Note: Within nine months of the publication of the mention of the grant of the European patent in the European PatentBulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with theImplementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has beenpaid. (Art. 99(1) European Patent Convention).

Printed by Jouve, 75001 PARIS (FR)

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(12) EUROPEAN PATENT SPECIFICATION

(45) Date of publication and mention of the grant of the patent: 02.07.2014 Bulletin 2014/27

(21) Application number: 99904160.1

(22) Date of filing: 20.01.1999

(51) Int Cl.:A61B 17/10 (2006.01)

(86) International application number: PCT/US1999/001203

(87) International publication number: WO 1999/037219 (29.07.1999 Gazette 1999/30)

(54) TISSUE ANCHORING SYSTEM AND METHOD

ANORDNUNG UND VERFAHREN ZUR VERANKERUNG VON GEWEBE

SYSTEME ET PROCEDE DE FIXATION DE TISSUS

(84) Designated Contracting States: AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE

(30) Priority: 26.01.1998 US 13434

(43) Date of publication of application: 15.11.2000 Bulletin 2000/46

(73) Proprietors: • Orthodyne, Inc.

Orlando, FL 32806 (US)• Cole, J., Dean

Orlando, FL 32804 (US)

(72) Inventors: • COLE, J., Dean

Orlando, FL 32804 (US)• JUSTIN, Daniel, F.

Logan, UT 84321 (US)

(74) Representative: Höhfeld, Jochen et alKlunker Schmitt-Nilson Hirsch KSNH Patentanwälte Destouchesstrasse 6880796 München (DE)

(56) References cited: EP-A- 0 464 480 US-A- 4 738 255US-A- 5 041 129

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Description

BACKGROUND OF THE INVENTION

[0001] The present invention relates to surgical devic-es and, more particularly, to devices for the repair of boneand soft tissue.[0002] It is a common requirement in orthopedic sur-gical procedures to anchor two or more elements togeth-er, such as pieces of a bone, two or more bones, or acombination of soft tissue and bone. This has been ac-complished by a number of devices, such as bone boltsthat penetrate two pieces of bone and use a nut to drawthe segments together, bone screws and interconnectingplates, wires circling at least two pieces of bone, or su-tures into the tissue.[0003] Often such devices require a relatively large ac-cess opening through surrounding and/or covering tissueto implant the anchoring devices. The enlarged accesssite may increase patient pain and lengthen recoverytime. Further, in some locations it is difficult and imprac-tical to make large access points to reach the appropriatesite because of surrounding joints and vessels. Even withdevices that penetrate the tissue in a substantially linearmanner, i.e. lag bolts, the fracture must often be reducedbefore drilling and insertion of the bolt. Further, some ofthese devices may be difficult to use since it may be hardto reduce a fracture between two bone segments andmaintain that reduction while the device is inserted. Thisis particularly true with small bone fragments were theuse of threaded implants may tend to rotate one bonesegment with respect to another, thereby creating a mis-alignment between the fragments.[0004] Cerclage systems provide an alternative to im-plants that must penetrate the bone to achieve fixation.Such devices have been taught by Miller et al. (U.S. Pat.No. 5,312,410) and Songer et al. (U.S. Pat. No.5,536,270). These systems rely on passing a cablearound two segments of bone and then tensioning thecable to squeeze the bone segments together. A signif-icant drawback of these systems is that they require ac-cess around the entire bone.[0005] Therefore, there remains a need for a conven-ient and effective system for securing two segments oftissue together. Such a system should preferably be op-erable through a relatively small insertion opening oropenings to securely hold two tissue segments.[0006] EP 0 464 480 discloses a suture anchor for se-curing a suture to body tissue in an arthroscopic surgicalprocedure. A suture anchor is secured to the suture. Aseries of stop members, such as spheres, ribs or ridgesare provided on the suture (20) for mating with a lockingmember in order to hold pieces of body tissue togetheruntil they are reattached or healed.

SUMMARY OF THE INVENTION

[0007] It is disclosed an anchor system that can com-

prise an elongated flexible member having a diameter,a proximal end, a distal end and a longitudinal axis; ananchor having a proximal end, a distal end, a central por-tion between the proximal end and the distal end and alongitudinal axis extending between the proximal end andthe distal end, the anchor including a longitudinal slotextending longitudinally from the proximal end to the cen-tral portion, the slot having a width greater than the flex-ible member diameter, the flexible member distal endaffixed adjacent the central portion. The anchor is move-able relative to the flexible member between a first posi-tion wherein the longitudinal axes of the flexible memberand the anchor are generally parallel with a portion of theflexible member adjacent the distal end residing withinthe slot and a second position wherein the longitudinalaxes of the flexible member and the anchor are generallyperpendicular.[0008] Another anchoring system which is also not partof the present invention, comprises an elongated flexiblemember having a proximal end, a distal end and a firstdiameter; and an anchor affixed to the distal end, theanchor moveable between an insertion configurationadapted for insertion through a tissue opening and ananchoring configuration adapted to inhibit passagethrough the tissue opening, the insertion configurationhaving a second diameter less than twice the first diam-eter, and the anchoring configuration having a third di-ameter greater than the second diameter.[0009] The system of the present invention as definedin claim 1 contemplates a crimping tool which comprisesan outer member having an inner passage and a distalend having an outer diameter. A crimping mechanism isdisposed within the inner passage adjacent the distalend. The crimping mechanism is movable between acrimping position and an open position.[0010] It is disclosed a method for joining two sectionsof tissue. The method includes providing a first anchor,an elongated member attached to the first anchor, a sec-ond anchor slidable on the elongated member and havinga deformable portion adapted to engage the elongatedmember, and a crimping tool having an outer memberand an inner member movably disposed within the outermember. The first anchor is inserted into a first sectionof tissue. The second anchor is threaded on the elongat-ed member. Tension is applied on the elongated memberto urge the first section of tissue toward a second sectionof tissue. The elongated member is threaded through thecrimping device, and the inner member of the crimpingdevice is moved with respect to the outer member therebydeforming the deformable portion of the second anchorand maintaining the tension applied to the elongatedmember.[0011] One object of the invention is to provide an el-ement for anchoring tissue.[0012] A further object is to provide such a system thatalso tightens and ligates the anchoring element.[0013] An additional object of the present invention isto provide a crimping tool.

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[0014] Other objects and advantages of the presentinvention will be apparent from the following description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015]

FIG. 1A is a perspective side view of the cable/an-chor element of the present invention in an anchorposition, ready to anchor tissue.FIG. 1B is a perspective side view of the cable/an-chor element of the present invention in an insertionposition, ready for delivery by the delivery device.FIG. 2A is a top view of the anchor of the presentinvention.FIG. 2B is a side view of the anchor of FIG. 2A.FIG. 2C is a right side view of the anchor of FIG. 2B.FIG. 3A is a top view of an alternative embodimentof the anchor of the present invention.Fig. 3B is a side cross-sectional view of the anchorof FIG. 3A.FIG. 4 illustrates the insertion step of the method ofuse of the system in anchoring a ligament to a bone.FIG. 5 is a front perspective view of an eyelet anchorof the present invention mounted on a delivery de-vice.FIG. 6 is a front perspective view of the eyelet anchorof FIG. 5 being affixed to a bone with an attachedcable extending through a bone opening protectorand secured by a second anchor.FIG. 7 (A-E) illustrates a method of use of a systemaccording to the present invention in anchoring twosections of bone together. In FIG. 7A the deliverysystem with anchor and attached cable are insertedthrough the bone. In FIG. 7B the anchor is pivoted.In FIG. 7C a washer and a ferrule are threaded ontothe proximal end of the cable, and in FIG. 7D theferrule is crimped onto the cable, and the cable iscut, leaving the bone fragments anchored as shownin FIG. 7E.FIG. 8 is a perspective side view of a tensioning,crimping and cutting tool of the present invention.FIG. 9A is a perspective view from the distal end ofthe tensioning, crimping and cutting tool of FIG. 8.FIG. 9B is a perspective cross-sectional view adja-cent the distal end of the tensioning, crimping andcutting tool taken along B-B’ of FIG. 9A.FIG. 10A is a side cross-sectional view of an alter-native cable tensioning mechanism for use with thetool of FIG. 8.FIG. 10B is a cross-section of the mechanism of FIG.10A taken along line B-B.FIG. 11 is a side view of an alternative embodimentof a tensioning, crimping and cutting tool of thepresent invention.FIG. 12 is a partial cross-sectional view of the toolof FIG. 11.FIG. 13 is a top view of the tool of FIG. 11.

FIG. 14 is a front partial cross-sectional view of stilla further embodiment of a tensioning, crimping andcutting tool not according to the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] For the purposes of promoting an understand-ing of the principles of the invention, reference will nowbe made to the embodiments illustrated in the drawingsand specific language will be used to describe the same.It will nevertheless be understood that no limitation of thescope of the invention is thereby intended, such altera-tions and further modifications in the illustrated device,and such further applications of the invention as illustrat-ed therein being contemplated as would normally occurto one skilled in the art to which the invention relates.[0017] Referring to Fig. 1A, a system according to thepresent invention includes a cable 20 having an anchor30 affixed to a distal end 202. A delivery device 40 is alsoprovided for aiding in inserting the cable 20 through tis-sue. The term "tissue" is used herein to include any man-ner of body part including without limitation, bone, carti-lage, ligaments, tendons, and muscle.[0018] Referring to FIG. 1A, cable 20 may be any elon-gated flexible member, the choice of material and sizebeing dependent upon the particular application. For thepurposes of illustration and without limitation, the flexiblemember is referred to and shown as a cable, although itis within the scope of the invention that a flexible membercould similarly be a filament, thread, suture, wire, sub-stantially flat ribbon type member, or any other flexiblemember suitable for implantation in the body. Cable 20may comprise such biocompatible materials as stainlesssteel, titanium, nitinol, plastic, bioresorbable material,composite material, or cobalt chrome alloy. The list ofpossible cable compositions is provided for the purposeof illustration and is not intended as limiting, it being un-derstood that selection of a cable may depend on theintended application. In a preferred embodiment for usein bone fracture reductions, cable 20 is a flexible multi-stranded metallic cable such as stainless steel as is al-ready known in the art. In a system for affixing two sec-tions of soft tissue together, suture material or an equiv-alent threadlike material can be used instead of metalliccable. Thus, it is to be assumed herein that the word"cable" should be taken to mean any flexible material thatcan be used in surgical applications for affixing two sec-tions of tissue together, and no limitations are intendedthereby.

Cable Anchor

[0019] Attached to the cable’s distal end 202 is a gen-erally cylindrical anchor 30 (FIGS. 2A and 2B) that hasa closed distal end 302, an open proximal end 304, anda partial bore 301 extending from the proximal end 304but not through to the distal end 302. The distal end 302is rounded to limit damage to surrounding tissue and for

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ease of insertion through the tissue to be anchored. An-chor 30 includes a longitudinal axis 303 that extends fromthe proximal end 304 to the distal end 302. The anchormay be constructed of a material similar to the cable orthe anchor may differ from the cable. In one combination,the cable is non-resorbable while the anchor is bioresorb-able such that the cable may be removed after a healingperiod and the anchor may remain in the body.[0020] The anchor 30 has a distal portion 317 havinga first cross-sectional diameter 306, or width, larger thanthe diameter 206 of the cable 20. In a preferred embod-iment, diameter 306 is less than twice diameter 206, thusproviding a relatively small insertion diameter. This firstcross-sectional diameter 306 generally coincides with acylindrical diameter. In a preferred embodiment, diame-ter 306 substantially equals the outer diameter of deliverydevice 40. A second cross-sectional dimension 308, orlength, is significantly larger than the width 306. Thislength 308 generally coincides with the length of the an-chor 30 from proximal end 304 to distal end 302.[0021] The anchor 30 also has a proximal portion 310opposite the distal portion 317, the proximal portion 310having a width 320, the proximal portion width 320 small-er than the distal portion width 306. The proximal portion310 includes a taper 318 tapering toward the proximalend 304 and a thickness 322. It will be understood thatupon engaging a surface with cable 20 proximally ten-sioned, taper 318 assists the anchor in flipping to an an-choring position and in sliding under adjacent tissue dur-ing the flipping process. There is a shoulder 311 betweenthe proximal portion 310 and the wider distal portion 317,for engaging the distal end of the delivery device 40.[0022] In addition, the anchor 30 has a generally lon-gitudinal slot 314 extending from the proximal end 304into the distal portion 317. Slot 314 has a width 312 equalto or greater than the cable diameter 206. The distal end202 of the cable 20 is affixed, for example, via crimping,within the anchor bore 301 between the anchor’s distalend 302 and the slot’s distal end 315 (see FIG. 1A). In apreferred embodiment, a four point crimp is applied toanchor 302 to secure cable 20 within bore 301. However,it is contemplated that an alternative crimping procedurecould be performed as well as welding, brazing, adhe-sive, etc. Additionally, cable 20 may include a loop at itsdistal end for attachment through an aperture in the an-chor. Any attachment means may be used provided thecable is secured to the anchor with sufficient strength forthe intended application.[0023] In a preferred embodiment, the anchor outerdiameter 306 is less than twice the cable diameter 206.This permits the cable and anchor combination to be in-serted through a relatively small hole or incision. How-ever, the length 308 is much greater than the anchordiameter 306 thereby providing a secure anchorage forthe cable.[0024] The anchor 30 is movable in relation to the cable20 between two positions: a first position (FIG. 1B) where-in the anchor’s longitudinal axis 303 is generally parallel

to the cable’s longitudinal axis 207 and the cable’s distalportion 201 resides within anchor slot 314, and a secondposition (FIG. 1A) wherein the anchor’s longitudinal axis303 is at an angle to the cable’s longitudinal axis 206 anda part of the cable’s distal portion 201 extends outsideanchor slot 314. Anchor 30 includes a curved surface324 adjacent slot 314 for the cable to bear against andlimit abrasion when in the second position. By the natureof the cable-anchor connection, the anchor 30 is biasedto the second position. This biasing occurs because thefirst position is unstable. Such biasing may be inducedby a pre-set curve in distal portion 201 of cable 20 posi-tioned within slot 314 tending to rotate anchor 30 to thesecond position. In addition to biasing the anchor towardsthe second position, taper 318 on the proximal end ofanchor 30 urges rotation of the anchor to the secondposition when it contacts a surface.[0025] FIGS. 3A and 3B show an alternative embodi-ment of the anchor of the present invention. The anchor350 includes a bead 352 having a bore 360 defined there-in. The distal end 362 of cable 354 is received within thebore and bead 352 is affixed to the cable. Pivoting mem-ber 356 includes a longitudinal slot 370 in communicationwith a longitudinal bore 364 extending to distal end 358.The bore 364 and slot 370 are sized to slidably receivecable 354 therein. The distal end 358 defines a sphericalcavity for receiving a portion of bead 352. Anchor 350 ispivotable from the first insertion position shown in FIGS.3A and 3B to an anchoring position as shown in FIG. 1A.

Delivery Device

[0026] It is disclosed a delivery device for insertion ofa cable and anchor combination. Although the device isillustrated for use with the above described anchor, it iscontemplated that the delivery device may be used oradapted for use with a variety of cable and anchor com-binations. A first embodiment of the delivery device 40(FIGS. 1 and 2) comprises a rigid metallic cylindricalmember having a length 405 sufficient to penetrate adesired surgical site and a longitudinal bore 401 extend-ing from a proximal end 404 to a distal end 402. The bore401 is sufficiently large to permit the anchor’s proximalportion 310 to fit thereinto but too small to permit theanchor’s distal portion 317 to fit thereinto. Although apreferred embodiment of the delivery device has the dis-tal portion of anchor 30 extending distally beyond thedistal end of the delivery device, it is contemplated thatanchor 30 could be entirely retained within the deliverydevice until it is deployed. In this embodiment (notshown), cable 20 could be fixed with respect to deliverydevice 40 to prevent accidental deployment of the an-chor.[0027] The cable/anchor 20/30 combination is insertedinto tissue with the aid of the delivery device 40, whichis used to provide mechanical stiffness to the cable 20.The cable’s proximal end 204 is passed through the de-livery device 40 from the distal end 402 through the bore

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401 to beyond the proximal end 404. The anchor’s prox-imal portion 310 is seated in the delivery device bore 401adjacent the distal end 402, and tension is maintainedon the cable’s proximal end 204 to retain the anchor 30in the first position. Although a preferred embodiment ofthe device shows proximal end 304 held within bore 401,it is contemplated that proximal end 304 may includethreads and delivery device 40 may similarly have coop-erable threads on the distal end such that the device maybe threadedly held on delivery device 40. Alternatively,there may be a frangible connection between proximalend 304 and the distal end of the delivery device, thefrangible connection breakable to permit anchor 30 tomove to the second position.

Crimping Tool

[0028] The present invention includes a crimping toolfor attachment of an anchor to a cable, suture or otherelongated member. It being understood that alternativecrimping devices may be used to secure anchors to theabove described system and that the crimping tool de-scribed below may be used or adapted for use with avariety of cabling and suturing systems. The crimpingtool of the present system is desirable for the ability tocrimp along the axis of a cable at a relatively distant sitethrough a small incision.[0029] Referring now to FIG. 8, crimping tool 50 of thepresent invention provides several advantages, includinga capability of crimping along the longitudinal axis of thecable 20 and of cutting and crimping in one motion. Al-ternatively, cutting and crimping could be performed sep-arately or by two separate tools with similar function andoperation to the single tool shown. The crimping tool 50comprises an outer elongated generally cylindrical mem-ber 52 having a bore 521 from a proximal end 524 to adistal end 522. A first crimping handle 528 is affixed toand extends radially outward from the outer member’sproximal end 524.[0030] The crimping tool 50 additionally comprises aninner elongated generally cylindrical member 54 havinga bore 541 dimensioned to permit cable 20 to pass there-through. The inner cylindrical member 54 is dimensionedto fit within the outer cylindrical member’s bore 521 andto be rotatable relatively thereto about a common longi-tudinal axis. A second crimping handle 548 is affixed toand extends radially outward from the inner member’sproximal end 544, which extends proximal of the outermember’s proximal end 524.[0031] The handles 528 and 548 are rotatable betweena first, open position wherein the respective distal ends529 and 549 are spaced apart by approximately 90 de-grees to a second, crimping position wherein the distalends 529, 549 are generally opposed. Movement of han-dles 528 and 548 causes inner member 54 and outermember 52 to rotate with respect to each other.[0032] The crimping means of the crimping tool 50 isillustrated in FIG. 9A, which shows the distal end 502 of

the tool 50. The distal end 522 of the outer member 52has a roughly half-moon-shaped solid portion 525 thatobscures approximately half of the bore 541. A protrusion526 positioned in spaced relation to the longitudinal axisextends radially toward the opening leading to the bore541.[0033] The distal end 542 of the inner member 54 hasa solid portion 545 that obscures the remaining portionof the bore 541 except for a bi-level stepped openingthereinto. Along the distal most portion is a first roughlysemicircular cutout 552 dimensioned, together with theouter member’s solid portion 525, to closely surround aferrule 94 therein when the handles 528, 548 are in theopen position. The outer member’s protrusion 526 is po-sitioned adjacent the cutout 552 when the handles 528,548 are in the open position.[0034] Longitudinally adjacent to and proximal of thesolid portion 545 is a second roughly semicircular cutout554 dimensioned to permit the cable 20 to freely slidetherethrough but too small to permit the ferrule 94 to passthereinto. When the handles 528, 548 are moved into thecrimping position, the first cutout 552 is rotated towardthe solid portion 525 and protrusion 526, and a ferrule94 residing therein is crimped onto the cable 20.[0035] It can be seen that the tool 50 provides the ad-vantage of crimping the ferrule 94 along the longitudinalaxis of the cable 20, rather than at a right angle thereto,such as is common in the art, which permits the proce-dure to be accomplished through a small unitary incisionwithout removing surrounding tissue.[0036] Although a preferred embodiment of the crimp-ing tool of the present invention is shown for use withcable 20 and ferrule 94, it is contemplated that the devicemay be sized for a specific application. Moreover, it iscontemplated that inner member 54 and outer member52 may have removable distal portions. A variety of sizesand configurations of distal portions may be interchange-able to fit a variety of flexible member and crimp config-urations and types. It is contemplated that the cabling,crimp and crimping distal portions may be packaged asa unit to ensure proper use by the end user with a stand-ard crimping tool 50.[0037] Means are also provided for applying longitudi-nal tension in a proximal direction relative to the tissueto be repaired. Many devices are know for providing ten-sion to a cable, however, many require a series of pulleysor other change of direction to accomplish the desiredtensioning.[0038] In one embodiment (FIG. 8) the inner cylindricalmember 54 has an externally threaded proximal portion550. A generally cylindrical tensioner 56 has a longitudi-nal bore 561 therethrough from a proximal end 564 to adistal end 562 that is adapted to be mateable with theinner cylindrical member’s threaded proximal portion550. A handle 565 is affixed in radially protruding relationto the tensioner 56 exterior for facilitating a rotation there-of.[0039] The cable-affixing means comprises a cleat 51

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positioned adjacent to the tensioner’s proximal end 564.The cleat 51, which is analogous to such devices knownin the art, is adapted to clamp the cable’s proximal end204 to restrain the cable 20 from moving in a longitudinaldirection relative to the inner cylindrical member 54 whenin a tightened position. When in a releasing position, thecleat 51 permits the cable 20 to slide there past.[0040] The cable-pulling means comprises the ten-sioner 56 and the inner cylindrical member proximal end544, which are relatively movable via a screwing motiontherebetween, which serves to change the tension onthe cable 20. For example, in use the inner cylindricalmember 54 and tensioner 56 are mated, and a cable 20is inserted through the inner cylindrical member bore 541and through the tensioner bore 561, and a proximal por-tion of the cable is clamped by tightening the cleat 51.Unscrewing the tensioner 56 relative to the inner cylin-drical member 54 serves to pull the cable 20 in a proximaldirection, increasing the tension thereon. The nut couldbe urged to prevent twisting of cable 20.[0041] A cutting mechanism is also provided within thetool 50 whereby, when the handles 528, 548 are movedfrom the open to the crimping position, the cable 20 iscut at a location proximal to or through the ferrule 94.Referring to FIG. 9B, the cutting mechanism comprisestwo jaws 527, 547, respectively, affixed within the bores521, 541 of the outer cylindrical member 52 and the innercylindrical member 54, and are placed into oppositionwhen the arms 528, 548 are closed, cutting the cable 20.[0042] In a particular embodiment the ferrule 94 is typ-ically formed of a metal, such as stainless steel, titanium,or cobalt-chrome alloy. However, in an alternate embod-iment the ferrule 94 may be made of a resorbable or non-resorbable polymer material.[0043] The tensioning mechanism shown in FIG. 8 maybe replaced with the alternative tensioning mechanismof FIG. 11. The alternative tensioning mechanism 590attaches to the distal end 584 of the inner member 54.Outer tube 575 is positioned about distal end 584 withspring 577 positioned between the distal end and internalshoulder 585. Inner member 54 includes at least one slot582 adapted to receive a retaining pin 581 to slidablyconnect the tensioning mechanism 590. Also disposedon the outer surface of distal end 584 are a series ofgrooves 583 or other markings to indicate the position ofthe outer tube 575 with respect to inner member 54. Innertube 586 includes a cleat 574 pivotally mounted thereonby pivot pin 576. Cleat 574 pivots between a clampingposition clamping a cable positioned in channel 580 anda non-clamping position, and extends through slot 578in the outer tube. Inner tube 586 further includes an ex-ternally threaded portion 579. A handle 570 having aninternally threaded bore is pivotably mounted on outertube 575 and is held in place by retaining spring 572.Rotation of handle 571 urges outer tube 575 againstspring 577, thereby tensioning a cable (not shown) dis-posed within channel 580. It will be understood that thetension applied to a cable may be estimated by calibrating

the spring force applied as outer tube 575 is adjacenteach index marking 583.[0044] A further embodiment of a tensioning, crimpingand cutting tool of the present invention is disclosed inFIG. 11. The crimping tool 900 includes an outer tube902 attached to a nose 904. This nose is attached to afront housing 922 which is interconnected with rear hous-ing 924. As shown in the partial cross-section view ofFIG. 16, inner tube 901 is disposed within outer tube 902and includes a bore 917 for receiving cable 908. Theposition of cable 908 within inner tube 901 is maintainedwith respect to movement toward the distal end 905 bytrigger pawl 906. Trigger pawl 906 is pivotally connectedto front housing 922 by pivot pin 939. As shown in FIG.12, spring 938 biases trigger pawl 906 into the cable re-taining position with engaging end 907 engaging cable908 adjacent the proximal end of inner tube 901. Triggerpawl 906 may be moved to a disengaged position byovercoming the force of spring 938 and moving triggerpawl 906 within slot 940 such that engaging end 907disengages cable 908.[0045] Rear housing 924 includes a cable tensionerassembly 926 for applying tension to cable 908 towardsthe proximal end 913. Tensioning assembly 926 is oper-able between a tensioning position and the released po-sition shown in FIG. 11, by movement of handle 910 withrespect to handle 912. Handle 910 is pivotally attachedto rear housing 924 by pivot pin 918. A linking bar 915 isjoined to handle 910 by pivot pin 916 and interconnectsthe handle with tensioning assembly 926 through pivotpin 924. Movement of handle 910 towards handle 912,fixedly connected to rear housing 924, causes tensioningassembly 926 to move proximally.[0046] Referring now to FIG. 12, tensioning assembly926 includes a pair of pawls that grip cable 908 whentensioning assembly 926 is displaced proximally and thatallow passage of the cable when tensioning assembly ismoving distally. Pawl 941 is pivotally connected to thetensioning assembly 926 by pivot pin 942. The pawl isurged into a locking position by spring 943. The pawlopposing pawl 941 is identical. Tensioning assembly 926further includes a set of belleville springs 944 that maybe adjusted by movement of threaded shaft 945 to in-crease or decrease the pressure applied to the cablewhen the gripping teeth of the pawls are disengaged withthe wire as the tensioning assembly is drawn forward.Springs 944 maintain the position of pin 924 within slot932. Spring 914 disposed between handles 910 and 912in openings 928 and 930 respectively, urges handle 910forward. This movement also urges tensioning assemblypawls against front wall 937 which in turn urges the pawlsinto a disengaged position shown in FIG. 12.[0047] In operation, tensioning assembly 926 is movedto apply proximal tension to cable 908. As previously de-scribed, trigger pawl 906 permits proximal movement ofthe cable. Once proximal tension is released by the ten-sioning assembly, trigger pawl 906 engages cable 908to prevent distal movement and thereby maintain the ten-

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sion while the pawls of the tensioning assembly are dis-engaged to permit the assembly to return to a forwardposition. This process may be continued until the desiredamount of cable tension has been achieved.[0048] Cable tensioner, crimper and cutter 900 alsoincludes crimping and cutting handles 934 and 936. Re-ferring to FIG. 13, handle 936 is fixedly attached to rearhousing 924 while handle 924 is connected by pivot pin946 to front housing 922. The handles are biased into aseparated position by spring 949 mounted on projection950 of handle 934 and received within opening 951 inthe rear housing. Handle 934 includes a slot 948 for re-ceiving an inner tube extension 947 (FIG. 12). Linearmovement of handle 934 toward handle 936 is translatedinto rotation of inner tube 901 by the engagement of innertube extension 947 in slot 948. The distal end 905 of innerand outer tubes 901 and 902 are configured as shownin FIGS. 14A and 14B such that rotation of the inner tubein relation to the outer tube results in crimping a ferruleand cutting a cable.[0049] Another embodiment of a tensioning, crimpingand cutting tool which is not part of the present inventionrelies on longitudinal movement of the components rath-er than rotational movement. Referring to FIG. 14, a ten-sioning, crimping and cutting tool 955 includes an innermember 959, an outer member 958 and a cable retainingassembly 975. Cable retaining assembly 975 is prefera-bly received within inner member 959 and includes a cleat977 pivotally mounted to be moveable between a disen-gaged position and an engaged position securely holdingcable 956. Retaining assembly 975 further includes athreaded section 976. Inner member 959 includes aflange 972. An internally threaded nut 973 is disposedabout flange 972 and engages threaded section 976. Nut973 is rotatably maintained in position by mounting pins974.[0050] Inner member 959 includes an externallythreaded section 971 adjacent flange 972 and at an op-posite end, a pair of spaced branches 978 and 979, eachhaving a flared section 980 and 981, respectively. Branch978 includes a cutting blade 962 and a crimping projec-tion 964 while branch 979 includes a corresponding cut-ting anvil 963 and crimping depression 965. It is contem-plated that inner member 959 may include more than twobranches and may have multiple projections disposedadjacent distal end 967.[0051] Inner member 959 is disposed within a prefer-ably tubular outer member 958. Outer member 958 in-cludes an inclined surface 960 adjacent distal end 966.Opposite the inclined surfaces is a flange 968. Nut 969is disposed about flange 968 and pivotally retained thereby mounting pins 970.[0052] In operation, cable 956, having a distal end an-chored in a tissue section (not shown), is threadedthrough inner member 959 and cable retaining assembly975. A ferrule 957, slidable along cable 956, is positionedwithin branches 978 and 979 adjacent crimping projec-tion 964 and crimping depression 965. Cleat 977 is ro-

tated to engage cable 956. Nut 973 is rotated about ex-ternal threads 976 to move the cable retaining assemblywith respect to the inner member, which bears against asection of tissue (not shown), and thereby applies tensionto cable 956. Once the desired amount of tension is ap-plied, nut 969 is rotated with respect to threads 971 tourge outer member 958 downward toward ferrule 957.As outer member 958 advances, branches 978 and 979are urged toward each other by acting against inclinedsurface 960. Thus, cutting blade 962 and cutting anvil963 cooperate to cut cable 956 while crimping projection964 and crimping depression 965 crimp ferrule 957 tosecurely engage cable 956.[0053] While threaded engagements have been illus-trated for applying cable tension and for moving the outermember, it is contemplated that other mechanismsknown to those skilled in the art may be applied to thedevice described herein. Moreover, nut 973 may be en-gaged by a torque wrench to provide the user with anestimate of the tension applied to cable 956.[0054] Variations of the longitudinal crimping tool uti-lize movement preferably occurring within the outer tubesuch that the opening in the tissue is not significantlyenlarged beyond the diameter of the outer tube as a resultof the crimping process.

Alternative Anchor Embodiments

[0055] An alternate form of a tissue anchor comprisesan eyelet anchor 32, the structure and function of whichare illustrated in FIGS. 5 and 6. The eyelet anchor 32 isaffixed at a proximal end 324 to the cable distal end 202,and the eyelet anchor 32 has an eyelet hole 321 at adistal end 322 for receiving an anchoring screw 79. Theeyelet anchor 32 also has a cable bore 323 adjacent theproximal end 324 adapted to permit cable 20 to passtherethrough and to be crimped therein.[0056] The delivery device of FIG. 1 is also usable withthe eyelet anchor 32 described above. In this case, theeyelet anchor 32 has a central portion 325 that is dimen-sioned larger than the distal portion of the delivery devicemember cylindrical portion bore 401 or 766. The eyeletanchor 32 further has a proximal portion 326 that is di-mensioned to reside within the distal portion of the deliv-ery device member cylindrical portion bore 401 or 766.Thus, as above, the eyelet anchor proximal portion 326is retainable within the bore 401 or 766 when the cable20 to which it is attached is under longitudinal tension ina proximal direction. Alternatively, it is contemplated thateyelet anchor 32 is formed of a deformable material whichtends to resume its original shape. It will be understoodthat an eyelet anchor 32 formed of such a material maybe deformed to be received within outer tube 76, suchthat inner tube 73 will force eyelet anchor 32 out of outertube 76. The anchor may then resume its larger originaldimensions.

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Tissue Anchoring Method

[0057] The method for utilizing the above-describedsystem comprises the following steps, as shown in FIGS.7A-E, for anchoring two sections of bone together. It isobvious to one skilled in the art that the same techniqueis applicable to a method for anchoring two differentbones together, for anchoring other types of tissue to-gether, or for anchoring another type of tissue to bone[see, e.g., FIG. 4, illustrating the anchoring of a ligament92 (here, a medial collateral ligament) to a bone 90 (here,the tibia)].[0058] Two holes 115 and 116 are drilled through thebone sections 90 and 91, the cable/anchor/delivery de-vice 20/30/40 combination is inserted through the holes115, 116 until the anchor 30 is completely through thedistal hole 115 (FIG. 7A). Although drilled holes are illus-trated, it is contemplated that anchor 30 may include asharp tip such that the anchor may be pushed throughunprepared bone or other tissue. The cable tension isreleased, which permits the anchor 30 to rotate and berestrained on the distal side of the distal hole 115 (FIG.7B). In addition to the anchor disclosed herein, it is con-templated that the insertion device could also be usedwith an anchor designed to be embedded within the bone,i.e. the anchor would not exit the distal cortical bone andinstead would be deployed in the cancellous bone.[0059] The delivery device 30 is removed from the ca-ble 20, and a washer 93 and ferrule 94 are threaded ontothe cable to a position adjacent the proximal hole 912(FIG. 7C). The cable 20 is then inserted into the crimpingtool 50 sufficiently far that the ferrule 94 is positionedwithin the first cutout 552 adjacent the second cutout 554.The cable 20 is clamped with the cleat 51 and pulled toa desired tension (FIG. 7D). Tensioner 56 may be un-screwed with respect to inner cylindrical member 54 whilecleat 51 securely holds cable 20, thereby pulling the bonefragments together and applying measurable compres-sion between the fragments. The crimping tool 50 isclosed to crimp the ferrule 94 onto the cable 20 and alsoto cut the cable 20 (FIG. 7E). Alternatively, the crimp maybe made first, and then a separate cable cutting tool (notshown) can be used for thicker types of cable.[0060] If desired, an eyelet anchor 60, such as shownin FIGS. 5, may also be used. In this case, the eyeletanchor 60 is threaded onto the cable 20 via cable bore602, which is at the proximal end 601, before the ferrule94 is threaded on, and, after the crimp is made, a screw61 is inserted through the screw hole 604, which formsthe eyelet, and into the bone 90 to attach the eyelet an-chor 60 (FIG. 5).[0061] The method described above may be per-formed utilizing any combination of the delivery devicesand tensioning, crimping and cutting tools describedherein.[0062] While the invention has been illustrated and de-scribed in detail in the drawings and foregoing descrip-tion, the same is to be considered as illustrative and not

restrictive in character, it being understood that only thepreferred embodiments have been shown and describedand that all changes and modifications that come withinthe scope of the invention are desired to be protected.

Claims

1. A system for joining tissue segments, comprising:

an elongated flexible member (20) having a dis-tal portion and a proximal portion;a first anchor (30, 32) fixedly attached to saiddistal portion, said anchor (30, 32) adapted toengage a first tissue section;a second anchor having an aperture for slidablyreceiving said elongated flexible member (20),said second anchor including a deformable por-tion adjacent said aperture and a washer (14,93), said deformable portion deformable to se-curely engage said elongated flexible member(20), said second anchor adapted to engage asecond tissue section; anda crimping tool (50, 900) having, a crimpingmechanism that comprises:

an inner cylindrical member (54, 901) hav-ing a bore (541, 917) dimensioned to permitthe elongated flexible member (20) to slidetherethrough; andan outer cylindrical member (52, 902) withan inner passage and a distal end and po-sitioned in surrounding relation to the innercylindrical member (54, 901) and rotatablerelative thereto about a common longitudi-nal axis between a holding position and acrimping position;wherein the inner and outer cylindricalmember have cooperating distal ends (502,905) adapted to hold the deformable portionin the holding position and to crimp the de-formable portion in the crimping position;said crimping mechanism being disposedwithin said inner passage adjacent said dis-tal end and having an inner chamber sizedto receive said deformable portion, wherebyactuation of said crimping mechanism de-forms said deformable portion to securelyengage said flexible member (20).

2. The anchoring system recited in claim 1, whereinsaid flexible member (20) is a cable and said secondanchor includes said washer (14, 93) and a ferrule(94) slidable over the cable (20).

3. The anchoring system of claim 2, wherein:

the inner chamber has a depression (554) there-

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in dimensioned to admit the ferrule (94); andthe outer cylindrical member distal end has aprotrusion (526) directed toward the depression(554) and positioned to apply pressure to theferrule (94) when in the crimping position.

4. The anchoring system recited in claim 3, wherein thecrimping mechanism further includes a cutter for cut-ting the cable (20) proximal of the ferrule (94).

5. The anchoring system recited in claim 4, whereinsaid cutter includes cooperating cutting surfaces(527, 547) affixed to the inner and the outer cylindri-cal members proximal of the depression (554) andthe protrusion (526).

6. The anchoring system of any one of claims 2 to 5,further comprising:

a first handle (548) affixed adjacent a proximalend of the inner cylindrical member (54, 901);anda second handle affixed adjacent a proximal endof the outer cylindrical member (52, 902);the first handle (548) and the second handle(528) for facilitating a relative rotation of the innercylindrical member (54, 901) and the outer cy-lindrical member (52, 902).

7. The anchoring system of any one of claims 2 to 6,further including means (56) for applying longitudinaltension to the cable (20) in a proximal direction.

8. The anchoring system of claim 7, wherein the tensionapplying means (56) comprises:

means (51) for affixing a proximal section of ca-ble (20) thereto; andmeans for pulling the affixed cable (20) in a prox-imal direction relative to the tissue.

9. The anchoring system recited in claim 7, wherein:

the inner cylindrical member (54, 901) has anexternally threaded proximal portion (550); andthe tension applying means (56) comprises agenerally cylindrical tensioner member (56) hav-ing a longitudinal bore (561) from a distal end(562) to a proximal end (564) dimensioned topermit the cable (20) to pass therethrough, thebore (561) having a threaded distal portionadapted to be screwable relative to the inner cy-lindrical member threaded proximal portion(550).

10. The anchoring system recited in claim 9, wherein theaffixing means (51) comprises a clamp (51) posi-tioned in cable-retaining relation to the tensioner

member bore (561), said clamp (51) movable be-tween a releasing position wherein the cable (20) isslidable there past and a tightened position whereinthe cable (20) is retained there against.

11. The anchoring system recited in claim 9, wherein thetension-applying means further comprises handlemeans (565) affixed to an exterior of the tensionermember (56) for facilitating a screwing motion there-of.

Patentansprüche

1. System zum Verbinden von Gewebesegmenten,umfassend:

ein längliches flexibles Element (20), das einendistalen Teil und einen proximalen Teil aufweist,einen ersten Anker (30, 32), der fest an demdistalen Teil angebracht ist, wobei der Anker(30, 32) angepasst ist, mit einem ersten Gewe-beabschnitt zusammenzuwirken,einen zweiten Anker, der eine Öffnung zum gleit-baren Aufnehmen des länglichen flexiblen Ele-ments (20) aufweist, wobei der zweite Anker ei-nen verformbaren Teil benachbart zu der Öff-nung und eine Unterlegscheibe (14, 93) enthält,wobei der verformbare Teil verformbar ist, ummit dem länglichen flexiblen Element (20) sicherzusammenzuwirken, wobei der zweite Ankerangepasst ist, mit einem zweiten Gewebeab-schnitt zusammenzuwirken, undein Crimpwerkzeug (50, 900), das einen Crimp-mechanismus aufweist, der umfasst:

ein inneres zylindrisches Element (54, 901),das eine Bohrung (541, 917) aufweist, diedimensioniert ist, es dem länglichen flexib-len Element (20) zu erlauben, dort hindurchzu gleiten, undein äußeres zylindrisches Element (52,902) mit einem inneren Durchgang und ei-nem distalen Ende, und das in einer umge-benden Beziehung zu dem inneren zylind-rischen Element (54, 901) positioniert istund relativ dazu um eine gemeinsameLängsachse zwischen einer Haltepositionund einer Crimpposition drehbar ist,wobei das innere und äußere zylindrischeElement kooperierende distale Enden (502,905) aufweisen, die angepasst sind, denverformbaren Teil in der Halteposition zuhalten und den verformbaren Teil in derCrimpposition zu crimpen,wobei der Crimpmechanismus in dem inne-ren Durchgang benachbart zu dem distalenEnde angeordnet ist und eine innere Kam-

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mer aufweist, die bemessen ist, den ver-formbaren Teil aufzunehmen, wobei eineBetätigung des Crimpmechanismus denverformbaren Teil verformt, um mit dem fle-xiblen Element (20) sicher zusammenzu-wirken.

2. Verankerungssystem nach Anspruch 1, wobei dasflexible Element (20) ein Kabel ist und der zweiteAnker die Unterlegscheibe (14, 93) und eine überdas Kabel (20) gleitbare Hülse (94) enthält.

3. Verankerungssystem nach Anspruch 2, wobei:

die innere Kammer eine Vertiefung (554) darinaufweist, die dimensioniert ist, die Hülse (94)aufzunehmen, unddas distale Ende des äußeren zylindrischen Ele-ments einen Vorsprung (526) aufweist, der inRichtung der Vertiefung (554) gerichtet und po-sitioniert ist, in der Crimpposition Druck auf dieHülse (94) auszuüben.

4. Verankerungssystem nach Anspruch 3, wobei derCrimpmechanismus des Weiteren einen Schneiderzum Schneiden des Kabels (20) proximal zu der Hül-se (94) enthält.

5. Verankerungssystem nach Anspruch 4, wobei derSchneider kooperierende Schneideoberflächen(527, 547) enthält, die an dem inneren und äußerenzylindrischen Element proximal zu der Vertiefung(554) und dem Vorsprung (526) befestigt sind.

6. Verankerungssystem nach einem der Ansprüche 2bis 5, des Weiteren umfassend:

einen ersten Griff (548), der benachbart zu ei-nem proximalen Ende des inneren zylindrischenElements (54, 901) befestigt ist, undeinen zweiten Griff, der benachbart zu einemproximalen Ende des äußeren zylindrischenElements (52, 902) befestigt ist,wobei der erste Griff (548) und der zweite Griff(528) zum Erleichtern einer relativen Drehungdes inneren zylindrischen Elements (54, 901)und des äußeren zylindrischen Elements (52,902) vorgesehen sind.

7. Verankerungssystem nach einem der Ansprüche 2bis 6, des Weiteren enthaltend Mittel (56) zum Auf-bringen einer längsgerichteten Spannung auf dasKabel (20) in einer proximalen Richtung.

8. Verankerungssystem nach Anspruch 7, wobei dasSpannungsaufbringungsmittel (56) umfasst:

Mittel (51) zum Befestigen eines proximalen Ab-

schnitts des Kabels (20) daran, undMittel zum Ziehen des befestigten Kabels (20)in einer proximalen Richtung relativ zu dem Ge-webe.

9. Verankerungssystem nach Anspruch 7, wobei:

das innere zylindrische Element (54, 901) einenproximalen Teil (550) mit einem Außengewindeaufweist, unddas Spannungsaufbringungsmittel (56) ein imAllgemeinen zylindrisches Spannerelement(56) umfasst, das eine Längsbohrung (561) voneinem distalen Ende (562) zu einem proximalenEnde (564) aufweist, die dimensioniert ist, esdem Kabel (20) zu erlauben, dort hindurch zutreten, wobei die Bohrung (561) einen distalenTeil mit einem Gewinde aufweist, der angepasstist, relativ zu dem proximalen Teil (550) mit Ge-winde des inneren zylindrischen Elementsschraubbar zu sein.

10. Verankerungssystem nach Anspruch 9, wobei dasBefestigungsmittel (51) eine Klammer (51) umfasst,die in Kabel-festhaltender Beziehung zu der Boh-rung (561) des Spannermittels positioniert ist, wobeidie Klammer (51) zwischen einer gelösten Position,wobei das Kabel (20) daran vorbei gleiten kann, undeiner festgezogenen Position, wobei das Kabel (20)dagegen festgehalten wird, bewegbar ist.

11. Verankerungssystem nach Anspruch 9, wobei dasSpannungsaufbringungsmittel des Weiteren einGriffmittel (565) umfasst, das an einer Außenseitedes Spannermittels (56) befestigt ist, um eineschraubende Bewegung desselben zu erleichtern.

Revendications

1. Système destiné à joindre des segments de tissu,comprenant :

un élément flexible allongé (20) présentant unepartie distale et une partie proximale ;un premier ancrage (30,32) attaché de manièrefixe à ladite partie distale, ledit ancrage (30, 32)étant apte à venir en prise avec une premièrepartie de tissu ;un second ancrage présentant une ouverturedestinée à recevoir par coulissement ledit élé-ment flexible allongé (20), ledit second ancrageincluant une partie déformable adjacente à la-dite ouverture et une rondelle (14, 93), ladite par-tie déformable pouvant être déformée afin devenir en prise de manière ferme avec ledit élé-ment flexible allongé (20), ledit second ancrageétant apte à venir en prise avec une seconde

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section de tissu, etun outil de sertissage (50, 900) présentant unmécanisme de sertissage qui comprend :

un élément cylindrique intérieur (54, 901)présentant un alésage (541, 917) dimen-sionné de manière à permettre à l’élémentflexible allongé (20) de coulisser à traverscelui-ci, etun élément cylindrique extérieur (52, 902)présentant un passage intérieur et une ex-trémité distale et positionné de manière àentourer l’élément cylindrique intérieur (54,901) et pouvant tourner par rapport à celui-ci sur un axe longitudinal commun entre uneposition de maintien et une position desertissage ;dans lequel les éléments cylindriques inté-rieur et extérieur comprennent des extrémi-tés distales qui coopèrent (502, 905) aptesà maintenir la partie déformable dans la po-sition de maintien et à sertir la partie défor-mable dans la position de sertissage,ledit mécanisme de sertissage étant dispo-sé à l’intérieur dudit passage intérieur adja-cent à ladite extrémité distale et présentantune enceinte intérieure dimensionnée pourrecevoir ladite partie déformable, en sa-chant que l’actionnement dudit mécanismede sertissage déforme ladite partie défor-mable de manière à venir en prise de ma-nière ferme avec ledit élément flexible (20).

2. Système d’ancrage selon la revendication 1, danslequel ledit élément flexible (20) est un câble et leditsecond ancrage inclut ladite rondelle (14, 93) et unevirole (94) pouvant coulisser sur le câble (20).

3. Système d’ancrage selon la revendication 2, danslequel :

l’enceinte intérieure présente un creux (554) di-mensionné dans celle-ci de manière à accepterla virole (94), etl’extrémité distale de l’élément cylindrique exté-rieur présente une saillie (526) dirigée vers lecreux (554) et positionnée de manière à appli-quer une pression à la virole (94) dans la positionde sertissage.

4. Système d’ancrage selon la revendication 3, danslequel le mécanisme de sertissage inclut en outreun moyen de coupe destiné à couper le câble (20)à proximité de la virole (94).

5. Système d’ancrage selon la revendication 4, danslequel ledit moyen de coupe inclut des surfaces decoupe qui coopèrent (527, 547) fixées sur les élé-

ments cylindriques intérieur et extérieur à proximitédu creux (554) et de la saillie (526).

6. Système d’ancrage selon l’une quelconque des re-vendications 2 à 5, comprenant en outre :

une première poignée (548) attachée de maniè-re adjacente à une extrémité proximale de l’élé-ment cylindrique intérieur (54, 901), etune seconde poignée attachée de manière ad-jacente à une extrémité proximale de l’élémentcylindrique extérieur (52, 902), etla première poignée (548) et la seconde poignée(528) facilitant une rotation relative de l’élémentcylindrique intérieur (54, 901) et de l’élément cy-lindrique extérieur (52, 902).

7. Système d’ancrage selon l’une quelconque des re-vendications 2 à 6, incluant en outre un moyen (56)destiné à appliquer une tension longitudinale au câ-ble (20) dans une direction proximale.

8. Système d’ancrage selon la revendication 7, danslequel le moyen d’application de tension (56)comprend :

un moyen (51) destiné à attacher une partieproximale de câble (20) à celui-ci, etun moyen destiné à tirer le câble attaché (20)dans la direction proximale par rapport au tissu.

9. Système d’ancrage selon la revendication 7, danslequell’élément cylindrique intérieur (54, 901) présente unepartie proximale à filetage extérieur (550), etle moyen d’application de tension (56) comprend unélément tendeur généralement cylindrique (56) pré-sentant un alésage longitudinal (561) allant d’uneextrémité distale (562) à une extrémité proximale(564) dimensionné de manière à permettre au câble(20) de le traverser, l’alésage (561) présentant unepartie distale à filetage apte à être vissée par rapportà la partie proximale filetée (550) de l’élément cylin-drique intérieur.

10. Système d’ancrage selon la revendication 9, danslequel le moyen d’attache (51) comprend une pince(51) positionnée dans une relation de retenue de câ-ble par rapport à l’alésage (561) de l’élément ten-deur, ladite pince (51) pouvant être déplacée entreune position de libération, où le câble (20) peut êtrecoulissé au-delà de celle-ci, et une position serrée,où le câble (20) est retenu contre celle-ci.

11. Système d’ancrage selon la revendication 9, danslequel le moyen d’application de tension comprenden outre un moyen formant poignée (565) attaché àun extérieur de l’élément tendeur (56) pour faciliter

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un mouvement de vissage de celui-ci.

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REFERENCES CITED IN THE DESCRIPTION

This list of references cited by the applicant is for the reader’s convenience only. It does not form part of the Europeanpatent document. Even though great care has been taken in compiling the references, errors or omissions cannot beexcluded and the EPO disclaims all liability in this regard.

Patent documents cited in the description

• US 5312410 A, Miller [0004]• US 5536270 A, Songer [0004]

• EP 0464480 A [0006]