EP2967792A2 - Single plane tissue repair patch having a locating structure - Google Patents

Abstract

A novel single plane tissue repair patch is disclosed. The patch has a base member with an opening there through, and a closure member associated with the opening. Mounted to the periphery of the bottom side of the base member is a locating structure. The mesh may be used in open surgical procedures for hernia repairs and other repairs of body wall defects.

Description

This is a conilnuaii o-b-part ofeo~pewd¾g commonly assigned U.S. Patent Application Senai No. 13/443347 filed . on April 10, 2012, which is incorporated by reference,

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The field of art to. which tins inveatkm pertains is implantable surgical tissue repair patches, more parricularly implan able surgical mesh hernia patches for use in hernia repair procedures.

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Hernia, repair is a relatively straightforward surgical procedure, the ultimate goal of which is to restore the mechanical integrity of the abdominal wall by repairing a muscle wall defect through which the peritoneum and possibl a section of the underlying viscera has protruded. There are various types of hernias, each with its own. specific surgical r air pr cedure, iricl.udi.ug ventral hernias, umbilical hernias, incisional hernias, sports hernias, femoral herrsks, and inguinal hernias. It is believed that most he nias are attributable to a weakness in sections of the tissues of the abdominal, wall

Precipitating events, such as unusual movements or lifting extremely heav weights, rnay cause the weak spots in the abdominal wail tissue to be excessivel stressed, resulting in tissae separation. or rupture and protrusion of a section, of peritoneum and underlying viscera, e.g., mtesthie, through the separated or ruptured tissue section.. This weakness may be attributable to several factors. Weakness in the abdominal wall may be congenital or may be associated with, a prior incision from, a surgical procedure or a troca wound. Other factor ma include trauma, genetic predisposition, and aging. Even though the commonly used, conventional surgical procedures tor correcting or repairing the vario us ty pes of hernias are somewhat specifi c, there is a eomtrtoualii with respect to the mechanical repair. Typically, the protrusion, of the peritoneum through a -muscle or abdominal wall defect results in a hernia sack containing the^' undotlyirsg and protruding viscera. The hernia sack Is dissected and the viscer are pushed back ^'into the abdominal cavity. Theu_* a tissue reinforcing or repair implant such a. -mesh patch device is typically implanted and secured at the site of the abdominal wall defect. Autologous tissue quickly grows into the mesh implant, providing the patient with a. secure and strong; repair. In certain patient presentations, it may he desirable to suture or otherwise close the defect without .an implant, although, this is typically much les desirable tor the optimal outcome.

Q e common type of hernia i s a ventral hernia, ^'thi type of hernia typically Occurs in the abdominal wall and may be caused by a prior incision or puncture, or by an area of tissue weakness that is stressed. There are severs! repair procedures that can be employed by the surgeon to treat such hernias, depending upon the individual characteristics of die patient and the nature of the hernia., In one technique, an onlay mesh is implanted on the dorsal, surface of the anterior fascia of the abdomin a l wai l. Another technique provides for an inlay mesh, where the prosthetic materia! is sutured to the abdominal wail and acts as a "bridge*' to close the abdominal defect,. Placement of a prosthetic mesh posterior to the rectus muscle of the abdominal wail is kno wn as the Reeves Stoppa or retroniuscu!ar technique, In this technique, a mesh implant is located beneath the m uscle of the abdominal w a ll but above the peritoneum. Implan tatio of the mesh in. the intra-peri.toneal. location, can. be done via an open or laparoscopic approach,. The tnesh is inserted into the patient abdominal, cavit through, an. open anterior incision or vi a trocar and positioned to cover the defect. The surgeon then fixates the mesh Implant to the abdominal wall with conventional mechanical fixation or with sutures placed through the ihj!. thickness of the abdominal walk There are a variety of such mechanical fixation devices that can be used in. laparoscopic. r open surgery, e.g., tacking instruments. Intraperitoneal, placement of mesh via an open approach, may he the desired technique of repair where the laym of the abdominal wall are atten uated and a laparoscopic approach,k not desired, Placement, of m esh via this technique presents several unique challenges including poor visibility during mesh handling ami f ation, poor handling, and deficient ergonomics of the currently available products. Mesh repair patch implants designed for iatraperiton al placeme t typically requires an additional treatmen or layer to function as a. tissue separating component to separate the viscera from the prosthetic abdominal wail repair layer, and. thereby prevent or substantially inhibit the formation of post-operative ad esions- The addition of this layer may add to the complexity of wound healing due to the presence and mass of an additional layer.

Although hernia repair patch implants exist for open ventral hernia repairs, there are deficiencies known to he associated with their use. The deficiencies include difficulty in handling the mesh, poor visibility during mesh handling, implantation and fixation, poor usa lity and ergonomics when usin a laparoscopic instmrnent, and the use of dual or multiple layers of mesh. The commercially available meshes repair patch implants ibr th s application typically have at least dual layers of mesh, or fabric with pockets or skirl so provide for affixation to the parietal, wall via the top layer or skirt, it can also he appreciated that multiple layer meshes introduce more foreign body mass and. tend to be more expensive and complicated to manufacture than a single layer mes implant.

Another deficiency associated with hernia, repair patch. mplants is the ease of locating the periphery of the patches so t hat a surgeon, may affix the patch to tiss ue by emplaclng tacks or other fasteners to properly secure the implants to tissue in the appropriate manner.

Accordingly, there is a need In this art for novel tissue repair implants, such as ventral^' hernia repair patch implants, that can be used in an. open surgical procedure, and which, d not require mesh, anchoring or affixation layer, and. which may be secured to tissue using a single or multiple crown technique. There Is also a need for tissue repair implants which facilitate the location of the peripheries of such implant by the surgeon. tsmnuu y of t e f m en km

Accordingly, noveltissue repair^■patches, arc disclosed. The bssue .repair patches have a substantially flat or planar has;e member. The base member is preferably a mesh. There is an opening located In the base member, and, there Is a closure member associated with the opening. The base member has a top side and a bottom side, and an outer periphery md a peripheral edge. Mounted to the bodora of the base member adjacent to or ou the periphery of the base member is a legating structure. The locating structure is preferably an engagement ring member, Optionally, the locating structure ^'has a downwardly extending flange member. The patch may have a polymeric layer on * least pan of at least one side of the base member. It is preferred that the side of the mesh that faces the viscera have a polymeric layer covering substantially all of that side, ^'The tissue repair patches of the present invention are especially useful m open he ni repai procedure, such as a. ventral hernia repair, and are also useful brother types of body wall tissue repairs.

Another aspect of the present invention is a method of repairing a body wall defect, such as a hernia, defect, in an open surgical procedure using the a ove^described tissue repair patch implants.

These and other aspects and advantages of the present invention will become more apparent from the following description and. accompanying drawings,

FIG . I Is a plan view of an embodiment of a single plane Ussus repair naesh patch of the present invention; the patch has a base member having an opening, and a. closure patch member mounted to the top side of the base member over the opening.

FIG, 2 is an exploded perspecti e view of the repair mesh patch of FIG.. 1.

FIG. 3 is to iilusiratkrn showing a surgical tacking Insrn.smeni^' having an elongated shab partially inserted nndemeath the flap member and. through the opening of the base member f the repair paten, of FIG, I ; the instmment shaft is seen as having access I» the bottom side of the base member.

FIG, 4 is a plan view of a^' tissue.- repair patch, of the- present invention that is similar to the repair patch shown in FIG. i, but which has a rectangular closure patch member connected aloag its opposed minor sides; the closure patch member is seen to contain a direction guide for use by the surgeon in orienting the patch during

implantation,

FIG. 5 is an exploded perspective view ill us&sHn two halves of another, embodiment of a. tissue repair patch of the present invention; the two halves are connected to form a repair mesh patch having closure flaps,

Ff G. 6 is a plan view of a. tissue repair patch of the present inven tion made by jolning the two halves seen In FIG, 5; the flap are in die at rest position.

FIG. 7 i a perspective iew of the tissue repair patch of FIG, 6; the flaps are In the at rest position,

PIG. 8 is a perspective view of the tissue repair patch of FIG. ? showing both of the flaps in the ap_: position, uncovering the opening In the base member, thereby prwtding access through the base member.

FIG, 9 illustrates the tissue repair patch: of FIG. 8 with a curved shaft of a snrgical tacking instrument ; inserted partially through the opening of the base member.

FiG. 10 is a pian v iew of another embodiment of a tissue repair patc of the present inve tion -the mesh patch, is seen, to have an opening with, a surgical suture and surgical needle mounted about the opening in a continuous mattress mints configuration.

FIG, 1 1 illustrates the tissue repair patch of FiG. .10, wherein, the opening has been closed by applying tension, to the suture after the patch has been affixed t the parietal wal l of t he patient over the hernia defect. FIG, 12 is- exploded perspective view of another preferred emoodiment of a tissue repair pa ch of the presen hiventiort; he patch is seen to have an upper closure flap and a lower closure flap mounted about an opening in the a e member,

FIG. 13 ix a.pkii.view of the tissue repair mosb. o FIG. 13, showing the closure flaps motmted about the opening in the base member with one closure flap adjacent to the-

:1.0 bottom side of the base member and one closure flap adjacent to the top side of the base member; the flaps are In an at test position.

FIG , 14 is a plan view of a preferred embodiment of a tissue repair patch of the present invention; the patc is seen to have a pair of closure flap members.

FIG. 14a is a cross-sectional view of the repair patch of FIG. 12 along View Line I da- 14».

FIG. 14b Is a magnified partial view of die cross-section of Hli. I2a.iliustratin.f| the flaps posi ioned aboni the opening in the. base member of the patch.

FIG. 15 is an exploded perspective view of two base member halves of the tissue repair patch of FIG.14; both halves have a closure flap member extending from the base member sections,

FIG. 16 is a perspective view of the tissue repair patch made by joining together the two halves seen in f 1(3,1 S; one closure flap i positioned: below the base member and oae closure flap is positioned above the base member.

FIG, I ? is a perspective view of the tissue repair xnesh patch, of FIG, lb; both closure flaps are In the up position such that the opening in the base member is accessible between the flaps,

FIG, I is a perspective view of the mesh repair patc of FIG. I ?, illustrating the distal cud of a curved elongated shaft of a surgical tacking instrument partial.l inserted through the opening of the base member in. a position below the patc to secure the mesh repair patch to tissue. FIG, 1.9 is a perspective vie w of the tissue repair parch of FIG. IB, wit both fla s optionally sutured together in an upward extending position to close the opening in the base member after the patch, has been affixed to tissue,

FIG. 20 is a cross-sectional side view of the tissue repair patch of FIG. 16 inserted into the abdominal cavity of a patient and positioned adjacent to. the patient's peritoneum.; a curved shaft of a surgical tackin Insimnient is seen inserted thorough an access opening such as a. hernia detect in the patient's body wall and through the opening in the base member of the repair patch, such that the distal end of the shaft is in position belo the patch to secure a section of the base member of the patch with a tack to the body wall.

FIG. .21 is a perspective view of the mesh repair patc of PIG. 1 ?, ill titrating the disiai end of a straight elongated shaft of a surgical tacking instrument partially inserted through the opening of the ba.se member in a position to secure the tissue repair patch to tissue,

FIG. 22 is a side view of the tissue repair patch of FIG. 21 inserted into the abdominal cavity of a patient .a»d positioned adjacent to the patient's peri ten eirai a distal section of .a straight shaft of a surgical tacking inst me is. seen, inserted thorough an access opening m the patient's body wall and through the opening in the base member of the repair patch, such that the distal end of the shaft is in position below the patch to secure a section of the base member of the patch with a tack to the body wall.

FIG. 23 is an illustration, of a. hernia repair procedure wherein a surgeon is securing the tissue repair patch of FIG, 17 to. position over a hernia defect using a.

surgical tacking instrument ha v ing a curved elongated shaft; the distal section of the shaft is inserted through an access opening in the patient's body wall and through an opening In the tissue repair patch in order to secure the tissue patch to the peritoneum; the surgeon 's hand is sees palpating the abdomen above the distal end of the shaft of the instrument to place a tack in. a desired position on the patch.

FIG. 24 is a. cross-sectional side view illustrating .a- preferred^' embodiment: of a tissue repair patch of the present invention in place over a hernia defect adjacent to a patient^ peritoneum curved, elongated shaft of a surgical tacking ittsimmeni has been positioned through m access opening in the patieafs body wall and through an opening in. the patch to attach, a section, of the ^'base member of the patch to the peritoneum; the patient's viscera! organs are seen positioned adjacen to the bottom side oft&e patch and through the opening In the body wall.

FIG. 25 is an exploded perspective view of an alternate embodiment of a mesh tissue repair patch of the present invention; the base member is seen to have an openin in the base member surrounded by a closure ring, md a closure patch having a mating closure ring is also shown,

FIG, 26 is a perspective vie w of the tissue repair patch of FKf 25 showing the: patch secured to the base member,

FIG, 27 illustrates a peritonea! view of the bottom side of a preferred embodiment of tissue repair patch of the present invention secured to the peritoneum with a double row of surgical tacks referred to as a double crown technique; the opening in the base member is seen to be closed, and both flaps ha e been po itioned upwardly a ay from the top of the base member; the flaps axe secured to close the opening in the base member.

FIG, 28 is a perspective view of an alternate embodiment of a mesh tissue repair patch of the present invention; the patch i seen to have a slit in the base member providing a central opening:, fICl 29 is a perspective view of the patch of FIG, 28 having a surgical suture mounted about the slit in a shoe lace type configuration to dose the opening in the slit.

FIG. 30 is a perspective view of the tissue repair patch of FIG. 29, after the suture ends have been tensioned, thereby closing the: opening and slit after the patch is secured to the patient' body wall . FIG, 31 is a cross-sectional view of a tiss e repair patch of the present invention, having ¾ locating structure positione on the bottom of the base member Pn the periphery. The tissue repair patch i shown located adjacent to a body wall below a hernia defcet A surgical tacking instrument is. shown with the distal end of its shaft positioned proximal to visceral side of the body wail with the shaft tip adjacent to the locating structure and in a position to fire tacks through the base member into the body wall. The beating structure is in the form of a ring.

FIG. 32 is a perspective view of the tissue repair patch of FIG, 3 i looking op from, a direction below the patch,

FIG. 33 is a perspective view of the tissue repair patch of FIG..3:1 showing the bottom of the repair patch arid tissue repair structure,

FIG . 34 is a partial magnified, side view of the repair patch of FIG. 31 showing the tip of the tacking instrument shaft adjacent to the locating structure,

FIG, 35 is cross-sectional view of an embodiment of a tissue repair patch, of the present invention having a locating structure; the structure is seen to have a textured surface. The patch is in position to be affixed to repair a body wall defect using a surgical tacking insirmneat

FIG. 36 is a partial oiagaiifed view of the patch of FIG, 36 showing the tip of the shah of the surgical tacking inxhonrent engaging the textured surface of the locating structure,

FIG, 37 is a cross-sectionat view of an. embodiment of a tissue repair patch of the present invention, having a locating strncture; th structure i seen to have a downwardly extending flange meraber formed from the periphery of the base member. The patch is in position to be affixed to repair a body wall defect using a surgic l tacki g instrument

FIG. M is a partial magnified view of the patch of FIG, 36 showing the ti of the shaft of the surgical, tacking instrument engaging the downwardly extending .Range member of the locating structure. FIG, 39 a partial magnified cross-seet nal view a tissu repair patch wherein the locating stateture is a down wardly extending ^'flange member mounted to the periphery of the base member,

FIG. 40 a partial magnified cross-sectional view a tissue repair patch, wherein, the locating structure is a .ring member having a downwardly extending il.an.ge member; the ring member is moun ed to the periphery of the to of the base member,

FIG. 41 a partial, magnified cross-sectional view a tissue repair patch, wherein, tire locatmg structure is a ring member having a downwardly extending flange member; the ring member is mounted to the periphery of the bottom of the base member,

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The novel tissue repair patches or devices of the present invention are particularly useful in. open^■ ventral or incisional hernia repair surgical procedures, The tissue repair patch devices consist of a base member h vin an opening.. The base member ha a closure member or device associated with the opening for securing the opening after implantation. The repair patch devices of the present invention have utilit in other conventional tissue repair procedure including inguinal hernia repair procedures, trocar puncture wounds, trocar incisional hernias, etc.

Tissue repair implants and surgical instruments tor appl ing tacks to fixate tissue repair implants are disclosed in the .following commonl assigned, co-pending patent applications, which are incorporated by reference: US Serial o . 12/464, 151 ;

12/464,165; 12/464J 77; 12/464J43; 12/944,651; and 2 i 5,275.

The tissue repair patches of the present inven tion ma be made from, any conventional biocompatible materials. The patches and their components are preferably made from eonventional biocompatible polymers that may be nonabsor a le or bioahsorbable, T he term bioahsorbable is defined to have its conventional meaning and includes both biodegradable and bioresorbable. Examples of such nonabsorbable polymers nicluds polypropylene, polyester, avian, ultra high moleeukr weight polyethylene, and the like and- combinations thereof Examples of Suitable bioahsorbabie polymers mclude poiyiactides (FLA), polyglyc0lid.es (PGA), polydioxanones (PBC PD¾ copolymers of FGA/!xmieihylene carbonate (TMC), copolymers ofPLA^rMC, and the like. If desired, combinations of .biocompatible nonafcsorbable polymers and bioabsorbahie polymers may be utilized to construct the tissue repair implant patch devices of the present invention.

Although it is preferred to use surgical meshes to construct the hernia repair patches of the present invention, other conventional woven or nonwoven surgical repair fabrics, or thermally formed implants may also be used. In addition, the tissue repair patches, may be made ro otber c !i est nai implantable materials such a PTPE (poiytetrafluoroethyieoe), e,g., ePTFE films aud laminates. The patches may consist of composites of polymeric films arid meshes, and/or fabrics,

The meshes useful in the hernia repaid patch devices of the present invention will he manufactured, in a conventional manner using conventional manufacturing equipment and methods including knitting, weaving, non-woven techniques, and the like. The meshes will typically have a pore stxe sufficient to effectively provide for tissue

-ingrowth; for example, they may have pore sizes in the range of about 0.3mm to about: 5mm, and other conventional sise ranges. Examples of commercially available no.nabsoi¼bie and bioabsorbahie polymeric meshes that may be used to construct the hernia repair patches of the present invention include ETH!CON PHYSiOMESH™ and E HICOM PROCEED™ Surgical Mesh, available from Etlucon, Inc., Route 22 West, Somerviile, r i 08876.

When constructing the novel tissue repair patches of the present Invention from, surgical fabrics other than, meshes, the fabrics will have open pores with a pore size sufficient -to effectively provide for tissue ingrowth;, for example, with a typical ske of about 0.3 mm to about 3mm, B "open pores'⁵ is meant openings that extend, from one side of the iabric to the opposed side, providing a pathway through t e fabric. The fabric repasr members ay be constructed from -.ttJoao ments, mu fUameuts, or

combinations thereof Examples of commercially available noa-«iestr fabrks thai can be used to manufacture the hernia repair -patches of the present inveniioa include woven fabrics, textiles and tapes for surgical applications. Other fabrics r materials include perforated condensed ePTFE films and nouwoven fabrics having pore sizes of at. least one millimeter. The non-mesh fabrics ma be constructed of conventional biocompatible materials.

The fabric or mesh may contain, in addition to a long-term stable polymer, a resorbable polymer (i.e., bloabsorhahle or ^'biodegradable). The resorbable and the long- term stable polymer preferably contain monofilaments and/or multifilaments. The terms resorbable polymers and bioabsorbable polymers are used, interchangeably herein . The term, bioabsorbable is defined to have its conventional meaning. Although, not. preferred., the fabric or mesh tissue repair member ma be manu&etrrred f om a bioabsorbable polymer or bioabsorbable polymers without any long-term stable polymers,.

T e tissue repair patches of the present invention may also include polymer films, The films may be attached to the top surface, the bottom surface or both surfaces and may also cover the peripheral edges of the repair patch devices or extend, beyond the periphery of the repair patch devices. The films that are used to manufacture the tissue repair patch implant devices of the present invention will have a thickness that is sufficient to effectively prevent adhesions fro.rn f rming, or otherwise fimctio as tissue barrier or tissue separating structure or membrane. For example, the thicknes may typically range from, about 1 μηι to about 500pm, and preferably ^'from about 5pm to about 50pm., however this will depend upon the Individual characteristics of the selected polymeric films. The films suitable tor use with, the repair patches of the present invention include both bioabsorbable and nonabsorbable films. The films are preferably polymer-based, and may he made from various conventional biocompatible polymers, including bioabsorbable and nonabsorbable polymers, bion- esorbahie or very slowly resorbable substances include poiyalkenes (e.g., polypropylene or polyethylene}, fluorinated poiyoieium (eg., polytetrailu^roethylene or polyvinyiidsue fluoride). polyamldes, polyurethanes, polyisoprenes, polystyrenes, po!ysi!icoaes, polyeaitomates, polyatylethef ketones (PEE s), poiyotethaeryllc acid esters, polyacrylie acid esters, aromatic polyesters, polyimides as well as mixtures and/or co-poiyrners of these substances. Also useful are synthetic bioabsorba le polymer material for example, polyhydroxy acids (e.g., polyteetides, poiygiycolides, poiyhydroxybutyrates, poiyhydroyyvaleriates), poiyeaprolaetones, polydioxarranes, synthetic and. natural oligo- and polyaraipo acids, polyphosphasenes, poly anhydrides, polyerthoesters,

polyphosphates, poiyphosphottates, polyaleohols, polysaccharides, and polyethers. However, naturally occurring materials such, as collagen, gelantm or natural-derived materials such as bioabsorbable Omega 3 fatty acid cross-linked gel films or oxygenated r generated cellulose ORC) can also be used.

The film used in the tissue repair patch, devices -of the_. present invention may cover the entire outer surface of the hernia patch Member or a part thereof. In some eases, it Is beneficial to ve films overkppkg the ^' ord rs -and/or peripherics of the repair patches. The repair patches of the resent invention may also have adhesion barrier layers attached to one or both sides. The adhesion barriers will typically consist of conventional biocompatible poly meric materials including but not limited; to absorbable and nonabsorbable polymers. Examples of conventional, nonabsorbable polymeric materials useful for adhesion bafflers include expanded

polytetratlueroethylene.. polytetTatluoroethyienej silicone, and the like. Examples of conventional absorbable polymeric materials useful tor adhesion barriers include oxidized regenerated cellulose, poligleqaprone 25 (copolymer of glycoiide and epsiion- caproi.actone)_vand the like.

It is particularly pmfered that the tissue repair patches of the present invention have a mesh, construction, and the embodiments illustrated in the Figures have such, a mesh cons ruotion. Th e tissue repair implants o f th e present invention have part i cu lar utility for hernia repair procedures,, but may he used in other tissue repair -surgical procedures as well Referring^' now to FIGS. 1-3, a tissue repair atch II) of the present invention is seem The patch 10 has a ^'mesh, cosstruction. Tile repair patch 10 is seen to have substantially flat or pl nar base member 20 and closure patch m mber 30- Tire base member 20 is diustrared having a sirbstantia!ly oval shape or c «ilgaratio«_s but may have other corrfiguraiions including , q«are, rectangular, circular, polygonal, etc, combinations thereof and fee like. The base member 20 is seen to have top side 22, bottom side 24, and periphery 26, Extending through the base member 20 is the s ot 40 ha ing opening 42 bounded ^'by- opposed sides 44 and opposed ends 43, The closure patch member 30 is seen to be a substantially flat or planar member hav ng a substantially oval configuration. The closure patch member 30 is seen to have top side 32, bottom side 34, and periphery 35. Closure patch member 30 is seen to have opposed curved ends 37 d opposed sides 38. Patch member 30 is mounted to di top of base member 20 via connections 39 along the ends 37 such drat the bottom side 34 of closure patch 30 is adjacent to the top side 22 of base member 20. The closure patch is mounted using any conventional affixation method to create the connections 39, including but act limited sewing, welding, tacking, riveting, s a ling gluing, etc., and the like. The closure patch. 30 is mounted to the base member 20 to cover the slot 40 and openin 42, Openings 48 adjacent to sides 38 provide access passages for surgical mstmments to and through, opening 42 of slot 40. A partial schematic of a surgical tacking instrument 6 which can be used to tack the base member 20 of patch. 10 to tissue is seen in FIG, 3. The histruns.eni. 60 has proximal, handle 62 and isurily extending elongated shaft 70 hav ng distal end 78, A distal section. 7-6 of the shaft: 70 is seen to extend through opening 48, underneath the bottom side 34 of closure flap 30 and through opening 42 of slot 40 such that it is positioned belo w the bottom side 24 of base member 20. The distal end 78 is seen, to be positioned in proximity to the periphery 26 of the base member 20 adjacent to bottom side 24 so that surgical tacks may be fired to secure the patch to tissue adjacent to the top side 22 of base member 20 d the to side 32 of closure patch member 30. The repair patch 1 i fixated around i ts perimeter 26 to tissue with fixation points placed, for exam le, about every I to 2 em, he,, the fixation, devices or tacks are separated by about I cm. t 2 em distances. Although in many embodiments of the tissue or hernia repair patches of the present iaveatioti it i preferred to have a slot in the base member to provide an opening through the bas member, the opening may be a slit or other ty pes of openings having different, geometric configurations may be uti&ed including circular, oval, rectaBgulap polygonal* etc., combinations thereof and the like. Although not preferred, it is possible to f rm the tissue repair patches of the present hivestion such that the base membe aad/ r closure member are curved or otherwise In more than one plane.

Once the tissue repai patch 10 of the present invention has been implanted and secured, to tissue by talking or other conventional methods (e.g., stapling, suturing, etc,), the shaft section 76 of surgical affixation instrument 60 is -removed from the body through the slo 40. The closure patch rnernber 30 prevents underlying tissue or viscera from moving through the slot 40 and opening 42.

An alternative embodiment of the tissue repair patch 10 is seen in FIG. 4. The patch 10 i seen to have similarly shaped base member 20_s however the closure member 50 is seen to have a substantially rectangular shape with opposed minor end sides 56 and opposed majo sides- 57. Closure member 50 has top side 52 and bottom side 54 adjacent to top side 22 of base member 20. The patch member SO is mounted to base member 20 over slot 40 by connections 59 along minor sides 56, The connections may be made as described previously. Openings 4b beneath sides 57 provide access to slot 40 and opening 42. As seen in FIG. 4, the tissue repair patch If) Is seen to have a direction »1 i ndicator 80 contained on or in the closure member 50. Indicator 50 may he

con ventional ly sew n, molded or formed, primed, dyed or lamin at ed tnio or onto the member SO, The indicator 8Θ is seen to have central section S I . having opposed transverse sections 82 extending thercfem. Extending longitudinally in an opposed manner are the longitudinal sections 85 and 87. Section.87 is seen to be thicker than section 85 ,. The indicator 80 allows the surgeon to determine the location of the patch, with respect to the patient after insertion by aligning the respecti ve ax s of the tissue repair patch 10 with respect to the patient and. the incision, allowing for more precise fixation, either using a tackin instran ent or using surgical suture for affixation. Such directional k kate may be used ih other embodiments of di tissue repair patches of the present invention.

Referring: ho w if* FIGS. 5--9, an alternati ve embodiment of tissue repair patch 100 of the ese t invention is seen.. The patch 100 is seen to have substantially flat or planar base member 1 10 formed from substantially flat or planar base sections 120 and 140, The base member 1 1 has bottom side 1 2, top side 1 14 .a» periphery 110, Base section 2 is seen to have straight side 1 2 having ends 124, Base section 320 is also seen to have curv ed side 126 having ends 128 that connect to ends 124. Extending out brom straight side 122 % the closure flap member 130 having hinged side 132 and free end 134 separated from side 122 by slot 136. Slot 136 has closed end 137 and open end 138. The closure flap member 130 is seen to have a generally rectangular configuration, but may h ve other geometric eon%umiens including circular, oval, polygonal, etc., combinations thereof and the like. Base section 140 is seen to haw straight side 142 having ends 144. Base section 140 is also seen, to have curved side .146 havin ends 148 that connect to ends 144, Extending out from, straight sid 142 is the closure flap member 150 having hinged side 152 and free end 154 separated from side 142 by slot 156. Slot 156 has. closed end 157 and. open end 15$. The closure dap member 150 is seen to have generally rectangular configuration, but may have other geometric configurations inclining circular, oval., polygonal, etc;, combinations thereof and the like; The base membe 1 1 and the tissue repair patch 100 are formed From the base sections 120 and 140 by ^'connecting the base sections along straight sides 122 and 142 alon seams 118, This can be done in. any conventional manner inehahng sewing, welding, tacking, stapling, gluing, etc., and combinations ami equivalents thereof It ca be seen thai oniy th e straigh t sides 122 an d 142 are conn ected on either side of the closure flap members 130 and 1.30.. The closure flaps member 130 and 1 SO are mounted together such that hinged side 132 of closure flap .! 30 is contained In slot 156 of flap member 150 and hinged side 15 of closure flap 140 is contained in slot 130 of closure member 1 0, This eneates the slit 160 In base mem er 1 10 having through opening 165 bounded by interior portions of straight sides 122 and 142 of the base sections 120 and 142, respectively, and also bounded by the hiaged sides; 132 and. 152 of the flap members 130 and I 50, respectively. in the at rest position as seen m FIG, 6, tlie flap member 130 rests upon the top side 145 of the base section 140 of base member 1 10, while he flap member 150 rest upon the to side 125 of base section 120. in this at rest coiifig fatioa the slit 160 aod opening 165 are covered, The tissue repair patch 100 i seen in the ready position in FIG, 8, with the closure flap member 130 and 150 in the upright position exposing the slit 160 aod opening so that a fixation iastmrnent ears be inserted through the opening 165, A tacking instrument 170 is illustrated in FIG, 9 with tissue repair patch 1 0 of the present invention. The tacking instnm en .! 70 is seen to have proximal handle 172 and actuation trigger 174, Extending ^'from the distal end 176 of h n le 170 Is the curved shaft ISO ha virtg distal section 182: and distal end 184. The distal section 182 is seen to be inserted, through slit 160 and opening 165 between upwardly extending flaps 130 and 150 such that the distal end 184 may he mo ed about the bodoo ide 112 of the base member 1 10 in order to secure the base member to tissue with surgical tacks. Once tacks are placed through the base member 1.1 of patch 100 to secure the p&teh 100 to tissue, the tacking insmmient 170 may be removed, .from the slit 160 and the two flap members 130 and 150 can be in.terloek.ed by folding or routing the flap members down ardly onto the top 1 4 of the base member 1.10. One or both of the flan members may be optionally bonded or affixed to the base member 1 10 using various conventio al closure methods including adbesives, sutures, surgical Beeeuers, etc.

An alternate embodiment 400 of single plane tissue repair patch of the present invention is seen in FIGS, i 0 and; 1 1. The repair patch 400 has a base member 4.1 having a top side 412 and botto : side 414. The patch has a. periphery 416. Located^' in the base member 410 is a silt 420 baying an. opening 424 hounded by sides 42:2. The sht 420 has ends 428. Mounted about the slit 420 is a surgical suture 430 having ends 432 and 434 and surgical needle 436 mounted to end 432, and optionally, although not shown, to end 434. T he sutu e 430 i mounted about the opening 424 in a conventional mattress suture (continuous) eoxrfignmtion. As seen In PIG. I I , the opening 424 is closed by tensioning the sumrs ends 432 and 434, causing the sides 4.22 to approximate. If desired, the suture: needles 436 can be used to engage tissue with the suture 430. Referring to FIGS. 28 and 29, a variation of suture mounting is illustrated. The repair patch 450 is similar to repair patch 400, but has a rectangularly shaped, bass member 451 hav ng opposed major sides 454 and opposed mister sides 456 connected by rounded comers 457, The base member 45 i has bottom side 451 a d top sid 459, and outer periphery 452, The base member 4 1 has centrally located si it 460 having an opening 464 bounded, by sides 462. The slit 460 has ends 468. Mounted about the sli 46 i a surgical suture 470 having ends 472 and 474, The suture 470 is mounted in a "shoe i ee type configuration. The suture 470 is seen to e motmted to slit 460 by engaging opposed sides 462 of slit 460 about the openin 464.. Suture 470 is seen, to ha e ends 472 and 474 located, adjace t to one another alon on end 468 of slit 460, The slit 460 is secured after placement of the patch 450 by pnillng on ends 472 and 474 thereby closing opening 464, The suture 460 m optionally have surgical needles mounted to one Or both of the ends 4? 2 and 474, The- base members 410 and 45 i may have any suitable geometric configuration.

A -preferred embodiment of a t ssu repair patch 200 of the present inven t ion is seen in F!QS . 12 and 33. The patch 200 is seen to have substantially flat or planar base member 210 having a top 212, bottom 214 and periphery .216. The base member 2,10 is seen to have an oval shape, but may have, other geometric shapes including rectangular, circular, square, polygonal, combinations thereof and the like. Located in the base member 210 is the slot 220 having opening 222 therethrough. Slot 220 is bounded by opposed sides 224 and 225 and curved ends 226. The patch 200 is seen, to have upper closure flap. 230 and lower closure .flap: 240, Upper closure flap 230 is seen, to have a substantially rectangular shape, although it may have other geometric configurations including circular, oval, rectangular, polygonal, etc,,, and the life. Flap 230 is seen to have top side 231 and bottom side 232, The flap 230 also has opposed sides 235 and 236 connected by opposed end sides 237. The flap 230 is mounted to the top side 212 of base member 210 adjacent to side 224 of slot 220 by connecting the flap 230 along its side 235 hi a conventional manner such as sewing, gluing, stapling, welding, riveting a d the like: to create a seam. 239. hi this manner, the flap 230 has its bottom, side 232 facing the top side 212 oi^'hase member 210, and is posiuonsd to cover slot 220 and opening 222 in the at rest position. The closure flap may be rotated upwardly about se m 239 to uncover slot 220 and. opening 222. Moimted -to she bottom side 214 of bas¾ member 210 is the oilier closure flap 240, Fla 240 is seea to have top sid 241 and bottom side 24:2. The flap.240. also has opposed sides 245 and 246 connected by opposed end sides 247. The flap 240 is raoimted to the bottom side 214 of base member 210 adjacent, to side 225 of slot 220 by connecting the flap 240 along its side 245 in a eonveirtional manner such as sewing, gluing, stapling, welding, riveting and the like to create a seam 249, In this maimer, the flap 240 has its to side 241 facing the bottom side 214 of base member 210, and is positioned t cover slot 220 and opening 222 in the: at rest position , The closure flap may be rotated downwardly about seam 249 to uncover slot 220 and opening 222.

T e flap 240 tnay also be rotated upwardly about seam 249 through slot 220 and opening

Referring now to FiOS. 14, 14a, Mb, d 15- 17_> a preferred tissue repair patch 250 of the presen indentio is seen. The patch 250 is similar to patch 200, but is constrected in. a differeni manner from two separate base section members,. The patch 250 is seen to have substantially flat or planar base member 260 formed f om

substantially flat or pl na base sections 270 and 280. The base member 260 has bottom side 264,. top side 202 and: periphery 206. Base section 270 is seen, to have straight side 272 having ends 274. Base section 270 is also seen to have side 276 having carved ends 278 that connect to ends 274. Extending out from straight side 272 is the closure flap member 290 having hinged side 292 and free side 294,_: The closure flap member 290 is seen to; ha ve a genera] !y rectangular configuration., but may have other geometric configurations including, circular, oval,, rectangular, polygonal, etc. and the like. Base section .280 is seen, to ha e straight side 282 having ends 284. Base section 280 is also seen to have side 2S having curved ends 288 that connect to ends 284, Extending out from straight side 2h2 is the closure flap member 500 having hinged side 302 and. free side 304. The closure flap member 300 is seen to have a. generally rectangular config mtion, but ni&y have other geometric coufiguratioirs including circular, oval, rectangular, polygonal, etc,, and the like, l re base member 260 sod the hernia closure patch 250 are formed from the base sections 270 and 280 by connecting the base sections along straight sides: 272 and 282 along seams 268. This can be done in. my conventional maimer Including Sewing., welding, tacking, stapling, gluing, etc., nd combinations and equi alents thereof it can be seen that the straight sides 272 asd 282 are connected on. either side of the closure flap members 290 and 309, thereby creating, a slit 310 be ween the members 290 and 300 having an opening 31.5. The slit 310 is bounded by the hinged, sides 292 and 302 of the closure, flap members 290 and 300 and has opposed .ends 312. Whe assembling the patch 250 nd base member 260, closure flap 290 is inserted through opening 315 in slit 310, In the at rest position as seen in FIGS, 12 and 16, the flap member 300 rests upon die top side of the base section. 270 of base member 260, while the flap member 29Q rest upon the bottom side of base section 280. In the at rest state, closure flaps 290 and 300 each eoveothe slit 310 and opening 315, It will be appreciated that either closure fla may be rotated through the slit 310 and opening 315, although patch 250 as idirstraled shows closure flap member 290 rotated though the slit and resurtg adjacent to the bottom side 204 of base member 260. In addition slit 310 may have other geometric configurations and. shape including a slot, etc.

Referring now to FIGS, 17-22, the repair patch 250 is seen in a ready position for secarement to tissue In a tissue repair procedure such, as a hernia repair procedure. As seen in PIG, 1.7, the patch, has bee placed in a, ready position by rotating fl p 300 upwardly away f m the top 262 of base member 260. flap 290 is also seen to be rotated upwardly through slit 310 and opening 315, By rotating closure flaps 290 and 300 in this manner, the sli 31 and opening 315 are uncovere providing access to a surgical instrumen such as a tacking instrument, o the surgeon.' fingers. A. surgical tacking instrument 320 is seen in f IG. 18 along with tissue repair patch 25 of the prese t invention. The tacking instrument 320 is seen to have prox im al handle 322 ao.d actuatio trigger 324 , Extending from the distal end 326 of handle 322 is the curved shaft 330 having distal section 332 and distal end 334. The distal end section 332 is seen, to be inserted through, slit 310 and opening 315 between upwardly extending closure flaps 290 and 300 such that the dls d end 334 may be moved about the bottom side 264 of the base rnenibsr 260 in order to secure the base member 260 to tissue with surgical tacks. The hernia patch 250 is seen, implanted in a patient lu FIG. 20. A cross-section off s body wall 370 having a surgically c ated opening 372 is seen. ^"Th body wall 370 is seen to have an inner peritoneal layer 374, a nex upper fascia layer 375, a next muscle layer 376, a fat layer 377, and -finally a top dermal layer 378, T e top side 262 of base member 260 is seen to be mounted adjacent to the peritoneal layer 334, with the closure flap members 290 aod 300 exiepdirag out aad through the opening 332. Shaft 330 of tacking instrument 320 is seen Inserted through surgical^' -opening 332, through slit 310 and opening 313 and into the patient's underlying body cavity. The distal end section 332 and distal end 334 are seen to be positioned adjacent to bottom side 26 of base member 260 in order to attach a. section of the base member 260 to the peritoneal layer 374, Referring to FIG. 1-9, the patch 250 is seen, with the flap memb rs 290 and 300 optionally secured along their bottom, sides 302 and 292 respectfully by surgical suture 380 having ends 381 and 382. Surgical needle 388 is attached to suture e d 281 . The- siuured flap members close the opening 315 in slit 10, Alternatively, the flap members ma be joined or secured togethe to close the slu 310 by conventional adhesives. surgical, fastene s, etc. The flap, members 290 and 300 may alternatively be utilised in their at rest position durin im lantation. The shaft of a tacking instrument would be inserted_: beneath flap 300 through slit 10 and opening 313 without rotatin the flaps upwardly. After seenreroeui, the flaps ma be left in the at rest position without additional securement of the flaps. The flap 290 would prevent tissue or visceral rom -moving into slot 310 and opening 315; any pressure against flap 290 a id cause it to seal against the bottom, side 264 of fese-membe 260, closing off si it 3.10.

A. surgical tacking instrument 340 having straight. shaft 350 that, can be used to secure a tissue repair patch of the present inven tion is seen in FIGS. 2.1 and 22. The in rutnent 340 has a proximal handle 342 with, an actuation, trigger 344. Extending from the distal end 346 of ^'handle 340 is the straight shaft 350 having distal section 352 and distal end 354, The distal, end section 352 is seen to be inserted, through alii 310 and opening 315 between upward iy extending closure flaps 290 and 300 such that the distal end 354 may be moved abont the bottom side 264 of the base member 260 in. order to secure the base member 260 to tissue with surgical tacks. The tissue repair patch 2.50 is seen implanted in a patient in FIG. 22. A eross-sect!on of a bod wall 370 having -a surgically created op n ing 372 is seen. The body wail 370 is seen to have an inner peritoneal layer 374, a next upper rascia layer 375, a next muscle layer 376, a fat layer 377, and finally a top dermal layer 378. The top side 262 of base member 260 h seen to be mounted adjacent to the eritoneal layer 374, with the closure flap members 29 and 300 extending out and through the opening 332. Shaft 350 of tacking instrument 350 is seen inserted through surgical opening 372, through slit 310 and ope ing 315 and mt . the patient's underlying body cavity.. The distal end section 352 and distal end 354 are seen to be positioned adjacent to bottom side 264 of base member 260 in order to attach a. section of the base member 260 to the peritoneal, layer 374.

FIGS. 23 and 24 illustrate the implantation of a tissue repair patch 230 of the present invention in a patient during a. surgical procedure to repair a hernia defect. The surgeo Is. seen to be holding the handle 322 of a surgical tacking instrument 320 with one band while engaging the trigger 324, The instrument has a . curved shaft 330,. and the proximal section 332 of shaft 330 has been placed through opening 372 of body wail 370, and through slit 313 and. opening 350 of hernia: repair patch 250, Repair patch 250 has been implanted i the patient's body cavit such that the upper side 262 of base member 260 is adjacent to the peritoneal layer 374. The closure flaps 290 and 300_. have been rotated upwardly to expose slit 310 and opening 315 and extend, out through opening 372 of body wall. 370 so that the extend, partially above dermal layer 378. The patient's ^"viscera 379 are seen to be adjacent to the bottom side 264 of base member 260, Shaft 330 of tacking instnnnem 320 is seen, inserted through surgical opening 372» through slit 310 and opening 15 and into the patient's underlying body cavity. The distal end section 332 and distal end 334 are seen to be ositioned adjacent to bottom, side 264 of base mem er 260 m order to attach, a section, of th e base member 260 to the peritoneal layer 374. The surgeon' s other hand is seen, to he palpating the patient's body wall 370 above the distal end 334 in order to locate the position of a- ack prior to delivering it by actuating trigger 324, Referring to FIG . 26, after implantation of the patch 250 and securentent with tacks 380, the bottom side 264 of base, member 260 may have, two concentric crowns of tacks 332 and 384 to secure the patch 25(5 to the peritoneal layer 374, Another embodiment, of a tissue repair patch of the present invention is; seen is¾ FfOS. 25 A 26. The repair patch 500 is seen to have substantially flat base Member 510 having top side 512 and ^"bottom side 514. Base member S 1 0 is se n to have circular opening 520 bounded by periphery 522. Closure mg 530 is seen to be mourned about periphery 522 of circular opening 520, The. patch 500 also closure pateb 540 having top side 542 and bottom side 544. Mounted to the bottom side 544 of patch 540 is mating closure ring 548. ating closure ring 54B is removcabiy eogageable with closure ring 530, When used in a surgical procedure, the surgeon removes the closure patch 540 from ase member 510 thereby exposing opening 5:20, Th base member 5 0 is then, implanted in a body cavity of a patient such that the to side 512 of base member 510 is adjacent to the inner layer of the body cavity such as the peritoneum. The sargeon then inserts a distal, section of the shaft of an attachment instrument such as a surgical lacker through opening 520 into the body cavity below bottom side 514 of the base member 510. After the base member 510 has been secured, to the inner layer of tissue and. the shaft of the seeuremcnt instrument has been removed, the surgeon mount the closure patch 540 to. the top side S 12 of the base member 510 such that the mating closure ring .548 and the closure ring 530 are engaged.

Referring to FIGS. .31 -41 , -additional embodiments of a tissue repair patch 600 of the esent inventio Illustrated. As seen. in. FIGS . 31. -34, the tissue repair patch 600 is seen to have a base member 610 having a top side 612 and a botto side 614. The patch has a periphery 616 and a peripheral edge 618. Located, in the base member 610 is a centrally located slo or sl.it 620 having an. opening 624 bounded by sides 622. The silt 620 has ends 628. If desired, the slit or slot 620 may be located such that it is offset from center, The base member 610 is illustrated having a substantially ova! shape or configuration, hut may have other configurations including square, rectangular, circular, polygonal, e c, combinations thereof and the like. Although it is preferred that the base member 610 be substaniiahy flat, it may he shaped, for exam le, curved, etc, Mounted to the bottom side 614 of base member 410 is the. ocating structure 650, ^'the structure 650 is seen to he a ring-like structure with a. top surface 652 and bottom surface 654. As illustrated, the top surface is substantially flat and the top surface has a. rounded coafigumtioft, such thai the cross-se t a Is D-shaped, However, it will he appreciated that the emss-seetion of the locating structure may have a variety of cross-sectional shapes, including but not limited to, circular oval, square, rectangular, polygonal, straight sections aed curved sections, combinations thereof and the like. The structure 650 will have a shape that generally, conforms to the periphery of the base member 610, for example, circular, oval, rectangular, sq are, polygonal, curved sides, straight sides, and combinations thereof The structure 65 has outer edge 55, inner edge 656 and central opening 657, although if desired, although not preferred, central opening 657 may be eliminated. The locating structures 650 may be made from biocompatible polymers and. bioabsor able polymers as described herein above, but it is particularly refe red to make the structures 650 from bioabsorable _.polymers. The structures 650 may be manufactured using conventional manufacturing processes, including injection, molding., machining, three-dimensional ink jet printing, solutio casting, extrusion, composite lamination, and. the like. The locating structures 650 may he attached to the base members 610 in variety of conventional manners, including gluing, welding, sewing, fastening with mechanical fns eners, co-molding, the use of hot platens or presses, thermofbrming, etc. In one em diment as described below, the struc ures 650 may be molded or formed into the base member 610.

.Referring now to FIG. 33., the tissue repai patch 600 is seen to be implanted In patient below a hernia defect 700 in a body wall 710. Surgically created opening 15 i contained in body wall 710 above the hernia defect 700, The bottom side 614 of the base member 61. is seen to be facing the patient's viscera, while the top side 612 of the base member 610 is adjacent to the interior side 7.12 of body wall 710. The device 600 is secured to the bod wal l 700 in a conventional, manner by surgical fasteners sueh. as surgical acks, etc. The tacks or fasteners are applied by inserting a distal section 815 of a shaft 810 of a. surgical tacking instrument 800 into opening 640 and locating the periphery 616 of the base member 61.0 with the distal tip 818 of the distal section 815 of the shaft 810, The periphery 616 is conveniently and: -accurately located by the surgeon moving the distal, end section 81.5 of the shaft 810 such that the tip 818 contacts or is proximate to the locating structure 650, Then, lacks or other securement or festening devices are fired through the base member 630 mio the body wall 710 about the satire periphery 616 of base member 610 by rnovmg and manipulating the tip 8. 8 about the beating structure 650. The locating structure 650 assists th surgeon in -finding and keahng the periphery 616 of the base member 610 for proper placement of the tacks or other secufemem or fastening ..devices. The: opening 624 in slit or slot 620 is secured and closed with an appropriate closure member as described herein above, such a sutures.

Referring now to FIGS. 35 and 36, an embodiment of a tissue repair patch .device 600 of the present invention havi ng locating structure 650 -with a textured top surface 660 is seen. The device 600 is seen to be .mounted adjacent to the bottom side of a body wall 710 beneath a heraia defect 700, The structure 650 is seen to have a bottom surface 660 that is textured, As shown, the surface 660 has a plurality of peaked ridges 662 extending up from surface 660, and haying bases 664 and peaks 667, The ridges 662 are seen to have a rectangular eross-seclion. The ridges may also be rounded and have other geometric cross-sections including square, rectangular, ovah semicircular, etc. Although not shown, the textured surface may be textured by grooves or other indentations, or by a combination of grooves or indentations and projections. The distal tip 818 of the distal section. SIS of sha.fr 8.10 of tacking or seeu ement insim em 00 is seen, to he located in. contact with textured surface 660 in position to fire tacks through base member 61 into body wall. 710.

A n. embodiment of an embodiment of tissue repair a tch device 600 of the present invention having locating structure 650 with a downwardly extending flange configuration is seen in FIGS, 37-41. Referring first to FIGS. 37, 38 and 39, the tissue repair patch device 600 is seen to have locating structure h50 in the form of a downwardly extending f lange member 670 that is made by molding or otherwise Forming part of the periphery 6.16 of base member 616. The flange member 670 is seen to have bottom, edge 672, inner side 674, outer side 676 and top 678, The flange member has a curved cross-section, but ma have other configurations and cross-sections includin straight and angled. The device 600 when emplaced adjacent, to a patient's bod wall 710 on the interior surface 712 as shown, is secured by manipulating the distal tip BIB of the distal eikm lS of shaft giO of the instrument 800 such mat the tip 818 is proximal to or touching the inner side 674 of flange member 670. As seen in. FIG, 39, the locating structure 650 may consist of a separate flange member 680 having top 682, bottom 684, inner side 6$6 and outer side 688. The to 12 ©flange member 680 ma be moonted to the periphery 616 or peripheral edge 618 of base member 610 in a conventional manner such as by gluing, welding, sewing, fastening, co-molding, etc. Th device 600 having flange member 680 is seen to be uiilked and implanted in a patient to repair a tiss e defect as previously described above.

Yet another embodiment of the tissue repair member 600 having a locating structure 650 with a downwardly extending flange structure is seen in FIGS. 40 and 41. The structure 690 is seen to consist of a. ring or peripheral element 691 and a downwardly extending flange section 695. The peripheral element 691 is seen to have top side 602, bottom side 693 and outer side 694. The downwardly extending; flange sectio 695 ^'has top 696, bottom 697, inner side 608, and outer side 699. The structure 690 may be mounted such that the bottom side 693 of peripheral element is on the to side 612 of bas member 614 adjacent to or on the periphery 616 and the peripheral edge 18 is co vered, or the structure 690 may be mounted such that the top s ide 692 of peripheral element 691 Is on the bottom side 614 of base member 614 adjacent to or on the periphery 616, The device 600 having structur 690 is seen to be ^'utilized and implanted in. a patient to repair a tissue defect as previously described above.

The repair palehes the present invention: may o tionally contain or be ce-ated ith sufficiently effective amounts of a active agent such as a therapeutic agent.. Substances which are suitable as active agents include conventional agent that may be naturally occurring or synthetic and may include hut are not limited to, for example, antibiotics, antimicrobials, antibaeterials, antiseptics., chemotherapeutics, cytostatics, meta tasis inhibitors, antideabetics, antimywhes, gynaecological, agents, uroiogiea! agents, anti-allergie agents, sexual hormones, sexu l hormone inhibitors, haemostypti.es, hormones, peptidc4¾nnones, antidepressants, vitamin such as Vitamin. C, antft.isianii.nes, naked. MA, pksmid D A, eationic DMA complexes, RNA, ceil constituents, vaccines, md cells ceisrriag naturally In the body or genetically mo fied ceils, la oae embodiment, the active agents may be antibiotics including such agents as gentamicui or ZEVTERA™ (cei obiproie medocarii) brand tibbtic {available .from Basi!e Pharo^eeutica Ltd., Basel Switzerland). In one embodiment, an implant may include broadband antimicrobi l used against different bacteria and. yeast {even in the presence of bodily !iqidds) sueii as octenidine, oetenidins dibydrochlon.de {available as active ingredient Octenisepi® dmafeetaoi from Sckdke & Mayr, orderstedt, Germany m poiybcxatnetbykne bignanide (PHMB) {available as active ingredient in LavasepfS from Braon, S iizeilandl itielosan, copper (Co), silver (Ag), nanosi!ver, gold {Ais), selenium (Se), gallium teed antiseptics such as Listerlne® mouthwash, a aur l--L>arginine ethyl ester (LABt myristamidoprop l diraethylarntne (MAPD, available as m active ingredient in S€HE¾€OD E^1M ), olea idopropy! dtnteihyl&mi e (OAPD, avail able as an active ingredien t in SCHERDDDI E^ 01 and stearamidopropyl dlmethyl&mine {SAPD, available as an active ingredient in SCHERCO^'DtNE^ S). In one embodimen tbe agen may be octenidine dihydrochfond (hereinafter^■referred to as oeiemdme and¾r PHMB,

Although it is p eferred to have a single, centrally located opening in. the hernia repair patch devices of the pres nt invention, the opening and associated, closure member m ay be offset from th center. Additionally, mo e than one opening and closure member may be nil Sized in the^■ hernia repair devices of the present invention.

Tbe following examples are illustrative of the principles and practice of the present invention:, although not limited thereto,.

A patient w t a ventral or ioeki nal hernia is prepared ^'.for an open ^'h x repair procedure in the following manner. The skin area surftmn iiig the hernia is Grabbed with a co:ave» io«al antimicrobial solution such, as feetadine. The patient ¼ administered conventional general anesthesia in a conventioual maimer by induction .and. inhalation. The surgeon then initiates the su g cal procedure by making an incision in the skin and subcutaneous tissue^■overlying: the hernia.. In the case ofp!anned inira-pcritoneal mesh placement, the hernia sac s opened . The edges of the healthy fascia around the defect are exami ned, and any attachments of the viscera to the abdominal wall are di vided to create a .fee space for fixation of the mesh.

At this point in the procedure, the surgeon then prepares a mesh tissue repair hernia patch of the present invention having a locating structure, and having closure flaps and base member for insertion through the abdominal, wail defect and into the abdominal cavity such that the top side of the mesh is adjacent to die peritoneum surrounding the defect, and. the bottom side of the mesh device is feeing down toward the patient's viscera. Stay sutures^' m y be placed through the mesh info the abdominal tissue as desired, i.e. at the four compass points of the mesh. (North, -South, Eas , West). The .flaps are rotated upwardly a fter placement to expose the opening in the base memb r of the mesh. The mesh is ^'fixated with a conventional -surgical taeker instrument or other means; of fixation. A lacker is inserted, through the opening such that the distal end of the lacker is between the mesh, and the viscera, and the surgeon locates the periphery of the repair patch by engaging the locating structure with the dp of the shaft of the taeke instrument. The perimeter of the mesh is then fixated osing a plurality of tacks in a crown configuration. The taeker is removed and the opening in the- mesh, is closed by folding the flaps as appropriate for the present in vention. The baps ma be optionally secured using adhesive, ^'suture,- ri vets, or other closure means, or may be returne -to their at rest position without securement to each other. The hernia defect may be primarily closed if desired, The skin incision is closed using appropriate suturing or closure techniques, and the incision is appropriately bandaged and the patient is moved -to a recovery room. The novel hernia repair de vices of the present kvention have mrmeroiss advantages. The no vei repair patch devices provide a. single layer mesh repair device that can be affixed via tacking in an open, intraperitoneal, hernia repair procedure. The repair patch devices have-additional advantages including less foreign material (Le., lower mass of foreign material) and the ability to implants single layer tissue repair mesh In open procedures. The tissue repair devices of the present invention, preferably made from mesh, may potentially accelerate the rate o tissue integration, provide less area, for hiofilm -formation, have a lower cost of ma ufacture and are easier to package, sterilize, and use with improved.ergonomi.es.

Althoug this invention has been shows and described with respect to detailed embodiments thereof, it will be understood by those skilled In the art that various changes in. form and detail thereof may be made without departing from the spirit and scope of the claimed invention.

Claims

Oaiois

We claim;

I , A. t ssu .repair patch, comprising: a substantially flat base membe having a top side and a bottom side and a periphery; locati ng structure is posi tioned adjaetefti to the periphery of the base member on the bottom side; m opening located in said base memberauch that the pocket is accessible through said opening; aad, a closure member associated with said opening,

2.. The tissue repair patch of claim 1 , additionally comprising a poly mcrie layer on at least one side of the base member.

3, The tissue repair patch of claim i , additionally comprising . adhesion barrier o at least one side of the base member.

4, The patch of claim 1 , wherein the; base member comprises a mesh.

5, The patch of claim j , wherein, the base member comprises & ftsbrie,

6, The patch of claim 5 wherein the fabric s woven ,

7, The patch of claim 5 wherein the fabrie is eonwovem

8 , The p&ieh of claim , wherein the base member camprises an expanded polymeric film,

9, The patch of claim. \ , wherein the base member comprises a biocompatible, nondegmdable polymer. s 10. The -patch, of da-im. 1, wherein the ase member comprises a hioabsorhahle polymer.

1 5 . The patch of claim ? wherein the nondegradahle polymer is selected irom the group^■consisting of polypropylene, polyester, nyio and ultra high molecular weight -polyethylene.. 0 12. The patch of claim 10, wherein the bloabsorbable polymer is selected from the group consisting of poiylaeiides, polyglycolides, poiydioxanones, polycaprolaetorses, copolymers of glycoHde and (rimethyleae^' carbonate, and copolymers of iactide-s and trimethyiene carbonate, and copolymers and blends thereof

13. The patch of claim j , wherein the base rnentber ecrrnptises a bioconiparible

S nondeg dable polymer and a hioabsorbable polymer,

14. The patch of claim 1 , wherein the opening is a slii.

.! S . The patch of claim 1 wherein the opening circular.

16. The patch of claim .1 , wherein, the opening is slot shaped.

17. The t ssu repair patch, of claim 1, wherein the closure member comprises0 opposed closure flap members hingingt mounted abou the opening,

18. Th tissue repair patch, of claim 1 , wherein the closure member comprises a tch kwm .an outer periphery, wherein, a sect on, of the peripher is mounted to the top side of the base member about the openin g, i , Th e tissue repair patch o f el a im ! , wh erein, the closure member comprises a5 surgical suture mounted about the opening.

20. The tissue repair patch of claim 1 , wherein, the closure member comprises a patch haying a top side and. a bottom side with an. engagement member extending from the bottom, side, and wherein the base member has a mating engagement mernber mounted t the top side about Ihe opening, such that the closure patch may be engaged, and

0 disengaged from the base member. s 21. The t ssu repair patch of claim I , wtietein the opening comprises a slit having opposed sid s and the closure member comprises a surgical suture threaded about the slit adjacent to the Sides.

22. The tissu repair patch of claim. .17, wherein the flaps have free end sections separated from the base member by slots, such that each closure flap member may be0 engaged in. the slot of a opposed flap member.

23. The patch of claim 1„ wherein the opening is ceotraby located.

24. The patch of claim 1, comprising at least two openings sod closure members.

25. The patch of claim 2. wherein the polymer film, comprises a nonabsorbable polymer: S 26. The patch of claim 2, wherein the polyme fil comprises a hioabsorhable

polymer:

27. The patch of claim 25. wherein the polymer is selected from the group consisting of silicone, PTFE, polyester, and polypropylene,

28. The patch of claim 26, wherein the bioabsarbahie polymer s selected from the0 grou consisting of oxidized regenerated cellulose, polydioxanone, poiigleeaprone 25

(copolymer of glyeoiide and epsilon-caprolactono) and combinations thereof

29. The patch of claim. 2, wherein, the polymer film is an adhesion barrier.

30. The patch of claim 3. wherein the adhesion hairie comprises a polymer selected from the group consisting of group consisting of oxidized, regenerated cellulose,5 polydioxanone, poliglecapmno 2$ (copolymer of glyeoiide and epsilon-caprolacione) and coniMuaiions thereof

31 . The. patch of claim 3, wherei the adhesion, harrier comprises a polymer selected fern the group consisting of silicone* PTFE, and ePTFE.

32. The patch of claim 1, wherein the locating staicture additionally comprises a downwardly extending flange member.

33. The patch of claim 1, wherein the locating structure is an engagement ring member.

34. The patch of claim 1, wherein the locating structure additionally comprises a textured surface.

35. The patch of) claim 1, wherein the locating structure comprises a bioafjsorbable polymer.

36. The patch of claim 35, wherein the bioabsorbable polymer is selected from the group consisting of oxidized regenerated cellulose, polydioxanone, poliglecaprone 25 (copolymer of giycolide and epsilon-capro Lactone), polylactide, polyglycolide and copolymers and combinations thereof.

37. The patch of claim 1 , wherein the locating structure is formed into the periphery of the base member.

38. The patch of claim 37, wherein the locating structure is a downwardly extending flange member.

39. The patch of claim 33, wherein the ring member has a D-shaped cross-section.

40. A method of performing a body wall defect repair, comprising the steps of:

A . inserting a tissue repair patch on an inside layer of a body wall having a tissue defect, wherein the repair patch comprises: a substantially flat base member having a top side and a bottom side and a periphery; a locating structure positioned adjacent to the periphery of the base member on the bottom side; m opening located in said base member; nd, a cl s re m&rai er associated wi h said opening;

B, os tioning the patch about the defect such that the top side of the base .member is adjacent to t e inside layer of the body wail;

^■C. ins rting the end of a s urgical fixation instrument through the opening to access me bottom side of the base .member to the beating structure, and fkathig t he base member to the inside layer of the body wal l;: and,

D, manipulachig the closure member to close off the opening,

41 , The method of claim 40, wherein fise tissue repair patch additionally comprises & polymeric layer on at least one side of said base member,

42, The method of claim 40, wherein the tissue defect is a hernia,