CA2026534A1 - Apparatus for attaching surgical suture components - Google Patents

Abstract

ABSTRACT
A pair of dies is disclosed for attaching a surgical needle having a generally cylindrical end portion defining an elongated aperture having a generally circular cross-section and a suture having a generally elongated end portion of generally circular cross-section corresponding in dimension to the elongated aperture of the first needle.
Each die has a pair of extensions spaced apart from each other and defines a generally circular crimping surface portion corresponding in dimension and configuration to the generally cylindrical outer surface portion of the needle.
The space defines a unique relief zone between the pair of extensions of the die and is of configuration and dimension sufficient such that when the ssuture is positioned within the aperture of the needle and the dies are respectively positioned about the corresponding portion of the needle, the application of impact force to the dies will cause crimping of the needle with respect to the suture so as to attach the suture and the needle while portions of material forming part of the needle adjacent the stricken area are permitted to be deformed and to collect within the relief zones defined between the pairs of arcuate surface portions.
Generally arcuate die overlap portions may be optionally provided on each die. A method of attaching a surgical needle to a suture is also disclosed.

Description

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(8843) ~PPARAIUS FOR ATTAC~ING SURGICAL SUlrURE_COMPONENTS

Background of the Invention 5 1. ~,eld o ~ the Ir,v~tion The present invention relates to surgical sutures and their productlon. In partioular, ~he invention relatas to surgical ~utures and apparatus for the atta~h~ent o~
surgical needles to surgical sutures.

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In th~ past~ surgi~ l needles With an ey~ ~or 15 raception o~ the~ ~utura have b~en used. ~ in co~ventional ~ewing~ tha thr~aad ls ~o~aetis~le doubl~d through thQ eya o~
t~ needle. The doubled end o~ th~ 1thxead ln th~ eye ~ust pass through tis~ues d~ring~ UIE;Q, 6~hich Q5~ar~as th~ openlng ~ad~ ~n the tissue. Th~s le~d8 to lo. 8 oi~ tightnes asld i~cr~a~ed tr~uma. Du~ to this pro~lem, th~r~ h~s ~e~n ~
tr~nd toward~ ~yel~ n~Qdl~ ln w~h ~ ~ ~n~ o~ ~h~ ~uture ~ attaGh~d to the n~dle ~o tha~ the ~utu~e ~ pulled through the t~s~ue thu~ ~ini~izi~g th2 op~nlng ~nd causing a ~ini~um Or t~u~a.
Th~ ~05~ co~on ~urgic 1 5utur~ o~ thi8 typ~
single-usa ne~dl~ of ~pp~opr~at~ ~iz~ ~nd ~hap~ whie~ is cri~p~d to th~ ~nd o~ ~ha ~utur~, ~o th~t th~ n~adlQ is u~ed on~Q and then dis~a~d~d. The attach~ent can be ~cco~plish~d by use o~ ~ 'tdrilled e~dn needl~; that is, one in whlch a : ~

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concentric aperture is fonned in the end of the needle in which the suture i5 placed and the needle crimped around the suture. AlternatiYely, a "flanged" needle may be utilized in which a U-shaped channel is stamped into the end of the 5 needle with the ends o~ the "U" being crimped about the suture to hold the suture together.
Tha attachment must be one which is: predictably secure; causes a minimu~n of da~age to tissue; is convenient ~or the using sur~eor~; permits sterilization; and entails 10 reasonable costs. In addition, ~he attachment must withstand the rigors o~ manufacture, sterilization, storage, shipment and use.
During use, it has bPen found that uporl completion o~ the st~tching procedure by the suryeon, it i8 con~enient 15 ~or thQ ~urgeon to b~ to readily detach th@ naedl~
the ~ature thus per~itting- the end o~ tha sutur~ to be tied or oth~ise sacured. The needle ~ay therea~ter be r~ov~d ~rom th~ woxk ar~a ~o a~ to avoid har~ to the patient, surgeon and other per~onnPl. Cutting th~ ~uture w~th 20 E;cissor~ or a ~calpel i~ 1 convenient ~ethod o~ dlsengaging tha needla but reguir~ an eactra in6tru~ent and an extra manipulatton.
Mors r~c~ntly, 'c~e~ s ha~ b~en de~rz'~ oped to attach the sutur~ to thls n~adle in a ma~ which per~$ts 25 tho ~urgeon 'co re~ad~;ly separ t~ the co~pon~nts by merely tugging at t:he needla at ~ end o~ th~ ~titchl2lg ~roc~dure.
q!21e pull re~uired ~or tugging the needle ~rom ~he suture i5 re~erred to in ~he U.S. Pharmacope$a as 'tneedle-attachnsn~n or ntes~ing ~ 8ecur~ty oS ~t~ch~nt o~
30 ey~less ne~dles to sutur~ or conver~ienc~, the terr~
"pull-out" i-~ used.

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1 Experience and testing procedures have determined that the pull-out must be at a sufficiently high valus that the suture may be placed without risk o~ the needle becoming detached ~rom the suture during placement; and yet it must pull-out at a value ~ar below the breaking strength of the suture and will predlctably pull-out before the suture breaXs~ In addition, the suture ~ust pull-out at a value which ls reasonably exertable upon the needle by the surgeon at the time of use.
Conventlonal crimp operations ~re dif~icul~ to control. Usually ~ cri~p is created betwe~n several dies which closa to a ~lxed gap. Any variation ~n: the crimping di2s, the n~edle size, the hole s$z~, or the suture size altars the degree o~ cri~p. Howe~er, w~th such t2chn1ques, 1~ the variation can b~ larger than is ~cceptabl~ in th~
~anu~acture of con~rolled r~le~se or controlled pull-ou~
suture~.
Th~.~on~ntional cri~ping ~thod r~quirQ~ ~h~t the bac~ ~nd o~ th~ n~edl~ be struck with two hal~ moon shaped di~. Th~ n~odl~ i~ than xotated 90 and th~ di@s aro arra~g~d to strik~ th~ n~edl~ a ~cond ti~e. In ~ ct, the ~lrst ~trik~ change~ a round~ hol~ in'co on~ o~ ~llptic~l sh~pe, i.~ a~or and ~inox axes., ~ ct o~ rotatlng ~hQ
nQ~dla 9o ~n~ r~peating th~ ~p~ra~ion to ~om~ extent, 25 cau~e~ thA ~$nor zxi~ to be~o~ ounterp~rt, and the ~or ~xis to beca~a th~ nor ~xis th~reby co~npletins th~
~ttac~mRnt in ~ rQl~ti~ely uni~orm ~&nner. I~he~ ~r~ct o~
thl~ procedure i~ to di~to~: the end o~ ~he n~edl~ reby cau. ins~ it to 105~ try. Th~ las~ ~entioned 30 disadvantagQ rasult~ ln ~orr~ponding ~yn~a~ry o~ tissue ap~r~ur~s dur~ng u~

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1 The diameter of the suture, the diameter o~ the needle,-the concentricity of the aperture in the needle, the outside diameter of th~ needle, the braid size of the suture, coating material, time and concentration of baths, and drying conditions are all extremely critical in predic~ing and controlling the pull-out force. In addition to size ef~ecte, the surfacs smoothness of the sutur~ and the needle aperture, and lubricants on either components affect the pull-out values. ~he conventional ~ethod of 10 cri~ping, as described, underscores many o~ th2se p~ra~n~trlc ~nconsi~tencies and nPcessarily utilizes ~nultiple hit~ to overcome these pro~ess variabilities.
To date, t~chn~ ~ues devised for connecting such .suture componen~ in a D3anner to perro~ withln the 15 -pre~erred guideline-s are not e~Se~tive in maintaining ~edle sy~metry ~nd uni~or~ity o~ di~4ensions, p~rticularly wi~h a singl~ hit. ~h~ present ~slvention avoids the ~orementioned di~dvantages and provides ~ dia and a ~ethod rOr att-~chir~g surgical ~uture~ to needles in ~ controll~d ~anne~ whil~
20 r~taining the sy~Qtry o~ the needla, all wlt~ 1QS~ ti~ and expens~ .

Th~ pr~nt ~nYention r~l~te~ to ~ noval ~plit ring ~ie ~or ~ttachlng ~o co~ponen~; o~ surgic~l ~utur~
which avoids thæ ~ore~a~tioned ~l~advant~ges o* Xnown tec~nique~ whil~ providing sutur~ conn~ctions whlch p~r~o2~
wi~hln thQ de~ired pred~t~r~insd par~eters. ~l~o~t ~erSect sy~try of t~ a~tachlng ~u~ur~ na¢dl~ i~B m~int~ined.

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1 The novel attaching dies are used to attach a suture either in the ~orm of a braid or ~onofilament, to a drilled end needle. The die is typically used in a suture attaching ~achine to attach a suture to a drilled 2nd surgical needle.
The novel split ring die provides an improved method of crimping surgical needles to sutures. Th~ novel split rin~ shape provides a ~ore uni~orm and qui~ker swage than obtainable using conventional attaching dies.
Th~ inve~tion provides two very ~ignificant improve~ents when compar~d to conventional di~s . A s~ ngle hit instead o:~ two or ~ore is used to develop the compresslon or ~wag~ ~orc2s while a ~ uely de~ned 6pa ::e wit~tn ~ach die provi~es fox r~caption and colloction o~
15 ~uper~luous ~DatQrial causQd ~y ~wag~ng act~on. This featur impro~re~ th~ ~nanu~acturing ecorlo~ics and reliability o~ the attaching procoss. Test reports con~ that p~edictable pull-out ~orces ar~ ach~ ~v~d in a convenient arld coratroll~d mannQr u~in~ ~h~ novel split ring sh&pe d~e o~ ~he present 20 inverltion . Fur~er, ~e needl~ try i~ ~aintained in a much l~pxoved ~a~hion. ~he l~proved neQdle ~y~Qtry is a ... ~ane~ to the ~urgeon and tha ~anu~ac~ur~r.
~ n a broader ~Qn~e, ~ lnvention r~lat~s to an ~pparatus ~or atta~hing two ~e~ber~, ~t l~ast a ~irst :aemb~r 25 ha~ing a genQxally cyli.ndriG~l out~r portion d~ ing 2In Qlongat~d ap~rtur~ ha~ring ~ nerally c~rcul~r cros~-3~c~ion, th~ ~con~ b~r includ~ng a gsn~rally elongat~d end portion o~ gen~rally circulax t:2:'0a~8 ~;~ction corres~on~ing ln ~ nsion to t~lQ ~long~te~ ap~ o~ ~a 30 ~ir~t ~ be~. A p~ir o~ dle3 ar~ prov~d~d, e~ch ~a~ing ~L

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2 ~ c~, 1 pair Or generally arcuate spaced surface portions corresponding in di~ension and configuration to the generally cylindrical outer surface portlon of the ~irst member. The space de~ines a relief zone b~tw2en the pair of 5 arcuate spaced inner sur~ace portions such that when the second ~ember ls positioned within the aperture o~ the first . member and the dies a~ re~pectively positioned a~out the correspondin~ portion o~ the first member with the generally arcuate surface portions facing th~ Sirst ~e~ber, applying ~pact force ~o the dies to displace the ~ie~ toward each other will cause cri~ping o~ the ~rst ~e~ber ~ith respect to th~ ~econd ~e~ber 80 as to ~ttach th~ ~e~r~ whila port~on~ o~ ~at~xial ~o~lng part o~ tha ~irst ~e~b~r - ad~ent th~ stricken area ar~ pQr~ittad to b8 de~or~d and ~o collect within th~ r~ zon~s ~etween th~ pairs Or arcuate surfaca portions.
A p~ir o~ dies ~ccording to ~he pre~ent invention are pr2~ably adapted ~or us~ in attaching ~ surgl~al nQedle to a surglcal suture. ~uch ~uture3 ~r~ typic~lly o~
sutur~ material~ such ~s ~ilX, nylont l~nen, cotton, polyethylene, polypropylQn~ a~nl~ stQ~l, n~tur~l ~ater~als ~uch as cat~ut, ~d ~yn~hatlc poly~ex. ~a~ing glycoli~ acid est~r ~nkage~ ~u~ect to hydrolytic degr~d~tlon to non-toxlc, t~ua co~pat~le ~b~or~abl~
co~ponents~ i~cluding polyglycol~c ~c~d. The ~ur~c~l su~ur~ i~ genorally ~d~ ~o~ a ~ak~ri~l whlch i~ bra~ded, twl~t~d or mono~ ment. Th~ needle ~ typically of stalnl~s~ steel o~ ~he drill~d end typ~. Typ~c~lly, thQ
8waging diQ3 ar~ o~ ~ h~rd~n~d ~at~r~al su~h as tungsten c~rbid~, and hl~h ~e~d ~teels.

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1 In the pxeferred embodiment the apparatus of the invention is used for attaching a surgical needle having a generally cylindrical outer poxtion defining an elongated aperture having a generally circular Gross-section and a suture having a generally elongated end portion of g~nerally circular cros~section corresponding in dimension to the elongated aperture o~ the first needle. A pair o~ dies are provided, eaeh having a pair of extensions spaced apart from each other and each de~ini~g a generally circular surface ~ortion ~or ~waging corresponding in dim~nsion and configuration to the general~y cylindrical outer ~urface portion o~ th~ n2edle. The space betw~en th~ extens~ons de~ines ~ relief zone between the pair of extensions and ls of con~iguration and di~ension suff~ci~nt 8UC~ that when the suture is positioned wl~hin thQ a~erture o~ thQ ~irst needle and the dies are respecti~ely positioned a~eut the corresponding portion o~ the needl~, the ~pplication 9~
impa~t forca to th~ d~es wlll cau~a cri~ping o~ the n~dlQ
wit~ res~ect to the sutur~ 80 a~ to attach the suturo and the n~edl~ whil~ portion~ o~ ~a~eri~l ~or~ing p~rt o~ the needl~ ad~acent ~h~ ~trick~n ~rea ar~ p~rmit~d to be de~ormed and to coll~ct within ~h~ relie~ zone~ de~ined bQtwa~n th~ ~xtension~ ~nd p8ir~ o~ axcuat~ ~ur~ac~
portions.
A ~thod ~ di8clos2d gor at~achin~ ~ ~urgic l n~edle hav~ng a gener~lly ey~ndr~cal ou~er por~ion and de~ining ~n elongated apertur~ h~ing ~ gen~ra~ly cir~ular cross-section~ and ~ su~ure ha~ng ~ g2n~rally elongated ~nd port~on o~ g~n~rally circular cros~-section corr~sponding in di~Qnsion to ~h~ alongated aperture 9~ khe needle. Th~

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1 method comprises ronfiguring a pair of dies such that each haq a pair of extensions spaced apart from each other and de~ining a generally circular surface portio~ corresponding in dimension and configuration to the generally cylindrical outer sur~ace portion o~ the needle, positioning an end portion of the suture withi~ the elongated aperture, positioning the pair o~ dies adjacent the corresponding cylindrical portion Or the needle with the generally circular surface portions ~acing the generally cylindrical outer portion Or ~he needle, applying inward ~oroe to the dies to displace the dies toward each other causing the generally c~rcular sur~ace~ o~ the dies to ~ngage the Sur~acQ portlon o~ tha needlQ to there~y Gause cri~ping the naedle and reduction o~ ~he aver~g~ di~ens~on o~ the 1~ aperture def~ned thereby. ~ho ~p ce be~ween th~ p ir~ o~
extensions o~ each di~ 1~ con~igured and ~i~ensioned to permit dPfor~ed ~aterial o~ th~ needle to collect th~r~w~ thin 80 a~ to ~aoilitatQ attach~ent o~ ~h8 n~edlo and the ~uture without di~tortion o~ th~ n~edl~ portion~
ad;acent there~o.
According to th~ m~thod o~ thQ in~ntion the needl~ ~ay ~e ~tachably att~ch~d to the sutur~ 80 as to b~
read~ly s~parat~d as ~nt1onQd, by a guiok tug provid~d ~y thQ surg20n. Altern~tively, ~he ~eedlQ may b~ ~orQ fir~ly attached to proYid~ a n~on ~tachabla~ ~uture ~ which cas~
the suture ~ay h~ ssp ratQd ~ro~ ~h4 nQ~dl~ in a ~ora con~Qntion~l ~ nner, by cutting with ~ci sors or ~calpQl.

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1 ~rief Descr~iption o~ the pr~winas Pre~erred embodiments of the invention are described hereinbelow with reference to the drawings wherein:
FIG. 1 is a plan view of a pair o~ conventional dual lap-overlap semi-circular shaped dies;
FIG. 2 is a plan view of a pair of split ring swaging dies accoxding to the present invention with a needla and suture positioned therebetween ~or attachment;
. FIG. 3 i6 an e~l~rged ~lan view o~ a po~ion o~
one o~ the split ring dies o~ Fig~ 2;
FIG. 4 is an elavational side Yi~W 0~ the ~plit r~ng dia shQw~ in Fig. 3;
FIG. 5 i~ ~ photo~icro~aph of an end vi~w o~ d needle with suture re~o~ed illustrating the e~fects o~ the crimping att~chment acco~pli~hed by a pair o~ 6plit.r~ng dies ae~or~ing to tha ~res~nt invention;
FIG. S is ~ photo~icrogr~ph ~lustrating a perspectiv~ view o~ th~ Ncrl~pQd~ naedla ~own in ~ig. 5, ~nd th~ ~ffect~ o~ the die~ on th~ ~ur~c~ o~ ~h~ n~
FIG. 7 ls a fxont ~i~w o~ a~ apparatu~ wlth ~hi~h the ~plit rlng dia~ according to ~h~ pre~ent ~nv~ntion ~ay ~ utilized to Attach a sutur~ to . ne~dle by crlmping;
FIG. 8 i8 ~ sid~ w o~ t~e ~pp~atUs $hown i~
Fig. 7;
~IG. 8~ i~ an axplode~ ~l@w illu~tr~tng th~ split ring di~s o~ the prQsent $nv~ntlon ~ounted in ~hQ ~ppar~tus of FigO 7 ~or ~ttachlng a 8U~UX~ ~0 a n~le; ~nd ','.'' ' ~ ' .

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1 FIG. 9 ls an exploded side view of a pair o~ split ring dies constructed according to the present ~nvention positioned l:o attach a sutura to a curved needle.

Detailed_Descr~ption o~ the Preferred Embodiments ~ eferring initially to ~ig, l there is illustr~tec a pair of conventional "lap-overlap" dies 10, 12 of the typ~
utilized to attach a suture to a surgical needle. The working surfaces o~ t~e dies a~e shown at 13 and are ~aeh generally se~1-circular in shapa. Th~ wox~i~g surface Or each die l~ shown æt 13 is a "lap" xegion and has adjacent arcuat~ corner portions ll designated as "overlap" regi~nc - to receive li~ited a~ounts-o~ exces~ needle materi21 ovQrflowing dur~ng the cri~ping process. Tha overlap region~ are o~ les~er rad~i than the lap r~gion a8 ~h~n ~md are not concentric therewith ~s shown. ~ha lap regio~ is co~figur~d and dim~ioned to reGeiv~ th~ ~longated apertured rear ~nd ~ortien of a ~urg~cal needl~ b~waen ;!O ~hQ~, To att~ch a needl~ to a suture, th~ di~s arQ
posit~on~d within an appar~tu~ a~ will bo d~crib~d hQre~nbQlOW~ Th~ appaxatUg i8 arranged to C~U8~ bo~h dies ~o si~ult~neou~ly mov~ toward aach other and strlka the needl~ while ~t ~ po~itioned between ~hç~. ~hi~ Cause~ the needlQ to beco~a elliptical in cross-sQction by portions o~
~etal deforming into rQgions ll~ Thlx proclDss~ r~duces t~2 aYeraga cro~s-s~ctional d~mension o~ the opening. Onc~ the dies Are impac:t~d toward each o~hex, ~:hey ar~ ~ep~r~tad and 3~ thQ n~edl3~ 1~ rotat~ 90. q~ di~s ar~ n IstrucJc onc~
~g~in ~nd the attachm~rlt 1~ ~omplek~d. ~n ess~nce, th .

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1 first striXe oauses the circular aperture in the needle to ~ecome elliptical. The second strike completes the attachment and reverses ~he distortion imparted to the needle. In certain instances still additional hits are required to secure the suture to the needle. This procedure necessitates at le~st a dual step attachment which in turn requires additional ti~e and labor.
Referrlng now to Figs. 2-4, there is illustrated a pair o~ split ring dies 14, 16 constructed according to the 1o prese~t lnvention. Each die is con~igured to have a semi-clrcular opening 19 which, when combined with th~ other di~ o~ the pair, ~orms a complete circular opening for reception o~ ~n elongat~d apertured needle o~ circular cro~s-s~ction.
. As shown in Figs. 2-4 and part~cularly ~n FigO 4 by the repr~sent~tlve di~ 14 o~ Fig. 2, the die o~ the presen~ invention has a oha~nel 18 de~ined ~etween two depe~d~ng ~ection~ 20, 22 o~ t~2 die. Pr~er2bly the ~irst ~ection 20 is o~ a ~hicXnes~ ~ual to t~e thlcknes~ oS th~
raar sect~on 22 ~ shown in Fig. 4. Further, each ~ect~on 20, 22 may ba eq~al in thiGkne.~s ~ thems~lves and to the th~cXness o~ channel 18. In other ~ord~, ~h~ thickn~5 0 .: ~ach ~ection 20, 22 ~d tha~ o~ ~hannel 1~ ~y ~e approxi~ately 1/3 o~ ~ae total thic~e s o~ ~e diR as ~hown 25 in FigO 40 The ch~nnel 1~ provided to reli~v~ needle mat~rial bQin~ swaged by the ~i~ wAerl ~ pai~ o~ di0~ ~r~
~u~ed to ast~ika a ne~dl~ po~itioned wlthin ~he circular shaped operling as d@scri~ed above. Thu~s, any ~t~rial which i8 atr~ckQn ~y s~ctlon~ 20, 22 and ~ngaged by swagin~
30 sur~ac:e~ 19, will r~dily accu~ulat~ by a ~wagiJIg ~ction into th~ r~ zon~ provided by channel 18 in th~ dle~ as wel~ as into the ovarlap a~ea 21. S~ult2ln~0usly therewith, : : -. : . i, ~

1 the apertured portion Or the ne~dle will be effectively crimped and attached to ~he suture by the physical reductior.
of the dimension of the aperture surxounding the suture.
Moxeo~er, the needle will retain its circular sym~etry in S the area of suture attach~e~ and the attachment will bP
completed in a fraction of the ~ime normally re~uired in the prior art. A circumf~erential ridge will for~ about t~e outside o~ the needle in the area of the crimp as shown in Figs. 5 and 6. The present invention contempl~tes the 10 provision o~ channel 18 with or without tha lap-overlap --:
relie~ zones 11.
~ e~errin~ now to ~igs. 5 and 6, two photo~icro- .
~raphs are shown o~ actual surgical needles which have ~een strucX ~y ~h~a spl~t ring di~ cons ructed according to the ~: 15 inv*nt~on. ~n Fig. 5 ~h~ n~Qdl~a i~ o~ th~ curv~Gd typa. In Fig. 6, the n~edle is a ~traight needlQ. ~n each exa~ple a raised circu~ere~tial ridge of ~at~arial ~waged and.d~or~d ~way f'ro~ th~ ar~a o~ th~ ~trik~ vident. ;~
Re~erring now to Figs. 7 and 8 therQ is shown ~n ~xe~plary~ apparatu~ 2~ on which ~utur~ ~ay ~ atta~hed to neadl~s utilizing a pair o~ thQ split ring di~ o~
pr~6ent invent~on. The ~pparatu~ ~4 ~own i8 ~anu~actur~d .
nnd ~axkRted a~ ~odel 6A Sutur~ ~tt~chinq ~achlnQ by B~G~
Sulzle, Inc., Syraeuse, New York. Other co~parable ~achines sUlt~blQ ~or attachlng ~utures ~ay bQ utillz~d with ~he dies o~ th* present anven~ion~
Th~ ~uture attaehing ~ach~n~ 24 ~s ~llustrated ~n Fig. 7 includes a t~bl~ 25 having ~r@adl~ 2~ whic~ i~ foot op~rat~d and connected via ~eadle r~d 28 ~o ~uture pre~
30~ T~ trRadl~ 26 is ~ountQ~ ~or plvotal ~ove~ent on pivot rod 32.

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Referring now to Fig. 8 there is shown a side view Or the apparatus shown in Fig. 7. The suture press 30 is encircled and is shown in enlarged form in Fig. 8A. As can be seen in Fig. 8A, the pair of split ring dies 14 which are constructed accordi~g to the invention are positioned within the jaws o~ th~ suture press 30 and arranged to be stricken against a needle with the suture in position as shown in Fig. 9.
The needle 34 shown in Fig. 9 ls o~ a curved type tO having a straight rear end portion which defines an elongated aperture 36 di~ensioned for reception and attachment to an appropriately s~z~d sutur2 38. Th~ naedle 34 i8 supported on a suide support having a "Y shaped" guide channel which positivQly deter~ines and positions the n4edle location and orient~tion as ~own. Th~rea~ter, appropriat~
ad~ustm~nt are ~d~ to pr~deter~ine the ~trlXQ ~orcQ to be transmltted to t~e needle a~d sutur~ as may bQ ~ppropriately c31culated to obtain a pr~deter~ined pull-out ~orc~
treadle ls depr~s~ed to cau~ th~ di~s to Etr~k~ th~ ~2edl~.
~t will ~ readily appr~clated th~t the dies o~
thQ pxesent inventton ~re ~art~cularly advanta~eou~ in ~hat all typ~s o~ ~utur~s ~ay b~ r~dily at~ac~d ~o n~dle~
having an aperture ~n ~halr ~lunt end, ~.~., drllled and ne~dl~s, utiliz~ng a ~ingla ~trik~ ~orc~ thereby ~volding the ne~d to provide ndoublQ-h~tU ~ttachmen~ as n~cessary wlth prlor art dies. ~hl8 procedure proYides ~ ~u~ura hav~ng ~ neQdl~ whic~ y~tr~al and una~ct~d ~y th~
d~torting ~orces pro~ided by dl~ and proc~dures Or th~
prior.art~ ~oreover, the singla-hit ~tta~h~ent p~oc~duæ~
3~ provide~ consls~nt and con~roll~d ~ttach~ent o~ th~ ~utur2 a~d th~ needle wh~ch addlt~o~ally raduce3 th~ ti~e and Q~ort to complet~ the ~ttachment. Die 11~ is increasedO

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1 rejected needle~suture attachments are reduced, and attachmant time is reduced. As a result the cost of producing a surgical suturP is sizably reducedO
Examples o~ comparisons of pull-~ut provided by the present invention nsplit ring" die) and prior art ("controll') attachments are provided in the following table.
~k~
split Ring vs. ~ontrols Siz2 0 . Pull-Out Forc Pre-Ste~iliz ~os~-Steril~
Control 1 ~o Data) n-10 2.8 kgs VICRY~ brand SYNTHETIC
~bsorbable 6UtUrQ
(~rior ~rt Double~Hit) 1~
eon~rol 2 n-10 1.8 kg~ n~10 1.8 ~sS
~ono~ila~ent nylon sutur~
(Prior ~xt Double-Hit) E~
Pre-Sterlli~ ost-sterillz Control 3 n-5 2.6 Xg~ n-5 2 . 9 kgs ~raided ~ynt~tic ab~or~ablo suture (Prlor Art Doubl~ ~it) Split Ring DiQ n~l5 3.2 kgs n-8 3.1 kgs Br~ided 3ynth~tic :~ ~b~or~ablo ~uture 8pllt R~ng n~ll 3.3 kg~ nsl5 2~9 kgs ~onogila~n~ nylon ~uture ,. . . . .

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1 The foregoing table ~learly illustrates and underscores the advantages ~f the pres nt invention in providing consistent and controlled needle/suture attachments using a 5ingle hit, In fact, in each case tha attachments ~ade according ~o the invention exhi~it~d pull-out forcPs to separate the suture from ~he needle at least egual to thos~ of the prior art double-hit ~or multiple hit) attachments. Sn each instance the attachment of the present invention was ~ccomplished by a single-hit procedure, ln a ~raction o~ the ti~e, and prov~ded ~ striXe zone in the needle ~re~ o~ distortlon~ or cold working e~ects. T~Q last ~entioned adversa ef~ect can bQ expectud with prior axt needle suture attach~ent ~ethods.
The ~waging dies o~ th~ present lnventlon may b~
utili~ed with 11 type~ o~ naedles such as curved ne~dles, straight needles, or th~ lik~, provided they hav~ ~n elongated apertu~ on their end portion ~or r~ceiving t~
~u~ur~. Sutux~s u~abla w~th the pr~sent in~ntion include silk, ~ylon, linen, cotton, polyester, polypropyl4ne, stainl~ te~l, n~ural m~tarial~ ~uch a~ ca~gut, synthetlc poly~ar~ havi~g glycolic acid ~t~x linkage~ 8~b~ct ~o hydrolytic degradatio~ to ~on-toxic ti~sU~ co~p~ti~le absorb~bl~ co~ponents, lnclu~lng polyglycolic a~d. T~
suturQs ~ay be ~onorila~n~ry o~ braided, ~b~orbabl~ or non-absorbabl~. ~he die~ o~ pres~n~ $nYen~ion ~re pref~rably con~tru~t~d o~ a hard6n~d ~r~al 6uch a~
tUng~ten carbid~, ~ow~ver, it uhould be under~tood that al~
materi~l~ suitabl~ ~or 8UC~ d~ construct~on ~ay be u~d, provlded ~he g~o~at~ie ~nd con $guXationa~ ~a~a~et~r~ taught by th~ pr~ent ~n~tio~ ar~ ~t.

' , . ' '' ;"' '. ' ~ ' ~, 1.

Claims (24)

1. An apparatus for attaching two members, at least a first member having a generally arcuate outer surface portion and defining an elongated aperture of generally arcuate cross-section, and a second member including at least an end portion of generally arcuate outer configuration corresponding in configuration and dimension t said elongated aperture of said first member, which comprises a pair of dies each having a pair of extensions correspondingly defining a pair of generally arcuate spaced surface portion corresponding in dimension and configuration to the generally arcuate outer configuration of said first member, the space defining a relief zone between said pair of extensions such that when said end portion Or said second member is positioned within said aperture of said first member and said dies are positioned about the corresponding portion of said first member, with said generally arcuate surface portions facing the first member, and inward force is applied to said dies to displace said dies toward each other, said generally arcuate surface portions of said dies engage said first member and cause crimping thereof while portions of material forming part of said first member adjacent the stricken areas are permitted to be deformed and to collect within said adjacent relief zones defined by said spaces between said extensions of said dies.

2. An apparatus for attaching two members, at least a first member having a generally cylindrical outer portion defining an elongated aperture having a generally circular cross-section, the second member including a generally elongated and portion Or generally circular cross section corresponding in dimension to the elongated aperture of said first member, which comprises a pair of dies each having a pair of generally arcuate spaced surface portions corresponding in dimension and configuration to the generally cylindrical outer surface portion of said first member, the space defining a relief zone channel between said pair of arcuate spaced inner surface portions such that when said second member is positioned within said aperture of said first member and said dies are respectively positioned about the corresponding portion of said first member, applying impact energy to said dies will cause crimping of said first member with respect to said second member so as to attach the members while portions of material forming part of said first member adjacent the stricken areas are permitted to be deformed and to collect within said relief czones between said pairs of arcuate surface portions.

3. An apparatus for crimping a cylindrical member for attachment to an elongated member of circular cross-section of dimension similar to the inner dimension of said cylindrical member which comprisies a pair of dies, each having a pair of inner arcuate surface porttion spaced apart from each other and adapted to receive and collect material forming part of said cylindrical member when said dies are positioned about said member and crimped with force sufficient to reduce the effective inner dimension of said cylindrical member to thereby attach said members while causing material forming part of said cylindrical member to be seaged and collected within said recesses whereby attachment of said members accomplished by crimping without substantial deformation or distortion of the cross sectional dimensions of said members.

4. A pair of dies according to claim 3 adapted for attaching a surgical needle to a surgical suture made of at least one of suture materials such as silk, nylon, linen, cotton, polyester, stainless steel, polypropylene, natural materials such as catgut, and synthetic polymers having glycolic acid ester linkages subject to hydrolytic degradation to non-toxic, tissue compatible absorbable components, including polyglycolic acid.

5. A pair of dies according to claim 4 wherein said surgical suture is made from a material which is braided, twisted or monofilament.

6. A pair of dies as in claim 5 wherein said swaging dies are preferably of a hardened material such as tungsten carbide or high speed steel.

7. An apparatus for attaching a surgical needle having a generally cylindrical end portion defining an elongated aperture having a generally circular cross-section and a suture having a generally elongated end portion of generally circular cross-section corresponding in dimension to the elongated aperture of said first needle, which comprises a pair of dies each having a pair of extensions spaced apart from each other and defining a generally circular surface portion corresponding in dimension and configuration to the generally cylindrical outer surface portion of said needle, the space defining a relief zone between said pair of extensions and being of configuration and dimension sufficient such that when said suture is positioned within said aperture of said needle and said dies are respectively positioned about the corresponding portion of said needle, the application of impact force to said dies will cause crimping of said needle with respect to said suture so as to attach the suture and the needle while portions of material forming part of said needle adjacent the stricken area are permitted to be deformed and to collect within said relief zones defined between said pairs of arcuate surface portions.

8. The apparatus according to claim 7 wherein each said circular surface portion extends from a first portion of a die face to a second portion of said die face.

9. The apparatus according to claim 8 wherein the intersections between each said circular surface and said die face defines an overlap material relief zone, said overlap material relief zone being comprised of an arcuate surface of radius less than the radius of said circular die surface and intersecting said circular die surface in the region of said die face.

10. The apparatus according to claim 9 wherein each said extension is approximately the same thickness.

11. The apparatus according to claim 10 wherein each extension is approximately the same thickness and said space therebetween is approximately the same thickness as each extension.

12. The apparatus according to claim 9 wherein each said extension of different thickness.

13. The apparatus according to claim 9 wherein a first extension is of a greater thickness than the second extension and the space therebetween is of thickness between the thickness of each extension.

14. A method of attaching a surgical needle having a generally cylindrical outer portion and defining an elongated aperture having a generally circular cross-section, and a suture having a generally elongated end portion of generally circular cross-section corresponding in dimension to the elongated aperture of said needle, comprising configuring a pair of dies such that each has a pair of extensions spaced apart from each other and defining a generally circular shaped surface portion corresponding in dimension and configuration to the generally cylindrical outer surface portion of said needle positioning an end portion of said suture within said elongated aperture, positioning said pair of dies adjacent the corresponding cylindrical portion of said needle with said generally circular surface portions facing the generally cylindrical outer portion of the needle, applying inward impact force to said dies to displace said dies toward each other causing the generally circular surfaces of said dies to engage the surface portion of said needle to thereby cause crimping of said needle and reduction of the average dimension of said aperture defined thereby, said space between said pairs of extensions of each said die being configured and dimensioned to permit deformed material of said needle to collect therewithin so as to facilitate attachment of said needle and said suture.

15. The method according to claim 4 wherein at least said portions of said dies defining said circular shaped surface portions is comprised of hardened material.

16. The method according to claim 15 wherein said hardened material is tungsten carbide.

17. The method according to claim 16 wherein said needle is manufactured of stainless steel.

18. The method according to claim 17 wherein said suture is detachably attached to said needle whereby said surface may be readily separated from said needle by a relatively sudden predetermined force provided by the user.

19. The method according to claim 17 wherein said suture is non-detachably attached to said needle whereby separation of said suture from said needle may be accomplished by cutting or the like.

20. The method according to claim 19 wherein the step of configuring said pair of dies comprises dimensioning each said extension such that they are approximately equal in thickness.

21. The method according to claim 20 wherein the step of configuring said pair of dies comprises dimensioning each said extension and said space therebetween such that they are approximately equal in thickness.

22. The method according to claim 19 wherein-the step of configuring said pair of dies comprise dimensioning one said extension so it has to have a thickness greater than the other.

23. The method according to claim 22 wherein the steps of configuring said pair of dies comprises dimensioning said space therebetween such that said space is of thickness approximately between the thickness of each extension.

24. the method according to claim 15 wherein said step of configuring said pair of dies further comprises providing generally arcuate overlap portions in the regions where said generally circular shaped surface intersects the die face.