Electronics – John C. Meade, Douglas M. Macarthur, Stephen M. Blinn, Christopher Saulnier, Brian R. Edwards, Gerald I. Brecher, Intuitive Surgical Operations Inc
Abstract for “Apparatus for tissue closure and method”
A tissue closure device comprises a pusher assembly with a drive shaft and an attached needle driver at the distal end. The needle driver can engage and rotate a suturing tip having a pointed and blunt ends about a rotational direction. It also includes a cartridge having a protective housing that houses the suturing tool and a cartridge holder. The cartridge is attached to the cartridge holders assembly at the distal end. Before and after complete rotation of the needle around the rotational axis, a pointed end of the suturing can be placed within the protective housing. An actuator may be used to control the drive shaft and needle driver. This will allow the removable electronic module to rotate the suturing rod around the rotational axis.
Background for “Apparatus for tissue closure and method”
“Surgery can present many challenges that can affect the patient’s health as well as the health and safety of the medical professionals. Some surgical procedures, like cardiac surgery or pneumonectomy, require access to the organ via sternotomy. This is a procedure that involves the division of the sternum with a suitable instrument such as a saw, or any other suitable cutting tool. The sternum must then be re-examined after the procedure. A sternotomy is usually performed by a medical professional using a stainless-steel needle with a sharp cutting tip. The suture consists of a length of stainless steel wire or a combination of flexible and stiff stainless steel cables. The combination cable/wire suture is manually drawn through the sternum on both sides. It is important that the wire protrudes from the sternum at the same time. The medical professional will remove the needle from the wire and wrap the end of one wire around another wire using forceps or their hands. Twisting the wires in a spiral or helical fashion is the next step. The medical professional will then cut the twisted wires to the desired length. They will use surgical tools to place the sharp, cut and twisted ends of wires in the space between the sternum’s re-approximated edges. This ensures that the wire ends do not penetrate the skin. In order to close the sternum along its length, typically six to eight wire sutures will be placed in the sternum.
The prior art sternotomy closing procedures pose many problems for the patient and the doctor. Manual suturing can be difficult as the suturing needle has to pass through dense, hard bone. Manual suturing involves handling a sharp suturing tool such as a forceps. This can lead to inadvertent needle pricks through the gloves of a nurse or surgeon. There is a risk of infection for staff, patients, the surgeon and nurses. It can be difficult and frustrating to manipulate an inflexible wire under the sternum or ribcage. The surgeon has traditionally had to lift the sternum up in order to place a suture into the bone. This puts the surgeon at risk of needle puncture due the force needed to reach the bone. Medical professionals can also be exposed to potentially fatal bloodborne diseases such as HIV/AIDS or Hepatitis C by being stuck to the wires’ sharp ends. The needle could also penetrate the heart, vessels and other structures, causing serious and sometimes fatal infections.
“Prior art Sternotomy Sutures for Use by Medical Professionals are described in U.S. Pat. No. 4,074,732 entitled “Wire Cutting Stripping and Twisting Tools;” U.S. Pat. No. No. U.S. Pat. No. No. U.S. Pat. No. No. 5,830 234 entitled “Method to Double Wire Sternotomy Sture,”? All of these are hereby included by reference in their entirety. Prior art sternotomy sutures require that the medical professional uses their hands or manual tools to manipulate and tension the sutures. U.S. Pat. No. No. 6,923,819 describes an apparatus and method of surgical suturing with threadmanagement. The entire document is herein incorporated by reference.
“It is clear that the art has a need for sternotomy closing devices and methods that are safe, reliable, user-friendly, and effective. This and other problems can be solved by the present invention.
The following description will clearly show the purpose and benefits of the invention. The methods and systems that are specifically described in the claims and written description of this invention, as well the attached drawings, will provide additional benefits.
“The invention provides an apparatus and a method of joining tissue such as bone tissue to achieve these and other benefits. A device is described that can be used to join tissue, such as for sternotomy recalibration. It includes a pusher assembly and a cartridge. The drive assembly includes a drive arm that extends from a shaft and a drive mechanism at the distal end. The drive mechanism can releasably engage and rotate a suturing tool with a pointed and blunt end around a rotational axis. The cartridge comes with a protective housing as well as the suturing tip. The cartridge is attached to the cartridge holders assembly via a distal end.
“According to a further aspect, the pointed end of a suturing nee is preferably placed within the protective housing prior and after complete rotation of the suturing nee about the rotational direction. A removable electronic module can be added to the device if desired. This actuator engages the drive shaft to rotate it and the drive mechanism, rotating the suturing tip about the rotational direction.
“According to a further aspect, the invention also provides a cartridge that houses a suturing tip. This can be used, if desired, in sternum refining. The cartridge comprises a housing with a curved shape and an inner wall as well as an outer wall. The inner wall of the housing has a track that allows the suturing tool to follow a curving path on the track. A housing aperture intercepts the track and shields the pointed end from the suturing nel during at least some of the revolutions.
“According to another aspect, the invention also provides a suturing tool for use in, for instance, sternum reapproximation. A curved body with a blunt end engages a suturing substance. The pointed end is protected at the end of a rotational cycle. A flexible leader that is attached to a wire suture is preferred for the suturing material.
“According to another aspect, the invention provides a means of joining tissue such as sternum-re-approximation. This method involves releasably attaching a cartridge with a protective housing, and a suturing to a cartridge-holder assembly of a tissue closing device. The method also includes placing the tissue closure device with the cartridge and the needle into an aperture to allow the needle to rotate about a rotating axis. This method also involves activating an electronic module that is coupled to a pusher, which causes the suturing device to rotate across the cartridge’s aperture. The suturing tool then moves through the tissue segment through which it passes through and pulls a suturing material through the segment. You can also use the device to stitch the second tissue segment.
“It is important to understand that the above general description and the detailed description are examples and are meant to further explain the invention claimed.”
The accompanying drawings are part of this specification and are included to illustrate the method and devices of invention. The drawings, along with the description, serve to illustrate the principles of this invention.
“Reference will now to the preferred embodiments of this invention. Examples of these are shown in the accompanying illustrations. In conjunction with the detailed description, the method and the corresponding steps will be described.
“The devices and methods described herein can be used to close tissue. The invention is especially well-suited for procedures that involve bony tissue such as sternotomy closings. The disclosed tissue closure device (or suturing device) is an electrically powered motorized device. You can use standard wall power or a battery as the power source. These tissue closure devices are designed to prevent accidental needle punctures for the medical practitioner and can be used to drive needles through bone tissue quickly and easily. The disclosed devices are used to close sternotomy. They protect the heart, vessels and other structures and reproduce the standard sternotomy closing technique. The disclosed embodiments allow for easier and faster manipulation of the wire/cable combination in the chest cavity or other anatomy. They also produce tissue closure in an efficient manner, so that the patient is not exposed to the health risks associated having a tissue segment such as the sternum open for longer than necessary.
“The major components of a tissue closing device according to the presently disclosed embodiments of the invention are generally shown at 50 in FIG. 1. The tissue closure device 50 is able to create a continuous or an interrupted suture to allow closure of the sternal halves following sternotomy. Device 50, a motorized and battery-powered device, is shown in the illustration. It prevents needle punctures during sternotomy or similar procedures. Device 50 provides reliable closure with standard wires and needles. It also replicates standard tissue closure techniques (e.g., Sternotomy). The device 50 is able to drive needles through bone and other tissues, eliminating the need for manual force. It also protects the heart and surrounding vessels from accidental needle punctures during closure.
Referring to FIG. “Referring to FIG. A shaft runs through the gear box 59, which also includes a stopplate 66, a bearing plate 68, as well as a drive wheel. The drive pin 63 is used to engage the drive wheel 67. It also mates with a hole made in a driveplate 80, which is part of a front-end assembly 70. The bearing surface 68 acts between the stop plate (66) and the drive wheel (67). The bearing surface 68 may be any lubricious material having a low coefficient of friction, for example fluoropolymer compounds such as those including polytetrafluoroethylene (PTFE).”
The electric motor 61 is preferably compact but powerful. One embodiment can use a DC motor from the Maxon Re-max 29 series, which is commercially available at Maxon Precision Motors, Inc., Fall River, Mass. Model no. Model no. 226784 is available. It weighs 159g, measures 29mm in diameter, generates 22 watts and has a speed rating of 7630 RPM. You can choose from the Maxon Gearhead GP32C, which measures 32 mm in size, as the gear box 59. Model no. The model no. 166943 is available, with 3 stages and a weight of 194g. It also has a 103-to-1 gear reduction ratio.
“The front end assembly 70, as shown, includes a pusher assembly (not seen) and a cartridge-holder assembly 72. The pusher assembly houses a drive mechanism (??pawl?) on its drive arm. A drive shaft runs along the length of the front assembly 70 and into the drive plate 80. An insert cartridge 90 containing a tissue closure needle 110 can be attached to the distal end 81 on the cartridge holder 72.
“FIG. 2A and FIG. FIG. 2A and FIG. 2B depict the front end assembly 70, which includes a pusher assembly 71, and the cartridge holder 72. The cartridge holder 72 houses the disposable needle cartridge 90 that contains the tissue closure needle 110. The pusher assembly 71/71 has a drive shaft/73 and a drive arms 75 which are in close contact with the needle 110 via an pawl. The drive shaft 7 engages the drive plate 80’s spline so that the drive shaft 73 can rotate with the drive plate 80. The electronic module can be attached to the front assembly by the drive shaft 73. This engages the bushing in the drive wheel. 67 FIG. 72 shows the cartridge holder assembly 72. 2B shows the cartridge holder assembly 72 (shown in FIG. The arms extend along mutually divergent directions so that there is an opening 78 for the user to see the device 50 while it is being operated. The support arms 76 have a minimal bulk and an open configuration that allows for a wide viewing area 78. This is the opening in the cartridge cartridge 90 and cartridge holders 72. It is this space between the first and second sides of a splitsternum, and needle advancement through this space during the operation of the tissue closing device 50. FIG. 2 shows an embodiment of the same configuration. FIG. 2 shows a plurality 76 support arms, but other variations include a single support-arm assembly. The support arm assembly 76’s shape and configuration 76 allows for precise device placement over the spine in the case of sternotomy. It also provides uniform advancement of the tissue closing device 50 after each stitch, providing a uniform and symmetrical suture. This protects the heart, adjacent vessels, and structures, from any accidental needle punctures.
The cartridge holder assembly 72’s distal end 81 is where the needle cartridge 90 can be attached. The circular housing of the needle cartridge 90 is made from a suitable medical-grade sterilizable metal or plastic material. The cartridge 90 should have a high degree of rigidity, as well as a low coefficient for friction. This will reduce the amount of power needed to move the needle contained within. Lubricomp DFP22H is a polycarbonate containing 10% of glass fill, 8% PTFE Teflon (Teflon) and 2% silicon. This material can give the cartridge up to 20% more power at the point where the needle is inserted. The housing can be easily retained by the distal tip 81 of cartridge holder 72 using known methods. For example, a plurality grooves along the inner lip in diametrically different positions are capable of engaging the same number of slots in the cartridge holder 72. When the grooves are engaged, the needle cartridge 90 can be held by the distal 81 of the cartridge-holder assembly 72. The torsion return spring (77) engages the shaft bar 74 and drive plate 80. It is responsible for returning drive shaft 73 to its “start?” position. The electronic module 60 attaches to the front assembly 70 so that the drive pin 63 engages the drive plate 80.
“As best illustrated in FIG. 31A and FIG. 31A and FIG. The rotating shaft is sealed against the front end by the first O-ring 57. The second O-ring 57 seals nearer to the housing, sealing the front end assembly against nose collar 157. A plurality of O rings 57 act as a barrier to keep the exterior of the device from the interior. As shown in FIG. A Teflon seal (57A) can also be used as shown in FIG. The barrier seal prevents any non-sterile germs or particles from escaping the device’s front end to the sterile exterior.
“FIG. “FIG. 3B and FIG. 3A) is located at the tip. It is found in a slot in drive arm 75 and connected to drive arm 75 via pivot pin 99. The pawl 95 drives the needle in a circular direction (not shown).
The cartridge contains the needle 110, and leaves only the sharp-pointed end 112 exposed. This position is also known as the “home” position. position. To eliminate needle-pricks from the cartridge handling or loading, the needle 110 is completely contained in the cartridge housing when it is in the home position. The aperture width in the cartridge corresponds to the gap in needle 110. This means that needle 110 in the home position does not extend into aperture 111. This alignment allows the needle 110 to remain entirely within the cartridge. It prevents accidental contact between the sharp pointed end 112 and the user’s fingertips during handling the disposable needle cartridge. This protects the needle 110 from accidental ‘needle-pricks’. This prevents accidental needle-pricks from happening and significantly reduces the risk of infection by pathogenic bacteria or viruses. To advance the pointed needle end 112, rotate the needle 110 in a curved track on the needle cartridge around the longitudinal axis 50. This will allow the needle 110 to first cross the aperture 111 before returning to its home position. The suturing material attaches to the needle 110 and follows the path of needle 110. The suturing material can then be cut, twist tied, and secured using a suitable method. You can place every stitch in the same way, no matter if it is a single interrupted stitch or a series continuous, running stitch. As a substitute for the tedious and time-consuming manual stitching process, the tissue closure or suturing device 50 can be used to either insert one single stitch or a series of continuous stitches.
“FIG. FIG. 5B and FIG. Sectional views of the tissue closing needle and pusher assembly are shown in FIG. 5B and FIG. FIG. FIG. 5B shows how a flat spring (96) exerts tension on the left pawl to propel it distally into the needle 110, and into the notch 95 b. The pawl 95 rotates and the notch 115b is picked up by the pawl 95, driving the needle 110.
“FIG. 5C shows that the pawl 95 is not in the notch115 b but engaging the surface of needle 110. The pawl 95 is moving along the outer surface 110 of the needle 110 when the notch 115b is encountered. The pawl tip contacts the ramp for the hole 115b, and the flat spring pushes 95 into the needle’s notch.
“FIG. “FIG. The pawl 95’s angled surface angles away from the stop 98. The pawl 95 must rotate clockwise so that the angled surface touches the pawl stop. FIG. 5B shows the contact of the pawl stop with the pawl 95. 5B. 5B.
“FIG. “FIG. 6 shows a close-up of the cartridge holder 72’s distal end 81. The 72-inch cartridge holder assembly is made of sterilizable medical quality material. It can be either a metallic material like stainless steel that allows it to be reused after sterilization, or a sterilizable plastic material that can be discarded after one use. The cylindrical cartridge holder 72 has a distal edge of 87 and aproximal edge of 89 that are oriented with respect to the device handle (not illustrated). An aperture 85 is located at the same dimension as the aperture in the disposable needle cartridge. A plurality 82 of slots are also located on the cartridge holder assembly 72. These slots can be used to engage the same number of retaining clips that are located in the needle cartridge housing (not illustrated). A cylindrical slot, not visible on the cartridge holder 72, is also located along the distal edge. It can engage a pivoting pin with identical diameter on a gate assembly (105). The support arm assembly 76 attaches the shaft segment 74 to the proximal edge of the cartridge holder 72. The gate assembly (105) prevents the needle falling out of the cartridge holder 72’s back. To allow a circular movement in the drive mechanism that engages needle, the gate assembly 105 pivots on the pivot pin 107. The stop pins 106 on the cartridge holder assembly cause gate assembly 105, to reverse and stop in the opposite direction. It is similar to a?see?-saw? ?up-down? motion. The cartridge holder 72 prevents the needle from being moved laterally or dislocated by the gate assembly 105. The gate assembly105 can pivot on the pivot pin107 so that drive arm 75, which is connected to the needle via the claw, can pass through the gate assembly105. The needle cartridge 90 can be locked on the cartridge holder 72 by engaging the anti-rotate bars 100. This will allow rotation in the opposite direction to the advancing direction, or ‘needle backing up? ”
“FIG. “FIG. 7 is a close-up of a disposable cartridge 90 according to the presently disclosed embodiments. It is preferably provided in a sterilized sealed packaging. The circular housing of the needle cartridge 90 is made from a suitable medical-grade sterilizable metal or plastic material. To reduce the amount of power required to move the needle contained within the cartridge 90, the material used to make it should be both rigid and low in friction. Lubricomp DFP22H is a polycarbonate containing 10% of glass fill, 8% PTFE Teflon (Teflon) and 2% silicon. This material can give the cartridge up to 20% more power for the point of the needle. The cartridge holder assembly may retain the housing 91 at the distal tip of suturing device 50. This can be done by using known methods, including a plurality 94 of grooves in diametrically opposed positions that can engage with the plurality slots located on the distal edge. A groove 93 is also included in the needle cartridge 90 that can engage the anti-rotate or locking bar 100.
“While the grooves allow the needle cartridge to be retained by its cartridge holder assembly 90 when engaged, the groove 93 when engaged together with the anti-rotate & locking bar 100 causes the aperture 97 in the needle cartridge to align with the cartridge holders assembly’scorresponding aperture. A circular groove, or “track”, is also included in the needle cartridge 90. The circular groove or?track’ in the needle cartridge 90 is located in the inner surface of the housing. 91. It lies in a plane perpendicular with the longitudinal axis of the housing 91 as well as that of the suturing devices 50. The track 92 is interrupted by the aperture 97.
The track 92 is used to position the arcuate suturing knife 110 made of medical-grade stainless steel or similar material. The radius of arcuate needle 110’s arc is approximately equal to that of the needle cartridge 90 located at the aperture 97. The normal home for the needle 110 is a?home’. The needle 110 normally resides in a?home? in the track 92 so that the gap between the arcuate and the cartridge 90 apertures is aligned. The pointed, sharp end of needle 110 is located on one side, within the limits of housing aperture 97. The pointed end is shielded by cartridge housing 91. The aperture 97 is on the opposite side. This is where the blunt end of needle 110 is found. It is attached to a suturing substance. The sharp, pointed end 110 of the needle is contained in the cartridge 90. It does not extend beyond the cartridge 90. The sharp, pointed end of needle 110 is therefore not visible to the user.”
“FIG. 8A is a close-up of the locking bar 100 and anti-rotate. FIG. 8B shows that the anti-rotate/locking bar 100 has a cartridge locking 101 which makes contact with needle cartridge 90 and locks them into place. It also includes an anti-rotate 102 which contacts the needle 110. The cartridge holder 72 is held by a coil spring 104. This allows the anti-rotate/locking bar 100 to move up or down to lock or unlock the needle cartridge 90 onto the cartridge holder 72.
“FIGS. 14A and 14B show a larger view of the distal end of the cartridge holder 72. FIG. FIG. 14A shows the needle cartridge 90 in an unlocked position. To lock the needle cart 90, rotate the needle 90 counterclockwise. The needle cartridge 90 can be unlocked by pressing the anti-rotate or locking bar 100 against the cartridge holder assembly 72. This will engage the coil spring, allowing the anti-rotate 100 and locking 100 to pivot at pivot point 103.
“FIG. “FIG. 9” shows an alternative cartridge locking mechanism. The cartridge holder 72 contains a locking pin 200 that can be slidably placed within it. The operator can slide the locking pin 200 from a position protruding from the cartridge holder assembly 72’s distal edge, 87 to a fully extended position by connecting a handle and button 203 to the pin 204. FIG. 11 shows the cross-sectional view. 11 shows that the locking pin 200 is biased so that it protrudes from the cartridge holder assembly 72’s distal edge, 87. This is due to the spring 201 located on the proximal end 200. The cartridge holder 72 secures the needle cartridge 90 to the cartridge. The grooves 94 and slots 82 are fully engaged. A locking pin recess 200 on the cartridge’s mating surface aligns with the pin 200. This allows the pin 200 to protrude into the recess, engaging the recess. This locks the needle cartridge 90 onto the cartridge 72. Although slightly larger than the locking pin 200, the locking pin recess is 202 has a similar cross-sectional design to that of the pin 200. One embodiment has the locking pin 200 having a circular cross-sectional form and the locking pin recess202 being circular. To remove the cartridge from its cartridge holder assembly, the user must engage the button 203 and handle 203 on the pin 200. Then slide the pin 200 towards the proximal end to retract it from the recess 202. After retracting the locking pin 200 the user can rotate 90 degrees the needle cartridge to release the grooves (94) from slots 82 and remove the cartridge from cartridge holder 72. FIG. 2 shows the locking pin recess. 12 is a perspective view showing a section of the mating, or proximal surface, of the needle cartridge.
“The locking and anti-rotate bar 100 is placed in the outer notch on the needle 110 to prevent rotation and prevent needle backing up. The needle 110 will not stray out of its sequence by engaging the anti-rotate and locking bar 100. FIG. FIG. 14B shows the needle cartridge 90 in locked position, both axially and rotationally.
The construction of the anti-rotate lock 100 and the locking bar 100 can be streamlined by using a locking pin 200 to secure the cartridge locking function. As shown in FIG. 13. An anti-rotate surface 302 can be included in the anti-rotate bars 300 to make contact with the needle 110. To prevent the needle from turning backwards, the anti-rotate bars 300 are biased by spring 304. They engage the anti-rotate 302 with outer notch 116 on the needle 110.
“As illustrated in FIG. 15 The cartridge 90 can be fitted with a suture retentioner 400 to prevent the suture material (138) from interfering in the operation of the suturing tool 50. The suture retainer400 helps keep the suture material, 138 from getting in the way of the cartridge 90’s needle track 92. FIG. 4 shows a front view of the needle retention 400. 16. The projections 401 allow the operator to guide suture material 138 into a needle retention recess 402. FIG. FIG. 17 shows that the detents 403 in the needle retention 400 cause the passageway to needle retainer 402 to be slightly smaller then the diameter of suture material 38. This allows the operator to press-fit suture material (138) into the needle recess 402. FIG. FIG. 18 shows how the detents 403 provide a narrower passageway for suture material to and from the needle retention recess 402. This prevents the suture material 140 from accidentally slipping out the needle retainer 400.
“The needle cartridge 90 may also be equipped as a needle brace 500. See FIG. 19. A needle brace 500 can be placed against the cartridge to prevent accidental movement of the needle 110 in the cartridge. This is done before loading the cartridge on the cartridge holder 72. This prevents the needle 110 not to move out of its track, thereby preventing it from being displaced by the cartridge 90. As shown in FIG. 20. The body 502 of the needle brace 500 is shaped to conform to the outside radial dimensions of cartridge 90. This allows a shoulder feature 503 to be placed near the cartridge’s proximal surface and the blunt end or hub of needle 110, which are both located within cartridge 90. FIG. 21. This prevents the needle 110 from turning in its track in the reverse direction. The vertical segment 504 from body 502 of the needle brace 500 prevents the pointed end of needle110 from moving forward on its track. This closely matches the inside radial dimension cartridge 90, and stops needle 110’s forward movement in its track. With the needle brace 500 in position, an individual can manipulate the cartridge/needle/suture assembly without fear of inadvertently moving the needle within the track of cartridge 90. This movement could cause the needle to be placed in a different order than it should after it has been attached to the cartridge holder 72. The needle brace 500 can be made of suitable medical-grade disposable metal or plastic.
The needle brace 500 can be attached to the cartridge’s inner circumference by pressing a frictional button? Fit, or via tabs placed along its periphery. These can work in conjunction with the corresponding depressions (not illustrated) along the cartridge’s inner circumference. The needle brace 500 can be further refined so that the vertical segment 504 forms a tab 504A, as shown in FIG. 22. Tab 504A is made of material that has enough elastic properties to allow it to bend slightly. This characteristic is also found in the Lubricomp plastic material. Installing needle brace 500 with the pointed end 110 at the end the track of cartridge90 causes the tab 504A bend slightly to snap over the tip 112 of the needle, locking it into place, as shown in FIG. 23. The needle brace 500 can be removed by using enough force to break the elastic resistance of the tab 504.
“FIG. “FIG. 24” is an exploded view of the removable electronic modules 60, which are a battery-operated electromechanical assembly. The electronic module 60 comprises the battery pack 62 as well as the electric motor 61. This includes the gearbox 59, an output shaft (58), as well as electronic circuits. The battery 62 can be re-charged and supplies power to the electronic module 60. The battery 62 must have a minimum of 400 discharge cycles. It should be capable of performing 18 stitches (or 36 total cycles) through tissue segments such as the sternum. The motor 61 generates the necessary rotational force for the tissue closing device 50 to work. The electronic module 60 is controlled by an electronics board that controls its operation using user-controlled power and actuation buttons. The electronic module 60’s current status is displayed on indicators that provide information to the user. The starting, stopping and torque control of the electric motor 61 are controlled by a microprocessor and firmware. Electronics also include the recharging circuit for battery pack 62. Non-sterile electronic module 60 may also be available and may be attached before surgery using an aseptic technique. After cleaning, charging and storage, the electronic module 60 can be removed from its front end assembly. FIG. 2 shows additional views of electronic module 60. 25(A) through 25(H).
“FIGS. 26A and 26B depict the tissue closure device 50, where the removable electronic module 60 is enclosed in a thermoplastic envelope 150 and a housing 151. The removable electronic module 60 is accessible via a door 152 that is locked with a clamp latch 53. The door 152 is located at the proximal edge of the device 160. The door 152 must be sealed and closed after the non-sterile battery pack has been installed. To prevent any non-sterile germs escaping from the device’s interior, the door 152 must be sealed with an O-ring seal or Teflon seal.
A funnel 600 is a temporary device that can be used to place a non-sterile electronic component 60 in a sterile handle 160. It is shown in FIGS. 27(A-F). The funnel 600 acts as a physical barrier between the person and the electronic module 60 (e.g. The non-sterile electronic module 60 is handled by the circulating nurse. The surgical scrub nurse is responsible for the sterile parts of the suturing devices 50. The handle 160, door 152 and latch 153 are the sterile components. When the funnel 600 is inserted into handle 160, it becomes sterile. FIGS. FIGS. 28(A-F) show that the funnel 600 contains a proximal and distal barrels 601 and 602, respectively, each of which is shaped in cross section to match the shape of the handle 160. A flange 603 is sufficient to separate the distal 602 and proximal 601 barrels of the funnel 600. It can be used as a barrier between the user inserting the electronic module 60, and the rest of suturing device 50. To help the user install the funnel 600 correctly vertically, an arrow 604 can either be printed or engraved onto the flange. An arrow 604 on the flange 603 or another suitable printing 605 can be used to help distinguish the proximal 601 and distal 602 barrels in the funnel 600. As shown in FIGS. 27B and 27E. As shown in FIGS. 27C and 27F. After the electronic module has passed through funnel 600 and been inserted into handle 160, the funnel600 is no longer considered sterile. It can be removed. You can close the door 152 in a sterile fashion and secure it with the latch153. This will also hold the proximal end 60 of the electronic module 60 in its place. The funnel 600 allows for the sterility of the outer surfaces of the suturing devices 50. A sterile, disposable drape can be attached to the periphery 603 of the funnel 600 in an alternative embodiment. This will increase the barrier that separates the sterile and non-sterile components. Attaching the drape to the 603 can be done with a high-strength adhesive that resists heat, moisture, and sterilizing gas.
“TABLE 1” – Power Error Low Battery – LED: Green Red Yellow REM Status.nOff Mode OFFOFF OFF Unit is not on and will not activate.nOn Mode ONOFF OFF Unit can be used.nActuating ONOFF OFF Unit has completed a cycle.nError mode ONON OFF indicates an error. The mechanism will return to its home position but not activate if the button is pressed. I.e. unit can do 6 more complete\nsutures.\nBattery drained ON ON ON Battery is drained. The unit will not turn on or actuate. This mode will cause the device to not turn on and not to act. Blinking rate is TBD.
“FIG. 30 shows a close-up of the stop plate (66) and drive wheel (67). This view is shown as transparent, permanent magnets 65 and 63, and the drive pin 63. The gear 59 shaft is also shown. The entry point to the gear 59 shaft is located in the middle of the stopplate 66. The stop plate 66 attaches to the gear box, 59 using screws 69. The stop plate 66 is a?U?-shaped? The track 64 is where the drive pin 63 rides. The drive pin 63 rides along track 64 as the device is actuated. This causes the electronic module to cause rotation. The device’s rotation is limited by the mechanical stops provided by track 64. To detect the travel distances, the permanent magnets 65 are used with the Hall Effect sensor 162, which is located at the distal end an electronic board 161 inside the removable electronic module 60. Combining the firmware and the electronic Hall Effect sensor 162, the firmware detects the extent of approximately 190 degrees rotations using the magnets 65 in drive wheel 67. The firmware adjusts the torque to the motor 61 once the end of motion has been detected to create a soft stop.
“FIG. 26C is the Hall Effect sensor 162 on the electronics board 161. It detects the rotational position 67 of the drive wheels 67. The magnets 65 pass near the Hall Effect sensor 162 when the rotation is close to the stopping point. This sends a signal to control electronics that the needle 110 will soon stop. The motor torque drops at this point. At the reduced torque level, the motor continues driving to the mechanical stop point. The motor stops turning when the drive pin 63 reaches the mechanical stopping point. Two magnets 65 are located in the drivewheel 67 to detect the approaching stopping points at the ends of the arc traveled.
“FIGS. 31A and 31B depict the main components of the suturing apparatus 50. FIG. 31A shows the electronic module 60 being drawn out of the front assembly 70. The torsion spring 77 is extended during the disengaged stage to allow the pusher assembly 711 to return to its?home? position. position. The drive plate 80 in the home position returns to its original position. A hole 84 is located on the drive plate 80 and ready for the drive pin 63 to be inserted. As illustrated in FIG. 31B The electronic module 60 was attached to the front assembly 70. The electronic module 60 can be connected to the drive shaft 73. A bushing 67 is located in the drive wheel. The drive pin 63 engages with the hole 84 on the drive plate 80.
The cartridge contains the needle 110, and leaves only the sharp-pointed end 112 exposed. This position is also known as the “home” position. position. To eliminate needle-pricks from the cartridge handling or loading, the needle 110 is completely contained in the cartridge housing when it is in the home position. The aperture width in the cartridge corresponds to the gap in needle 110. This means that needle 110 in the home position does not extend into aperture 111. This alignment allows the needle 110 to remain entirely within the cartridge. It prevents accidental contact between the sharp pointed end 112 and the user’s fingertips during handling the disposable needle cartridge. This protects the needle 110 from accidental needle-pricks. This prevents accidental needle-pricks from happening and significantly reduces the risk of infection by pathogenic bacteria and viruses. To advance the pointed needle end 112, rotate the needle 110 in a curved track on the needle cartridge around the longitudinal axis 50. This will allow the needle 110 to first cross the aperture 111, then return to its home position.
“FIG. 32B is an expanded view showing the crimp 137 which houses the ends the two materials that make up a tissue closing suture material. The tissue closing material comprises the flexible leader 136 that is attached to the wire suture (138) by the crimp. Each end of the crimp has an opening. The first opening 137a accepts flexible leader 136, while the second opening 137b accepts wire suture 138, The flexible leader 136 is inserted into the first opening, 137 a. Next, the crimp137 is mechanically crimped in order to engage the flexible lead 136. The wire suture (138) is then placed in the second opening 137b. Next, the crimp (17) is mechanically crimped so that it engages the wire suture (138). The crimp 137 can engage the flexible leader136 and wire suture138 using any type of mechanical engagement, including soldering, welding, and laser welding. To make it more easy to slide through the holes, the crimp 137 is curved. The crimp137 is slim and sleek, making it easy to pass through tissue, cartilage, or bone.
“The suturing tool 50 should be held in the dominant hand by the physician. FIG. FIG. 35 illustrates an example of a suturing device with an ergonomic handle 160. FIGS. FIGS. 36A-C depict aspects of the front of the device 50 with cartridge 91 attached. FIGS. FIGS. 37A-D depict aspects of the rear sides (FIGS. 37A and 37B, the bottom side (FIG. 37C and the top (FIG. 37D) Suturing device 50 with the cartridge 90. FIG. FIG. 38 shows an example of a suturing device with a pistol-like handle 160. The handle 160 is non-sterile and provided to the healthcare professional. The sterilization of the device 50 is the responsibility of the hospital or office according to the techniques in the art. These include gravity steam sterilization and Steris. FIG. 35, the electronic module 60 is enclosed by a hollow body that contains an activator button. It may also have flush ports along its handle/body to allow for fluid or suction cleaning. FIG. 38 shows an embodiment of FIG. The handle can contain the electric motor 61 and battery pack 62, as long as it is within the scope and spirit.
“An embodiment of the suturing device 50 has a handle that does not have batteries. Instead, it is powered by external electric power from the OR. The external electric power embodiment of the device has an autoclavable motor embedded in the handle and a sterilizable cord attached to it. The sterilizable cord would connect the device to a power supply unit located outside of the operating room’s sterile zone. The power unit would plug into the wall and convert 120 volts (or 240 volts), to the voltage level that is appropriate for the motor. The cord, which is sterilizable, transmits power to the unit that contains the motor as well as the driving mechanics. The control electronics may also be found in the external power unit, rather than the handle. This configuration change would decrease the handle’s size.
“The suturing device 50 can be used in any procedure that requires dense soft tissue closure or bony tissue. The chosen tissue should be flexible enough to allow penetration with one of the many needle tips available. Another possible use is the repair or incisions of injuries to the attachment points of quadriceps tendon and Achilles tendon. Also, rib reapproximation following lateral thoracotomy. It may be beneficial to use non-metallic needle material with a cartridge 90, cartridge holders assembly 72, or pusher assembly 711 of the device 50. Non-metallic suture materials can include braided or monofilament nylon or prolene, Dacron, natural material like silk or catgut, as well as synthetic absorbable material like polyglycolic acid or polyglactin.
As an example, sternotomy procedures require that the handle of device 50 be sterilized in hospital autoclaves before being delivered to the operating area. The charger has charged the battery pack 62 in the electronic module 60 and it is now brought into the non-sterile section of the operating area. A surgical scrub nurse will open the sterilized package containing device 50 as part of routine setup of the surgical area. The scrub nurse will open the handle’s rear portal and present it to a circulating nurse outside the sterile operating area. The scrub nurse will then be able to grasp the sterile funnel 600 at the flange 603 by the handle 160 and insert it into device 50. The fully charged electronic module 60 will be taken by the circulating nurse. She will then insert the module 60 through the handle 160’s open rear portal using standard aseptic techniques. The circulating nurse will then grab the funnel 600’s flange 603 and pull it out of the handle 160. The circulating nurse can assist with this process by grasping the funnel 600 using a clamp or sterile forceps. The portal will be closed by the scrub nurse. She will seal the electronic module 60 into its handle. Now, the reusable device 50 can be loaded with the disposable suture cartridge.
“When it’s time to close your sternum, the nurse will open the disposable sterile suture cartridges 90. A typical 6-pack will contain six packs. The cartridge holder assembly 72 is used to hold the suture cartridge 90. The device 50 must be checked to ensure that the power light is off and the LED lights 156 are not lit. The needle cartridge 90’s slots at 10 o?clock and 2:20 o?clock are aligned to the tabs at 10 o?clock and 2:20 o?clock on the cartridge holder 72. The cartridge holder 72 is aligned with needle cartridge 90. It is then pushed onto the 72 cartridge holder 72 and rotated counterclockwise to secure the needle cartridge 90 in its place. The locking pin 200 aligns with the locking hole 202 on the cartridge 90. At this point, the locking pin 200 can be engaged with the locking hole 202. After the cartridge holder assembly 72 has been secured, the needle brace 500 can be removed from cartridge 90. After the cartridge holder assembly 72 has been secured to the cartridge holder assembly 72, the Power On button 154 will be activated. The device 50 will then turn on the green LED. Next, press the actuation button 55 to cycle the needle 110 one more time before placing the device 50 into the surgeon’s hands. The needle 110 should rotate one revolution per cycle, so the device 50 should cycle twice. Now, the device 50 can be used to place your first suture. The surgeon will place the suture. The device 50 will be handed to the scrub nurse. The surgeon will place sutures from the top of the sternum to the bottom at his discretion. The sternum is usually closed with six to eight stitches. To enhance the safety of the device 50’s operation, it can be programmed so that each cycle of actuation requires the operator to press Power-on button154 before pressing the actuation buttons 155.
“To begin the sternotomy closing, any embodiment the sternotomy close device 50 is placed at the site. The device 50 should be between a first and second side of a splitsternum. The typical starting point is usually around the manubrium 170 (or the head) of your sternum. 40. With his or her left arm, the surgeon will lift one side of each divided sternum. The surgeon aligns the perforation (or opening) of the needle cartridge 90 with the cut edge of his or her sternum. This allows him to locate the point where he wants the suture to go under the cartridge top. To elevate the divided sternum, the surgeon can use the lower edge 72 of the cartridge holder assembly. This eliminates the need for the surgeon to place his/her hand underneath the sternum. The needle will be inserted into the sternum by the surgeon from the outside (outside). Before positioning the device 50, the surgeon presses Power-on button154. Then, he presses the actuation buttons 155 while holding it 50 at the desired position. The following actions take place when the button 155 has been pressed: The electronic controller turns the motor and gearbox clockwise. This motion is transferred inside the electronic module to drive shaft via the following chain: Drive shaft to gearbox shaft to drive plate to drive shaft to the driver arm. The pawl is held by the drive arm. The pawl is held in place by the rear drive notch. The drive arm is rotated through a half-circle arc. The pawl pushes a needle through the first half of one revolution. This is the stroke that penetrates your sternum. The drive arm will stop when it reaches the end a stroke. The drive arm will reverse its direction and return to the starting position. The drive arm will stop once it reaches the starting position. Now, the drive arm starts to turn clockwise. The pawl grabs the front needle notch from the end of the stroke and pulls it through. The drive arm will stop when it reaches the end. The drive arm will then reorient and return to its original position. The device 50 automatically powers off when the drive arm reaches its starting position. Now the needle has been driven completely through the sternum. The needle has created a hole in the flexible leader. Now, the surgeon will turn the device counterclockwise to pull the leader through the one-side of the sternum. To pull the flexible leader through the chest, the surgeon may use his left hand. Now, the surgeon will raise the other side. The surgeon aligns the needle cartridge 90 with the sternum bone. He then determines the point at which he wants the suture to penetrate. The surgeon presses the Power button 154 and then the actuation buttons 155 to allow the needle to enter the patient’s sternum from within. These steps are repeated. The flexible leader is now through the sternum. To remove the needle cartridge from the device 50, the surgeon can press the cartridge locking surface 101 on the anti-rotate/locking bar.
“The device 50 can be passed to the nurse for loading a second cartridge 90. Following standard procedure for any sternum closure suture, the surgeon will use both his hands to pull the flexible lead and suture through the sternum. Standard procedures are used to remove the monofilament suture’s needle, flexible leader, and crimp ferrule. The surgeon then places a second suture. This continues until all remaining sutures are placed, usually to the area around the xiphoid process 172. The sternum is closed using standard surgical procedures after all necessary sutures have been placed. The device 50 can be cleaned, sterilized and charged. One common procedure is: A clean-up crew will wipe the outside of 50 device with disinfectant. The electronic module will then be removed from the rear portal. The electronic module is placed in non-sterile equipment storage to be charged on the designated charger. A validated cleaning protocol will be used to clean the device handle. A validated sterilization protocol will be used to sterilize the device handle.
“A Teflon seal or an O-ring seal between the cartridge holder assembly 72 and the pusher assembly 72 provides a sterility barrier. The drive shaft of the pusher will rotate within the Teflon sealing 57A/O-ring 57 to prevent any debris from moving down the drive shaft. This will keep it from getting inside the tissue closure device 50.
This invention describes a method for sternum-re-approximation. This method involves: (a) attaching a cartridge with a protective housing, a suturing tip to a cartridge-holder assembly of an sternotomy closing device; (b), placing the cartridge in an aperture in the sternotomy closing device to cause rotational movement of suturing tips across the cartridge; (c) inserting an electronic module coupled with a pusher assembly to activate the suturing tool to move the needle across the aperture; (d), pulling the suturing material through the second side; The steps (b) through the (e) continue until the length of the first and second sides of the splitsternum are re-approximated.
“All patents, applications for patents, and published references cited in this document are hereby included by reference in their entirety. You will appreciate that many of the disclosed and other functions and features, as well as other alternatives, can be combined into other systems and applications. Many modifications, variations, and improvements to the invention may be made by persons skilled in the art. These modifications are included in the following claims. It is therefore intended that the present invention includes modifications and variations within the scope of the appended Claims and their equivalents.
Summary for “Apparatus for tissue closure and method”
“Surgery can present many challenges that can affect the patient’s health as well as the health and safety of the medical professionals. Some surgical procedures, like cardiac surgery or pneumonectomy, require access to the organ via sternotomy. This is a procedure that involves the division of the sternum with a suitable instrument such as a saw, or any other suitable cutting tool. The sternum must then be re-examined after the procedure. A sternotomy is usually performed by a medical professional using a stainless-steel needle with a sharp cutting tip. The suture consists of a length of stainless steel wire or a combination of flexible and stiff stainless steel cables. The combination cable/wire suture is manually drawn through the sternum on both sides. It is important that the wire protrudes from the sternum at the same time. The medical professional will remove the needle from the wire and wrap the end of one wire around another wire using forceps or their hands. Twisting the wires in a spiral or helical fashion is the next step. The medical professional will then cut the twisted wires to the desired length. They will use surgical tools to place the sharp, cut and twisted ends of wires in the space between the sternum’s re-approximated edges. This ensures that the wire ends do not penetrate the skin. In order to close the sternum along its length, typically six to eight wire sutures will be placed in the sternum.
The prior art sternotomy closing procedures pose many problems for the patient and the doctor. Manual suturing can be difficult as the suturing needle has to pass through dense, hard bone. Manual suturing involves handling a sharp suturing tool such as a forceps. This can lead to inadvertent needle pricks through the gloves of a nurse or surgeon. There is a risk of infection for staff, patients, the surgeon and nurses. It can be difficult and frustrating to manipulate an inflexible wire under the sternum or ribcage. The surgeon has traditionally had to lift the sternum up in order to place a suture into the bone. This puts the surgeon at risk of needle puncture due the force needed to reach the bone. Medical professionals can also be exposed to potentially fatal bloodborne diseases such as HIV/AIDS or Hepatitis C by being stuck to the wires’ sharp ends. The needle could also penetrate the heart, vessels and other structures, causing serious and sometimes fatal infections.
“Prior art Sternotomy Sutures for Use by Medical Professionals are described in U.S. Pat. No. 4,074,732 entitled “Wire Cutting Stripping and Twisting Tools;” U.S. Pat. No. No. U.S. Pat. No. No. U.S. Pat. No. No. 5,830 234 entitled “Method to Double Wire Sternotomy Sture,”? All of these are hereby included by reference in their entirety. Prior art sternotomy sutures require that the medical professional uses their hands or manual tools to manipulate and tension the sutures. U.S. Pat. No. No. 6,923,819 describes an apparatus and method of surgical suturing with threadmanagement. The entire document is herein incorporated by reference.
“It is clear that the art has a need for sternotomy closing devices and methods that are safe, reliable, user-friendly, and effective. This and other problems can be solved by the present invention.
The following description will clearly show the purpose and benefits of the invention. The methods and systems that are specifically described in the claims and written description of this invention, as well the attached drawings, will provide additional benefits.
“The invention provides an apparatus and a method of joining tissue such as bone tissue to achieve these and other benefits. A device is described that can be used to join tissue, such as for sternotomy recalibration. It includes a pusher assembly and a cartridge. The drive assembly includes a drive arm that extends from a shaft and a drive mechanism at the distal end. The drive mechanism can releasably engage and rotate a suturing tool with a pointed and blunt end around a rotational axis. The cartridge comes with a protective housing as well as the suturing tip. The cartridge is attached to the cartridge holders assembly via a distal end.
“According to a further aspect, the pointed end of a suturing nee is preferably placed within the protective housing prior and after complete rotation of the suturing nee about the rotational direction. A removable electronic module can be added to the device if desired. This actuator engages the drive shaft to rotate it and the drive mechanism, rotating the suturing tip about the rotational direction.
“According to a further aspect, the invention also provides a cartridge that houses a suturing tip. This can be used, if desired, in sternum refining. The cartridge comprises a housing with a curved shape and an inner wall as well as an outer wall. The inner wall of the housing has a track that allows the suturing tool to follow a curving path on the track. A housing aperture intercepts the track and shields the pointed end from the suturing nel during at least some of the revolutions.
“According to another aspect, the invention also provides a suturing tool for use in, for instance, sternum reapproximation. A curved body with a blunt end engages a suturing substance. The pointed end is protected at the end of a rotational cycle. A flexible leader that is attached to a wire suture is preferred for the suturing material.
“According to another aspect, the invention provides a means of joining tissue such as sternum-re-approximation. This method involves releasably attaching a cartridge with a protective housing, and a suturing to a cartridge-holder assembly of a tissue closing device. The method also includes placing the tissue closure device with the cartridge and the needle into an aperture to allow the needle to rotate about a rotating axis. This method also involves activating an electronic module that is coupled to a pusher, which causes the suturing device to rotate across the cartridge’s aperture. The suturing tool then moves through the tissue segment through which it passes through and pulls a suturing material through the segment. You can also use the device to stitch the second tissue segment.
“It is important to understand that the above general description and the detailed description are examples and are meant to further explain the invention claimed.”
The accompanying drawings are part of this specification and are included to illustrate the method and devices of invention. The drawings, along with the description, serve to illustrate the principles of this invention.
“Reference will now to the preferred embodiments of this invention. Examples of these are shown in the accompanying illustrations. In conjunction with the detailed description, the method and the corresponding steps will be described.
“The devices and methods described herein can be used to close tissue. The invention is especially well-suited for procedures that involve bony tissue such as sternotomy closings. The disclosed tissue closure device (or suturing device) is an electrically powered motorized device. You can use standard wall power or a battery as the power source. These tissue closure devices are designed to prevent accidental needle punctures for the medical practitioner and can be used to drive needles through bone tissue quickly and easily. The disclosed devices are used to close sternotomy. They protect the heart, vessels and other structures and reproduce the standard sternotomy closing technique. The disclosed embodiments allow for easier and faster manipulation of the wire/cable combination in the chest cavity or other anatomy. They also produce tissue closure in an efficient manner, so that the patient is not exposed to the health risks associated having a tissue segment such as the sternum open for longer than necessary.
“The major components of a tissue closing device according to the presently disclosed embodiments of the invention are generally shown at 50 in FIG. 1. The tissue closure device 50 is able to create a continuous or an interrupted suture to allow closure of the sternal halves following sternotomy. Device 50, a motorized and battery-powered device, is shown in the illustration. It prevents needle punctures during sternotomy or similar procedures. Device 50 provides reliable closure with standard wires and needles. It also replicates standard tissue closure techniques (e.g., Sternotomy). The device 50 is able to drive needles through bone and other tissues, eliminating the need for manual force. It also protects the heart and surrounding vessels from accidental needle punctures during closure.
Referring to FIG. “Referring to FIG. A shaft runs through the gear box 59, which also includes a stopplate 66, a bearing plate 68, as well as a drive wheel. The drive pin 63 is used to engage the drive wheel 67. It also mates with a hole made in a driveplate 80, which is part of a front-end assembly 70. The bearing surface 68 acts between the stop plate (66) and the drive wheel (67). The bearing surface 68 may be any lubricious material having a low coefficient of friction, for example fluoropolymer compounds such as those including polytetrafluoroethylene (PTFE).”
The electric motor 61 is preferably compact but powerful. One embodiment can use a DC motor from the Maxon Re-max 29 series, which is commercially available at Maxon Precision Motors, Inc., Fall River, Mass. Model no. Model no. 226784 is available. It weighs 159g, measures 29mm in diameter, generates 22 watts and has a speed rating of 7630 RPM. You can choose from the Maxon Gearhead GP32C, which measures 32 mm in size, as the gear box 59. Model no. The model no. 166943 is available, with 3 stages and a weight of 194g. It also has a 103-to-1 gear reduction ratio.
“The front end assembly 70, as shown, includes a pusher assembly (not seen) and a cartridge-holder assembly 72. The pusher assembly houses a drive mechanism (??pawl?) on its drive arm. A drive shaft runs along the length of the front assembly 70 and into the drive plate 80. An insert cartridge 90 containing a tissue closure needle 110 can be attached to the distal end 81 on the cartridge holder 72.
“FIG. 2A and FIG. FIG. 2A and FIG. 2B depict the front end assembly 70, which includes a pusher assembly 71, and the cartridge holder 72. The cartridge holder 72 houses the disposable needle cartridge 90 that contains the tissue closure needle 110. The pusher assembly 71/71 has a drive shaft/73 and a drive arms 75 which are in close contact with the needle 110 via an pawl. The drive shaft 7 engages the drive plate 80’s spline so that the drive shaft 73 can rotate with the drive plate 80. The electronic module can be attached to the front assembly by the drive shaft 73. This engages the bushing in the drive wheel. 67 FIG. 72 shows the cartridge holder assembly 72. 2B shows the cartridge holder assembly 72 (shown in FIG. The arms extend along mutually divergent directions so that there is an opening 78 for the user to see the device 50 while it is being operated. The support arms 76 have a minimal bulk and an open configuration that allows for a wide viewing area 78. This is the opening in the cartridge cartridge 90 and cartridge holders 72. It is this space between the first and second sides of a splitsternum, and needle advancement through this space during the operation of the tissue closing device 50. FIG. 2 shows an embodiment of the same configuration. FIG. 2 shows a plurality 76 support arms, but other variations include a single support-arm assembly. The support arm assembly 76’s shape and configuration 76 allows for precise device placement over the spine in the case of sternotomy. It also provides uniform advancement of the tissue closing device 50 after each stitch, providing a uniform and symmetrical suture. This protects the heart, adjacent vessels, and structures, from any accidental needle punctures.
The cartridge holder assembly 72’s distal end 81 is where the needle cartridge 90 can be attached. The circular housing of the needle cartridge 90 is made from a suitable medical-grade sterilizable metal or plastic material. The cartridge 90 should have a high degree of rigidity, as well as a low coefficient for friction. This will reduce the amount of power needed to move the needle contained within. Lubricomp DFP22H is a polycarbonate containing 10% of glass fill, 8% PTFE Teflon (Teflon) and 2% silicon. This material can give the cartridge up to 20% more power at the point where the needle is inserted. The housing can be easily retained by the distal tip 81 of cartridge holder 72 using known methods. For example, a plurality grooves along the inner lip in diametrically different positions are capable of engaging the same number of slots in the cartridge holder 72. When the grooves are engaged, the needle cartridge 90 can be held by the distal 81 of the cartridge-holder assembly 72. The torsion return spring (77) engages the shaft bar 74 and drive plate 80. It is responsible for returning drive shaft 73 to its “start?” position. The electronic module 60 attaches to the front assembly 70 so that the drive pin 63 engages the drive plate 80.
“As best illustrated in FIG. 31A and FIG. 31A and FIG. The rotating shaft is sealed against the front end by the first O-ring 57. The second O-ring 57 seals nearer to the housing, sealing the front end assembly against nose collar 157. A plurality of O rings 57 act as a barrier to keep the exterior of the device from the interior. As shown in FIG. A Teflon seal (57A) can also be used as shown in FIG. The barrier seal prevents any non-sterile germs or particles from escaping the device’s front end to the sterile exterior.
“FIG. “FIG. 3B and FIG. 3A) is located at the tip. It is found in a slot in drive arm 75 and connected to drive arm 75 via pivot pin 99. The pawl 95 drives the needle in a circular direction (not shown).
The cartridge contains the needle 110, and leaves only the sharp-pointed end 112 exposed. This position is also known as the “home” position. position. To eliminate needle-pricks from the cartridge handling or loading, the needle 110 is completely contained in the cartridge housing when it is in the home position. The aperture width in the cartridge corresponds to the gap in needle 110. This means that needle 110 in the home position does not extend into aperture 111. This alignment allows the needle 110 to remain entirely within the cartridge. It prevents accidental contact between the sharp pointed end 112 and the user’s fingertips during handling the disposable needle cartridge. This protects the needle 110 from accidental ‘needle-pricks’. This prevents accidental needle-pricks from happening and significantly reduces the risk of infection by pathogenic bacteria or viruses. To advance the pointed needle end 112, rotate the needle 110 in a curved track on the needle cartridge around the longitudinal axis 50. This will allow the needle 110 to first cross the aperture 111 before returning to its home position. The suturing material attaches to the needle 110 and follows the path of needle 110. The suturing material can then be cut, twist tied, and secured using a suitable method. You can place every stitch in the same way, no matter if it is a single interrupted stitch or a series continuous, running stitch. As a substitute for the tedious and time-consuming manual stitching process, the tissue closure or suturing device 50 can be used to either insert one single stitch or a series of continuous stitches.
“FIG. FIG. 5B and FIG. Sectional views of the tissue closing needle and pusher assembly are shown in FIG. 5B and FIG. FIG. FIG. 5B shows how a flat spring (96) exerts tension on the left pawl to propel it distally into the needle 110, and into the notch 95 b. The pawl 95 rotates and the notch 115b is picked up by the pawl 95, driving the needle 110.
“FIG. 5C shows that the pawl 95 is not in the notch115 b but engaging the surface of needle 110. The pawl 95 is moving along the outer surface 110 of the needle 110 when the notch 115b is encountered. The pawl tip contacts the ramp for the hole 115b, and the flat spring pushes 95 into the needle’s notch.
“FIG. “FIG. The pawl 95’s angled surface angles away from the stop 98. The pawl 95 must rotate clockwise so that the angled surface touches the pawl stop. FIG. 5B shows the contact of the pawl stop with the pawl 95. 5B. 5B.
“FIG. “FIG. 6 shows a close-up of the cartridge holder 72’s distal end 81. The 72-inch cartridge holder assembly is made of sterilizable medical quality material. It can be either a metallic material like stainless steel that allows it to be reused after sterilization, or a sterilizable plastic material that can be discarded after one use. The cylindrical cartridge holder 72 has a distal edge of 87 and aproximal edge of 89 that are oriented with respect to the device handle (not illustrated). An aperture 85 is located at the same dimension as the aperture in the disposable needle cartridge. A plurality 82 of slots are also located on the cartridge holder assembly 72. These slots can be used to engage the same number of retaining clips that are located in the needle cartridge housing (not illustrated). A cylindrical slot, not visible on the cartridge holder 72, is also located along the distal edge. It can engage a pivoting pin with identical diameter on a gate assembly (105). The support arm assembly 76 attaches the shaft segment 74 to the proximal edge of the cartridge holder 72. The gate assembly (105) prevents the needle falling out of the cartridge holder 72’s back. To allow a circular movement in the drive mechanism that engages needle, the gate assembly 105 pivots on the pivot pin 107. The stop pins 106 on the cartridge holder assembly cause gate assembly 105, to reverse and stop in the opposite direction. It is similar to a?see?-saw? ?up-down? motion. The cartridge holder 72 prevents the needle from being moved laterally or dislocated by the gate assembly 105. The gate assembly105 can pivot on the pivot pin107 so that drive arm 75, which is connected to the needle via the claw, can pass through the gate assembly105. The needle cartridge 90 can be locked on the cartridge holder 72 by engaging the anti-rotate bars 100. This will allow rotation in the opposite direction to the advancing direction, or ‘needle backing up? ”
“FIG. “FIG. 7 is a close-up of a disposable cartridge 90 according to the presently disclosed embodiments. It is preferably provided in a sterilized sealed packaging. The circular housing of the needle cartridge 90 is made from a suitable medical-grade sterilizable metal or plastic material. To reduce the amount of power required to move the needle contained within the cartridge 90, the material used to make it should be both rigid and low in friction. Lubricomp DFP22H is a polycarbonate containing 10% of glass fill, 8% PTFE Teflon (Teflon) and 2% silicon. This material can give the cartridge up to 20% more power for the point of the needle. The cartridge holder assembly may retain the housing 91 at the distal tip of suturing device 50. This can be done by using known methods, including a plurality 94 of grooves in diametrically opposed positions that can engage with the plurality slots located on the distal edge. A groove 93 is also included in the needle cartridge 90 that can engage the anti-rotate or locking bar 100.
“While the grooves allow the needle cartridge to be retained by its cartridge holder assembly 90 when engaged, the groove 93 when engaged together with the anti-rotate & locking bar 100 causes the aperture 97 in the needle cartridge to align with the cartridge holders assembly’scorresponding aperture. A circular groove, or “track”, is also included in the needle cartridge 90. The circular groove or?track’ in the needle cartridge 90 is located in the inner surface of the housing. 91. It lies in a plane perpendicular with the longitudinal axis of the housing 91 as well as that of the suturing devices 50. The track 92 is interrupted by the aperture 97.
The track 92 is used to position the arcuate suturing knife 110 made of medical-grade stainless steel or similar material. The radius of arcuate needle 110’s arc is approximately equal to that of the needle cartridge 90 located at the aperture 97. The normal home for the needle 110 is a?home’. The needle 110 normally resides in a?home? in the track 92 so that the gap between the arcuate and the cartridge 90 apertures is aligned. The pointed, sharp end of needle 110 is located on one side, within the limits of housing aperture 97. The pointed end is shielded by cartridge housing 91. The aperture 97 is on the opposite side. This is where the blunt end of needle 110 is found. It is attached to a suturing substance. The sharp, pointed end 110 of the needle is contained in the cartridge 90. It does not extend beyond the cartridge 90. The sharp, pointed end of needle 110 is therefore not visible to the user.”
“FIG. 8A is a close-up of the locking bar 100 and anti-rotate. FIG. 8B shows that the anti-rotate/locking bar 100 has a cartridge locking 101 which makes contact with needle cartridge 90 and locks them into place. It also includes an anti-rotate 102 which contacts the needle 110. The cartridge holder 72 is held by a coil spring 104. This allows the anti-rotate/locking bar 100 to move up or down to lock or unlock the needle cartridge 90 onto the cartridge holder 72.
“FIGS. 14A and 14B show a larger view of the distal end of the cartridge holder 72. FIG. FIG. 14A shows the needle cartridge 90 in an unlocked position. To lock the needle cart 90, rotate the needle 90 counterclockwise. The needle cartridge 90 can be unlocked by pressing the anti-rotate or locking bar 100 against the cartridge holder assembly 72. This will engage the coil spring, allowing the anti-rotate 100 and locking 100 to pivot at pivot point 103.
“FIG. “FIG. 9” shows an alternative cartridge locking mechanism. The cartridge holder 72 contains a locking pin 200 that can be slidably placed within it. The operator can slide the locking pin 200 from a position protruding from the cartridge holder assembly 72’s distal edge, 87 to a fully extended position by connecting a handle and button 203 to the pin 204. FIG. 11 shows the cross-sectional view. 11 shows that the locking pin 200 is biased so that it protrudes from the cartridge holder assembly 72’s distal edge, 87. This is due to the spring 201 located on the proximal end 200. The cartridge holder 72 secures the needle cartridge 90 to the cartridge. The grooves 94 and slots 82 are fully engaged. A locking pin recess 200 on the cartridge’s mating surface aligns with the pin 200. This allows the pin 200 to protrude into the recess, engaging the recess. This locks the needle cartridge 90 onto the cartridge 72. Although slightly larger than the locking pin 200, the locking pin recess is 202 has a similar cross-sectional design to that of the pin 200. One embodiment has the locking pin 200 having a circular cross-sectional form and the locking pin recess202 being circular. To remove the cartridge from its cartridge holder assembly, the user must engage the button 203 and handle 203 on the pin 200. Then slide the pin 200 towards the proximal end to retract it from the recess 202. After retracting the locking pin 200 the user can rotate 90 degrees the needle cartridge to release the grooves (94) from slots 82 and remove the cartridge from cartridge holder 72. FIG. 2 shows the locking pin recess. 12 is a perspective view showing a section of the mating, or proximal surface, of the needle cartridge.
“The locking and anti-rotate bar 100 is placed in the outer notch on the needle 110 to prevent rotation and prevent needle backing up. The needle 110 will not stray out of its sequence by engaging the anti-rotate and locking bar 100. FIG. FIG. 14B shows the needle cartridge 90 in locked position, both axially and rotationally.
The construction of the anti-rotate lock 100 and the locking bar 100 can be streamlined by using a locking pin 200 to secure the cartridge locking function. As shown in FIG. 13. An anti-rotate surface 302 can be included in the anti-rotate bars 300 to make contact with the needle 110. To prevent the needle from turning backwards, the anti-rotate bars 300 are biased by spring 304. They engage the anti-rotate 302 with outer notch 116 on the needle 110.
“As illustrated in FIG. 15 The cartridge 90 can be fitted with a suture retentioner 400 to prevent the suture material (138) from interfering in the operation of the suturing tool 50. The suture retainer400 helps keep the suture material, 138 from getting in the way of the cartridge 90’s needle track 92. FIG. 4 shows a front view of the needle retention 400. 16. The projections 401 allow the operator to guide suture material 138 into a needle retention recess 402. FIG. FIG. 17 shows that the detents 403 in the needle retention 400 cause the passageway to needle retainer 402 to be slightly smaller then the diameter of suture material 38. This allows the operator to press-fit suture material (138) into the needle recess 402. FIG. FIG. 18 shows how the detents 403 provide a narrower passageway for suture material to and from the needle retention recess 402. This prevents the suture material 140 from accidentally slipping out the needle retainer 400.
“The needle cartridge 90 may also be equipped as a needle brace 500. See FIG. 19. A needle brace 500 can be placed against the cartridge to prevent accidental movement of the needle 110 in the cartridge. This is done before loading the cartridge on the cartridge holder 72. This prevents the needle 110 not to move out of its track, thereby preventing it from being displaced by the cartridge 90. As shown in FIG. 20. The body 502 of the needle brace 500 is shaped to conform to the outside radial dimensions of cartridge 90. This allows a shoulder feature 503 to be placed near the cartridge’s proximal surface and the blunt end or hub of needle 110, which are both located within cartridge 90. FIG. 21. This prevents the needle 110 from turning in its track in the reverse direction. The vertical segment 504 from body 502 of the needle brace 500 prevents the pointed end of needle110 from moving forward on its track. This closely matches the inside radial dimension cartridge 90, and stops needle 110’s forward movement in its track. With the needle brace 500 in position, an individual can manipulate the cartridge/needle/suture assembly without fear of inadvertently moving the needle within the track of cartridge 90. This movement could cause the needle to be placed in a different order than it should after it has been attached to the cartridge holder 72. The needle brace 500 can be made of suitable medical-grade disposable metal or plastic.
The needle brace 500 can be attached to the cartridge’s inner circumference by pressing a frictional button? Fit, or via tabs placed along its periphery. These can work in conjunction with the corresponding depressions (not illustrated) along the cartridge’s inner circumference. The needle brace 500 can be further refined so that the vertical segment 504 forms a tab 504A, as shown in FIG. 22. Tab 504A is made of material that has enough elastic properties to allow it to bend slightly. This characteristic is also found in the Lubricomp plastic material. Installing needle brace 500 with the pointed end 110 at the end the track of cartridge90 causes the tab 504A bend slightly to snap over the tip 112 of the needle, locking it into place, as shown in FIG. 23. The needle brace 500 can be removed by using enough force to break the elastic resistance of the tab 504.
“FIG. “FIG. 24” is an exploded view of the removable electronic modules 60, which are a battery-operated electromechanical assembly. The electronic module 60 comprises the battery pack 62 as well as the electric motor 61. This includes the gearbox 59, an output shaft (58), as well as electronic circuits. The battery 62 can be re-charged and supplies power to the electronic module 60. The battery 62 must have a minimum of 400 discharge cycles. It should be capable of performing 18 stitches (or 36 total cycles) through tissue segments such as the sternum. The motor 61 generates the necessary rotational force for the tissue closing device 50 to work. The electronic module 60 is controlled by an electronics board that controls its operation using user-controlled power and actuation buttons. The electronic module 60’s current status is displayed on indicators that provide information to the user. The starting, stopping and torque control of the electric motor 61 are controlled by a microprocessor and firmware. Electronics also include the recharging circuit for battery pack 62. Non-sterile electronic module 60 may also be available and may be attached before surgery using an aseptic technique. After cleaning, charging and storage, the electronic module 60 can be removed from its front end assembly. FIG. 2 shows additional views of electronic module 60. 25(A) through 25(H).
“FIGS. 26A and 26B depict the tissue closure device 50, where the removable electronic module 60 is enclosed in a thermoplastic envelope 150 and a housing 151. The removable electronic module 60 is accessible via a door 152 that is locked with a clamp latch 53. The door 152 is located at the proximal edge of the device 160. The door 152 must be sealed and closed after the non-sterile battery pack has been installed. To prevent any non-sterile germs escaping from the device’s interior, the door 152 must be sealed with an O-ring seal or Teflon seal.
A funnel 600 is a temporary device that can be used to place a non-sterile electronic component 60 in a sterile handle 160. It is shown in FIGS. 27(A-F). The funnel 600 acts as a physical barrier between the person and the electronic module 60 (e.g. The non-sterile electronic module 60 is handled by the circulating nurse. The surgical scrub nurse is responsible for the sterile parts of the suturing devices 50. The handle 160, door 152 and latch 153 are the sterile components. When the funnel 600 is inserted into handle 160, it becomes sterile. FIGS. FIGS. 28(A-F) show that the funnel 600 contains a proximal and distal barrels 601 and 602, respectively, each of which is shaped in cross section to match the shape of the handle 160. A flange 603 is sufficient to separate the distal 602 and proximal 601 barrels of the funnel 600. It can be used as a barrier between the user inserting the electronic module 60, and the rest of suturing device 50. To help the user install the funnel 600 correctly vertically, an arrow 604 can either be printed or engraved onto the flange. An arrow 604 on the flange 603 or another suitable printing 605 can be used to help distinguish the proximal 601 and distal 602 barrels in the funnel 600. As shown in FIGS. 27B and 27E. As shown in FIGS. 27C and 27F. After the electronic module has passed through funnel 600 and been inserted into handle 160, the funnel600 is no longer considered sterile. It can be removed. You can close the door 152 in a sterile fashion and secure it with the latch153. This will also hold the proximal end 60 of the electronic module 60 in its place. The funnel 600 allows for the sterility of the outer surfaces of the suturing devices 50. A sterile, disposable drape can be attached to the periphery 603 of the funnel 600 in an alternative embodiment. This will increase the barrier that separates the sterile and non-sterile components. Attaching the drape to the 603 can be done with a high-strength adhesive that resists heat, moisture, and sterilizing gas.
“TABLE 1” – Power Error Low Battery – LED: Green Red Yellow REM Status.nOff Mode OFFOFF OFF Unit is not on and will not activate.nOn Mode ONOFF OFF Unit can be used.nActuating ONOFF OFF Unit has completed a cycle.nError mode ONON OFF indicates an error. The mechanism will return to its home position but not activate if the button is pressed. I.e. unit can do 6 more complete\nsutures.\nBattery drained ON ON ON Battery is drained. The unit will not turn on or actuate. This mode will cause the device to not turn on and not to act. Blinking rate is TBD.
“FIG. 30 shows a close-up of the stop plate (66) and drive wheel (67). This view is shown as transparent, permanent magnets 65 and 63, and the drive pin 63. The gear 59 shaft is also shown. The entry point to the gear 59 shaft is located in the middle of the stopplate 66. The stop plate 66 attaches to the gear box, 59 using screws 69. The stop plate 66 is a?U?-shaped? The track 64 is where the drive pin 63 rides. The drive pin 63 rides along track 64 as the device is actuated. This causes the electronic module to cause rotation. The device’s rotation is limited by the mechanical stops provided by track 64. To detect the travel distances, the permanent magnets 65 are used with the Hall Effect sensor 162, which is located at the distal end an electronic board 161 inside the removable electronic module 60. Combining the firmware and the electronic Hall Effect sensor 162, the firmware detects the extent of approximately 190 degrees rotations using the magnets 65 in drive wheel 67. The firmware adjusts the torque to the motor 61 once the end of motion has been detected to create a soft stop.
“FIG. 26C is the Hall Effect sensor 162 on the electronics board 161. It detects the rotational position 67 of the drive wheels 67. The magnets 65 pass near the Hall Effect sensor 162 when the rotation is close to the stopping point. This sends a signal to control electronics that the needle 110 will soon stop. The motor torque drops at this point. At the reduced torque level, the motor continues driving to the mechanical stop point. The motor stops turning when the drive pin 63 reaches the mechanical stopping point. Two magnets 65 are located in the drivewheel 67 to detect the approaching stopping points at the ends of the arc traveled.
“FIGS. 31A and 31B depict the main components of the suturing apparatus 50. FIG. 31A shows the electronic module 60 being drawn out of the front assembly 70. The torsion spring 77 is extended during the disengaged stage to allow the pusher assembly 711 to return to its?home? position. position. The drive plate 80 in the home position returns to its original position. A hole 84 is located on the drive plate 80 and ready for the drive pin 63 to be inserted. As illustrated in FIG. 31B The electronic module 60 was attached to the front assembly 70. The electronic module 60 can be connected to the drive shaft 73. A bushing 67 is located in the drive wheel. The drive pin 63 engages with the hole 84 on the drive plate 80.
The cartridge contains the needle 110, and leaves only the sharp-pointed end 112 exposed. This position is also known as the “home” position. position. To eliminate needle-pricks from the cartridge handling or loading, the needle 110 is completely contained in the cartridge housing when it is in the home position. The aperture width in the cartridge corresponds to the gap in needle 110. This means that needle 110 in the home position does not extend into aperture 111. This alignment allows the needle 110 to remain entirely within the cartridge. It prevents accidental contact between the sharp pointed end 112 and the user’s fingertips during handling the disposable needle cartridge. This protects the needle 110 from accidental needle-pricks. This prevents accidental needle-pricks from happening and significantly reduces the risk of infection by pathogenic bacteria and viruses. To advance the pointed needle end 112, rotate the needle 110 in a curved track on the needle cartridge around the longitudinal axis 50. This will allow the needle 110 to first cross the aperture 111, then return to its home position.
“FIG. 32B is an expanded view showing the crimp 137 which houses the ends the two materials that make up a tissue closing suture material. The tissue closing material comprises the flexible leader 136 that is attached to the wire suture (138) by the crimp. Each end of the crimp has an opening. The first opening 137a accepts flexible leader 136, while the second opening 137b accepts wire suture 138, The flexible leader 136 is inserted into the first opening, 137 a. Next, the crimp137 is mechanically crimped in order to engage the flexible lead 136. The wire suture (138) is then placed in the second opening 137b. Next, the crimp (17) is mechanically crimped so that it engages the wire suture (138). The crimp 137 can engage the flexible leader136 and wire suture138 using any type of mechanical engagement, including soldering, welding, and laser welding. To make it more easy to slide through the holes, the crimp 137 is curved. The crimp137 is slim and sleek, making it easy to pass through tissue, cartilage, or bone.
“The suturing tool 50 should be held in the dominant hand by the physician. FIG. FIG. 35 illustrates an example of a suturing device with an ergonomic handle 160. FIGS. FIGS. 36A-C depict aspects of the front of the device 50 with cartridge 91 attached. FIGS. FIGS. 37A-D depict aspects of the rear sides (FIGS. 37A and 37B, the bottom side (FIG. 37C and the top (FIG. 37D) Suturing device 50 with the cartridge 90. FIG. FIG. 38 shows an example of a suturing device with a pistol-like handle 160. The handle 160 is non-sterile and provided to the healthcare professional. The sterilization of the device 50 is the responsibility of the hospital or office according to the techniques in the art. These include gravity steam sterilization and Steris. FIG. 35, the electronic module 60 is enclosed by a hollow body that contains an activator button. It may also have flush ports along its handle/body to allow for fluid or suction cleaning. FIG. 38 shows an embodiment of FIG. The handle can contain the electric motor 61 and battery pack 62, as long as it is within the scope and spirit.
“An embodiment of the suturing device 50 has a handle that does not have batteries. Instead, it is powered by external electric power from the OR. The external electric power embodiment of the device has an autoclavable motor embedded in the handle and a sterilizable cord attached to it. The sterilizable cord would connect the device to a power supply unit located outside of the operating room’s sterile zone. The power unit would plug into the wall and convert 120 volts (or 240 volts), to the voltage level that is appropriate for the motor. The cord, which is sterilizable, transmits power to the unit that contains the motor as well as the driving mechanics. The control electronics may also be found in the external power unit, rather than the handle. This configuration change would decrease the handle’s size.
“The suturing device 50 can be used in any procedure that requires dense soft tissue closure or bony tissue. The chosen tissue should be flexible enough to allow penetration with one of the many needle tips available. Another possible use is the repair or incisions of injuries to the attachment points of quadriceps tendon and Achilles tendon. Also, rib reapproximation following lateral thoracotomy. It may be beneficial to use non-metallic needle material with a cartridge 90, cartridge holders assembly 72, or pusher assembly 711 of the device 50. Non-metallic suture materials can include braided or monofilament nylon or prolene, Dacron, natural material like silk or catgut, as well as synthetic absorbable material like polyglycolic acid or polyglactin.
As an example, sternotomy procedures require that the handle of device 50 be sterilized in hospital autoclaves before being delivered to the operating area. The charger has charged the battery pack 62 in the electronic module 60 and it is now brought into the non-sterile section of the operating area. A surgical scrub nurse will open the sterilized package containing device 50 as part of routine setup of the surgical area. The scrub nurse will open the handle’s rear portal and present it to a circulating nurse outside the sterile operating area. The scrub nurse will then be able to grasp the sterile funnel 600 at the flange 603 by the handle 160 and insert it into device 50. The fully charged electronic module 60 will be taken by the circulating nurse. She will then insert the module 60 through the handle 160’s open rear portal using standard aseptic techniques. The circulating nurse will then grab the funnel 600’s flange 603 and pull it out of the handle 160. The circulating nurse can assist with this process by grasping the funnel 600 using a clamp or sterile forceps. The portal will be closed by the scrub nurse. She will seal the electronic module 60 into its handle. Now, the reusable device 50 can be loaded with the disposable suture cartridge.
“When it’s time to close your sternum, the nurse will open the disposable sterile suture cartridges 90. A typical 6-pack will contain six packs. The cartridge holder assembly 72 is used to hold the suture cartridge 90. The device 50 must be checked to ensure that the power light is off and the LED lights 156 are not lit. The needle cartridge 90’s slots at 10 o?clock and 2:20 o?clock are aligned to the tabs at 10 o?clock and 2:20 o?clock on the cartridge holder 72. The cartridge holder 72 is aligned with needle cartridge 90. It is then pushed onto the 72 cartridge holder 72 and rotated counterclockwise to secure the needle cartridge 90 in its place. The locking pin 200 aligns with the locking hole 202 on the cartridge 90. At this point, the locking pin 200 can be engaged with the locking hole 202. After the cartridge holder assembly 72 has been secured, the needle brace 500 can be removed from cartridge 90. After the cartridge holder assembly 72 has been secured to the cartridge holder assembly 72, the Power On button 154 will be activated. The device 50 will then turn on the green LED. Next, press the actuation button 55 to cycle the needle 110 one more time before placing the device 50 into the surgeon’s hands. The needle 110 should rotate one revolution per cycle, so the device 50 should cycle twice. Now, the device 50 can be used to place your first suture. The surgeon will place the suture. The device 50 will be handed to the scrub nurse. The surgeon will place sutures from the top of the sternum to the bottom at his discretion. The sternum is usually closed with six to eight stitches. To enhance the safety of the device 50’s operation, it can be programmed so that each cycle of actuation requires the operator to press Power-on button154 before pressing the actuation buttons 155.
“To begin the sternotomy closing, any embodiment the sternotomy close device 50 is placed at the site. The device 50 should be between a first and second side of a splitsternum. The typical starting point is usually around the manubrium 170 (or the head) of your sternum. 40. With his or her left arm, the surgeon will lift one side of each divided sternum. The surgeon aligns the perforation (or opening) of the needle cartridge 90 with the cut edge of his or her sternum. This allows him to locate the point where he wants the suture to go under the cartridge top. To elevate the divided sternum, the surgeon can use the lower edge 72 of the cartridge holder assembly. This eliminates the need for the surgeon to place his/her hand underneath the sternum. The needle will be inserted into the sternum by the surgeon from the outside (outside). Before positioning the device 50, the surgeon presses Power-on button154. Then, he presses the actuation buttons 155 while holding it 50 at the desired position. The following actions take place when the button 155 has been pressed: The electronic controller turns the motor and gearbox clockwise. This motion is transferred inside the electronic module to drive shaft via the following chain: Drive shaft to gearbox shaft to drive plate to drive shaft to the driver arm. The pawl is held by the drive arm. The pawl is held in place by the rear drive notch. The drive arm is rotated through a half-circle arc. The pawl pushes a needle through the first half of one revolution. This is the stroke that penetrates your sternum. The drive arm will stop when it reaches the end a stroke. The drive arm will reverse its direction and return to the starting position. The drive arm will stop once it reaches the starting position. Now, the drive arm starts to turn clockwise. The pawl grabs the front needle notch from the end of the stroke and pulls it through. The drive arm will stop when it reaches the end. The drive arm will then reorient and return to its original position. The device 50 automatically powers off when the drive arm reaches its starting position. Now the needle has been driven completely through the sternum. The needle has created a hole in the flexible leader. Now, the surgeon will turn the device counterclockwise to pull the leader through the one-side of the sternum. To pull the flexible leader through the chest, the surgeon may use his left hand. Now, the surgeon will raise the other side. The surgeon aligns the needle cartridge 90 with the sternum bone. He then determines the point at which he wants the suture to penetrate. The surgeon presses the Power button 154 and then the actuation buttons 155 to allow the needle to enter the patient’s sternum from within. These steps are repeated. The flexible leader is now through the sternum. To remove the needle cartridge from the device 50, the surgeon can press the cartridge locking surface 101 on the anti-rotate/locking bar.
“The device 50 can be passed to the nurse for loading a second cartridge 90. Following standard procedure for any sternum closure suture, the surgeon will use both his hands to pull the flexible lead and suture through the sternum. Standard procedures are used to remove the monofilament suture’s needle, flexible leader, and crimp ferrule. The surgeon then places a second suture. This continues until all remaining sutures are placed, usually to the area around the xiphoid process 172. The sternum is closed using standard surgical procedures after all necessary sutures have been placed. The device 50 can be cleaned, sterilized and charged. One common procedure is: A clean-up crew will wipe the outside of 50 device with disinfectant. The electronic module will then be removed from the rear portal. The electronic module is placed in non-sterile equipment storage to be charged on the designated charger. A validated cleaning protocol will be used to clean the device handle. A validated sterilization protocol will be used to sterilize the device handle.
“A Teflon seal or an O-ring seal between the cartridge holder assembly 72 and the pusher assembly 72 provides a sterility barrier. The drive shaft of the pusher will rotate within the Teflon sealing 57A/O-ring 57 to prevent any debris from moving down the drive shaft. This will keep it from getting inside the tissue closure device 50.
This invention describes a method for sternum-re-approximation. This method involves: (a) attaching a cartridge with a protective housing, a suturing tip to a cartridge-holder assembly of an sternotomy closing device; (b), placing the cartridge in an aperture in the sternotomy closing device to cause rotational movement of suturing tips across the cartridge; (c) inserting an electronic module coupled with a pusher assembly to activate the suturing tool to move the needle across the aperture; (d), pulling the suturing material through the second side; The steps (b) through the (e) continue until the length of the first and second sides of the splitsternum are re-approximated.
“All patents, applications for patents, and published references cited in this document are hereby included by reference in their entirety. You will appreciate that many of the disclosed and other functions and features, as well as other alternatives, can be combined into other systems and applications. Many modifications, variations, and improvements to the invention may be made by persons skilled in the art. These modifications are included in the following claims. It is therefore intended that the present invention includes modifications and variations within the scope of the appended Claims and their equivalents.
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