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WO1999003403A1 - Coin permettant de fixer des tissus sur un os - Google Patents

Coin permettant de fixer des tissus sur un os Download PDF

Info

Publication number
WO1999003403A1
WO1999003403A1 PCT/US1998/014847 US9814847W WO9903403A1 WO 1999003403 A1 WO1999003403 A1 WO 1999003403A1 US 9814847 W US9814847 W US 9814847W WO 9903403 A1 WO9903403 A1 WO 9903403A1
Authority
WO
WIPO (PCT)
Prior art keywords
wedge
bone
rectilinear slot
tissue
proximal top
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/US1998/014847
Other languages
English (en)
Other versions
WO1999003403A8 (fr
Inventor
R. Thomas Grotz
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to AU84953/98A priority Critical patent/AU8495398A/en
Publication of WO1999003403A1 publication Critical patent/WO1999003403A1/fr
Publication of WO1999003403A8 publication Critical patent/WO1999003403A8/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
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • 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
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0642—Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
    • 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
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0647—Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments

Definitions

  • This invention relates to the fastening of tissue to bone, such as a Bankart lesion of the shoulder. More particularly, a biocompatible wedge is disclosed, together with the method of use, and the resultant joint after surgery.
  • suture anchors have commonly been utilized. These anchors are generally known, such as the Mitek SUPERANCHOR sold by the Mitek Company of Westwood, Massachusetts, a subsidiary of Johnson and Johnson. These anchors have as their principal object the fastening of a suture to the bone. Once the anchor is in place, the suture is either threaded around or through the tissue to be fastened to the bone. This suture must hold flesh to the bone for a sufficient period of time for healing to occur.
  • a stabilizer device for insertion to a hole in bone that both fastens tissue to the bone and forms a suture anchor.
  • a central body extending along a longitudinal axis forms a hollow core having laterally positioned distal and proximal faces.
  • Bone anchors extend outwardly from the device and are barb-shaped so as to permit anchoring to bone upon expansion of the device.
  • a central plug fastened within the hollow core of the invention. Once the device is inserted within a predrilled hole in bone, the central plug expands the bone anchors, firmly anchoring the device to bone.
  • tissue to be fastened to the bone is literally skewered at the end of the anchor.
  • the tissue is then fastened with the stabilizer interior of the predrilled hole.
  • the device can be used alone for the anchoring of tissue to bone or, alternatively, sutures anchored by the device can be used in conjunction with the skewered and fastened tissue.
  • this material can be made from biodegradable material.
  • This device is punctate in its fastening of tissue to bone. That is to say, where tissue separates from bone, such as a Bankart's lesion in the glenoid labrum that is formed in the classical human shoulder separation, multiple stabilizers must be used in side-by-side relation to effect surgical repair. Each stabilizer forms a point of attachment of the tissue to the bone. Tissue between fasteners must be anchored by sutures. Even then, a series of fastening points are made with spatial separations therebetween. Accordingly, in the following disclosure I adapt the principles of skewered fastening in bone to the continuous fastening of tissue to bone.
  • a wedge for insertion into a rectilinear slot in bone fastens tissue for continuous refastening of separated tissue from bone.
  • the wedge when directed toward the elongate rectilinear slot and viewed in side section has a distal apex of about 0.5 mm, a proximal truncated top of about 2.0 mm, and a continuous or stepped taper extending therebetween.
  • the wedge when viewed in the plane of the rectilinear slot includes a dimension of about 8 mm from the apex to the truncated top and is about 1 cm in length.
  • the wedge When viewed in plan toward the proximal truncated top, the wedge is sinusoidal in shape defining a series of prominences and depressions relative to the elongate slot analogous to a corrugation nail.
  • suture fastening apertures - preferably elongate parallel to the proximal end - are placed for looping tissue fastening sutures prior to wedge insertion.
  • a plurality of barbs - preferably placed at the prominence - together with the compression of the wedge within a rectilinear slot cause anchoring to bone upon wedge insertion to the rectilinear slot prepared within the bone.
  • Skewering tips at the end of the wedge enable skewered tissue to be entrained with the wedge into the bone upon insertion of the wedge within a previously prepared rectilinear slot in the bone.
  • anchoring bone is exposed and a rectilinear slot is cut having a width in the order of 1.0 mm, a depth in the order of 8 mm, and an elongate length sufficient to accommodate side-by-side all wedges that are to be used.
  • the wedge is mounted to an inserting probe and any optional sutures organized along the length of the probe.
  • flesh to be inserted is conventionally "teased" onto the skewering tips and the wedge (s) inserted utilizing the probe.
  • Fastening of the tissue entrained by the wedge within the elongate slot occurs by action of the skewers together with wedge compression of the entrained tissue at the prominences of the wedge.
  • flesh to be reattached to the bone can optimally vascularize at the defined depressions between the wedge and rectilinear slot in the bone.
  • Fig. 1 A is a front elevation illustrating the wedge with protruding barbs, bottom skewers, and elongate suture holding apertures
  • Fig. IB is a side elevation illustrating the wedge shaped cross-section with the barbs in profile for holding the wedge to bone
  • Fig. 1C is a top plan view of the wedge illustrating the slight sinusoidal configuration defining alternating prominences and depressions with barbs at the prominences for keying the wedge to bone;
  • Figs. 2 A and 2B are perspective views of the wedge;
  • Fig. 3 is a perspective view of one wedge fully inserted within the insertion slot, skewering and wedging tissue into place with an optional suture protruding from the slot with an inserter and a second wedge overlying the same previously prepared insertion slot having teased and skewered tissue impaled as the second wedge is about to be inserted into the slot; and
  • Fig. 4 is a plan view of two wedges holding separated and broken bone into apposition for healing. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to Figs. 1 A-1C, wedge W is shown. Wedge W includes proximal top T, distal bottom B, with wedge W defining continuous taper 14 therebetween (see Fig. IB). In a dimension capable of being utilized on the average adult human, wedge W is 1 cm side to side (see Fig. 1 A), 8 mm top to bottom (see again Fig. 1A), 0.5 mm at distal bottom B, and 2 mm at proximal top T.
  • wedge W when entered into a previously prepared slot in bone, wedge itself into engagement with the bone.
  • Three factors assist such wedging.
  • wedge W defines continuous taper 14 from distal bottom B to proximal top T. Providing that the prepared slot in bone has a dimension less than wedge W at proximal top T, wedging of wedge W into bone will occur.
  • wedge W at proximal top T is given a curved profile so as to define prominences P and depressions D.
  • barbs R are located and typically have a triangular shape with barb apex 18 adjacent distal bottom B and barb truncated prominence 20 towards proximal top T.
  • section 22 of barbs R increases with taper 24 from the proximal to the distal portion of wedge W.
  • wedge W has skewers S adjacent and defined in distal bottom B.
  • Skewers S are here shown defined within distal bottom B by round cuts 32. These leave skewer points 30 for impaling tissue with rounded flats 32 therebetween to contain and compress gathered tissue. It will be understood that skewer points 30 thus impale but do not cut tissue and enable impaled tissue to be entrained with the wedge into a previously prepared bone slot. It will be understood that depressions D serve a serendipitous function.
  • wedge W the purpose of wedge W is to enable impaled tissue to reattach to bone.
  • Depressions D define a spatial interval between a previously prepared bone slot and wedge W. In this area, vascularization readily occurs with reattachment through bone/tissue growth rapidly occurring.
  • suture apertures 33 are preferably provided. These suture apertures 33 are preferably oblong parallel to proximal top T. Sutures are conventionally threaded through such apertures. It is important to note that unlike the case of the conventional suture anchor, sutures here are optional - and not required. Indeed it is a preferred use of the disclosed apparatus that sutures can be omitted entirely.
  • Wedge W can be made of biocompatible or physiologically inert materials.
  • Such materials include titanium and its alloys, stainless steel, and cobalt-based alloys or plastics.
  • Bioabsorbable materials are preferred. These include aliphatic polyesters of alpha-hydroxy acid derivatives as described in Rokkanen, P.V. (1991) "Absorbable
  • Figs. 3 and 4. The reader will understand that preferred surgical techniques here utilized are through arthroscopic surgical techniques. In the description that follows, it will first be assumed that such arthroscopic techniques have "exposed" bone and flesh to be fastened. Thereafter, and for the operating orthopedic doctor, a verbal description will be given of a shoulder repair utilizing the apparatus and method of this invention. For simplicity, elaborate illustration of the surgical technique will not be provided. Referring to Fig. 3 and providing an oversimplified explanation, a perspective schematic view of a shoulder operation underway is illustrated. Glenoid cup
  • Inserter I has a dimension for introduction by trocar. It includes folded U- shaped ends E trapping wedge W therebetween. Proximal top T with its sinusoidal profile 26 abuts wedge driving end 36. As shown, suture 38 may optionally be both "organized" to inserter I as well as assist in maintaining wedge W to inserter I. Such holding of suture 38 can occur either at notches within inserter I or by wrappings about inserter I such as an elastic rubber ring (neither shown). Inserter I is utilized to "tease" tissue to be skewered onto skewers S at distal bottom B of wedge W. Thereafter, wedge W is inserted to slot L entraining tissue to be fastened to the bone.
  • this wedge W can be used for holding separated or broken bones in apposition.
  • Two wedges Wi and W 2 are each illustrated placed across fracture U in the single bone illustrated. In this case, slot L is cut substantially normal to the parting of the bone with the respective wedges causing apposition until healing.
  • wedge W should be prepared on inserter I so that it is properly fixed in an effort to avoid detachment. If sutures are desired, they should be placed by the surgeon selecting the suture of choice and the number of sutures intended for use. The inserter and the wedge should be placed on the operating table proximate to the wound area and kept sterile. Next, the incisions are made.
  • one of the usual arthroscopic wounds can be eliminated and the arthroscopic lateral wound is placed 1 cm posterior to the greater tuberosity of the humerus, 1 cm beneath the inferior acromion lateral cortex in the palpable "dent or divot" just behind the lateral aspect of the humeral head. That wound is made horizontally or perpendicular to the axis of the body a quarter inch in size and with the assistant surgeon distracting distally the arm.
  • a blunt trocar is entered posterior to the insertion of the supraspinatus tendon, i.e., the rotator cuff on the greater tuberosity, and it is directed toward the anterior rim of the glenoid, thus entering the shoulder with the 3M trocar and its blunt trocar directional device.
  • the anterior wound is made a half inch in length also perpendicular to the axis of the body or horizontal, and it is located medial to the biceps tendon slightly lateral to the anterior gleno-humeral joint line 1 cm inferior to the inferior acromion.
  • the second wound is the anterior one-half inch wound, the larger of the two wounds, and it is made just lateral to the gleno-humeral joint 1 or 2 cm beneath the inferior cortex of the acromion.
  • the lateral smaller wound is for arthroscopic visualization for fluid ingress and egress if a 3M portal system is available. If the 3M portal system is not available, then a third wound must be made posteriorly along the gleno-humeral joint a centimeter or two beneath the inferior acromion a quarter inch in length horizontal and could be used for a 3M pump or other pump application to allow for egress and pressure measurement.
  • the anterior wound in any case is the working portal. It has the largest wound, one-half inch in length, and is entered with a blunt device including the cannula and center rounded trocar from the anterior shoulder skin toward the posterior back of the shoulder aiming for the gleno-humeral joint line.
  • the cannula most suited for this procedure is the Smith Nephew 1 cm diameter newly produced device.
  • the Smith Nephew blunt trocar is removed and synovitis or debris is removed as the joint is irrigated through the cannula. Careful inspection of the joint is then obtained by using a probe to determine the amount of separation of the glenoid labrum from the glenoid fossa per se.
  • the edge along the anterior glenoid rim is prepared by using the arthroscopic debrider, such as an ARTHROWAND device for tissue ablation, or and/or a burr to expose a linear superficial layer of exposed bone.
  • the arthroscopic debrider such as an ARTHROWAND device for tissue ablation, or and/or a burr to expose a linear superficial layer of exposed bone.
  • the purpose of this is to denude the cortex and create an adjacent superficial vascularity that will bring a small amount of bleeding bone to the foreground, thus allowing repair tissue perfusion with oxygen and nutrients once the tissue repair is complete.
  • the lesion is studied as regards its length and the type of repair necessary is determined. If the lesion is 1 cm or greater, the wedge application would be appropriate. Instead of drilling a hole, as one would do conventionally, an oscillating saw or similarly functioning device made for this purpose is passed through the cannula from the anterior to posterior, through the anterior shoulder wound and preplaced cannula, and it is directed aligned longitudinally with the avulsion site of origin over the prepared bone and a slot is made. The slot is made to cover the length of injury tissue and is approximately 1 mm wide and 8 mm deep.
  • the saw is removed and any additional debris removed and inspection is preformed again.
  • the wedge is then introduced and lined up parallel with the segment of avulsed tissue to be reconnected. It enters that tissue and approaches it with the skewers S necessarily angulated in such a manner so as to be able to skewer the tissue from anterior and direct it posteriorly toward and ultimately into the base of the slot.
  • the wedge is next impacted on its proximal end (towards the surgeon) until the wider surface of the wedge is flush with the surface of the prepared bone.
  • the inserter is released from the wedge and the optional sutures are used if desired to engage any additional necessary tissue repair or reefing of a patchulous joint. This is done with the routine suture passing equipment and according to the technique chosen by the primary surgeon. Thereafter, withdrawal of cannulae and closure of all wounds occurs with the surgery essentially being complete.
  • wedges W shown herein can be as much as 3 cm of width and 1 cm of depth, or for the rotator cuff attaching tendon to bone, a wedge 2 cm wide and 1 cm in depth may be used.
  • tissue in describing the fastening of flesh or biocompatible synthetic material to bone.
  • the fastening of certain biocompatible materials to bone can work as well.
  • the illustrated slotting ofbone can be dispensed with.
  • a wedge with entrained tissue can force its own opening to the tissue into which fastening or refastening is to occur, such as in repairing longitudinal fibrocartilage tears.

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

Abstract

L'invention concerne un coin (W) destiné à être inséré dans une fente rectiligne (L) ménagée dans un os et permettant de fixer à nouveau, et en continu, des tissus séparés d'un os. Lorsqu'il est vu selon un plan coupant sa partie supérieure proximale tronquée (T), ce coin (W) présente une forme sinusoïdale définissant une série de saillies (P) et de creux (D) par rapport à la fente allongée (L). Au niveau de l'extrémité proximale, se trouvent des orifices de fixation de points de suture, de préférence allongés et parallèles à l'extrémité proximale, destinés à permettre le passage des points de suture retenant des tissus avant l'introduction du coin (W). Une série de pointes (R), situées de préférence au niveau des saillies (P), et la compression du coin (W) au sein d'une fente rectiligne (L), provoquent l'ancrage à l'os après introduction de ce coin (W) dans la fente rectiligne (L) ménagée au sein de l'os. Des têtes de fixation, situées au niveau de l'extrémité du coin (W) permettent aux tissus qu'elles fixent d'être entraînés avec ce coin (W) au sein de l'os et ce, après insertion du coin (W) à l'intérieur d'une fente rectiligne (L) préalablement ménagée dans l'os.
PCT/US1998/014847 1997-07-18 1998-07-18 Coin permettant de fixer des tissus sur un os Ceased WO1999003403A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU84953/98A AU8495398A (en) 1997-07-18 1998-07-18 Wedge for fastening tissue to bone

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US5304497P 1997-07-18 1997-07-18
US60/053,044 1997-07-18

Publications (2)

Publication Number Publication Date
WO1999003403A1 true WO1999003403A1 (fr) 1999-01-28
WO1999003403A8 WO1999003403A8 (fr) 1999-04-29

Family

ID=21981574

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1998/014847 Ceased WO1999003403A1 (fr) 1997-07-18 1998-07-18 Coin permettant de fixer des tissus sur un os

Country Status (2)

Country Link
AU (1) AU8495398A (fr)
WO (1) WO1999003403A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5690649A (en) * 1995-12-05 1997-11-25 Li Medical Technologies, Inc. Anchor and anchor installation tool and method
US5797932A (en) * 1995-11-24 1998-08-25 Jong-Deok Park Muscle clamping device

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5797932A (en) * 1995-11-24 1998-08-25 Jong-Deok Park Muscle clamping device
US5690649A (en) * 1995-12-05 1997-11-25 Li Medical Technologies, Inc. Anchor and anchor installation tool and method

Also Published As

Publication number Publication date
AU8495398A (en) 1999-02-10
WO1999003403A8 (fr) 1999-04-29

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