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1. WO2011002962 - DEVICE AND METHOD FOR TREATMENT OF INCISION OR HERNIA

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[ EN ]

DEVICE AND METHOD FOR TREATMENT OF INCISION OR HERNIA

[0001] This application claims priority under 35 U S C §119 to US Provisional Patent Application Number 61/222,691 , which was filed on July 2, 2009

[0002] This disclosure relates generally to devices and methods for treating abdominal incisions or defects, and more particularly, to prosthetic devices for treating midline incisions or hernias

Background

[0003] Most surgical incisions can be closed using only sutures However, closing an abdominal incision in patients suffering from gross abdominal wall loss, particularly loss of viable fascial tissue, due, for example, to prior surgeries or necrotizing infection, can be challenging In addition, some patients may be prone to dehiscence and/or herniation after surgery due to structural defects or disease

[0004] Currently, repair of abdominal wall incisions not amenable to primary suture closure is sometimes performed using a synthetic mesh (such as, polypropylene, prolene, polytetrafluroethylene meshes, etc ) to reinforce the fascia and restore abdominal wall continuity However, for many patients, incision closure and treatment of abdominal wall defects remains difficult, particularly due to the complications resulting from synthetic mesh use such as enteric fistulae formation and infection, which weaken the integrity of the incision closure

[0005] The present disclosure provides methods and devices for improved closure of surgical incisions and/or repair of abdominal wall defects

Summary

[0006] In one aspect of the present disclosure, a device for treating abdominal incision or hernia is provided. The device comprises an elongate element having a first longitudinal axis and at least one sheet connected to the elongate element along the first longitudinal axis, wherein the at least one sheet comprises a porous biocompatible material and the elongate element has a strength that is at least equal to that of the at least one sheet.

[0007] In another aspect of the present disclosure, a method for treating a midline incision is provided. The method includes providing an implant comprising an elongate element having a first longitudinal axis and at least one sheet connected to the elongate element along the first longitudinal axis. The elongate element is positioned along the midline incision, and the at least one sheet is positioned on the anterior and/or posterior sides of rectus abdominis muscle surrounding the midline incision.

[0008] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.

[0009] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate methods and embodiments of the invention and together with the description, serve to explain the principles of the various aspects of the invention.

Brief Description of Drawings

[001O] FIG. 1A shows an exemplary embodiment of an implant for treatment of an incision or hernia;

[0011] FIG. 1 B is a cross-sectional view of the embodiment depicted in FIG. 1A taken along line AA';

[0012] FIG. 1C depicts an alternate configuration of the implant depicted in FIG. 1A;

[0013] FIG. 1 D is a cross-sectional view of the configuration depicted in FIG. 1 C taken along line BB';

[0014] FIG. 2A is a cross-sectional view of the abdominal wall;

[0015] FIG. 2B illustrates an outline of a midline abdominal incision;

[0016] FIG. 3A shows a method of positioning an implant in the abdominal wall for a midline incision closure, in accordance with an exemplary embodiment of the present disclosure;

[0017] FIG. 3B illustrates an alternate method of positioning an implant in the abdominal wall for a midline incision closure, in accordance with an exemplary embodiment of the present disclosure ;

[0018] FIG. 4 illustrates a method of suturing an implant to the abdominal wall for a midline incision closure, in accordance with an exemplary embodiment of the present disclosure; and

[0019] FIG. 5 is a flowchart showing the steps of treating an abdominal incision using an exemplary implant of the present disclosure.

Description of Exemplary Embodiments

[0020] Reference will now be made in detail to embodiments consistent with the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

[0021] In this application, the use of the singular includes the plural unless specifically stated otherwise. In this application, the use of "or" means "and/or" unless stated otherwise. Furthermore, the use of the term "including", as well as other forms, such as "includes" and "included", is not limiting. Also, terms such as "element" or "component" encompass both elements and components comprising one unit and elements and components that comprise more than one subunit, unless specifically stated otherwise. Also the use of the term "portion" may include part of a moiety or the entire moiety. Additionally, in this application, the terms "rectus sheath" and "rectus fascia" may be used interchangeably, unless specifically stated otherwise.

[0022] The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described. All documents, or portions of documents, cited in this application, including but not limited to patents, patent applications, articles, books, and treatises, are hereby expressly incorporated by reference in their entirety for any purpose.

[0023] The present disclosure provides methods and devices for effective incision closure following a surgical procedure and/or abdominal wall treatment for structural abdominal wall defects. In one aspect, the devices and methods disclosed herein are used for closing abdominal incisions when primary suture closure is not feasible due to loss of abdominal muscle and/or fascia. In some embodiments, the devices and methods disclosed herein are used for midline incision closure following a surgical procedure. In another aspect, the devices and methods are used as a treatment for ventral or incisional hernia, e.g., for treatment of midline incisional hernia. In various embodiments, the methods and devices of the present disclosure can be used for prophylactic treatment, e.g., to prevent incisional hernia. In some embodiments, the methods and devices of the present disclosure can be used to treat preexisting abdominal wall defects or to assist in closure of incisions or hernias where insufficient abdominal tissue is present.

[0024] In one exemplary embodiment of the present disclosure, incision closure is performed using an implant comprising an elongate element and at least one sheet connected to the elongate element along a longitudinal axis of the elongate element. When performing an incision closure, the elongate element is positioned along the incision line, and the at least one sheet is positioned on the anterior and/or posterior side of the abdominal muscles surrounding the incision. In one embodiment, the biomechanical properties (e.g., the tensile strength, compressive strength, torsional strength, toughness of the material, etc.) of the elongate element are equal to that of the at least one sheet. In another embodiment, certain biomechanical properties (e.g., tensile strength, stiffness, tear strength) of the elongate element are greater than that of the at least one sheet. The relative mechanical properties of the elongate element and the sheet may be determined based on the specific application of the implant. For example, in one embodiment, a strength of the elongate element is twice that of the at least one sheet. In another embodiment, a strength of the elongate element is at least three times that of the at least one sheet.

[0025] In one exemplary embodiment, the sheet comprises a porous biological material. In some embodiments, the sheet comprises a collagenous material. In certain embodiments, the sheet comprises an acellular tissue matrix, which may support revascularization and repopulation of the implanted matrix with the patient's own cells to further strengthen the treatment site and lower the risk of matrix dislodgement. In some embodiments, the acellular tissue matrix includes a dermal matrix. In one such embodiment, the sheet is derived from human skin (e.g. ALLODERM®, LifeCell Corp, Branchburg, NJ) that has been processed to remove both the epidermis and the cells that can lead to tissue rejection and graft failure, without damaging the dermal matrix. In another embodiment, the sheet is derived from porcine dermis (e.g. STRATTICE™, LifeCell Corp, Branchburg, NJ), which is processed to remove cells and tissue antigens while maintaining the ability to support cellular growth and tissue regeneration and/or remodeling. In another exemplary embodiment of the present disclosure, the sheet of the implant comprises a porous synthetic mesh (e.g., polypropylene, prolene, or polytetrafluroetheylene mesh). In one such embodiment, the synthetic mesh facilitates tissue incorporation into the implant.

[0026] In one exemplary embodiment consistent with the present disclosure, the elongate element is a cylindrical body comprising an immunologically inert and biocompatible material. The material may be a synthetic polymer (such as, polypropylene, polytetrafluroetheylene, etc.) or a non-synthetic material. In one embodiment of the present disclosure, the elongate element comprises a biological mesh that is rolled concentrically into a cylindrical structure. In one such embodiment, the biological mesh comprises an acellular tissue matrix (such as, ALLODERM® or STRATTICE™).

[0027] In various embodiments consistent with the present disclosure, the elongate element and sheets can be produced from tissue that is allogeneic or xenogenic to a human recipient. Allogeneic sources may be obtained from living

donors or cadavers. Xenogeneic sources can include a variety of different non-human mammals. For example, as noted above, one suitable biologic material for production of the sheets and elongate element is STRATTICE™, which is a porcine-derived tissue matrix. However, other xenograft sources can be used.

[0028] Allogeneic or xenogenic tissues can be processed to remove antigens known to elicit an immune response in the recipient. For example, various decellularization processes or enzyme treatments are known that allow removal of cellular and/or extracellular antigens that may be immunogenic. Further, in various embodiments, the tissues can be derived from animals that are genetically modified or altered to have diminished expression of antigens known to be immunogenic in humans. For example, in one such embodiment, the tissues are harvested from an α1 ,3-galactosyltransferase (α1 ,3GT) deficient pig or other animal to prevent hyperacute rejection of the implant by the recipient. Different methods of producing α1 ,3GT deficient pigs have been previously described in Dai, Y. et al., "Targeted disruption of the α1 ,3-galactosyltransferase gene in cloned pigs," Nat. Biotechnology 20, 251 -255 (2002), and Phelps, C. J. et al., "Production of α1 ,3-galactosyltransferase-deficient pigs," Science 299, 41 1 -413 (2003), which are incorporated herein by reference.

[0029] In some embodiments of the present disclosure, the elongate element can include a strip or piece of connective tissue from an allogeneic or xenogeneic source. For example, suitable connective tissues can include ligament, tendon, and/or fascia.

[0030] In one exemplary aspect of the present disclosure, the prosthetic implant is used for treatment of a midline abdominal incision, which is a vertical incision made along the linea alba between the two rectus abdominis muscles of the abdominal wall. In certain patients, the linea alba may be absent or shifted from the abdominal midline due to abdominal wall defects. In such cases, the midline incision may be performed along the anatomical midline of the abdominal wall, instead of the linea alba (if present). When closing the midline incision, the elongate element is positioned along the incision, and the at least one sheet is positioned over and/or under the rectus abdominis muscles surrounding the incision. The linea alba located in the abdominal midline is a three-dimensional composition of connective tissue fibers from abdominal wall muscles, which plays a significant role in stabilizing the abdominal wall. Use of a connective tissue material for the elongate element, therefore, facilitates reliable closure of the midline incision and provides good aesthetic results. The elongate element may, however, comprise any biological or synthetic material that is immunologically compatible, is structurally and functionally similar to the linea alba, and facilitates duplication of the abdominal wall physiology.

[0031] FIG. 1A shows an exemplary embodiment of a prosthetic implant 10 in accordance with the present disclosure. FIG. 1 B illustrates a cross-sectional view of the embodiment depicted in FIG. 1A taken along line AA'. FIG. 1 C depicts an alternate configuration of implant 10, and FIG. 1 D is a cross-sectional view of the configuration depicted in FIG. 1 C taken along line BB'. Implant 10 comprises an elongate element 12 and at least two sheets 20a and 20b connected to the outer surface of elongate element 12 on opposite sides of a longitudinal axis 14 of the central element. The sheets can be connected to elongate element 12 using absorbable biological sutures (e.g. catgut, polyglactin, etc.), non-absorbable sutures (e.g. nylon, polypropylene, etc.), surgical staples, clips, or tissue adhesives. In one embodiment, as illustrated in FIG. 1A-1 D, sheets 20a and 20b

are connected to elongate element 12 along the midline of the sheets. In such an embodiment, attachment of sheets 20a and 20b to elongate element 12 divides the sheets into two halves.

[0032] As depicted in FIGS. 1A-1 D, sheet 20a forms two flaps 21 a and 22a of equal dimensions upon attachment to element 12. Similarly, sheet 20b forms two symmetrical flaps 21 b and 22b. Sheets 20a and 20b may, however, be connected to elongate element 12 along any longitudinal axial line of the sheets. In some embodiments consistent with the present disclosure, the flaps formed by connection of the sheets to the elongate element are asymmetrical.

[0033] In one embodiment, sheets 20a and 20b extend along a plane substantially parallel to longitudinal axis 14, as illustrated in FIGS. 1A and 1 B. In such an embodiment, sheets 20a and 20b form two pockets between flaps 21 a and 21 b and 22a and 22b, respectively, when attached to elongate element 12. In an alternate embodiment, sheets 20a and 20b are folded away from elongate element 12, as illustrated in FIG. 1 C and FIG. 1 D, such that sheets 20a and 20b form two pockets between flaps 21 a and 22a and 21 b and 22b, respectively.

[0034] Although sheets 20a and 20b are generally shown in a rectangular form in the figures, the depiction is only for illustrative purposes, and any suitable size, shape and form can be used depending upon the specifications of the surgical procedure and the extent of repair necessary. In one embodiment, as illustrated in FIGS. 1A and 1 C, the lengths of both sheets 20a and 20b are equal to the length of elongate element 12. The lengths of elongate element 12 and sheets 20a and 20b are selected to span the length of the incision. However, in some embodiments, the length of implant 10 may be shorter than the length of the incision, depending on the extent of the restorative procedure and the amount of reinforcement required in the abdominal wall The geometry of implant 10 may be tailored to the intended application prior to the surgery or during the surgical procedure Further, in some embodiments consistent with the present disclosure, implant 10 comprises multiple sheets that are superimposed, or layered, to provide additional reinforcement to the abdominal wall The multiple sheets may be chemically or physically bonded to each other to facilitate positioning of implant 10 in the abdominal wall

[0035] The method of performing an incision closure using prosthetic implant 10 will now be described with reference to FIGS 2A and 2B, which illustrate the anatomy of the abdominal wall and an abdominal midline incision outline, respectively FIG 2A shows a cross-sectional view of the abdominal wall comprising the rectus abdominis muscles 50, hnea alba 52, transversalis fascia 54, peritoneum 56, subcutaneous fat 58, skin 60, anterior layer of fascia 62 and posterior layer of fascia 64 FIG 2B shows a midline incision 100 made through hnea alba 52 between rectus abdominis muscles 50 and around umbilicus 66 Further, although this method is described for midline closure, the method of incision closure disclosed can be applied for the treatment of any incision type and/or to treat other structural abdominal wall defects

[0036] During closure of midline incision 100, elongate element 12 of implant 10 is positioned along the line of incision, and sheets 20a and 20b are positioned on the anterior and/or posterior sides of rectus abdominis muscles 50 Prior to the positioning of elongate element 12, potential spaces for the placement of the sheets 20a and 20b may be created by dissection around the incision using a blunt instrument or the surgeon's fingers In one embodiment of the present disclosure, when the midline incision is above the arcuate line of the abdomen

spaces between the rectus abdominis muscles 50 and the anterior and posterior layers of fascia 62, 64 may be dissected for placement of the sheets 20a and 20b. Elongate element 12 is then aligned with the midline incision, and the sheets are inserted into the dissected pockets, as shown in FIG. 3A. Below the arcuate line, the posterior layer of fascia 64 is not present, and therefore, the posterior flaps 21 b and 22b are positioned in spaces dissected between rectus abdominis muscles 50 and transversalis fascia 54 or positioned to cover the transversalis fascia 54 or peritoneum 56.

[0037] In another embodiment of the present disclosure, as illustrated in FIG. 3B, sheets 20a and/or 20b overlay anterior layer of fascia 62, and on the posterior side, the sheets are positioned between posterior layer of fascia 64 and transversalis fascia 54 or overlying the transversalis fascia or peritoneum.

[0038] In some patients receiving implant 10, the anterior and/or posterior layers of fascia 62, 64 may be partially or completely lost due to multiple prior surgeries, necrotizing infections, and/or other complications. In such cases, sheets 20a and 20b are simply positioned in proximity to the rectus muscles 50. If the fascia is partially present, it may be abraded by the surgeon to expose the rectus muscles and release blood to initiate the would healing process. The sheets then spontaneously anneal with the rectus muscles. When the sheets comprise a biological matrix material, the sheets may be remodeled by the patient's own cells, thereby, facilitating rapid integration of the sheets into the repair site.

[0039] In another embodiment of the present disclosure, elongate element 12 is aligned with the midline incision in accordance with the configuration shown in FIGS. 1C and 1 D, such that the rectus muscles 50 are supported between flaps 21a and 22a of sheet 20a on one side of the incision, and flaps 21 b and 22b of sheet 20b on the other side.

[0040] Following the placement of sheets 20a and 20b into the treatment site, the sheets are secured to the rectus muscles. The sheets 20a and 20b can be secured using a variety of anchoring systems, including, for example, sutures, staples, clips, and/or tissue adhesives. As used herein, securing the sheets 20a and 20b to the rectus muscles will be understood to include securing the sheets 20a and 20b directly to the rectus muscles and to include securing the sheets to a layer of the abdominal wall adjacent to the rectus muscles, including a layer of rectus fascia, transversalis fascia, or peritoneum.

[0041] In some embodiments, as shown in FIGS. 3A and 3B, the sheets are secured using sutures that pass through a portion of the sheet, the rectus abdominis muscles, and/or the posterior and/or anterior layer of fascia. The suturing needle is inserted through layers of the abdominal wall and sheets 20a and 20b, and then reversed to retrace the path through the abdominal wall layers and sheets. The free ends of sutures 70 are tied together on the anterior side of sheets 21 a and 22a. In some embodiments, as shown in Fig. 3A, the sutures may be tied anterior to the anterior layer of fascia 62. Sufficient care is taken to avoid incorporation of visceral or other structures into the suture line. Sutures are placed along the line of incision to ensure complete reapproximation of the abdominal wall. The frequency of the lateral suture anchors is determined by the surgeon during the procedure.

[0042] In some embodiments, the reapproximation is performed using continuous or interrupted loop sutures 80, as shown in FIG. 4. Suture loops 80 incorporate elongate element 12 in order to secure the fascia and or rectus

muscles to the elongate element 12. This applies tension to the abdominal wall structures and draws them medially to close the incision. Loop sutures 80 may be used in conjunction with interrupted sutures 70, as described above, or alone.

[0043] FIG. 5 is a flowchart diagramming the steps of treating an abdominal wall following a midline incision using implant 10. As noted, the method can be used for prophylactic treatment of the incision (e.g., to prevent dehiscence) or to facilitate closure of incisions or defects that are difficult to close with sutures alone.

[0044] The first step in closing the midline incision includes optionally creating potential spaces for the placement of sheets 20a and 20b on both sides of the midline incision (step 510) if needed. In one aspect of the present disclosure, spaces between rectus muscles 50 and anterior layer of fascia 62 are dissected for placement of the sheets on the anterior side of the ventral abdominal wall, and spaces between rectus muscles 50 and posterior layer of fascia 64 or transversalis fascia 54 are created for placement of the sheets in the posterior side of the abdominal wall. In another aspect, the sheets are positioned over anterior layer of fascia 62 and below posterior layer of fascia 64. In such a procedure, the surgeon creates spaces between fascia 62 and subcutaneous fat 58 on the anterior side on the abdominal wall. On the posterior side, spaces between fascia 64 or rectus muscles 50 and transversalis fascia 54 may be dissected. Alternatively, on the posterior side, the sheets 20a and/or 20b may be placed between the transversalis fascia and the peritoneum. Step 510 may not be required if an adequate region for attachment of the sheets to rectus abdominis muscles is already present or if a patient is suffering from substantial loss of fascia 62, 64.

[0045] The second step comprises positioning elongate element 12 of implant 10 along the midline incision (step 520) to begin approximation of the wound margins. In one exemplary embodiment, the cranial end of elongate element 12 is aligned with the superior end of the midline incision, and the caudal end of the implant is aligned with the inferior end of the incision. The size of the implant could be adjusted by the surgeon either before the procedure, or during the placement of the implant.

[0046] The next step is the insertion of the sheets into the spaces created in step 510 (step 530) or on the appropriate sides of the rectus muscles if no spaces have been created.

[0047] Next, the sheets are secured in place (step 540). As described above, the sheets can be secured using, sutures, staples, clips, tissue adhesives, or other suitable means. The method of securing the device and the suturing technique are determined by the surgeon during the procedure. This is followed by closure of the skin using either non-absorbable or absorbable sutures. Alternatively, surgeons may use surgical staples for skin closure due to speed of application and ease of removal.

[0048] Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.