CA2183984C - Apparatus for attaching soft tissue to bone - Google Patents

Apparatus for attaching soft tissue to bone

Info

Publication number
CA2183984C
CA2183984C CA002183984A CA2183984A CA2183984C CA 2183984 C CA2183984 C CA 2183984C CA 002183984 A CA002183984 A CA 002183984A CA 2183984 A CA2183984 A CA 2183984A CA 2183984 C CA2183984 C CA 2183984C
Authority
CA
Canada
Prior art keywords
anchor
bone
head
shaft
dome
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA002183984A
Other languages
French (fr)
Other versions
CA2183984A1 (en
Inventor
Kerry Zang
Jeffry Skiba
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Orthopaedic Biosystems Ltd Inc
Original Assignee
Orthopaedic Biosystems Ltd Inc
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Filing date
Publication date
Application filed by Orthopaedic Biosystems Ltd Inc filed Critical Orthopaedic Biosystems Ltd Inc
Publication of CA2183984A1 publication Critical patent/CA2183984A1/en
Application granted granted Critical
Publication of CA2183984C publication Critical patent/CA2183984C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B17/0642Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/8605Heads, i.e. proximal ends projecting from bone
    • A61B17/861Heads, i.e. proximal ends projecting from bone specially shaped for gripping driver
    • A61B17/8615Heads, i.e. proximal ends projecting from bone specially shaped for gripping driver at the central region of the screw head
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8875Screwdrivers, spanners or wrenches
    • A61B17/8877Screwdrivers, spanners or wrenches characterised by the cross-section of the driver bit
    • A61B17/888Screwdrivers, spanners or wrenches characterised by the cross-section of the driver bit the driver bit acting on the central region of the screw head
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8875Screwdrivers, spanners or wrenches
    • A61B17/8886Screwdrivers, spanners or wrenches holding the screw head
    • A61B17/8888Screwdrivers, spanners or wrenches holding the screw head at its central region
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409Instruments for applying suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0414Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/044Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0445Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors cannulated, e.g. with a longitudinal through-hole for passage of an instrument
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0459Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B2017/0647Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B2017/0647Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
    • A61B2017/0648Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks threaded, e.g. tacks with a screw thread
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0811Fixation devices for tendons or ligaments
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S606/00Surgery
    • Y10S606/916Tool for installing or removing orthopedic fastener

Abstract

This invention is an anchor (78) for attaching soft tissue to a bone. The anchor employs a head (80) having a central dome with a suture bore (86) extending therethrough. The dome also includes a pair of substantially flat, oppositely disposed lands (100, 100a) configured for engagement by a driving tool (120) for inserting the anchor into bones. A shaft (90) extends from the head, and includes a first series of helical threads (92) having a first diameter, and a second series of helical threads (94) interleaved with the first series ofthreads. The second series of threads has a diameter substantially different than the first diameter. The anchor further employs a guide wire bone (114) extending along the length of the anchor shaft.

Description

WO 95122931) 2 1 8 3 9 8 4 r~""~ ~? "
APPARATUS FOR ATTACHING SOFT TISSUE TO BONE
,5 Technical Field The present inYention relates generally to apparatus for attaching soft tissue to bone, and more particularly to a bone anchor which functions as an dlld~ lll site for sutures used to retain soft tissue in intimate contact with a bone to pemmit It:dlld~l of the soft tissue to the bone.
B.,.,l~ I Art And Technical Problem The principal cu""~ull~"ts of a skeletal system, for example a human skeletal system, include bones which comprise the r, dl 11 =\ k for the body, cartilage which forms ~5 the c~""t:~,ti"~ and supporting stnuctures among the bones, and ligaments which bind the bones together. When a ligament becomes detached from a bone, for example due toan athletic or other injury, it is often desirable to reattach the ligament to the bone.
Ligaments and other soft tissue (e.g., tendons) may be reaUached to a bone in a number of different ways. For example, Goble etaL, U.S. Patent No. 5,013,316, issued May 7, 1991, discloses a soft tissue anchor Culll~JIiaill~ a footing stud that includes a drill and followed by self tapping threads, wherein the footing stud is ananged for turning and tapping into a bone mass. A longitudinal hole is disposed within the footing stud and is configured to receive and retain therein a tack which includes an undersurface cU""uli,i"~
spikes for engaging and pe~ y a ligament. When the tack is urged into the bore of the footing stud, the spikes engage the soft tissue and maintain it in intimate contact with the bone.
Goble et aL, U.S. Patent No. 4,738,255, issued April 19, 1989, discloses a suture anchor system that includes a drill and guide dlldll91~111t~11l for drilling an opening into a ., ?~
WO 95/22930 218 3 9 8 4 7` ' PCT/US9510240~
bone mass which is outwardly flared to aG~,ullllllod_~ a suture anchor dispensed from an applicator, which suture anchor is configured to be expanded within the bone mass to secure the anchor within the undersurface of the bone. As tension is applied to the suture, the anchor remains underneath the surface of the bone.
Hayhurst et aL, U.S. Patent No. 5,037,422, issued August 6, 1991, discloses a bone anchor which comprises an elongated, thimble-shaped body having slots extending It:llylll.. - throu3h the body and a suture receiving opening provided in the tip of the body. At least one ridge or barb extends outwardly from the exterior of the body and defines an edge which is adapted to be lodged in the wall of a bore fonmed in the bone 10 mass. The tip of the anchor is configured to be inserted into a bore in the bone, such that when tension is applied to the sutures, the resilient walls of the anchor are flared outwardly, locking the anchor into the bore within the bone.
Paulos et aL, U.S. Patent No. 4,988,351, issued January 29, 1991, discloses a sofl tissue washer for use with a bone screw for attaching sofl tissue to a bone. The washer 15 comprises a plurality of sharp pins extending from the distal face of the washer, there being a plurality of posts interposed among the pins also extending from the distal face of the washer. The washer comprises a central bore for receiving a bone screw ,i,l. As the bone screw is tightened into the bone, the sharp pins engage the sofl tissue to retain the tissue in intimate contact with the bone; the posts limit the degree of 20 pel~elldliul~ of the pins into the bone such that the distal face of the washer is Illdi~ illed a ~ d~l~llllilled distance from the bone surface, such that the sofl tissue7s Illdillldilled between the distal face of the washer and the bone.
Anspach Jr., U.S. Patent No. 5,102,421, issued April 7, 1992, discloses a suture anchor in the fomm of a rivet having three radially extended flanges configured for 25 pe~ ,d~iui~ into a bone. A cylindrical extension projects rearwardly from the flanges and
2 8 ~ g ~ ~
WO 95r22930 1 ~, 11 J ., ~ ~A, I
has a suture secured thereto. A plurality of spiral grooves are fommed within the flanges to facilitate turning of the ankle as it is tapped into a bone mass. The ' ~ liùl~d grooves also serve to define a series of serrations Ill~l.L ' ~, which senrations aid in preventing ~ d~_ ' of the anchor.
Other known devices attempt to dispose the suture anchor site wholly within or u" ;It:" ,eall, the bone surface, such as the "Quick Anchor" bone anchor manufactured by Mitek Surgical Products, Inc. of Norwood, Massachusetts. The Mitek auick Anchor bone anchor is configured to be dropped within a bore of a bone mass using a collar device, functioning to retain expàl)ddL,lt: wings in a retracted position during insertion. Once the device is inserted into the bone cavity, the wings expand, much like a grappling hook, to prevent ~:' ' ' of the device. Presently known suture anchor devices are y in several respects. For example, the suture ~lle~,lllll~lll sites of many known devices are of sharp or otherwise irregular construction, tending to irritate adjacent tissue. Moreover, many known devices tend to migrate within the bone mass, which may result in the device becoming lodged within a joint. In addition, presently known devices require culllbt:laulllc: tools and accessories for inserting the device, for example devices which require turning or screwing during insertion.
A suture anchor is thus needed which overcomes the sl ,u, luu, ";"ys of the prior art.
Summary Of The Invention The present invention provides a suture anchor which addresses the sl ,ol Ico" ,i"y:, : - ' with the prior art.
In accu,dd,~ce with one aspect of the present invention, a bone is provided which includes an elongated shaft having a flat head portion attached to a proximal end thereof.
The head portion further comprises a rounded cap or dome which functions as a suture anchor site. During i" ' " ' ~, the surgeon drills an elongated bore into the bone mass, 21g`3984 WO 95122930 PCT/lJS9!i/0240~
and presses the shafl portion of the bone anchor into the bore. In dCCul~dllc~ with a further aspect of the present invention, the bore includes a counterbore configured to receive the flat head portion of the anchor. The dome extending from the flat portion is suitably configured with openings through which sutures may be threaded, such that the 5 sutures are securely anchored to the bone by the anchor device. The sutures may then be attached to soft tissue in a c~ .lt;olldl manner.
In accu,dd"ue with a further aspect of the present invention, the elongated shafl portion of the anchor device comprises a plurality of fnl~l,u-,u,,i-,dl tines which, when tension is applied to the sutures, tend to flare outwardly, locking the anchor in place and 10 preventins outward migration of the device. Inward migration of the device is precluded by the t~ d~ lll of the undersurface of the flat head portion of the device with the counterbore.
In acc~,~d"~,~ with yet a further aspect of the invention, the dome portion of the anchor device is suitably of integral construction with the head portion of the device, 15 resulting in superior pullout strength of the device.
In accu,dd,,ce with yet a further aspect of the invention, the shaft portion of the anchor device comprises a plurality of l~ . grooves extending along the length of the shaft resulting in a plurality of arcuate, spaced-apart tines extending along the length of the shaft. These grooves provide sites for bony ongrowth, further preventing axial and 20 rotational migration of the device within the bone.
Brief D~scii, ' Of The Drawing Figures The subject invention will be l~ illdrl~:l described in conjunction with the appended drawing figures, wherein like numerals designate like elements, and:
Figure 1 is a schematic view of an dl IdlUllli~ y nommal human heel bone showing 25 soft tissue properly attached to the bone;

WO95l22930 2 1 8~8 4 ~ '02i~1 Figure 2A is a schematic diagram of an exemplary flat bone anchor site showin3 soft tissue detached from the bone;
Figure 2B is a schematic diagram of the bone anchor site of Figure 2A shown prepared for receiving the bone anchor of the present invention;
Figure 2C shows the bone anchor site of Figures 2A and 2B showing the subject bone anchor in situ, Illdillldillill~ the reattached soft tissue in intimate contact with the bone;
Figure 3 is a side elevational view of an exemplary ~" ~bù~ "~:"L of the bone anchor device in accu,dd"~,e with the present invention;
1û Figure 4 is a cross-section view of the bone anchor device of Figure 3 taken along line IV-IV of Figure 3;
Figure 5 is a cross-section view of the head portion of the bone anchor device of Figures 3 and 4; and Figure 6 is an end view of the anchor shown in Figure 4, taken along line Vl-VI of Figure 4;
Flgure 7 is a first view of an altemate e",L.o i;",~"l of an exemplary anchor;
Figure 8 shows the anchor of Figure 7 rotated 9û degrees;
Figure 9 is a top view of the anchor shown in Figures 7 and 8;
Figure 1û is a side elevation view of an exemplary ~ ;llldlll of a driving tool in 2û ac.,c"~d"~,e with the present invention;
Figure 11 is a cross-section view of the driving head shown in Figure 10 taken along lines Xl-XI of Figure 1û;
Figure 12 is an altemate thread configuration useful in the subject anchors; andFigure 13 is a further altemate thread configuration using in accu,.la~)ce with the present invention.

WO95122930 21~3984 r~ c~
Detdiled D~ ,c, i~Jti~l1 of Preferred' E~_...,)ld,y ~II,L ' ,h Referring now to Figure 1, a ligament 12 extends between a human tibia 16 and a human calcaneus bone (heel bone) 10 in an a"dLu",i~_:'y nonmal ankle joint. Ligament 12 is attached to tibia 16 at an dlldl,lllllelll site 18, and attached to calcaneus 10 at arl d~ld~.lllllelll site 14. Although dlld~lllllelll sites 14 and 18 appear to form an arcuate line in Figure 1, those skilled in art will d~,l,Ule~ . that soft tissues such as ligament 12 typically adheres to a bone over an irregular region which, for purposes of this discussion, is ~ JIU~ . by the arcuate dlld~,lllllelll site shown in the Figure.
When soft tissue such as ligament 12 becomes detached from the bone, for example, as a result of an athletic injury or the like, it is often desirable to reattach the soft tissue to the bone. In this tegard, it has become common practice to grasp the free (detached) end of the tissue with sutures, and to securely anchor the sutures to the bone proximate the ledl~d~,l""enl site. If desired, the adjacent joint may be i"", ' " -' for a period of time to pemmit ledlld~,lllllelll. vVith the soft tissue held in intimate contact with the bone, the tissue will naturally grow back into the bone surface, fimmly ledlld~.l lil l9 itself to the bone in a relatively short period of time. For example, soft tissue 12 may begin lldellilly itself to calcaneus 1û in a matter of twenty-one days, and will be substantially ledlld~.lled to the point that the patient may walk on the ankle joint in as little as eight weeks. After d,lJ,~JIU,Xill ' Iy sixteen weeks, the ledlld.,lllllelll process is substantially completed.
The natural physk~lu~i-;al process whereby the soft tissue grows back into the bone occurs relatively quickly; hence, the useful life of the bone anchor device used to attach the suture to the bone proximate the led~ld~,ll",elll site is thus on the order of sixteen weeks. However, because removal of the anchor device may require destruction of at least a portion of the reattached tissue, it is often desirable to simply pemmit the suture W0 95122930 2 1 8 3 9r 8 ~
anchor to remain within the bone p~:""d"el,~ly. That being the case, it is highly desirable that the suture anchor exhibit a high pullout strength during the early stages of l~d~d~,lllll~ll~, and to exhibit a high resistance to migration thereafter. In addition, inasmuch as the suture anchor typically remains in sitlJ pe""d"~":'y, it is desirable that the suture anchor be minimally intnusive; that is, the suture anchor advantageously comprises smooth, dl ld~Ul l liC~. J cu" ",dti~le surfaces exposed to adjacent tissue and bony structure.
Referring now to Figures 2A-2C, an exemplary soft tissue l~dl~d~lllllC:II~ site 21 suitably comprises a bone 2û (for example analogous to calcaneus 10) and soft tissue 26 1û (for example analogous to ligament 12) which has become detached from bone 2û.
Those skilled in the art will appreciate that the structure of bone tissue is generally either compact, cortical bone, Le., the hard, dense, outside layer of bone, or spongy (also referred to herein as cancellous bone), which contains many small cavities which may be filled with marrow. Moreover, bones are also generally classified according to their shape;
that is, bones are either long (as in the bones of the ~ 5), short (for example,bones of the wrist, ankle, and sesamoid bones), or flat (such as bones of the cranium, scapula, and ribs). In addition, certain bones, for example bones of the vertebrae, are classified as irregular.
With continued reference to Figure 2A, bone 20 may comprise a flat bone having an outer layer 22 of compact bone enclosing an inner-region 24 of cancellous bone.
Referring now to Figure 2B, le:d~d~ lll site 21 may be suitably prepared for l~dlld~,lllllt:ll~ of soft tissue 26 (not shown in Figure 2B for clarity), by fomming a bore 28 extending through outer layer 22 and into the cancellous portion 24 of bone 20. With IllUlllC~ dly reference to Figure 2C, an exemplary suture anchor device 40 may then be inserted into bore 28 to maintain soft tissue 26 in intimate contact with bone 2û to pemmit _ . _ . .. ... _ . _ . _ . . . . . . _ . ... . . . . . . . . _ _ _ _ ~1839&4 the soft tissue to naturally reaUach itself to the bone.
Refenring now to Figure 3, suture anchor 40 suitably comprises a shaflt portion 44, a head portion 42, and a neck portion 54 interposed Il,e" ' ' 1. Neck portion 54 is suitably integral with head portion 42, and in a preferred exemplary t~ di~ llL, is 5 substantially cylindrical in shape.
Head portion 42 suitably comprises a disc portion 43 and a dome 66 extending therefrom. Dome 66 advantageously includes one or more suture tunnels 68, as described in greater detail below in conjunction with Figures 5 and 6.
Disc portion 43 further comprises a substantially flat, annular, undersurface 56 and 10 a substantially flat, annular upper surface 60 separated by a circumferential land 58. In a.,~,u,~d"~,~ with a preferred exemplary ~ bo.li~ , disc portion 43 suitably comprises a first beveled surface 62 joining land 58 and upper surface 60, and a second bevelled surface 64 joining land 58 and undersurface 56.
With continued reference to Figure 3, shaft portion 44 suitably comprises a plurality of fru~i,u~.o"i~,dl tines 46A-46F. In the illustrated ~",~di",e"I, shaff portion 44 suitably comprises six (6) tine segments, namely, respective segments 46A-46F. However, any suitable number of tine portions may be employed in the context of the present invention, for example in the range of one to twelve or more, depending on the particular bone mass within which the device is to be installed, and most preferably on the order of four to eight 20 tine portions.
In acc~"~a,~ce with a further aspect of the invention, respective tine portions 46A-46F each comprise a flat annular surface 48 disposed in a plane substantially perpendicular to the longitudinal axis of anchor 40, an angled, fru ,~,u~,~"i~,dl portion 52, and an arcuate junction 50 defining the junction between flat portion 48 and angled portion 52. Shaft portion 44 suitably temminates at a flat, distal land 70.

218398~
WO95/22930 r~l,./,.. ~u~
Vvith contin~ed reference to Figure 3 and as discussed in greater detail below in conjunction with Figure 6, shaft portion 44 suitably comprises one or more grooves 72 extendin3 along the length of shaft portion 44.
More particularly and with reference to Figures 3 and 6, respective grooves 72A,72B, and 72C are suitably spaced apart along shaft 44, fomming respective tine sections 74A, 74B, and 74C. As best seen in Figure 3, each of respective tine sections 74A-74C
comprises a portion of respective tine segments 46A-46F. Although respective grooves 72A-72C are su~ "';~l!y semicircular in cross section as shown in Figure 6, virtually any geometry may be employed such that respective tine sections 74A-74C are spaced apart from one another. In this way, when anchor 40 is installed within a bone mass, bony ingrowth may penetrate the interstices fommed by respective grooves 72A-72C
il.~,.lll~:li;dl~ tine segments 74A-74C. The presence of this bony ingrowth helps ensure that anchor 40 remains stationary within the bony mass. In particular, the presence of bony ingrowth within respective grooves 72A-72C substantially impedes rotationalmigration of anchor 40, as well as sub~ldl.'i.A ~y impeding axial migration (either into the bone or out of the bone) by enveloping the complex geometric stnucture cu,,,,u,i ,i,,~ shaft 44.
Referring now to Figures 4-6, the outer diameter of shaft 44 may be substantially constant along its length in acco~-ld~,~.e with a first ~",b~di,l,~"l of the invention (not shown). In the alternate preferred t~ budi~ l shown in Figure 4, the outer diameter of the tines suitable decreases, for example linearly, from tine segment 46A to tine segment 46F.
More particularly, the diameter of shaft 44 may decrease along its length d,U,UlUd~,llilly land 70, such that an included angle E defined by the convergence of the 21,83984 WO 95/22930 PCT/US95/0240~
range of 5-6 degrees, and most preferably on the order of six degrees. In the illustrated t:",L,odi",t:"Lwhereineachrespectivetinesegment46A46FissuitablysuuOlall 'Iyequalin length, i.e., wherein each tine segment has an d,U~JlU~.;II.-'~Iy equal axial dimension, the various angles defined by junction 50 increase from tine segment 46A to tine segment 46F, that is, each respective land 48 cull~:a,uùlldilly to tine segments 46A-46F decreases along the length of shaft 44 (to the left in Figure 4), each angled segment 52 also decreases along the length of shaft 44, and the angle defined by junction 50 for each tine segment ~.u~l_o~OIldi~ increases along the length of shaft 44 (i.e, from right to le~t in Figure 4). In this regard, while the respective angled junctions 50 cull~o~Jûlldillg to the various tine segments are shown as a sharp comer in the drawing Figures, it may be advdllLdyt:uus from a manufacturing standpoint to include a small radius at junction 50 in lieu of a sharp corner.
Vvith continued reference to Figure 4, an inteMal angle R may also be defined for each tine segment. Consistent with the foregoing discussion, the angle R for each tine segment will increase along the length of shaft 44 (i.e., from right to left in Figure 4).
In a preferred ~IllL~di,,l~ of the invention, an axial dimension, for example, acommon dimension for each respective tine segment 46A-46F, may be defined as shown in Figure 4. In a particularly preferred e",uodi",~ , axial dimension for each tine segment is suitably on the order of .025 -.040 inch, and most preferably on the order of about .030 inch, such that the length of shaft 44 for the 6 tine ~Il,L,~di,llt:llL shown in the Figures is on the order of d,U,UlUAillldLtlly .180 inch. In particular, the length of shaft 44 is most desirably d,u,ulu,d,ll.A~ly .120 inch for use in conjunction with small bones or for use with small children, and may suitably be on the order of .240 inch for use in middle si~ed bones or in average sized people, and a,u,ul~ ' ~y .360 inch for large bones and/or for use in larger individuals.

21~39~
WO95/22930 r~ 7'~1 While any desired angle E may be employed in the context of the present invention, an angle on the order of five degrees facilitates convenient insertion and self-alignment of anchor 40 into bore 28, as discussed in greater detail below.
With continued reference to Figure 2 and 4-6, a surgeon suitably prepares a 5 l~dlld~.llllltllll site 21 in the following manner.
With particular reference to Figure 2B, a bone drill (not shown) is suitably employed to introduce bore 28 in the bone site, which extends through compact layer 22 and cancellous layer 24. The total length of bore 28, i.e., from the outer surface of compact layer 22 until the bottom 29 of bore 28, is referred to in Figure 2B as dimension 35. With 10 IllUlll~lltdly reference to Figure 4, dimension 35 (Figure 2B) ~,u"~:,pu",l~ to dimension D
of anchor 40, and is advantageously in the range of .20 inch to .50 inch, and most preferably in the range of .33 inch to .45 inch. In practice, it may be desirable for dimension 35 of bore 28 (Figure 2B) to exceed dimension D of anchor 40 (Figure 4) by a small amount, for example on the order of .001 to .020 inch. In this way, disc portion 43 of head 42 is dd~dlltayt:Ously disposed beneath the surface of compact bone layer 22 when anchor 40 is installed.
With continued reference to Figure 2B, a counterbore 30 is suitably created in compact layer 22, either by using the same drill employed to create bore 28 or by using a secondary tool in addition to or in conjunction with the drill used to create bore 28. In 20 order to maintain proper alignment, counterbore 30 and bore 28 are desirably created using a single tool (not shown). With IllUlllt:llldly reference to Figures 2B, 3, and 4, the axial dimension of counterbore 30 is suitably equal to or slightly greater than the thickness of disc 43 (c~ Jul ld;~ ly to dimension F in Figure 4), and is suitably on the order of .020 to .50 inch, and most preferably on the order of about .40 inch. The depth of counterbore 25 30 is limited by the thickness of compact bone layer 22 in the vicinity of the It:dl~d..lllll~lll site, and, hence, the size of anchor 40 is advantageously selected in acc~,.ld, I-,e with the physical dilllèllsiolls of the ledlldull~e~l site.
In any êvent, the depth of bore 28 should be selected so that undersurface 56 ofdisc 43 engages COIle ~pUllUilly surface 31 of counterbore 30; that is, while base 70 of device 40 should desirably be proximate base 29 of bore 28 when anchor 40 is installed, it is not necessary that base 70 of device 40 contact base 29 of bore 28, whereas it is highly desirably that undersurface 56 of device 40 physically engage surface 31 of counterbore 30. In this way, inward axial migration of anchor 40 will be substantially inhibited to the extent the integrity of compact bone layer 22 in the vicinity of counterbore 30 remains intact.
The diameter of bore 28 should be selected to be equal to or slightly smaller than the largest diameter of respective tine segments 46A-46F. More particularly, the diameter of bore 28, illustrated as dimension 32 in Figure 2B, is advantageously on the order of .010 to .040 (and most preferably on the order of .028 inch) smaller than dimension G
(see Figure 4) of device 40. In this way, the various arcuate junctions 50 ~_ullea,uOll-lilly to the tine segments will frictionally engage the circumferential walls of bore 28 during insertion of anchor 40 into device 28. Depending on various physicaM~lldldl-Lelil~ b of the material c~lll,uliailly anchor 40 as discussed in greater detail below, and further depending on the hardness of the bone and the vicinity of ledlld~,lllllelll site 21, and further depending on the physical dilllel~siù~,s of the various tine segments in the vicinity of respective junctions 50, the frictional e"ydye",e"l between shaft 44 and bore 28 may result in a deflection of the tine segments as the device is inserted into the bore, the deflection of compact bone 22 and cancellous bone 24 proximate the device, or a cu,,lL,i,ldLiu,, of both. To the extent anchor 40 frictionally engages the bone during insertion, the outward flaring of respective tine segments 46A46F (and particularly in the 2~83~4 ~`
W09S122930 P~ v..,~ 21~1 region of respective arcuate junctions 50) with respect to the bone proximate thereto will inhibit outward axial migration of anchor 40.
Finally, the diameter of counterbore 30 should adv...,~dy~uusly be d,l.J,UlU~dlll '~,ly equal to or slightly greater than the diameter of disc 43 (dimension L in Figure 4). In the 5 preferred exemplary t:lllbudillldlll shown in the drawing Figures, dimension L is suitably on the order of .020 to .10 inch, and most particularly on the order of .040 to .075 inch, and most preferably on the order of about .0625 inch. Thus, the diameter of counterbore 30 should suitably be on the order of .000 to .030 inch, and most preferably on the order of .020 inch, greater than dimension L to facilitate optimum seating of device 40 within 10 counterbore 30.
With continued reference to Figures 2B and 2C, after l~:dllcl~,ll",e:llL site 21 is properly prepared by the surgeon, anchor 40 may be suitably inserted into bore 28, for example by urging the device into the bore by pressure exerted by the surgeon's thumb or forefinger, or by tapping the device with a suitable impact tool. When anchor 40 is 15 fimmly seated within the bore, soft tissue 26 may be suitably secured to the dlld.,lllll~
site with one or more sutures 36, as is known in the art. In this regard, sutures 36 may be threaded through tunnel 68 prior to inserting anchor 40 into the bore, after the anchor is partially seated within the bore, or upon fully seating the anchor within the bore.
More particularly and with reference to Figures 5 and 6, the cross-sectional area 20 of tunnel 68 is suitably large enough to ac~,u,,,,, - ' ' one or more sutures extending through the tunnel. It is also desirable to ensure that sumcient material is present within dome 66 to avoid breakage even as substantial tension is applied to the sutures, for example durin~ dlld~,llllle:lll of the soft tissue. Moreover, the cross-sectional area of tunnel 68 should also be sumcient to pemmit standard suture needles to conveniently pass 25 through the tunnel, even when device 40 is seated within a bone.

~ ~ l WO 95122930 218 3 9 ,8,4, r~l/u~,~ 02 iol--~
To facilitate the cu"~ "l threading of sutures through anchor 40 in sitv, an included angle P ~so~ I with tunnel 68 may be defined, which is suitably on the order of 10-60 degrees, and preferably on the order of 25-35 degrees, and most preferably about 30.6 degrees. Furthemmore, the distance between the respective openings 5 cu",,uli~ tunnel 68 may be cull/_"i~ defined as dimension Q (Figure 6), suitably on the order of .030 to .090 inch, and preferably on the order of .050 to .075 inch, and most preferably about .060 inch. Finally, the diameter of tunnel 60 is suitably on the order of .020 to .060 inch, and most preferably about .045 inch.
Once anchor 40 is installed within the bone site, for example as shown in Figure 2C, and soft tissue 26 is suitably reattached to the bone site via sutures 36, it is desirable to minimize irritation of soft tissue 26 and surrounding tissue by device 40. In this regard, it is desirable to seat disc 43 within counterbore 30 to the extent pemmitted by the dll ' ' CCIl~i_ I ' I of bone site 21. In addition, it is desirable that the geometry of dome 66 be such as to minimize discomfort ~ with the contact between dome 66 and the adjacent anatomy.
More particularly, dome 66 is suitably highly polished, and exhibits a smooth, curved surface, for example a hyperbolic, ellipsoid, or s~",i:"Jl,t:,i~.al shape. In addition, the respective openings cu""~ i"~ tunnel 68 may be radiused, bevelled, or otherwise configured to avoid sharp comers. In a particularly conferred ~ di"~ I, dome 66 suitably comprises a substantially unifomm radius on the order of .100 to .176 inch, and most preferably on the order of .130 inch resulting in a maximum dimension C (Figure 4) on the order of .020 to .070 inch, and most preferably about .050 inch.
For le:dlldl,lllll~ sites such as that shown in Figure 2, Le., wherein a substantially flat bone surface is available, disc 43 may be substantially seated within counterbore 30.
However, it may also be desirable to employ anchor 40 at It:alld~,lllllt:llI sites which are 2 18398~
W0 95122930 ~ r ~
either concave, convex or othenwise irregular. Accordingly, the diameter and thickness of disc 43, as well as various other di,,,~ ;u,,~ of head 42 (in particular the dome 66) may be configured to provide adequate material strength to avoid breakage as tension is applied to the sutures, while at the same time providing smooth, I~UIIdLJ~ V~3 and minimally invasive surfaces to reduce irritation of surrounding tissue.
In accu~da~)G~ with a further aspect of the present invention, anchor device 40 is advantageously made from any suitable L,iu, , '' ' material, for example titanium alloy, stainless steel, class six implant grade plastic, and the like, or any other Liucull, '' material which exhibits adequate pullout strength, sufficient strength to avoid breakage as the sutures are pulled, and having sufficiently low brittleness to avoid breakage during long teml usage of the device in si~u. Altematively, in view of the relatively short useful life of device 40 (as discussed above), device 40 may be made from a suitable biodL~ ~ul lJd~ material, for example, polyglycolic acid, a material distributed by Johnson & Johnson under the name ORTHOSORB~M.
In acbu,dd",,e with a further aspect of the invention, shaft 44 and, if desired, neck portion 54 and at least underside 56 of disc 43 may suitable exhibit a course finish to further promote bony ingrowth and thereby further stabilize anchor 40 against any degree of migration.
In accu,dc",.,~ with a further aspect of the present invention, and with reference to Figures 7 to 9, the suture anchor 78 suitably comprises a shaft 90 and a head 80. Shaft 90 is suitably integral with head 80, and in a preferred exemp~ary ~Illbodi,,,t:,,L, is substantially cylindrical in shape.
- With particular reference to Figure 7, shaft 90 further comprises respective major threads 94 and minor threads 92. As shown, preferably threads 92 and 94 are interleaved and each suitably arranged in a helical pattern. In addition, and with , _ .. . . . _ .. _ . _ . _ . . . . . ~ _ _ _ .

wo ss/22s30 ~ 4 ~ . 021^~
reference to Figure 8, the dis~al end 96 of shaff 90 is preferably pointed for easy p~l1ell..'iull and self-tapping into the bone matter. Preferably, distal end 96 is fommed by tapering or angling of shaft 90, such as at an angle Q on the order of about 30 - 45 degrees. The outemmost point of distal end 96 is preferably rounded, such as by being radiused on the on the order of about .010 inch. It should be d,u,ule~,idle i, however, that alternative pre-tapping end cor':g~ , may be employed in the context of shaff 90and/or that conventional pre-tapping Illelll~ iuluyie~ (e.g. pre-drilling and the like) may be employed as desired even with self-tapping corlfi~ " la.
A preferred orientation of interleaved thread patterns 92, 94 is in a so-called "hi-iow configuration". As will be d,u~le~,idle~i by those skilled in the art, such a configuration includes minor threads having a dimension of between about 60% to about 85%, andmost preferably about 75%, of the dimension of the major threads. Such a configuration with bone anchors is believed to offer advantages over other bone screw configurations because it allows for greater recruitment of bone material, and particularly of the soff cancellous bone matter, the part of the bone that the majority of the anchor fastens to.
In addition, because only half of the threads have a large diameter, the amount of torque required to set the anchor tends to be reduced.
Referring still to Figure 7, in a preferred exemplary elll~u iilllcll~ of the invention, the spacing between either consecutive major threads 94 or of consecutive minor threads 92 is suitably on the order of 5 -16 threads per inch, and most preferably on the order of about 9 threads per inch. Thus, the spacing of the interleaved ~.u~ iull of major and minor threads is suitably between about 10 - 32 threads per inch, and most suitably on the order of abolJt 18 threads per inch.
In ac~,ol idll~,é with the preferred exemplary elllbo iilll~lll the diameter of shaff 90, as illustrated by dimension C, is suitably on the order of about .040 to about .175 inch, W095177930 2 1 ~3~ ~ p "" In7 _1 and most preferably on the order of about .080 or .125 inch; the diameter of minor threads 92, as illustrated by dimension E measured from the central axis x of shaft 90 to the outer edge of minor thread 92, is suitably on the order of about .060 to about .255 inch, and most preferably on the order of about .118 to .190 inch; and the diameter of 5 major thread 94, as illustrated by dimension B measured from the central axis x of shaft 90 to the outer edge of thread 94, is suitably on the order of about .100 to about .300 inch, and most preferably on the order of about .157 to .256 inch.
The particular configuration and dimension of threads 92, 94 may vary depending on a variety of factors. For example, typically it is desirable that the height and number 10 of threads be chosen to optimize pull-out strength and minimize insertion torque as anchor 78 is worked into the bone masg. Preferably, the height of minor thread 92 is bQtween about 25% to about 70% the height of thread 94, and more preferably about 50%.
While anchor 78 is shown as having an equal number of major threads 94 and minor threads 92 per inch, it should be d,U,Ul~,idl~d that the number of threads per inch 15 may vary as between the major and minor thread pattems, or that vary over the length of anchor 78. For example, the number of threads per inch, while being the same for both major threads 94 and minor threads 92 might be suitably varied over the length of anchor 78, say for example with the pitch increasing from bottom 96 to the top of shaK
90. That is, it may be desirable to have more threads per lineal inch in one region along 20 the axis of the shaft than in other regions along the axis of the shaft. It is believed that such a construction may optimize the pull-out strength of anchor 78, while at the same time desirably reducing the stress to the bony material upon insertion of anchor 78.
Threads 92 and 94 are also suitably surface finished to minimize stress on the bony material as anchor 78 is inserted therein. In ac.,u,~d,,.,e with a preferred 5 t:" l~dil "~"I of this aspect of the present invention, the outer surfaces or edges of threads .. . . .. .. _ _ _ . _ . .. . _ .. . . . . . . . _ _ _ _ wO 95/22930 2 1 ~ 3 9 8 l; s ~ tA7~_~
92, 94 are optimally rounded or smoothed, for example to exhibit a radiused surface on the order of about .002 to about .005 inch. As will be d,U,Ul~.idlt:d by those skilled in the art, such finish can be e,l~ d through electro-polishing, fine bead sanding or the like.
Referring now to Figure 8, each of respective threads 92 and 94 preferably comprise an angled helical upper surface 108, an angled helical under surface 110, and a helical edge 112 i~ uu""e~i;"~ surfaces 108 and 110. Preferably, surface 110 is y angled from the outer edge of threads 92 and 94 to the body of shaft 90.
This angle is illustrated by dimension N and, in a prefenred ~IllL~i",t:lll, is typically about 25 degrees. Similarly, upper surface 108 is preferably angled upwardly from the edge of threads 92, 94 to the body of shaft 90, as is illustrated by dimension O, typically about 5 degrees. The thickness P of the helical edge 112 i"' _u""~.li"~ upper surface 108 and lower surface 110 is typically about .005 inch.
Vvith continued reference to Figure 7, head 80 suitably comprises a curvalinear dome 82 and a substantially flat, annular undersurface 88 separated by a circumferential segment 84. Head 80 preferably further includes two oppositely facing grooves, e.g., semicircular grooves 102, 102a and a suture tunnel 86, e.g, having a circular or elliptical cross-section, passing through dome 82 such that tunnel 86 extends between grooves 102, 102a. As will be discussed in greater detail below, a driving tool 120 (Figure 10) suitably adapted to receive head 80 in such way as to minimize the risk of driver slippage when torque is applied to anchor 78 is optimally utilized to set anchor 78 into a bone.
Head 80 is substantially superior to the prior art in that its curvalinear shapeminimizes the irritation of surrounding tissue while also minimizing the distance that head 80 protrudes above the bony material. Furthemmore, the configuration of head 80 adds addltional benefit in that it impedes the migration of anchor 78 into the bone material and ~ ,~? ~
WO95122930 2183984 r~l,u. lA? ~l makes anchor 78 easily retrievable, a significant advance from the prior art.
Many times, anchors will be inserted so that the entire anchor imbeds below the cortical surface of the bone. After time, the bone will grow over the anchor making it very difficult to retrieve. In this situation, a doctor must bore a hole into the bone and search 5 for the buried anchor. Because head 80 stays in the upper cortical surface of the bone, bony overgrowth will not likely cover head 80 and, thus, head 80 will not likely be lost beneath the cortical surFace.
Vvith reference now to Figure 9, segment 84 preferably is circular in shape suitably exhibiting two substantially flat sides 100, 100a parallel to tunnel 86. Cut or otherwise fommed into sides 100, 100a are respective grooves 102, 102a. In a preferred Lodi,,,~:,,l of this aspect of the invention, the dimension F between sides 100 and 100a is suitably on the order of about .060 to about .240 inch, and most preferably on the order of about 0.140 inch. The depth G of grooves 102, 102a is suitably on the order of about .020 to about .080 inch, and most preferably on the order of about .050 inch. The radius of grooves 102, 102a is suitably on the order of about .020 to about .080 inch, and most preferably on the order of .050 inch. It should be d,~ ' ' ' however, that grooves 102, 102a may be variously configured such as, for example, exhibiting a square, rectangular or other suitable configuration.
Arc segments 104, 104a of segment 84 are preferably curvalinear, optimally 20 circular in nature. In a preferred exemplary t:lllbu.lilllt~, dimension l is suitably on the order of about .080 to about .250 inch, and most preferably on the order of about .157 inch.
Referring back to Figure 7, dome 82 preferably consists of a smooth curved surface, e.g., a symmetrical sinusoidal shaped element having respective connected 5 inward and outward facing arcs. The radii of both arcs are preferably equal and are 2183.g.84 ' W0 95/22930 ~ ` ' r~ 4~
illustrated as dimension J in Figure 7. Preferably, dimension J is on the order of about .040 to about .100 inch, and most preferably on the order of about .047 inch.
Preferably dome 82 is configured to possess an upper smooth curvalinear configuration. For example, as shown best in Figure 8, dome 82 and segment 84 5 combine to form the stnucture surrounding tunnel 86, and the distance K from the top of dome 82 to underside 88 is suitably on the order of about .060 to about .120 inch, and most preferably on the order of .080 inch. Preferably, head 80 is suitably di~ iùl~ld to ensure that undersurface 88 seats against the outer surface of the bone into which anchor 78 is inserted, while ",i"i",i~i"g soft tissue irritation by segment 84; for example, by configuring segment 84 to exhibit a thickness L on the order of about .015 to about .040 inch, and more preferably on the order of .022 inch.
It should be el~U,Ul~:l..id~:d, however, that other anchor head configurations may be suitably utilized. For example, dome 82 and segment 84 could be suitably modified to maintain the general curvalinear c~"'ig I " " while at the same time affording other 15 benefits. In this regard, segment 84 could be provided with one or more nibs or other protrusions (not shown) on underside 88 thereof to facilitate attaching of tendons or the iike between head 80 of anchor 78 and the bone into which it is inserted.
With reference now to Figures 7 and 9, a tunnel 86 is suitably configured to pass completely through head 80 between parallel sides 100 and 100a. Preferably, tunnel 86 20 exhibits a cross-sectional area suffficiently large enough to permit a standard suture needle to conveniently pass therethrough, particularly in the presence of one or more sutures extending therethrough. Tunnel 86 is a significant ddV...ICC~ over the prior art in that if a suture breaks while in anchor 78, a doctor can conveniently thread a new suture through hole 86. Previously, the anchor had to be removed to insert a new suture.
5 In ac.,u,dcl,,.,~ with a preferred ~ udilllelll~ of this aspect of the present invention, the 2I~3;g8~ ~
WO 95122930 . ~
tunnel 86 exhibits a diameter on the order of about .040 to .100 inch, and more preferably on the order of about .065 inch or .075 inch. Tunnel 86 is suitably positioned near underside 88. Preferably, the distance M from an axis passing through the center of tunnel 86 to underside 88 is on the order of about .020 to about .050 inch, and more preferably on the order of about .032 inch.
To minimize discomfort r-- ' with the contact between head 80 and adjacent anatomy, the edges of head 80 and the respective openings ~,u""u,i:,i"g tunnel 86 may be radiused, bevelled, or otherwise configured to avoid sharp corners. This can be ~,.,,,,"",!; I~ed by any suitable manner, such as by machining, grinding, electro-polishing, fine bead blasting and the like. In particular, respective junctions 106 and 106a of tunnel 86(i.e., the tunnel openings) are preferably radiused to prevent sutures passed through tunnel 86 from being snagged or severed by any sharp corners contained thereon. In a preferred e~llb~di~llellI of the invention, the radius of edges 106, 106a is suitably on the order of about .004 inch.
Anchor 78 may be configured to exhibit any length A depending on the nature and type of bone it is intended to be used with. In dcculddll.,è with a prefenred aspect of the present invention, anchor 78 exhibits a length on the order of about .125 -1.5 inch, and most preferdbly on the order of .472 - .551 inch.
Still refening to Figures 7 to 9, in a further elllL~dilllellI of the present invention anchor 78 may be suitably configured with an axial bore 114 extending through the entirety thereof. Bore 114 preferably exhibits a diameter R suitably on the order of about .020 to about .10 inch, and more preferably on the order of about .030 to about .075 inch.
- In general, preferably the thickness of the walls of shaft 90 surrounding bore 114 are on the range of about .020 to about .10, more preferably about .025 inch.
Anchor 78 having bore 114 extending therethrough is, in accu,-ld".,e with this , . , . , .. , . . , . = =, . = .. . . . . _ . _ . _ _ _ _ _ ~ 18398 wo ss/22s30 r~ 1C
aspect of the present invention, suitably configured to enable a guide wire to be ad~/allla~ Ously passed through anchor 78 while in use. For example, in some circumstances, it may be desirable to pin sofl tissue to a bone before inserting a bone anchor. For example, if a doctor is fixing a tendon in a shoulder, he may want to pin the 5 tendon in place before inserting the anchor. In this respect, once the tendon is lightly secured in place, the doctor may install a suitable guide wire into a desired position and slide anchor 78 with bore 114 over the wire for anchor position guidance. In this situation.
when anchor 78 is inserted into the bone matter, head 80 advantageously will residè
directly on top of the sofl tissue, securing the tissue between underface 88 and the bone 10 surface, thereby adding extra stability to the tissue/bone interface.
Because, in this configuration, head 80 uu~l..t;/cly engages the soflt tissue, to aid in holding the tissue to the bone, a preferred e~llluu~ ll of head 80 may include small teeth (nibs) on underside 88, or, ~", ' /~,ly, underside 88 may be concave in shape instead of substantially flat. In addition to the configuration of head 80 in ac.,~,da"c~ with this aspect, a doctor can also utilize sutures passed through tunnel 86 of head 80 to further secure the sofl tissue in place.
In aGc~"lal~c~ with a further aspect of the invention, as shown in Figure 12, any suitable head configuration, e.g., domed head 80, as described above, can be used in conjunction with "pushtite" threads 142 which comprise a suitable helical screw thread pattern. Threads 142 are configured such that anchor 140 can be secured in the bone by pushing it into a pre-tapped hole, and can be removed by unscrewing it. The preferred t:lllLudilll~:lli of anchor 140 differs from the tine configuration of anchor 40 in that anchor 140 can be advantageously backed out of the bone. while retaining the deflecting properties of the tines discussed above in conjunction with Figures 3 - 6. Anchor 40, once inserted, tends to be diffficult to remove because tines tend to catch. With the wossn2s30 ', ~
u~ l shown in Figures 7 - 9 and in Figure 12, to remove anchor 140, driving tool120 (Figure 10) can be used in conjunction with head 80 to reverse it out.
In ac..u,dd",,e with yet a further aspect of the invention, as shown in Figure 13, a suitable head (e.g., head 80) can be used in conjunction with "twin lead" threads 152 which comprise a plurality of equal height il,t~ ;l helices. A benefit of anchor 150 is that it can be secured into a pre-tapped hole in two revolutions, yet still provide an ~c,,~ pull-out strength that is similar to other threaded anchors.
Referring now to Figures 10 and 11, driving tool 120 suitably comprises a handle122, a driving head 124, and a shaft 126 interposed II,el-L ' ,. Driving head 124 is positioned at the distal end of shaft 126 and preferably comprises a hollow cylindrical cavity 128. r~ ,ut~ oppositely displaced tabs 130 and 130a are suitably provided on the inside of cavity 128. Driving head 124 is suitably configured to fit over and/or engage head 80 of anchor 78 (see Figures 7 to 9) with tabs 130 and 130a positioned to fit within grooves (notches) 102 and 102a in head 80. In a~.c~,-ld"-.~ with a preferred aspect of the invention, driving head 124 may exhibit a depth sufficient to receive the entirety of head 80 within. Typically the depth of driving head 124 will be slightly larger than the height of head 80, and is suitably on the order of .065 - .125, and most preferably on the order of about .085 inch.
A further aspect of driving head 124 is that the inside wall 132 of cylindrical cavity 128 is tapered inward such that when head 80 is inserted into driving head 124, head 80 wedges against inside wall 132, thus creating an i"~ r~ "ce or friction fit and securing head 80 inside driving head 124. In addition, because head 80 is held inside cavity 128 by an i"' r~ b~ or friction fit, head 80 will release from cylindrical cavity 128 when pressure is reduced between the head and the inside wall (i.e., when the driving tool is pulled away from the anchor). The taper of inside wall 132 is shown by dimension W and d 21g39g4 WO 95/22930 PCT/US95/0240~
may vary depending on the .li",~:"~;u"s of head 80; however, dimension W is generally on the order of about S degrees.
Because of this unique configuration, when anchor 78 is inserted into driving tool 120, it will not fall out, allowing a doctor to all ' _ 'Iy place the anchor in hard to reach 5 places without needing to hold the anchor with his other hand. In addition, this configuration can make surgery safer and more efficient because it reduces the chances of dropping the anchor inside the body.
Although the subject invention has been described herein in conjunction with the appended drawing Figures, those skilled in the art will appreciate that the scope of the 10 invention is not so limited. Various l"odiril,d~;ù~)s in the dlldllgtllllelll of the cv~,uu~
discussed and the steps described herein for using the subject device, may be made without departing from the spirit and scope of the invention as set forth in the appended claims.

Claims (26)

We claim:
1. An anchor for reattaching soft tissue to a bone, comprising:
a head including a dome portion having a channel extending therethrough for receiving sutures; and a shaft portion extending from said head portion, said shaft portion including a plurality of radially spaced apart tine segments extending along the length thereof, each of said tine segments comprising a plurality of axially spaced apart resiliently deformable tines.
2. A screw type bone anchor for attaching soft tissue to a bone, comprising:
a head having a central dome with a suture bore extending through the dome and a pair of substantially flat, oppositely disposed lands configured about said dome, said lands being configured for engagement by a driving tool for inserting said anchor into the bones; and a shaft extending from said head, said shaft including a first series of helicalthreads having a first diameter, and a second series of helical threads interleaved with said first series of threads, said second series of helical threads being characterized by a second diameter substantially different than said first diameter.
3. The anchor of claim 2, wherein said suture bores configure to accommodate a plurality of sutures.
4. The anchor of claim 2, wherein each of said lands further comprises a groove configured to receive a corresponding tab of a driving tool.
5. The anchor of claim 2, further comprising an axial guide wire bore extending along the length of said anchor, such that a guide wire may be journaled through said guide wire bore.
6. A soft tissue anchor assembly, comprising an anchor and a driver, wherein:
said anchor comprises a head and a shaft extending therethrough, said shaft comprising a plurality of threads configured to engage said bone for securely mounting said anchor into said bone, and wherein said head is characterized by a central dome portion having a suture bore extending therethrough and a flat land configured to engage said driving tool; and said driving tool comprises a proximal handle portion and a distal engaging portion, said engaging portion comprising a concave cavity configured to releasably grasp the head of said anchor upon the application of manual force to said driving tool when said driving tool is in contact with said head, said engaging portion further comprising a driving region configured to contact said land of said head as said driving tool urges said anchor into the bone.
7. Assembly of claim 6, wherein said land comprises a notch in said driving region comprises a corresponding tab configured for receipt within said notch to facilitate the transfer of torque from said driving tool to said anchor.
8. An anchor for reattaching soft tissue to a bone, comprising:
a head disposed at a proximal end of said anchor, including a dome portion having a channel disposed herein for receiving sutures, said channel being configured such that said sutures extend in the direction of said proximal end when engaging soft tissue; and an integral shaft portion immovably affixed to and extending from said head portion and terminating at a distal end opposite from said proximal end, said shaft portion including at least two circumferentially spaced apart grooves defining at least two circumferentially spaced apart tine sections extending along at least a portion of the length of said shaft, each of said tine sections comprising a plurality of resiliently deformable tines spaced apart along at least a portion of the length of said shaft.
9. The anchor of claim 8 wherein each of said tines comprises an upper surface disposed in a plane substantially perpendicular to a longitudinal axis of said anchor, a frustroconical portion, and an arcuate junction defined by the intersection of said upper surface and said frustroconical portion; and further wherein the distance from said longitudinal axis to said arcuate junction for each of said tines decreases along the length of said shaft portion from said head to said distal end.
10. The anchor of claim 9 wherein said distance decreases linearly along said shaft portion, resulting in an angle of approximately zero to ten degrees between said axis and an imaginary line connecting said respective arcuate junctions.
11. The anchor of claim 8 wherein said anchor further includes a flathead portion disposed at the junction between said dome portion and said shaft portion, said flathead portion being integral with said dome portion and having a diameter larger than said shaft portion for impeding axial migration of said anchor into said bone.
12. The anchor of claim 11 wherein said flathead portion includes a substantially flat, annular undersurface, a substantially flat, annular upper surface, and a circumferential land extending therebetween, and wherein a first beveled surface joins said circumferential land and said upper surface and a second beveled surface joins said circumferential land and said undersurface.
13. The anchor of claim 11 wherein said flathead portion has a diameter in the range of .020 to .10 inches.
14. The anchor of claim 8 wherein each of said tines has an upper surface disposed in a plane substantially perpendicular to a longitudinal axis of said anchor, a frustroconical portion, and an arcuate junction defined by the intersection of said upper surface and said frustroconical portion; and wherein the angle between said upper surface and said frustroconical portion for each of said tines increases along the length of said shaft portion from said head to said distal end.
15. The anchor of claim 8 wherein said channel comprises at least two channel segments intersecting in said head so as to form an angle in the range of 120 to 170 degrees.
16. The anchor of claim 15 wherein each of said channel segments exhibits a length in the range of .030 to .090 inches and a diameter in the range of .020 to .060 inches.
17. The anchor of claim 8 wherein said dome portion exhibits a radius of curvature of approximately .100 to .176 inches and a thickness on the order of .020 to .070 inches.
18. The anchor of claim 8 made of a material from the group consisting of titanium alloy, stainless steel, class six implant grade plastic, and polyglycolic acid.
19. The anchor of claim 14 wherein each of said tine sections comprises one to twelve axially adjacent tines having an axial spacing in the range of .025 to .040 inches.
20. The anchor of claim 19 wherein said shaft portion has a length on the order of .180 to .360 inches, and wherein said distal end is substantially flat.
21. A bone anchor for securing a suture to a bone and having a longitudinal axis, comprising:
a head including a dome portion having a tunnel for receiving a suture; and a shaft portion extending from said head portion to a distal end, said shaft portion including a plurality of tine segments each having an upper surface disposed in a plane substantially perpendicular to said longitudinal axis, and a plurality of grooves extending along said shaft portion and dividing each of said plurality of tine segments into a plurality of tines;
wherein each of said tines comprises said upper surface substantially perpendicular to said longitudinal axis, a frustroconical portion, and an arcuate junction defined by the intersection of said upper surface and said frustroconical portion, wherein the angle between said upper surface and said frustroconical portion for each of said tines increases along the length of said shaft from said head to said distal end.
22. The bone anchor of claim 21 wherein the distance from said longitudinal axis to said arcuate junction for each of said plurality of tines decreases along the length of said shaft portion from said head to said distal end.
23. The bone anchor of claim 21 further including a flathead portion between said dome portion and said shaft portion, said flathead portion being integrally connected to said dome portion and having a diameter larger than the diameter of said shaft portion for impeding axial migration of said bone anchor into said bone.
24. The bone anchor of claim 23 wherein said flathead portion includes a substantially flat, annular undersurface, a substantially flat, annular upper surface, and a circumferential land and wherein a first beveled surface joins said circumferential land and said upper surface and a second beveled surface joins said circumferential land and said undersurface.
25. The bone anchor of claim 24 wherein said tunnel of said dome portion has at least two openings, said at least two openings intersecting in said head at said longitudinal axis so as to form an angle in the range of 120 to 170 degrees.
26. The bone anchor of claim 25 wherein said plurality of grooves extending along said shaft portion have a semicircular configuration.
CA002183984A 1994-02-23 1995-02-23 Apparatus for attaching soft tissue to bone Expired - Fee Related CA2183984C (en)

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US08/200,163 US5522843A (en) 1994-02-23 1994-02-23 Apparatus for attaching soft tissue to bone
US08/200,163 1994-02-23
PCT/US1995/002401 WO1995022930A1 (en) 1994-02-23 1995-02-23 Apparatus for attaching soft tissue to bone

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US5720766A (en) 1998-02-24
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US5522843A (en) 1996-06-04
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CA2183984A1 (en) 1995-08-31
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MX9603624A (en) 1997-04-30
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