AU2012202695B2 - System and method for attaching soft tissue to bone - Google Patents

Abstract

Abstrac Disclos d herein are methods and devices for securing soft tissue 804 to a rigid material such as bone 806. A bone anchor 810 is described that comprises a base and a top such that suture material 808 may be compressed between surfaces on the base and top to secure the suture 808 to the anchor 810, Also described is an inserter 812 that can be used to insert the bone anchor 808 into bone 806 and move the anchor top relative to the anchor base to clamp suture Haterial 808 there between. Also described is a soft-tissue 804 and bone 806 piercing anchor 1 00 and associated inserter 802, Methods are described that allow use of the bone anchors 300 and 81 to provide multiple lengths of suture material to compress a large area of soft ti sue 804 against bone 806, FIC, lbF

Description

AUSTRALIA Patents Act 1990 COMPLETE SPECIFICATION Standard Patent Applicant (a) : KFX Med cal Corporation In mention Tit .e sYSTEM AN METHOD FOR ATTACHING SOFT TISSUE TO BONE The f llowLng statement is a full description of this invention, including :he best method for performing it known to me/us: SYSTEM AND METHOD FOR ATTACHING SOFT TISSUE TO BONE Background of the Invention Field of tl'e Ins ention 5 The present invention relates to medical devices and procedures. More aricularly, the present invention relates to devices and methods for securing soft iss e to a rigid material such as bone. e cription of e Related Art There are !everal medical procedures where a surgeon needs to attach soft tissue 10 suc: as ter don or other soft connective tissue to bone, One common example is a torn otator cuff, wl ere the supraspinatus tendon has separated from the humerus causing pai and loss o ability to elevate and externally rotate the arm. To repair a torn rotator IufU; typically a surgical procedure is used to suture the torn tendon to the bone using a ariety of methods. Some procedures utilize large incisions and involve complete is etz chment oft 1e deltoid muscle from the acronion. Small diameter holes are made in Syone for passing suture material through the bone to secure the tendon. Such large ikacilion pr oced res are traumatic, causing prolonged pain and recovery time. Other pro edures male small incisions and use arthroscopic techniques to attach sutures L sing either small diameter holes or a bone anchor. However, it is difficult to 20 manipulate sutures within the surgical site using arthroscopic techniques. In addition, 'hen knot tying is used to secure the suture to a bone anchor, it is difficult to properly adjust the tension of the suture while tightening the knot. Similarly, when the suture is attac hed to a bone anchor prior to insertion of the anchor into the bone, it is difficult to judg: the appropriate point of attachment so that the suture will be properly tensioned 25 upor insert on of the bone anchor into the bone. Thus, there is a need for methods and devices tha: allow easy arthroscopic attachment of a suture to a bone anchor after the aichnr is inserted into the bone without the use of knot tying. Summary of the Invention The present invention is particularly suited for use in arthroscopic procedures, 20 ir cluding b t not limited to rotator cuff surgery. More broadly, it can be used in any procedure in which it is desired to fAx a suture to a solid object without tying of knots, including not on y arthroscopic procedures, but also open surgery, and can be used for -2such diverse purposes as bladder neck suspension, tendon and ligament affixation or repair, prosthe ic attachment, and rotator cuff repair. In ore em odiment, a method of attaching soft tissue to bone is disclosed, the method co prises: ins rating a first anchor into bone, wherein after insertion, the first anchor is s positioned undareath the soft tissue; passing a first length of suture from said first anchor over the soft tissue; inserting a distal member of a second anchor into bone at a position beyond an edge of the soft tissue, wherein the second anchor comprises said distal member anc a proximal member; after inserting the distal member of the second anchor, tensioning the first 1 gth of suture to compress an area of tissue to bone between the edge of the soft 10 tissue anc the first anchor; and after tensioning the first length of suture, moving the proximal nem er of the second anchor distally towards the distal member of the second anchor, thereby fixedly securing the first length of suture at the second anchor position Without ty .ng ly knots. In another bodiment, the first length of suture is attached to the first anchor prior to 1.3 :nst ion of the first anchor into bone. In an their embodiment, the method comprises forming a hole in the bone into which Ihe distal nemt or of the second anchor is inserted. In another embodiment, the distal member of the second anchor comprises a first pro imally facing surface. 20 In another embodiment, the proximal member of the second anchor has a second distally facing s irface facing toward said first surface. In another :mbodiment, the proximal member is configured to move relative to said distal me ber such that it can be positioned in a first configuration wherein said first and secc nd sur Faces are spaced apart and be positioned in a second configuration wherein said 2S f .rst and second surfaces are in close proximity, In another mbodiment, the distal member of the second anchor is tapered. [n ano er embodiment, a proximal portion of the distal member of the second anchor com Prises A sut re gripping structure, In ano her embodiment, a proximal end of the distal member of the second anchor 30 c m risess a hole opening into a central bore. n anot er e bodiment, sides of the central bore comprise threads. -3- In another embodiment, the proximal member of the second anchor is cylindrically sh ped, In auDther embodiment, a central bore extends through the proximal member of the second anchor. In another embodiment, inserting the distal member of the second anchor and moving the proxi mal member of the second anchor distally toward the distal member comprises usi-ig an ranch r inserter comprising a handle, a tube, and an inner member, wherein the )nn ar member extends through the tube and the central bore in the proximal member of the ec nd anchor d is removably coupled to the distal member of the second anchor. 10 In another embodiment, the inserter comprises an inner tube and an outer tube, wh ein t e in er tube extends through the outer tube, and wherein the inner member extends tah-ugh the inner tube. In another embodiment, the tube is movable longitudinally relative to the inner eiaber. 1s In an other embodiment, the invention includes comprising coupling the first length of Autire to the se-ond anchor prior to inserting the distal member of the second anchor into 1Sons In another embodiment, the tensioning comprises manually pulling on the first length cf suture. 20 In another embodiment, the method comprises inserting a third anchor into bone, *herein after insertion, the third anchor is positioned underneath the soft tissue; passing a s ccnd length of suture from said third anchor over the soft issue; tensioning the second ingth of suture independently from the first length of suture; and after tensioning the first # d second len s of suture, moving the proximal member of the second anchor distally 25 tow rds the dista member of the second anchor, thereby fixedly securing both the first and sco ad lengths c f suture at the second anchor position without tying any knots. (n ano her embodiment, a method of attaching soft tissue to bone is disclosed, the method comprising: inserting a first anchor into bone, wherein after insertion, the first atchr is positioned underneath the soft tissue; passing a first length of suture from said 30 ist anchor ove- the soft tissue; coupling the first length of suture to a second anchor, voheiein the second anchor comprises a distal member and a proximal member, wherein seid proximal niember is cylindrically shaped and comprises a central bore extending tl4er hrou; a er coupling the first length of suture to the second anchor, inserting the -4dis al member of the second anchor into bone at a position beyond an edge of the soft ssue; after in erting the distal member of the second anchor, tensioning the first length of sut are to camp ess an area of tissue to bone between the edge of the soft tissue and the first nchor; ar d after tensioning the first length of suture, moving the proxinal member of the s ecnd anchor distally towards the distal. member of the second anchor, thereby fixedly ec ring the first length of suture at the second anchor position without tying any knots, h rein inserting the distal member of the second anchor and moving the proximal member o the second anchor distally toward the distal member comprises using an anchor Snserter comprising a handle, a tube, and an inner member, wherein the inner member 10 Oxtends th-ough the tube and the ventral bore in the proximal member of the second anchor hnd is rem vab y coupled to the distal member of the second anchor. In another embodiment, a method of attaching soft tissue to bone is disclosed, the method c mprising inserting a first anchor into bone, wherein after insertion, the first anc or is positioned underneath the soft tissue; passing a first length of suture from said iS hrst anchor over the soft tissue; inserting at least a portion of a second anchor into bone at position beyond an edge of the soft tissue; after inserting said at least a portion of the Sec nd anchor, tensioning the first length of suture to compress an area of tissue to bone between the edge of the soft tissue and the first anchor; and after tensioning the first length qfs ture, mixed y securing the first length of suture at the second anchor position without 20 tin any knots, wherein at least one of said anchors comprises an anchor tip and a hollow c ylinder, Where n the anchor tip comprises an aperture through which suture material is tyre ded prior to insertion of the at least one anchor. In another enbodiment, the anchor tip comprises an engaging member adapted to e1g ge an inner surface of said cylinder. 2-5 n another embodiment, the anchor tip comprises an anchor inserter attachment n ienber. [n another embodimcnt, the insertion of the at least one anchor comprising an anchor tia d a hollow cylinder comprises using an inserter that comprises a handle, an outer s eeve, and an i ner member, wherein the inner member extends through the outer sleeve 3o ad the hol ow cylinder and is attached to the anchor inserter attachment member, - 5- In another embodiment, the inserter comprises an inner tube extending through the ouler sleeve and through the hollow cylinder and contacts the anchor tip, wherein the inner ie mber erten s through the inner tube. In another embodiment, the inner tube is fixed relative to the handle. 5 In another embodiment, the inner tube is movable axially relative to the outer sleeve. In another embodiment, the suture material runs from inside the handle of the inserter, through the inner tube, and through the aperture in the anchor tip. In another embodiment, the suture material runs through a bore in the handle and passes through a hole in an end of the handle. 1.0 In an their embodiment, the handle comprises a spool at a proximal end of the handle adapted to hold excess suture. In another embodiment, the suture material is wrapped around the spool. In another embodiment, the spool is integral with the handle, In another embodiment, the insertion of the at least one anchor comprising an anchor 1 tp End a hollow cylinder comprises tapping on the inserter with a hammer. In ano er embodiment, the method comprises coupling the first length of suture to the 4t le ast one anchor comprising an anchor tip and a hollow cylinder prior to inserting the at 1las one anchor comprising an anchor tip and a hollow cylinder. In ano her embodiment, the tensioning comprises manually pulling on the first length 20 cf suture. In ano her embodiment, the method of attaching tissue to bone comprises inserting a t4irc anchor into bone, wherein after insertion, the third anchor is positioned underneath t4e soft tissue; passing a second length of suture from said third anchor over the sofn issue; tnsioning he s second length of suture independently from the first length of suture; and 25 a1ter tensioning the first and second lengths of suture, fixedly securing both the first and s co d len ths of suture at the second anchor position without tying any knots, n another embodiment, a method of attaching soft tissue to bone is disclosed, the njet-od corpris as inserting a first anchor into bone, wherein after insertion, the first ach r is positi ned underneath the soft tissue; passing a first length of suture from 30 sdid irst anchor over the soft tissue; inserting at least a portion of a second anchor into bone at a position beyond an edge of the soft tissue; after inserting said at least a pdrtion of the se ond anchor, tensioning the first length of suture to compress an area of ti sue to bon between the edge of the soft tissue and the first anchor; and after -6tersionin the first length of suture, fixedly securing the first length of suture at the sec ond archor position without tying any knots; wherein at least one of said anchors comprise an anchor tip and a hollow cylinder, wherein the anchor tip comprises: an ape rture t rough which suture material is threaded prior to insertion of the at least one 5 anc hor, an engaging member adapted to engage an inner surface of said cylinder, and an anchor inserter attachment member, wherein insertion of the at least one anchor o uprising an anchor tip and a hollow cylinder comprises using an inserter that :o prises a ha dle, an outer sleeve, and an inner member, wherein the inner member sxt rds t ought the outer sleeve and the hollow cylinder and is attached to the anchor 1 D nserter attachment memberIn another embodiment, the invention includes an anchor or securtig a future to bone, including an anchor base adapted to be securely fixed ntc the bone and a suture securing mechanism coupled to the anchor base and os .tioned pro imally relative to the anchor base, the mechanism adapted to receive d secure a su-ue moved laterally into the mechanism. 15 In an ther embodiment, the anchor base comprises lateral protrusions adapted to i esi 3t remc val c f the anchor base from bone. In another embodiment, the lateral protrusions include threads adapted to allow the mchor base to be screwed into bone. In another embodiment, the suture securing mechanisms comprises at least two 20 surf ices ad apted to secure a suture by clamping the two surfaces together, In another embodiment, the two surfaces are adapted to be positioned such that t ie suture can b freely moved laterally between the surfaces prior to clamping. In ano her embodiment, an anchor for securing a suture to bone is disclosed, the anclor inc uding an anchor base adapted to be securely fixed into the bone, a first 25 s arface coupled to the anchor base and positioned proximally relative to the anchor base, and a second surface coupled to the anchor base and positioned proximally relative to the anchor base, wherein the first and second surfaces are adapted to be relate vely positioned in at least two configurations, one of the configurations such that a gap is p rese between the first and second surfaces so that the suture can be no p sitioned betwen the first and second surfaces by moving the suture laterally into the gap, and the other of the configurations such that the first and second surfaces are i cls pr ximity so that the suture can be securely clamped between the first and s Co d surf ces. -7- In another embodiment, the first surface is even with or below the bone's surface when the anchor base is securely fixed into the bone. In another embodiment, the first surface comprises indentations and the second ur ace co mpri es protrusions adapted to fit within the first surface's indentations. 5 In another embodiment, the first surface is generally proximally facing and the second ur ace is gene ally distally facing when the anchor base is securely fixed into the bone. In anc ther enbodiment, the first surface is a proximal surface on the anchor base and he second surfae is a distal surface on an anchor top adapted to couple to the anchor base, In another embodiment, the anchor comprises a third surface; and a fourth surface 10 acing the third surface, wherein the third and fourth surfaces are adapted to be relatively pos tioned in at least two configurations, one of said relative configurations such that the ou th surface i 5 above the bone's surface when the anchor base is securely fixed into the hon-. and a gap is present between the third and fourth surfaces so that a suture can be eely passed between the third and fourth surfaces above the bone's surface, and the other s5 Of s aid rel tive configurationss such that the third and fourth surfaces are in close proximity 4 o that a suture -an be securely clamped between the third and fourth surfaces. In another embodiment, the second surface as adapted to be positioned above the bone's surf ace when the anchor base is securely fixed into the bone and when a gap is resentt beween the first and second surfaces such that the suture can be positioned 20 1 between the firs: and second surfaces above the bone's surface. In ano her embodiment, the invention includes a method of attaching soft tissue to Iond including passing a length of suture over the soft tissue, inserting an anchor into the bone, and securing the length of suture to the anchor after the inserting without p ass ng an nd of the length of suture through any aperture in the anchor and without 25 tying any kaots. n another embodiment, the method of attaching soft tissue to bone, wherein said s ca ing co zprises moving the length of suture laterally into a suture securing mechanism. n another embodiment, the method of attaching soft tissue to bone, wherein after said ecuri g, the anchor is not inserted further into the bone. 30 In ano er :mbodiment said inserting comprises screwing the anchor into the bne - 8- In another embodiment said securing comprises clamping the suture between at ea t two urfaces on the anchor. In ano other embodiment said passing occurs prior to said securing. In anothe- embodiment said passing, inserting, and securing are done s :roscopically, In another embodiment, the invention includes a method of attaching soft tissue to bon is disclosed, the method comprising including inserting a first anchor through the soft tissue, wh -ein the first anchor comprises a length of suture fixedly secured to the 1irst anchor prior to insertion, inserting the first anchor into the bone, passing the 10 leng th of sature over the soft tissue, and fixedly securing, after the passing, the length of s-ture to a second anchor. In anohor embodiment, the method further comprising, after inserting the first anchor t roagh the soft tissue and before inserting the first anchor into the bone, moving the first nelor laterally relative to the bone so as to move the soft tissue laterally relative to the is -one, In ano her :rnbodiment, inserting the first anchor through the soft tissue comprises directly piercing the soft tissue with the first anchor, In another embodiment, inserting the first anchor into the bone comprises directly piercing the bon with the first anchor without drilling any holes. 20 [n ano her embodiment, inserting the first anchor into the bone comprises deploying lateral protrusicns on the first anchor, wherein the lateral protrusions are adapted to prevent the first anchor from being removed, n another embodiment, the passing step comprises passing the length of suture over the s ft tiss e w- thout the suture being coupled to the second anchor, 25 n ano her embodiment, fixedly securing comprises, in order: inserting the second aichr with the length of suture coupled thereto into the bone; tensioning the length of stu e; and fixedly securing the length of suture to the second anchor. n another embodiment, the step of inserting the second anchor comprises inserting the auch r directly into the bone without the anchor passing through the soft tissue. 30 :n another embodiment, fixedly securing comprises, in order: inserting the second auchr wit- no suture coupled thereto into the bone; tensioning the length of suture; and fi ly se ing he length of suture to the second anchor. -9- In an ther embodiment, the step of fixedly securing is performed without tying any 0nots, In another embodiment, the step of fixedly securing is perfonned without passing the Sue thr ugh any apertures in the second anchor, In another mbodiment, the inserting steps, passing step, and fixedly securing step re :onducted a-throscopically. In another bodiment, a method of attaching soft tissue to bone, the soft tissue don prising a fl st surface adjacent to the bone's surface and a second surface opposite the irst su-face is disclosed, the method comprising inserting a first portion of a length 10 o f stature i to t ie second surface of the soft tissue, passing a second portion of the I sngth of s.1ture over the second surface of the soft tissue, inserting a first anchor with .o suture coupled thereto into the bone, and fixedly securing the length of suture to the iaseted first an-:hor, with the proviso that no part of the first portion of the length of suture is passed out of the second surface of the soft tissue. is In ano her enbodiment, the first portion of the length of suture is fixedly secured to a second anchor and said step of inserting the first portion into the second surface comprises inse ting tle second anchor into the second surface. In another embodiment, the method further comprising after inserting the second anc- or intt the second surface, moving the second anchor laterally relative to the bone so 20 as tc move the soft tissue laterally relative to the bone and then inserting the second anchor i to the bone. In ano, her embodiment, the step of fixedly securing is performed without tying any knots. [n another rnbodiment, a method of attaching soft tissue to bone, further comprises, 25 prior to the fixedly securing step, tensioning the length of suture. In ano her embodiment, the tensioning comprises a user grasping the suture and p pulling. [n ano her embodiment while pulling, the suture is contacting the first anchor.In a ot 1er embodiment, the invention includes a method of attaching soft tissue to bone so is di closed, the method comprising inserting a first anchor with a length of suture pre coup led thereto through the soft tissue, inserting the first anchor into the bone, inse ng a second anchor with no suture coupled thereto into bone, passing the length -10- (f s nature ver t 1e soft tissue. and fixedly securing the length of suture to the inserted ec nd anchor. In an ther embodiment, the method further comprises, after inserting the first anchor thr ugh the soft tissue and before inserting the first anchor into the bone, 5 no ing the first anchor laterally relative to the bone so as to move the soft tissue l ter ally re ative to the bone. In another anbodiment, a method further comprises, after inserting the first anchor i ito the bone, fixedly securing the pre-coupled length of suture to the first anchor. In another embodiment, inserting the first anchor into the bone comprises deploying 10 lteral pro rusicns on the first anchor, wherein the lateral protrusions are adapted to yrev ent the first anchor from being removed. [n ano ter snbodiment, the step of fixedly securing is performed without tying any lnois. [n another mbodiment, the method further comprises prior to the fixedly securing is sep. tensioning e length of suture, [n another embodiment, the tensioning comprises a user grasping the length of suture and ulling. In an ther embodiment, while pulling, the suture is contacting the second a elorIn other embodiment, the invention includes a method of attaching soft 20 t ssue to bone is disclosed, the method comprising inserting a first, second, and third a chor into the bone, fixedly securing a first length of suture over the soft tissue to the f rst and se:;nd anchors, and fixedly securing a second length of suture over the soft tissue to the firs1 and third anchors. n ano er embodiment, the first anchor is positioned beneath the soft tissue and the 25 sco id and third anchors are positioned laterally to the soft tissue. n another embodiment, the first and second lengths of sutures are fixedly secured to t e f.rst anchor prior to insertion into the bone, n another embodiment, inserting the first anchor comprises directly piercing the soft tissu. with the first anchor, moving the first anchor laterally relative to the bone so as to 30 non the soft tissue laterally relative to the bone, and directly piercing the bone with the frst anchor without drilling any holes, - 11 - In atothei embodiment, inserting the first anchor comprises deploying lateral protrusions on the first anchor, wherein the lateral protrusions are adapted to prevent the first anch r froin being removed. In an other embodiment, while inserting the first anchor, the first and second lengths of 5 utre are not coupled to the second or third anchors. In anc ther embodiment , the first anchor is positioned laterally to the soft tissue and the secondd an thirl anchors are positioned beneath the soft tissue. In an ther embodiment, the first and second lengths of suture are fixedly secured to ihe second and hird anchors prior to insertion into the bone. 10 In another embodiment, inserting the second and third anchors comprises directly piercing the sof tissue with the second and third anchors, moving the second and third in ors laterally relative to the bone so as to move the soft tissue laterally relative to the bon , and iirec ly piercing the bone with the second and third anchors without drilling any Iole s, 15 In ano her bodinent, inserting the second and third anchors comprises deploying lateral prolrusicns on the second and third anchors, wherein the lateral protrusions are edapted to prevent the second and third anchors from being removed. In another :mbodiment, while inserting the second and third anchors, the first and sec d lengths of suture are not coupled to the first anchor. 20 In ano her embodiment. the method further comprises; tensioning the first length cf suture pror t> fixedly securing the first length of suture; and separately tensioning the second length of suture prior to fixedly securing the second length of sutureIn another embodiment, an anchor for securing a suture to bone is disclosed, the anchor c m >rising an chor base adapted to be securely fixed into the bone, the anchor base 25 comprising a fiast proximal surface and an anchor top, the anchor top comprising a distal member coupled to the anchor base and a first proximal member comprising a first distal surface, wherein the anchor top is adapted to couple to the anchor base in at least two config rations, one of the configurations such that the first distal surface is above the bone's surface when the anchor base is securely fixed into the bone, such 30 that a suture car be freely passed between the first proximal and first distal surfaces above the tone' surface, and the other of the configurations such that the first distal -12urthce is in cl se proximity to the first proximal surface, such that a suture can be ecurely clamped between the first proximal and first distal surfaces, In another embodiment, the anchor base comprises an axial bore adapted to receive the ist il me ber cf the anchor top. s In anc other embodiment, the axial bore comprises lateral protrusions and the distal m ber of the nnchor top comprises indentations adapted to engage the lateral protrusions or nhibiti rg proximal movement of the distal member relative to the axial bore. In ano her embodiment, the first proximal surface comprises indentations and the first distal surftwcc comprises protrusions adapted to fit within the first proximal surface's 10 i ad ntatio s. In anoh er embodiment, the anchor top further comprises a second proximal member do rising a second distal surface and wherein the first proximal member comprises a sec nd pro xima surface, wherein the first and second proximal members are adapted to be positioned relative to each other in at least two configurations, one of said relative 1.s configurations such that a gap is present between the second proximal and second distal surfaces sc that a suture can be freely passed between the second proximal and second cistd surfaces aove the bone's surface, and the other of said relative configurations such t at the second proximal and second distal surfaces are in close proximity so that a suture can :e sect rely clamped between the second proximal and second distal surfaces. 20 In ano her embodiment, an anchor for securing a suture to bone is disclosed, the at or comprising a substantially hollow cylinder comprising an open end and o rising a portion of its walls cut in such a manner so as to allow the cylinder to efom uncer stress and form lateral protrusions, a substantially pointed tip coupled to t e ,ylinder opposite the open end, wherein the pointed tip is adapted to pierce the 25 bon, and a su ure receiver coupled to the pointed tip and positioned within the substantially hollow cylinder so that a suture may be attached to the suture receiver a rd extend throu gh the cylinder and out of the open end. :n ano her embodiment, the lateral protrusions consist of two protrusions opposite e ach other. 3a :n ano her embodiment, the anchor further comprises a stress inducing member Cu led to e ti and extending through the cylinder and out of the open end, wherein the - 13 qyli der is adapted to deform when force is applied to pull the stress inducing member proximally out of the cylinder. In another embodiment, after the cylinder has deformed, the stress inducing member is i4apted to break free from the tip upon continued application of force. s 1In ano other embodiment, the stress inducing member is a wire. In another embodiment, the suture receiver comprises an eyelet. In another anbodiment, the suture receiver is dimensioned such that when the suture pasc es through the eyelet, the suture is securely clamped between the suture receiver and theliollow cyli der, Brief Description of the Drawings FIGURm 1 depicts attaching soft tissue to bone using a single bone anchor and a stitch. FIGURE 2 depicts attaching soft tissue to bone using a two bone anchors with a is sutu:e stretched there between. FIGURES 3A-3C depicts various geometries of bone anchors and suture patterns f Dr attachi g soft tissue to bone. FIGUl ES 4A-4D depicts the base of a two-part suture anchor that can be inserted i to bone. 20 FIGURTES 5A-5C depicts the top of a two-part suture anchor. FIGU ES A and 6B depict the suture anchor top of Figures 5A-5C inserted into t ie suture anchor bottom of Figures 4A-4D. FIGlOPES 7A and 7B depict a suture anchor inserter. FIGURE 8 depicts components on a suture anchor inserter for attaching to bone 25 and nanip rating a suture anchor. FIGUES 9A-9E depicts manipulation of a suture anchor using a suture anchor inseer to nser the suture anchor into bone and attach suture material to the suture ancl-or. FIGULES 10A and 10B depict a piercing bone anchor in an un-deployed 30 ( ItURE 3 OA) md deployed (FIGURE 10B) state. -14- FIGE IR I depicts a piercing bone anchor tip. FIGURE 12 depicts an anchor inserter for inserting a piercing bone anchor. FIU RE 13 depicts the interface between a piercing bone anchor and an anchor 5 FIGURE 14 is a cut-away view of a bone anchor inserter. FIGU RE 15 depicts a safety switch mechanism for a bone anchor inserter. FIGURES 16A-16F depict a method for attaching soft-tissue to bone using a iercing b ne a ichor and a suture capturing anchor, Detailed Description of the Certain Embodiments to In var ous inbodiments, soft tissue may be attached to bone utilizing one or more on: anchors with suture attached thereto. As used herein, "suture" refers to any flexible st'uctu-e that can be stretched between two or more anchors and includes, witl out liiitati n, traditional suture material, single or multiple stranded threads, or a mesh structure. In some embodiments, suture is passed over the top of the soft tissue is so t aat the suture can press the soft tissue against the bone. In one embodiment, a :ngh of suture is attached to a single bone anchor, One non-limiting example, depicted in Figure 1, includes stitching the suture 10 to the soft tissue 12, such as by an incline mattr ss stitch, and then securing the suture 10 to the single bone anchor 14 t iat is inse ted into the bone 16, However, in other embodiments, a length of suture is 20 attached t multiple bone anchors. The use of multiple bone anchors increases the f >o mrint over which the suture material presses the soft tissue against bone. One non 1 miing example , depicted in Figure 2, includes two bone anchors. One anchor 20 is posi ioned n a medial location underneath the soft tissue 12 and a second anchor 22 is posi ioned ateral to the soft tissue 12. The suture 10 is attached to both anchors. 2S In one emb diment, the suture 10 is attached to the lateral bone anchor 22 only a er the medial bone anchor 20 is inserted and the suture 10 is passed over the soft tissu: 12. onc embodiment, the suture 10 is attached to the medial bone anchor 20 p-ior to insetior of the medial bone anchor 20. Thus, in this embodiment, the surgeon does not need to pass the suture through the soft tissue 12 from beneath the soft tissue 30 1 2. In one enbc diment, the procedure involves inserting the medial bone anchor 20 with suture 10 p e-attached through the soft tissue 12. The medial bone anchor 20 may - 15 he-1 be mhovec laterally relative to the bone 16 in order to pull the soft tissue 12 .aterally relative to the bone 16. After appropriate positioning of the soft tissue 12, the -edial bo:1e anchor 20 may then be inserted into the bone 16. The lateral bone anchor 22 nay then be inserted into the bone 16. The suture 12 may then be passed over the 5 o tissue 12 md attached to the lateral bone anchor 22. In some embodiments, a ateral bor e anhor 22 is provided to which suture 12 can be attached without tying my knots or without passing the suture 12 through any aperture in the lateral bone c aor 22. In sore embodiments, multiple anchors and multiple suture lengths may used to 10 rovide a wider area of pressure of the soft tissue against bone. For example, as ep cited in FigJe 3A, three anchors are used with two lengths of suture 26 and 28. Altcrnativoly, a mesh structure 29 may be stretched between the three anchors. In ano-her exnpl:, as depicted in Figure 3B, four anchors are used with two lengths of sut re. In still another example, as depicted in Figure 3C, four anchors are used with 1.5 rou lengths of suture, In some embodiments, the individual suture lengths may be part (f a larger continuous suture. For example, in Figure 3A, the suture lengths 26 and 28 nay be pai of a larger length of suture such that the lengths 26 and 28 are joined at r ial bone anchor 20. Those of skill in the art will appreciate that there are any uber of anchor and suture geometries that can be used. I c In sonC er bodiments, the medial bone anchors 20 are designed so that they can le easily pierce- through the soft tissue 12 and bone 16. In some embodiments, the lateral bon: anchors 22 are designed so that they can easily capture suture material ei inserlion of the bone anchors 22. Together, these design features provide a sutu ing s stem and method that provides an increased footprint of suture pressure 25 against the soft tissue 12 and ease of implementation for a surgeon. For example, in SOM: embodim ts, the entire procedure may be done arthroscopically, with the sarg on needing only to insert the medial bone anchor 20 with suture optionally pre a tarhed throug. a first port, insert the lateral anchor 22 through a second port, pass the futuree ver the soft tissue 12 by capturing it from within the second port, and 30 s= -ing the suture to the lateral anchor 22, Accordingly, described below are certain e nbodime ts of anchors adapted to capture suture material and anchors adapted to e sil y pierce: through soft tissue and bone. St e Capturing Anchor -16- One e nbo iment is a bone anchor that allows easy capturing and securing of a uture after the bone anchor is inserted into the bone. In one embodiment, the bone ncor inc udes a suture securing mechanism positioned on the proximal end of the $one anchor (i. -, the end nearest the surface of the bone and the surgeon). In one s mbodiment, th : suture securing mechanism allows a suture to be moved laterally into tie mechanism By "laterally," it is meant that the suture can be moved into the ecaanisr by moving the suture in a direction that is generally perpendicular to the oxis of the suture. In other words, the suture can be moved into the mechanism without t re ding a end of the suture into the mechanism. In one embodiment, the suture can 10 1e :ixedly secured within the mechanism without tying any knots. By "fixedly secured," i is meant that the suture within the securing mechanism cannot be easily rioved relative to the bone anchor. One embodiment is a bone anchor that allows easy attachment of suture material -y clamping the suture material between two surfaces on the bone anchor, The bone is nc or may be configured such that the bone anchor is inserted into the bone without t e suture material attached. The two surfaces of the suture securing mechanism may t e spaced apart so as to form a gap between the surfaces. The suture material may be r ass d between the two surfaces and tensioned as desired followed by clamping of the ttvo surface s together, thereby clamping the suture material there between. 20 In one embodiment, the bone anchor consists of two parts: an anchor base and an actor top. The anchor base may be designed to be inserted into a hole in the bone vith a proximal surface facing up. The anchor top may be coupled to the anchor base via a distal mer ber. A proximal member on the anchor top may have a distal surface f cir g down toward the proximal surface on the anchor base. The coupling of the 25 a or top :o the anchor base may be such that the anchor top can move relative to the a chor base such that it can be positioned in one configuration where there is space b teen the proximal surface on the anchor base and the distal surface on the proximal n ber of the anchor top. In another configuration, the proximal member of the chor top may be position such that there is very little space, if any, between the 30 poximal surface on the anchor base and the distal surface on the proximal member of the anchor top. Thus, in the first configuration, suture material may be easily passed bht een the twc surfaces and tensioned as desired. In the second configuration, the - 17 - ;utt re ma erial may be clamped between the two surfaces such that the suture is ecured to the bone anchor. One embodiment of an anchor base 100 is depicted in Figures 4A through 4D. igure 4A is a perspective view showing the side 101 and bottom 102 of the anchor E base 100. The bottorn 102 of the anchor base 100 may advantageously be tapered to faci itate inserting of the anchor base 100 into bone. In some embodiments, a hole is pretrilled into the bone to facilitate insertion of the anchor base 100. In other m- odime its, the anchor base 100 is forced directly into the bone, thereby creating the hoIc. The sides 101 of the anchor base 100 comprise threads 104 so that the anchor 10 basc 100 nay b inserted into bone using a screwing action. In sorne embodiments, the anchor base 10) may be tapped to start the threads 104 into the bone followed by scre vng the anchor base 100 into the bone. When the hole in the bone is predrilled, the ole is adva itageously drilled with a diameter smaller than the diameter of threads 104 so th t the threads engage the bone through the sides of the hole. It will be is apprecatec that means other than threads may be used to secure the anchor base 100 t b ne. Far example, angled protrusions may be used that provide greater resistance removal of t e anchor base 100 than to insertion. The protrusions may be static or c4epiyable once the anchor is inserted. The top of :mchor base 100 preferably includes a structure 106 for facilitating the 20 d riv ng or screwing of the base 100 into the bone. In the illustrated embodiment, this comprises a hex nut structure 106 that facilitates engagement with a hex nut driver for scre ing t e anchor base 100 into the bone. It will be appreciated that other structures known in thre art for engaging tools used for screwing action may be used instead of bex nut structure 106, and that this structure can be indented into or extending out 25 f-orr the to i of e anchor base 100, or can alternatively be formed on the sides of the anc or base 100 With reference to Figure 4B, which is a perspective view of the top and side of anc1or base 101, the top (proximal end) comprises a bole 108 in the centre for receiving the anchor top, which is described below. The top of anchor base 100 also 30 c~nt ains a sutu-e gripping structure such as a circular groove 110 that may be c >ncentric 1vith ole 108, Because of groove 110, the proximal surface of anchor base 12J0 s not flat a d comprises top surfaces 112 and 114, bottom surface 116, and side su rfe.ces 118 an 120. In some embodiments, some or all of these surfaces may be - 18 te tired tuch as with a scallop shape or grooves so as to inhibit movement of suture material ressed against the surfaces. Although a grooved surface is illustrated, it will be appreciated that other shapes for the proximal surface of anchor base 100 are also co temple ted, including multiple concentric grooves, a series of protruding ridges, a s "ve" sh ped channel, or any other suitable structure that permits a suture to be securely lcked against the top or proximal end of the anchor base 100. Hole 108 in anchor base 100 is an opening into a central ("axial") bore into the anchor bse 100. The sides of the central bore preferably include structures for grping something inserted into the central bore, such as ratchet structures 122. 10 Figare 4C shoy a central ratchet bushing 126 that fits within the central bore and contains the ratchet structures 122. In the embodiment of Figure 4C, the ratchet htnctures 122 are constructed by cutting U shaped cuts into bushing 126. The U sha ed cts then define tabs that make up the ratchet structures 122. It will be ppreciated tha other shapes and methods for making ratchet structures may be used. is Th purpose of ratchet bushing 126 is to receive the anchor top and secure it to the :ne >or base 101) It will be appreciated that other methods of securing the anchor top (o t-e anchor base 100 may be used, such as a frictional fit or threading. Furthermore, the anchor top may be coupled to the anchor base 100 using means other than hole 108 and bushing 126. For example, the anchor top may be coupled via structures at the 2 kerimeter 1athet than the center or by a hinge. Figure 4D depicts a cross section through the center of anchor base 100. This iiew illustrates central bore 130 and groove 110. The proximal surfaces 112, 114, 116, 18 and 120 are also apparent. Central bore 130 preferably does not extend all the way through the anchor base 100. Instead, a smaller bore 132 is present at the distal 25 end 102 of the anchor base 100. Smaller bore 132 is used to receive a wire connected to an anchor insrter. It will be appreciated that other structures than bore 132 may be usea for attachirg the wire and that other means than a wire may be used to secure the acl- or to the an hor inserter. Figures 5A through 5C illustrate one embodiment of an anchor top 200. Figure 3o 5A provides a perspective view of the side and top of the anchor top 200 and Figure 5o provides a perspective view of the side and bottom of the anchor top 200. Anchor p 00 hai two members, a distal member 202 and a proximal member 204. The d stall member 2D2 comprises an elongated shaft, the longitudinal direction of which - 19 - ;haji be consid red to run along the axis of the distal member 202. A series of grooves r other mating or locking surfaces or structures 206 exist along a portion of the tutide surface of the shaft. The distal member 202 is designed to be inserted into the 4enral bore 130 of the anchor base 100. The ratchet structures 122 in the anchor base S {00 engage grooves 206 to couple the anchor top 200 to the anchor base 100. The tate et structur s 122 are oriented such that the distal member 202 can be easily moved in the distal direction in central bore 130 with the ratchet structures 122 nalping into he grooves 206 as the distal member 202 is moved downward. -owever, whe the ratchet structures 122 are snapped into grooves 206, proximal 10 o ement of cistal member 202 is inhibited. Thus, the anchor top 200 may be atcheted down into anchor base 100. Because the ratchet structures 122 exist along sub tantially the entire surface of the central bore 130 (see Figure 4C), the anchor top 00 may be coupled to the anchor base 100 in several positions, In other words, in one bodiment the anchor top 200 need not be ratcheted into the anchor base 100 as far is 4s it will go for t to be secured to the anchor base 100. The proximal member 204 of anchor top 200 is generally cylindrical in shape with dihneter larger than distal member 202. A hole 208 may advantageously be provided ih the center of proximal member 204. With reference to Figure 5B, the bottom of <istE member 02 also contains a hole 210. Holes 208 and 210 open into a central 20 ore through the anchor top 200, This central bore allows the wire referred to above to t d through 1he anchor top 200 to be secured to bore 132 in the anchor bottom 100, t us allowing the anchor bottom 100 to be attached to an anchor inserter while still a lowing ancho- top 200 to be ratchet into anchor bottom 100. Figure 5B also i lus rates that p -oximal member 204 contains a groove 212 in its distal surface. Thus, 25 t e istal surface e of proximal member 204 is not flat and comprises distally facing sarftces 214 and 216 and side facing surfaces 218 and 220. In some embodiments, sm m or all of these surfaces may be textured such as with a scallop shape or grooves s a to inhibit movement of suture material pressed against the surfaces. In some enb diments, texturing in the distal surfaces of proximal member 204 match texturing 30 in e proximal surfaces of anchor base 100. It will be appreciated that the illustrated enb diments represent only one possibility; thus, other shapes for the distal surface of proximal memb r 204 may also be used. Figure 5C depicts a cross section through the -20 - .ce ter of anchor top 200. In this figure, the central bore 226 is depicted as are surfaces 21t, 216, 218, and 220 and grooves 206. Figures 6A and 6B depict cross sections showing how the anchor top 200 may be co pled to anchor base 100 to form the complete anchor 300. In Figure 6A, the anchor s top 200 is coupled to anchor base 100 with the proximal member 204 separated from |the anchor base 100. The anchor top 200 is secured to anchor base 100 by distal me-ber 202 extending into central bore 130 of the anchor base 100. The distal member 202 is secured by ratchet structures (not shown) engaging grooves 206 in distal member 02. Central bore 226 in anchor top 200 and central bore 130 in anchor o basil 100 allow a wire to extend into the top of the anchor 300 and be secured to bore 132. Alternatively, the wire may be secured at other locations within central bore 130. th s the wire, which can be coupled to an anchor inserter, can hold the entire anchor assinbly 300 and still allow anchor top 200 to move relative to anchor base 100 and the wire. 15 Figure 6B .epicts the anchor assembly 300 with the distal member 202 of anchor top 200 ratcheted all the way into central bore 130 in anchor base 100. In this donfiguration, it can be seen that proximal surfaces 112, 114, 116, 118, and 120 of the anchor base 10 and distal surfaces 214, 216, 218, and 220 of the proximal member 204 of anchor top 200 form passageways 302 and 304. The size of passageways 302 20 and 304 are advantageously such that when a suture passes through them, it will be domressed so t 2at it is securely attached to the anchor 300. Another embodiment of the present invention is an inserter designed to insert and rianipulate an :nchor such as described in Figures 1-3. One such inserter 400 is depi-ted in Figures 7A and 7B. Inserter 400 comprises a handle 402 and an outer tube 25 404. As depicted in Figure 7A, the handle 402 comprises a cover 403. Figure 7B depicts the insert ter 400 with cover 403 removed. Not depicted in Figures 7A and 7B are en inner tube disposed inside outer tube 404 and a wire disposed within the inner tube As will be described in more detail below, the inner and outer tubes may be used to manipulate a anchor 300 such as that described in Figures 4-6. The wire may be 30 used to couple the inserter 400 to the anchor 300 as described above, Inserter 400 also comnrises an outer tube manipulator 406 and a wire manipulator 408. Outer tube manipulator 406 comprises release button 410. Outer tube manipulator 406 is securely attac ed to outer tube 404. Outer tube manipulator 406 may move longitudinally -21 relative to handle 402 and the inner tube when release button 410 is pressed. Thus, wh outer tub manipulator 406 is moved, outer tube 404 also moves. Wire manipulator 408 comprises wire grabber 410 to which the wire is attached. The wire extends from wire grabber 410, through handle 402, and then through the s inner tube, In ene embodiment, wire manipulator 408 also comprises a release button 412. When release button 412 is pressed, the wire manipulator 408 may be pressed inte the handle 402 to contact and thus provide additional tension on the wire. When in use, the additional tension causes the anchor base 100 to mover relative to inserter 400 When eno igh tension is provided to the wire by wire manipulator 408, the wire 1 ma break free from the anchor 300 at its attachment point in bore 132 or at some othcr predeterrr ined location along the wire. It will be appreciated that any suitable breed able attachment means may be used for securing the wire to the anchor 300. For example, the wire may be fictionally secured into bore 132 or it may welded to the anchor base 10( using a weld that is weaker than the wire itself or a portion of the wire is where breaking is desired may be weakened. In one embodiment, the wire is notched so a to create i weaker region in the wire that will break upon application of suitable fore. The tip 414 of outer tube 404 is depicted in more detail along with inner tube 420, wir 422, and anchor 300 in Figure 8. The end of outer tube 404 may comprise a hex 20 rAut driver structure 424 for receiving the hex nut structure 106 of anchor base 100, Of dZomse, any oth.r suitable engagement structure can be provided on the inserter 400 and the anchor base 100 in order to facilitate placement of the anchor base 100. Wire 422 extends out of inner tube 420 and into the central bore in the anchor top 200 to attach to anchor base 100 as described above, In some advantageous embodiments, the 25 wire length and tension is adjusted such that the proximal member 204 of anchor top 2|00 uts against the end 426 of inner tube 420. Figures 9A through 9E depict how inserter 400 and anchor 300 may be used to insert the anchor 300 into bone and attach a suture to it. Figure 9A depicts the conf guration for inserting the anchor 300 into bone. Outer tube 404 and outer tube 30 man pulator 406 (see Figures 7A and 7B) are positioned relative to inner tube 420 and han le 402 (see Figures 7 and 8) so that the outer tube 404 engages hex nut structure 106 n the anchc base 100. It is advantageous in this configuration for the anchor top 200 :o be in a p sition relative to the anchor base 100 such as depicted in Figure 6 A. -22 - In t le configuration of Figure 9A, a surgeon may then screw the anchor base 100 into bone by twistin g handle 402 of inserter 400 (see Figures 7A and 7B). After the aichor base 100 is inserted into the bone, the outer tube 404 may be slid backward relative to the inner tube 420 and handle 402 to expose the anchor top 200 s Auc as in Figure 9B. One or more lengths of suture 600 may then be placed in the spa e between -he distal surface 602 of the proximal member 204 of anchor top 200 and the proximal surface 604 of the anchor base 100 by moving the suture laterally into the space as depicted in Figure 9C. The suture 600 may be manually tensioned as desired. In so e embodiments, tensioning of the suture 600 is aided by pulling the 10 nsutre 600 against the distal member 202 of the anchor top 200. After appropriate tensioning of suture 600, wire manipulator 408 may be pressed to tosion the Wire, causing the handle 402 of the inserter 400 and the inner tube 420 tp be pulled down towards the anchor base 100 so that inner tube 420 ratchets the anchor top 200 down into the anchor bottom 100 as depicted in Figure 9D. As the is anchor top 200 s pushed axially down, suture 600 will be clamped between the distal surf ice 602 of the proximal member 204 of anchor top 200 and the proximal surface 604 of the anchor base 100 (see also Figure 9C). The clamping will force the suture to 'be c Dmpressed within the passageways 302 and 304 depicted in Figure 6B and thus be secured to anchor 300. The fit between the anchor top 200 and the anchor base 100 in .20 the clamping region is such that the suture 600 is firmly gripped, but is not cut, when it is c amped in place. Appropriate edges that may contact the suture are preferably beveled or round ed to avoid damage to the suture. After anchor top 200 is ratcheted suff ciently into anchor base 100, wire manipulator 408 (see Figures 7 A and 7B) in itise er 400 may be compressed further to further tension wire 422 (see Figure 8) such 2S that wire 422 breaks free from its attachment to anchor base 100, thus leaving the ae-cor 300 free from inserter 400 with suture 600 securely attached as depicted in Figure 9E. Although a particular inserter device for inserting and manipulating anchor 300 hias been described, it should be understood that other inserter designs may be used for 30 nean pulating the parts of anchor 300 described above to insert the anchor into bone and secure suture material to the anchor. For example, it may be possible to use separate tools fo inserting the anchor and securing the suture material. In addition, in aiter2ative emb diments, the anchor base 100 may be connected to the anchor top 200 -23 thrc ughout the procedure, or the anchor base may be separately inserted into the bone, and the anchor top can be attached thereafter by axially sliding the distal end of the ancior top 200 into the hole 108 in the anchor base 100. It will be appreiated by those of skill in the art that the anchor 300 and inserter 400 5 Provide a system for easy attachment of a suture to bone. The anchor 300 may be inserted into bo e with minimal disruption of surrounding tissue. Only an access route having the di eter of the outer tube 404 and the anchor base 100 is required, Fu hermore, the suture can be securely attached to the anchor 300 and tensioned as desired without having to insert additional instrumentation into the site or without 10 perfrining any cumbersome attachment maneuvers such as knot tying. It should also be Appreciated that the general principle illustrated by this system of inserting an anchor into bone without having suture material pre-attached and then attaching suture to t1e anchor without tying any knots may be implemented using any appropriate system other than the specific embodiments depicted in Figures 4-9. 15 Tiss w and Bono Piercing Anchor One embodiment is a bone anchor adapted for piercing through the soft tissue and into underlying bone. In one embodiment, the suture material may be pre-attached to the ?iercing bo:e anchor so that after implantation, a suture passes from the bone anc- or through a the top of the soft tissue for easy passing over the soft tissue. In one 20 emb diment, the piercing bone anchor has two configurations, a first configuration having a small -iameter for easy piercing through soft tissue and bone and a second depihyed configuration where structures such as protrusions are deployed to prevent the bone anchor from being easily removed from the bone, It one embodiment, the anchor includes a substantially hollow cylinder having a 25 portion of its walls cut in such a manner so as to allow the cylinder to deform under axial stress and form lateral protrusions. The lateral protrusions may thus prevent the ahelor from being easily removed from the bone after deployment. In one einb diment, the anchor comprises a pointed tip coupled to the hollow cylinder for piercing the soft tissue and bone, hi one embodiment, suture is pre-attached to the 30 poin ed tip inside of the hollow cylinder. In other embodiments, suture is pre-attached at oher location s on the piercing anchor, such as at the proximal end of the hollow cylir der. -24- One embodiment of a deployable piercing anchor is depicted in Figures 1 OA and 10. In Figure 10A, the anchor is depicted in a pre-deployed state. The anchor i ncludes a subs antially hollow cylinder 650 with a plurality of cuts 652 in the side of the -ylinder 650. The cylinder 650 is open on one end 654. On the other end, a pointed 5 tip 56 is disposed, allowing the anchor to pierce through soft tissue and bone, hi tigure I OB, th: anchor is depicted in a deployed state. Stress is applied in an axial direction such t fat the cylinder 650 collapses along cuts 652 so as to form two lateral win s 660. The lateral wings 660 prevent the anchor from being removed from the bon . Hinges 662 connect one end of each wing to either the top or the bottom parts of 10 anchor body. These hinges deform and fold, in the plane tangent to the anchor body at that point when the anchor is deployed. A strip of material 664 connects the top and bottom wing or each side of the anchor body, and serves as a hinge between the two as well as aiding in alignment of the wings during deformation. The tips of the wings adjacent to the connecting strip 664 utilize rolling edges 666, which ensure uniform 15 ali ent and smooth transition during deformation. Those of skill in the art will app eciate that Eny number of geometries of cuts in the cylinder 650 may be utilized to create a deformable structure that will produce lateral protrusions upon exposure to streE s. In some mbodiments, structures may be positioned within the cylinder 650 for 20 attaching sutures and engaging with an anchor inserter, hi one embodiment, such structures are oupied to the anchor tip 656 within the cylinder 650. Figure 11 depicts one such embodiment. Attached to the tip 656 is a structure 670 through which there is an aperture 672. The structure 670 may be adapted to engage the inner surface of cylinder 650 for attaching the tip 656 to the cylinder 650. The attachment mechanism 25 may be by forc-d fit, frictional fit, threads, welding, adhesive, or any other suitable rneans. Suture material may be threaded through the aperture 672 in order to attach the stu e to the anchor. The suture material may be secured to the tip 656 by tying the sutu-e around st future 670, tying a knot in the end of the suture that prevents it from being pulled thr ugh the aperture 672, clamping the suture between the structure 670 30 and :he inside of the cylinder 650, adhering the suture to structure 670 by welding or adhesive, or an / other suitable means, In one embodiment, the suture material is attack hed to the a chor at tip 656 prior to use of the anchor, -25 - An anchor inserter attachment structure 674 may also be coupled to the tip 656. This structure 574 may couple to an anchor inserter through a wire or any other suit le means. The attachment between the anchor inserter and the anchor at this poi t may be used to apply axial stress to the anchor for deploying the anchor as s described above. The attachment at this point may also serve to keep the anchor attached to the inserter prior to deployment. One embodiment of an anchor inserter suitable for use with the above-described anelor is depicted in Figure 12, The anchor inserter comprises a grasping handle 700 to which is attached an outer sleeve 702 which is fixed relative to the handle 700. The 10 oier -ing anchor 704 is disposed at the end of the sleeve 702. A deployment lever 706 may be pressed by a user to deploy and detach the anchor 704 as described below, A safe y switch 7 8 may be provided to prevent the anchor 704 from being deployed pre aturely. A spool 710 may be provided at the proximal end of the handle 700 for hold ing excess suture. A lid 712 may be provided for gaining access to the inner 15 domponents of the inserter, : Figure 13 depicts the anchor 704 coupled to the inserter. As described above, the a hc or 704 cor prises a hollow cylinder 650 with cuts in the sides and a pointed tip 656. Furthermore, as depicted in Figure 11, a suture receiving aperture 672 and an i se- er attachment structure 674 are attached to the pointed tip 656 within the cylinder 20 650. The outer sleeve 702 of the inserter may fit over the open end 654 of the cylinder 650 or be flush vith the open end 654. The outer sleeve 702 may thus hold the top part of the anchor 704 steady during insertion. In an alternative embodiment, the outer sleeve 702 may fit over the length of the cylinder 650 to prevent the cylinder 650 from 4eforming while it is being inserted into bone. In this alternative embodiment, the 25 oute- sleeve 702 may be retracted prior to deployment of the anchor. An inner tube 720 may be positioned within the outer sleeve 702 and the hollow cylinder 650 and cpnt ot the top surface of the anchor tip 656 (see Figure 11). The inner tube 720 p ovides struc al reinforcement of the anchor 704 and pushes against the tip of the abc or 704 whi e it is being driven into bone or tissue. The inner tube 720 may be 30 fixed relative to the handle 712 and outer sleeve 702 during insertion, however, during dployment of the anchor 704, the inner tube 720 may be released by switching safety sivitch 708 so that the inner tube 720 can move axially relative to the outer sleeve 702 while: the anchor cylinder 650 collapses. A wire may be positioned inside of the inner -26tuhe 720 runni rg from within the handle 712 through the inner tube 720 to the anchor 704 and attach d to the anchor inserter attachment structure 674. During deployment, the lever 704 nay be pressed to pull the wire axially towards the handle 700, The axi lly move t of the wire forces the anchor 704 to press against outer sleeve 702 s anc stresses the cylinder 650, causing it to deform and deploy. During collapse of the cylinder 650, tle inner tube 720 will also move in an axial direction toward the handle 700. Upon flurt1er stress on the wire, the wire may break free from the anchor inserter attachment str eture 674, releasing the inserter from the anchor 704. Suture material mav run from the inside of handle 700 through the inner tube 720 to attach to the 1-o anc or 704 through aperture 672 (see Figure 11). Upon detachment of the anchor inserter from t-e anchor 704, the inserter may be withdrawn, leaving the inserted and deployed anchor with suture coming out of the open end 654 of the cylinder 650. The sut re will still be coupled to the inserter through the inner tube 720, handle 700, and around spool 10. Those of skill in the art will appreciate other inserters and is mechanisms that may be used to insert and deploy the piercing anchors described he in. For example, rather then axially stressing the anchor 704 by pulling the tip 656 in an proximal direction, the cylinder 650 may be pushed in a distal direction to deft rn the cyli der 650. Figure 14 is a cut-away view of the handle 700, showing the inner workings of the 20 ane or inserter. The suture material attached to a piercing anchor at the tip of the izs -ter may pa s through the central bore of the inner tube 720 and through a bore 750 in the handle 700. The suture material may then pass through a hole 752 in the end of the handle 700 and be wrapped around the spool 710, which may be integral with the andle 700. The wire attached to the anchor inserter attachment structure 674 in 25 the anchor may also pass through the central bore of the inner tube 720 and may then proceed around a pulley 754 and attach securely to the handle 700 at point 756. The pulley 754 may be attached to the lever 706. When the lever 706 is pressed down, the pulley 754 will ove toward the back end of the handle 700, causing the wire attached to the anchor to retract. Because of the use of pulley 754, the wire will retract twice 30 the distance as the pulley 754 moves. The safety witch 708 may be used to prevent the lever 706 from being pressed and prevent the inner tube 720 from moving unless the safety switch 708 is in the corr et position, The safety mechanism operates via a drum 760 disposed within the -27ha die 700 to yhich the safety switch 708 is attached. Moving the safety switch 708 rotates the drur 760 within the handle 700, Figure 15 shows the drum 760 and safety switch 708 mechanism in more detail. The inner tube 720 passes through a central bor: in the drurn 760. On the other side of the drum 760, the inner tube 720 is attached s to a stopper 762. The stopper 762 has a through-hole 764 to permit passage of the deployment wire and suture. The stopper 762 may be positioned within a cavity 766 in the end of the d 760. A second similarly shaped cavity may be disposed within the han-le 700. The stopper 762 and attached inner tube 720 may only be allowed to move axidly relative to the handle 700 when the safety switch 708 and drum 760 is rotated 10 so 'hat the cavity 766 in the drum 760 is aligned with the matching cavity in the handle 700. W en the cavities are aligned, the stopper 762 is allowed to move from the cavity 766 to the cavity in the handle 700, thus allowing the inner tube 720 to move axially and the anchor to be deployed. Additionally, the drum 760 comprises a groove 768. A spring-loaded sliding pin is 770 (see Figure 14) may be coupled to the lever 706. The lever 706 can only be moved when the drum 760 and switch 708 are rotated so that groove 768 is aligned with the pin 70. Thus, both the stopper 764 and the pin 770 prevent the anchor from being deployed unless the switch 708 is in the correct position. Those of skill in the art will appreciate other mechanisms that could be used for 20 deploying a deployable anchor and providing safety mechanisms to prevent premature deployment. Exa pie Using a Piercing Anchor and a Suture Capturing Anchor The above- described anchors may be used in a surgical procedure for attaching soft tissue to b ne. One example of such a procedure is depicted in Figures 16A 25 through 16F, In Figure 16A, the piercing anchor 800 attached to an anchor inserter 802 as described above is pierced through soft tissue 804 that has become detached from undrlying bone 806. In Figure 16B, the anchor inserter 802 is moved laterally relative t6 e bone 806 so as to stretch the soft tissue 804 laterally relative to the bone 806. Once the soft ti sue 804 has been stretched to the desired position, the anchor 800 is 30 inserted into the bone 806 and the anchor 800 is deployed as described above and the inser ter 802 is detached from the anchor 800, leaving a suture 808 attached to the anch r 800 and extending through the soft tissue 804. The anchor 800 may be inserted - 28 into bone 806 by tapping on the inserter 802 with a hammer or by any other suitable me as of applying axial force. Figure 16C depicts the deployed anchor 800 with att ched suture 808, The suture 808 will extend into the inserter 802. Next, as depicted in Figure 16D, a suture capturing anchor 810 is inserted into the s bor e 806 using the inserter 812 as described above. In Figure 16E, the inserter 812 is then retracted to expose the suture capturing mechanism. The suture 808 is then passed over the soft tissue 804 and laterally moved into the suture capturing mechanism and ten ioned. Final lly, as depicted in Figure 16F, the suture capturing mechanism is deployed to capture the suture 808, the anchor inserter 812 is detached from the 10 anchor 810, an- the suture 808 is cut to detach it from the suture inserter 802. The res It is a lengt-1 of suture 808 between the bone anchors 808 and 810 that presses the soft tissue 804 against the bone 806. Multiple anchors and sutures may be used to produce geont ries such as depicted in Figures 2 and 3 and variations thereof. It will be appreciated that there are numerous stitches, suture threading patterns, and is anchor patterns that may be used to secure soft tissue to bone by the methods and devices described herein. These variations as well as variations in the design of the above described anchor devices and inserter devices are within the scope of the present disclosure. Methods of At ching Soft Tissue to Bone 20 Various embodiments include methods for attaching soft tissue to bone. In some erbodiments, the methods include using the bone anchors described above. In one embodiment, a >one anchor is inserted into the bone and then a length of suture is pass ed over the oft tissue and secured to the anchor after inserting the anchor without tying any knots or without passing the suture through an aperture in the anchor. In 25 som: embodimnts, the suture is secured to the anchor by laterally moving it into a secuing mech nsm. In one embodiment, securing the suture to the anchor includes cir ping the su ure between at least two surfaces on the anchor. In one embodiment, the anchor is not inserted further into the bone after securing the suture to it. In another embodiment, a first anchor with a suture pro-attached is inserted 3 0 through the soft tissue and into the bone. The suture may then be passed over the soft tissu: and fxedly secured to a second bone anchor. In one embodiment, the first anchor is inserte by directly piercing the soft tissue and the bone. In one embodiment, -29late al protrusicn may be deployed on the first anchor to prevent the first anchor from being removed. In one embodiment, the suture may be coupled to the second bone anchor prior tc insertion and then fixedly secured after insertion, In this context, "coupled" mea s that the suture is attached to the bone anchor but not fixedly secured, 5 such that the suture can move to some extent relative to the bone anchor. In an alte-native embadiment, the suture is not coupled to the second bone anchor during its ins ion. In another embodiment, a first portion of suture is inserted into the proximal surf ce of the soft tissue. A second portion of the suture (e.g., the portion proximal to the inserted portion) is then passed over the proximal surface of the soft tissue and fixe ly secure to a bone anchor. In one embodiment, the procedure may be penrfned without passing the first portion of the suture back out of the proximal surf tce of the s ft tissue. In one embodiment, this result is accomplished by the first porton of the suture being attached to an anchor that is inserted through the soft tissue is and into bone. One embodiment includes inserting a first anchor with a pre-coupled suture thro gh soft tiss ue and into bone. The suture may then be passed over the soft tissue and fixedly secured to a second anchor. In one embodiment, the pre-coupled suture is fixely secured o the first anchor prior to insertion. In an alternative embodiment, the 20 pre-coupled suture can move relative to the first anchor prior to insertion and is fixedly secured after insertion. In another embodiment, multiple lengths of suture are attached to multiple act ors. In one embodiment at least three anchors are inserted into bone, A first length of snture may be secured between a first and second anchor and a second length of 25 sutu e may be secured between the first and a third anchor. In one embodiment, the first anchor is p sitioned beneath the soft tissue and the second and third anchors are posi-ioned later lly to the soft tissue. In an alternative embodiment, the first anchor is posi ioned latere1ly to the soft tissue and the second and third anchors are positioned ben ath the soft tissue. In some embodiments, the lengths of suture are fixedly secured 3 0 to th: anchor(s) positioned beneath the soft tissue prior to insertion of those anchor(s). In one embodiint, the different lengths of suture may be tensioned separately. -30- In various erbodiments, prior to fixedly securing suture to a bone anchor, it can be tensioned. I. one embodiment, tensioning is accomplished by manually pulling on the suture such as by a surgeon grasping the suture using an appropriate instrument and then pulling. In one embodiment, the suture may be pressed against the bone a aneicor to provide leverage for pulling. For example, the suture may be wrapped partly aro nd a proximal portion of the anchor prior to pulling. Although tie invention has been described with reference to embodiments and ex 1ples, it sh uld be understood that numerous and various modifications can be ma e without parting from the spirit of the invention. Accordingly, the invention is 10 limi ed only by he following claims, -31-

Claims (25)

1. A met od of attaching soft tissue to bone, comprising: insertir g a first anchor into bone, wherein after insertion, the first anchor is positi ned under eath the soft tissue; s passing a first length of suture from said first anchor over the soft tissue; insertng a distal member of a second anchor into bone at a position beyond an edge of the soft tissue, wherein the second anchor comprises said distal member and a proximal member; after inserting the distal member of the second anchor, tensioning the first length 10 of sute to compress an area of tissue to bone between the edge of the soft tissue and the first a4chor; and after tensioning the first length of suture, moving the proximal member of the second anchor distally towards the distal member of the second anchor, thereby fixedly securing the first 1ngth of suture at the second anchor position without tying any knots. is 2. The me hod of claim 1, wherein the first length of suture is attached to the first anchor prior to ins rtion of the first anchor into bone,

3. The me hod of claim 1, comprising forming a hole in the bone into which the distal member of tie second anchor is inserted.

4. The method of claim 1, wherein the distal member of the second anchor 20 coMprses a first poximally facing surface,

5. 1 The meto d of claim 4, wherein the proximal member of the second anchor has a second distally facing surface facing toward said first surface.

6. The method of claim 5, wherein said proximal member is configured to move relative to said dis al member such that it can be positioned in a first configuration wherein 25 said first and second surfaces are spaced apart and be positioned in a second configuration wherei said first aid second surfaces are in close proximity,

7. The method of claim 1, wherein the distal member of the second anchor is tapered

8. The method of claim 1, wherein a proximal portion of the distal member of the 30 second anchor com rises a suture gripping structure.

9. The method of claim 1, wherein a proximal end of the distal member of the second mchor comn rises a hole opening into a central bore,

10. The met od of claim 9, wherein sides of the central bore comprise threads. -32- The method of claim 1, wherein the proximal member of the second anchor is cylindrically shaped.

12. The me hod of claim 1, wherein a central bore extends through the proximal mernber of the sec nd anchor. s 13. The me aod of claim 12, wherein inserting the distal member of the second anchor and moving the pr oximal member of the second anchor distally toward the distal member comprises using an anchor inserter comprising a handle, a tube, and an inner member, wherein the inner member extends through the tube and the central bore in the proximal mefnbor of the sec nd anchor and is removably coupled to the distal member of the second i0 anchor

14. The method of claim 13, wherein the inserter comprises an inner tube and an outer tube, herein the inner tube extends through the outer tube, and wherein the inner member extends through the inner tube.

15. The method of claim 13, wherein the tube is movable longitudinally relative to the is inner n ember.

16. The method of claim 1, comprising coupling the first length of suture to the second anchor prior to inserting the distal member of the second anchor into bone.

17. The method of claim 1, wherein the tensioning comprises manually pulling on the first le gth of sutur e. 20 18. The method of claim 1, comprising: inserting a third anchor into bone, wherein after insertion, the third anchor is positioned underneath the soft tissue; passing E second length of suture from said third anchor over the soft issue; tensionirg the second length of suture independently from the first length of 25 suture; and after tensioning the first and second lengths of suture, moving the proximal membe- of the second anchor distally towards the distal member of the second anchor, thereby fixedly se uring both the first and second lengths of suture at the second anchor position without tying any knots. 30 19. A method of attaching soft tissue to bone, comprising: inserting a first anchor into bone, wherein after insertion, the first anchor is position ed underne th the soft tissue; passing a first length of suture from said first anchor over the soft tissue; -33 - coupling the first length of suture to a second anchor, wherein the second anchor compr ses a dista member and a proximal member, wherein said proximal member is cylin cally shaped and comprises a central bore extending there through; after coupling the first length of suture to the second anchor, inserting the distal s member of the sec nd anchor into bone at a position beyond an edge of the soft tissue; after ins rating the distal member of the second anchor, tensioning the first length of sutu to compress an area of tissue to bone between the edge of the soft tissue and the first an hor; and after tensioning the first length of suture, moving the proximal member of the io second anchor dis tally towards the distal member of the second anchor, thereby fixedly securing the first length of suture at the second anchor position without tying any knots, where: inserting t e distal member of the second anchor and moving the proximal member of the second ancor distally toward the distal member comprises using an anchor inserter coniprising a han le, a tube, and an inner member, wherein the inner member extends 15 through the tube aud the central bore in the proximal member of the second anchor and is removably coupled to the distal member of the second anchor.

20. A metho I of attaching soft tissue to bone, comprising: inserting a first anchor into bone, wherein after insertion, the first anchor is position ed underne th the soft tissue; 20 passin a first length of suture from said first anchor over the soft tissue; inserting at least a portion of a second anchor into bone at a position beyond an edge of the soft tissue; after inserting said at least a portion of the second anchor, tensioning the first length of suture to compress an area of tissue to bone between the edge of the soft tissue and 25 the firs anchor; and after tenioning the first length of suture, fixedly securing the first length of suture at the s cond anchor position without tying any knots;, wherein at least one of said anchors comprises an anchor tip and a hollow cylinder, wherein he anchor tip comprises an aperture through which suture material is 30 threaded prior to in ertion of the at least one anchor.

21. The method of claim 20, wherein said anchor tip comprises an engaging member adapted to engage inner surface of said cylinder. -34-

22. The nrethod of claim 20, wherein said anchor tip comprises an anchor inserter aftac iment mem >er.

23. The method of claim 22, wherein insertion of the at least one anchor comprising an anchor tip and a hollow cylinder comprises using an inserter that comprises a handle, an 5 outer sleeve, and an inner member, wherein the inner member extends through the outer sleeve and the hollow cylinder and is attached to the anchor inserter attachment member.

24. The m ethod of claim 23, wherein the inserter comprises an inner tube extending through the outer sleeve and through the hollow cylinder and contacts the anchor tip, wherein the innet member extends through the inner tube. 1o 25. The method of claim 24, wherein the inner tube is fixed relative to the handle.

26. The m thod of claim 24, wherein the inner tube is movable axially relative to the outer sleeve.

27. The ithod of claim 24, wherein suture material runs from inside the handle of the inberter, through the inner tube, and through the aperture in the anchor tip. is 28. The inethod of claim 27, wherein the suture material runs through a bore in the handle and passes through a hole in an end of the handle.

29. The method of claim 28, wherein the handle comprises a spool at a proximal end of the handle ada ted to hold excess suture. 30, The me- hod of claim 29, wherein the suture material is wrapped around the spool. 20 31. The me-hod of claim 30, wherein the spool is integral with the handle.

32. The me hod of claim 22, wherein insertion of the at least one anchor comprising an anc or tip and A hollow cylinder comprises tapping on the inserter with a hanmer.

33. The me- hod of claim 20, comprising coupling the first length of suture to the at least o e anchor comprising an anchor tip and a hollow cylinder prior to inserting the at least 25 one an hor comprising an anchor tip and a hollow cylinder. 34, The method of claim 20, wherein the tensioning comprises manually pulling on the first length of suture.

35. The met] od of claim 20, comprising: inserting a third anchor into bone, wherein after insertion, the third anchor is 20 positioned underneath the soft tissue; passing a second length of suture from said third anchor over the soft issue; tensioni g the second length of suture independently from the first length of suture; nd - 35 - after tensioning the first and second lengths of suture, fixedly securing both the first and se ond lengths of suture at the second anchor position without tying any knots. 36, A methc d of attaching soft tissue to bone, comprising: - inserting a first anchor into bone, wherein after insertion, the first anchor is 5 positio ed under ath the soft tissue; passing a first length of suture from said first anchor over the soft tissue; inserting it least a portion of a second anchor into bone at a position beyond an edge obthe soft tis ue; after inse ing said at least a portion of the second anchor, tensioning the first Length 10 of suture to compiess an area of tissue to bone between the edge of the soft tissue and the first anhor; and after tensioning the first length of suture, fixedly securing the first length of suture at the second anchor position without tying any knots; wherein a: least one of said anchors comprises an anchor tip and a hollow cylinder, 15 wherei1 the anchor tip comprises: an apertme through which suture material is threaded prior to insertion of the at least one anchor, an engaging member adapted to engage an inner surface of said cylinder, and an anchor inserter attachment mrnber, wherein insertion of the at least one anchor 20 corprising an ancor tip and a hollow cylinder comprises using an inserter that comprises a handle, an outer sleeve, and an inner member, wherein the inner member extends through the outer sleeve arid the hollow cylinder and is attached to the anchor inserter attachment member. - 36 -