US20060116718A1 - Device and method for tacking a prosthetic screen - Google Patents

Abstract

Prosthetic screen tacking device including a filament with at least one barb and one or more of a perpendicular foot at one end, a loop at the other end and a needle at the other end. When a needle and loop are present, the loop is situated between the barbs and the needle. The barbs are situated near the foot and angulated to permit movement of the device through a prosthetic screen and body tissue in one direction, but prevent movement in the opposite direction toward the foot. When the loop, or another form of an expanded portion of the filament, is present, it prevents the premature retrograde dislodgement of the filament from the abdominal wall after the loop has been forwardly passed through the abdominal wall and before the barbs engage with the abdominal wall. Methods of using the device with and without an associated button are disclosed.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application is a continuation-in-part of U.S. patent application Ser. No. 10/636,841, filed Aug. 7, 2003, and U.S. patent application Ser. No. 10/841,929 filed May 7, 2004, both of which are incorporated by reference herein.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The invention relates to a device and method that simplifies the attachment of a prosthetic screen (also referred to as a hernia patch or mesh) to the abdominal wall during the repair of abdominal wall hernias.
• 2. Brief Description of the Prior Art
• The layer or layers of fascia in the abdominal wall that surround the peritoneal cavity are the strong structures that maintain the integrity of the peritoneal cavity. If there is a defect in the fascia, abdominal contents may penetrate weaker layers of the abdominal wall (comprised of muscle or fat) and push ahead the abdominal cavity's thin lining (peritoneum) so that abdominal contents, such as omentum or bowel, within their envelope of peritoneum, become situated in a subcutaneous position, often causing a visible bulge.
• Viscera being squeezed through a fascial defect can cause pain. When a visceral structure becomes trapped outside a fascial plane, it is said to be incarcerated. Incarcerated viscera can be strangulated by a narrow fascial defect, producing ischemic necrosis. This may lead to infection and death if not surgically repaired. Hernias are therefore usually repaired electively, before they become incarcerated or strangulated.
• Historically, hernias of the abdominal wall were repaired by closing the fascial defect with sutures. Large hernias tend to recur if closed in this way. Prosthetic screens, made of plastic mesh or sheets, are now frequently used to cover large fascial defects. One way to implant the prosthetic screen is illustrated in prior artFIG. 1. Here, the prosthesis1 is attached to thefascia2cof theabdominal wall2 with sutures3. This is relatively easy to do, but the repair has a high rate of failure because the sutured prosthesis often pulls away from the fascial edge.
• Other ways to secure prosthetic screens are shown in prior artFIGS. 2-5. In each of these methods the prosthesis1 overlaps the edge of thefascia2c. These methods are less likely to fail. Increased intra-abdominal pressure tends to force the periphery of the prosthesis against the abdominal wall rather than pull the prosthesis away from the fascia. A gap where both prosthesis and fascia are absent is less likely to develop.
• If the prosthetic screen is allowed to overlap the edges of the fascial defect, there are a number of ways it can be secured in place as illustrated in prior artFIGS. 2-5. The sutures3 can secure thefascia2cto the prosthesis1 inward from the edge of the prosthesis as shown in prior artFIG. 2. This is technically easy when the surgery is done in the conventional “open” approach. However materials such as Gortex™ or polypropylene mesh used for prosthetic screens are soft and may buckle and deform outside the suture line, so that the structural advantage of the overlap with fascia is not realized.
• A better method is to secure the prosthesis1 to theabdominal wall fascia2cwith sutures3 as close to the edge of the prosthesis as possible, while maintaining generous overlap between prosthesis and intact fascia as shown in prior artFIG. 3. However, it can be difficult to secure an overlapping intraperitoneal prosthesis at its periphery when performing surgery using a conventional open approach. Access to the inside surface of the abdominal wall overlying the periphery of the prosthesis is limited. The more the overlap, the more difficult the access.
• In order to achieve generous overlap the surgeon may bring the sutures through the abdominal wall as shown in prior artFIGS. 4 and 5. The midpoint of a suture3 may be tied to the edge of the prosthesis1, and the two ends brought out directly through theabdominal wall2 near one another, through a single small separate incision4 in theskin2aas shown in prior artFIG. 4. Both ends of this transmural suture3 are then tied together, placing the knot5 beneath the skin in thesubcutaneous tissue2bas shown in prior artFIG. 5. The skin incision4 is closed separately with skin sutures6 or staples (not shown). This process is completed around the periphery of the prosthesis.
• If surgery is done by a minimally invasive technique (i.e., laparoscopic surgery), the surgeon's view is from within the abdominal cavity looking up at the anterior abdominal wall. The periphery of the prosthesis can be fixed to the abdominal wall by direct suture (using a laparoscopic suture technique), or by using one of several fixation devices, such as staples or helical tacks. Alternatively, sutures can be fixed to the prosthesis before it is introduced into the peritoneal cavity. Once the prosthesis is correctly positioned, both ends of these sutures can be pulled through the abdominal wall and the same small skin incision and the ends tied together, placing the knot subcutaneously. Transmural sutures provide the most secure fixation of prosthetic screens. Hernia recurrence rates are lower when transmural sutures are used. A combination of techniques, using a few transmural sutures, at equidistant points along the periphery of the prosthesis, with staples or helical tacks in between, is also useful.
• Despite the many advances made in laparoscopic suturing techniques as well as in open hernia repair, there are still many problems to be overcome. One problem is that in order to secure the prosthesis to the abdominal wall at a single point with a transmural suture, each suture end must be pulled separately through the abdominal wall. This is time consuming. Another problem is that after placement of both ends of each suture through the abdominal wall, they must be clamped together above the body wall while other transmural sutures are placed, because it is much easier to place transmural sutures before the prosthesis is hoisted up against the abdominal wall. Clamping insures that suture ends do not inadvertently pull out of the abdominal wall during this process. Many clamps clutter the operative field and the sutures and clamps tend to entangle one another. Furthermore, multiple short skin incisions must be made to set the knot of each tied pair subcutaneously. This process is somewhat time-consuming and the multiple skin incisions produce a poor cosmetic result. Moreover, when two strands of suture are tied subcutaneously to secure a prosthetic screen, tissues of the abdominal wall are captured and partially strangulated within the ligature. This often produces postoperative pain and cosmetically undesirable dimpling of the skin at the ligature sites.
OBJECTS AND SUMMARY OF THE INVENTION
• It is therefore an object of the invention to provide a device and method to fix a prosthetic screen to the abdominal wall.
• It is another object of the invention to provide a device and method to fix a prosthetic screen to the abdominal wall that is applicable to both the open and laparoscopic methods of hernia repair.
• It is still another object of the invention to provide a device and method to fix a prosthetic screen to the abdominal wall which requires penetrating the abdominal wall only once for each point of fixation.
• It is yet another object of the invention to provide a device that is more easily grasped by a suture passer than is a single strand of suture.
• It is a further object of the invention to provide a device that impedes accidental withdrawal once it is passed through the abdominal wall.
• It is also an object of the invention to provide a device and method to fix a prosthetic screen to the abdominal wall that does not require the tying of sutures.
• It is another object of the invention to provide a device and method to fix a prosthetic screen to the abdominal wall that does not require a skin incision to obtain subcutaneous fixation.
• It is still another object of the invention to provide a device and method to fix a prosthetic screen to the abdominal wall that does not strangulate tissues of the abdominal wall.
• It is another object of the invention to provide a device and method to fix a prosthetic screen to the abdominal wall that is particularly applicable to open surgery.
• In order to achieve these objects and others, which will be discussed in detail below, one embodiment of a prosthetic screen tacking device according to the invention includes a barbed filament with a perpendicular foot at one end, or other structure at that end which prevents the tacking device from passing entirely through the prosthetic screen to which it is attached. The foot may be a linear form, so that end of the device forms a T. The barbs are situated near the foot and angulated in such a manner that they permit movement of the device through tissue in one direction (away from the foot), but prevent movement in the opposite direction (toward the foot). Instead of a plurality of barbs, a single barb can be provided.
• A second embodiment includes a loop at the end of the filament opposite the foot.
• Using the second embodiment of the tacking device and the open method of hernia repair, several tacking devices of the second embodiment are pulled through the prosthetic screen equidistantly along the periphery (circumference) of the prosthesis. The assembly is then positioned within the open abdominal cavity, over the viscera. A suture passer (a needle-like implement with the ability to grasp sutures) is then used to penetrate the abdominal wall at a point opposing the location where one tacking device penetrates the prosthesis, a point substantially beyond the edge of the fascial defect. The suture passer grasps the loop of the tacking device, and draws it back through the abdominal wall, so that the loop lies external to the body. The loop is then disengaged from the suture passer. The tacking device remains in place because the loop impedes accidental withdrawal from the abdominal wall. The same action is repeated until the loops of all devices are passed through the abdominal wall. Each device is then pulled further through the abdominal wall by grabbing the loop and pulling upward. The devices are pulled as far as possible using appropriate force to draw the prosthesis against the abdominal wall. This action draws the barb(s) into the abdominal wall and through at least one fascial layer. Each device is then pulled by its loop under tension. The skin, where penetrated by the device, is simultaneously pressed downward, further compressing the abdominal wall, and the filament is severed at skin level. Pressure is released, the abdominal wall expands and the severed end of the filament recedes beneath the skin. The barb(s) on the remaining portion of the filament prevent dislodgement of the device, which prevents the prosthesis from pulling away from the abdominal wall. The abdominal wound above the prosthesis is closed as completely as possible by standard technique, and the operation is concluded.
• The tacking device of the invention can be similarly utilized in a laparoscopic procedure. Here the devices are loaded onto the periphery of the prosthesis, the assembly is rolled up or folded introduced through a cannula or port site into the peritoneal cavity. Within the peritoneal cavity the assembly is unrolled or unfolded and oriented so that the loops are upward towards the abdominal wall. A suture passer is then used to penetrate the abdominal wall at a point corresponding to the preferred point of fixation of a particular device and the procedure proceeds substantially the same as described above.
• Other embodiments of the invention incorporate needles, swaged or attached by other means, to the embodiments described above and are primarily used only during open surgery. One such embodiment, a third embodiment of the tacking device, includes a barbed filament with a perpendicular foot at one end (or other structure which achieves the same function as described above) and a needle at the other. The foot may be a linear form, so that end of the device forms a T. The barbs are situated near the foot and angulated in such a manner that they permit movement of the device through tissue in one direction (toward the needle), but prevent movement in the opposite direction (toward the foot).
• Using the third embodiment of the tacking device and the open method of hernia repair, the needle of a tacking device is passed through the prosthetic screen at a point along the periphery of the prosthesis. The tacking device is pulled so that the filament and barb(s) pass through the prosthesis and the foot, which cannot penetrate the prosthesis, is adjacent to the prosthesis. The assembly is then positioned near or within the open peritoneal cavity. The needle is then used to penetrate the abdominal wall at a point that will oppose the location where the tacking device penetrates the prosthesis when the prosthesis is finally secured against the abdominal wall. The needle and portion of the filament is drawn up through all layers of the abdominal wall. The needle is then disengaged from the filament and the free end of the filament is clamped. A second tacking device is similarly passed through the prosthesis at another point along the periphery of the prosthesis so that its foot is adjacent to the prosthesis. The needle and portion of the filament of this tacking device are then passed through the abdominal wall, and the needle disengaged and the filament clamped. More tacking devices are passed through the prosthesis and abdominal wall in a similar manner, so that tacking devices are distributed around the entire periphery of the prosthesis and wound, and are relatively equidistant from one another where they pass through the prosthesis and where they pass through the abdominal wall. Each device is then pulled further through the abdominal wall by grabbing the filament and pulling upward. The devices are pulled as far as possible using appropriate force to draw the prosthesis against the abdominal wall. This action draws the barb(s) into the abdominal wall and through at least one fascial layer. The skin, where penetrated by the device, is simultaneously pressed downward, further compressing the abdominal wall, and the filament is severed at skin level. Pressure is released, the abdominal wall expands and the severed end of the filament recedes beneath the skin. The barb(s) on the remaining portion of the filament prevent dislodgement of the device, which prevents the prosthesis from pulling away from the abdominal wall. The abdominal wound above the prosthesis is closed as completely as possible by standard technique, and the operation is concluded.
• A second embodiment of the invention incorporating a needle includes an expanded portion such as a loop located between the barb(s) and the needle. The expanded portion, when passed entirely through the abdominal wall, obviates the need for a clamp to hold the device in place while the other devices are installed, since it impedes retrograde passage of the device through the abdominal wall. In particular, a loop is also useful in pulling the filament up through the abdominal wall to secure the barb(s).
• One advantage of the tacking device of the invention over the conventional transmural suture is that it requires one filament rather than two suture ends to be drawn through the abdominal wall to secure the prosthesis at any point on its periphery. Thus, half the work is required.
• Another advantage of the embodiments with loops is that the loop of the device provides an excellent handle that can be used to secure the barb(s).
• Another advantage is that the loop of the device provides an excellent handle that a suture passer can grasp more easily than a single suture strand.
• Another advantage of the embodiments with loops, or other expansions in place of the loop, is that once pulled through the abdominal wall, the device will not easily be inadvertently withdrawn, since the loop, or other expansion, will prevent withdrawal. Conventional sutures on the other hand can be accidentally withdrawn if not secured by a surgical clamp.
• Another advantage is that no knot is required when using the device.
• Another advantage is that no skin incision is required to place a knot subcutaneously.
• Another advantage is that, unlike a transmural suture, this tacking device will not strangulate tissue of the abdominal wall and therefore will not produce as much postoperative pain.
• Another advantage is that, unlike a transmural suture, this device will not produce cosmetically undesirable dimpling of the skin.
• Furthermore, a knot below a skin incision is more likely to become infected than is the single filament of the tacking device of the invention, which retracts into the abdominal wall well below a small skin puncture site. Infectious agents are then less likely to travel down to infect the prosthetic screen. Use of the tacking device of the invention will result in fewer prosthetic screen infections, which are a major cause of morbidity, re-operation and recurrent hernia. Infected prosthetic screens must often be removed to control infection.
• Another advantage during open surgery of the embodiments wherein the tacking device includes a needle is that a suture passer is not needed since the device includes a needle which can be used to thread the filament through the body tissue.
• Another improvement of the present invention is a new barb design which passes through the skin easier when being installed and provides greater holding strength when installed.
BRIEF DESCRIPTION OF THE DRAWINGS
• The invention, together with further objects and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying drawings wherein like reference numerals identify like elements.
• FIGS. 1-5 illustrate prior art methods of securing a prosthetic screen;
• FIG. 6 is a side elevational view of a first embodiment of a prosthetic screen tacking device according to the invention;
• FIGS. 7-10 illustrate how the first embodiment of the novel prosthetic screen tacking device is used in conventional open surgery;
• FIGS. 11 and 12 illustrate how the first embodiment of the prosthetic screen tacking device is used in laparoscopic surgery;
• FIG. 13 is a side elevational view of a second embodiment of a prosthetic screen tacking device according to the invention;
• FIGS. 14-17 illustrate how the second embodiment of the novel prosthetic screen tacking device is used in conventional open surgery;
• FIGS. 18 and 19 illustrate how the second embodiment of the prosthetic screen tacking device is used in laparoscopic surgery;
• FIG. 20 is a side elevational view of a third embodiment of a prosthetic screen tacking device according to the invention;
• FIGS. 21 and 22 schematically illustrate how the third embodiment of the prosthetic screen tacking device is used in conventional open surgery;
• FIG. 23 is a side elevational view of a fourth embodiment of a prosthetic screen tacking device according to the invention;
• FIGS. 23A and 23B show alternative structure to the loop in embodiments of the prosthetic screen tacking device in accordance with the invention;
• FIGS. 24 and 25 schematically illustrate how the fourth embodiment of the prosthetic screen tacking device is used in conventional open surgery;
• FIGS. 26-28 illustrate different embodiments of the foot of the tacking device;
• FIGS. 27A and 28A show alternative structure to the foot in embodiments of a prosthetic screen tacking device in accordance with the invention;
• FIGS. 29-31 illustrate different embodiments of the barbs of the tacking device;
• FIG. 32 is a broken side elevational view of a filament with a barb according to another embodiment of the invention;
• FIG. 33 is a view similar toFIG. 32 rotated 90 degrees about the axis of the filament; and
• FIGS. 34-38 illustrate embodiments of a button that can be passed over the filament in order to further secure the tacking device and prevent its withdrawal from the abdominal wall.
DETAILED DESCRIPTION OF THE INVENTION
• Referring first toFIG. 6, a first embodiment of a prostheticscreen tacking device10 includes afilament12 with aperpendicular foot14 at one end and at least onebarb18 adjacent to thefoot14. Thefoot14 may be a linear (or planar) form, so that end of thedevice10 forms a T or may have other configurations as described in more detail below with reference toFIGS. 26-28A. The barb(s)18 are angulated in such a manner that they permit movement of thedevice10 through a prosthetic screen and body tissue in one direction (toward end17), but prevent movement in the opposite direction (toward the foot14).
• FIGS. 7-10 illustrate how the tackingdevice10 is used in the open method of hernia repair.Several devices10 are pulled through the prosthetic screen1 equidistantly along the periphery (circumference) of the prosthesis1. The assembly is then positioned within the open peritoneal cavity, over the viscera (FIG. 7). A suture passer7 is then used to penetrate the abdominal wall at a point opposing the location where one device penetrates the prosthesis, a point substantially beyond the edge of the fascial defect. The suture passer7 grasps thefilament12 towards itsfree end17 and draws a portion of thefilament12 back through all layers of theabdominal wall2, including theperitoneum2d,fascia2c, muscle if present (not shown),subcutaneous tissue2bandskin2a, so thatend17 offilament12 lies external to the body.Filament12 is then disengaged from the suture passer and itsfree end17 clamped to prevent withdrawal back through theabdominal wall2. The same action is repeated until the free ends17 offilaments12 of all devices are pulled through theabdominal wall2.
• Eachdevice10 is then pulled further through the abdominal wall by grabbingfilaments12 near their free ends17 and pulling upward so that the barb(s)18 engage the abdominal wall as shown inFIG. 8. The devices are pulled as far as possible using appropriate force to draw the prosthesis1 against theabdominal wall2. When all devices have been pulled in this fashion the prosthesis is secure against the abdominal wall circumferentially.
• Eachdevice10 is then pulled upward by itsfilament12 near itsfree end17 under tension. Theskin2a, where penetrated by the device, is simultaneously pressed downward as shown inFIG. 9, further compressing the abdominal wall, and the filament is severed at skin level. Pressure is released, theabdominal wall2 re-expands and the severed end of the filament recedes beneath theskin2aas shown inFIG. 10. The barb(s)18 on the remaining portion of the filament prevent dislodgement of the device, which prevents the prosthesis1 from pulling away from theabdominal wall2. The abdominal wound above the prosthesis1 is closed as completely as possible by standard technique, and the operation is concluded.
• The tackingdevice10 can be similarly utilized in a laparoscopic procedure. Here the devices are loaded onto the periphery of the prosthesis. The assembly of prosthesis and tacking devices is rolled up or folded and introduced into the peritoneal cavity through a cannula or, with the aid of a tool9, through aport site8 in the abdominal wall2 (FIG. 11). The assembly is unrolled or unfolded and oriented within the peritoneal cavity so that the free ends17 offilaments12 are upward towards the abdominal wall (FIG. 12). The procedure continues in substantially the same manner as described above with reference toFIGS. 8-10.
• Turning now toFIG. 13, a second embodiment of a prostheticscreen tacking device20 includes afilament22 with aperpendicular foot24 at one end and aloop26 at the other end. At least onebarb28 is provided adjacent to thefoot24. Thefoot24 may be a linear form, so that end of the device forms a T or may have other configurations as described in more detail below with reference toFIGS. 26-28A. The barb(s)28 are angulated in such a manner that they permit movement of the device through a prosthetic screen and body tissue in one direction (toward the loop26), but prevent movement in the opposite direction (toward the foot24).
• FIGS. 14-17 illustrate how the tackingdevice20 is used in the open method of hernia repair.Several devices20 are pulled through the prosthetic screen1 equidistantly along the periphery (circumference) of the prosthesis1. The assembly is then positioned within the open peritoneal cavity, over the viscera (FIG. 14). A suture passer7 is then used to penetrate the abdominal wall at a point opposing the location where one device penetrates the prosthesis, a point substantially beyond the edge of the fascial defect. The suture passer7 grasps theloop26 of the device and draws it back through all layers of theabdominal wall2, including theperitoneum2d,fascia2c, muscle if present (not shown),subcutaneous tissue2bandskin2a, so that the loop lies external to the body. The loop is then disengaged from the suture passer. The tacking device will remain in place, because substantial force is necessary to withdraw the loop even before the barb(s) engage the abdominal wall. The same action is repeated until the loops of all devices are pulled through the abdominal wall.
• Eachdevice20 is then pulled further through the abdominal wall by grabbing theloop26 and pulling upward so that the barb(s)28 engage the abdominal wall as shown inFIG. 15. The devices are pulled as far as possible using appropriate force to draw the prosthesis1 against theabdominal wall2. When all devices have been pulled in this fashion the prosthesis is secure against the abdominal wall circumferentially.
• Eachdevice20 is then pulled by itsloop26 under tension. Theskin2a, where penetrated by thedevice20, is simultaneously pressed downward as shown inFIG. 16, further compressing theabdominal wall2, and thefilament22 is severed at skin level. Pressure is released, theabdominal wall2 re-expands and the severed end of the filament recedes beneath theskin2aas shown inFIG. 17. The barb(s)28 on the remaining portion of thefilament22 prevent dislodgement of thedevice20, which prevents the prosthesis1 from pulling away from theabdominal wall2. The abdominal wound above the prosthesis1 is closed as completely as possible by standard technique, and the operation is concluded.
• The tackingdevice20 can be similarly utilized in a laparoscopic procedure. Here the devices are loaded onto the periphery of the prosthesis. The assembly of prosthesis and tacking devices is rolled up or folded and introduced into the peritoneal cavity through a cannula or, with the aid of a tool9, through aport site8 in the abdominal wall2 (FIG. 18). The assembly is unrolled or unfolded and oriented within the peritoneal cavity so that theloops26 are upward towards the abdominal wall2 (FIG. 19). The procedure continues in substantially the same manner as described above with reference toFIGS. 15-17.
• Turning now toFIG. 20, a prostheticscreen tacking device30 includes afilament32 with aperpendicular foot34 at one end and aneedle35 at the other end. At least onebarb38 is provided adjacent to thefoot34. Thefoot34 may be a linear form, so that end of the device forms a T or may have other configurations as described below. The barb(s)38 are angulated in such a manner that they permit movement of the device through the prosthesis and body tissue in one direction (toward the needle35), but prevent movement in the opposite direction (toward the foot34).
• FIGS. 21 and 22 schematically illustrate how the tackingdevice30 is used in the open method of hernia repair. Theneedle35 of a first tackingdevice30 is passed through a prosthetic screen1 at a point along the periphery (circumference) of the prosthesis1. The tacking device is pulled so that thefilament32 and barb(s)38 pass through the prosthesis and thefoot34, which cannot penetrate the prosthesis, is adjacent to the prosthesis. The assembly is then positioned near or within the open peritoneal cavity. Theneedle35 is then used to penetrate the abdominal wall2 (left side ofFIG. 21), at a point that will be opposing the location where the tacking device penetrates the prosthesis when the prosthesis1 is secured against theabdominal wall2, a point substantially beyond the edge of the fascial defect. The needle and portion offilament32 is drawn up through all layers of theabdominal wall2, including theperitoneum2d,fascia2c, muscle if present (not shown),subcutaneous tissue2bandskin2a, so that theneedle35 lies external to the body (right side ofFIG. 21). Theneedle35 is then disengaged or cut-off from the filament32 (FIG. 22) and thefilament32 is held in place with a clamp (not shown).
• A second tackingdevice30 is similarly passed through the prosthesis1 at another point along the periphery of the prosthesis1, so that itsfoot34 is adjacent to the prosthesis. Theneedle35 and portion of thefilament32 of this tackingdevice30 are then passed through theabdominal wall2, and itsneedle35 disengaged and filament clamped, as had been done with the first tacking device. More tackingdevices30 are then passed through the prosthesis1 andabdominal wall2 in a similar manner, so that tackingdevices30 are distributed around the entire periphery of the prosthesis1 and wound, and are relatively equidistant from one another where they pass through the prosthesis1 and where they pass through theabdominal wall2.
• Eachdevice30 is then pulled further through the abdominal wall so that the barb(s)38 engage the abdominal wall as shown inFIG. 22. Thedevices30 are pulled as far as possible using appropriate force to draw the prosthesis1 against theabdominal wall2 with the aid offoot34. When alldevices30 have been pulled in this fashion, the prosthesis1 is secure against theabdominal wall2 circumferentially.
• Eachdevice30 is then pulled under tension. Theskin2a, where penetrated by the device, is simultaneously pressed downward, as described above, further compressing theabdominal wall2, and thefilament32 is severed at skin level. Pressure is released, the abdominal wall re-expands and the severed end offilament32 recedes beneath the skin. The barb(s)38 on the remaining portion offilament32 prevent dislodgement ofdevice30, which prevents prosthesis1 from pulling away fromabdominal wall2. The abdominal wound above prosthesis1 is closed as completely as possible by standard or conventional techniques, and the operation is concluded.
• Turning now toFIG. 23, a fourth embodiment of a prostheticscreen tacking device40 includes afilament42 with aperpendicular foot44 at one end and aneedle45 at the other end. At least onebarb48 is provided adjacent to foot44.Foot44 may be a linear form, so that end of the device forms a T or may have other configurations as described in more detail below. Barb(s)48 are angulated in such a manner that they permit movement of the device through tissue in one direction (toward needle45), but prevent movement in the opposite direction (toward foot44). According to this embodiment, aloop46 is formed in the filament at a location between barb(s)48 andneedle45. Theloop46 performs the same functions as doesloop26 of tackingdevice20, as previously described, except for the function of serving as a handle for a suture passer to grasp.
• FIGS. 24 and 25 schematically illustrate how the tackingdevice40 is used in the open method of hernia repair. Theneedle45 of a first tackingdevice40 is passed through a prosthetic screen at a point along the periphery (circumference) of the prosthesis1. The tacking device is pulled so that thefilament42,loop46 and barb(s)48 pass through the prosthesis and thefoot44, which cannot penetrate the prosthesis, is adjacent to the prosthesis. The assembly is then positioned near or within the open peritoneal cavity. Theneedle45 is then used to penetrate the abdominal wall (left side ofFIG. 24), at a point that will be opposing the location where the tacking device penetrates the prosthesis when the prosthesis1 is secured against the abdominal wall, a point substantially beyond the edge of the fascial defect. Theneedle45,loop46, and portion offilament42 is drawn up through all layers of theabdominal wall2, including theperitoneum2d,fascia2c, muscle if present (not shown),subcutaneous tissue2bandskin2a, so that theneedle45 andloop46 are external to the body. Theneedle45 is then disengaged or cut-off from the filament42 (right side ofFIG. 24). The tackingdevice40 will remain in place, because substantial force is necessary to withdrawloop46 even before the barb(s)48 engage theabdominal wall2.
• A second tackingdevice40 is similarly passed through the prosthesis1 at another point along the periphery of the prosthesis1, so that itsfoot44 is adjacent to the prosthesis. Theneedle45,loop46 and portion of thefilament42 of this tackingdevice40 are then passed through theabdominal wall2, and theneedle45 disengaged and thefilament42 clamped, as had been done with the first tacking device. More tackingdevices40 are then passed through the prosthesis1 andabdominal wall2 in a similar manner, so that tackingdevices40 are distributed around the entire periphery of the prosthesis1 and wound, and are relatively equidistant from one another where they pass through the prosthesis1 and where they pass through theabdominal wall2.
• Each tackingdevice40 is then pulled further through the abdominal wall by grabbingloop46 and pulling upward so that the barb(s)48 engage theabdominal wall2 as shown inFIG. 25. Thedevices40 are pulled as far as possible using appropriate force to draw the prosthesis1 against theabdominal wall2 with the aid offoot44. When alldevices40 have been pulled in this fashion, the prosthesis1 is secure against theabdominal wall2 circumferentially.
• Eachdevice40 is then pulled by itsloop46 under tension. Theskin2a, where penetrated by the device, is simultaneously pressed downward as described above, further compressing theabdominal wall2, and thefilament42 is severed at skin level. Pressure is released, theabdominal wall2 re-expands and the severed end offilament42 recedes beneath the skin. The barb(s)48 on the remaining portion of thefilament42 prevent dislodgement of the device, which prevents the prosthesis1 from pulling away from theabdominal wall2. The abdominal wound above the prosthesis1 is closed as completely as possible by standard or conventional techniques, and the operation is concluded.
• Instead ofloop46, other structure which enables thedevice40 to remain in place with at least a portion of thedevice40 above theabdominal wall2 and thebarbs48 entirely below theabdominal wall2 can be provided without deviating from the scope and spirit of the invention. This structure counters the risk that thedevice40 will return through theabdominal wall2 before at least theforwardmost barb48 engages theabdominal wall2. This structure can be situated near the forward end of thefilament42 as isloop46.
• Generally, the structure will constitute an expanded portion of filament which, once forcibly passed through theabdominal wall2, will not be easily withdrawn from theabdominal wall2 in the absence of intentional force, i.e., it impedes retrograde passage of thedevice40 through theabdominal wall2. Thus, inadvertent pressure against the screen1 will not result in thedevice40 being dislodged from theabdominal wall2 whileother devices40 are being partially implanted and before all are pulled further into theabdominal wall2 so that theirbarbs48 engage theabdominal wall2.
• Loop46 is one example of an expanded portion of filament with other examples being abarb46aangulated in such a manner that will not significantly impede movement of thedevice40 through tissue in one direction (away from the foot44), but will significantly impede movement in the opposite direction (toward the foot44)(seeFIG. 23A) and aspherical bead46b(seeFIG. 23B).Bead46bmay alternatively be elliptical. To achieve the stated function,barb46ahas a point more proximate the end of thefilament42 at which thefoot44 is situated than the end of thefilament42 at which theneedle45 is situated.
• Devices10,20,30 and40 may be color coded so that they may be more easily identified for handling in the proper sequence. They may be made of a biodegradable and absorbable material (e.g., polylactic acid, polydioxanone, polyglycolide, etc.) so that they disintegrate and disappear after the prosthetic screen is naturally integrated into the abdominal wall and no longer able to dislodge.
• As mentioned above, the geometry offeet14,24,34 and44 can vary. Examples are shown inFIGS. 26-28A.FIG. 26 shows alinear foot14a.FIG. 27 shows acircular foot14b, andFIG. 28 shows anelliptical foot14c.FIG. 27A shows aspherical foot14dandFIG. 28A shows anellipsoid foot14e.
• Instead of any offeet14,24,34,44, any other structure which prevents the end of the device below therespective barbs18,28,38,48 from passing through the prosthetic screen can be used in the invention without deviating from the scope and spirit thereof. This structure can be at the end of the device asfeet14,24,34,44 are, or can be arranged below therespective barbs18,28,38,48 yet not directly at the end of the device.
• As mentioned above, the configuration ofbarbs18,28,38 and48 may also vary.FIG. 29 showsbilateral barbs18a.FIG. 30 showsunilateral barbs18b, which may alternate on different sides of the filament, or be positioned along different planes with respect to the axis of the filament.FIG. 31 showsconical barbs18c.
• Another barb configuration, barb18d, is illustrated inFIGS. 32 and 33. Barb18dhas anupper end101 and alower end102. The barb18dis flared in two directions from theupper end101 to thelower end102. As shown inFIGS. 32 and 33, the two directions are mutually orthogonal. This results in a wedge-shaped barb having a generally triangular cross-sectional profile (seeFIG. 33) with a relatively largelower end102 as compared to theupper end101, i.e., with a tapered form. This barb18dpenetrates tissue more easily and provides greater holding strength.
• Barbs in prosthetic screen tacking devices disclosed herein generally taper from a maximum transverse dimension on a side away from the loop, or other expanded portion of filament or needle whichever is/are present, to a minimum transverse dimension on a side more proximate the loop or other expanded portion of filament or needle. This encompasses a right angle triangular barb on one side of the filament, which does not have an undercut rearward surface (the rearward surface extends perpendicular to the filament), or a double barb, extending to each side of the filament. Alternatively, the barb may be a single non-right-angled barb that has a point pointing rearward. Such a barb may have a transverse dimension, starting at the rearward facing point, that first increases and then decreases again as you move forward along the barb.
• Each barb may be considered to have a forward-facing surface (a surface facing the forward end of the filament at or proximate which the loop or other expanded portion or needle is/are situated) which is inclined from a surface of the filament and one or more sharp points arranged at a rearward end of the forward-facing surface. Barbs may also include a rearward-facing surface extending at an angle from a surface of the filament and which meets the forward-facing surface at the point(s). Depending on the angle at which the rearward-facing surface extends from the filament surface, an inwardly directed notch can be formed at the rear of the barb.
• The tacking devices of the invention may also be used in conjunction with a button111 as shown inFIGS. 34 and 35. After the filament or loop is pulled through the body tissue, the filament or loop is pulled through the button111 and the button11 is advanced downward along the filament until it locks behind barb(s), e.g.,barb18cas shown inFIG. 35. It will be appreciated that the button111 may be used with any of the barbs described above. The button111 preferably has an outer diameter that is substantially larger than the width of the barbs. This makes it even more difficult for the tacking device to be withdrawn in the direction of the foot, securing the prosthesis even more. The button111 may be allowed to sit on the surface of the skin, or be buried subcutaneously through a small skin incision. The button111 shown inFIGS. 34 and 35 is a simple perforated disk, sufficiently plastic so that thebarb18ccan be passed through the disk in one direction, but not the other.
• A different kind ofbutton112 is shown inFIGS. 36-38. Thebutton112 is provided with aslot120. Theslot120 allowsbutton112 to pass over thebarbs18,28,38 and48 when rotated to a first orientation shown inFIG. 37. When the button is rotated to a second orientation, shown inFIG. 38, it cannot be withdrawn.
• There have been described and illustrated herein a device and method for affixing a prosthesis to the abdominal wall. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as so claimed. In particular, while multiple structures for enabling a surgical tacking device in accordance with the invention to operatively remain in place with at least a portion thereof above the abdominal wall or other the body tissue and the barbs entirely below the abdominal wall or body tissue are disclosed and multiple structures for preventing the rearward end of filament from passing through the prosthetic screen and thus the abdominal wall or body tissue, it is contemplated that all combinations of such structure are within the scope and spirit of the invention. Moreover, the needle can be used in all of the possible combinations.

Claims (31)

1. A surgical tacking device suitable for the fixation of a prosthetic screen to body tissue, said device comprising:

a filament having a first end and a second end;

at least one barb arranged on said filament between said first and second ends, said at least one barb being configured and angulated to allow said filament to pass through body tissue when said first end is pulled but to prevent said filament from passing through body tissue when said second end is pulled; and

first means on said filament above said at least one barb in a direction toward said first end for enabling the surgical tacking device to remain in place with at least a portion of the surgical tacking device above the body tissue and said at least one barb entirely below the body tissue.

2. The device ofclaim 1, wherein said first means are situated at said first end of said filament.

3. The device ofclaim 1, wherein said first means comprise an expanded portion of said filament.

4. The device ofclaim 1, wherein said first means comprise a loop of said filament.

5. The device ofclaim 1, wherein said first means are arranged to forwardly pass through the body tissue when said first end is pulled and prevent or inhibit backward passage through body tissue once said first means has been forwardly passed through the body tissue.

6. The device ofclaim 1, wherein said filament, said at least one barb and said first means are formed in one piece.

7. The device ofclaim 1, further comprising second means on said filament below said at least one barb in a direction toward said second end for preventing said second end of said filament from passing through the prosthetic screen.

8. The device ofclaim 7, wherein said second means are at said second end of said filament.

9. The device ofclaim 8, wherein said second means comprise a foot.

10. The device ofclaim 9, wherein said foot is substantially planar and substantially linear, circular or elliptical.

11. The device ofclaim 9, wherein said foot is substantially spherical or ellipsoid.

12. The device ofclaim 7, wherein said second means comprise a bead attached to said filament.

13. The device ofclaim 1, further comprising a needle on said first end of said filament, said first means being arranged between said at least one barb and said needle.

14. The device ofclaim 13, wherein said needle is swaged to said filament.

15. The device ofclaim 13, wherein said first means comprise a barb configured and angulated to have at least one point facing said second end of said filament.

16. The device ofclaim 13, wherein said first means comprise a spherical bead.

17. The device ofclaim 13, further comprising second means on said filament below said at least one barb in a direction toward said second end for preventing said second end of said filament from passing through the prosthetic screen.

18. The device ofclaim 17, wherein said second means are at said second end of said filament.

19. The device ofclaim 1, wherein said at least one barb tapers from a maximum transverse dimension on a side away from said first means to a minimum transverse dimension on a side more proximate said first means.

20. The device ofclaim 1, wherein said at least one barb has a rearward facing point and a rearward facing surface extending at an angle greater than 90 degrees to said filament such that said at least one barb has a transverse dimension from said rearward facing point that first increases and then decreases moving forward along said at least one barb.

21. The device ofclaim 1, wherein said first end of said filament is a forward end and said second end of said filament is a rear end, said at least one barb having a forward-facing surface inclined from a surface of said filament and at least one sharp point arranged at a rearward end of said forward-facing surface.

22. The device ofclaim 21, wherein said at least one barb further includes a rearward-facing surface extending at an angle from a surface of said filament and which meets said forward-facing surface at said at least one point.

23. The device ofclaim 1, wherein said at least one barb comprises a plurality of barbs.

24. A method for affixing a prosthetic screen to the wall of the abdomen, comprising:

attaching a plurality of surgical tacking devices to the screen, each tacking device including a filament having a first end and a second end, and at least one barb between the first and second ends;

delivering the screen with attached tacking devices to the peritoneal cavity;

passing a portion of each tacking device through the abdominal wall; then

pulling the portion of the tacking device to draw more filament through the abdominal wall until the at least one barb of each tacking device lodges in the abdominal wall and affixes the screen to the abdominal wall; and

constructing each tacking device to enable it to remain in place with at least a portion of the tacking device above the abdominal wall and said at least one barb entirely below the abdominal wall.

25. The method ofclaim 24, wherein the step of constructing each tacking device to enable it to remain in place comprises arranging an expanded portion between the at least one barb and the first end.

26. The method ofclaim 24, wherein the step of constructing each tacking device to enable it to remain in place comprises arranging a loop of the filament at the first end or between the at least one barb and the first end.

27. The method ofclaim 24, wherein the step of constructing each tacking device to enable it to remain in place comprises arranging a barb on the filament angulated to allow passage of the filament through the abdominal wall in a direction toward the first end, but impede passage of the filament through the abdominal wall in a direction toward the second end.

28. The method ofclaim 24, further comprising forming the tacking devices to prevent the second end of the filament from passing through the screen when the filament is drawn through the abdominal wall.

29. The method ofclaim 28, wherein the step of forming the tacking devices to prevent the second end of the filament from passing through the screen comprises arranging a foot at the second end of the filament.

30. The method ofclaim 24, further comprising cutting the tacking devices at a point between the first and second ends after the screen is affixed to the abdominal wall so that when the surgical procedure is concluded no parts of the tacking devices penetrate into or through the skin.

31. The method ofclaim 24, further comprising arranging a needle at the first end of each tacking device, the step of passing a portion of each tacking device through the abdominal wall comprising passing the needle of each tacking device through the abdominal wall from inside to outside.

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