WO2012094057A1

WO2012094057A1 - Implantable plug for repairing a soft tissue defect

Info

Publication number: WO2012094057A1
Application number: PCT/US2011/059524
Authority: WO
Inventors: Shekhar Nimkar
Original assignee: C.R. Bard, Inc.
Priority date: 2011-01-04
Filing date: 2011-11-07
Publication date: 2012-07-12

Abstract

An implantable plug for repair of a soft tissue defect includes a plug body formed of soft tissue repair fabric, such as a strip of surgical mesh fabric. The plug includes an outer section and an inwardly folded section, with each section including a multiple of segments. At least two segments of the inwardly folded section may be connected in a top-to-bottom direction that is substantially less than a height of the plug, mitigating forces acting on one side of the plug from translating to an opposite side of the plug.

Description

IMPLANTABLE PLUG FOR REPAIRING A SOFT TISSUE DEFECT

FIELD

The invention relates to an implantable plug for repairing a soft tissue defect, such as an abdominal wall hernia.

BACKGROUND

Various implantable prosthetic devices in the shape of a plug are known for repairing soft tissue defects, such as abdominal wall hernias. Representative is the PERFIX PLUG available from Davol Inc., a subsidiary of C.R. Bard, Inc., assignee of the present application. The PERFIX PLUG includes a conical mesh outer body having a rounded, closed tip and an open base. A filler body is located within the outer conical body. The filler body consists of petals formed by die-cutting a cruciform-type pattern from two sheets of mesh fabric, then overlaying one sheet on top of the other. The overlayed sheets are then attached at their center to the tip of the outer body, providing upstanding petals filling the outer body.

A plug that minimizes the amount of prosthetic repair material required, and/or reduces the amount of scrap generated during fabrication, particularly where specialized and expensive soft tissue repair fabrics are involved, may be desirable.

SUMMARY

In an illustrative embodiment, an implantable plug for repairing a soft tissue defect includes a plug body of soft tissue repair fabric having an outer section and an inwardly folded section. The inwardly folded section constitutes at least two inwardly folded segments, each such segment having an innermost end. The plug is configured so that forces acting on one side of the plug are not substantially translated to an opposite side of the plug. The plug has a top and a bottom both of which are open. A connection, such as one or more stitches, may be provided between at least two inwardly folded segments, the connection having a length that is substantially less than a height of the plug. The connection may be provided along a center of the plug or elsewhere. The plug body may be formed of a strip of soft tissue repair fabric.

In another illustrative embodiment, an implantable plug for repairing a soft tissue defect includes a plug body of soft tissue repair fabric having an outer section and an inwardly folded section. The inwardly folded section constitutes at least two inwardly folded segments, each such segment having an innermost end. A connection is provided between the at least two inwardly folded segments, the connection having a length that is substantially less than a height of the plug. The plug has a top and a bottom both of which are open. In certain embodiments, the length of the connection may be less than 50%, 25% or 10% of the height of the plug. The connection may be provided along a center of the plug or elsewhere. The plug body may be formed of a strip of soft tissue repair fabric.

The foregoing is a non-limiting summary of the invention, which is defined by the attached claims. Other aspects, embodiments, and features will become apparent from the following description.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component that is illustrated in various figures is represented by a like descriptor. For purposes of clarity, not every component may be labeled in every drawing.

The advantages and features of this invention will be more clearly appreciated from the following detailed description, when taken in conjunction with the

accompanying drawings.

Fig. 1 is a view of a plug according to the invention;

Fig. 2 is a top view of the plug shown in Fig. 1;

Fig. 3 is a sectional view of the plug shown in Fig. 2; Fig. 4 is a view of a plug and underlay combination; and

Fig. 5 is a view of an inner plug incorporated within an outer plug.

DETAILED DESCRIPTION OF EMBODIMENTS

It should be understood that aspects of the invention are described herein with reference to the figures, which show illustrative embodiments. The illustrative embodiments described herein are not necessarily intended to show all embodiments in accordance with the invention, but rather are used to describe a few illustrative embodiments. Thus, aspects of the invention are not intended to be construed narrowly in view of the illustrative embodiments. In addition, it should be understood that aspects of the invention may be used alone or in any suitable combination with other aspects of the invention.

A plug 10 for repairing a soft tissue defect, such as a hernia, includes a body formed of prosthetic repair fabric having an outer section 12 and an inwardly folded section 14. The outer section and the inwardly folded section may include, respectively, multiple segments. Adjacent segments 16, 18 of the outer section may be spaced from each other, contiguous, or a combination of mixed spaced and contiguous segments. Adjacent inwardly folded segments 20, 22 also may be spaced, contiguous or a mixture of spaced and contiguous segments. Although a similar spatial relationship may exist amongst both the segments of the outer section and of the inwardly folded section, different spacing arrangements may be used in the outer section as compared to the inwardly folded section.

Two or more inwardly folded segments may be joined together by stitching, bonding, adhesive, or other joining arrangement as should be apparent to one of skill in the art. In certain embodiments, the length of the connection between such two or more inwardly folded segments is minimized enhancing the compliance and flexibility of the plug. It is believed that pulling forces applied to one side of the plug are less likely to be translated to an opposite side of the plug when the connection between inwardly folded segments has been limited. Consequently, the likelihood of suture tension induced pain, at the location of anchoring sutures that secure the plug to neighboring tissue, should be reduced. Expansion and compression of the plug should be facilitated with a limited length connection, allowing the plug to respond dynamically to movement of

surrounding tissue. Contraction forces also may be better compensated for as compared to designs where inwardly folded segments are joined along a substantial aspect, if not the full length, of the height of the plug.

As shown in the Figures, the plug has a height between a bottom 30 and a top 32. A connection between two or more inwardly folded segments preferably occupies just a small percentage of that height. Various embodiments include less than 75%, 50%, 40%, 30%, 20%, 10% , 5% and 3% of the height. For example, and without limitation, a suture or other thread-type structure may be passed between two inwardly folded segments and then knotted to join the two segments together. In a particular

arrangement illustrated, one or more stitches 24 are placed through a pair of inwardly folded segments at or near the bottom 30 of the plug and tied together. As should be apparent to one of skill in the art, the connection may be located anywhere at or between the bottom 30 and top 32 of the plug. Without limitation, then, in certain embodiments the connection may be located at a midpoint or intermediate region along the height of the plug, or at or near the top of the plug. The remainder of the two inwardly folded segments may remain unconnected, or additional fixations between these segments may be provided. Although the connection of two inwardly folded segments has been described, three or more inwardly folded segments may be joined via a single

connection. Further, any of a joined group of inwardly folded segments may be connected to other inwardly folded segments if desired. In addition to, or in lieu of, the direct connection between inwardly folded segments, indirect connections also are contemplated. For example, and without limitation, a first inwardly folded segment may be stitched or otherwise attached to an underlay or onlay at a first location, and a second inwardly folded segment may be stitched or otherwise attached to the underlay or onlay at a second location. Further, where the plug includes both an underlay and onlay, then a first inwardly folded segment may be joined to one of the underlay and onlay and the second inwardly folded segment may be joined to the same or to the other of the underlay and onlay.

The number of inwardly folded segments and outer segments is not necessarily a limitation of the invention. Thus, the soft tissue repair plug is not limited to six segments in each section as illustrated. The shape of the respective segments may vary, as should be apparent to one of skill in the art. As an example, and without limitation, the inwardly folded segments may have a substantially triangular shape as shown, as well as other shapes including rectangular, elliptical, circular, tear-drop, other polygon-like shapes, and other configurations. An innermost end of the inwardly folded segment may be rounded, pointed, flat or other shape as should be apparent to one of skill in the art. Segments of the outer section may be straight, convex, concave, serpentine, as well as have other forms as should be apparent to one of skill in the art. Moreover, shapes of the inwardly folded segments and of the outer segments may vary within an inwardly folded section and/or outer section, as should be apparent to one of skill in the art. Thus, although each inwardly folded segment in the Figures has the same shape, and each outer segment in the Figures also has the same shape, varying configurations within one or both sections are contemplated.

The depth of the inwardly folded segments is not necessarily a limitation of the invention. As shown, an end 34 of one or more inwardly folded segments may be located at or near the center 36 of the plug. In such case, the ends of opposed segments may be closely adjacent one another. In other embodiments, the ends of the inwardly folded segments may be spaced farther away from the plug center. The lateral spacing of the inwardly folded segment ends may be contiguous, closely spaced, spread apart, or a combination of any of such spatial relationships. The ends of the inwardly folded segments may lie in a circular pattern as shown, although other arrangements are contemplated as should be apparent to one of skill in the art. In certain embodiments, the depth of the inwardly folded segments may vary. Accordingly, an end of a first inwardly folded segment may be closer to the center of the plug then an end of a second inwardly folded segment. The outer segments may lie along a circular pattern as shown, although other arrangements are contemplated as should be apparent to one of skill in the art. In certain embodiments, the distance from the center of the plug to respective outer segments may vary amongst the plurality of segments within the outer section. For example, one or more outer segments may be located closer to the center of the plug as compared to other outer segments. In certain embodiments, some or all of the outer segments define an outer periphery of the plug.

As illustrated, the plug when viewed from the top or bottom, may have a flower- type appearance. The inwardly folded segments and outer segments combine to form 'petals' 40 which also may be characterized as nodes. The petals may have a substantially triangular shape as shown, as well as other shapes including rectangular, elliptical, circular, tear-drop, other polygon-like shapes, as well as other configurations. Adjacent petals may be spaced from each other, in contact, or include a hybrid of contiguous and spaced arrangements. The size and shape of the petals may be uniform or varied. The petals may be larger than the spacing between adjacent petals, the same size as, or smaller than such spacing. An inward end of one or more petals may be located at a central region of the plug, as shown, or remote from the center of the plug. The plug may have a generally uniform exterior dimension from top to bottom. In certain embodiments, the plug defines a generally cylindrical profile. In other embodiments, the plug profile may be reduced at one or more locations along its length. In one such embodiment, the bottom aspect of the plug may be narrower than the top aspect; for example, and without limitation, such a plug may have a generally cone- shape. Other plug profiles are contemplated as should be apparent to one of skill in the art.

As shown, the plug may be open at the top 32 and bottom 30 and such an opening 42 may extend completely through the plug. The plug may further include an onlay, an underlay, or both an onlay and an underlay. The onlay and/or underlay may be separate from the plug or attached to the plug. In one embodiment, the bottom of the plug is attached to an underlay 50. One or more stitches may run through the plug bottom and underlay. The one or more stitches may be applied anywhere along the length of the bottom, with one embodiment having the connection located at the center of the plug. Connections between the plug and underlay may be continuous or intermittent. Although a suture or other filament for stitching the plug and underlay has just been described, other connection mechanisms are contemplated including, without limitation, fusing the components together and adhesive bonding. The foregoing connection arrangements also will be suitable for attaching the plug to an onlay. Where the plug includes an underlay and an onlay, the same or different connection mechanisms may be employed for attaching the plug to the respective patch features.

The plug may be formed from a strip of soft tissue repair fabric. A jig or template includes portions corresponding to the outer segments and the inwardly folded segments. The strip is threaded into and about the jig and then heat may be applied to set the fabric strip into the plug shape. Alternatively, or in addition, the free ends of the strip may be joined together such as by stitching, fusing, or adhesive bonding. After removal from the jig, two or more inwardly extending segments may be stitched or otherwise connected together, such as through the innermost ends of the segments. Preferably, such ends are joined by a single, loose stitch at or near the bottom of the plug. Other locations for a single, loose stitch, as well as lengthier connections whether formed of stitches or other connection mechanisms also are contemplated. In one or more embodiments, all of the innermost ends of the inwardly extending segments are free of separate connections with each other. If desired, an underlay and/or onlay may be attached to the plug. In one embodiment, an underlay is sewn to the bottom of the plug. One or more stitches are passed between the underlay patch and at least one of the inwardly extending segments. In certain embodiments, separate stitches are passed through two inwardly extending segments and the underlay patch. These stitches may indirectly connect the two segments together or may supplement a direct connection between them. The underlay and/or onlay generally are larger than the plug top or plug bottom with which they are associated (whether or not actually connected with the plug). In certain embodiments, the underlay and/or onlay may have a circular or elliptical shape.

The plug, and either or both of an onlay or underlay if applicable, may be formed of any fabric material suitable for repair or augmentation of a soft tissue defect. Without limiting the foregoing, the fabric may constitute a resorbable material, a permanent material, or a hybrid of resorbable and permanent materials. Non-limiting examples of resorbable fabric materials include resorbable polyesters such as polyglycolic acid (PGA), polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA), polydioxanone (PDO), polycaprolactone (PCL), any other resorbable polyester, polyhydroxyalkanoate (PHA), as well as collagen, calcium alginate and combinations of any of the foregoing. Permanent fabric materials include polypropylene, polyethylene, polyester,

polytetrafluoroethylene, and other non-resorbable polymers having application in soft tissue repair fabrics. Some or all of the plug, and one or both of an onlay or underlay if associated with the plug, may be configured to promote tissue ingrowth into interstices of the fabric and/or around the fabric structure. The fibers included in the fabric may be monofilament or multifilament. The fabric may be formed by knitting, weaving, braiding, molding, and other textile construction methodologies. Further, non-porous fabrics also are contemplated. If desired some or all of the surfaces of the plug, and either or both of an onlay and underlay if applicable, may include a barrier. The barrier may include a gel, foam, film or membrane that is applied to the fabric. Alternatively, the fabric may be treated to form a barrier portion thereof. Connection mechanisms for joining ends of the inwardly extending segments or for attaching the plug to an onlay and/or underlay, may be permanent or resorbable. The plug, and either or both of an onlay or underlay if applicable, may further include a bioactive agent, such as an analgesic, antibiotic, anesthetic or anti-inflammatory agent. A suture, thread or other like structure may by threaded through, or otherwise incorporated in, the plug, such that manipulation of the suture will cause a reduction in the size and/or shape of the plug. Such an arrangement allows some customization of the size and/or shape of the prosthetic device.

We now describe a representative use of the soft tissue repair plug, in this case in the repair of an inguinal hernia. For a direct hernia, the hernia defect is circumscribed at its base and the contents reduced. A prosthesis such as described above is squeezed into a smaller configuration and then inserted into the defect opening. The compressive forces on the plug are released, allowing the outer plug body to expand against the tissue wall defining the defect while the top or leading end of the plug may extend preperitonealy. For an indirect hernia, the lipoma of the spermatic cord and the hernia sac are dissected free. The implant is then located within the internal ring; again with the top or leading end may project into the preperitoneal space. In any of the foregoing procedures, one or more of the petals may be secured to adjacent tissue or muscle. If an underlay and/or onlay is provided (either attached to or separate from the plug), then such patch(es) may be positioned to cover the wall structure over and adjacent the defect site. Either patch may be shaped by the physician to match the anatomy. Particularly with respect to an onlay, a slit may be provided in the patch to form tails that may be spread apart to accommodate the spermatic cord. The plug is not limited to use only in repair of inguinal hernias and has application in repairing other soft tissue defects as should be apparent to one of skill in the art.

Fig. 5 illustrates an implantable plug 100 including an inner plug 102 located within an outer plug 104, where the inner plug includes any of the previously described plug embodiments. The outer plug may have a truncated conical profile with a closed, generally planar tip or leading end 106 and an open, opposite base 108 as is shown. Further, some or all of the outer plug may be pleated 110 or otherwise configured to facilitate compression and expansion of the outer plug. In certain embodiments, the outer plug is conformable to irregularities in the shape of a defect into which the implantable plug is inserted. The outer plug may be taller, shorter, or the same size as the inner plug. Other shapes and arrangements of the outer plug are contemplated as should be apparent to one of skill in the art. The inner plug and outer plug may be unattached and separable from each other or they may be joined together such as by stitches, adhesive bonding, heat fusion, or other arrangements as should be apparent to one of skill in the art. Without limiting the possible locations for attachment between the inner and outer plugs, it is observed that suitable attachment points include between the bottom of the inner plug and the planar end of the outer plug, and between the outer section of the inner plug and the sidewall of the outer plug, as well as combinations of these attachment sites. Some or all of the side portions of the inner plug and outer plug may in contact. Alternatively, the inner plug may be spaced from the sidewall of the outer plug. The inner plug and outer plug may be formed of any fabric material suitable for repair or augmentation of a soft tissue defect, and the same materials previously indicated as suitable for the soft tissue repair plug, and onlay or overlay where applicable, of Figs. 1- 4 would suffice. In certain embodiments two or more inner plugs may be located side- by- side, or in another orientation, within the outer plug.

Having thus described several aspects of at least one embodiment of this invention, it is to be appreciated various alterations, modifications, and improvements will readily occur to those skilled in the art. Such alterations, modifications, and improvements are intended to be part of this disclosure, and are intended to be within the spirit and scope of the invention. Accordingly, the foregoing description and drawings are by way of example only.

What is claimed is:

Claims

1. An implantable plug for repairing a soft tissue defect, comprising:

a plug body including soft tissue repair fabric and having an outer section and an inwardly folded section, the inwardly folded section constituting at least two inwardly folded segments with each such segment having an innermost end, wherein the plug is configured so that forces acting on one side of the plug are not substantially translated to an opposite side of the plug, and wherein the plug has a top and a bottom both of which are open.

2. The plug recited in claim 1 including a connection between the at least two inwardly folded segments, the connection having a length that is substantially less than a height of the plug.

3. The plug recited in claim 2, wherein the length of the connection is less than 50% of the height of the plug.

4. The plug recited in claim 3, wherein the length of the connection is less than 25% of the height of the plug.

5. The plug recited in claim 4, wherein the length of the connection is less than 10% of the height of the plug.

6. The plug recited in claim 2, wherein the connection includes a tied stitch between the at least two inwardly folded segments.

7. The plug recited in claim 6, wherein the tied stitch is located at the innermost ends of the at least two inwardly folded segments.

8. The plug recited in claim 1, wherein the ends of the at least two inwardly folded segments are at or adjacent the center of the plug.

9. The plug recited in claim 1, wherein the ends of the at least two inwardly folded segments are spaced from the center and adjacent areas of the plug.

10. The plug recited in claim 2, wherein the plug includes a top region, a bottom region, and an intermediate region therebetween, and wherein the connection is located in only one of the top region, bottom region, and intermediate region.

11. The plug recited in claim 1, wherein the outer profile of the plug is substantially cylindrical.

12. The plug recited in claim 1, further including at least one of an onlay or an underlay.

13. The plug recited in claim 1, wherein at least one of the inwardly folded segments is attached to the at least one onlay or underlay.

14. The plug recited in claim 1, wherein the plug body is formed of a strip of soft tissue repair fabric.

15. An implantable plug for repairing a soft tissue defect, comprising:

a plug body including soft tissue repair fabric and having an outer section and an inwardly folded section, the inwardly folded section constituting at least two inwardly folded segments with each such segment having an innermost end, a connection between the at least two inwardly folded segments, the connection having a length that is substantially less than a height of the plug, and wherein the plug has a top and a bottom both of which are open.

16. The plug recited in claim 15, wherein the length of the connection is less than 50% of the height of the plug.

17. The plug recited in claim 16, wherein the length of the connection is less than 25% of the height of the plug.

18. The plug recited in claim 17, wherein the length of the connection is less than 10% of the height of the plug.

19. The plug recited in claim 15, wherein the connection includes a tied stitch between the at least two inwardly folded segments.

20. The plug recited in claim 19, wherein the tied stitch is located at the innermost ends of the at least two inwardly folded segments.

21. The plug recited in claim 15, wherein the ends of the at least two inwardly folded segments are at or adjacent the center of the plug.

22. The plug recited in claim 15, wherein the ends of the at least two inwardly folded segments are spaced from the center and adjacent areas of the plug.

23. The plug recited in claim 16, wherein the plug includes a top region, a bottom region, and an intermediate region therebetween, and wherein the connection is located in only one of the top region, bottom region, and intermediate region.

24. The plug recited in claim 15, wherein the outer profile of the plug is substantially cylindrical.

25. The plug recited in claim 15, further including at least one of an onlay or an underlay.

26. The plug recited in claim 15, wherein at least one of the inwardly folded segments is attached to the at least one onlay or underlay.

27. The plug recited in claim 15, wherein the plug body is formed of a strip of soft tissue repair fabric.