CA2906349A1 - Single plane tissue repair patch having a locating structure - Google Patents

Abstract

A tissue rapir patch is disclosed having a base member (610) with an opening (620) therethrough, and a closure member (not shown) associated with the opening. Mounted to the periphery of the bottom side of the base member is a locating structure (670). In the preferred embodiment the base member comprises a mesh and may be used in open surgical procedures for hernia repairs and other repairs of body wall defects.

Description

2 PCT/US2014/020071 SINCLE :PLANE TISSUE 'REPAIR :PATCH HAVING A I,OCATING
STRUCTURE
Reference to Related Applications This is a continuation-inpart of co-pending commonly assigned US, Patent Application Serial No. 13/443,3.-V filed on April 1.0, 2012, Which is -incorporated hy 1.0 reference.
Technical Field Thefield of art to which this invention pertainsis :implantable surgical tissue repair pat:du* Moreparticularly implantable surgical mesh. hernia patches for iise in hernia repair procedures.
BaClitlround of the invention :Hernia -repair is a relatively straightfOrward.surgical. procedure, the ultimate goal of WWI is to reStom the mechanical. integrity of the:ztbdaminal :wall by repairinga musclo defect-thiough which the peritoneum and possibly a -section of the-underlying -viscera has protruded. There are various typesolhernias, each with its own -20 specific .surgicai repitifprocedure, 'including ventral hernias, ntI1caI herniaS, incisional hernias, sports hernias, &moral 'hennas, and inguinal hernias. It is 'believed. that most herniaS are attributable to a weaknem in sections athe times of the abdominal wall.
Precipitating -events, such as unusualmovements or lifting extremely heavy weights,..rnay cause the 44,va1c. spot. in the abdominal wail:tissue to. be eKcessively .25 stressed, resulting ìn tissueseparation or rupture and-protmion of-a section of peritoneum and underlying visetitas eg.. inteAine,, through th6 separated or ruptured time. section. This weak-new, may be attributableto several factors. Weaknem ín ttìc -abdomitad wall may be cong,enital or may beaSsociated with a prior incision from a surgical procedure or a trocar. wound.. Other factors rnay include trauma genetic 30 predisposition, and aging.

5- Even though the eommonly used, conventional surgical procedures for correcting ortepaiting the various types of hernias.are Somewhat specific, there- is a commonality with respect to the niechanical repair. Typically, the protrusion of the peritoneum throngh a MIMIC or abdominal wall defect results in abernia sack containing the underlyingand protruding viscera, be hernia sack is dissected -and the viscera. are 1.0 pushed back into the abdominal -cavity. Then, a tissue minforcirtg:or repair implant such amesh path device is typically lanted arid -secured at the. site-of the abdominal wall defect. Autologous tissue quidkly is into the mesh implant, .providing the patient wit-ha secure and strong repair. In certain patient presentations, itotay be desirable to suture or otherwise close the defect without .an implantõ although. dna is typically tnuch 15 less desirable for the optimal outcome.
One,- common type of hernia is a ventral berni* This- type of hernia typically occurs in the abdominal -small and may be caused by a prior -incision or puncture-, orby an arOg of tissue- weakness-that is,- gressed. Them are several repair procedures that can be employed by the surgeon to treat such hernias, depen.ding upon the individual 20 characteristics of the patientand the name of the hernia, hi one technique, an Way mesh is.implanted onthe dorsal surface. of the anterior fascia of the abdornin.al wall.
Another tethnique provides -for an inlay .mesh, where the prosthetic material is sutured to the abdominal wall and..actS is a "bride to. close:the abdominal defect.
.Placement ola.
prosthetiomesh posteriorto the metus -muscle of the -abdominal wall is known as the Reeves Stoppa Or retrotriuseular technique. In this technique, a meshimplant iS located beneath the muscle of the abdominal wall but above the:mone:um. Implantation of the mesh in the intratperitoneal. location can. be-done via an -open or laparoscopic approach.
The mesh is insert&I into the patient'sabdominal -cavity thrOughati open anterior incision or via a trocar and positioned to cover the defect. Theaurgeon then fixates the mesh 30 implant-to the abdominal wall -with eonventimal mechanical fixation or with statues placed through the. full.thickness of the abdominal wall There :are a variety of such rrtceharticalfiXation devices that Call.be used in laparoseopic. or open surgery, e,gõ
tacking instruments, lntraperitoneal placem.ent of mesh via an open approach may -be the desired technique of repair where the layers ofthe abdominal wall-are attenuated and a.

5- laparoscopic approach. is not desired. Placement of MOSII via -this technique presents several unique challenges including-pootviMbility duringonesh handling and.
fixation, poor handling, and -deficient ergonomics of the currently -available products.
Mesh repair patch implants desi,gned for intraperitoneal placement typically requires an.additional treatment. or layer to function as a. tissue separating compotient.tosetvrate -the viscera from the .prosthetie abdominal wkIll repair layer, and thereby prevent or substantially inhibit the formation of post-operative adhesions. -Ile 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 be associated veith their use. 11e- deficiencies include- difficulty inhandling the mesh, poor visibility during mesh handling, implantation and fixation, poor usability and. ergoriornics when. using alaparoscopie instrument, and the. use of dual or multiple layers of-mesh.. The commercially available meshes repair patch -implants tbr this- application typically h.ave at least dual. layers -of rnesh. or fabric with poCkets or skirts.
to-provide for affixation to the parietal -wall via the top layer or skirt..
It can also be :240 appreciated .that multiple layer meshes introduce more foreign body rriaSs and te.nd to be more expensive and complicated. to manufacture than a single layer.mesh.
implant.
Another deficiency associated with. hernia. repair patch-implants is-the ease of locating the periphery of the patches so that surgeon may affix the patch to ti.ssue by emplacirtg tacks or other fitsteners to properly secure the implants to. tissue in the appropriate -25 Manner.
Accordingly, there is a need in this art for novel 11,8,110 repair. implarns, S11C11 ask.elitrat- hernia repair patch implants; that .can be- used in an open surgical procedure, and -which do not .require a mesh. anchoring ar affixation layer;
and 'which may be secured to tissue using a 'single o.r multiple crown technique. There is alsou need for 30 ti%1.1e repair implants which- facilitate the location ofthe .peripheries of such implants by the surgeon.

3 Summary a the Invention Accordingly, nov:el..tissue repair-patches. a:re disclosed. The tissue. repair patches have asubstantially flat or .t)lanarbase member. The kik, member ikrirefbrably a 1.11eth.
There is an opening located in thebase member, and, thcre, is a closure member associated with the opening. The base member has a top side and a bottom side, and an outer periphery aid a peripheral edge.. Mounted to the bottom of the base member adjacent.to. or on the periphery of the-b.ase member is: a. locating 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 at least part 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 substa.ntially all of that side. The tissue repair patches of the :present invention are. especially tiseful in an open hernia:repair procedure, such as aventral hernia repair, and. are. also useftil in-other types of body wall tissue repairs:
Another aspect. of the present invention is.- a method.Of repairin a body wall .20 defect,- such as a:hernia defect,:in an open surgical procedure using.the a.bove-described tissue repair patch ithplants-, These and other aspects and-adVantages ofthe present inVention will betorne mom apparent frorn the follovving:description and accompanyin.g drawing prief Description of the Dramiitm FIG. I is a plan. vicw of ait embodiment of a single plane ti&suerepair mesh patch o:f the present: invention; the patch has -a 'base meMber having an o.petting, and a. closure patch -camber mounted:to the top side attic. base -member over the Nang.
Fl....is an exploded perspective view ofthe :repair trieSh patch of FIG, 1.
30 .FIG. 3. is an illusMation showing a surgical tacldrig instrument having an.
elongated .sbaft partially inserted undemeath the flap member and through the opening of

4

5- the 'base, member of -the repair pat& of Hal; the instrument shall is seen as-having access to the bottom Side of the base nietnbcr..
NG, 4- is a plan view of a time repair patch of thepresent inVention that is similar to the repair patch shown in Fki. I, but which i1t13 a rectangular closure patch member connected along its opposed Minor sides;. the clown: patch member is seen to contain a dimtionguide for use. by the surgeon in:orienting the patch dating implantation.
'RC 5 is. an exploded perspective view illustrating two halves. of another embodiment of a tissue repair patch atilt?, pment invention; the two halves ate connected to -fonn a repair mesh patch having closure flaps, FIG, 6 isa plan view of a tsierepair- patch of the present invention made by ning the two halves seen in Fla 5; the flaps- are in the at rest position.
FIG, 7 is a perspective view -of the tissue repair patch of FIG, 6; the as are in the at rest pt3sition.
Ha 8 is a perspective view of the tissue repair patch of FIG.? showing both of the flaps .in the. up pcKsition, 411cQVcring the.opening ix the:base. member thereby ptvviding access through the base-member, .FIG.. 9 illustrates the tissue repair patch of FIG. 8 with :a curved shaft of a surgical %eking instrumentinscrted partially through the opening .of the base member.
FIG, 10 is a plan view of another embodiment of.a ti stierepair patch of the .25 present invention;The mesh patch is seen to have an opening with a surgical suture and surgical needle mounted about the opening: in a 'continuous mattress suture cotfiguration..
PLtI 1.1. illustrates the. tissue repair patch of FIG, wherein the opening has been closed by applying tension. to :the sutureafter theputch .has been affixed to the parietal wall of -the patient over did- hbrnia defect, 5- FIG. 12 is an exploded perspective view eat:I-other preferred embodiment of a tissue repair patch of the present inVetition.; the, patch is seen to .have an -upper olosure flap-and a lower closure flap nmunted about an. opening in the base mentber:
Ha 1-3 is a .plai . view of th.e tissue repair mesh. of FIG. 13, showing the elosure flaps mounted bout the opening in the base member -with one closure flap acijacent to the la bottom site of the base Member and oneclosure fly adjacent to the top side of the base member; the flaps: atv in an at rest position.
FIG. 14 is a plan view of a preferred embodiment of a tissue repair patch of the present :invention; the patch is seen to have a -pair-of closure flap members.
FIG: 14a .is across-sectional view of the repair patch of FIG. :12 along View Line 15 14a-14a, FIG, 141 is a magnified partial viel,v Utile cross-section of MG.
12a.i1luStrating the flaps posi timed-about the opening -in the base member of the patch.
.FIG 1-5 is an -exploded perspctctive view of two base member halves ofthe tissue repair patch of FIG. 121; both halves have a closure flap member extending from the base 20 member sections.
FIG. 1.6 is a perspective _view of the tissue repair patch Made by joining Wgether the two halves seen in _FIG..15; one closure flap is positioned below the base member and.
met-Imre:nap is positioned above. the base member.
FIG, 17 is aperspective view of the tissue repair Inoh patch of FIG. 16. both.
.25 closureflaps are in thenp position such-that the openingin the base-member:is accessible between the flaps.
FIG. .18 is a perspective- view of.the mesh repair patch ofFIG. 17, illustrating the distai end of a curved elongated shaft of a surgic.al tacking instrum.ent -partially inserted through the opening of the base member-in a positionblw the pat& to secure the Mesh 30 repair patch to tissue.

6 5- FIG. 1.9 isa /1mila-five view of the tissue tepair patch of FICI, 1-8, with both flaps optionallysutured tog-ether hi an upward extending position to close the opening in the base member after the -patch has been atiixed-to tissue.
.PG. 20 is a cross-sectional side view of the tissue repair patch of MG. I
t":i. inserted into the abdominal cavity of a patient and. .positioned adjacent to. the patient's peritoneum;
1.0 a curved shaft of a surgical tacking instrument is.seen inserted thorough- an access opening such as a hernia defect in the .patienes.bo.dy wall and through the openingin 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 menther of the patch with .a tack to the body walt.
.2.1 is kperspective view of the mesh -repair patch of Fla 17, illustrating the 1.5 distal end of a straight elongated shaft of a sumical tae.king instrument partially inserted through the opening ofthe base member in a position-to Secure thetissue -repair patch to tis,sue, HQ, 22 is a side view of the tissue-repair patch of FIG. 21 inserted into the abdominai cavity of a patient and positioned adjacent to the patient's peritoneum; a distal 20 section ofa straight shaft of a surgical tacking instrument is. seen ed-thorough an accem opening in the patient's body .wall- and through the opening: in the.base merriber of the repair patch, such that the distal end of the shaft- isitt -position WOW
the patch to secure a section Orthe 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 .25 securing the tissue repair patch of FIG. 17 in position over a hernia defect using a surgical tacking instillment having a curved elongated Shaft; the distal section of the thaft is insetted thmugh .an access opening in thepatient's body wall and through an -opening in the tissue repair patch ìn order to -secure the tisime patch to the peritoneum; the surgeon's hand is seen palpating the abdomen above the distal -end of the.
shaft of the 3 instrument to place a tack in adesired -position on the patch, is a. cross-sectional side.view illustrating a-preferred embodiment of-a tissue repair patch of the present invention in 01-al:cover a hernia defect adjacent to a

7 5- patient's peritoneum; a curved elongated shaft ola surgical tacking :instrument h.as been positioned tinvagh an access opening it the patient's body wafl and through an opening in the patch to attach a section of the base member of:the patch to the peritoneum; the patient's visceral organs are seen .positioned adjacent. to the bottom side of the patch and the peritoneum, ad the closure- flaps an seen to exten.d. Upwardly through the-opening in the body wall.
FIG. 25 is an exploded :perspective view of an alternatt. embodiment of a mesh tis.sue repair path of thepresent invention; the base member is seen to have an opening-in the base member surrounded by a closure ring,. and a closure patch haying a mating.
closure ring is also: &bon.
MO, 26 is a peispective view of the tissue repair pateh of FIG. 25 -showing the:
patch secumd to the base member.
Fla 27 illuStrates A Oritoneal view of the hnttorn side of apreferredeinbodiment ofa tissue repair path of the present invention secured to the peritoneum with a double tow of surgical :tacks referred to as a double crown technique; the opening in the base mernber is seen to- be closed, and both flaps have been positioned upwardly away 'from the top of the. base member; the flarg4 are smured to closefthe- opening in the base mother:
FIG. 28 is a perspective view of an alternate enibodiment oft mesh :tissue repair patch of the present invention; the-patch is seen -to have a slit in the base member .25 providing a central opening.;
.FIG, 29 is a perspectiv.e view Ofth.e patch of FIG, 28 :haying a surgical suture mounted about- the slit in a shoe lace :type configuration to-close the tIpcning in the slit.
FIG. 'MI is a.petspective view of th.e tissue repair patch of FIG. 29 after the suture ends have:heen tensionekthereby closing the: opening and slit after the patch is secured 30 to the .patticnt's body wall.

8 5- FIG. 31 is a. cro.wsectional view of a tissw repair patch of the present invention having a locating structure- positioned on the bottom of the base metriberon the periphery. The tissue repair patch is shown :located adjacent to a body wall below a hernia d.a&ct, A surgical tacking instrument is -shown with the-distal end. of its. shaft:
positioned pioxlinal to .viscenti side of the body wall with the shaft: tip adjacent to the locating structutv and in -a position to firetacks through the base -member into the body wall. The !peeing structure is ìrt the- form of a ring.
Mi.. 32 is a -perspective view of the tissue repair patch of FIG. 31 looking up from a direction below the patch.
FIG. 33 is aperspective view olthe tissue repair patch of FIG..31 showing tbe bottom of the mair patch and tissue repair -structure.
FIG. 3-4 is a partial magnified. side view of the -repair patch of Fla 31 showing the.
tip of thettteking insimment Shaft adjacent to the locating striicture.
FIG. .35 is cross-sectional view ofall Crlikv4inicut of a -tissue repair patch of the.
present illVention having; a locating structure; the structure is seen. to have a. textured surface, The patch is it position to be affixed to-repair -a body wall defect using a surgical tacking instrument.
FIG. 36 is a partial. magnified -view. ofthe -pawh MG.
36.A-towing, the tip of the sìtafL of the surgical tacking instrument -engaging the textured surfitce.
oldie locating structure.
-.25 Ha 37 is a moss=-axtional. viewi-of art erribodiment of a tissue repair patch of the present invention having a locating structure; the structure is seen to-have a downwattly extending flange -member formed from the periphery of the base member. The patch is in twition to be affixed to repair a. body wall &Act .using a surgical tacking instrument.
FIG. 38 is a partial magnified view of the-patch of FIG. 36 showing thc tip.
of the shaft of the-surgical:tacking instrument engaging the downwardly extending flange Member of the locating structure..

9 5- FIG. 39 a partial magnified cross-sectional .view-a tissue -repair patch wherein the locating struCture is a downwardly extending-firm& Member mounted to the periphery of the base member.
FIG. 40 a partial magnified cross-sectional view a tittsue repair -patch.
wherein the locating -structure is- a ring member having a dmeawardly extending flange member; the ring member is mounted .to the periphery of the to.p of the base member.
MG. 41 a 'partial. magnified croSs-sectional view a tissue repair patch wherein. the locating structure is a ring member having a downwardly extending flange member; the.
ring member is -mounted to theperiphery of the 1)ottorn-of the base member.
Detailed lleseription of-the Invention Mellow! tissue repair patches ordevices- of the. present invention are-particularly useful in opera- ventral or incisional hernia repair surgical procedums, The.
tissue repair patch devices conSistof a base -merriber havingan opening. The base member has; a

10 closure member or -d.evice associated with the opening fl-nt seeming the opening after implantation. The -repair patch -devices -of the present invention have utility- in other conventional tissue repair procedures. ibcluditg inguinal hernia repair procedums, trOcar puncture wounds, trocar incisional hernias, ete., Tissue, repair implants and .surgical in.struments for applying tacks to fixalc tssue .25 repair iinplatits aredisclosed in the. following commonly assigned, pending patent applicationS, whieh .are incorporated by reference: US Serial Nos. 12/464,151;
1.2/464,165;12/464,177; 12/464,143; 1.2J94051; and 121815,275.
The tissue repair patches of the present invention .may be madefrom. any conventional biocOmpatible -materials. Thepatches and their components are geeferably 30- made from conventional.biocompatible polymers ling may be non absorbable or bioabsorbable; The tertn bioabsorbable. ìs .iefined -to have. its conve.ntional .meaning and 2.0 5- includes both- biodegradable arid bioresorbahle. Examples of such nonabsorbable poiymerS include polypropylene, polyester, nylonoiltra high molctular weight polyethylene, and the like. 1-.1td.- combinations thereof, :Examples otsuitable bioabsorbable polymers include polylactides (PIA), polyglycolides (PGA)õ polydioxanones Pl?S), copolymers of PGAStrimethylene carbonate WW1 copolymers of :PIAIRIC, and the like. If desired, conthinations of biocompatible nonabsorbable polymers and bioabsorbable polymerS May be utilized to construct the, tisaue 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 frornother -conventional implantable materials such as.PTFE
(polytetrafluoroethylene), &. ePITE films and. larninates. The patches.may consist cif composites of polymeric filnis and rueShes, andlor fabrics.
The -meshes useful. in the hernia repair patch devices of the .present Mvention will .20 be manufactured in a conventional manner using convet)tioital manufacturing equipment and methods ineluding-kriitting, veetiving, non-woven Ictliniques, and the like. The, meshes will typically have. a pore sizesufficient to effectively provide for tissue ingrowth; for example, they may have pore sizes :in the :range of aboutØ.3mit. to about 5min, and. other conventional sizeranges, EXamples of commercially available nonabsorbable arid bioabsorbable polymeric-meSlaes that ratty be used to -construct -the hernia -repair patches of:the present invention-include PHYSIOIMESITEm and ETHICON PROCEEDIm Surgical Mesh,- available from Ethicon, :Inc, Route. 22 \Vest, Sotnerville, NJ 0.8876.
When constructing be novel tissue -repair patches-of-the-present inverition from.
surgical fabrics other than trieShes, the fabrics will have open pores with a pore, size sufficient -to effectively provide for tissuo ingrowth; for example, with a typical size of about 03 -mtn. to about 3rrim. By. "open pores" is meant openings that extend from-one side of the -fabric to the opposed. side, providing a pathway through the.fabric. 'The.fahric repair members may be: constructed from monofilaments, multifilaments, or combinations thereof, Examples of cornmercially available no fTabrics that can be used to manufacturethe hernia repair patches of the present invention. Melude woven.
fabrics, textiles and. tapes fir surgical applications. Other fabrics or -materials include perforated condensed ePTFE films -and nonwoven falorica having f)ore Sizes of at. leaSt one millimeter. The non-mesh-fabrics may be constricted of conventional biocompatible Materials.
'The fabric or mesh rnay :contain, îr additiou.to a long-term stable polymer, -a resorbable polymer (i.e., bioabsorbable or biodegradable). The resorbable Ond the long-term stable polymer preferably. contain monofilaments and/or multifilaments.
The terms re,sorbable polymers and bioabsorbable polymers are used interchangeably-herein. The tem. bioatks.orhable is defined to have its conventional meaning. Mthough..not pmfe.rredõ
the fabric or -mesh tissue repair mentber may be- immufactumd from a bioabsorbable polymer or bioabsorbable polymersvidthout anylorig-tem stable -polymers.
The tissue repair patches of thepresent ittvention may also ineludepollner .20 The films m.ay be attached. to the top surface, the bottom surface or both surfaces- and May also cover theperipheral edges of the repair patch. devices or extend beyond the periphery of the repair patch devices. Tlhc films that are used to manu:fiteture. the tissue repair patch implant devices of the present invention- will have a thickness that is sufficient to effectively prevent a.dhesio:ns Awn. forming, or qt.horwise ftinction:as a tissue barrier or tissue:separating:structure or membrane. For example, the thickness-ma:y typically range frOin about Ipm to about 500pm, and--prefertibly from about 5Arn to about 50pm, however this will d.epend upon the individu.al Characteristics of the selected polymeric films. The films suitable for .use with. the repair patches of the present.
invention. inchide -both bioabso.rbable andnonabsorbable films. The filins.are preferably polyinerlatsed and may be -made from ..various conventional blocompatible polyme.rs, including bioabsorbable and noriabsorbable polythets.. Non,reso:tbable or very slowly resorbable substances includ:e polyaikenes (eõgõ, :polypropylene or polyethylene), fluorinated polyolefins polytetrafluoroethyleneor polyvin);./lidene fluoride), 5- polyamides, polyurethanes, pol yisoprenes, polystyrenes, .poly silicones, .polyearbonates, polyarylether ketones (PEEKs), polyinethiterAicaeid esters polyacrylic acid esters, aromatic .polyesters, polyimides as well as mixtures andior co-pol.'111(TS of these, substanc.es. Also. usellil are synthetic bioabsoiltable polymer materials. for example, polyhydroxy acids (e.g., pcilylactides; polyglycolides, polyhydroxybutyrates, polyhydroxyvaleriates), polycaprolactoms, polydioxanones, syntheticand natural oligo-and poly-amino acids, polyphosphazertesõ poll/anhydrides, polyorthoesters, polyphosphates,polyphosphonates, polyalcohols, polysaccharides, and polyethers, I4owever,naturally occurring mate:rials such as collagen, gelantin or natural-detivea materials such ashioabsorbable Omega 3 .fatty acid cross4in.ked gel films or oxygenated I5 mgenerated cellulose (011.C) can also be used.
The_ films_ used in the tissue -repair patch. devices -of the present invention n.tay cover the- entire outer surfaces- of the hem ia patch nterriber or a part thereof, ln some cases, it is tlenofk.fal to have films overlapping the bordersandlor peiipheries of the repair patches', The repair patches of the present invention may also haw adhesion 20 barrier layers attached to one or both sides. The adhesion barriers will typically-consist of conventional biocompatible polytneric.materials including but not limited:
to absorbable and nonabsorbable polymers. Examples of conventional nonabsorbable polymeric materials usefal for adhcsiortbaniers include expand.ed polytetraftuoreethylenes polytetrafino.roethylene, silicones And the like.
Examples of .25 conventional absOrbable .polytneric materials -useful for adhesion baiTiers inelude oxidized regenerated cellulose, poliglecaprone 25 (copolymer of glycolide and epsilon-caprolactone),. and the like.
It is particularly preferred that the tissue repair patches of the :present invention have a mesh constrUctions and the -embodirnents illustrated in the Figures have such a 30 mesh -construction.- Th.e tissue repair it-pp./ants oldie present invention have pa:rticular ttiì.ity-for herniarepair ptocedureS, but .maybe used itt -othr tissue repair -surgical procOures as well, Referringnow to FIGS. 1:-3, a tissue repair patch IO-of the present invention is:
seen.. The .patch 10 has a :meth conatruction. ilte repair .r)ateh 10 is seen to have substantially fi4t or planar base member 20 and closure patch mentber 30. 'The base meniber 20 is illustrated having-a substantially oval.shape or configuration, but may havo other configurations including square, tectangular, circular, polygonal, etc,:combinations thereof arid the like. The has member 20 is.seert to :have top.side 22, bottom side 24, and periphery 26. Extending through the base member 20:is:the Slot: 40 having opening 42 bounded :by opposed sides 44 and opposed ends 43. The &star patch merriber 30 is seen.
to be a .substantially .flat or planar member having a substantially oval configuration. The closure patch member .30 is seen to have tOp side 32, b.ottom.side.34, and.
periphery 35.
1.5 Closure. patch member 30 is Seal to have. opposed. curved ends 37 and opposed sides 38.
Patch member 30 is:mounted to the-top:of base member 20 via. connections 39 along the ends 37 -stivh that 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.cma.te the connections 39, including but not limited to sewing, welding, tacking, .20 rivetine, stapling, gluing,. etc., and the like. The closure patch 30.Is mounted to the base inerither 20 to:cover the slot 40 and opening 42. Openings 48 ad jacent to -Sitie.8: 38 provide aCCeSS passages for surgical instruments-to and through opening 42 of -Slot 40. A
partial schematic. ofa surgical tacking instrument 60 which can be used to tack the bast.
member 20 of patch 10 to tissue is seen in FIG. 3, The instrument 60 has proximal 25 handle 62 anddistally extending elongated:shaft 70 having. distal end.
78.. .A distal setAion 76 -of the shaft 70 is seen. to extend thnnigh opening 48, underneath. the bottom side 34 of closure flap 30 and through opening 42 of slot 40 sucb that it is positioned below 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 30 surgical tacks may b.f.: fired to secure the patch tP ti$Stle adjacent to the top. side. 22 of base member 20 and the top side 32 of closure path member 30. The repair-patch. 10 is -fixated around its petititeter-26 to tissue with fixation poitas placed, for ex.araple, about every l to 2 cm, c.. the fixation devices or nteks are -separated by about l -cm. to 2 cm distances, AltIvugh in many .embodiments of the. tissue or- hernia repair patches of the 14.

5- present invention it -is preferred to have a slot in the base meniber to .provide .art opening through. the base member, the opening May b:e a. slit ot other types of o.penirig,s having different: geometric configurations may be -utilized including circular. OVal, rectangular, polygonal, ete,, on thereof and the like, >Although not preferred, it.
is pOssible thform the tissue repair patches of the present invention such thatthe base member JM andior closure menther are-curved or otherwise in:more-than one plane.
Once -the tissue repair-patch 10 ofthe present invention. has been implanted and secured. to tissue by tanking:or other conventional methods. (e:g., stapling, sunning. etc.), the shall section 76 of-surgical affixation instnmient-60 is -removed. from the body through the slot O. The closure. patch member 30 prevents underlying -tissue or viscera 15 from moving through the slot 40 and o.pening 42.
.An alternative embodiment of the :tissue repair patch 10 is seen in FIG. 4.
The patch 10 is. seen to have similarly shaped base member 20, however the closure meniber 50 is seen to havea. substantially rectangular shape with opposed minor end sides 56 and op-posed major sides: 5.7. Closure.rnember50 has top side 52 .and bottom side...54 adjacent .20 to top side 22 orbase tnernber 20.. 'The patch member-50 is mounted to base member 20 Over.' Slot 40 by connecting-is 59 along rn orsìdos 56, Tbe.connections may be -made as described previously. Qpenings 48 beneath sides 57 provide access to slot 40 and opening 42. _M seen in FIG. 4, the tissue repair .patch 10 is seen to have a directional.
indicator -80 contained on pr -in the closure menftr 50. Indicator 50 may be.
25 conventionally sewn., 'molded orformed, printed, dyed oriamin.ated into or onto the member-50. The indicator 80 is seen to have -central section 81, having oppeised transverse se:ea:0ns 82 extending therefrom. 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 deter.mine tbe location of .the pate.h.
30 with rk.-sp.ect. to the patient after insertion by aligningthe respective axes of the tissue repair .pateh 10 with tespeet to the patient and the intiMon, -allowing for mo.re- precise-:fixation, either :using a tacking instrument or using surgical sutures. for affixation, -Such 5- directional indicators may bettsed with other embodiments ofthe tissue repair patches of die present inVention.
Referring how-to MS. 5,-9, an -altemativeemboditnem of.
erepair patch 100 oftbe present invention is seen. Thcpatch 100 is seen to have substantially at or planar base member 110 formed from substantially fiat or planar base sections 120 and 140. The base member 110 has. bottom side 112,, to side 114 rind periphery 116. Base section 120 is seento have straight side 122 having ends 124. Base section 120. is. also seen to have curved side 126 having-ends 128 that conneetto ends 124..
Extending out.
from straight side 122 is the closure flap meniber 130 having hinged-Side 132 and flu end :134 separated from- side 122 by slot 136. SW 136 .has closed end 137 and open end 15 138: The closure flap member 130 i ken to have a generally rectangular configuration, but may hEWC other geometric configurations including eirc.ular, oval, .polygonal, etc., combinations -thereof and the like. Base section 140-is seen to havestraight side 142 having ends 144. Base section 1,40 is also seen to have curved -side .146 having ends -1.48 that:connect to ends 144. Extending out 'from straiaht side- 142 is the closure flap 20 m.ember 150 having hi.nged side 152 and free end 154 separated from.
side .142 by slot 156.. $lot 156-has. closed end. 157 and. open end 158. The closure flap member 150 is seen to have a. generally rectangular configuration, but may have othergeometric configurationS including circulars OVai., polygonal, etc, combinations thereof and. the like:
The base -member 110:and the tissue repair patch 100 art formed. from the has sections 25 120 and 140 by 'connecting the base sectiOns aim* straight sides 122 and 142 filet*.
seams. 118. This Cart be done in any conventional manner including sewing, welding, tacking, stapling, .gluing, etc., and combinations and equivalents thereof It can. be seen thatonly the straightSides 122 and 142 are connected on either side Of the closure. flap members. 130 and 150. The closure flaps members 130 and 150 are .mounted together -30 such that hing(4. side 132 of:closure flap 130 is contained in slot 56 of flap member 150 and hinged side 1.52 of closure flap 140-is contained in skit 136 of closure member 130, This. creates the slit 168. basemetriber 110 having through opening.165 bounded by interior -portions of straightsides 122 and 142 of the base Sections .120 and 142, 5- respectively, and also bounded b ythe hinged sidm 132 and 152 of the flap members 130 an:d 150, respectively, In the at rest position as seen in FIG. 6, the flap member.130 rests upon the top side 145 of the base section 140 ofbase member 110, while the flap member 150-rest upon the top side-125 of base section 120. In:this at rest configuration the slit 160 and opening 165 are covered. The tissue repairpatch 100 is. seen: in the ready 1.0 position in FIG. 8, with the closure flap members-130 and 150 in the uprightposition exposing the slit 160 and o.paning so that a fixation instruinent can. be inserted thniugh the -opening1.65. A tacking instrument .170 is illustrated in FIG. 9 with tissue repair patch 100 .of the present ilMution, The tacking instmme:nt .170 :is seen to have proximal.
handle.172 and actuation trigger 174. Extending front the distal end 176 of handle 170 i6 i5 the eutved shaft 180- having 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 about the bottom side- 112 of the base member 110 in order to secure the-base .member to tissue with surgical tacks. Once tacks am. placed through the base -member 1 .10 of pateh 100 to secure the :patch 100 to .20 tissue, the- tacking instrument 170 may be removed. from -theslit 160 and -the -two flap Meta-en 130 and I.50.can beinterlock.ed by /biding or-rotating the flap inetribers down wardlyonto the top 114 of the base member 110. One or .both of the flap members may be optionally 'Waded or affixed. to the base member 110 using 'various COMTeiltiOnai.
dOSUre Methods including adhesives, sutures, surgical fasteners, etc, 25 .Ati alternate ernbodiment 400 of a Single plane tissue repai.r patch of the present invention is seen in FIGS. .10 and 11. The repair patch 400 has a base member having .a top side 412 and a bottom side 414. The patch. has a periphery-416:
Located in the base member 410 is a slit 420 having an. opening 424 bounded by sides 422.
Theslit 420 has -ends 428. Mowed about the slit 420 is a surgical suture 430 havingends 432-30 and. 434 and surgical needle: 436 mounted to end 432, and Optionally, although not shown, to end 434. The suture 430 is -mounted alvut the opening 424 in a conventional mattress suture (continuous) configumtion. As-seen in..F1G.1.1, the opening 424 is closed by tensioning the -suture ends 432 and 434. causing the Side s-422 to approximate.
desired.-the suture-needles 436 can be used to engage tissue with the suture 430.

5- Referring to FIGS. 28 and 29, a variation-of suture.mounting is ilInstrated: The rep-air pateh-450 is similar to repair patch 400, but has a: rectangulady Shaped basemember451 having mosed major sides 454 andepposed minor sides 456 connected by rotmded Comers 457.- 1.7he base member 451 has bottom 4de 45-8. and top side 459, and outer periphery 452: 'The base MCMber 451 has centrally located slit 460 having an opening 464 bounded by sides 462. The slit 460 has ends:468. Mounted about the slit 460 is a Surgical sututt 470 having ends 472 and 474. The suture 470 -6 mounted it a "shoe late"
type configuration.. The. suture 470 is seen to be .monnted to Ait 460 by engaging opposed -sides 462 of slit 460. about the opening 464õ Suture 470 is seen to have ends 472 and 474 located.adjacent to OM mother along. one.. end 468 of slit 460. The sin 460 is :secured after placement-of the.patch 450 by pulling-on ends-472 and 474 thereby- closing opening 464. The suture 460 may optionally haVe surgical needles- mounted tO
one or both of the ends 472 and 474. The members 410 and 451 may -have any suitable, geometric: configuration.
A preferred embodiment ofa tissue repair patch 200 of the present ì ventiott is seen in FIGS. 12 and 13. The patch 200 ísstwn to have a substantially flat .or planar base member 210 having a. top 21.2, bottom 214 and periphery .216.. The base member 210 is seen to havan oval shape, but may" have. other geometric shapes including rectangular, circular, square; polygonal, combinations therenf and tbelike. Located in the base member 210 is theslot 220 having opening 222 therethrough. Slot 220 is bounded by Oppsed sides 224 and 225 and curved ends 226. The patch 200 is seen -to have upper.
closure flap. 230 and lower-closure flap 240. (ipper closure flap 230 is seen to have a sul-stantially rectangular shape., although it may have.other geometric configurations including circular, oval, rectangular, polygonal,-etc:and the likeõ Flap 2:30 is ken to have top side 231 and bottom sido232. The flap 230 aiso .has opposed-sides 235 and :23.6 connected by opposed end sides 237. The flap 230 iS Mounted to the top shit 2.12 ofbase member 21.0 adjacent to side 224 of slot.220 by connecting the flap 230 along its side 235 in a conventional manner StiCh-Wl sewing, gluing, stapling, .welding, riveting and the like to-create a seam. 239. In this manner-, the flap :23.0 lui,s its bottom side 232 facing the top side 212-of ba.se -member 210, and is -positioned to coverslot 220 and (vening-222 in the 5- at rest -position. The closure flap inay be rotated upwardly about seam 239 to uncover slot 220 and opening 222. Mounted toihe bottom side 214 or but menther2-10 i6 the other closure .flap 240: Flap 240 is seen to have top side. 241 and bottom side 242. The flap 240. also has opposed sides 245 and 246..connected by opposed. end sides 247. The flap 210 .ìs mottnted to the bottorn.Side 214 of base member 210 adjacent to side-225: of slot 220 by connecting the flap 240 along its -side 245 in aeon ye-IWO:nal manner such as Se:wing, gluing, stapling, welding, riveting and the like to create a Seam 249. In this mannerõ the flap 240 has its -top- side 241 facing the bottom side 214 of base meniber 210, and is positioned. to cover slot 220 and. ope,:ning 222 :in the: at :rest position, The -closure flap may be rotated dowirwardly about .seam 249 to uncover slot 220 and opening 222..
1.5 The. flap 240 may also be. rotated Upwardly aboutseam 249 through -Slot 220 and opening Refbrring now :to FIGS. 14, 14a, 14b, and 15-17, a preferred tissue repair patch 250 of the present invention is seen. The patch 250 is similar to patch-200, but is-constructed:in a different manner from. two separate base- section members.
The patch 250 is seen to have substantially flat or planar base member 260 formed from substantially flat or planar b4.5,ze seotims 270 and. 280. 'The base member 260 has bottom side 264, top side 262 and periphery 266, Base section 2:70 is seen to havesmight side 272 having ends 274. Base-section 270 ia also Setil to:havoside 276 haing curved. ends -278 that connect to ends 274, Extending -out from straight side 2-72 is the closure flap -25 inernber 290 having hinged side 292 and free side- 294,, The closure, flap member. 290 is seen to have a generally rectangular configuration., but may have other geometric configurations including,. circular, oval, rectangular, polygonal, ete. and the-like. Base section 280 is seen. ter sestxaight side-28.2 haVing ends..284. Base.
set...lion :280 isalso seen -to have side 286 having curved ends 288 that connect to ends 284.
Extending oust from straight side 282 is the elOsure flap member 300 .having hinged side 302 and free side 304. The closure flap member 300 is seen to have a gencolly rectangular configuration., butmay have other geometric configurations -including circular, oval, rectangular, polygonal, etc., and the lik.e. The .base member 260 and the hernia closure patch 250 are fbrmed torn the base sections 270 and 280 by connecting.; the.
base seetions 5- along straight sides 272 and 282-along seams 268. This can be done in any conventional m.annerincluding Sewing, weldikI, tacking, stapling, -gluing, etc., and Combinations and equivalents thereof. It can be seen that tbe. straight sides 2n and 282 areconneeted on either side of the closure flap members, 290 and 300, thereby creating a slit 310 between the nembers 290 and 300 having an opening 315. 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.
When. assmbling the patch 250 and as member 260, closure -flap 290 is h'iserted through opening 315 in slit 310, :In the at rest position as seen in FIGS. 12 and 16, the flap member 300 rests upon the top side of the haw- section 270 of base :member 260, Nvhile the flap member 290 rests upon the 'bottom side of base section-280: In the at rest state,. closure thin 290. and 300 each cover-the slit 3:10 and opening 315. It will be appreciated that either closure flap. thity: be rotated through the slit 310 And opening 315, although patch:250 as illustrate,d shows closutv flap member 290 rotated though the slit and resting adjacent to the bottom side..264 of base member 260.1n addition slit 310 may have other geometric configurations and. shapes including a slot, etc;
Referring now to FIGS. :17-22, the repair patch 250 is seen in a ready position for securement to .tissue in a tissue repair procedim such, as a hernia repair procedure, As seen in Fla 17, the patch- has been placed. in &ready position by rotating-flap 30.0 upwardly awayli7oin the top 262 of base member.260. Flap 290 is also seen to be rotated upwardly -through. slit 3.10 arid opening 315, By rotating closure 'flaps 290 and 300 in this -25 manner, the slit 310 -and opening 315 ate uncOvered providing access to a surgical instrument, such as it tacking instrument, or the surgeon's fingers. A.
surgical tacking in-sit-mem 320 is seen in..Fla 18 along with tiSSIle repair patch 250 of the present invention. The tacking instrument 320 is seen to haveproximal handle 322 :and actnation trigger 324. Extending fmm the distal end 326 of handle 332 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.3.15 between. upwardly Ntending closure flaps 290 and 300 such that the distal end 334 may he moved about thebottom side 264of the. basso Member-260 in order to.Secure. Me base member 260 to tissue with surgical tacks. The -hernia patch 250 is wen implanted in a patient in FIG. 20. A crossr-sectiort-of a body wall 370 having a surgically created opening 37 is seen. The body wan 370 is seen to have an inner peritoneal layer 374, àitet upper .fascia layer 375, a next rankle layer 376, it fat layer 377, and finally a top demial layer 378. The top. side 262 of base member 2.60is seen-to be mounted adjacent to the peritoneal. -layer 334, with the closure -flap member 0 and 300 extendingotaand thiough the:opening-332. Shaft 330 cif tacking instrument.
320 is seen inserted through sumicalopening 332, through slit 310 and opening 315 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 264 of-base mentber .260 in order to attach a section of thebase member 260 to the peritoneal layer 374.. Referrinu to FIG. 19, the patch 250 is seen. with the flap members 290 and 300 optionally secured along their i5 bottom sidel.3302:and 292 respectfully by surgical- suture..380 having ends 381 and 382.
SurOcal needle -388 is attached t SUture'end 28-1. The -Sutured- flap Members 'close- the opening 315 in slit 310, Alternatively, the flap Members May be joined or secured together to close the slit 310 by conventional adhesives, surgical. fasteners, etc. 'rhe flap.
tnernbm 290 and .3(10 may alternatively be unli.7*.xl in their at rest position. during.
.20 implantation. The shaft ofa tacking instrument would. be inserted beneath :flap. 300 through slit 110 and opening 315 without rotating he flaps upwardly. After securement, the flaps may be left in the-at rest position without additions/ securement Of the flaps.
The flap 290 would prevent tissue or visceral from -moving ink) Slot 310 and opening 315; any pressure against flap .290 would Cell$e it to seal against the bouomside 264 of 25 basemember 260, closing off 4it 31Ø
A. -surgical tacking instilment :340 having a straight.shaft :350 that can be used to secure a tissue repair patch-of the. present- .invention is seen in FIGS. 2/
arid 22. The instrument 340 WS apmximal handle:342 with an actnation trigger 344, .Extetiding from the distal. end 346 of handle 340 is the- straight shaft 350 having distal section 352 and 30 distal end. 354. The distal end section 352 is WO to be inSerted-through slit-310 and opening 315 between. upwardly extending closure flaps 290 .and 300 such that -the-distal end 354 may be -moved -about the. bottom side 264 of the base member 260 ia .
order to secure the base niernber 2.60 to tissue- with surgical tacks. The tissue repair patch 250 is seen implanted in a. patient in FIG. 22. A cross-section of a body wall 370 having-a surgically created opening 372 is- seen. 'the body wall 370 is-seen to have aninner peritoneal-layer 374, a next upper fastia Ii13k1 375, aritylniuscle- layer 376, a fat layer 377, and finally a top dermal layer 378.. Thc top side 262 abase member 260 is seen to be mounted adjacent to the peritoneal layer 374, with the closure flap members 290 and 300 eNtending out and through.the opening 332. Shaft3.50 of tacking instrument:350 is seen -inserte /ough surgical -opening 372 ..through slit 310 and-opening 115 tuid into. the.
patient'S underlying body Cavity. The distal end section 352 and distal end 354 are seen to be positioned adjacent to bottom si.de 264 of base member 260 in order to attach a section of the base member 260 to theperitoneal layer 374.
FIGS. 23 and 24 illustrate the implantation of a tissue repair patch 250 of the present invention in a patient during a .stirgieal procedureto repair a hernia deka Tb.e surgeon is. seen to be holding the handle 322_ of a surgical tacking instillment 320. with one band.while engaging the trigger 324. Theinstniment has a curved shaft.
330,. and the proximal section 332 of shaft- 130 has been placed thrum/It opening 372 ofbody wall 370, and thivugh slit 3.15 and openi.ng 350 of hernia repair patch 250. Repair patch 25 has been implanted in. the patient's body cavity such that the upper Side_ 262 of base mentber 260 -is adjacent to the peritoneal layer 374. The closure flaps 290 and 300.
have been rotatedupwardly to :expose slit-310 and opening 315 and extend. Mt through -opening 372 of body 370 so that they extend partially above dermal layer .378. The patient's viscera 379 are seen to be adjacent to the bottom side 264 of base rnembc,r 260. Shaft -25 330 of tacking instrurnent 320 iS :wen inserted through surgical cipening 372 thrmgh slit 3.10 anclopcning 315 and into the patient's underlying body cavity. The.
distal end section 332 and distal end. 334 are: seen to be positiontkdadjacent to lvtiorn side: 264 .of base member 260 inorder to attach a section oldie base member 269 to the peritoneal.
layer 374. The surgeon's other hand: is seen to be palpating the patient's body wall 370 above the distal end 334 in order to locate the position of atack prior to delivering it: by actuating trigger 324. R.eferring to FIG 26, after implantation of -the patch 250 and scourement.with tacks 3.80, the bottom side 264 .of base member 260 may have.
two concentric CTOWYIS of tacks 382 and .384 to SeCitte the patch 250 to the peritoneal layer 374.

5- Another embodiment (-.f a- tissue-repair patch a the- present invention is seen in F1QS. 25 and 26. The repair patch 500 is seen to have substantially at base Member 510 having top side 512 and bottom side:-5.-I4. Base member 510 is seen to have circular opening; 520 bounded by peripher,y 522. Clostmering 530 is seen to be. mounted about periphery 522 of circular opening 520. The. patch 500 also has: closure patch 540 having top side 542 and bottom side 544. Mounted to the bottom:side 544 of patch 540 is Mating closure ring .548. Mating cloSure ring 54 ís removeably engageable-With closure ring 530. Vhen used in a surgical procedum the surgeon removes the closure path 540 from base member 5:10 thereby exposing opening 520.. The base member 510 is then.
implante.d in a body cavity-of a .patient such that the topside 512 of base member 510 is is adjacent.to. the inner layer of the body cavity such as-the peritoneum.
The surgeon .then inserts a distal section of the shall. Ofan attachment. instrument such as a surgical tac.ker through opening 520 into the body cavity below bottOm side 514 of the base merriber 5.10. After the base -member 510 has been secured. to. the inner layer of tissue and the -shaft of the securement instrument has been remove.d, the surgeon mounts the-closure .20 patcb 540 to. the top side 51.2 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 embrxlimentsof a tissue repair patch 600 of the present invention. 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 bottom. side 614.
The- patch -25 has a periphery 616 and a peripheral edge 618. Located in the base .member 610 iS
centrally located slot or slit 620 having an opening 624 bounded by sides 622.
The slft 620 hasends 628. If desired, the-slit or slot 620 .rnay be located such that it is ollSet ftom center, The base number 610 -is illustrated having a substantially oval shape or configuration, but may have other configurations including square, rectangular, circular, 30 polygonal, etc, combinations thereof and the like. Although it is .preferred -that the base member 6.1.0 be substantially flat, it -may be shaped, for exam's.), curved, etc... Mounted to the bottom -side 6.14 of base member-610 is tholocating structure 650. The structure.650 is &MI to bez ringrlike. :structure with a top surface .652 and lx)ttorn-surface 654. As illustrated, the top -surface-is. substantially flat and the-top:surface has a rounded 5- configuration, such that -the crom-seetion D4;haped. However, it will be appmeiated that the-cross-Section of the locating StruCture May 'have a Vatiety of croSS-sectional shapes,. inchtding *hut not limited to, circular oval, square, rectangular, polygonal, straight sections and curved seetions, combinations thereof and the lik:e. The structure 650 will have a shape that .generally conforms to the periphery of the base member 610, .for example,. circular, oval, rectangular, square, polygortal, curved sides., straight sides., and coithinations thereof. The structure 650- has miter edge 655, inner edge 656 and central.
opening 657, although if desired, although, not preferred, central opening 657 may he-eliminated.. The locating strictures 650. may be made from.biocotible polymers and.
hioabsorbahle polymers as. described herein above, but it is .particularly -preferred to make the structures 650 from bioabsorable pol3nnem. The stmetures (i50 may he -manufacture4 using conventional manufacturing processes, -including Mjection Molding, machining,.
three-dimensional ink. Jet printing, solutiOn casting, extrusion, composite lamination., and.
the like. The locatina structures 650 may be: attached to the base members 610 in a variety of conventional mannerS, including gluing, welding, sewing, 'fastening with .20 mechanical. fasteners, co -molding, the use of hot platens or presses.
Merino:I:brining, etc, Inone embodiment as described below, -the-structuits 650 may be .molded-orformed into the base member .610.
R.eferning now- to FIG. 33., the tissue-repair patch 600 is :seen to be implanted in.
patient below a hernia defect 700 in a body wall 710. Surgically created opening 7.15 is -25 contained .in body wall 710 above- the 'hernia defect 700. The bottom side 6.14 of the base member 61.0 is seen to be facing the patient's viscera., while the.top side 6.12. of theba.se :member 6.10 is adjacent to the .interior side 7.12 ofbo4 wall 7.1Ø The device 600 is secured. to -the body wall 700 in. a conventional. manner by surgical.
fasteners such as surgical. tacks, etc. The tacks orfasteners art applied.byinserting a distal section .81-5 of 30 a- shaft 810 of a surgical tacking instillment 800 into opcning 640 and lOcathigõ the periplun 616 -of the base member 610 mi.ith the distal tip. 818 of thedistal section 815 of the shaft -810. The-periphery 616. is -conveniently and -accurately located by the. surgeon -riming the distal. end section.81.5 of the shall 810 such that the tip 8.18 contacts or is proximate-to -the locating structure 650µ Then, tue:ks or other securement or fastening 5- d.evices are fired through the base member 610 into the -body wall 710 about the entire periphery. 616 'abase Member 610 by ntoving and Manipulatthe tip 818 about the locating strncture 650. 'The locating structure 6.50 assists the surgeon in finding and locating the periphery 616 -of the base member 610 ibrproper placement of the tacks or other securement or fasteningdevices. -The opening 624 M slit or slot -62.0 is secured and 1.0 closed With an appitpriate closure member as -described herein above, such as sutures.
Refining now to FIGS. 35 and 36, an. embodiment of a. time repair patch .dovice-600 of the present invention having locating structure 650 -with a textured top surface() is seen. The device 600 is seen to be-mounted adjacent to the bottom side-of-a body wall 710 beneath-a hernia. defect 700. The structure 650 is seen to.have a bottom sulfate 15 660 that is textured. As shown,. the surface 6(4 has a.plurality of peaked ridges 662 emending up from surface 660, and having bases 664 and peaks 667. The -ridges 6.62.-are seen to have a rectangular ctOS;s-section. The rid.gesmay also be rounded and have other geometric cross-sections includingstware, rectangular, Mai, semicircular, etc.
Although not shown, the texturedsurface may be textured by grooves or other indentations, or by a 20 combination of grooves or indentations and projections. The distal tip 818 of thedistal section 813 of shaft 810 oftacking or securement instrument 800 is seen tc. be located in.
contact with textural surface-660 in position to firc tacks through base member 610 into body .wall. 710.
An embodiment of an erribodiment of a tissue repairpatch device 600 of the 25 piesent invention having locating structure. 650 with a downwardly emending flango.
configukution is seen in FIGS. 37-41. Referiing first to FIGS. 37, 38 and 39, the-tissue repair patch device 600 is seen to have a: locating structure (60 ìn th.e fOnn of a downwardly extending flange member-670 that is made by- molding or otherwise forming prt of the periphery. 616 of base member 610. The flangemember 670.-is..secri to have 30 bottorn edge-672, inner side 674, outer side 676-and top 678. Thellange member has a eurvederess-Section,:but may have other configurations and-cross-sections including-straight and angled, 'the device 600 when emplaced adjacent. to a patient's body wall 710 on. the interior surface 712 as shown, is secured by m.anipulating the distal tip -81.8 of the.

5- distal- seetion-8-15 ofshaft 810 of the ins/nu-nem 800 such that the tip 818 is .proximal to or touching the inner side 674 of-flange member 6M. AS seen in FIG, 39, the locating structure 650 may consist of-a separate flange member 680. h.aving top 682, bottom. 684, itiner,side 686 and. outer side 688. The top 612 of -flange member 680 may be mounted to the periphery 616 or peripheral edge 618 of:base. member 610 in -#
conventional manner.
such as by gluing, welding, sewing, -fastening, co-ntolding, etc. The device 600 having flange metriber seento be utilized and Unplowed in apatient to repair a tissue defect as previouSly described above.
Yet nother etrihodiment 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 smicturc 690 is seen to consist of a ringor petiph.eral element 691 and a downwardly extending flange section 695.. The peripheral element 691 is seen to have top side- 692, bottom side 693 and outer sick 694. The dovenwardly extending:flange-section 695 hos-top (i96, bottom: 697, inner Side 698, and. outer side 699. The structure 690may be mounted such that. the bottom- side 693 of peripheral -element is on the top side 612 of base. member 614 adjacent to or on the periphery 616 and the peripheral edge 618 is coveredoor the structure. 690 may be mounted :such that the top side 692 of peripheral clement 691 is on the bottom side 6-14 of base member-614 adjacent to oron -the periphery 616., The device 600 having structure 690 iS seen to he utilizexì
and implanted in a patient to repair a tissue defectus previously described above.
The repair patches of th.e present invention may optionally contain or be coated with sufficiently effective amounts of an. active -agent Such- as -a therapeutic -4gettt.
Substances *hid are suitable US active. agents include conventional agents.
that ntay be naturally occurring or symhetic and ma:s,,, include but are not limited to, .for example, antibiotics, antimicrobials, antibacterialS, antiseptics, chemotherapeuticsõ
cytostatiesõ
metastasis inhibitors, anticleaboties, antitnycoties, lAynaecological. agents, urologieal agents, anti-allergic agents, sexual. hormones, sexual hormone inhibitors, -haemostypties, hormones,iieptidt.s4woriones, -antidepressants, vitamins. such as 'Vitamin C, -antihistamines, naked DNA., plasmid DNA, cationic. DNA -complexes, RNA, cell 5- constituents, vaccines, and cells-.oceurring naturally in the body or :genetically modified cells.
la. one -embodiment, he active agents ntay be antibiotics: including suCh agents as gentatnicin or ZEVTERATN (ceflobiprole- medoctuil) brand antibiotic (available from Basilea Phannacentica Ltd., Basel Switzerland). In one embodiment, an implant -may include 'broadband antimicrobials. used against different bacteria and yeast (even in the presence of bodily liquids) such as octenidine, octenidine dihydrochloide (availa.ble as active- ingredient OeteniseptIP disinfectant from Schulke- & Mayr, Norderstedt, any as), polybexamethylene biguanide (PHMB) (available as active ingredient Lavasept:k from Braun. Switzerland), triclosan, copper (Cu), silver (Ag), nanosilver,õ
gold OW,.
selenium (Se), .gallium- (Ga),.tautolidinc,. N-thlorotaurine,:aleohol based-antiseptics such as ListerintA mouthwash, N a-lauryl-learginine ethyl ester (LAE),õ
myristamidopropyl dimethylamine (MAPD, available as an active ingredient -in SCHERCODINPm I\4), oleamidupropyl dirt ethylamine (GAD, available_ _as an active -ingredient = in ScHEROODINErm 0),. and stearamidopropyl dimethylamine (SAPP* available as an active ingmdient ín SCHER.CODINETh S). In one ernbodiment, the agent may be.
octenidine &hydrochloride (hereinafter-referred to as octernidine) andior Although it is preferred. to have 4 single, centrally located opening in the hernia repair .patch devices of-the present invention, the opening and associated closure tneniber maybe offset from the. center. Additionally, more than oneopcning and closure member may be utilized in thetemia impair devices of the present invention.
The following examples are illustrative-of theprinciplesand practiee.of the pmsent invention, -although not limited thereto, Intattole 1 5. A. -patient with a ventral or ineisional hernia is prepared-for an open hernia rep-air procedure in the -following manner. The skin area Suntunding the hernia is -scru'bbed with a conventional antimicrOhial solution such. as betadine. The patent is -administered.
conventional general anesthesia in. a conventional manner by -induction and inhalation.
The surgeon then initiates die surgical procedure by making an ineision in -the Ain and.
stibcutaneous tissueoverlying:-the hernia. In the. case of pianned ìitra-peritoneal mesh placement, the hernia Sae ísopened> l'heed.ges-of the healthy fakia arotmd the defixt are examined. and any attachments of the: viscera to the abdominal wall are divided to create a free space for fixation -of the mesh.
At this point in the procedure-, the surgeon then- prepares a mesh tissue repair hernia patch of the .pressent invention having a locating SITLICtUret and lurving closure flaps anda base member for insertion through the abdominal wall. defect and into the abdominal cavity such that the top side of the mesh is adjacent to the p er itoneurn.
surrounding the defect, and. the bottom side of the mesh device is -facing down toward. the patient's viscera. Stay sutures :may be placed through the meg) into the abdominal. tissue as desired, i.e. at thc four compass points of the mesh (North, -South, East,.
West). The flaps are :rotated upwardly after placement to expose the opening :in the base member of the mesh. The- mesh is-fixated with a. conventionalsurgical tacker instrument or other means of fixation. A taek.er is inserted through the 0:pening- such that the distal end of the tacker-is between thernesh. and -the viscera, and the surgeon locates theperiphery of the -25 repair patch by engaging the locating struCture with the tip of th.e shaft of th.e tacker' instrument. The. perimeterof the mesh is then. fixated using a plurality of tacks in a crown configuration. The tacker 14:1 removed and the openingin the mes:h is closed by folding the flaps as appnoptiate -fix the present invention. The flapionay be optionally seettml. using adhesive-, -suture,- rivets., or other closure means, or may be returned -to their at rest position -without. Setatement to each other. The hernia defect may be primarily closed if desired.. The skin ineision is closed using. appropriate saluting.
or closure techniques, ancl. the incision. is appropriately bandaged -and the patient is moved to a recovery -room.

5- The novel hernia repair devices of the present invention have numerous advantageS. The novel repair patch -devices prOvi& a single layer mesh repair device that can bc affixed vi.a tacking in an open intraperitoneal. henna repair procedure. The-repair patch devices have .additional advantages including less foreigamaterial.
lowermaSs of foreign materialyand the:ahility to implant a single layer tissue repair mesh. -in -open procedures-. The -tissue repair devices -of thepresent invention, preferably made -from niegh, May potentially aCeelerate the rate of tissue integration, provide less area for biofilm fonnation, have a lower cost ofmanufac.ture, and are easier to package, sterilize, and use with improved.ereonornics..
Although this invention has been shown anti described with respect -to detailed embodiments thereof, it will be understood by those...skilled inthe art that various changes in form and detail thereof -may be made, without. departing from the spirit and scope of the.
claimed. invention,

Claims (42)

Claims We claim

1. A tissue repair patch, comprising:
a substantially flat base member having a top side and a bottom side and a periphery;
a locating structure is positioned adjacent to the periphery of the base member on the bottom side;
an opening located in said base mwmber such that the pocket accessible through said opening; and, a closure member associated with said opening.

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

3. The tissue repair patch of claim 1, additionally comprising an adhesion barrier on 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 1, wherein the base member comprises a fabric.

6. The patch of claim 5 wherein the fabric is woven.

7. The patch of claim 5 wherein the fabric nonwoven.

8. The patch of claim 1, wherein the base member comprises an expanded polymeric

9. The patch of claim 1, wherein the base member comprises a biocompatible, nondegradable polymer.

10. The patch of claim 1, wherein the base member comprises a bioabsorbable polymer.

1. The patch of claim 7 wherein the nondegradable polymer is selected from the group consisting of polypropylene, polyester, nylon, and ultra high molecular weight polyethylene.

12. The patch of claim 10, wherein the bioabsorbable polymer is selected from the group consisting of polylactides, polyglycolides, polydioxanones, polycaprolactones, copolymers of glycolides and trimethylene carbonate, and copolymers of lactides and trimethylene carbonate, and copolymers and blends thereof.

13. The patch a claim 1, wherein the base member comprises a biocompatible nondegradable polymer and a bioabsorbabIe polymer.

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

15. The patch a claim 1 wherein the opening is circular.

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

17. The tissue repair patch of claim 1, wherein the closure member comprises opposed closure flap members hingingly mounted about the opening

18. The tissue repair patch of claim 1, wherein the closure member comprises a patch having an outer periphery, wherein a section of the periphery is mounted to the top side of the base member about the opening.

19. The tissue repair patch of claim 1, wherein the closure member comprises a surgical suture mounted about the opening.

20. The tissue repair patch of claim 1, wherein the closure member comprises a patch having 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 member mounted to the top side about the opening, such that the closure path may be engaged and disengaged from the base member

21. The tissue repair pitch of claim wherein the opening comprises a slit having opposed sides and the closure member comprises a surgical suture threaded about the slit adjacent to the sides.

22. The tissue 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 be engaged in the slot of an opposed flap member

23. The patch of claim 1, wherein the opening is centrally located.

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

25. The patch of claim 2, wherein the polymer film comprises a nonabsorbable polymer.

26. The patch of claim 2, wherein the polymer film comprises a bioabsorbable 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 bioabserbable polymer is selected from the group consisting of oxidized regenerated cellulose, polydioxanone, poliglecaprone 25 (copolymer of glycolide and epsilon-caprolactone) 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 barrier comprises a polymer selected from the group consisting of group consisting of oxidized regenerated cellulose, polydioxanone, poliglecaprone 25 (copolymer of glycolide and epsilon-caprolactone) and combinations thereof.

31. The patch of claim 3, wherein the adhesion barrier comprises a polymer selected from the group consisting of silicone, PTFE, and ePTFE.

32. The patch of claim 1, wherein the locating structure 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 bioabsorbable 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 glycolide and epsilon-caprolactone), 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 fiat 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;

an opening located in said base member; and, a closure member associated with said opening, B. positioning the patch about the defect such that the top side of the base member is adjacent to the inside layer of the body wall;
C. inserting the end of a surgicaI fixation instrument through file opening to access the bottom side a the base member to the locating structure, and fixating the base member to the inside layer of the body wall; and, D. manipulating the closure member to close off the opening.

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

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