CA2092400A1 - Bone fastener - Google Patents

Abstract

A bone fastener (10) for fixing either a suture (20) or a rivet within a predrilled bone hole includes an expandable sleeve (14) having an axial bore and a pin (12) forcible insertible into the axial bore (18), the expandable sleeve (14) being configured to be insertible into a bore drilled in bone, at least a portion of the pin (12) having an outer diameter greater than the inner diameter of at least a portion of the axial bore. The fastener (10) is emplaced by inserting the sleeve (14) into a predrilled hole in the bone, and then forcing the pin (12) into the axial bore (18), so that the wider portion of the pin (12) presses outward against and expands the narrower portion of the sleeve (14), causing the sleeve (14) to forcibly contact the walls of the bone hole and fixing the pin (12) and sleeve (14) firmly in place within the hole. Also, apparatus (30) for emplacement of such a fastener (10) includes a holder (32) for holding the expandable sleeve (14) in position within the predrilled hole in the bone, and a plunger (40) moveable in relation to the holder (32) for forcing the pin (12) into the bore, so that the pin (12) can be forced into the axial bore (18) without imposing substantial net forces toward or away from the bone.

Description

WO 92/04874 P~IU~9l/07003 ~ ~t i c,J
BONE FASTF~NER
Background of the Inv~ntion This inventio~ relates ko fixation of objects to bone.
This application is a Cont~nuation-In-Part of our copendi~g U.S.
patent application Serial No. 588,025, filed September 25, 1990.
A variety of techniques are ava~lable for af~ing objects, such as soft tissue, to bone. The oldest tech~L~que for af~ng soflc ti~sue to bone is to pass a thread through the bone and sew the tissue down to the bone. Many si~es, shapes and types of suture and needles are available to accomplish this task. Today, this method is ~till used for repair of tendons and 10 ligaments in the hands of older osteoarthritic patients, although passing sutures through bone is generally difficult and tedious.
Venable et al. (1937), Annals Surg, Vol. 105, pp. 917-38, describes reactions of bone to metals, and recommends using Vitalillm, an iron free and body ~luid re~istant alloy, for inte~rnal fi~ation de~ices, and particularly15 for screws. Prior to this publicatio~, soft tissue repa~r~ generally had beenaccomplished Wit}l string (suture), silver wires, or ivory pegs. Following publicatio~ of Venable et al., screws came into common 3urgical use, ~t first for repairi~g bone fractures, and later for attaching 80ft tis~ue to bone.
Vitalium staples were described for use in ~oflt ti~sue repairs about 20 1940. Later many different types and styles of ~aple were suggested, includillg, for example, staples having four legs, or barbs in the legs, or various configurations of crossmember, including dentitions.
Metal implants, including implants made of stainless steel, arts subject ill time to corrosio~ and con~equent loss of structure. Moreover, the 25 presence of metal in an anatomical ~3ite can interfere with certain imaging diagnostic or therapeutic treatments near the site, such as magnetic resonance imag~ng; and where the u9e of such imaging is iIIdicated, any metal impla:llts may first have to be surgically removed. Patient sensitivity to free nickel ions in sta~nless steel impl~t~ has fileled a growing 30 controversy regard~ng the use of materials co~taiDing high quantities of llickel, ~duding nickel-titaDium alloys such as Nitinol.

wO 92/04c'.74 PC~/US91/07003 9 '~, 4~ 0 Generally, the tissues react to metal screws and staples as forei~
bodies, and these objects can be expected to loosen in time as a result of r0jection of them by the tissues. A loosened screw or staple can be e~pelled from the bone, and can lodge in a joint, where it can cause damage to 6 articulating surfaces. In a SigIlifiCant proportion of cases, where the screw or staple has been e~cpelled or has loosened, it must be removed in a sub~equent surgical procedure.
Since the development of the stainless steel screw and staple, many small improYements have been made for fi~ing sof'c tissue to bone. In o~e 10 improvement, described for e:~ample in Daniel et al., Chapter 8, In: Jackson et al. (1987), The Anterior Cruciate Deficient Enee, C.V. Mosby, pp. 114-126, a circular pla~tic washer vith spikes on its undersurface is installed beneath the screw head to provide fi~ation without crushing the tis~ue, and toothed washer dev~ces have been commercialized by, for example, A.O.
15 Synthes, Switzerland. This method was u~til recently widely accepted as the be8t method of fixatillg sof~ tis~ue to bone, except in shoulder repair where suture~ passed through hole~ drilled through the glenoid msrgin and &ough t~le edge of the gienoid cap~ule continue to be used for approx~mating the capsule to the glellohumeral nm, generally as described 20 in Banka~ (1938), British Jour. Surg, Vol. 26, pp. 23-39. Rowe et al.
(1984), Jour. Bor~e Joint Surg, Vol. 66A, pp. 159-68, for e~ample, describes using a Bankart procedure and in all instances avoiding the uBe of metal impla~ts such as staples and 9crews ~n the vicinity of the shoulder joint.
Necrosis of the sof~ ti~sue can re~ult if the t~si3ue ii3 too tightly 25 clamped by screws or staples, and iseveral attempts have been made recently to ~mprove the sof~ ti~sue fi~cation by screws and staples to o~ercome this problem. such as by using toothed washers, as described above, or by u3~Ilg stand-off deviices to prevent crushinig the soft tissue. On the other hand, if the soft tissue is too loosely fixed to the bone, ~e holding 30 power of the tissue attachment is inadequate to faciiitate effective soft tissue reattachmient to bone. Because it is almost imposi3ible to adjw3t the , '~

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.: ., ; ,, . , ~ . ,, .: . . . , ~ . . ; -WO 92/04874 P~/US!~/07003 compression exerted by screws and staple~ on so~ tissue, these devices are not fully satis~ctory for so~ tissue repa~r. The surgeon's fondness ~or suture in soft tissue repairs has never diminished, ow~ng primar~ly to the fact that, by setting the tension of the ~uture, the surgeon can fix the ~oft 5 tissue to the bone as tightly as is appropriate ~n the particular case and according to the surgeon's practice.
Somers et al. ('1985), U.S. Patent No. 4,632,100, describes a cylindrical suture anchor hav~ng a drill ~ormed at one end and flights of screw threads at the other end. The de~ice combines a drill point for 10 penetrating the hard outer cortical bone vvith a screw for f~ng the device ~Ilto the hard bone, providing for drilling the bone and ~nstalling the anchor in one operation. A Somers et al. dev~ce, marketed as STATAKrM by Zimmer, Inc. (Warsaw, Indiana~, is 3crewed into a 4.5 ~ diameter bone hole, and is intended to be countersunk ~nto the cancellous bone to a depth 15 up to 18 mm, and so it is not ideal for use in smaller joints. The relativelylarge size a~d the comparatively high cost of the dev~ce, and its requirement for a large hole in the bone, may be a deterrent to its u~e, and it has not been well recei~ed.
Goble et al. (1986), U.S. Patent No. 4,7385255 de~cribes a ~uture rivet 20 that can be iIlserted into and locked in place in a preformed hole in bone.
The initial pilot hole is cut us~l~g a drill ha~Jing scissonng blades, so that the resulthg hole is flared or skirted, having a greater diameter deeper within the bone than at the entry to the bone surface. ~e a~chor itself includes a r~vet and a slotted nng. The slotted r~g, which passes ~he smaller entry 25 hole, is inserted within the bone, and then the rivet is passed into the holeand through the ling, ~ractur~g the ring at the point where it is slotted and flaFing the r~ng so that it cannot pass out through the entry hole, locking the assembly illtO the bone hole. The Goble et al. apparatus is relatively complicated, and the ~Mssoring device can ~e lmreliakle in use.

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W O 92/04874 P ~ /US91/07003 2 ~
atturna et al. (1987), U.S. Patent No, 4,898,156, descr~bes a suture anchor assembly consist~ng of a titanillm body affixed to a n~ckel titanium arc of wire. I~he nickel titanium arc is of pseudoelastic nitinol, which can be strained such that the arc will straighten completely, allovMng the assembl 5 to be placed into a predrilled bone hole. The titanium body has a drilled cross hole which allows a suture to be attached to the body prior to ~nsertion in the bone hole. The installation tool consists of coaxially disposed cannulae, which constrain the Ditinol arc prior to insertion.
NicholsGn et al. (1987), U.S. Patent No. 4,899,743, describes a suture 10 anchor installation tool that holds the Gatturna et al. suture anchor so thatthe nitinol arc is unconstrained, essentially hanging outsi~le the installation tool. Pr~or to insertion the assembly resembles a one barbed fi3h hook in the end of a small spear. A hole is predrilled in the bone, and the anchor assembly is gently pushed i~to the predrilled hole, a~low~ng the ~ickel 1~ ,titanillm arc to slide down the side of the hole. A Gatturna et al. anchor and Nicholson et al. installation tool, commercialized by Mitek ~3urgical Product~, Inc., beg~nning in late 1989, have become a preferred method of anchoring soft ti~sue to bone; many were sold in the first year followi~g FD~ approval. The device can be effective in aidi~ng in soft ti~ue 20 reattachment, and has an advantage in requiring a relatively narrow hole in the bone.
However, the Gatturna et al. anchor is set by applying traction to the suture, and 80 the device does not lend itself to use as a rivet, ~n which no ,~
~uture would be required to anchor the tissue. Moreover, use of the device 25 is contraindicated in ~rery so~, cancellous bone, as is typical of bone in many joints, 90 the device is not optlmal for such procedures as rotator cuff repair,osteoarth2itis joint reconstruction, and the like. VVhen the Gatturna e~ al.
anchor is deployed in an arthroscopic application using the Nicholson et al.
installation tool, the protruding b~rb can engage seIlsititre tissues dur~3~g 30 placement and cause damage to th-tissues. ~

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wo 92/0487~ PCr/US~/û7û03 ~ ~3 ~ w '~ 3:3 '3 Hayhurst (1988), U.S. Patent No. 4,741,330, and ~ternstional patent Publication No. WO 89/10096 describes a suture anchor including a generally bullet-shaped resilient plastic member ha~ing a rounded convex base from which legs e2rtend. The legs, which are prov~ded w~th outward~
5 pointing barbs on their outer surface, diverge outwardly when the member is in a relaged state. The member is compressed ancl inserted into a predrilled bo~e hole, and then allowed to rela2~, so that its resilience is said$o urge the legs out~vard against the bone hole wall. lnne anchor supposed to be set by apply~ng tension to the suture, causing the edges of the legs 10 and the surface barbs to dig i~to the bone. A similar device, marketed by Acufex Microsurgical, is drive~ into the bone hole apparently into the cancellous bone, and ~ then set by pressing a spreader downward between the legs wbile p~li~g upward on the suture to force open the legs.
:Bays et al. (1990), U.S. Patent No. 4,924,865, de~cribes a 15 bioabsorbable tack for jo~n~ng severed or tor~ soft tis~ues, such as cartilage.
The stem of the generally T-shaped tack is hollow and covered with barbs on its outer ~urface. ~he tack is ~mplanted by passing the ~tem through a hollow cylindrical applicator and passing a needle through the a2c~al bore irl the 8tem, then dri~ring the needle, tack and applicator ~rough the ti~sues to 20 the desired depth, and then v~ithdrawing the needle a~d applicator, leaving the tack in place.
Summary of the In~entio~
In general, in one aspect, the invention features a bone fasterler, includillg an expandable sleeve having an axial bore aIld a pin forcibly 25 insertible iIlto the a~ial bore, the e~cpandable sleeve being confi~ed to be insertible into a bore drilled in bone, at least a portion of the p~ll havirlg an outer diameter greater than the inner diameter of at least a portion of the axial bore~
The irlventio~ provides for fi:~ing either a su~re ~sstener or a rivet 30 within a ~TOW, shallow hole predrilled in the bone. The ~aste~er is emplaced by inserting t;he sleeve into a predrilled hole in the bone, and then : ' .. ~, . ~, . , . . . . . . , . . - .
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wo 9~/04874 PCr/US9l/07003 2~92~ 6-forc~ng the p~n ~nto the axial bore, so that the wider portion of the pin presse~ outsvard against and expands the narrower portion of the sleeve, causing the sleeve to forcibly contact the walls of the bone hole and fi~ing the pin and sleeve firmly in place within the hole.
In some preferred embodiments, the pin includes a head for reta~ning an object to be attached to the bone; the sleeve has a generally cylindrical configuration; the outer surface of the sleeve when the sleeve is expanded con~olms to ~rregularitie9 in the bone hole wall; the outer surface of the sleeve i~ provided with a plurality of protrusions; the outer surface of the :~
sleeve is provided with at least one annular ridge, and preferably the outer surface of the sleeve is threaded; the sleeve is made of a thermoplastic material capable of expanding when pre sed outwardly by the p~n; the thermoplastic material is capable o:f conforming under pressure with :
irregularities in ~e bone hole wa:ll; the thermoplastic material is preferably a high density biocompatible polymer such as a high density polyethylene, or a h~-gh density polypropylene; the pin includes a~ axial bore; the pin is made of a high ~mpact material, preferably a high impact biocompatible polymer such as for e~ample a polycarbonate or a polysulfone or an acetal resin snch as DuPont DelrinTM.
In another general aspect, the inve~tion features a method for establishing a fastener in a predrilled hole in bone, including steps of inserting into the hole an e~pa~dable sleeve hav~ng an a~Qal bore, and : -forcing into tlle a2nal bore a pin, at least a portion of the pin having a diameter greater than that of at least a portion of the a2~al bore, so that as 25 the pin is forced into the axial bore the wider portion of the pin presses outward again~t the narrower portion of the sleeve, causing the sleeve to e~pand against the walls of the hole and f~xiIlg the pin and sleeve firmly in place ~Wit~ the hole.
Preferably, during the Btep of forc~ng the pin into the axial bore a 30 counter ~orce i~ imposed on the e~pandable sleeve in a direction about oppo~ite rom, and in ~ magni~de about ec~ual to, the ~orce impo~ed on the ,'.

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wO 92/04874 P~/US91/07~)3 2~2~

pin, to m~nimize any net force toward or away from the bone during the e2~pansion of the sleeve against the walls of the hole.
In another general aspect, the invention ~atu~es apparatus for emplacement of a fastener according to the invention including a holder for 5 holding the expandable sleeve in po~ition within the predrilled hole in the bone, and a plunger moveable in relation to the holder for forcing the pin into the bore, so that the pin can be forced into the a~ial bore withollt imposir~g ~ubstantial net ~orce~ toward or away ~rom the bone.
In preferred embodiments, the holder includes a generally 10 cylindrically ~aped hollow body having a front and a rear end, the body be~r~g severably attached near its front end to the rear end of the expandable sleeve, means moveable within the body for ~Or~iDg the pin ~nto the e2~pandable ~leeve, and means for ~evering the attachment between the holder and the expandable sleeve after the pin has been forced into the 15 expandable sleeve; the 3everable attachment of the holder body to the expandable ~leeve include~ an annular portion connecting the front end of the body to the rear end of the expandable sleeve; the severable attach~nent includes a web or a plurality of spoke members connecting the f~ont end of the body to the rear end of the ~leeve; the severable attschment is more 20 re~tant to being ~evered by ~orce~ urging the holder body ~ a ~ontward or rearward direction iII relation to the 91eeve than in a direction perpendicular to the front-to-rear a~is; the ~everable attachr~ent i~ a removabie couple, preferably a rotationally removable couple such as a threaded or bayonet attachment; the pin forcing means includes a rod that can be moved fi~ontwardly and rearwardly with respect to the holder.body :and that when moved firontwardly can abut the rear end of the pin to force it into the a~cial bore in the expandable sleeve; the attachment sever~ng .
me~ns includes a cutting edge such as a cylindrical blade having a~ anntllar cutiing edge; the seve~ing means is activatable ~dependently of the plu~ger; the severing means includes heating means ~uch as, for e~ample, a cautenznt or~ loop, for so~eDlrg the attachme~.

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': ' , ' wo 92/04874 PCr/US91/07003 `~,092~ 8-The rearward portion of the sleeve can be configured to provide a head", ~o that the sleeve can be passed first through the object to be attached to the bone and then into the predrilled bone hole, and then fi~ed by forcible ~nsertion of the p~, for attachment of objects such as, for example, bone plates, or for attachn~ent of 80ft tissues, without u~e of sutures. A part of the sleeve between the bone-engaging portion and the head can be smooth, providing a "standof~ beneath the head when the faste~er i8 fi~ed, and the sleeve can be further configu:red at a selected distance frontward from the head to provide a "~top for engaging the edge of the bone hole and limiting the depth to which the sleeve can be passed into the bone, so that the staIldoff can have a selected height above the bone.
In preferred embodiments at lea~t a part of the rearward portion of the ~leeve is configured to form a head; more prefierably the head is :.
configared as a flange; the flallge has a circular marg~; the sleeve is ~mooth over a part of its length frontward of the head; at least a part of the ~leeve at a di~ance frontward from the rearward end of the sleeve is expanded to form a stop. '~ -I~ ~ome sleeve configurations a sleeve hav~ng a threaded outer surface can have all outer diameter at its widest point that is somewhat ~:
greater tha~ the i~er diameter of the bo~e hole, so that the 31eeve can be turl~ed into the hole rather than merely slipped into the hole. In such config~lrations the screw threads serve to tap the hole to ~ome degree as the sleeve is turned into the hole. Such an arrangement can provide placement of the slee~e to a more precise depth with~n the bone, a}ld, where the fastener is adapted to have a head, such an arrangement c~n provide for a more prec~se degree of compres~ion of the tissue or other object to be :
fastened between the head and the bone surface during placement of the sleeve. Once the ~lee ve htas been placed to ~he de~ired depth, or the object 30 has been compre33ed to the desired degree, the screw threads can hold the 31eeve in place temporarily. Then ~e fa3tener i6 fi~ced in place by forci~g ~;

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'"' ~o g2,04874 2 ~ ~ 2 d~ ~ ~ PCI/U~9l/07003 the pin into the a~ial bore of the sleeve. As in embodirnents in which the unexpanded sleeve slips without substantial resistance into the bone hole, fixation is effected in sel~-tapping screw thread embodiments by expansion of the sleeve in the bone hole, and deformation of the outer portions of th sleeve and conformation of the outer surface of the sleeve with irregularities in the bone hole wall. In self-tapping embodiments, 8 portion of the screw threads can be sufficiently hard to provide for cutting or abrading the bone while the sleeve is turned into the hole.
In other preferred embodiments the outer sur~ace of the sleeve is configured to folm screw threads having an outer diameter slightly larger than the inner diameter of the bone hole; a portion of the screw threads is sufficiently hard to tap the bone hole to a degree as the unexpanded sleeve is turned into the bone hole.
De6cription of Preferred Embodimengs Drawin~s Figs. 1.1 - 1.4 are a series of diagrams, drawn in sectional news along the lorlg a~cis, showing emplacement into bone of a bone fa~tener according to the invention.
Figs. 2.1 aDd 2.2 are diagrams, drawn in sectional views as in Figs.
1.1 and 1.4, showing emplacement into bone of a bone fastener hav~ng a head according to the invention.
Figs. 3.1 and 3.2 are diagrams, drawn in sectional view a~ in Figs. 1.1 a~d 1.3, showing apparatus for ef~ecting emplacement of a fastener according to the ~nvention.
~g. 4.1 is a diagram, drawn in sectio~al view as in Fig. 1.1, of an alternative bone fastener according to the invention having the ~orm of a self-tapping screw.
Figs. 4.2 and 4.3 are diagrams, drawn in sectional view as in Figs. 1.2 and 1.3, showing alternative severable attachment for use in a headed ~a~tener.

WO 92/04874 Pcr/lJS91/07003 2~92~)u - 10~
Fig. ~ is a diagram, drawn in sectional view as in Fig. 2.2, showing in place a bone fastener having a head and a ~tandoff according to the invention.
Fig. 6 is a diagram, drawn in sectional view as in Fig. 5, showLng in 5 place an alternative bone fastener havLng a head and a stop, providing a specified standoff according to the invention.
Fig. 7 is a drawing as in Fig. 1.4, but in a less diagrammatic representation, show~ng deformation of the o~er portion of the sleeve within irregularities in the bone hole wall resulting from forcible expan~ion 10 of the ~leeve w~thin the bone hole.
Figs. 8.1 and g.2, and 9.1 and ~.2 are diagrammatic representations in transverse sectional view, ~howing alternative ~everable attachment of the ~as~ner sleeve and the holder according to the inveIItion.
Figs. 10.1, 10.2 are drawings in elevationsl and a ~ial view3 ~howing a 15 preferred expandable fastener sleeve aDd holder according to the invention.
Fig. 10.3 iB a ~èction thru the a~is of the fastener sleeve ~nd holder of Fig. 10.1, and Fig 10.4 i~ a detail of the portion indicated at D in Fig. 10.3.
Figs. 11.1, 11.2 are drawings in elevational and axial views ~howing a filrther preferred e2~pandable fastener s}eeve and holder accordillg to ~e invention.
Fig. 11.3 is a section thru the a~is of the fastener sleeve and holder of Fig. 11.1, and Fig. 11.4 is a detail of the portion indicated at D in ~ig. 11.3.Figs. 12.1, 12.2 are drawing~ in elevational and axial views show~ng a pre~erred headed pin in~ertible into the axial bore of an expandable fastener sleeve to form a rivet fastener according to the invenl;ion. i~
Fig. 12.3 is a section thru the axis of the headed pin of Fig. 12.1.
Str~lcture The bone fastener accordillg to the Lnvention generally includes a pin and an expandable ~leeve having an a~ial bore. In it~ une2~panded ~tal;e the 30 expanda~le sleeve can be in~erted illtO a predrilled hole in the bone withoutsubstall~ial re~i~taI~ce between the wall of the hole and outer portion~ of the WO ~2/04874 PCT/US91/07003 sleeve. The diameter of at least a portion of the p~n is greater than that of at least a portion of the axial bore, 50 that when the pin is forced into the aYial bore, the wider portion of the pin presses outward against the narrower portion of the sleeve, cansing the sleeve to expand ag~ st the 5 wall of the hole, fi~ing the pin within the sleeve firm~y with~n the hole and providing the fastener. The pin or the expandable sleeve, or both of them, can be adapted to prov~de a ~astener for a suture or ~ provide a rivet.
I~he descliption that follows illustrate~, by way of ea~ample, embodiments of suture fasteners and rivets according to $he invention.
Suture fastener Fig. 1.4 illustrates in diagrammatic sectional view a suture fa~tlener 10 emplaced in a predrilled hole in bone according to the invention. Pin 12 has been forced into e2~pandable sleeve 14, expandiIlg sleeve 14 to pre~3s outer portions 16 against wall 4 of the hole in bone 2. Suture 20, which can 15 be, for e~ample, a stanslard braided polye3ter (Dacron) suture, is knotted aga~nst front end 22 of pill 12 and passes through a2~ial bore 18 in pin 12 out of the fastener, where it call be lLqed to attach ~oft ti~sue to the bone atthe fi.~cation ~ite.
In practice, 3leeve outer po~tions lL~ will have become distorted as 20 they conform to irregularities in the bone hole wall 4 under the outward pressure caused by the intn~sion of the pin 12 into the a2~ial bore of the sleeve. Sleeve 14 may, if the expansion is great enough, nlpture; a ruptured sleeve may provide sufficient fi2~ation, provided that the p~n 12 is firmly.held within. For clarity of presentation in the :Figs., except in Fig. 7,25 the exparlded sleeve 14 is shown undistorted; and the bone hole is shown as being larger relative to the width of the expanded sleeve than would be de~irable for firm fi2cation of the fastener. Fig. 7 shows a less diagrammatic representation of the appearance in section of a fastener lO emplaced in a hole ~n corl;ical bone 2 whose diameter is somewhat less than the diameter 30 of the une~panded sleeve. As Fig. 7 illustrates, the outer sur~ace of the . ~ .. . .. . , . ..... ... . ; . , . ~ , . , -: . : . ~.. . , . . ... ~ .. ~

wo 92/04874 PCI/US9l/07003 2a924U -12-sleeve 16 is so deformed as it conform to irreg~larities 6 ~n bone hole wall 4 .
that the threaded form of the onter sur~ace of the unexpanded sleeve is practically nnrecognizable. The shape assumed by the expanded sleeve in any particular bone hole depends in part upon characteristics of the 5 particular bone hole and of the bone matter itsel~.
The expandable sleeve 14 i8 preferably constructed of a biocompatible implant matenal that is sufficiently deformable that, when e~panded within the bone hole, will conform to a substantial degree with irregularities in the bone hole wall, and the pin 12 is preferably constructed of a relatively hard 10 biocompatible implant materlal such that the pin can cau~e the sleeve to e:~pand and to deform against and conform to irregularities in the bone hole wall. Suitable sleeve material~ include, for e~ample, an implant grade high den~ity polyethylene, and suitable pin materials include, for egample, an implant grade high impact polymer such as a Delrin 100 acetal resin or a 15 polycarbonate. The sleeve or the pin can be made usillg a combination of materials, provided that they provide for an appropnate combination of biocompatibility, and (in the ~lee~re) deformability and conf~rmability relat*e to the bone, and (in the pin) incompre3~ibility or hardne~ relative to the sleeve and to the means for forcing the pin into the ~leeve a~ 1 bore, 20 and ~ufficient rigidity to lhold the suture or the object to be attached to the bo:~e.
Figs. 1.1 - 1.3 show emplacement of fastener lO within a hole 3 previously drilled in the bone 2 at the fixation site, using preferred emplacement apparatus 30, which is adapted to provide for firm fixation of 25 the fasteller without impo~ing ~ubstantial forces UpOIl the bone itself ~n directions toward or away from the bone.
Referring now to Fig. 1.1, expandable sleeve 14, hav~ng ax~al bore 13 and outer surface 15, is shown in an unexpanded state, in which the a~ial bore has a diameter a and the outer surface has a diameter b at its widest 30 pomt or poillts. Dlameter b is no greater thar. the diameter o ol the bone ; .

W0 92/04874 Pcr/us9l/07003 2 d~ ~ 5 hole 3, so that sleeve in its une:!~panded state passes Lnto hole 3 substantially without resistance.
Emplacement apparatus 30 includes a generally cylindrical holder body 32 ha~ring an in~ide diameter d greater than the outside diameter e of 5 the rear end 17 of sleeve 14. Sleeve rear end 17 is attached to holder body front end 34 amlular attachment portion 36.
Pin 12 is shown in Fig. 1.1 poised with its beve]Led ~ont portion 11 close to similarly beveled re~r portion 19 of the imler ~ ace of the e~p~ndable ~leeve 14. As Fig. 1.2 shows, a plunger 40, havLng a rod 42 10 surrounded by a cylindrical blade 44 is ~ntroduced by way of the rear erld 38 of the holder body 32, and the plunger is urged forward, ~o that its :Front end 46 abut~ rear end 48 of pin 12. Then plunger 40 is ~urther urged frontward, presYing pin 12 before it into a~ial sleeve bore 13. Figs. 1.~ and 1.3 show the progress of expansion of sleeve 14 as beveled front portion 11 15 of pin 12 pres~es outward against the inner surface of sleeve 14 as p~rl 12 is forced firontward to its filll e~ctent, as show~ in Fig. 1.3. .:
As pin 12 approaches its full frontward position, CUttiIlg edge 49 of cylindrical blade 44 approaches, then meets, and then passes ~hrough annular attacl~ment portion 3 6i, severillg the sleeve 14 fi~om the holder body 20 32, a~d thereby fieeing the ~ully expanded and firmly fixed fa~tener 10 ~rom the emplacement apparatus ~0. Ihe emplacement apparatus ~0 i~ then withdrawn, leaving the fastener and the suture in place at the fi~ation site in the bone. ` : .
Sleeve outer sur~ace 16 has protrusions, shown in Figs. 1.1 - 1.4 as a 25 plurality of annular ndges 16, for engaging irregularities in the bone hole wall 4 as the sleeve deforms and conforms to the bone hole wall as it is forcibly expanded within bone hole 3.
Figs. 11.1 - 11.4 show a more preferred erllplacement apparatus, generally ~imilar $o fastener assembly ~0 in Figs. 1.1 - 1.3, but differ~g in 30 ~ome par~iculars. Fa~tener assembly 23lD includes a holder body 232 .....

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u~o 9~/04874 Pcr/US~1/07003 '~92~ 14-severably attached to an e~pandable ~leeve 214; the latter has an a~ial bore 213 and an outer ~urface 215. E~ ndable sleeve 214 (~ee deta~l at Fig.
11.4) is shown in an unexpanded state, in which the outer diameter b of the outer surface 215 is no greater than the diameter of the bone hole, so that 5 the sleeve pas~es into the bone hole substantially without resistance, as described above with reference to :IFig. 1.1. Generally cylindrical holder body 232 has an inside diameter d greater than the outside diameter of the rear end 217 of s~eve 214. E~pandable ~leeve rear end 2~1L7 is joined to holder body front end 234 by annular attachment portio:n 2316. E~pansion of the 10 sleeve ~14 within the bone hole is efFected by pressiDg into the a~ leeve bore 213 a pin (not shown in Figs. 11.1 - 11.4) having an outer diamet(3r greater than the diameter a of the a~ial ~leeve bore.
For fi2~atio~ in, ~or e2cample, the humoral head or the glenoid proce~s, the diameter b of a suitable unexpanded sleeve is about 3.5 mm, and the 15 length of the engagement portion of the sleeve (that i~, the portion of the sleeve t~at, when fully emplaced, co~tacts the bone hole wall) is about 10 mm.
Figs. 10.1 - 10.4 8ho~ 3till another more pre~erred emplaceme:llt apparatus, like that of Figs. 11.1 - 11.4 in maIIy particulars, but adapted for 20 use with a pin hav~llg a head, to provide a rivet fastener. Such a pin 412 having a head 414 is shown by way of example in, and de~cribed below with reference to, Figs. 12.1 - 12.3. Like fa~tener assembly 230, rivet fasteIler assembly 330 includes a holder body 332 severably attached to an expaIIdable sleeve 314 (~hown in the ~e2panded state Lll the Figs.); the 25 latter has an a~{ial bore 3 1 3 and an outer surface 315. Generally cylindrical holder body 332 has an inside diameter d substantially greater than the outside diameter of the rear end 317 of sleeve 314, and great enough to accommodate the diameter e of head 414 of pin 412. Expandable ~leeve rear end 317 is joined to holder body front end 334 by a~ular at~achment .: . , . , . .:, . ~, ......... .

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wo 92/04874 PCI/USgl/07003 portion 3~6, which is provided with a circular undercut 338 to facilitat~
separation of the sleeve from the cyl~ndrical holder body, at the co;npletion of the emplacement of the fastener in the bone, as descr~bed further below.

Rivet fastener The expandable sleeve, as described above with respect to Figs. 1.1 -1.4~ can be adapted to form a "rivet" fior directly riveting soft ~ue, or an object ~uch as a bone plate, to the bone at the fi~atioII site. Figs. 2.1 and 2.2 show ~r~ e~ample of such a nvet, in which the rear end OI the sleeve is . -a configured to form a head.
Referring now to Fig. 2.2, showing the rivet fastener ~ ed in a predrilled bone hole, the rivet head is formed as a flsnge 62 at the rear end ~i4 of e~pandable ~leeve 14. The ~ont surface 63 of tbe flange ~2 i~
generally planar and perpendicular tc the a~s A-A' of the sleeve, and the 15 rear surface fi6 i~ contoured to provide a smoo~, generally dome~haped head, thinner near the margin than toward the center.
The rivet is preferably emplaced in generally the same ~ashion as is the ~uture fastener, de~cribed above with reference to ~ig~. 1.1 - 1.4, and preferably i~ provided wit~ similar emplacement appara~us 30 and is 20 in~talled using similar plullger 40, as shown in Fig. 2.1. ~ere, the sleeve is fir~t passed t~rough the object (for example, 80fl; tissue ~uch as a ligament : . :
or a bone prosthesis such as a plate) to be attached to the bone, and then is . ::~
inserted into the bone hole ~ar enough to pro~ide an appropriate compre~sion of t~e attached object onto the bone ~urface. Pre~erably the .
2~ front end of a ~leeve adapted for use as a r~vet for attachi~g soft tissue tobolle is contoured to pass easily through the tissue, and the axial bore does not pass through the *-ont eud of the sleeve. A generally cor ical sleeve fro~t end 61 is suitable for retrie~ng and passing through soft tis~ue such ~ a~ a lig2ment. The rear surface 6~ of the flange 52 i~ attached to holder 30 body iEront e~d 34 by annular at~achment por~io~ ~6. As descri~ed above !~

.
:' wo 92/04874 Pcr/VSgl/07003 2~92'1oo 1~-with reference to Figs. 1.2 and 1.3, as plunger 41) is urged frontward, it presses pin 12 hefore it ~nto axial sleeve bore 13, expanding sleeve 14 as p~n 12 is forced ~ontward. As pin 12 approaches its final position, at which its rear ~urface 46 is appro2~imately flush with the rearmost part B7 of the rear 5 surface of flange 62, CUttillg edge 48 of cylindrical blade 44 approaches, then meets, and then pa~ses through annular attachment portio~ 66, :~
severing the sleeve 14 from the holder body 32, and thereby freeing the fully expanded and firmly fi~ed ri~ fa~tener 60 frorn the emplacement apparatus 30. The em~lacement apparatus is then withdrawn, leaving the 10 rivet ~astener in place at the fixation site in the bone, compressing the attached object 7 between the front surface of the head and the surface of the bone 2.
A3 w~ll appear from Fig. 2.2, the rear head surface 66 can be lef'l with a small r~m of connective material ~ollowing sevenng as described above.
15 Alternate configulation for the head and severable attachment is shown by way o~ example in Fig~. 4.3 and 4.4. As 3hown in Fig. 4.4, the in:Der surface lBO of the ~leeve ca~ be provided with aIm~ilar e~cavation 168 just frontward of the ~everable attachment 166. The excavation is formed sufficie~tly deeply into the material of the head so that when the CUttillg or 20 sheari~g means passes through, an annular fragment 160 is cut iEree of both the head surface 155 and the sleeve 32, alld arly remaining coImection 162 between the head sur~ace and the ~leeve is so thin that it provides little resistance to the 9imply pulling the sleeve away from the fixed faste~er.
As noted above, the sleeve is fabnicated fi om a relatively deformable material, while the pin is of a harder material, so that urgiIlg the pin into ~.
the axial bore of the sleeve deforms the sleeve o-ttward against the wall of the bone hole. We have discovered that a stronger and more durable rivet fastener can be made according to the invention by using a pin having a head, ra~her than by fo~ming the head as a flange at the rear end of the wo 92/04874 ~ 2 ~ Pcr/US91/07003 sleeve. The head of the resulting rivet is thus of the stronger pin matenal, and the neck portion of the rivet is supported by par~ of the barrel of the pin. , Such a headed pin is shown by way of example in Figs. 12.1 - 12.2, 5 and a preferred fastener assembly for use with a hea.ded pin is shown by way of example in, and described above with reference to, Figs. 10.1 - 10.4.
Referring now to Figs. 12.1 - 12.3, pin 412 has a generally cylindrical barrel 416 traversed by an axial bore 418, provided at its rear end w~th a head 414 a~d at its front end with a beveled portion 411L.
The expandable sleeve 314 passes without resists~nce i~to the bone hole, as described above generally; for emplacement as a bone r~vet, the gleeve i8 positio~ed within the bone hole so that an e~ternally smooth neck portion 304 projects above the bone surface, to provide a stando~ between the rivet head arld the bone surface, generally as de~cnbed in more deta~l 1~ below with reference to Figs. ~ and 6. ~ a~mular ridge 302 can retain a tissue-locki~g washer, preventing loss of the washer during inse~tio~ of the sleeve into the bone hole.
The outer diameter r of the cylindrical barrel 414 is about t:he same as, or slightly smaller than, the inner diame~r 6 of the ~eck portion ~04 of 20 the expandable sleeve ~14; and ~he diameter r is larger than the imler diameter a of l~e axial bore 313, so that a~ the pin 412 is forced ~nto the a~al bore 313, it passes w~thout substarltial resisl;ance through the neck portion, but cause~ the bone~ngagiIIg portion to e~pand outwardly against the wall of the bone hole. Thus, as pin 412 is urged firontward the beveled . ) 25 portion 411 presses outward against the inner surface of the bone-engaging portion of the ~leeve, beginning at the be~reled portion ~19 of the ~ter~or of the sleeve, as described generally above with reference to Fig. 1.1 - 1.3. As the *~ont surface 453 of the p~n head 414 contacts the rear surface of the annular attachment portion 336 between the rear of the neck portion of the 30 sleeve and the front portio~ o~ the holder body, the progress of ~he pin : ~ :
:

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within the sleeve i9 stopped, and further ~rontward urging of the pin cau~es a failure of the ~nular attachment portion ~136, effecting separation of the fully installed fastener from the holder body. Then the emplacement apparatus can be withdrawn from the site. Preferably, the head is provided with an abrupt front edge 454, to effect a shearing act;ion; and the annular attachment portion 336 preferably is pro~ded with a circular undercut 338 to further improve the precision of ~e separation.
Thu~ emplaced, the resulting rivet fastener is anchored firmly in place within the bone hole by the intimate contact of the deformed surface . :
of the bone-engaging portion 31~ of the expanded sleeve 314 with the bone hole wall; the sha~t 41L6 of the pin 412 within the a~ial bore 313 holds the ;
e~panded sleeve tightly against the bone wall. The neck portion 304 of the sleeve stands above the bone ~u~face, supported by the more rearward portion of the pin shaft 416 within. The head 414 of the pin 412 abut~ the part of the annular attachment 336 that rema~ns at the rear end of the ~leeve follow~ng separation from the holder body, 90 that the material to be fastened by the rivet is confined about the supported neck portion 304 of the sleeve, between the bone surface and the fro~t-facing surface 4Ei3 of the . .
pin head. :
Insertion tool : --A preferTed emplacement apparatu~ retains the pre~ngaged ~a3tener a~sembly plior to activation. The apparatus includes rlleans ~or pressing the pin into the-slee~e and then separat~ng the base frol:n the assembly.
The fætener assembly can be a disposable cartridge 60, as shown for example in the suture ~astener assembly of Figs. 3.1 and 3.2. The cartridge colltains the fastener assembly, the pin and a means of easily attaching the disposable carSridge to the appara~us.
In more detail, with reference to Figs. 3.1 and 3.2, a fastener assembly 60 i~cludes disposable cartridge ~;2 Gontai~i~g emplaceme~t apparatu3 30, including holder body 32 attached by aDnular attachmLent . ,. .. ,, .., . . . , - .. : :: : .................... . . . . . ' .:
,. . . . ` . ,, ::, :.
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~/O 92/04874 PCr/U~91/07003 7 ~

portion 36 to expandable sleeve 14 as described above with re~erence to Fig.
1.1, preloaded with plunger 40 and pin 12, poised with its beveled portion 11 close to the beveled portion 19 of the ~leeve 14, as shown in Fig. 1.1; and provided with a suture 20, passing through the a~ial bore 18 of the pin and 5 through an axial bore 4~ of the plunger and knotted aga~nst the front end ~ ~:
22 of the pin. The knot 20 is fully contained w~thin the ~leeve prior to emplacement of the fastener in the bone hole, so that it cannot inter~ere with the insertion of the fastener into the hole.
An axial bore 64 ~n nose 66 of cartridge 62 is dimensioned to closely 10 fit the outside diameter of the rear portion of the sleeve 14, as shown more clearly ~n Fig. 1.2, and, for clar~ty of presentation, excluded from othsr Figs.The holder body with attached ~lee~e is passed ~rom behind forw~rd through a~ial bore 64, 90 that the front ~urface 34 of holder body 32 contacts an ~nner surface 66 of nose 66, preventing further forward 15 movement of the holder body and attached ~leeve with respect to the cart~idge.
The c~ idge can additionally include a takeup ~pool 79, ~or storage of the free en~, of suture 20. When the appar~tus is loaded, ~utu~e 20 is arranged to pass from the knot in front end 22 of pinL 12, through pin a~nal ~0 bore 18, through out through hole 81 in the wall of plu~ger a~ial bore 47, and o;rer and around spool 79. As the emplacement apparatus is withdrawn, leav~ng the fastener, with the ~uture attached, fixed in place in the bone hole, as described above with reference to Fogs. 1.1 - 1.4, the fiee end of the suture 20 pays oflf from the takeup spool.
Cartridge 62 is then removably attached to hand held nneans for urging the plunger 40 firontward with respect to the cartridge. In th0 configurati~n shown by way of example ~ Figs. 3.1 and 3.2, the hand held means 70 consists of two handle elements 72, 74, slidal~ly engaged to provide a comfortable pistol g~ip 80 by which the rear handle elemellt 74 can be moved in a front-and-rear directio~ with respect to the front handle :'' ' '''"`' . :

wo 92/04~74 PCr/lJS9l/07003 2 ~ 9 ''~ ~ ~ 2~) -element 72 by squeezing the pistol grip 80. The front end 73 of the ~ront handle element 72 is adapted for removably mounting the rear end 68 of cartridge 62, for example in bayonet fashion, as shown in Figs. 3.1 and 3.2.
The front end 75 of the rear handle element 74 includes a push rod 7B
5 whose front end 77 abuts the rear end ~0 plunger 40 when the handle elements are assembled and the cartr~dge is mounted onto the front end 73 of handle front element 72, as shown in Fig. 3.2.
Alterna$ively, an axial bore 79 can be arra~ged to pass rearward through push rod 76 and handle rear portion 74, as shown for example in lû Figs. 3.1, for conducting the suture rearward from the knot at the front end of the pin all the way to the outside, as for example at the rear.
With the apparatus so as~embled, the surgeon gra~ps the apparatus :
by the pi~tol gr.tp, and directs the expandable sleeve to the d0~ired depth into the predrilled hole in the bone. Then, while holding the apparatu~ in 1~ place, the surgeon squeezes the grip X0 sliding the rear handle element 74 frontward with respect to the front handle element 72, as indicated by the arrow 100. The push rod 76 presse~ against the rear end 50 of pltmger 40, urg~ng the plunger frontward with respect to the holder body 30, and thereby pre~sing the pin 12 into the a2cial bore of the sleeYe 14, causing the 20 sleeve to expand w~thin the bone hole, and then cau~ing the cylindrical blade 48 to ~ever the connection betweeIl the sleeve alld the holder body, lea~ring the fa~te~er fixed in the bone as described above with re~erence to Figs. 1.2-1.4.
The e~nplacement apparatus of Figs. 10.1 - 1û.4 or 11.1 - 11.4 25 operates generally as described above with reference to Figs. 3.1 and 3.2, except that the holder body 232 or 332 is connected at the rear by a snap-on interlock w~th the hand held means ~or urging the plunger frontward with respect to the ex~andable sleeve, rather than retained bv way of a nose portion 66 of the cartridge 60.

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wo 92/0~l874 PCI/US91/07003 2 ~

Preferably the snap-on interlock is configured as an insertible spring-loaded connector, in which a rear portion of the holder body forms the "male" part of the connector and a portion of the hand-held activator forms the "~emale part. With reference now to either of Figs. 10.1 or 11.1, 5 flange ~10 is situated with a rear surface ~12 situated a f~ed distance rearward from the ~everable attachment of the expandable sleeve to the holder body. To the rear of the flange 510 is a groove ~14 having a frontward-facing surface 616 generally perpendicular to the ax~s of the holder body, and the holder body taper~ to rearward from the outer edge of 10 the surface 616. The hand held mean~ (not shown in the Fig~.) is provided with a generally cylindrical bore for receiving that portion of the holder body situated to the rear of the flange; and is prov~ded with one or more keepers that are moved away from the a~is by the advancing taper ~18 and . .
then spring into the groove 514 and lock against frontward-facing groove 16 ~urface ~ when the rear portion of the holder body i~ correctly positioned wit~i~ the recei~nng bore. The rear-facing ~urface 612 of the flange 610 contacts a par$ of the hand held means adjacent the holder body recei~ng bore, to provide a Atop establishirlg the correct rearward po~ition of the holder body wit~in the hand held meaIls. The hand held mea~ pro~ided 20 with a plunger that can be urged frontwardly with re~.pect to the holder body receiving bore along the holder body axis, drivillg the pin before it toward and into the aacial bore of the expandable sleeve.
Pre~erably the length of the plwlger is fixed in relation to the fixed front-to-rear distance between the rear surface 512 and the severable 2~ attachment of the e~pandable sleeve to the holder body, and a stop is provided to limit the extent ~ontward to which the plunger can be urged within the hand held means, so that the separation of the exyaIldable sleeve from the holder body is complete at just the point where the plunger has ~,: . ., wO 92/04874 PCT/I)S91/070~3 2 ~ 0 - ~2 -been moved to its frontmost limit. Thi~. ensures proper emplacement of ~he fastener in the bone hole, provided that the holder body i~. properly mounted in the handle and the user urges the plunger frontward as far as it will go.
Example Preliminary tests have demonstrated the effectiveness of prototype fastener and emplacement apparatus configured gener~lly as described with reference to :Eiigs. 1.1 - 1.4, and made and dime~sioned as follows (dime~iollal abbreviation~ are indicated on Figs. 1.1 ~L~d 1.4).
The ~leeve ~vas formed of natural high density polyethylene (PE), 10 type PDC 9122, supplied by Pla~tic Distributing ~orp., and dimensioned to slide easily into a 3.5 mm (0.138 inch) diameter lc) bone hole. Ilhe outer surface of the sleeve was machined to a 6-32 ~crew thread configuratioII to provide protru3ions, rat~er thaD annular ridges a~ ~hown ill Figs. 1.1 - 1.4, as screw threads are easier to form. A 6-32 screw thread configuration -~
provides a 0.138 ~nch outermost diameter (lb), so that the sleeve can be in8erted illtO the 3.5 mm bone hole ~vithout resistance. The a cial bore of the sleeve wa~ of a uniform 0.090 inch diameter (a), and it~ len~ was 0.138 inchea The pin was formed of DuPont Delrin 100, m~chined to have the 20 gerleral shape ~hown in Figs. 1.1 -1.4, and an outermost diameter (g) of 0.125 inch. Delrin is much less deforma~le than the [?] polyethylene of which the sleeve is made. ~he tapered leading edge of the pin permits the relatively incompre3sible pin to be forced into the 0.090 inch slee~e a~nal bore and to expalld the relatively soft sleeve, generally as showll in Fig 1.3.
25 When the pin has been fully inserted within the 91eeve, the device, as shown diagrammatically in Fig. 1.4, can have an outermost diameter (h) appro~nmately 0.170 i~ch, providing for substantial deformation of the outer por~ions of the sleeve into the irregular w 11 of the bone hole, and thereby forming a firm fastener for the sleeve and pm. The p7n has an a:~al bore of 30 diameter 0.046 inches ~i), which accepts a pair of sutures for later use in attaching soft tis~ue to the bone sur~ace. Before insertion of the pin, tlhe ~ ;

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WO 92/0~874 PCI/U~;91/07003 ?

sutures are pasied through the axial bore of ~he pin and their ~rontward ends are knotted so that they stop against the fi:ontward end of the pin.
The outside configuration of the sleeve is a 6-32 thread which provides a series of ridges which assist in perm~tting defoTInation of the sleeve in the bone hole and con~ormation of the sleeve outer surface as it is pressed irlto the 0.138 inch diameter bone hole. In this prototype the threads are not used for turning the sleeve i~to the bone, but rather to facilitate deformation of the outer portion of the sleeve when the sleeve is e~panded within the bone hole. When the hard delrin pin is pressed into l;he sleeve, the threads of the insert are de~ormed by ~Tegular~ties in the hard cortical bone hole wall, locking the fastener, and the pin compresE~ed within it, into place, as shown by way of example, and less diagrammatically than in the other Figs., as described above with reference to Fig. 7.
The sleeve was formed with an a~mular con:~lection to a cylindrical holder body as descr~bed above with reference to Figs. 1.1 - 1.4, and enclo~ed wi~hin a cartridge and provided with emplacement apparatus as described above with reference to Figs 3.1 and 3.2, configured arld dimensioned as follows.
The holder body was formed as a cylillder having inside diameter (d) 0.156 inch and outside diameter (j) 0.218~ and length 0.420 inche~. The con~ecting portion between the holder body and the rearward end of the ~leeve vvas formed as an annulus having inside diameter 0.125 inches and outside diameter 0.218 inch, and lengthwise thickness (k) 0.012 inches.
The plunger and attachment severiI~g me~s was constructed by position~ng a stainless steel rod within a closely-fitting stainless steel tube,and machining the tube to provide a punch-and-die configuration generally : :as in Figs. 1.2 alld 1.3., ha~ring an outer diameter (1) 0.150 inch. The severiIlg means w~s formed by machining the fror~t end of the tube to form a sharpened step~ located appro~mately 0.060 ~nches rearward ~rom the wO 92/0487~ PCr/US9l/07003 2ai~'2~0u -24-blunt front end of the plunger; the tube wall had a thickness (m) about 0.012 inch.
As the plunger is pressed f:rontward, it pres~es the Delrin pin before it into the sleeve, expanding the sleeve and deform~ng it against the bone hole wall. When the pin approache~ the point where it has been pressed ~;
fully into the sleeve, the sharpened step reaches the û.012 Lnch thick connecting annulus and passes through it, s~ear~ng it and qeparating the fastener insert fro m the holding body. Then the emplacement apparatus is withdrawn together with the plunder and the holder body, leaving the 10 fastener f~xed within the predrilled bone hole.
A 3.5 n~m (0.138 inch) diameter hole was made in the bone to a depth of 8 ~Im using a disposable spade drill with a stop to limit the hole depth.
The prototype device was emplaced as described above with reference to Figs. 3.1 and 3.2 in femur bone recovered from a pig cadaver, and then was 15 tested as follows.
The hole was drilled into the pig femur cortical bone appro~nately normal to the bone surface to a depth about 8 mm using a step ~ill. Then a suture fastener loaded with a pair of ~ 2 nonsterile braided polyester sutures was ~serted into a cartridge and coupled to an in~tallation tool, 20 and positioned and f~2~ed in the bone hole as described above. Innen a knot was tied ~ the sutures at ~ome distance from the fasten0r and looped o~er an ~metek Accuforce Cadet digital force gauge, 0-50 lbs. rau1ge (Ma~sfield &
Green). The slack in the sutures was taken up by drawing the force gauge by hand away from the faste~er in a dLrection perpendicular to the bone 26 ~urface, and then the holding force was tested by sharply pullitlg the force gauge away from the bone by hand in a direction perpendicular to the bone surface. In such prel~Linary tests the astener held, and the suture broke.
These results demonstrate a holding capacity superior to those shown in similar tests using known dev~ces now on the market. Apparently~ the 30 fa~tener accordillg to the invention provide~ a superior platform to secure the ~stener because it is locked into good dense bone, and because the . . .

wo 92/04874 PCI/US91/070~3 a conformity of the sleeve sur~ace with irregularities in the bone provides a superior fi2~ation. Moreover, there are no sharp edges i~ the fastener that can abrade the suture.
IJse The bone fastener according to the invention can be used for fastening to bone any of a variety of objects, including tissues such as ligaments or tendoIls and prostheses such as bone plates. The fastener and emplaceme~t apparatus can be used in any of a wide v~riety of orthopedic surgical procedures alld settillgs. The fastener can provide superior holding capacity and relatively small size, and can be installed according to the invention without h~Tnrnering and without imposing any substantial net force toward or away from $he bone surface, and so the ~nvention pro~des for fastening in surgical settings in which bone anchors have not been used, or have been used with less success.
The fastener according to the invention is of a readily drillable material, and the in~talled fastener is situated near the bone sur~ace. I~us, removal of the dev~ce from the bone in a later ~urgical procedure is ~traightforward. If remo~al of a fastener is indicated, the ~urgeon can s~mply use a drill, preferably of a somewhat smaller diameter than the 20 o~ al bone hole, to e~cca~ate the pin, and then the aIlchor and any debris can be simply withdrawn from the hole.
O~er Embodime~t~ ~
Other embodiments are withi~i the following claims. For example the sleeve and pin can have other configurations and dLmen~ions. The sleeve 25 can, for example, be configured to fit in a bone hole hav~ng other than cylindrical shape. I~e fastener can be made smaller or larger than shown in the example, according to the size and characteristics of the bone at the particular fi~cation site. As a practical matter the lower limit of the fastenerdiameter depends ~pon providing a pin whose diameter is great e~ough that 30 it can be ~orced without collapsing into the as~al bore of the sleeve; ~or this ;
rea~on a ~asteller can be made sccording to the in~ention having a sma~ler wo 92/04874 PCr/US9l/070~3 2~9'~4~a -26-diameter, where the pin has no axial bore, a~ for example in headed rivet configurations. At the upper l~mit of size, as a practical matter a fastener ~equi~ng a very large hole i~ the bone may excessi~ely compromise the bone structure itself, and in some circumstances a plurality of smaller 5 fasteners according to the invention may be preferred over a s~ngle larger one. For rivet configurations, as for e~ample in implantation of artificial ligaments, a fastener diameter as great as 10 mm or r~ore may be des~red.
Other fastener configurations are within the inventioIl. For e~ample, a fastener ha~ring the rear end of the ~leeve configurecl to form a head can 10 also be provided vn~h a standoff, as ~hown for example in Figs. 5 and 6.
Referring now to Fig. 5, a fastener gO with a head 92 and a standoff 94L
between the head and the bo~e ~urface is ~hown f~ed Ln bone and used to attach a ligament at the fi~ation ~ite. Ihe une~panded sleeve can have its outer surface threaded over an e~tent that is to contact the bone hole wall, 15 and lef~ smooth over an e~tent between the threaded portion and the head.
And, referring now to Fig. 6, the outer su:rface of the sleeve 100 can be configured to provide a ~top 102 at the junction between ~he ~tandoff 104 a~d the portion of ~e ~leeve surface that contact~ the bone wall, to limit preci~ely the depth to which the sleeve is inserted into the bone hole. Stop 20 102 can be formed, ~or e~a~ple, as a pa* of "ears", projecting far enough out from the ~leeve 90 that they contact the bone sur~ace at the edge of the bone hole, stopping the ~rontward progress of the sleeve *lrther into the hole. VVben the surgeon senses the contact of the stp with the bone surface, the pin advancing mechanism can be activate1, effecting fixation of the 2~ fas~ener at the predetermined depth. Standoff fasteners can be dimensioned to provide for various insertion depths and s~andoffs, according to the particular surgical setting.
As ~hown in Fig. 4, the sleeve can be configured to be turned into the bo~e hole by sel~-tapping screw threads 110, and then fi~ed ~n pl~ce by 30 forcing a pi~ 2 into the a~al bore 113 of the sleeve 114 as des, ribed generally abo~e. I~l this configuration, as in the others dec,cribed herein . ,. -wo 92/04874 ~ PCr/lJS9l/07003 according to the invention, fi~atiQn of the fastener i~ the bone hole is effected by the e~pansion of the sleeve in the hole, and the deformation of the sleeve and conformation of its outer surface with :iITegularities in the bone hole. The screw threads provide for positioning of the fastener in the 6 hole at a de~ired depth, or for apply~ng a desired force upon the object between the fastener head 116 and the bone surface, prior to f;~ation by forcing the pin into the a~al bore in the sleeve.
In such a turnable screw thread configuration, the tLnexpanded sleeve can be turned into a bone hole hav~ng a diameter ~omewhat smaller than 10 the outside diameter of the screw threads, so that ~e screw threads self tap the hole to some extent as the sleeve is turned into the hole. Although the threads are not meant to tap the bone hole to an e~tent sufficient by itself to effect firm fixation of the fastener, it can be useful to harden those surfaces of the screw threads that cut or abrade the bone hole wall, as for 15 example thread edges and beari~g ~urfaces 116. Such harden~g ca~ be provided, for e~cample by forming the sleeve of a relat*ely de~ormable polymer material that can be hardened by application of heat or radiation, and then irradiating ~elective parts of the ~leeve surface to harden it at those parts. Or, the sofl;er sleeve can be provided over selected parts of its 20 surface with a thin coating of a harder or more durable material. Once such a sleeve has been turned into the bone hole to ~he desired depth, t;he piD can be forced into the ax~al bore of the ~leeve, e~panding the sleeve, deforming the outer portion of the sleeve and redistributing the relatively harder ~ ace port;ions so that the deformed surface substi3ntially coIIfo~
25 to iITegularities in the bone wall.
The sleeve cian be made USiClg i~y biocompatible material that results in a sleeYe that expands in the bone hole when the pin is forced`into the axiial bore of the sleeve; a~d preferably the sleeve surface, when the sleeve ~is e~panded outwardly, deforms and con~orms to irregularities in the bone 30 hole wall. The sleeve can be made U~iIlg a combination of materials that provide the de ired combination of properties for the pi~ticular .:

:, WO 92t0487'~ PCl/US91/07003 2 ~ 9 '~ 3 0 - 28 -configuration; for example, the head and standoff portion of a ~leeve adapted for use as a rivet can be made of a less deformable matenal than the surface portion of the sleeve that conforms to the bone wall. And, as described above with reference to Fig. 6, the portions of the screw threads 5 that in ef~ect tap the bone hole as the sleeve is turned inko the bone can be made of a harder material khan the underlying sleeve mass.
Materials appropriate for mamlfacture of the sleeve include, fo:r e~ample, low density polyethylenes (PE 6010 and PE 2030) a~d polypropylene (13R9A and 23M2) (all Rexene, Dallas, IX). Of these, for 10 e2~ample, PE 601û and 13R9A have been EDA approved, as Class VI
implant materials.
The pin can be made using any biocompatible mateIial or combinakion of material~ such that the pin is su~iciently i~compres~ible that it serves to e:~pand the sleeve outward again~t the bone hole wall when 1~ forced into the sleeve ax~al bore, and such that the pin can withstand the force of the plunger o~ its rear surface.
Beside~ biocompatible material~ known at pre~ent, other materials whose biocompatibility has not yet been demonstrated can be used in tl:le pin and the ~leeve, and in the emplacemen~ apparatus, a~ will be evident to 2Q those of ordinary skill. UltemTM, ~or example, is a moldable, thermofo~ble polyetherimide polymer t~at has hardness, shear strength, and tensile s*ength character~tics that make it suitable ~or use Ln the pL~; -and moreover UltemTM is autoclavable.
Configurations can be employed for the severable attachment between 25 the holder body and the sleeve other than the complete arlIlulus of severable material descnbed above with reference to Fig. 1.3. For example, the attachment can corlsist of webbillg between the holder body and the sleeve, or spokes 136 of severable material arranged at intervals between the holder body 32 and the sleeve 14, as ~hown for example iIl Fig. 8.1. Now 30 the cutt~ng toolg shearng tool, or heating mea~ ~ed sever only the spokes, as Yhown at ~L36' ill Fig. 8.2. Or, a cutting tool, sheari3~g tool, or heati~g WO 92/1)4874 PCI/US91/07003 element may be unneces3ary where the severable attachment can be broken by applying force in a selecti~e direction. as shown for e~ample in Figs. 9.1 and 9.2. In Fig. 9.1, holder body 32 is attached to sleeve 14 by a plurality of very attenuated spokes 236. I'he front-to-rear dimension of each of 5 spokes 236 is sufficiently thick that it can withstand the counterforce required to balance the force of urg~ng the pin into the ~leeve a2nal bore.
But the connection of the spol~e to the sleeve 14 i8 thin enough so ~hat, with the pin fillly inserted into the sleeve, and the sleeve fixed in the bone hole, the holder body can be rotated about its long a~is, as indicated by arrow 200 10 in Fig. 9.1, to break o~the attachrnents as shovrn at 236' in Fig. 9.2, freei~g the ~astener from the holder body.

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Claims (31)

Claims

1. A bone fastener, comprising an expandable sleeve having an axial bore and a pin forcibly insertible into the axial bore, the expandable sleeve being configured to be insertible into a bore drilled in bone, at least a portion of the pin having an outer diameter greater than the inner diameter of at least a portion of the axial bore.

2. The bone fastener of claim 1 wherein said pin includes a head for retaining an object to be fixed to the bone.

3. The bone fastener of claim 1 or 2 wherein said pin includes an axial bore.

4. The bone fastener of claim 1 or 2 wherein said pin is made of a high impact material.

5. The bone fastener of claim 4 wherein said pin material comprises a high impact biocompatible polymer.

6. The bone fastener of claim 4 wherein said pin material comprises a polycarbonate.

7. The bone fastener of claim 4 wherein said pin material comprises a polysulfone.

8. The bone fastener of claim 1 or 2 wherein said sleeve has a generally cylindrical configuration.

9. The bone fastener of claim 1 or 2 wherein the outer surface of said sleeve is configured to include a plurality of protrusions.

10. The bone fastener of claim 1 or 2 wherein the outer surface of said sleeve is provided with a plurality of protrusions.

11. The bone fastener of claim 1 or 2 wherein the outer surface of said sleeve is provided with at least one annular ridge.

12. The bone fastener of claim 1 or 2 wherein the outer surface of said sleeve is threaded.

13. The bone fastener of claim 1 or 2 wherein said sleeve is made of a thermoplastic material capable of expanding when pressed nutwardly by said pin.

14. The bone fastener of claim 13 wherein said thermoplastic material is capable of conforming under pressure with irregularities in the bone hole wall.

15. The bone fastener of claim 13 wherein said thermoplastic material comprises a biocompatible polymer.

16. The bone fastener of claim 13 wherein said thermoplastic material comprises a high density polymer.

17. The bone fastener of claim 15 wherein said thermoplastic material comprises a polyethylene.

18. The bone fastener of claim 15 wherein said thermoplastic material comprises a polypropylene.

19. The bone fastener of claim 17 wherein said thermoplastic material comprises a high density polyethylene.

20. The bone fastener of claim 18 wherein said thermoplastic material comprises a high density polypropylene.

21. A method for establishing a fastener in a predrilled hole in bone, comprising inserting into the hole an expandable sleeve having an axial bore, and forcing into the axial bore a pin, at least a portion of said pin having a diameter greater than that of at least a portion of said axial bore, so that as said pin is forced into said axial bore the wider portion of said pm presses outward against the narrower portion of said sleeve, causing said sleeve to expand against the walls of the hole and fixing said pin within said sleeve firmly in place within the hole.

22. The method of claim 20 wherein the step of forcing said pin into said axial bore include imposing a counter force on the expandable sleeve in a direction about opposite from, and in a magnitude about equal to, the force imposed on said pin, to minimize any substantial net force toward or away from the bore during the step of expanding said sleeve against the walls of the hole.

23. Apparatus for emplacing a bone fastener as claimed in claim 1 or 2, comprising a holder for holding said expandable sleeve in position within the predrilled hole in the bone, and a plunger moveable in relation to said holder for forcing said pin into said sleeve axial bore, whereby said pin Can be forced into said sleeve axial bore without imposing substantial net forces toward or away from the bone.

24. The apparatus according to claim 22 wherein said holder comprises a generally cylindrically shaped hollow body having a front and a rear end, said body being severably attached near its front end to the rear end of said expandable sleeve, means moveable within said body for forcing said pin into said expandable sleeve, and means for severing aid attachment between said holder and said expandable sleeve.

25. The apparatus according to claim 23 wherein said holder body is severably attached to said expandable sleeve by an annular portion connecting said holder body front end to said expandable sleeve rear end.

26. The apparatus according to claim 22 wherein said plunger includes a rod that can be moved frontwardly and rearwardly with respect to said holder body, the front end of said plunger abutting the rear end of said pin to force said pin into said sleeve axial bore when said rod is moved frontwardly.

27. The apparatus according to claim 22 wherein said attachment severing means includes a cylindrical blade having an annular cutting edge.

28. The fastener according to claim 1 or 2 wherein at least a part of the rearward portion of said sleeve projects radially outward to form a head.

29. The fastener according to claim 27 wherein said head is configured as a flange.

30. The fastener according to claim 27 wherein said sleeve is smooth over a part of its length frontward of said head.

31. The fastener according to claim 27 wherein at least a part of said sleeve at a distance frontward from said rearward end of said sleeve is expanded to form a stop.