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WO2001034036A1 - Dispositif d'ancrage articule et outil pour l'introduire - Google Patents

Dispositif d'ancrage articule et outil pour l'introduire Download PDF

Info

Publication number
WO2001034036A1
WO2001034036A1 PCT/US2000/030745 US0030745W WO0134036A1 WO 2001034036 A1 WO2001034036 A1 WO 2001034036A1 US 0030745 W US0030745 W US 0030745W WO 0134036 A1 WO0134036 A1 WO 0134036A1
Authority
WO
WIPO (PCT)
Prior art keywords
anchor
anchor member
insertion tool
site
longitudinal axis
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.)
Ceased
Application number
PCT/US2000/030745
Other languages
English (en)
Inventor
Lehmann K. Li
Ernie Corrao
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.)
Linvatec Corp
Li Medical Technologies Inc
Original Assignee
Linvatec Corp
Li Medical Technologies Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Linvatec Corp, Li Medical Technologies Inc filed Critical Linvatec Corp
Priority to CA002389063A priority Critical patent/CA2389063C/fr
Priority to EP00978438A priority patent/EP1229840A4/fr
Priority to AU15903/01A priority patent/AU781140B2/en
Priority to JP2001536049A priority patent/JP2003513695A/ja
Publication of WO2001034036A1 publication Critical patent/WO2001034036A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0406—Pledgets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409—Instruments for applying suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0414—Suture 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0417—T-fasteners

Definitions

  • the present invention is relates to fixation devices or anchors and tools and methods for emplacing the same.
  • the present invention in particular, relates to medical anchors, for example, suture anchors or prosthesis anchors.
  • the invention further relates to a method and apparatus for implanting such devices in biological materials, for example bone.
  • the present invention relates to a medical anchor which can be inserted through a longitudinally or even curved extending bore hole so that the anchor is initially substantially aligned with the bore hole, and then, the emplacement tool manipulated so that the anchor pivots to form an undercut in the bore hole.
  • the present invention is particularly suitable for the emplacement of anchors adapted to repair ligaments, for example rotator cuff ligaments, interior cruciate ligaments (ACL's) and other ligaments.
  • the anchor is also suitable for prosthesis fixation.
  • U.S. Patent No. 6,117,161 a medical anchor is disclosed which can be emplaced in a groove which extends substantially parallel to the surface of the bone and then rotated along an axis defined by an employment tool and which axis is perpendicular to the extent of the groove to form an undercut in the walls of the groove to secure the anchor.
  • a medical anchor which can be emplaced in a borehole so that the anchor is initially substantially aligned with the borehole and then, via an emplacement tool, manipulated so the anchor pivots in two axes to form an undercut in the borehole.
  • a medical anchor which can be emplaced in a bore hole so that the anchor is initially substantially aligned with the bore hole and then, using an emplacement tool, rotated about the axis of the tool.
  • a deploy spring causes the anchor to deploy and rotate about an axis perpendicular to the axis of the tool to initially engage the borehole. Further rotation of the tool causes the anchor to cut into the borehole. The rotation by the user and action of the spring causes the anchor to screw into the borehole as it turns on two axes.
  • a further object of the invention is provide a method and apparatus for emplacing an anchor into a borehole in substantial alignment with the bore hole and once inserted, activated simply so that it engages with the walls of the borehole by moving to a position substantially at an angle (up to a perpendicular angle) to the borehole.
  • Such an anchor would be suitable, for example, to repair rotator cuff and other ligament injuries such that the appropriate attachment strength is provided.
  • the present invention comprises an apparatus and method for delivering an anchor member which sets in biological tissue.
  • the apparatus and method for delivering the anchor member into biological tissue comprises the following basic steps:
  • Steps (a)-(c) may be performed through open or minimally invasive surgical techniques.
  • the anchor is caused to rotate by a simple, non-rotational motion of the emplacement tool.
  • the insertion hole may e a pre-made borehole or may be an aperture formed by the anchor member or the emplacement tool during the step of inserting.
  • Figs. 1A, B, C, D and E show steps in the insertion of an anchor according to a first embodiment of the invention
  • Figs. 2A and B shows steps in insertion of a second embodiment of an anchor according to the present invention
  • FIG. 3 A, B, C, D and E show steps in the insertion of a third embodiment of an anchor according to the invention
  • Fig. 4 is an isometric view of the anchor according to the third embodiment
  • Fig. 5 is a side view of the anchor according to the third embodiment.
  • Fig. 6 is a top view of the anchor according to the third embodiment prior to deployment
  • Fig. 7 is a top view of the anchor according to the third embodiment during deployment ;
  • Fig. 8 A, B, C, D and E are progressive views of the anchor viewed proximally along the bone hole axis showing the anchor during different stages of deployment;
  • Figs. 9, 10 and 11 shows details of the distal end of a tool for installing the anchor according to the third embodiment in a pre-deploy, mid-deploy and full deploy positions, respectively.
  • FIGS. 1 A, B, C, D and E show an apparatus comprising the distal end 10 of an insertion tool 10', either disposable or reusable, with an anchor 20 attached thereon and inserted into a predrilled bone hole
  • the anchor 20 is flipped outwardly by the biasing force of a push member 22 (Fig. IB) until the anchor reaches an approximately perpendicular position relative to the bone hole, as shown in Figs. ID and IE.
  • Push member 22 can be driven by another member that is actuated at a proximally located handle of the tool 10'.
  • the push member 22 may be a spring-like member.
  • the member 22 has a spring characteristic, as shown in Fig. ID, allowing the member to deflect when the tool is withdrawn.
  • the tool 22 can also be a spring member whose spring provided biasing force causes the initial outward rotation of the anchor 20.
  • the tool 10' is thereafter removed, as shown in Fig. IE, leaving the anchor 20 in position, as shown, approximately aligned perpendicular to the axis of the tool 10' and borehole, with suture 24 looped around an internal passage or passages of the anchor.
  • the anchor has been set initially by the force of the pusher member 22.
  • the pusher member is released by a suitable actuating force (e.g. depressing a button on tool 10'). No rotation of the tool was required to set the anchor. See Figs. 1 A, B, C and D.
  • the pusher member 22 is activated to flip the proximal end 23 of the anchor outwardly into the wall of the bone hole.
  • Distal end 23 A likewise penetrates into the bone hole as the anchor 20 rotates about axle 26.
  • Edges 28 and 29 of the anchor 20 are provided with sharp edges to facilitate penetration into the bone hole.
  • the anchor is separated from the insertion tool, leaving a secured anchor and suture 24 with which to reattach soft tissue. See Fig. IE.
  • the anchor 20 can be separated from the tool by causing forked distal end
  • axle 26 can be made of two spring biased sections that move oppositely horizontally in the pivot holes under bias of a tension spring, allowing the tool to be removed.
  • the tool and anchor can be caused to separate automatically upon exertion of a predefined withdrawal force, such as by providing a frangible or breakable connection between tool and anchor that ruptures upon application of a predefined withdrawal force.
  • Figs. 2A and B show a multi-piece anchor 30 in a bone hole in a predeployed state (Fig. 2A) and post deployed state (Fig. 2B).
  • the anchor 30 is positioned in the bone hole and then actively deployed such that the proximal tips 32 and 33 of the anchor 30 are pushed outwardly and penetrate into the bone as the anchor is pulled proximally.
  • the anchor 30 has two elements 30A and 30B disposed on a common shaft 34. The two elements are pushed by a pusher member (not shown) or by a spring like member (not shown) to cause the elements to pivot about the shaft and cut into the bore hole. Each member has a sharp edge 32', 33' to allow it to cut into the borehole.
  • the anchor is made from multiple parts as shown.
  • This anchor 30 is intended to be attached to the distal end of an insertion tool which is not shown in the figures.
  • a distally directed force is applied to the proximal ends of the anchor to bias the sharp edges 32' and 33' to engage into the wall of the bone hole.
  • the edges of the proximal ends 32 and 33 of the anchor will penetrate the bone walls and move the anchor members to an angle distinct from the axis of the bore hole. See Fig. 2B.
  • Suture strands are connected to the anchor at or near the pivot point 34 of the anchor with which soft tissue can be attached to the bone.
  • Figs. 3 A, B, C, D and E show stages of deployment of another embodiment of the anchor of the invention.
  • the anchor itself is shown in Figs. 4to 7 and is formed approximately by slicing a cylinder in two parallel planes which are set at an angle to the long axis of the cylinder.
  • this anchor 50 is formed approximately by slicing a portion of a cylinder along two parallel planes at an angle to the axis 51 of the cylinder, thereby forming surfaces having sharp edges 52 and 53.
  • the cylinder section thus formed is provided with a center hub portion 55 having openings 57 and 58 surrounding the central hub portion.
  • a suture 24 is threaded through the openings and around the hub portion 55.
  • Figs. 4to 7 shows stages of deployment of another embodiment of the anchor of the invention.
  • the anchor itself is shown in Figs. 4to 7 and is formed approximately by slicing a cylinder in two parallel planes which are set at an angle to the long axis of the cylinder
  • a pusher member 60 is disposed in a cylinder 70 of the insertion tool 10; shown only schematically.
  • the anchor is initially disposed at the distal end of the cylinder 70, inside a portion 74 of cylinder 70 of decreased wall thickness.
  • Sutures 24 are wrapped around the center hub 55 of the anchor as shown.
  • the pusher member 60 pushes the anchor 50 out of the cylinder 70 into the bore hole.
  • the pusher member 60 causes the anchor to pivot about its center.
  • the pusher member 60 may have a rounded end 62.
  • the anchor Upon further movement of the pusher member, the anchor attains the position shown in Fig. 3C, which is adequate deployment.
  • the insertion tool 10' is removed as shown in Fig. 3D, and an upward tug can optionally be provided to the sutures to ensure that the anchor is secured as shown in Fig. 3E.
  • Such tugging is only optional and is a good check to ensure that the anchor is secure. It may further cause some additional rotation of the anchor, as shown in Fig. 3E, although such further rotation is not required.
  • the anchor is adequately set in the position shown in Fig. 3D.
  • An advantage of this design is that the anchor 50 is not attached to the tool, so that separation occurs simply upon withdrawal of the tool.
  • Figs. 4, 5, 6 and 7 shows various views of the anchor.
  • Fig. 4 shows an isometric view.
  • Fig. 5 shows a side view.
  • Fig. 6 shows a top view of the anchor as it is disposed in the cylinder prior to deployment and
  • Fig. 7 shows the anchor in a top view after full deployment.
  • Figs. 8A, B, C, D and E correspond to Figs. 3 A, B, C, D and E and show the anchor in the various stages of deployment, viewed from a proximal location.
  • Fig. 9 shows the anchor 50 according to the third embodiment and the preferred embodiment of the distal end of a tool for deploying the anchor 50.
  • the distal end of the tool includes an outer tube 70' and an inner tube 60'.
  • Tube 60' functions as a pusher member.
  • the inner tube 60' has an end 64 which is formed at an angle to conform to the angled surface of the anchor 50.
  • the suture 24 is looped around the center hub 55 of the anchor 50.
  • the outer tube 70' has a stop shoulder 72 and at the distal end having a reduced diameter portion 74.
  • the stop shoulder 72 functions as a stop for limiting movement of the outer tube 70' into the borehole in the bone surface indicated at 90. Once the stop shoulder 72 is seated on the bone surface 90, as shown in Fig.
  • the pusher member 60' is moved in the direction of arrow 68 and the anchor is pushed into the borehole, shown at 40.
  • the anchor 50 is still maintained in the same orientation due to its abutting against the reduced diameter portion 74 and the angled end 64 of pusher member 60'.
  • the anchor member of the embodiments shown may be shaped as a disk, oval, blade, kidney, be pointed, polygonal, or have any symmetrical or asymmetrical geometrical shape or be a solid or have fenestrations.
  • the anchor member may have sha ⁇ edges, points, protrusions, cut outs, curves or other defining features.
  • the anchor member may be two dimensional or three dimensional.
  • the anchor member may be made from metal, a polymer, a bioabsorbable material, bone, or any other biocompatible material. To insert the anchor, a hole in the bone may or may not need to be pre-made or pre-drilled, depending on the sha ⁇ ness of the leading point of the anchor or tool, or whether there may be cutting surfaces, such as threads, on the anchor.
  • the insertion tool may be designed for a single use, i.e., disposable, or as a reusable instrument. Also, the insertion tool may be designed for open or minimally invasive surgery.
  • the activation element to initiate the outward bias of the anchor may be a spring, lever, rod or any other suitable design element. Near the distal end of the insertion tool may be a shoulder stop to indicate the maximum depth of anchor insertion into biological tissue for more precise and reliable engagement of the anchor.
  • the anchor and insertion tool assembly may be provided as a single use device, in which case, it can be made with simplicity and provides convenience.
  • the anchor is set by simple motions, i.e., vertical insertion of the tool, depression of a button or other member to activate the biasing spring 22 and/or withdrawal of the tool. Rotation of the tool is not necessary to set the anchor.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Rheumatology (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un procédé servant à poser un élément d'ancrage (20) dans un tissu biologique consistant à: accéder d'abord au site d'introduction et le préparer pour l'élément d'ancrage (20); maintenir l'élément d'ancrage (20) à une extrémité distale (10) de l'outil d'introduction (10'); poser ensuite l'élément d'ancrage (20) dans le site au moyen de l'outil d'introduction (10'); puis amener l'élément d'ancrage à tourner (20) autour du premier axe perpendiculaire à l'axe longitudinal de l'outil d'introduction (10'), de sorte que l'élément d'ancrage (20) pénètre dans le tissu du site prévu en tournant autour du premier axe, d'une première position sensiblement alignée avec l'axe longitudinal à une seconde position à un angle relatif à l'axe longitudinal; et enfin, retirer l'outil d'introduction (10') du site en question, en y laissant l'élément d'ancrage (20) fixé.
PCT/US2000/030745 1999-11-11 2000-11-10 Dispositif d'ancrage articule et outil pour l'introduire Ceased WO2001034036A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CA002389063A CA2389063C (fr) 1999-11-11 2000-11-10 Dispositif d'ancrage articule et outil pour l'introduire
EP00978438A EP1229840A4 (fr) 1999-11-11 2000-11-10 Dispositif d'ancrage articule et outil pour l'introduire
AU15903/01A AU781140B2 (en) 1999-11-11 2000-11-10 Toggle anchor and tool for insertion thereof
JP2001536049A JP2003513695A (ja) 1999-11-11 2000-11-10 トグルアンカーおよびそれを挿入するツール

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US16489899P 1999-11-11 1999-11-11
US60/164,898 1999-11-11
US18889400P 2000-03-14 2000-03-14
US60/188,894 2000-03-14

Publications (1)

Publication Number Publication Date
WO2001034036A1 true WO2001034036A1 (fr) 2001-05-17

Family

ID=26860963

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2000/030745 Ceased WO2001034036A1 (fr) 1999-11-11 2000-11-10 Dispositif d'ancrage articule et outil pour l'introduire

Country Status (6)

Country Link
EP (1) EP1229840A4 (fr)
JP (1) JP2003513695A (fr)
AU (1) AU781140B2 (fr)
CA (1) CA2389063C (fr)
TW (1) TW477686B (fr)
WO (1) WO2001034036A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003061530A1 (fr) * 2002-01-16 2003-07-31 Smith & Nephew Instrument servant a inserer un element d'ancrage de suture dans un tissu
US20140257380A1 (en) * 1999-08-09 2014-09-11 Bonutti Skeletal Innovations Llc Method of connecting body tissue to a bone
US8845699B2 (en) 1999-08-09 2014-09-30 Bonutti Skeletal Innovations Llc Method of securing tissue
US8845687B2 (en) 1996-08-19 2014-09-30 Bonutti Skeletal Innovations Llc Anchor for securing a suture
WO2024076686A1 (fr) * 2022-10-06 2024-04-11 INTERNATIONAL LIFE SCIENCES, LLC d/b/a ARTELON Ancrages chirurgicaux, instrumentation et procédés d'utilisation

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6959851B2 (en) * 2003-07-16 2005-11-01 Tyco Healthcare Group Lp Surgical stapling device with tissue tensioner
JP6829847B2 (ja) * 2019-06-06 2021-02-17 株式会社プロメット アンカー

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5269809A (en) * 1990-07-02 1993-12-14 American Cyanamid Company Locking mechanism for use with a slotted suture anchor
US5522846A (en) * 1993-05-14 1996-06-04 Bonutti; Peter M. Suture anchor
US5845645A (en) * 1993-05-14 1998-12-08 Bonutti; Peter M. Method of anchoring a suture
US6102934A (en) * 1998-06-02 2000-08-15 Li; Lehmann K. Anchor tool and method and apparatus for emplacing anchor in a borehole

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5203787A (en) * 1990-11-19 1993-04-20 Biomet, Inc. Suture retaining arrangement
US6660022B1 (en) * 1999-06-01 2003-12-09 Smith & Nephew, Inc. Rotor blade anchor and tool for installing same

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5269809A (en) * 1990-07-02 1993-12-14 American Cyanamid Company Locking mechanism for use with a slotted suture anchor
US5522846A (en) * 1993-05-14 1996-06-04 Bonutti; Peter M. Suture anchor
US5845645A (en) * 1993-05-14 1998-12-08 Bonutti; Peter M. Method of anchoring a suture
US6102934A (en) * 1998-06-02 2000-08-15 Li; Lehmann K. Anchor tool and method and apparatus for emplacing anchor in a borehole

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP1229840A4 *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8845687B2 (en) 1996-08-19 2014-09-30 Bonutti Skeletal Innovations Llc Anchor for securing a suture
US20140257380A1 (en) * 1999-08-09 2014-09-11 Bonutti Skeletal Innovations Llc Method of connecting body tissue to a bone
US8845699B2 (en) 1999-08-09 2014-09-30 Bonutti Skeletal Innovations Llc Method of securing tissue
WO2003061530A1 (fr) * 2002-01-16 2003-07-31 Smith & Nephew Instrument servant a inserer un element d'ancrage de suture dans un tissu
WO2024076686A1 (fr) * 2022-10-06 2024-04-11 INTERNATIONAL LIFE SCIENCES, LLC d/b/a ARTELON Ancrages chirurgicaux, instrumentation et procédés d'utilisation

Also Published As

Publication number Publication date
JP2003513695A (ja) 2003-04-15
AU781140B2 (en) 2005-05-05
EP1229840A1 (fr) 2002-08-14
AU1590301A (en) 2001-06-06
TW477686B (en) 2002-03-01
CA2389063C (fr) 2008-01-29
EP1229840A4 (fr) 2009-03-25
CA2389063A1 (fr) 2001-05-17

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