CA1259875A

CA1259875A - Two-piece tissue fastener with coinable leg staple and retaining receiver and instrument for applying same

Info

Publication number: CA1259875A
Application number: CA000456803A
Authority: CA
Inventors: Donald M. Golden; William P. Mcvay
Original assignee: Ethicon Inc
Current assignee: Ethicon Inc
Priority date: 1983-06-20
Filing date: 1984-06-18
Publication date: 1989-09-26
Also published as: DE3467501D1; JPH0380018B2; AU2952784A; AU565190B2; US4573469A; BR8403004A; ZA844641B; EP0129441A1; JPS6012046A; GR81918B; EP0129441B1

Abstract

Abstract of Disclosure A fastener is provided to hold together separated portions of mammalian tissue and includes an open loop fastening member and a receiver adapted to receive the legs of the fastening member. The legs of the fastening member are then deformed to effect engagement of the fastening member and receiver. An instrument is provided for holding the receiver on one side of the tissue portions and for inserting the fastening member through the tissue portions and into the receiver. The instrument also 1) deforms the legs of the fastening member to effect the engagement of the fastening member with the receiver and 2) severs the protruding portions of the legs.

Description

TWO-PIECE TIS5UE FASTENER WITH COIN~BLE LEG STAPLE
~N~ ~ETAI~ING RE OE IVER AND MET~OD AND INSTRUMENT
FOR APPLYING S~E
5 Technical Field This invention relates, in general~ to the fastening together of portions of t~ssue in surgical procedures and is especially advzlntageous in the ~ur~ical closure of internal organ tissue.
Back~ und of the ~nvention In various surgical procedure~, fasteners ~n the form of staples or the like are employed for holding tissue portions together t~ fa~ilitat~e healing of a wound or incision~ For example, a locking ~taple, hav1ng a tongue and groove structure by which the staple ~s locked, is disclosed in U.S.
Patent No. 2,881,762, A metal staple espe~ially adapted for ligating blood vessels is disclosed in U.S. Patent : No. 3~079,608. International Patent Application No. PCT/SU79/
00049, which is available to the public, discloses a variety of fastening devices and instruments for performing circular anastomoses on the l~rge intestlne. The a~orementioned dis~losures ~erve as e~amples of a wide variety of ~issue fastening devi~es and techniques that may be employed in general and/or specific 6urgical ~i~tua~ions.
One common type of ~a~tening device or joining or bolding together ~cfft ti~sue por~ion ls the generally ~Un-shaped staple which ~g typicall~
fabricated from a ~uf~table metal. Such ~taples, alth~ugh generally descr~hed as having tw3 legs ~oined ts:~ ~efine 2 ~ hape when unclinched" 21ay al~o be regarded ~s having ~ o~nfiguration of ~n "open~ loop when unclin~hed. The legs ~ee~ not 3S necessarily be paralle~ but ~re typically adap.ed for ~TH 548 f penetrating the tissue portions and for receiving between them some of the tissue material.
Other examples of U-shaped or open loop staples, as well as of methods and instruments for applying such staples to tissue, are disclosed in UrS~ Patent Nos. 3,252,643, 3,482,428, 3,692,224, 3,790,057, 3,795,034, 3,889,683, 4,198,982, 4,316,468 and 4,319,576.
Other tissue fastening devices have been pro-posed and differ from staples per se in that theseother devices may have a plurality of components and do not have to be clinched in the manner used to set a staple. One such device is disclosed in U.S. Patent No. 4,060,089 and includes a fastener s-trip provided with a plurality of longitudinally spaced, parallel prongs which are adapted to pene-trate two overlapped tissue portions from one side so that the distal ends of the prongs project from the other side of the tissue portions. 'rhe fastener device further includes a retainer strip which is adapted to be placed on the other side of the tissue portions opposite the fastener strip to engage the ends of the projecting fastener strip prongs and thus secure the tissue portions tightly between the fastener strip and the retainer strip. Such a fastening device may be fabricated from a biodegrad-able or absorbable material.
Yet another tissue fastening device having a plurality of components is known. The fasteners of that device are made from various polymeric materials and the legs of the U-shaped portion of the fastener have a taper to improve the penetration in the tissue.
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~L~5~7~

Although n~any of the above-di scussed types of ti ssue fasJcening deYices and ~cechniques are ~atisfai:tory in various applications, there i8 a need 'co prov:Lde an improved fastening device, especially 5 one completely fabricated from absorbable materials.
Also, it would be d~sirable to provide an ~mproved fastening device fabricated from absorbable _.............. material~ that can provide primary zlpproximation of the tissue edges to insure that the tissue edges ar~
10 in oontinuous contact~ Further, ~;uah an ~mproved - ~astener should provide a desi red amount of hemostatic oompression to minimize bleeding, but allow ~ome collateral blood circulation to the wound or in~ision edges of the tissue to promote healing. In ~ddition, such an improved fastener should have the capability to accommodate varying tissue thicknesses and 8hould leave as little tissue cuff or margin as pos~ible in effecting ~he joining of the tis~ue.
~urther, it would be b~neficial if such an i~proved fastener had ~ oonfigur~tlon t~at ~ould enable the fa~tener to be fabri~ate~ with 1) as ~mall a size as p~ssible to mini~ize dosage and 2) wlth a minimum of sharp edges or protrusions. Also, another . desirable feature o~ such ~n l~proved fastener would be ~ fastener c~nfiguration that dld not form, or oontribute to the formation of, pockets o In~ec~ion in the ti~sue.
~ urther, ~uch ~n improved fastener ~uld desirably provide the 8urgeon ~1~h tactil~ ~e~dback and oompen~ating ~on~rol during the appli~ation of the fa~tener.
~ inally; ~uoh an improved ~2stener shoul~
have ~he eapability for ~aintaining the ti~gu~
p~rtions in ~ppro~i~a~ion and o~mpre3sion for a mi~imum of 21 days ETH-~8 It would also be advantageous to provide a ~imple yet effective method for joining tissue portions together w~ th such an improved fastener and to provide an instrument for applyinlg ~uch an S improved fastener according ~o such a mel:hod. It w~uld be desi rable 1 f the improved rnethod o~uld be effected with a variety of diffarenl: embodi~nen~s of ~uc:h an improved fastener by means of appropriate instruments .
Su~nmary of the Invention ~ ~mproved fas'cener is prc~vided to hold toge~cher ~epara~ed portions of mammalian tissue such as are defined by a wound or incision, to facilita'ce healing of the wound or ~ncision, The fastener comprises an open loop fastening member wh$ch has a pair of legs adapted to penetrate two overlapped tissue portions and which has a link connecting the legs. ~he l;nk is adapted to lie substantially against one of the tissue portions.
A receiver i~ provideB for ~eing ~isposed against ~he other of the tissue portions opposite ~he fastenirlg member and has means for r~ceiving the fastening ~nember legs after the legs have bees inserted through ~he ti~sue po~tlons.
At le~s'c a por~ion of each of the legs or at least a portion of the receiver consi~'cs of ~Dal:erial that is init1ally defor~able un~er the ~pplication of pressure via a tool or instr~nent to e~Efe~t engagement of the ~astening metnber leg~ and receiver after the tissue portlon~ h~ve been peretroted by the fastening ~e~nber legs and ~f~cer the l~gs ~sve been received in the receiver.
Ac~rd~ng to the ~nethod iEor iol~ ng ti El~ue portions wi~h the f~stener ~ the two ti~ue portions are fir~t approxim~ d in ~ generally face-to-face ET~'-548

2~ ~7 ~

relationship. Next, the fastenin~ member is posi~ioned on one side o~ the ~issue portions ~ith the leqs orient~d at an appropriate angle to penetrate the tissue portions. The receiver is positioned on the other ~ide of ~he ti-~sue portions opposite the fastening member and generally in alignment with the fastening member legsO
Relative movement ls then effec~ed between ~he fas~ening member on ~he one hand and ~he ~is~ue portions and receiver on the other hand to oause penetration of the tissue portions by the fastening member legs and to cause a portion of each of the fastening member legs to be received within the reeeiver. The relative movement is effected until ~5 the link i8 disposed against the surface of one of the tissue portions and until the receiver is disposed against the other of the ~issue p~rtions.
Finally~ deformation of the ~astening m~mber legs or of the receiver or deformation of bo~h ~he ~0 receiver and the fastening me~ber legs is effected with a tool or instrument ~o as to provi~e engagement of the fastenin~ ~ember leg~ and receiver.
A tool or ins~rument for applying at leas~
one fastener to hold ~ogether..the separated portions of the mammalian tissue in acoordance w;th the above-d~scrlbed method preferably include~ a fir~t aW for holding the fa~tening ~ember on one ~ide of the ti~sue port~ons with the leg5 oriented in ~n appropr~ate ~ngle ~o penetrate the tis~ue p~rtions.
The in~trume~t al~o includes a ~ecDnd jaw for holding th~ re~eiver on ~he other ~lde o ~he ~13sue portions opposite the ast~ning ~e~ber and gèn~rally in ali~nment with the fa~tening ~e~ber legs.
The in~trument further includes ~ean for mov~ng the first and ~econd ~aws between 1) an open ET}~-5 4 ~

position for receiving the tissue portions between them and 2) a position in which the jaws are at least partially closed. Means are also provided on the instrument for moving the fastening member relative to the first jaw to penetrate the tissue portions with the legs of the fastening member and to locate at least portions of the legs of the Eastening member within the receiver in the second jaw.
Additionally, the instrument is provided with a deforming member movable relative to the second jaw for being urged against the fastening member legs, the receiver, or both so as to deform the fastening member legs, the receiver, or both for thus effecting an engagement of the fastening member legs and receiver. The deforming member i5 preferably moved by a suitable mechanism in response to movement of -the first and second jaws to at leas-t a partially closed position.
According to a further broad aspect of the present invention there is provided a fastener adapted to hold together separated portions of mammalian tissue, such as are defined by a wound or incision, to facilitate healing of the wound or incision. The fastener comprises an open loop fastening member. The fastening member comprises a pair of legs adapted to penetrate the tissue portions and a link connects the legs that is adapted to lie substantially against one of the tissue portions. A receiver is adapted to be disposed against the other of the tissue portions opposite the fastening member. The receiver has means for receiving the fastening member legs after the legs have been inserted through the tissue portions. At leas-t a portion of each of the legs or at least a portion oE the receiver consistS f a material-that is initially deformable under the application of a predetermined~amount of pressure to effect engagement of the fastening-member legs and receiver after the tissue portions have been penetrated by the fastening member legs and after the legs have been received in the receiver.

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-6a-Acrording to a still further broad aspect of the present invention -there is provided an instrument for apply-ing at least one fastener to hold together separated portions of mammalian tissue, such as are defined by a wound or incision, to facilitate healing of the wound or incision.
The fastener includes an open loop fastening member that comprises a pair of legs adapted to penetrate the tissue portions and a link connecting the legs that is adapted to lie substantially against one of the tissue portions. The fastener further includes a receiver adapted to be disposed against the other of the tissue portions opposi-te the fastening member and adapted to accept the legs of the fastening member. The instrument comprises a first jaw for Holding the fastening member on one side of the tissue portions with the legs oriented at an appropriate angle to penetra-te the tissue portions. A second jaw is provided for holding the receiver on the other side of the tissue por-tions opposite the fastening member and generally in alignment with the fastening member legs. Means is provided for moving the first and second jaws between an open position for receiving the tissue portions therebetween and an at least partially closed position. Means is provided for moving the fastening member relative to the first jaw to penetrate the tissue portions with the legs of the fastening member and to locate at least por-tions of the legs of the fastening member within the receiver in the second jaw. A
deforming member is movable relative to the second jaw member for being urged against the fastening member legs, the receiver, or both to deform the fastening member legs, the receiver, or both to thereby effect an engagement of the fastening member legs and receiver. Means is also provided for moving the deforming member to effect the deformation.

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1~25~

-6b-Nun~erous other features of 1) various embodiments of a novel -tissue fastener, 2) of methods for applying such embodiments of the tissue fastener~ and 3) of embodiments of an instrument for applying the tissue fastener in accordance with such methods will be apparent from the following detailed description and accompanying drawings.

Brief Description of the Drawings In the accompanying drawings forming part of the specification, and in which like numerals are employed to designate li.ke parts throughout the same, Figure 1 is a fragmentary perspective view of two portions of mammalian tissue defined by an incision or wound and being held together by a plurality of novel fasteners;
Figure 2 is a greatly enlarged, fragmentary, cross-sectional view taken generally along the plate 2-2 ~n Figure l;

.

Fi9UEe 3 i5 a fragmentaryv cross-sectional view taken generally along the plane 3~3 in Figure 2;
Figure 4 is an exploded, per~pective view of ~ first emb~iment of the fastensr E;hown in Figure l;
Figure 5 is a side view oi the fastening mem~er of the fas~ener illus~ratea in ~igure 4;
Figure 6 i~ an end ~iew ol. th~ astening member of the fastener lllu~trated in Figure 4;
Figure 7 is a top plane Yiew of the receiver of the fastener illustrated in Figure 47 ~ igure 8 is a cross-sectional view taken generally along the plane B-8 and Figure 7;
Figure 9 is a cross-sectional view taken generally along the plane g-9 in Figure 8;
Figure 10 is a si~e view of an instrument for applying the first embodiment of the fast~ener illustrated in ~igures 1-9;
Figure 11 is a grea~ly enlarged, fragmentary, front end view o~ the instrument illustrated in Figure 10;
Figure 12 is a greatly enlarged, fragmen~ary, ~op plane v~ew of the instrumen~ of Figure 10;
Figures 13-l6 are greatly enl~rged~
fragmentary, partial cros~-~ectional view~ of ~he instrument of Figure 10 illustrating the sequen~2 of opeEation of the in~trument;
~igure 17 ~s a greatly enlarged, fragmentary plane view of the instrument lower jaw t~ken along the pla~e 17-17 in Flgure 13;
. Fiyure 18 i a greatly enlarged, fragmentary, cros~-~ectional v~ew of the front end of the ~aws of the in~rument ~n the ~losed pos~ n ~hown ~n Figure 16;

~TH~548 ~5~

Figure lg is a fra~mentary, cross-sectional view similar to Figure 18 ~ut limited to the end of the lower jaw and showiny a modified form of the instrument;
Figure 20 is a fragment~ry, partial, cross-sectional view of a ~econd embodiment of the fastener shown in an orientati~n similar ~o that of the orientation of the firs~ embodi~nt of the fastener in Figure 2;
Figure 21 is a frag~entary, cros~-sectional - YieW taken generally along the plane 21-21 in Figure 20;
Figure 22 is a side Yiew of the receiver of the second embodiment of the fastener shown in Figures 20 and 21;
Figure 23 is a top plane view of ~he receiver of the se~ond embodiment of the fastener of Figures 20-22;
Figure 24 is a cros~-sectional view taken generally along the plane 24-24 in Figure 22;
Figure 25 is a fragmentary, partial, cross-sectional view of a third emhodimen~ of ~he : fastener ~hown in an ori~ntation ~i~ilar to that of the orientation of the first embodi~ent of the fastener in Figure 2;
Flgure 26 is a fragmen~ary, ~ross-~ectional view taken generally along the plane 26-26 in Figure 25;
Figure 27 is a ~i~e view of the receiver of the third embDdi~ent of the fastener of Fiqures 25 and 26;
Figure 28 is ~ ~op pl~ne view of ~he third fastener embodiment rec~iver of Figur~s 25-275 and Figure 29 i~ a ~ross-sectlonal v~ew tak~n generally along ~he pl~ne 2~ 29 in Figure 27O
Description of the_Pr~erre~ ~m~odiment

3~ ~his invention ~ay ~e u~ed ~n ~any ~ifferent forms. The specl~ic~tion ~nd the ~Dmp~nying dr~ing~
~TH-548 ~5~

_g _ disclose only a few specific forms as an example of the use of the invention. ~he precise shapes and ~ize~ of the compvnents herein des~ribed are not essential to ~he in~ention unless otherwi~e indicated. ~he inventlon 1~ not intended to be limited to the embodi~ents illustrated, and the aoope of the inventi~n will be p~inted out in the appended claims~
THE FASTENER ~IRST ~BODIMENT
A first embodiment of tbe fastener is illustrated in an assembled oonfiguration in Figures 1-4 and i~ generally indicate~ therein by reference numeral 50O Individual parts of the fastener are shown in Figures 5-9.
The plurality of such fasteners 50 are illustrated in Figure 1 as holding together separated portions 52 and 54 of mammalian tissue, such as are defined by a wound or incision, to fa~ilitate healing of the wound or incision.
The fastener includes tw~ ~omponents r a generally ~-shaped or open loop fas~enlng member 60 and a receiver 62 which are ~niti~lly ~eparated as illustrated in ~igure ~ whi~h are adapted to cooperate to oompress or hold bet~een them the tissue portions 52 and 54 as illustrated in Fiyur.es 1-3.
As is best illustrated in ~igure 4~ the fastening member 60 includes 1~ a pair of legs 66 adapted ~o penetra~e ~he tl~sue portion~ ~nd 2) a llnk 68 which is o~nne~ted to ~he leg~ 66 and which i5 adap~ed to lie ~ubst~ntially ~ga$n~t one of the ~is~ue 3C p~rtions (e-g- ? tiæsue p~rtion 54 ~n F19ure 2). The legs 66 of the astening ~ember are generally parallel ~o eaGh other a~a ~re gener~lly perpendiculær ~9 ~he link 68. Preferably, ~ach leg 66 has ~ ~olid, generally ~ylindrical o~nfigurat~n ~ith ~ conical end 3~ 70 (Figures 4 6) to f~cilitate or aid in the .

penetration of the tissue ~ortions. The link 68 may have the regul~r parallelpiped shape illustrat2d or may have any other suitable shape.
As best illustrated in Figures 7-9, the receiver 62 includes a central member 72 joining a pair of leg receiving members 74. Each leg receiving member 74 defines a~ least one p~sage 76 i.-or receiving one of the fastening ~ember legs 66 as best illustrated in Figure 39 If the fastening member legs 66 have a cylindrical configuration as illu~trated, then the receiving member passages 76 are preferably cylindrical bores o sufficient diameter to permit ~he legs 66 to be received ~loosely or in slid~ng engagement). Each receiving member 74 and the passage 76 defined therein lS cooperate as means for receiving and encompas~ing at least a portion of one of the fastening ~ember legs 66 after ~he leg has been in~erted through the ti~sue portions as best illustrated in ~igures 2 and 3.
Preferably, each receiving me~ber 7~ of ~he receiver 62 defines a first aperture 78 ~Figures 3 and 9) co~munica~ing from the exterior of the receiviny ~ember 74 wlth the interior of the passage 76. Also, a ~e~ond aper~ure 80 (Pigures 3 and 9) i~ provided in the receivin~ member 74 opposite the fir~t ap~rture 78 for ~ommunicating be~ween the exterior of the receiving ~ember 74 and the interior of the pa~sage 7~. ~t least one of these ~wo apertures 78 and 80 i8 intended to scoo~od~te the inser~ion of a r~m-like aember of a tool or instrumen~ for defor~ing ~he fa~tening ~ember leg 66 in a manner des~ribed in d~tail hereinaf~er.
The other of ~he aper~ures 78 and 80 ~ay ~unct$on ~o pos~t~ on the re~ei~er 62 ~hin ~he ~ns~rument in a manner Al~o de~cribed in detail her~inafter.
The fastening ~e~ber 60 and ~be receiver 62 may be formed from ~uitable ~a~er$al~, ~ueh a~

~25~

thermoplastic polymer m~terials that are absorbable by mammalian tissue. For example, the fastening member 60 has bee!n ~atisfactorily molded ronn a ~opolymer of lactide and glycolide. Preferablyl, the fastenîng member 60 is molded in a heated moLd, is pos~ scoured, and is annealed.
METHOD FOR APPLYING TEE FASTENER
--- According to the novel method of joining tissue portions with the above-described fastener 50, the tissue portions 52 an~ 54 ~igures 1~3) are approxi~ated in surface~to-~urface relationship. The fa~tening member 60 is then p~sitioned on one side of the ti~sue port~ons with the legs 66 oriented at an appropriate angle to penetrate the tissue portions.
is The receiver 62 is held on ~he other side of the tissue portions opposite the fastening member 60 and generally in alignment with the fastening member legs 66.
Specifically, the passages 76 are aligned ~ith ~he fastening member legs 66.
Next, relat~ve movement between the fastening member 60 and the receiver 62 is sffected to urge the fastening member and the receiver closer together to cause the fastening member legs 66 to penetrate the ~issue portions 52 and 54 and *o loc~te at Iea~
portions of the ~astening member legs 66 wi~hin the receiver 62. The relative ~ov~ment betwèen the fastening ~ember 60 ~nd the receiver 6?~ i8 t~rmin~ted when ~he ~astening member link 68 i8 ~t ~ de~ired ~i~tance from the receiver 62 to ~ecure the ~i~sue portions together. Preferably~ ~his ~ovement is tarminated after the ti~ue pDrtions hAvg ~een mpressed toge~her a de~ired amount.
At thi~ pDint, the di~t~l ends of ~he fastening ~e~ber leg~ 66 ~ ypically protrude from the receiver opp~si~e the ~ide of ~he r~ceiver tha~ is contaeting one of ~he tissue portions. ~n ~igures 1 2, the legs 66 are not shown protruding beyond the receivec 62 since, in accordance with a preferred further step of the method, the protruding p~rtions have been severed flu~h wi~h the xeceiver 62, An instrument for applying the fa~tener 50 and severi~g the legs 66 are described in detail hereina~ter.
_ Xowever, ln its broadest form, the method of applyin~
the ~asSener 50 to the tissue portions does not neces~arily require the ~everance of the protruding portions of the fastening ~ember legs 66.
Regardless of whether or not the protruding p~rtions of the fastening member legs 66 are severed~
the fastening member legs 66 and/or the receiver 62 are acted upon in a certain manner to effect an engagement of the legs 66 with the receiver 62 to hold the two tissue portions together. To this end, in a preferred form of the method, each fastenlng member leg 66 is deformed or coined to force a bulged out portion 79 of each fastenin~ member leg 66 ~nto engagemen~ with the receiver 62.
Specifically, as bes~ illustrated in Figures 2 and 3, a force may be applied by ~eans of a tool ~r instrument through one or both.of ~he apertures 78 and 80 ln the re~eiver 62 and against a port~on of each leg 66. The amount of or~e i~ such that the pre~sure on each leg 66 defor~ a port~on 79 of the le9 materlal outwardly into either end of one or bo~h ~f the apertur~s 78 and 80 as ~s best illustrated ~n Figure 2.
To acoom~odate this bulglng out of the 1~9 portion 79, the ~pertures 78 ~nd 80 have ~ ension (mea~ured normal ~o longitudinal ~xi`~ of the pa~age 76) that i~ greater than the ai~ension o~ ~he pa~sage 76 ~measur~d n~rmal to the longitudinal ~ of ~he passage). In ~he embodiment illu~trat~d in ~he ~gures ~5~

1-9, the apertures 78 and B0, when viewed from the ~ide, are seen to each have a generally right rectangular oonfiguration (with ~omewhat rounded corners) with a length greater than the diameker of the cylindrical bore passage 76. This aeoommoda~es tbe bulged out portion 79 of the fastening ~ember leg ~aterial and thus effects a ri~et-like engagement of the leg 66 ~ith the receiver 62.
It has been found that the above described method of applying the fastener 50 to the ti~sue portions results in a relatively strong retention structure ~omprising the fasteniny member 60 and engaged receiver 62. Further, one 8i ze fastener 50 may - be u~ed for a varie~y of different tissue thicknesses since the fas~ening member 60 can be in~ertea into th~
receiver 62 to the desired depth and the leg~ 66 can then be deformed ~o effect the engagement of the legs and recei~er with the desired amount of ti~ e compression. This deformation ~an take place at any point along the length of each leg 66, depending on tis~ue ~hickness. Such a fast~ner ~ru~ture and ~e~hod of applying the faste~er readily acoommodate applic~tion ~f ehe fa~tener 50 by ~e~ns of a ~uitable instrumen~ tha~ can be designed to apply a plurality of ~uch fa~teners simultaneously.
With the embodiment of the fasten~r 50 described above, th~ 1~9~ 66 ~re deformed ~nto engag~ment w~h the receiver 62. ~ow~ver~ lt 1~ ~o ~e under to~d th~t ~he leg~ 66 ~y be for~e~ with ~per~ures or no~ch~ ~no~ illu~tratea~ and ~h~
portions of the recelver 62 ~ay be defor~ed lnto the leg notches or ap~r~ures for ~f~eeting the ~ngagement between the receiver 62 and fasteninq ms~ber 60~
Further9 a o~mbination of both the ~eformation of the receiver 62 and ~he ~eform~tion of the legs ~6 ~y a1BO
ET~-548 7~

-~4-be used to effec~ engagemen~ of ~he receiver 62 and fastening ~ember 60.
With the ~bove-described method, the protruding portions of the astening member legs 66 may S be seveled during or after the step of deforming the legs 66 and/or re~eiver 62. Preferably, during the step of severing the protruding portions of the _ fastening member legs 66, ~he protruding portions of the ~astening ~ember l~gs are surrounded with a 6uitable oontainer for catching the leg protruding portions after they are s*vered so as to prevent the severed portions of legs from falling ~to ~he surrc~unding tissue or body cavity.
The material from which the fas~ening member legs 66 are formed is preferably selected to accommodate the de~orming action. To this end, oopolymers of lactid~ and glycolide have been found to work satisfactorily. If just the legs are to be de~ormed, ~he recelver 62 need not be fabricated from such a relatively ea~ily deformable matetialO On the other hand, the oopolymers of lactide and glycolide may be made relatively ~nelastic enough to ~unction well as a receiver als~s even if it i~ not lntended that the receiver be de~ormed.
Regardless of the 1Daterials selected ~or the fastening member 60 and receiver 62s it may be desirable to effec~ ~he method of de~o~ing the fa~tening leg~ 66 ~nd/or receiver 62 with the ~aid of heat to ~of~cen ~he material. Su~h heat may be provided by a suitable proc~e~ (e.g., eleetrical re6~Hnce heating). Such hea~ing would redu~e the ~agnit~de of the mechan$cal forc~s required to effec~ ~he ne~e~sary deforma~ion~

~TH-54B

FASTENER APPLIER INSTRU~ENT
A tool or ins~rument ~or alpplying ~he first embodiment of the fas~ener 50 ~s i].lu~tra~ed in Figures 10-19 and is designated generally by the reference S numeral 100. ~s is best illus~ra~e!d in Figures 10, 11, and 12, the instr~fflent in~l~de a fir~t ~aw 101 for holding the fas~ening ~ember 60 on one side of the ti~sue p~rtions w~th the fastening ~ember legs 66 orien~ed a~ an appropriate angle to penetrate the ti~sue portions 52 and 54. The in~trument 100 further includes a se~ond jaw 102 for holding the receiver 62 on the o~her side of the ti~sue portions opposite the fastening member 60 and generally ~n ~lignment with the fastening member legs 66.
The first ~aw 101 and second iaw 102 are pivotally mounted together about a pin 104. Also pivotally mounted to pin 104 i~ a fastening member driving frame lOfi which function~ as a means for moving the fastening member 60 relative to the first jaw 101 2a to penetrate the tissue portions 52 and 54 with the legs 6S of the fa~tening member and ~o ~ocate at least portions of the fa~tening member legs 66 within the receiver 62 held in the ~eoond jaw 102.
A first 8ci~80r8-typq handle lever 108 extends rearwardly from the driving fra~e 106. Therefore, the fastening member ~ovin~ means or drlving fr~e 106 can be regarded a~ being mounted to, and e~ending ~orwardly from, ~he flr~t hsndle l~ver 108. The first handle lever 108 defin~s ~ ~Y~ ~onf1gur~tion ~h~re it i~ joined to the dr~ving fra~e 106~ hi~ ~o~nt, the fron~ end of the handle l~Yer 108 de~ln~ an engaging ~urface 109 for engaging ~he lo~er ~terior ~r~ion of the s~cond j~w 102 when the ~a~s ~01 ~d 102 are clo~ed : ~Figure 16).

~5~3B7`-?

A second scissors-type handle 110 is pivotally mounted about ~ pin 112 to the upper rear portion of the seeond jaw 102. The se~ond j2W 102 can be alternatively regarded as being pivotally mou~ted to, S an~ extending from, the second handle leYer 110. Bo~h handle levers 108 an~ 110 are adap~ed for relative movement to~ard and away from each other.
As best illustrated in Figure 13, the second handle lever 110 is biased outwardly from the first handle leYer 108 by means of a helical ~ompressio~
spring 114 ~Figure 13). The ~pring 11~ is disp~sed - within a bore 116 in the upper rear portion of the ~econd jaw 102 and ~ears upwardly against an annular bearing ring or plate 118 which is secured to the unaerside of the second handle lever 110.
As best illustrated ~n Figure 13, ~he first jaw 101 is mounted to the pin 104 in the manner that perm~ts the first jaw 101 to move relative to both the fastening member driving frame 106 and the second ~aw 102. The first jaw 101 i~ adap~ed to oDoperate wi~h the astening member drivlng frame 106 a~ bæst lllustrated in Figures 12 and 14. Specifically, the front end of ~he jaw 101 defines a pas~ag~ in the form of a ~-shaped slot 120 ~or reoeiving ~he fastening 25 m~mber 60 for receiving a general~y T-shaped pu~her member 122.
As best illustr~ted in Figure~ 13 ~nd 14, the cros6wise portion of the ~-sh~ped ~lot~or passage 120 fun~tions as a ehannel ~or ~rictlonally receivlng the fas~ening member 60 and the croæ~ ~ar portion of the pusher member 122. The ba~e of ~he pusher ~ember 122 extends out of the ~lot 120 and i~ ~iidsbly dlsposed with1n an aperture 126 at ~he front of the f~tenlng member driving frame 106 as bes~ illus~rated ~n Fi~ure ~5 18. This moun~ing of the pusher me~ber 1~2 in the ~TH-54B

frame 106 facilitates entry of ~he pusher member 122 into the T-shaped slot 120 of the first jaw 101.
The pusher ~ember 122 pref.erably includes an upwardly projecting tab 123 (Figur~ 13) o retain the pusher ~ember 122 within the fastening member driving frame 106 when the frame 106 is ~il.ted upwardly in the orientation shown in Figure 13.
_ The second jaw 102 holds ~.he fastener receiver Ç2 in a ~lot 127 as best illustra~ed in Figure 14 and houses ~he fas~ening member leg deforming and severing mechanism as is next explained in detail. The lower ~aw 102 includes ~ generally cylindrical anvil member 130 slidably disp~sed within a cylindrical bore 132 and biaæed outwardly a predetermined amount by means of a helical ~pring 134. Tbe dist~l end of the anvil 130 has a curved or somewhat hemi~pherical configuration adapted to enter into one of the re~eiver apertures 78 or 80 (Figure 9) to vertically position the receiver 62 withi~ the second ~aw 102. Lateral positioning o the 20 receiver 62 in the ~econd jaw 10~ is effectea by the four walls defining the slot 127 in the lower ~aw 102.
To accommodate the insertion of the re~eiver 62 into the ~econd iaw 102, the bo~tom of the receiver 62 is preferably rounded ~o ~s. to t~ngentially es~gage 25 the hemispherical end of the anvil laember 13û and cause the anvil member 130 to be pu~hed rearwardly against the ~pring 134 until the receiver apert~res 78 ~nd Bû
are aligned with the anvil ~ember 130. At thl~ point, the anvil me~aber 130 ~ bi~sed outwardly into one of 3û the rece$ver apertures to fix the vertlcal po~ition of ~he re~eiver 62 in the second ~aw 102.
~ s bes~ illu6tr~ted in Figure~ 13, 17, ~nd 18, a pair of deformin~ me~bers 150 are ~ounted ~or movement within the ~eoDnd i~w 102. Pref~rably, as best illustrated in Figures 13-17, the defor~lng ~T~-548 members 150 are part of a uni~ary reciprocative actuating member 15~ which is slidably disposed irl a receiving cavity 156 (Figures 16 and 18) in the second ~aw 102.
Also unitary with the reciprocative actuating member 154 are two cutting b,lades 160 which are spaced below, and in ali~nment with, the deforming members 150.
. A novel means is provided for ~oving the deforming member~ 150 and the cutting blades 160 forwardly into the fastener. Specifically, the reciprocative actuating member 154 includes a flexible drive member 170 extending rearwardly in ~n arcuate channel 172 in the second ~aw 1~2. ~he flexibl~ drive member 170 includes a disk 174 at its distal end which 15 is received in a cylindrical bore 176 defined in the sec~nd handle lever 110.
Normally ~ when the handle lever~ 108 and 110 are in the unactuateA, open position illus~rated in Figure 13, the spring 114 biases the handle levers 108 2û and 110 apart so that the annular ring 118 ~ecured to the se~ond handle lever 110 pulls up on the di~k 174, and hence pulls the attached flexible drive ~mber 170 upwardly and rearwardly relative to the front of the instr~nent. This causes the recipro~ative actuating member 154 to be pulled rearw~rdly ln it~ recei~ing ~vity 156 1:o ~he fully retr~cted position illu~'crated in Figure 13. *-On the other han2, when th2 handle le~ ers 10û
and llû are closed in the orient~ n I llustr~ted in 3Q Figure 16, di~k 174 i~ ~oved do~nwardly by the ~econd handle lever 110 to force the drive me~ 170, and hence the a~tua~ g ~ember 154, f~rwardly to the extended position lllustrated in Figures 16 ~nd 18.
The re~ultirlg action of the deforaning member~ 150 and blad~s 160 on the fastener i~ described ln de'cail hereinaft~r ~ETH-548 ~19-A~ best illustrated in Piqure 13, the second handle lever 110 is prefer~bly provided with a pair of depending skirts 177 (one of which i~ visible in Figure 10 and the other of which is visib]Le in Figure 13) to inhibit access to the flexible drive member 17D and spring 114. A15Q~ as best iilustrated in ~igure 13, the upper rear p~rtion of the ~econd jaw 102 defines a flat abutment surface 180 between the ~kirts 177 for ec~operatin~ with the undersiae of t~e ~econd handle 10 lever 110 to limit the movement of the second handle lever 110 relative to the ~ec~nd jaw 102 and, hence, relative ~o the first handle le~er 108. ~his, of course, limlts the forward travel of the rec:Lprocative actuating member 154 to the positon illustr3~ed in Figure 16.
In ope~ation, the tool is initially oriented as illustrated in Figure 13 with the first jaw 101 and the second jaw 102 tempQrarily held apart to permit ~he insertion of the receiver 62 into the ~lot 127 of the lower jaw 102. ~hen properly inserted, the receiver is engaged as described above by the anvil ~ember 1309 ~ext, the fas~ening member 60 is inserted in ~he drivins frame channel 120 ~s illus~ra~ed ln ~igures 13 and 14. Then, as illustr~ed in Figure 14, the fir~t jaw 101 and the ~eo~nd jaw 102 are d~sp~ed on either side of the tissue p~rtions 52 and ~4 that have been approxi~a~ed in ~urface-to-~urface~relationship.
The first handle lever 103 i8 pulled toward the ~ond handle lever 110 to bring the pusher ~ember 122 o~ 40p of ~he fasteninq ~ember 50 ~nd in~o the chann~l 120.
Initially, the ~econd h~ndl~ lev~r 110 doe~ not pivot rel~tive to the ~e~nd jaw 102 becau~e the force ~pplied to the hændle lever 110 i~ ~ot qreat enough ~o overo~me the for~e of ~pring 11~. Con~quently, rela~ive movement occur~ between ~he ~riv~ng ~r~me 106 -20~
and the seco~d jaw 1~2 so tha~ the pusher member 122 forces tvhe ~astening mem~er 60 through the ~issue portions, 52 and 54 and into ~he receiver 62.
In the instrument embodi~ent illustrated in ~igures 13-16, the downward movement of the pusher member 122 terminates when the driving frame 106 pivots to the orientation illustra~ed in ~igure 15. A~ this _ point, the engaging ~urface 109 of the first handle lever 108 engages the bottom exterior ~urface o~ the ~e~nd jaw 102 and prevents ~ further pivoting of the frame 106 and second jaw 102 about the pin 104. This precludes undue compressi~n of the t~ssue portions 52 and 54. However, it ls to be realized that the engagement of the ~econd jaw 102 by the first handle lever 1~8 may not be necessary in ~ome situations and that no limitation of the downward movement of the pusher member 122 need neces~arily be provide~l.
If the eng~glng ~urface 109 is provided on the handle 108 for engaging the ~econd ~aw 102, then further movemen-t of the fir~t handle lever lOR ~owards the second handle lever 110 is prohibited when the first handle lever 108 reaches the orientation illus~rated i~ ~igure 15~ At this point, any further force applied to squee~e ~he ~o ~ogether handle levers 108 and 110 acts to overcvme the force of ~prin9 114 and to cause the ~eoDnd handle lever 110 to pivot about the pin 112. Thi~ drives ~he reciproca~ive actuating member 154 forwar~ to the po~i~ion illustrated in Figure 16.
When ~he ~eoond handle lever 110 engages the top ~urfa~e 180 ~f the rear pDr~ion of the ~eoQnd jaw 102, further orward m~v~m~nt of the re~iproaative actuating me~ber 154 is nece~sarily prevented. At this poin~; the defor~ing ~ember~ 150 have be~ome positioned :
wlthin the ~pertur~ (7B or 80 in Figure 9~ of ~be ~TH-548 -21;
receiving member b2 and have deformed a portion of each of the fastening member legs 66 to ~hereby effect an engagem.ent of the fastening ~ember legs 66 and receiver 62 in the manner described in detail above with respect to Figures 1-9.
Similarily, when the actuating ~em~er 154 is in the extend~d position as illustrated in Figure 16, the ~paced-apart cutting blades 160 have ~oved acros5 the bottom of the receiver 62 to ~ever the protruding 1~ por~ions o~ ~he legs 66 from the ~actening member ~0 at substantially the same time the legs are being deformed into engagement with the receiver 62 by ~embers :L50 .
Preferably, the cutting blades 160 are arranged to sever the protruding portions of the legs flush with the bottom of the receiver ~o as to eliminate the possiblity of protrusions that oould injure surrounding tissue.
Even if the engagement surace 109 is not provided as part of the fir~t handle lever 108 and 20 associated frame 106, the instrument 100 will function in the same manner as jus~ described. Specifically, even ~hough the downward ~ovement of the pusher ~ember 122 is not terminatea by mechani~al engage~ent of interacting parts of the in~tr~nent; the force required 25 to compress the ti~sue portion~ 52 and S4 bet~een the fa~3tening member l~nk 68 and the econd jaw 102 eventually becoines 80 great ~cha~ the spring 114 i~
overcome and the ~econd handle 110 piYotE; ~:0 the position il7ustr~ted in Figur~ 16 ~o ~ffect ~che deformat~o~ of ~he g~ten~ng me~ber legs 66 and ~he ~everance of the protruding po~t~n~ of tbe leg~.
If desire~, t~e instru~en~ 100 ~y be provided with ~eans for heating the deforming me~ber5 150.
Although n~t illu~trat~d, ~uch ~e~ting me~n~ o~uld ~n~lude elec~ri~al r~si~ance hea~ing element~ pDwered by a suitable ba~tery. ~ea~ing of ~he deforming members 150 would reduce the amount of force required to ~ause deormation of the fastener leg material.
After the fa~tener 50 has been applied as illustrated in Figure 18, the handle levers 108 and 110 are opened. The ~econd jaw 102 can be disenyaged from the receiver 62 by pulling the seoond jaw 102 away from the receiver 62 5which is now secured to the ti~sue with the fastening ~ember 60). It is possible to 10 disenqage the ~econd ~aw 102 from the receiver 62 because the curved distal end of the anvil 130 in the ~eoond jaw 102 will be forced further into the receiving cavity 132 and out of ~he rPceiver aperture as the second jaw 102 is pulled downwardly past the 15 bottom of the receiver 62.
Figure 19 illustrates a ~nodification of the instrument 100 shown in ~igure~ 10-18. Specifically, a cage, housing, or container 192 is provided at the bottom of the second jaw 102 for receiving the severed portions of ~he fastening member legs 66. This prevents the severed portions of the legs from fall~ng into the body ~avity. ~he housing 192 can be designed so it is readily movable from the ~econ~ ~aw 102 when desi red for di ~posing of the ~e~ered leg portions.
Although the $nstr~nent 100 has been illustrated as being des~gned to deform th~ ~asten$ng member legs into engagement ~th the r~eiver ~ubstantially ~i~ult~neously with the step o~ ~vering the protrud~ng en~ of the leg~, it i~ to be realized ~hat ~he ~tep of severing ~he leg~ ~ay be effect~d before or after t~ defor~ation ~tepO
Furth~r, although the in~trument 100 preferably include~ the cutting bl~es 160 for ~e~ering thQ proiecting pbrtions of the legs 66 ~s de~cribed above, in ~ome appl16ations ~t ~ay not be desir~ to ~TH-548 ~ 23-sever the legs. In sueh applications t the cutting blades 160 may, of ~D~rseg be omittea from the instrumelllt i de~ired.
Although the ~nstrument 100 has been i11UBtrated as designed for applying one fastener at a time, it is to b2 realiged t~at the in~trument may be ~od~fied ~o apply a p~urality of fasteners _ ~imultaneously. ~or example, the jaws oould be ~ade ~onsiderably wider and ~ould be provided with a plurality of cavities 132 and passages 120 for holding th~ receivers 62 and fastening members 60, respectively, and with a plurality of pusher members 122.
HE FASTENER: SECOND EMBODIMENT
The seoond embodiment of the fastener is illustrated in Figures 20-24 and is designated generally by the reference numeral 50A. The elements of the second embodiment 50A that are identical or ~nct~onally analogous to those of ~he first embodi~ent 50 are designated by reference numerals ldentical to those used for the first embodiment with the exception that the second emb~diment refer~nce numerals are fo~lowed by ~he upper ~ase letter A whereas the first ~mbDdiment r~ference numerals are not ~ollowed by any letter.
~ ~he fa6tener 50A ha an open loop or U-shaped : . 25 fastening member 60A with legs 66A ~ubstantially identical to the fa~en~ng member 6~ of the first embodiment descr~bed above with r~fer~nce to Figures 1-9.
~ he a~tener 50A ~18Q lnclu~s a recei~er 62A
w~ich is ~i~ilar t~ ~he receiv~r 62 of the firs~
embodi~ent of the fa~tener 50 describe~ abo~e with reference ~o Figur~s 1-9. ~he recei~er C2A has central ~ember 72A ~oining ~ pair of leg re~eiv~nq member~ 74A. ~ach leg receiv~ng m~mber 74~ defines a generally cyl~ndrical bore 76A for r~ceiving one of 3~ the fastening me~ber leg~ 66A.
ETH-~8 Further, esch receiving member 74A defines one aperture 78A communicating between the exterior of the receiving member and the interior of the bore 76A. Unlike the receiver 62 of the first embDdi~enk of ~he fa~tener 50 described aboYe wi~h reference to Figures 1-9, the receiver 62A does not have a second aperture opposi~e the aperture 78~. The aperture 78A
_~. functions to a*mi~ a deforming ~emher of a suitable instrument tha~ is used in ~pplying the ~as~aner 50A
to tissue portions. ~he deforming ~ember of the instrument would pass through the ~perture 78A and deform the leg 66A to produce a bulged out portion 79A (Figure 20). To accommodate the bulged out por~ion 7gA, the aperture 78A has a dimension ~as measured in the direction normal to the longitudinal axis of the fa~tening member leg) which is larger than the diameter of the leg re~eiving bore 76A.
Thus~ ~he bulged out por~ion 79~ ~c~s to retain the ~astening member 60A ln ~he receiver 62A.
The second embodimen~ of the fastening rnember 50~ may be applied with a suitable irlstrument similar to the instrument 100 described abo~e with reference ~o Figures 10-19. ~owever, su~h an inst:rument would not require t~e ~pring bia~ed anvil (anvil 130 illustrated ~n Figure 18). Other ~ui~able ~eans for temporarily ali~ning the receiver 62A
vert$~ally wlthin the instrumen~ low~r ~ w would be providedO
THE FASTENER: THIRD ~MBODIMENT
A third e~bod1~ant of the ~ en~r is illust~ate~ 1n Figure~ 25 29 ~herein ~he fast~ner i~
~e~igna~ed generally by reference numeral 50Bc ~he element~ of the third emb~ai~ent o~ the ~ast~ner 5Q~
that are ~denticaL or fun~tion~lly anaglous to those of the fir5t ~mbDdiment of the f~s~en~r 50 are designated by re~erence numerals identiGal ~o those used for the first embodiment with the exception that the third embodiment reference numerals are followed by the upper case letter B whereas no letter ~ollows ~.he first embodiment reference numerals~
The third embodiment of the fastening member 5QB includes a generally ~-shaped fastenins member 60B that is substantially identical, ~n the unappl~ed condition, ~o the fastening member 60 of the firs~ embodiment of ~he fa~tener 50 described above with reference to Figures 1-9. The ~hird embodiment of ~he fastener 50B also ~ncludes a receiver 62B that includes a ce~ral member 72B
joining a pair of le~ receiving member~ 74B. Each lS leg receiving m~mber 74B de~ines at least one passage, such as a cylind,rical bore 76, or receiving one of the fas~ening me~.,ber legs 66B.
` ~he height of ea~h leg receiving member 74B
i5 less than the height of each leg receiving m~mber 74 of thc firfit emb~iment of the fa~tener S0 described ~bove w~th reference to Figures 1-9.
Further, n~ apertures ~such as aperturçs 78 ~d 80 $n the rec~ver 62 of the first embodiment of the faste~er 50 illu~trated in Figures 1-4) are prov~ded~ Rather, the legs 66B ~re deformed, a~ by produoing ~ bulge 79B (Figure 25), adja~ent the ~ide o~ the re~e~ver 62B that faces a~ay fro~ the tis~ue r~ortion 52 and 54.
The deforrnation of the astening membe~
legs 66~ may be e~fected with a instru~ent ~milar to the instrument 100 describ~d ab~ve ~ith re erence to F$gures 10-19. ~owever, the spring biasea ~nvll 130 of the instrument lU0 (Fi~ure 18) n~ed not be provided~ ~ather~ a fixed ~nYil ~y be pro~ided in ~uch an instrument ~mmediately below the bDtto~ of the receiver. In addition, the cutter blades ~such as cutter blades 160 of the instrument 100 illustrated in Figure 18) would be spaced below the bottom of the receiver 62B by an amount sufficient to accommodate the deformed por~ion 7gB of the fastening - member legs.
THE FASTENER: FOURTH EMBODIMENT
- Although not illustrated, the fastener design may also include an interferenc2 fit or friction fit feature. For example, the fastening ~ember legs may be pr~vided with protrusions for engaging suitable portions of the receiverO The friction fit would provide a retention restraint in addition to the restraint provided by the permanent deformation of the legs ~nd/or receiver.
ALTERNATIVE DESIGN FEATURES
In the figures, the two legs of the fastening member are connected by a portion of the fastening member (e.g., the link or clamping member) which is illustrated as being generally straight and - extending perpendicular to the two legs. ~he structure need not be limited to such a shape however. Instead, all or a portion of the length of the fastening member between the two legs may be arched or arcuate or may include an arcuate portion (e.g., an inverted U-shaped configuration)O This would function to initially provide a fre~ space between ~he upper tissue por~ion and the top of the fastening member to allow for ~ome expansion ~f the tissue.
However, in those situation~ where increased initial tissue compression is desired, a modified receiver structure may be provided to co~perate with the above-des~ribed arcuate fas~ening member. Specifically, the re~eiver need not have a ETH~548 flat upper surface as illustrated, Rather, the upper surface of the receiver may be arcuate (e.g., convex) so as to ~Fenerally match or correspond with the arcuate sh.ape of the fastening member. This can result in an increased compression of the two tissue portions between the receiver and fastening member.
From the foregoing, it will be observed that numerous variations and moaifications may be effected without departing from the true spirt and scope of the novel concept of the invention. It is to be understood that no limitation with respect to the specific articles, instruments, and methods illustrated herein is intended or should be inferred. It is, of course, intended to cover by the appended claims all such modifications as fall within the scope of the claims.

Claims

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. A fastener adapted to hold together separated portions of mammalian tissue, such as are defined by a wound or incision, to facilitate healing of the wound or incision, said fastener comprising:
an open loop fastening member, said fastening member comprising a pair of legs adapted to penetrate said tissue portions and a link connecting said legs that is adapted to lie substantially against one of said tissue portions;
a receiver adapted to be disposed against the other of said tissue portions opposite said fastening member, said receiver having means for receiving said fastening member legs after said legs have been inserted through said tissue portions;
at least a portion of each of said legs or at least a portion of said receiver consisting of a material that is initially deformable under the application of a predetermined amount of pressure to effect engagement of the fastening member legs and receiver after the tissue portions have been penetrated by said fastening member legs and after said legs have been received in said receiver.

2. The fastener in accordance with claim 1 in which said fastening member is a generally U-shaped member, in which each of said legs has a generally solid cylindrical shape, and in which the end of each leg opposite said link has a generally conical configuration to aid in tissue penetration.

3. The fastener in accordance with claim 1 in which said legs are generally parallel to each other and are generally perpendicular to said link.

4. The fastener in accordance with claim 1 in which said fastening member is molded from a thermoplastic polymer and in which said receiver is molded from a thermoplastic polymer.

5. The fastener in accordance with claim 4 in which said receiver is molded from nylon.

6. The fastener in accordance with claim 1 in which said fastening member is molded from a thermoplastic polymer in a heated mold, in which said fastening member is post-scoured, and in which said fastening member is annealed.

7. The fastener in accordance with claim 1 in which said receiver includes a central member joining a pair of leg receiving members.

8. The fastener in accordance with claim 7 in which each said leg receiving member defines at least one passage for receiving one of said fastening member legs.

9. The fastener in accordance with claim 8 in which each said passage is a generally cylindrical bore.

10. The fastener in accordance with claim 8 in which each said receiving member defines a first aperture communi-cating from the exterior of the receiving member with the interior of said passage and a second aperture opposite the first aperture communicating from the exterior of said receiving member with the interior of said passage.

11. The fastener in accordance with claim 10 in which each said aperture has a generally right rectangular configuration.

12. A fastener adapted to hold together separated portions of mammalian tissue, such as are defined by a wound or incision, to facilitate healing of the wound or incision, said fastener comprising a fastening member having a pair of legs adapted to penetrate said tissue portions and a link connecting said legs that is adapted to lie substantially against one of said tissue portions; said fastener further comprising a receiver adapted to be disposed against the other of said tissue portions opposite said fastening member, said receiver having receiving means for receiving and encompassing a portion of each of said fastening member legs after said legs have been inserted through said tissue portions, at least a portion of each of said legs consisting of a material that is initially deformable under the applica-tion of a predetermined amount of pressure exerted by a tool or instrument to deform said material against portions of said receiver adjacent said receiver receiving means to thereby effect engagement of the fastening member legs and the receiver after the tissue portions have been penetrated by said fastening member legs and after said legs have been received in said receiver receiving means.

13. An instrument for applying at least one fastener to hold together separated portions of mammalian tissue, such as are defined by a wound or incision, to facilitate healing of the wound or incision, said fastener including an open loop fastening member that comprises a pair of legs adapted to penetrate said tissue portions and a link connect-ing said legs that is adapted to lie substantially against one of said tissue portions, said fastener further including a receiver adapted to be disposed against the other of said tissue portions opposite said fastening member and adapted to accept the legs of the fastening member, said instrument comprising:

a first jaw for holding said fastening member on one side of said tissue portions with said legs oriented at an appropriate angle to penetrate said tissue portions;
a second jaw for holding said receiver on said other side of said tissue portions opposite said fastening member and generally in alignment with said fastening member legs;
means for moving said first and second jaws between an open position for receiving said tissue portions therebetween and an at least partially closed position;
means for moving said fastening member relative to said first jaw to penetrate said tissue portions with the legs of said fastening member and to locate at least portions of said legs of said fastening member within said receiver in said second jaw;
a deforming member movable relative to said second jaw member for being urged against the fastening member legs, the receiver, or both to deform the fastening member legs, the receiver, or both to thereby effect an engagement of the fastening member legs and receiver; and means for moving said deforming member to effect said deformation.

14. The instrument in accordance with claim 13 further including first and second handle levers connected for relative movement toward and away from each other, said fastening member moving means being mounted to and extending from said first handle lever, said second jaw being mounted to and extending from said second handle lever, and said first jaw being mounted to said instrument for movement relative to both said fastening member moving means and said second jaw.

15. The instrument in accordance with claim 14 in which the first jaw includes channel for frictionally receiv-ing said fastening member and in which said fastening member moving means includes a pusher member for engaging said fastening member and being received in said first jaw channel adjacent said fastening member.

16. The instrument in accordance with claim 13 further including a movable anvil member in said second jaw for engaging a portion of said receiver and said fastening member legs and further including means for biasing said anvil member into engagement with said receiver and said fastening member legs.

17. The instrument in accordance with claim 13 further including a cutting blade associated with said second jaw and further including means for moving said blade relative to said second jaw adjacent said receiver to cut off portions of said fastening member legs extending beyond said receiver when said jaws are in said at least partially closed position

18. The instrument in accordance with claim 17 in which said instrument is adapted to apply one fastener at a time and in which said instrument includes a reciprocative actuating member slidably disposed within said second jaw;
in which said deforming member and said cutting blade are unitary with said reciprocative actuating member; in which said instrument includes a handle lever pivotally mounted to said second jaw; in which said instrument further includes handle lever biasing means for biasing said handle lever into a first position relative to said second jaw; and in which said actuating member includes a drive member adapted to be engaged by said handle lever when sufficient force is applied to said handle lever to overcome said handle lever biasing means and move said handle lever relative to said second jaw away from said open position for engaging said drive member to thereby move said actuating member relative to said second jaw to effect the deformation with said deforming member and the cutting off of said fastening member legs with said cutting blade.