TITI.S SUTURE HMΪIPUIATING XHfiTRUMENT WITS GRASPING MSMBBRS

PTPT.n OP THE INVENTION

This invention relates to inctrumenta £σr suturing tissues and morts particularly CO a device which passes or retrieves a euturc within a patient.

BACKGROUND OF TH iNVKMTTnW

Sutureα are widely used within patients to secure two or more layers r>t ^q nft tissue together, or to secure soft tissue to bone. During open procedures in which a large incision provides ready aσσβoσ to the tissues, surgeonc have little difficulty in passing suture to the surσical site anril then retrieving or withdrawing the suture to provide two free ends on either si<-_ ol the tissue. The o ^p n c of suture thereafter are knotted, or utilized for additional suturing of the Lissue.

There are an increasing number of closed procedures conducted through one or mrvr rannulae. Access to tissues is provided through narrow passageways within the camiulas. During some endoscopic and arthroscopic procedures, suture is delivered through α first ca._nula using an elongated needle and threaded through one side of the tissue. Thereafter, the suture mu&L be retrieved, through a β*uond cannula using narrow grasper- ype forceps or an eJnngsf ^p d hollow suture retriever hαviuμ an Internal wire loop. The wire loop is extendable beyond the tip Of the re i pv to capture a free end of Lhe suture. While gra3pers can grab <_ middle portion of A sucure,

the wire loop of the βutur* retriever can only be passed around a free end of the euture. Therefore, two or more instrument■ typically are required to perform endoscopic or a throβcopie euturing.

Several devices having an eye or groove tor placinQ a suture through t ssue are diceloeed in U.S. Patent Noe. 5,222,577 (Esser) and 5,281,237 (Giiupelson) . Other instruments wh c deliver outurc internally through the instrument, and methods of usiim same, are disclosed in π s Patent Nos. 4,923,461 (Caepari, ct al.) and 4,335,027 (Yoon), for example. instrumentE with two or more graspiuy elements are presently used in other surg cal fields such as for retrieving gall Gtones. In non.surgical fields, object reLrievers are sold in csrrain hardware stores for retrieving screwe, nut3 and other items. Alaσ available are pickle toners having t ree or four wirea which are protrudable to graβp a pickle from a jar.

SUMMARY OF THE INVENTION

Therefore, i is an object of the present invention to provide an improved, versatile SUturft manipulating instrument wh h pxovides multiple suturing functionσ within a patient.

It is a further object of this invention to prov e such an instrument which can pie_.t;e suft tissue to pass suture or other surgical filament through the tissue.

Yet another object of this invention is to provide SUCh instτ-πmι»nt which can graop and then withdraw a middle portion of a s ture to retrieve i from the body.

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A sr. ll further object of this invention is* to provide an improved suture manipulating instrument which selectively enables relative movement between a surgical filament and the instrument or firmly captures the filament to prevent relative movement during passing or retrieval of the filamen tht-ough tissue.

Thia invention features a surgical instrument having an outer hollow member having a passageway extending therethrough. A handle is disposed near its proximwl end for enabling manipulation of the outer member. A inner movab.e •u-isembly reciprocates through the passageway. A Hietal end of the inner assembly is drivable distally through the passageway from a retracted position to an extended position protruding distally beyond the distal end of the outer member. Th« distal and of the inner assembly terminates in at least fire*I and second grasper m mbe .! for traveling past »nd on either side of a port fin of a surgical filament in the eAleiided position and for encircling the filament portion in the retracted position to enable manipulation of lhe filament within the patient.

In one fimhoHiment, the firot and second grasping members are formed of resilient wir^s, one of which terminates distally in a curved, hook-like element. The proximal end of Lhe inner assembly defines a handle element r. which a firet force is applied to drive the distal end of Lhe inner assembly to the extended DOSltlon, and th? instrument further includ<»κ a spring element which biases the inner acocmbly coward the retracted position by providing a second force. The inner assembly further includes a _f locki g element having a resilient arm defining a

detent which is releacably received by a recess in the handle. The recess includes a proximal guide channel defined by the handle along which detent is linearly slid ble to guide reciprocation of th ^p inner aeeβmbly and to inhibit itc rotation. The recess further includes a lock opening at the distal end nf the guide channel which communicatec between the passageway nd the exterioi ul Lhe handle to receive the rit-t. -nt of r.he resilient arm when the inner assembly is in the extended position.

In a preferred embodiment, the distal end of the inner assembly resLs lullv within the passageway in the retracte position for drawing the encircled filament portion at least partially into the passageway to restrict relative movement between the filament and the instrument, and the instrument further includes an ini-.f-rmediate position in which the first and occond grasping members encircle the filament portioj. but enable relative movement between the filament ar.u the instrument. The detent υf the -.wsilient arm has a leading surface ππ a trailing surface, and the handle defines the lock opening as an elongated port having a distal edge and « proximal x- ^ή r x- ςs ch that the leading ourface of the detent .e.Lϋ against th« port's distal edge in the extended pofi11"ton and the trailing surface rests against the port's proximal *dy« in the intermediate posit-nπ.

The riiei sl end of the instrument prefex-αbly terminates in a sharp distal tip for penetrating tissue. The distal *»πH -iβ curved upwardly oo that its distal opening faces laterally and the distal tip μiυjectS longitudally. A IongiMi al slot openo distally into the dictal opening and ex ends _proκimally theieliotn. The longitudal AIor i β a width

sufficient to accommodate the encircled filament Dortion, especially during passing of the filament through tiςcue.

BRIEF DESCRIPTION. PF_THK DRAWINGS

Other objects, features and advantages will occur from the following description of preferred embodiments and the accompanying drawings, in which:

Fig. l is a top view of a suture manipulating instrument according to the present invention in an intβτ-ττiΛdiat* position; rig. 2 ia a aide, partial cross-sectional view of the instrument of Fig. 1 in a retracted position

Figs. 3A - 3C show an alternative suture manipulating instrument retrieving suture through tissue;

Fig. 4 ic a cide view o£ the pro.cimal portion of the inner assembly of Fiqs. 1 and 2; ϊig. 5 is an enlarged top view of the dictal end υ£ Lhe inner assembly and graβpinq membere of the instrument of Fig. 1;

Fig. 6 i-s a si e cross-sectional view of the prnv mal orfiii of the outer aβeembly shown in Fig. 2; and

P1 . 7 s a rt-ar pn view of the outer assembly shown in Fig. G.

DETAILED DESCRIPTION OP TTTC PREFERRED EMBODIMENT* This invention may be arrnmpl ish»»rt by a βuture management inctrument 10, Figs. 1 and 2, having eui υuLer hollow member 12 with an integral handle 14 and an elongated needle 16 which terminates in a __2isLαl end 10. A passageway 20 through needle 16

terminates with a distal opening 20. As best shown in Fig. 2, the distal portion of the needle 16 curves upwardly such that distal opening 20 faces laterally while a sharp tip 22 projects longitudally lelaLive Lυ r.he insr.mment i 0.

A pair of grasping members 24, 26 extend bftynnd r.he distal end 18 in the intermediate position shown in Fig. l. The needle 16 further defines a longitudai suture slot 28 which terminates a its dictal end with the distal opening 20. As shown in fig. 2, a portion of filament 30 is carriabie by r.he instrument 10 in a retracted pooition auch that filament legs 32, 34 extend from the slot 28. This configuration ic particularly useful for passing suture or other surgical filament into and through tissue as described in relation to Figs. 3Λ - 3C below. The term "filament" encompasses all types of sutures including monofilaments, tapes and braided ribbons. ₄

The βuture management instrument 10 further includes an inner uιυγu_ιbl<_ atseeπibly 40 having an elongated p.lpmι». t to. which terminatee in graaping members 24, 26. λs shown in Figβ. 2 <__ιd 4, the element 42 is embedded in a plunger- && which terminates at its proximal end in an enlarged head o handle 46. In its central portion, t e piπngpr tt has a recilient arm 48 which terminates in a laterally Droiecting detent 50. The arm 48 deforms to a cavity 52 in the retracted position as shown in Fig. 2 Lu travel in a oroximal guide channel b4. As shown i Figs. 2 and 6, the handle 14 defines the proximal guide channel 54 which in turn communicates at its distal end wlr.h a lock opening 60. The channel 54 guides longitudai reciprocation of the inner assembly

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40 and inhibits relative rotation between the assembly 40 and the outer hollow memhp-r 12. The channel 54 also enables to detent 50 to have a larger height than the inner diamCLer Of the handle 14 which therefore enables the detent 50 to both key into the channel S4, Fig. 2, and project Into the lock opening 60, Fig. 1.

As shown in Figβ. 1, 2 and 6, the lock opening CO is αu elongated port having a loading edge 62 and a trailing edge 64. The detent. 50 rescs againσt the trailiuy edge 64 In the intermediate position showing Fig. l and rests against, the leading edge €3 in an extended position.

The extended, intermediate and retracted positionσ arc shown in Figs. UA - 3 , respectively, for an alternative suture management instrument 10a having a straight needle 16α ith Slanted distal opening 20a. The needle 16a is shown in Fig. 3A with its r ^' stal end 18a piercing and extending through soft tissue 70, Symmetrical grasping members 24a, 26a are shown in *n extended position assing on either side of a surgical suture 72. T extended position is maintained by continuouβ exertion of a first manual force against first surface 82, Pig.4, to overcome the second biasing force of opring 80, Fig.2.

During reLrieval, the first manual force is discontinued, which allowc αpring Θ0 to drive tttfi inner element 42a of the inner assembly proximally to diαw symmetrical grasping members 24a, 26a partially within the diotal end 18α. A camming effect against the rim u£ distal opening 20a forces the grasping members 24a, 26a toward each other to encirrlc the cuturc 72 in αu intermediate positio . In one procedure, the instrument 10a is withdrawn while in -tile intermediate osition to enable rβlativa movement

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between the auture 72 and the grasping members 24a, bΛ. Thin procedure ie especially useful When 1C is esi ed to access one end of che suture 72 while leaving the remainder of the auture 72 oα Lhe lar Side of the tissue 70.

Tn *n alternative retrieval procedure, Che inner element 42a i« further withdrawn manually into a retracted poβiti rm while the needle 16a protrudes through the tissue 70. Relative movement between the suture 72 and the instrument 10* iε thereby inhibited, and the captured portion of the auture 72 is thereafter Withdrawn through the tiσσue 70 as shown in Fig. 3C. Both legs of the suture 72 on either side of the captured portion are- therefore withdrawn simultaneously through the tissue 70.

The retracted position is particularly useful during paecing or delivery- £ a βuture through tissue. The suture Slot 2B. Pig. 2, in the diotαl end 18 enable^ the legs 32, 34 of the suture 30 to easily follow behind the sharp edge 22 vhil.e precenting a low profile. Further, the suture 30 while wiLhin the slot 28 avoids damage by contact which might- ntherωiβe occur with sharp edges surrounding the distal opening 20, or by abrasion against tissue or of. ^r instruments. The tissue penetration ability o£ distal end 18 alβo remains unencumbered b SU iir ^p 30 when it rests in slot 28.

The inner assembly 40, Fig. 2. is biased toward Lhe retracted posi ion by a spring 80. The inner assembly 40 ic driven to the intermediate or extended positions by applying pressure to a first, concave surf-are 82, Pig. ι , to counteract the biasing force applied to * second surface 84 behind the opring ,80. A second, prnyima ^" !. force io applied manually tO

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surface 86 of the plunger han le 46 to pull the inner assembly 40 from the intermediate poαition to the retracted position by overcoming the resistance provided by detent bO against diβtal edge 64. Alternatively, the detent 50 lias a greater height to protiude above the upper surface of the rβσeβe 60 to enable manual depreαsion of the detent SO. which provides ρue>h-bUtton release* of the inner assembly 40.

In one construction, the instrument 10 as an overall le.-yLh , Fig. 2 , cit 9.3 inch in the retracted position, ith the plungei 44 fully depressed, the Liμs of asymmetric grasping members 24, 26 protrude approximately 0.37 - 0.44 inch beyond tήe end of the needle 16. The proximal guide channel 54 has a width of approximately 0.12 inch and ά longitudai length of 0.66 inch. The lock opening 60 has <± length of 0.38 inch and a width of 0.12 inch. The handle 14 and the plunger 44 are tormed of DE RIN polyacetaj or NϊLON polymer. The needle 16 as a f tal le gth of approximately 6.6 inch, of which the proximal 0.6 inch is embedded within the plunger 44 as snown in Fig. 4, and 0.7 inch of the distal end of the needle 16 curves upwardly by approximately 0.25 inch. The needle 16 is 304 otainleββ steel 14 TW hypodermic tubing having an outer diameter of 0.07-0.09 inch, prereraoiy 0.083 inch, and an inner diameter o£ 0-067 inch. The suture slot 28, K g. 1. hae a length of 0.1 inch and a width of 0.03 ineh with radiuced edges to avoid damage to suture.

Tile proximal end of outer hollow member 12. Fig*. G and 7, has a length HL Of 2.fc inch, a maximum handle height HH Of 1.2 inch and a width HW of 1 inch. Handle 14 has rimw 90, 92 which provide convenient grip e>£ thα instrument, lo ror the surgeon by using the

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index and middle fiuyer resting upon upper and lower surfaces 94, 9d , rββpβetivoly. Dietal cylinder 38 dud proximal cylinder 100 are integrally formed with the handle 14. Diβfcal cylinder 98 has an outer diameter of approximately 0.25 inch and secures the proximal end of needle IS therein, A leading surface 102 of the cylinder DO is chamfered at angle A of approximately 0 degree

Troximal cylinder 100 haβ an outer diamet-.er ϋf 0.45 inch and an inπ ^p r diameter of 0.38 inch. The cylinder 100 defines an inner c*vity 104 which receives Che lunσβr portion tt . Fig. 4. The plunger 44 has an overall length PL of 1.98 inch and handle 46 has a height. PH of 1 inch. In this construction, plunger handle 5 iε a circular button-type handle. Alternatively, ct tinαer loop or oth r t pe of handle can hfi utili2βd.

Plunger 44 is centered within ravity 104, fig. 6, by ribs no. Fig. 4. Trailing surface 51 of detent 50 is perpendicular in this construrf nn, but alternatively is chamfered at a 45 degree angle to aβaiεt unlocking of the detent during transition from the intermediate position to the retracted position. Leading eurfacc 53 has a perpendicular upper surface which then curves gradually to the underoide of arm 48.

Element 2 is a hollow Lube formed of 304 eteβl having an outer dia cLex of 0.058 inch and an innβx diameter ύ.U46 inch, and a length of ' . 1 inch. hA proximal end of grasper meuibeis 24, 26 , Fig. 5, are crimp*d into the distal end of the tubular element 42. O as A members 34, 2€ are formed u£ 0.018 diameter 302 spring lempered stainless st-eel jnusic wire having an overall length of approximately

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..16 inch. Whnn erimp*J in the end of element 42, the wires 24. 26 have a st-.raight length S of 0.55 Inch and a total projecting lwngth GL of . inch. Λ gap Q of 0.11-0.15 inch ifl maintained in the extended position shown in Fig. 5. Grasping wires 24, 26 form an angle B of approximately 30 degrees. Gms er tip 122 is curved back upon itself to assist snagging of a Buture, hile tip 120 is onl slightly curved Lϋ facilltare disengagement when a βuture is being βeparuted or released from t-h* inctrument 10. Alternatively, graεpcr members 24, 26 are formed from a single, U-shaped Wire whose central portion ia secured Lo the element 42.

In this construction, spring 80, Pig. 2, its formed of 302 sr.ainlesς εtccl with a spring temper, p.uch catalog number C0180-020-08fln-5 available from Associated Spring in Bristol, Connecticut. The spring ΛCi hao an outer diameter of 0.18 "inrh, a wire diameter of 0.02 ir^ch, a trr.* length of 0.8 inch and, when COmprp.sββci, a eolid height of 0.2'/ inch. The opring rate, whiwh provides th« second, biasing force, is approximately 4.4 lb/in.

Although specific featureo of the invention are shown in come drawings and not in thers, thio iβ for convenience only as earh feature may be combined with any or all of the other fealures in accordance with the invention.

Uthfir mbodimβnto will uo ur to those skilled in the art «*πd arc within the following claims.