beam 92, and extends between beams 95 and 102. Beam 106 runs perpendicularly to beam 102, at the same location as beam 102, from which beams 104 and 102 extend distally ahead.

“Bridges 112, 116, and 118 extend distally to the forward of beam 112. Bridge 116 is centered on the longitudinal axis for frame 88. Bridges 114, 118 and 116 are spaced symmetrically in relation to bridge 116. Three-sided tabs 120 are located outwardly from bridges 112, 116, and 118. Frame 88 is designed so that tabs 120 have major directions that run parallel to the frame’s longitudinal axis. Tabs 120 are organized in pairs. A tab 120 that extends outwardly beyond a bridge 114 or 116 is joined by a laterally aligned 120 that extends outwardly past the opposite side of the bridge. Tabs 120 also have the added feature that tabs extend outwardly beyond one bridge 114-116-118. The tabs 120 extend outwardly to the sections laterally adjacent to the bridges 120. Frame 88 is constructed such that the tabs 120 are placed in rows. In the illustrated version, each row has six tabs. Tabs 120 are spaced longitudinally apart.

“Some versions of the invention are shaped so that the tabs120 have a length of approximately 0.5 to 4.0 mm. The width of the tabs 120 is the distance that the tab extends from the associated bridge 114 or 116. It can be between approximately 0.5 to 2.0 mm. Each row of tabs 50 in frame 88 are spaced approximately 0.5-4.0 mm from each row of laterally adjacent ones. Frame 88 is also shaped in such a way that any tab 120 that extends from the center-located bridge 116 is separated from any adjacent tab that extends from bridges 114 or118. This separation is usually a minimum 100 microns.

Frame 88 is further shaped so that each tab 120 has a rectangular opening in the center. The tab openings 122 have their major axes at the same level as the tabs 120. Each of the openings 122 has been sized to accommodate a control module 54. The tabs 120 that extend from the bridges 114 or 118’s outer edges have tapered rear and front sections. These sections are perpendicular with the longitudinal axis of a frame. These sections (unidentified) taper so that the tab 120’s length decreases slightly when it extends beyond the bridge 114 and 118 to which the tab is attached. The tab corners (corners not known) are rounded at the edges.

“Several rectangularly shaped beams (124), also part of frame88, link bridges 114 to 116 to 118. Frame 88 is designed so that a beam of 124 runs between bridges 114 and 116 while a beam of 124 extends from bridge 116 to bridge 118. A beam of 124 can be found between bridges 116 and 118. The beams 124 have been arranged so that a pair if laterally adjacent beams are located in front and behind all other tabs 120. The pair of beams 124-6 are immediately in front of the tabs 120’s most proximal row. The illustrated version of this invention shows nine rows of tabs. There are therefore 18 pairs of beams that are laterally adjacent. Each beam 124 is measured in width. This refers to the distance parallel with the longitudinal axis of frame 88. It is usually 2.0 mm, but more often it is 0.5 mm.

“As mentioned above, the tabs 120 that extend from bridge 116 are separated from adjacent tabs 120 integral to bridges 114 or 118. The tabs 120 are separated longitudinally from the inter-bridge beams 124. There are I-shaped slots (123) around the tabs 120, which can be found between bridges 112 and 116 as well as between bridges 126-7 and 118. As we have seen, the primary void for each slot 123 is the void for one of the array slots 70. Each frame slot 123 is therefore substantially the same shape as an array slot 70. Each frame slot 123 is approximately 25 microns larger than an array slot70.

Frame head 130 is designed to have slots 132 and 130. Each slot 132’s void is the primary space of an array slot 76. Each slot 132 is therefore the same shape as the associated array slot 76.

“Returning back to FIG. “Returning to FIG. 2 it is clear that two layers of liquid crystal plastic (LCP), insulating material, are placed around the opposing surfaces of frame.88. LCP layer 136 is placed over the passive side 88 of the frame and the control modules 54 within the frame. (The ?passive? (The?passive? side of the array/frame corresponds to the side where the electrodes 52 are located. The?active? The?active? Seite of the array/frame is where the electrodes 52 are located. LCP layer 136’s outer surface acts as the passive side of the array 50. LCP layer 138 is the first intermediate LCP and is placed over frame 88. The passive side of LCP layer 138, which is not placed against frame 88 or control modules 54, is covered by layer 136. Layer 140 is the second intermediate LCP and is placed over layer 138’s active side. Layer 142 is the third intermediate LCP and is placed over layer 140. Layer 144 is an active side LCP layer that is placed on the active side of layer 140. LCP layer 144’s outer surface functions as the active side exposed front of the array 50.”

“The active side LCP layer144 contains the electrodes 52. The second intermediate LCP layer 140 contains one layer of conductors, specifically 56. The third intermediate LCP layer 142 contains a second layer of conductors. Specifically, conductors 56. Vias 146 are formed between control modules 54, 56 and LCP intermediate layer. They extend through this layer. Vias 148 are formed between the control modules 54, and conductors 56 and extend through LCP intermediate layer 138 and 140. The electrical connections between control module 54, and conductors 56, and 58 are provided by the vias 146, 148. Plural vias 150 are formed within and extend through intermediate LCP layer 138, 140, and 142. Each via 150 is an electrical connection between the control module 54 and the electrode 52 to which it is associated.

“II. “II. Method of Assembly”

“The assembly and assembly of the plural electrode array 50, or the batch assembly of plural arrays 50 starts with the fabrication of plural frames. 88 The frame 88 is made by cutting a section of the material to which it will be formed. This sheet is called a coupon 160 (see FIG. 3. The described invention coupon 160 is made from Nitinol. It has a thickness of between 25 and 100 microns. Frame coupon 160 is 10 microns thicker than the heights of control modules 54, which are located in frames 88.

“Using chemical etch processes, sections of coupon 160 are removed in order to create a number of through openings. To prevent them from being removed, coupon sections that will remain in the frame are masking prior to the etching. These openings are defined by the etching process and include through openings that both define the outer perimeter of plural frames (88) as well as the structural characteristics of each frame. A slot 162 is shown in FIG. 4. The slot 162’s width varies around the perimeter of the associated frame 88 to determine the outer shape of this frame. Slot 162 has a narrow width where the tab 120 extends from one of bridges 114 and 118. Slot 162 is adjacent to the tab-free sections of bridges 112 and 118. It has a wider width.

“In this etching stage, each slot 162 has been formed so that the frame 88 is not completely separated from the coupon’s surrounding portion. Instead, the slot 162 can be broken up into sections using a variety of retaining tabs 164. Each tab 164 (one shown in FIG. 4A) is between the frame (one in FIG. FIG. 4A shows only one tab 164, but typically multiple tabs 164 extend between frames 88 and 160. Two tabs 164 are present in the described embodiment of the invention. The tabs 164 are located opposite the longitudinal center axis (88) of the frame with which they are associated.

“In some embodiments of the invention, plural-etching or other materials removal processes are performed to the coupon 160 in order for the frames 88 to be defined. The plural etching process is used to shape the coupon 160 so that its tabs 164 are less thick than the remaining coupon 160. These plural etching procedures are used in some versions of the invention to make the tabs 164 thicker than the portions of coupon 160 that have not been removed.

“Oxide is applied to the coupons that form the frames 88 after the Nitinol coupon 160 has been shaped. First, you must mask off any portions of the coupon 160 that are not intended to function as array frames. The mask is usually a photo-resisting resin. The coupon is then placed in a chamber, and the silicon oxide is applied to the unmasked area. The plasma enhanced chemicalvapor deposition process is used to deposit the oxide. As shown in FIG. 5. In FIGS. 163 and 163, the silicon oxide coating is shown. 5, 15, and 15 have a thickness of between 1000 and 10,000 Angstroms. Some versions of the invention have the coating thicknesses ranging from 1,500 to 4000 Angstroms.

The coupon 160 can be shaped to form the frames 88. If the array 50 is intended for use over tissue that isn’t planar, this processing may be performed. Frames that are still part of coupon 160 are bent permanently so that they approximate the contour of the tissue to be applied with assembly arrays 50. If arrays 50 are to be applied over the spinal cord then each frame 88 should be shaped so that on one side its longitudinal axis the frame curves out from the plane of coupon 160. The frames 88 that extend beyond the coupon 160 are not illustrated.

You can frame shape by pressing the coupon 160 between opposing dies. The attached frames 88 can be bent by the die’s geometric features. After the frames 88 have been pressed into the desired shape, heat is used to set the frames. Heat can be generated by heaters within the individual dies, external heaters, or heat transfer from the liquid around the dies. The carriers are able to bend and heat simultaneously the frame 88 in the desired manner, and can undergo plastic deformation.

“A coupon for LCP, coupon 176. First seen in FIG. 8 is designed to identify the plural passive side LCP layers (136), to which the frames are bonded. FIG. FIG. 6 shows the process. It starts with placing a backing 172 onto a vacuum chuck 170. A vacuum chuck is an object, such as a wafer, that can be held by a vacuum drawn and that can spin. As discussed below, this particular vacuum chuck 170 can be rotated at speeds of up to 10,000 RPM. Backing 172 is made from a rigid material that can withstand the above described processing steps without cracking. Backing 172 is a silicon wafer in one form of the invention. It has a shape similar to a circle, with a section at one end. Backing 172 can have a width of 150 mm or a thickness of 500 nm.

“Once backing 170 has been positioned on chuck 170 a adhesive 174 can be evenly applied to the backing’s exposed face, as shown in FIG. 7. Backing 172 uses one such adhesive. It is made from a mixture of phthalic acidide and ethanediol, which is sold under the trade name CRYSTALBOND by electron Microscopy Services, Hatfield, Pa., USA. After the adhesive 176 has been applied to backing 172, it is important to rotate chuck 170 so that the adhesive 176 is properly applied. For approximately 10 seconds, chuck 170 rotates at approximately 500 RPM. The adhesive is spread over the entire backing by rotating chuck 170, and then backing 172 and adhesive 173. Chuck 170 can be rotated at speeds between 1,000 and 3,000 RPM for about 5 to 20 seconds. The adhesive 174 is evenly distributed over the entire backing by rotating the backing 172. These spins are done at room temperature. The backing 172’s exposed surface is covered with adhesive 174. This layer is about 1 to 5 microns thick. The adhesive 174 is applied over backing 172 to reduce variation of thickness by less than 1%.

After adhesive 174 has been evenly spread on backing 172, the backing can be seated on a press-chuck 175 as shown in FIG. 8 blocks.

“After backing 172 has been transferred to the press adhesive 174 is applied backing 172. The LCP coupon 176 is then applied to the adhesive’s exposed surface as shown in FIG. 8. Coupon 176 has a thickness 50 microns. LCP coupon 176 is shaped in a way that approximates backing 172. Coupon 176 has an area greater than that of layers 136, which is the support layer that the coupon was designed to form. The surface area of coupon 176 is also smaller than that of backing 172. LCP coupon 176 is specifically shaped so that the coupon’s outer perimeter is approximately 5-50 microns inwardly of the backing 172. This difference in surface area is illustrated in the drawings.

“As also shown by FIG. 8 – A glass plate 178 is placed over the LCP coupon 175. Plate 178 is between 0.5 and 3.0 cm thick. Glass plate 178 has an area so that it extends beyond both the coupon 178 and backing 172. Particularly, although not visible in FIGS. 8. and 9. Plate 178 extends at most 0.5 cm beyond backing 172. Two of the clamps 180 shown extend from the glass coupon’s exposed surface to press chuck 175. Glass plate 178 is held by clamps 180 to hold it in place. The clamped assembly can then be transferred to a bond chamber 182, where the pressure can be controlled. FIG. FIG. 9. Bond chamber 182 is represented in the background rectangle.”

“Clamps 180 have been removed. The LCP coupon 176 is removed from glass plate 178. Press chuck 175. The backing adhesive-LCP coupon assembly has been lifted. (Steps are not illustrated). FIG. As shown in FIG. 11., the LCP Coupon 176 is now securely attached to the backing172 by adhesive174. 11. The outer surface of coupon 176 has a uniform height over its backing 172 due to the heat and vacuum pressing. This is the “uniform height” It is understood that the height at which the LCP coupon 176 is placed above backing 172 is not uniformly distributed by less than 5%, and more often 1.5%.

LCP coupon 176 can now be added to the code. In a series of steps, it can be bent into plural array passive side LCP layers. This process involves removing portions of coupon 176. The photo resist is first applied to the coupons 176 that do not have slots. The unmasked parts of the LCP coupon can then be removed using an oxygen plasma reactive Ion etching process (O2 PlasmaRIE). The remaining coupons 176 are then stripped of any mask material. These steps are done while coupon 176 is still bonded to backing 172. These processes resulted in coupon 176 appearing as shown in FIG. 12. This Figure LCP coupon looks substantially the same as it did in FIG. 11. As shown in FIG. 12 shows two of the slots shown in FIG. Each of the LCP coupon 176 slots becomes a section of one the slots 70 or 76 that extends through the array 50. For example, slots 184 and 186 are sections of one tab 68-defining slot 70. It will be apparent that the array 50 will be constructed between slots 184-186.

“In the next set of steps, the frame coupon 160 will be bonded to the LCP coupon coupon 176’s exposed face. This surface is exposed to oxygen plasma in preparation for bonding. This is done in a vacuum chamber. The LCP coupon’s surface is roughened by the oxygen plasma. The exposure lasts approximately 20 minutes.

Frame coupon 160 is placed over the LCP Coupon 176 once the surface has been roughened. The frame coupon 160 is positioned so that frame coupon slots 123, 132 and 176 are in registration with the LCP coupon. FIG. 15 where the parallel sections of the one frame coupon I-slots123 are in registration over those LCP coupon slots184 and186. FIG. FIG. 13 shows the extent to that the outer margin of LCP coupon176 is inwardly receded from back 172. FIG. 160 shows the extent to the which the outer edge of frame coupon 160 is inwardly receded from the LCP coupon’s outer perimeter. These are only illustrations.

“Once frames 88 have been bonded to LCP coupon176, the sections 160 of the frame coupon 160 that are not part of the frames can be lifted from the LCP coupon176. This is done by first mechanically serving tabs 164 (FIG. 4) from the frames. Manually removing the remaining coupon 160 from the LCP coupon 175.

“The partially assembled arrays are created by the removal of remnants of the frame coupon 160 and the LCP coupon176. 14, 15. The plural frames 88 are bonded with the LCP coupon176. FIG. FIG. 15. This is a section of 88. More particularly, FIG. FIG. 15 shows a cross-section through one tab 120 adjacent beams, 124 in a single frame. It is seen that the tab opening 122 is placed over an underside section of the frame, which forms LCP coupon 175. Each of the LCP coupons slots 184 and186 are located between the frames tab 120 and the adjacent beam 124, due to the location of the frames 88 on LCP coupon176.

“As shown in FIG. 16. The next step in batch assembly of electrode arrays 50 will be the placement of control modules 54 into the tab openings. 122 The control modules 54 are electrically protected by the oxide coating 163, which is placed around the frames’ window-defining edges 88.

“Prior the first intermediate LCP layer, LCP layers layers 138, being applied on the frames 88. These layers 138 were fabricated with a LCP coupon coupon 196 in FIG. 17. LCP coupon number 196 is made from the same material that LCP coupon number 176. LCP coupon number 196 has a thickness between 75 and 150 microns. LCP coupon number 196 can be processed by placing coupon 196 on a backing. Backing 192 is in FIG. 17. Layer 194, an adhesive layer holds LCP coupon 696 to backing 192. LCP coupon number 196 is attached to backing 192 using the same process as LCP coupon number 176. These process steps won’t be repeated. These process steps can be used to obtain the LCP coupons 224 to 244 and 266 to, respectively backings 220, 234 and 262.

“After LCP coupon number 196 has been attached to backing 192,” plural recesses 198 will be formed in coupon 196. Each recess of 198 doesn’t extend through coupon 196. Each recess 198 is confined to the coupon’s outer surface and extends inwardly to a depth that is at least equal to the thicknesses of the frames 88. LCP coupon 196 creates recesses 198 by first masking the coupons 196 that do not contain the recesses. The recesses can then be formed using the oxygen plasma RIE method in the unmasked areas of the coupon 196. The aluminum mask can then be removed. As seen best in FIG. FIG. 21 shows that each recess has an outline that is identical to the shape of the frame. Each recess 196 is equal in size to the area of the recess 88. The depth of recesses 196 is at minimum equal to the thicknesses of frames 88.

After recesses 198 have been formed in LCP coupon 196 the coupon is then subject to a second oxygen plasma RIE treatment. The etching process creates a variety of openings. FIG. 19 shows these openings. 19 extends from the base recesses 198 all the way to the end of the LCP Coupon 196. Many of these openings can be represented by slots 202 or 210 in FIGS. 19, 21 and 212, respectively, in FIG. 21. These slots 202 to 210 are part of the array slots 70, 76 after they have been assembled. Specifically, the slots 202 and 220 are two different sections of one of the array I slots 70. Each slot 212 is a part the array slot 76.

“In the LCP coupon number 196, another set of openings is formed, through bores 209, 206, and 208. Each through bore 204 has a circular cross section with a diameter between 5 and 1000 microns, and sometimes 50 to 250 microns.

FIG. 20. Bores 204,206, and 208 are used to deposit metal, such as gold. This gold is deposited in one step. First, a thin layer (approximately 500 Angstroms) of titanium is applied using a sputtering process that covers the entire coupon 196. The titanium bonds to the LCP coupon number 196’s inner cylindrical walls, which define the bores of 204,206 and 208. The titanium layer is then covered with a gold layer of approximately 1000 Angstroms. This layer is applied to the entire coupon 196 by sputtering. This titanium layer is first applied, as titanium adheres well both to LCP and gold.

“Once the thin layer of gold has been applied, gold can then be plated in bores 204-206 and 208. This plating is done by masking the coupon so that only bores 204-66 and 208 are visible. An electroplating process is used to apply the gold so that the bore can be filed. The previously applied gold acts as a seed layer, to which the electroplated golden bonds. The mask layer that was gold-covered is removed. The remaining coupon is then removed from the thin layers covered in titanium and gold.

The metal in bores204 acts as an array via 146 between control module 56 and conductor 56. Bores 206’s metal cores function as sections of array vias148 that run between the control module 56 and the conductor 58. Bores 208’s metal cores function as sections of array vias 150 between the control module 54, and the overlying electro 52. FIG. FIG. 20 shows these cores of metal identified by the vias they become.

LCP coupon 196 is now available by adding the via-forming metallic. FIGS. 20 and 21. The coupon 196 contains a number recesses, namely 198. Each recess 198 can receive a frame 88. There are a number of slots, 202, 210, and 212 that extend from the base of each recess, 198, through polymer to the opposing face of coupon 196, which is bonded to the adhesive layer 194. These slots correspond to the sections of the array slots. Each pair of slots 202, 210 belongs to one of the array I slots 70. The slots 212 and 76 are located in the array head. FIG. 2 shows plural metal columns. 21 is represented by a black dot. It extends from the base of the recess 198 to face of coupon 196.

“Once LCP coupon number 196 has been formed to delineate the plural LCP intermediate layers, 138, the coupon number 196, attached to backing 192, is inverted (step non shown). The LCP coupon number 176 is inverted and the inverted coupon 196 is placed in registration. FIG. 22. The two coupons 176 & 196 are aligned so each recess of coupon 196 is registered over the one in frame 88.

FIG. 23. The frames 88 and control modules 54, which were previously installed in the frames, are now seated in the recesses. 198 The outer surfaces of LCP coupon 176 and 196 meet. You should know that the LCP coupons 176 and 196 have via forming metal columns. These metal columns sit over the bond pads 54. (Control module bond pad not illustrated.)

“Inverting LCP coupon number 196 and positioning coupon 196 over coupon 171 should be a reminder that coupon 196 is in fact positioning coupon 196.

The coupons are joined by a thermally-induced pressure bond after the LCP coupons 176 & 196 have been pressed together. The LCP from the opposing coupons 176 and196 becomes semi-liquid, and the two together form a unitary structure. These plural LCP coupons and the plural array LCP layers are shown as separate layers to aid understanding of the invention.

“Once the assembly has been removed from the oven it will appear as shown in FIG. 24. Between the LCP coupons 176-196, the control modules 54 and frames88 are embedded. LCP coupon176, the coupon forming layers 136, remains bonded to backing132. This coupon extends through vias 146-148 and 150.

“An LCP coupon, coupon 224, in FIG. 25 is designed to form the plural intermediate LCP layers 140. Coupon 224 is between 10 and 50 microns thick. To secure coupon 224 to its backing (backing 220 in FIG.), the previously mentioned bonding steps are used. 25. It can be seen here that adhesive layer 222 holds LCP coupon 220 to backing 223. LCP coupon number 224 has a thickness between 10 and 50 microns. LCP coupon 224, after it has been thermally compressed bonded to the backing 220, is not shown. This drawing would be identical to FIG. 17 shows LCP coupon number 196 after it has been press bonded to backing 192. This drawing is therefore omitted.

LCP coupon 224, bonded to backing192, a series 228 grooves (one shown) is etched on the coupon’s exposed face. Grooves 228 were formed using the LCP coupon 224. Grooves 228 can be formed by using the same etching steps that were used to create recesses 198 and 196 in LCP coupon 269. The grooves 228 have a depth of 5-15 microns relative the LCP coupon 224. Grooves 228 are generally rectangular in cross-sectional shape.

“LCP coupon number 224” can also be shaped to create a variety of openings as shown in FIG. 26. Slots are a type of LCP coupon opening. They are represented by slots 226 or 234. These slots are segments of the array slots 70-76. Coupon slots 226 and 234, respectively, are different sections of what when the array 50 has been assembled. The I-shaped slot 70 is also one of these I-shaped slots. LCP coupon coupon 224 slot sections 226 and 234 are almost identical to the sections 202, 210 and 226 of LCP coupon.196.

“The second type openings in LCP coupon 224, are those through which conductors forming sections vias 148 or 150 extend. FIG. FIG. 26 shows these openings through bores 231 and 223. The through bores 223 and 232 are analogues to the bores 206, 208, formed in LCP coupon number 196. Bores 230, 232, and 208 have the same cross sectional dimensions and shape as bores 296, 208, respectively.

“In a series, the metal is first placed in bores 230-232, and then in grooves 228, in a sequence of steps. Initialy, a gold seed layer and a titanium adhesion are placed over the entire coupon 224. These layers are the same thickness as those described previously. A photo resist mask is then placed on top of the LCP coupon 224. Only the bores 230 & 232 are left exposed by the mask. Bores 230, 232 are then filled with gold using an electroplating process. This is followed by the removal of the first mask. Coupon 224 is then covered with a second mask. The outlines of grooves 228 are left exposed by this mask. The coupon 224 then goes through a second electroplating step. This is where gold is used to fill in the grooves 228. After this electroplating process is complete, the mask, underlying gold and titanium layers will be removed. It is important to understand that the first electroplating process is to ensure that the gold rises above the bores 230 & 232. To ensure that the exposed face on the LCP coupon 226 is uniformly plated with the gold, the second electroplating is done.

“As a result of the selective plating coupon 224, it appears as in FIGS. 27, 28. The grooves are 228 in the gold. These are known as conductors 56. Bores 230 and 223 are used to store gold cores. These cores are section of vias 148 or 150 and are identified by their identification. FIG. FIG. 28 shows the exposed face LCP coupon 224. LCP coupon coupon 224’s face is planar as it will meet LCP coupon coupon 196’s exposed planar face. The LCP coupon 224’s face is marked with 236 dashed lines. These lines represent the boundaries of individual LCP intermediate sections 140 that will be formed by different sections. There are three main branches of conductor 56 within each section of LCP coupon 224. Each boarder defines a specific section. The branches extend from the trunk conductor, not illustrated, but formed on the LCP coupon 224. Each primary branch has a number of secondary branch conductors. Plural pairs of dots are also shown within the sections of LCP coupon 224. These dots are the heads of partially formed vias 148 & 150.

Once LCP coupon number 224 has been fabricated, the coupon is inverted. LCP coupon is placed over LCP coupon number 196. LCP Coupon is placed so that LCP Coupon 224 slot sections 226 & 234 are registered with LCP Coupon 196 slot sections 209 and 210; conductors56 are in registration over vias146; via sections 146 & 150 of LCP Coupon 224, and in registration with LCP coupons 176. LCP coupon coupon 224 is bonded to LCP coupons 176 using the same process. Illustrations of these steps should not be repeated as they are almost identical to those used to bond LCP coupon 161.

LCP coupon 228 is bonded to LCP coupon 193. After that, backing 220 can be removed from coupon 224. To remove backing 220 from coupon 196, follow the same steps as for backing 192. These steps are completed and a number 50 partially assembled electrode arrays 50 can be disposed of on backing 172. FIG. FIG. 29 shows a portion 50 of this array. Control module 54 is located in the frame tab 120. The tab 120 and the adjacent beams 122 are placed between LCP coupons176 and 196 which, respectively, form layers 136, and 138. LCP coupon 194 is used to dispose of the LCP coupon 224. It forms plural second intermediate LCP layers 140.

FIG. 244 shows an LCP coupon 244. The LCP coupon 244, as shown in FIG. 30, is then processed to create plural third intermediate LCP layer 142. LCP coupon 24 has a thickness that is similar to coupon 224. Initially. LCP coupon 244 is bonded with a backing 240 by following the previously mentioned LCP-to?backing bonding procedures. Although not illustrated, the end result is identical to the backing and LCP coupon assemblies of FIG. 17. Layer 242 is a layer of adhesive that holds coupon 244 and backing 240.

“Plural grooves 248, one of which is shown in FIG. 30 are then formed in LCP Coupon 244. Grooves 248, which are integral to LCP coupon 244, have a cross-sectional geometry similar to grooves 228. They also share the same width and depth dimensions. Grooves 248 refer to the void spaces within the LCP coupon 244 where the metal forming array conductors (58) can be deposited. In LCP coupon 244, the grooves 248 are formed at the locations where conductors 58 must be present.

“Once grooves 248 form in LCP coupon 244, plural openings are illustrated best in FIG. 31 are found in the coupon. These are called slots. These are slots that run through an individual array and are sections of the slots 70 or 76. FIG. 31 are shown with slot sections 246 & 252 illustrated in FIG. Sections 246 and 252 represent portions of an I-shaped slot 70 that runs through the array.

Bores 250 are the other type of openings that can be formed in LCP coupon 244, as shown. Bores 250 are used to receive metal deposits that, after forming the arrays 50, become portions of vias 150.

Once the coupon has been opened, the metal can be deposited in the grooves 248, and the bores 250. You can use the same steps to deposit metal into grooves 228 and bores 230 and 223 of LCP coupon 224, as well as in bores 250 and 248 of LCP coupon 228. FIG. shows the results of depositing this metal. 32. The conductors 58 will work as metal that is deposited in grooves 248, and the metal that is identified as such is 248. The metal cores formed in bores 250 are the same as sections of vias 150 and are therefore identified as such.”

Once LCP coupon 244 has been fabricated, the coupon is inverted. LCP coupon 244 should be placed over LCP coupon 224. LCP Coupon 244 is placed so that LCP Coupon 224 Slot Sections 246 and 252 and conductors58 are registered over vias148; via sections 256 off LCP Coupon 244 and via sections 238 in LCP Coupon 224. To bond LCP coupon 244 and LCP coupon 224, the same steps are used. The steps for positioning and bonding LCP Coupon 196 are almost identical to those described previously. These steps are not repeated.

The backing 240 can then be lifted off LCP coupon 244 by following the previously described backing lifting off process. The partially assembled electrode arrays 50 are still bonded to backing172. FIG. FIG. 33 shows that the partially assembled electrode arrays include an LCP layer, which is not present in FIG. 29. The LCP coupon 244, which is the third intermediate LCP layer 142, is now disposed of over coupon 224. This coupon forms the second intermediate LCP layer 140. The conductors 58, and portions of 150 are embedded in the LCP layers.

FIG. 266) shows an LCP coupon. 34 is designed to create the plural active side LCP layer 144. Coupon 266 must be at least 50 microns thick. Coupon 266, which is used to process coupons, must be first bonded to the backing 262 using adhesive layer 264.

“Once the LCP coupon 266, which is attached to backing 262, is secured, plural rectangularly shaped recesses or openings are created in the coupon, as shown in FIG. 34. These openings and recesses are created in multiple oxygen plasma RIE processes. The coupon 266 is formed by a first oxygen reactive ion engraving process. Slots are created to allow the coupon to extend fully through the coupon. FIG. 34 of these slots are represented in FIG. After assembly 50 of each array, the through slots 276 and 270 become sections of slots 70 and 76 which extend through the array. Rectangular recesses 272, shown in the first etching, are made using LCP coupon 266, Each recess 272 serves as the void space in which, in a later step, the metal that will form the base pad for each electrode 52, is deposited. The second etching process creates recesses 272 that are identical in shape and dimension to array electrodes 52. Recesses 276 have a depth of about 5-40 microns. Through openings 274 are formed by the third oxygen plasma RIE. These openings extend downwardly from the base of recesses 270. Each through opening 274 is circular in cross-section and has a diameter between 10 and 300 microns. The base of each through opening 274 is the recess 266, from which the opening extends to face 266.

The metal is then placed in recesses 272 or openings 274 to create the electrodes 52. The masking of coupon 266 is an initial step. Only the through openings 274 of the coupon are left unmasked. The sputtering process then deposits the iridium into the through openings 274. However, the iridium isn’t deposited in full to fill all of the openings 274. The iridium is only partially filled by the coupon 266 that was disposed against backing 262. Each opening 274 is only partially filled. The 5-10 microns in the top of each opening 274 are not filled. While the mask is still in place, titanium can be sputter-deposited on the coupon 266, to fill the remaining openings 274 Each through opening contains a column made of metal. The lower part is iridium and the upper is titanium. Each one of these metal columns can be considered an integral button 282 to the electrode 52. FIG. FIG. 35 shows an electrode, but the plural metal layers that make each button 282 is not illustrated.

The first mask can be removed once the electrode buttons 282 have been formed. The entire LCP coupon 266 is covered with a titanium adhesion layer of approximately 500 Angstroms. The titanium layer is then covered with a gold seed layer of approximately the same thickness. The coupon 266 is then covered with a second mask. The only parts of the coupon 266 that are left exposed by the second layer of masking are the recesses 272. The recesses are then filled with gold by electroplating the LCP coupon 266, which is made of gold. “The mask, as well as the titanium and gold that were underneath it, are removed.”

“The electrodes 52 can now be considered fabricated after the mask has been removed. FIG. 35. The electrode has a gold base pad 288, and the recess LCP coupon contains the recess 272. The base pad is covered by the LCP, which runs through the base pad and the exposed face 266 of the polymer coupon 266, where there are many buttons 282. The electrode 52’s exposed surfaces are formed by the exposed faces of the iridium cores. Because iridium provides an excellent interface against living tissue, buttons are made with iridium faces. Because titanium adheres well with iridium liquid crystal polymer, gold and gold, the buttons 282 have titanium sections.

FIG. 36. FIG. FIG. The coupon 266’s face is planar. The coupon 266 has many slots. FIG. FIG. 36 shows only two sections of slot, the sections 270 and 276, respectively. These slots are made into sections of the array slots 70-76 after the fabrication of the array 50. The exposed surfaces of electrode base pads 280 are visible on LCP coupon 266, which is also visible from the exposed face.

After the LCP coupon 266 has been shaped and the metal layers have been deposited, the coupon 266, is bonded to LCP coupon 224. LCP coupon 266 is positioned above LCP coupon 224. LCP coupon 266 should be positioned against LCP Coupon 224 so that LCP coupon 224’s gold base pad 280 for each electrode 52 is placed against the face of the complimentary via 150. LCP coupon 266, which is bonded to LCP Coupon 224 via the thermal induced compression bonding procedure, is now completed. Vias 150 bond to LCP coupon 266 by thermal induced compression bonding process. The backing 262 can then be lifted from LCP coupon 266, using the previously described backing lifting off process. This stage of the assembly of plural electrode arrays 50 is when an array in cross-section would appear in the assembled form depicted in FIG. 2.”

The plural electrode arrays 50 are still bonded to backing 172. Each of the 50 arrays are a part of a laminate structure made by the LCP coupons 176 to 196, 224, 244 or 266. To separate the arrays and the surrounding laminate sections from the backing 172 before removing them, LCP laminate cuts are made. This is done by a press.

“Once arrays 50 have been defined on backing 172, the arrays can be removed from backing and the surrounding remnant LCP lamination. The backing adhesive 174 is then removed from the backing. This is done by following the previously mentioned backing liftoff process. The arrays are then dried and cleaned before being tested for their functionality.

“Post-manufacture of the electrode array assembly 50, there are substantial portions that consist of the stacked layers LCP film layers 136 to 138 and 140 to 142 to 144, which are stacked one upon the other. These layers do not contain any electrical components, conductors, or support members. These LCP film laminations make up the body of the array, which extends from frame 88. This body can be thought of as membranes that extend beyond the section of the array where the frame 88 is embedded. Referring to FIG. Returning to FIG. 1A, there are two such membranes. Membras 302 is the LCP film laminate section that extends between longitudinally adjacent frame tabs 120, which extend outwardly beyond frame bridges 114 or 118. FIG. FIG. Other membranes, such as membranes 304 extend into the rectangular spaces between bridges 114-116, 118, and beams 124.

“Also, while it is not obvious, it should be noted that the frames slots 123 and 132 have LCP layers 136 or 140 which overlap by at least 25 microns. These LCP layers cover all exposed edges of frame 88.”

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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.