SURGICAL PROSTHESIS

Abstract: A surgical prosthesis having a non-bioabsorbable layer and a bioabsorbable layer including hyaluronic acid and carboxymethyl cellulose, a method of manufacturing the prosthesis using an adhesive, and a method of using the surgical prosthesis to seal an opening in the body of the patient are disclosed.

Description: SURGICAL PROSTHESIS BACKGROUND OF THE INVENTION An unwanted opening in a body cavity, such as an mcisional hernia, is often repaired using a prosthetic mesh (e g , a polypropylene mesh) to line the inner surface of the body cavity wall at the opening Viscera in the body cavity display a strong tendency to adhere to exposed mesh during the healing process This tendency frequently results in significant postoperative complications SUMMARY OF THE INVENTION In general, the invention provides a laminated surgical prosthesis and methods of making and using the prosthesis The prosthesis includes a non-bioabsorbable layer having an outer wall-facing surface and an inner bioabsorbable layer-facing surface, an adhesive, and a bioabsorbable layer containing hyaluromc acid (HA) and/or carboxymethyl cellulose (CMC) The HA and CMC (HA/CMC) can be chemically modified e g , as descπbed in U S Patent No 5,017,229 The non-bioabsorbable layer can be a mesh of polypropylene or poly(ethylene terephthalate) The bioabsorbable layer has an outer viscera-facmg surface and an inner non- bioabsorbable layer- facing surface which is attached to the bioabsorbable layer- facing suiface by the adhesive In addition, the inner non-bioabsorbable layer- facing surface of the bioabsorbable layer is preferably porous to facilitate binding with the inner bioabsorbable layer- facing surface of the non-bioabsorbable layer The pores can be about 10-500 μm in diameter, (e g , 30-300 or 40-100 μm in diameter) and can traverse the bioabsorbable layer from the outer viscera- facing surface to the inner non-bioabsorbable layer- facing surface The amount of HA and CMC in the bioabsorbable layer can vary In one example, the ratio of the amount of HA to the amount of CMC is between 1 0 01 and 0 01 1 Exemplary HA CMC ratios are 1 2, 1 1 and 2 1 The various layers of the prosthesis can have selected densities as follows The non- bioabsorbable layer may have a density of about 6 3 to 9 5 g/ft 2 (e g , 7 9 g/ft 2 ) The bioabsoibable layer may have a density of about 2 0 to 4 5 g/ft 2 (e g , 3 0 g/ft " ) The adhesive may have a density of about 2 7 to 4 1 g/ft' (e g , 3 4 g/ft " ) The adhesive is preferably bioabsorbable and may contain polyglycohc acid, polylactic acid, polycaprolactone, polydioxanone, polyestercaibonate, polyhydroxyalkonate, or copolymers thereof For example, the adhesive can be a 1 1 copolymer of polyglycohc acid and polylactic acid The invention also includes a method of repairing an opening in a wall enclosing a body cavity by positioning the suigical prosthesis of the invention over the opening and in contact with an inner surface of the wall, then closing the opening The method of repairing an opening in a wall may also pieferably include securing the prosthesis to the wall, e g , by suturing In addition, the invention features a method of producing a surgical prosthesis b> applying an adhesive to a surface of a non-bioabsorbable sheet, and adhering a bioabsorbable composition to the surface of the non-bioabsorbable sheet subsequent to the application of the adhesive to the surface of the non-bioabsorbable sheet The composition pieferably contains hyaluromc acid and/or carboxymethyl cellulose The adhering step may include placing the bioabsorbable composition onto the surface of the non-bioabsorbable sheet and heat-piessing the composition m a process such as lamination As used herein, "non-bioabsorbable layei" means a layer that contains components that aie not readily absorbed, degraded, oi otherwise decomposed when present m a body cavity (e g , the human peritoneal cavity) As used herein, "bioabsorbable layer" means a layer containing components that can be degraded or absorbed at some time after implantation of the prosthesis, such as within weeks or months following implantation The bioabsorbable products are preferably eliminated from the body or metabolized As used herein, "hyaluromc acid" and "carboxymethyl cellulose" means those compounds and the chemical denvatives thereof, e g , as described in U S Patent No 5,017,229 As used herein, "heat-pressing" means a process that involves pressing at least two materials into contact with each other while heat is applied to at least one of the materials Other features and advantages of the invention will be apparent from the following detailed description, figures, and claims BRIEF DESCRIPTION OF THE DRAWING Fig 1 is a perspective view of a prosthesis of the invention, with the bioabsorbable (HA/CMC) layer and adhesive partially separated from the non-bioabsorbable layer Fig 2 is a plan view of an opening m a wall of a body cavity before repair Fig 3 is a plan view of the opening m Fig 2 with the prosthesis shown m Fig 1 properly positioned for repan Fig 4 is a plan view of the opening and prosthesis m Fig 3, the opening now being closed by sutures Fig 5 is a cross sectional view of the repaired wall taken at line 36 shown in Fig 4 DETAILED DESCRIPTION In general, the invention relates to a surgical prosthesis having at least three layers A first non-bioabsorbable layer, is made of a material such as polypropylene and can have a thickness of about 400 to 650 microns or a density of about 6 3 to 9 5 g/ft 2 (e g , 7 9 g/ft 2 ) A second layer that is bioabsorbable is made from a material such as hyaluromc acid, carboxymethyl cellulose, or mixtures thereof and can have a thickness of about 150 to 300 microns or a density of about 2 0 to 4 5 g/ft " (e g , 3 0 g/ft 2 ) The first and second layers are affixed to each other by a third layer, I e , an adhesive, formed of a material such as a copolymer of polylactic acid and polyglycohc acid The third layei can have a thickness of about 25 to 200 microns or a density of about 2 7 to 4 1 g/ft 2 (e g , 3 4 g/ft 2 ) Referring to Fig 1 , a prosthesis 10 includes a non-bioabsorbable mesh 12 made of a polymer such as polypropylene or poly(ethylene terephthalate) The mesh may include woven strands, a woven mesh of fibers, a preformed square pattern, or similar configurations Mesh 12 includes a wall-facing surface 20 and a bioabsorbable layer- facing surface 18 Bioabsorbable layer 14 is preferably formed of HA and CMC and has non-bioabsorbable layer-facing surface 22 affixed to bioabsorbable layer-facing surface 18 of mesh 12 by an adhesive 16 The adhesive 16 may be, for example, a l l copolymer of polyglycohc acid and polylactic acid The bioabsorbable layer 14 also includes a viscera- facing surface 24 The bioabsorbable layer 14 contains pores 26 that are adjacent to the non-bioabsorbable layei- facing surface and more preferably traverse the layer from viscera-facmg surface 24 to non- bioabsorbable layer-facing surface 22 Although the pores traverse the layer m this particular embodiment, it is to be understood that in other embodiments (not shown), the pores may not ti averse the entire bioabsorbable layer During manufacturing, the adhesive 16 preferably infiltrates the pores 26 and facilitates the binding of bioabsorbable layer 14 to the mesh 12 In some embodiments the wall-facing surface 20 and the viscera facing surface 24 of the bioabsorbable layer 14 differ in coloration, visible surface markings or a tactile feature This facilitates identification of the respective surfaces and proper orientation of the prosthesis 10 by the surgeon As shown in the drawings, the prosthesis 10 may be used to repair an opening 28 in a wall 30 of a body cavity 32 that contains a viscera surface 34 (e g , bowel, omentum, etc ) To repair the opening 28, the prosthesis 10 is inserted into body cavity 32 at opening 28 The prosthesis 10 is positioned so the wall-facing surface 20 of mesh 12 covers the opening 28 of the body cavity 32 with the wall-facing surface 20 facing the wall 30 of the body cavity, and the bioabsorbable layer- facing surface 18 faces the viscera 34 The bioabsorbable layer 14 covers the bioabsorbable layer-facing surface 18 and protects the viscera 34 from adhering to the mesh 12 during healing The repair of the opening 28 in body cavity 32 is then completed by closing the opening 28 with sutures 38 In time, the bioabsorbable layer 14 is absorbed by the body, leaving bioabsorbable layer-facing surface 18 of the mesh 12 directly facing the viscera 34 However, by the time bioabsorbable layer 14 is absorbed, the opening 28 has healed to an extent where the tendency to form adhesions between the wall 30 of the body cavity and the mesh 12 has abated This abatement is the result of the reestabhshment of a mesothehal lining on the mside surface of wall 30, over healed opening 28 During the healing process, the mesh 12 attaches to the wall of the body cavity Based on the above description and the examples described below, one skilled in the art can utilize the present invention to its fullest extent The following examples are illustrative of how one skilled in the art may make and use the prosthesis of the invention and are not to be construed as limiting the remainder of the disclosure in any way. Any publications cited in this disclosure are hereby incorporated by reference Example 1 A 1 x 1 inch piece of polycaprolactone/polyglycohc acid (PCL/PGA) 90/10 copolymer film (at a density of about 8 g/ft " ) was placed on top of a 1 x 1 inch piece of MARLEX® polypropylene mesh A HA/CMC composition was produced generally following the procedures described in U S Patent No 5,017,229 A carbodnmide modified HA/CMC powder was suspended m deio zed HτO at a concentration of 1 % (w/v) using a high shear blender (Tun ax T50 with G45F head) for 10 minutes The HA/CMC suspension was poured into a polystyrene tray or TEFLON@-coated stainless steel tray at a density of 4 g/ft" and lyophihzed into solid foam sheets The shelf temperature was ramped down to -20°C at a rate of 0 l °C/mιn The drying cycle was initiated with vacuum set at less than or equal to 150 mtorr, and the shelf temperature was raised at 0 l°C/mιn to -12°C The shelf temperature was held at -12°C for 180 minutes and then raised at 0 l°C/mm to 0°C The shelf temperature was then held at 0°C for 900 minutes and then raised at 0 1 °C/mιn to 27°C The foam sheet was removed after the foam temperature reached the shelf temperature Scanning electron microscopy of the resulting foam indicated a range of pore sizes about 50-300 μm in diameter A 1 x 1 inch piece of HA/CMC foam was placed on top of the PCL/PGA film, which was on top of the polypropylene mesh This configuration was placed between two TEFLON®-coated stainless steel plates and pressed a Carver Laboratory Press The conditions for lamination were 250°F for 30 seconds with no pressure, then 15 seconds at 2 metric tons of pressure The prosthesis was removed from the press, allowed to cool, and then removed from between the TEFLON®-coated stainless steel plates The HA/CMC component of the one piece prosthesis did not exhibited any discoloration, nor did the polypropylene show signs of melting In addition, the vaπous layers of the prosthesis were well-incorporated into adjacent layers Example 2 A 2 x 2 inch piece of PCL/PGA 95/5 copolymer film (at a density of 8 g/ft " ) was placed on top of a 2 x 2 inch piece of MARLEX® polypropylene mesh Then a 2 x 2 inch piece of HA/CMC foam, produced according to Example 1, was placed on top of the PCL/PGA film This sandwich was placed between two TEFLON® sheets with a 0 4 mm spacer and then pressed between chrome plates using a Carver Laboratory Press The spacer is a metal shim placed between the chrome plates that allows for the maintenance of a predetermined gap thickness and prevents pressing the mesh completely through the surface of the foam The conditions for lamination were 220°F for 45 seconds with no pressure, then 15 seconds at 2 metric tons pressuie The material w as removed from the press, allow ed to cool at 4°C, and then removed from the plates The PCL/PGA, HA/CMC foam, and mesh components were all well-mcorporated into adjacent layers m the prosthesis To determine whether the adhesive was necessary to produce a well-adheied, uniform distnbution of HA/CMC over the polypropylene mesh, a 1 25 x 4 125 inch piece of mesh was placed in a TEFLON®-coated tray A 0 6% (w/v) suspension of HA/CMC was poured over the mesh to achieve a density of 4 5 g/ft " and lyophihzed into a solid foam sheet as described in Example 1 The distribution of the HA/CMC foam matrix on the polypropylene mesh was uneven, with regions of the mesh having dense coverage of HA/CMC and other regions of the mesh having light coverage of HA/CMC Thus, the adhesive was desirable for producing a prosthesis haung an even distribution of HA/CMC over a mesh The role of the adhesiv e in the prepaiation of the prosthesis was further inv estigated by eliminating the adhesive in another method for producing a prosthesis A 1 x 1 inch piece of HA/CMC foam produced as described in Example 1 was placed on top of a 1 x 1 inch piece of MARLEX® polypropylene mesh, then pressed between two TEFLON®-coated stainless steel plates using a Carver Laboratory Press The foam and mesh were then laminated by heating at 330-350°F foi 30 seconds with no pressure, then for 15 seconds at 2 metric tons of pressure The prosthesis was removed from the press, allowed to cool, and removed from the stainless steel plates There was poor or no incorporation of the HA/CMC foam into the mesh Thus, the adhesive was desirable for incorporation of the layers of the prosthesis into adjacent layers In addition, it was concluded that the relatively neutral (in terms of hydrophobicity) adhesive facilitated contact between two dislike materials a hydrophobic non-bioabsorbable synthetic polymer mesh and a hydrophihc bioabsorbable polymer Example 3 HA/CMC foam produced according to Example 1 was subjected to dehydrothermal treatment (DHT) at 100°C for 6 hours A 2 25 x 2 25 inch piece of polyglycohc acid/polylactic acid (PGA/PLA) 50/50 copolymer film (at a density of about 6 g/ft " ) was placed on top of a 2 25 \ 2 25 inch piece of the foam aftei DHT Then the 2 25 x 2 25 inch piece of MARLEX® polypropylene mesh was placed on top of the PGA PLA film This configuration was placed between two TEFLON® sheets with a 0 4 mm spacer and pressed between two chrome plates using a Carver Laboratory Press The conditions for lamination were 240°F for 45 seconds with no pressure, then pressing for 20 seconds at 3000 pounds (lb) pressuie The material was removed from the press, allowed to cool at 4°C, and then removed from the plates The PGA/PLA, HA/CMC foam, and mesh components were all well-incorporated into adjacent layers in the prosthesis Example 4 Two 3 x 3 inch pieces of HA/CMC foam made according to Example 1 and two 3 x 3 inch pieces of MARLEX® polypropylene mesh were each spray-coated on one surface with a 3% (w/v) solution of PGA/PLA. 50/50 copolymer in methylene chloride to achieve a 15% final w eight gam All four pieces were individually packaged in Chex-All® II pouches and subjected to (DHT) at 100°C for 6 hours Then a single foam piece was placed on top of a single MARLEX® piece, with the spray-coated surface of one piece contacting the spray- coated suiface of the other piece This configuration was placed between t o TEFLON® sheets with a 1 45 mm spacer and pressed between two chrome plates using a Carver Laboratory Press The conditions for lamination were 240°F for 1 mmute with no pressure, then 30 seconds at 7000 lb pressuie The material was removed from the press, allowed to cool at 4°C, and then removed from the plates The PGA/PLA, HA/CMC foam, and mesh components were all well-mcorporated into adjacent layers in the prosthesis This procedure was repeated for the remaining two pieces To determine the desirability of the porous nature of the HA/CMC foam m the prostheses produced immediately above, a 2 x 2 inch piece of non-porous, glycerol plasticized HA/CMC film and a 2 x 2 inch piece of BARD® mesh (Da\ ol, Inc ) were spray - coated on a surface with a 3% (w/v) solution of PGA/PLA 50/50 copolymer in methylene chloride to achieve a 15% final polymer weight gam for each of the film and mesh The non- porous HA/CMC film was placed on top of the mesh with the spray-coated surfaces contacting each other This configuration was placed between two TEFLON® sheets with a 0 625 mm spacer and then pressed between two chrome plates using a Carver Laboratory Press The film and mesh were then laminated at 240°F for 1 minute with no pressure, then for 45 seconds at 1000 lb pressure The prosthesis was removed from the press, allowed to cool in a 2-8°C cold room, and removed from between the chrome plates The prosthesis exhibited little, if any, infiltration of the mesh by the film, in contrast to the prosthesis having the porous HA/CMC foam The practical effect of the minimal infiltration in the nonporous HA/CMC film prosthesis was also compared to the porous HA/CMC foam prosthesis Both types of prostheses produced in this Example were evaluated for surgical handling and placement properties in a rabbit hernia repair model (Dmsmore, The American Surgeon 65 383-387, 1999) When the prosthesis having the porous HA/CMC foam layer w as prehydrated prior to the surgical insertion, the prosthesis did not delammate The prosthesis could be handled adequately to surgically repair the defect in the animal In contrast, the prosthesis having the nonporous HA/CMC film layer delaminated into two pieces when prehydrated and was not able to be used to repair the body cavity opening m the rabbit hernia repair model To evaluate the physical strength and integrity of the porous HA/CMC foam prosthesis versus the nonporous HA/CMC film prosthesis, the wet bond strength of each was determined using an m vitro phosphate buffered saline (PBS) immersion assay 1 x 1 inch sample prostheses were each placed into a 50 ml vial filled with 30 ml of PBS The vials were then moderately agitated at 37°C The samples were then removed from the vials, placed in 100% ethanol to remove the water, and then stained with the dye alcian blue, which binds to HA The extent of staining correlated with the amount of HA remaining on a mesh The results from the PBS immersion assay are summarized in Table 1 TABLE 1 Duration of Immersion Test Group Assessment Foam Prosthesis 2 hours HA present, 100%o of mesh covered with dark blue staining Film Piosthesis 2 hours no HA present, no staining Foam Prosthesis 6 hours HA present, 100% of mesh covered with dark blue staining Film Prosthesis 6 hours no HA present, no staining The lack of staining for the nonporous film prosthesis appeared to be due to delamination of the film from the mesh after 2 or more hours of immersion In contrast, the porous foam prosthesis retained HA after 6 hours of immersion Example 5 The prosthesis having a porous HA/CMC foam layer prepared m Example 4 was further evaluated in a rat hernia repair model (Dmsmore, supra) and was compared with the performance of MARLEX® polypropylene mesh only A 1 x 1 inch full thickness defect was excised from the rectus abdomims muscle of rats to prepare the animal model The defect was repaired by suturing the test material into the defect using a continuous suture pattern In one set of animals, the composite prosthesis was used for repair of the hernia, with the HA/CMC layer facing the viscera In another set of animals, MARLEX® mesh only was used for repair of the hernia The rats were sacrificed 28 days after repair and graded for adhesion formation using the following scale: 0 = no adhesions, 1 = less than or equal to 25%o of the defect covered by adhesions, 2 = 26 to 50% of the defect covered by adhesions, 3 = 51 to 75% of the defect covered by adhesions, and 4 = greater than 75%o of the defect covered by adhesions The results are shown m Table 2 TABLE 2 Average Extent % of Animals of Adhesions w/no Adhesions Test Group Polypropylene Mesh Only (n=5) 3 O ± l .O 0 Composite Prosthesis (n=10) 0 7 ± 0 7* 40 *Sιgnιficantly different from mesh only group (Tukey-Kramer, p < 0.05) Average extent of adhesions is expressed as the mean ± one standard deviation The results in Table 2 indicated that the composite prosthesis of the invention was superior to the polypropylene mesh m preventing adhesions in vivo Other embodiments are included within the following claims. For example, the bioabsorbable layer may contain chitosan, alginate, or other bioabsorbable materials or combinations of materials In addition, the prosthesis may contain a protein drug, non- steroidal anti-inflammatory drug, small molecule drug, or the like The drug may be incorporated in any portion of the prosthesis (e g , the bioabsorbable layer or the adhesive) to provide for the controlled release of the drug into the body cavity to be repaired with the prosthesis Similarly, the mesh layer may be formed of a variety of materials that are not reactive or minimally reactive with the tissue of the patient Although the preferred form of the present invention has been described above, such description is for illustrative purposes only, and it is to be understood that changes and variations may be made to the present invention without departing from the spirit or scope of the following claims

Claims: Claims We claim 1 A surgical prosthesis comprising a non-bioabsorbable layer having an outer wall-facing surface and an innei bioabsoibable lay ei -facing surface, an adhesive, and a bioabsorbable layer comprising a material selected fiom the group consisting of hyaluromc acid and carboxymethyl cellulose, the bioabsorbable layer having an outer viscei - facing surface and an inner non-bioabsorbable layer-facing surface attached to the bioabsorbable layer-facing surface of the non-bioabsorbable layer by the adhesive, wherein the bioabsorbable layer contains pores in the non-bioabsorbable lay ei -facing surface 2 The prosthesis of claim 1, wherein the non-bioabsorbable layer comprises polypropylene 3 The prosthesis of claim 1 , wherein the non-bioabsorbable layer comprises poly(ethylene terephthalate) 4 The prosthesis of claim 1 , wherein the non-bioabsorbable layer is a mesh 5 The prosthesis of claim 1 , wheiem the adhesive is bioabsorbable 6 The prosthesis of claim 1 , wherein the adhesive comprises polyglycohc acid 7 The prosthesis of claim 1 , wherein the adhesive comprises polylactic acid 8 The prosthesis of claim 1 , wherein the adhesive comprises a copolymei of polylactic acid and polyglycohc acid 9 The prosthesis of claim 8, wherein the ratio of the total amount of polyglycohc acid to the total amount of polylactic acid m the adhesive is about 1 1 10 The prosthesis of claim 1, wherein the adhesive comprises a polymer selected from the group consisting of polycaprolactone, polydioxanone, polyestercarbonate, and polyhydioxyalkonate 1 1 The prosthesis of claim 1 , wheiem the bioabsorbable layei comprises hyaluromc acid and carboxymethyl cellulose 12 The prosthesis of claim 11, wherein the ratio of the total amount of hyaluromc acid to the total amount of carboxymethyl cellulose in the bioabsorbable layei is about 2 1 13 The prosthesis of claim 1, wherein the pores traverse the bioabsorbable layer from the viscera-facmg surface to the non-bioabsorbable layer-facing surface 14 The prosthesis of claim 11, wherein the pores are about 10-500 μm in diameter 15 The prosthesis of claim 14, wherein the pores are about 30-300 μm in diametei 16 The prosthesis of claim 15, wherein the pores are about 40-100 μm in diameter 17 A method of repairing an opening in a wall enclosing a body cavity of a human patient, the method comprising providing a surgical prosthesis formed of a non-bioabsorbable layer having a wall-facing surface and a bioabsorbable layer-facing surface, an adhesive, and a bioabsorbable layer comprising a material selected from the group consisting of hyaluromc acid and carboxymethyl cellulose, the bioabsorbable layer having a viscera- facing surface and a non-bioabsorbable layer-facing surface attached to the bioabsorbable layer-facing surface by the adhesive, wherein the bioabsorbable layer contains pores in the non-bioabsorbable layer-facing surface; positioning the surgical prosthesis over the opening of the patient, in contact with an inner surface of the wall; and closing the opening. 18. The method of claim 17, wherein the non-bioabsorbable layer comprises a polymer selected from the group consisting of polypropylene and poly(ethylene terephthalate). 19. The method of claim 17, wherein the adhesive comprises a polymer selected from the group consisting of polyglycohc acid, polylactic acid, polycaprolactone, polydioxanone, polyestercarbonate, polyhydroxyalkonate, and copolymers thereof. 20. The method of claim 17, wherein the bioabsorbable layer comprises hyaluronic acid and carboxymethyl cellulose. 21 . The method of claim 20, wherein the ratio of the total amount of hyaluronic acid to the total amount of carboxymethyl cellulose in the bioabsorbable layer is about 2: 1. 22. A method of producing a prosthesis, the method comprising providing a non- bioabsorbable sheet; applying an adhesive to a surface of the non-bioabsorbable sheet; and adhering a bioabsorbable composition to the surface subsequent to application of the adhesive to the surface, the bioabsorbable composition comprising a material selected from the group consisting of hyaluronic acid and carboxymethyl cellulose. 23. The method of claim 22, wherein the adhering step comprises placing the bioabsorbable layer onto the surface and heat-pressing the composition to the surface. 24 A surgical prosthesis comprising a non-bioabsorbable layer having an outer wall-facing surface and an inner bioabsorbable layer-facing surface, an adhesive, and a bioabsorbable layer comprising a material selected from the group consisting of hyaluromc acid and carboxymethyl cellulose, the bioabsorbable layer having an outer viscera- facing surface and an inner non-bioabsorbable layer- facing surface attached to the bioabsorbable layer- facing surface of the non-bioabsorbable layer by the adhesive 25 The prosthesis of claim 24, wherein the bioabsorbable layer contains pores that traverse the bioabsorbable layer from the viscera-facmg surface to the non-bioabsorbable layei -facing surface 26 A surgical prosthesis comprising a non-bioabsorbable layer having an outer wall-facing surface and an inner bioabsorbable layer-facing surface, an adhesive, and a bioabsorbable layer having an outer viscera-facing surface and an inner non- bioabsorbable layer- facing surface attached to the bioabsorbable layer- facing sui face of the non-bioabsorbable layer by the adhesive, wherein the bioabsorbable layer contains pores the non-bioabsorbable layer-facing surface 27 A surgical prosthesis comprising a non-bioabsorbable layer having an outer wall-facing surface and an inner bioabsorbable layer-facing surface, an adhesive, and a bioabsorbable layer having an outer viscera-facmg surface and an inner non- bioabsorbable layer- facing surface attached to the bioabsorbable layer- facing surface of the non-bioabsorbable layer by the adhesive, wherein the non-bioabsorbable layer has a density of about 6.3 to 9.5 g/ft 2 , the bioabsorbable layer has a density of about 2.0 to 4.5 g/ft " , and the adhesive has a density of about 2.7 to 4.1 g/ft .

Inventors: BUTLER TIMOTHY J, GREENAWALT KEITH E, BUTLER, TIMOTHY, J., GREENAWALT, KEITH, E.
Applicants: GENZYME CORP, GENZYME CORPORATION
Application year: 2000
Main classification: A61L31
IPC codes: A61F2, A61L15, A61L27, A61L31