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WO1990000370A1 - Agrafe pour os - Google Patents

Agrafe pour os Download PDF

Info

Publication number
WO1990000370A1
WO1990000370A1 PCT/GB1989/000750 GB8900750W WO9000370A1 WO 1990000370 A1 WO1990000370 A1 WO 1990000370A1 GB 8900750 W GB8900750 W GB 8900750W WO 9000370 A1 WO9000370 A1 WO 9000370A1
Authority
WO
WIPO (PCT)
Prior art keywords
staple
legs
bone
securing means
cross member
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/GB1989/000750
Other languages
English (en)
Inventor
Malcom Irving Ellis
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.)
MIE MEDICAL RESEARCH Ltd
Original Assignee
MIE MEDICAL RESEARCH Ltd
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 MIE MEDICAL RESEARCH Ltd filed Critical MIE MEDICAL RESEARCH Ltd
Publication of WO1990000370A1 publication Critical patent/WO1990000370A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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
    • A61F2002/0817—Structure of the anchor
    • A61F2002/0823—Modular anchors comprising a plurality of separate parts
    • A61F2002/0829—Modular anchors comprising a plurality of separate parts without deformation of anchor parts, e.g. fixation screws on bone surface, extending barbs, cams, butterflies, spring-loaded pins
    • 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
    • A61F2002/0847—Mode of fixation of anchor to tendon or ligament
    • A61F2002/0852—Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes
    • 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
    • A61F2002/0847—Mode of fixation of anchor to tendon or ligament
    • A61F2002/0864—Fixation of tendon or ligament between anchor elements, e.g. by additional screws in the anchor, anchor crimped around tendon
    • 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
    • A61F2002/0876—Position of anchor in respect to the bone
    • A61F2002/0888—Anchor in or on a blind hole or on the bone surface without formation of a tunnel

Definitions

  • This invention relates to the bone staple, particularly but no exclusively to the kind used for securing a natural o artificial ligament to a bone.
  • an artificial ligament is secured t the bone adjacent the joint by means of a simple U shape staple, the legs of the staple being driven into the bone an the ligament end being trapped between the bone and the head o the staple. It is important that the ligament is securely hel until tissue ingrowth can occur.
  • Incapacitation of a patient fo several weeks, for example by means of a plaster cast not onl restricts normal activity but may also lead to a significan loss of muscle bulk, increasing the rehabilitation period of th patient.
  • conventional staples suffer from th disadvantage that they become loose after a short period of time. Bone tissue does not regenerate in regions of high mechanica stress, with the result that the staple can work loose quickly, releasing the ligament.
  • EP33641 illustrates th disadvantages of the prior art. Disposition of the cuttin points of the staple legs at the outer side of the staple, tend to cause the legs to separate as the staple is driven home. Since the tissue retention element does not incorporat apertures surrounding the legs, it can become loose once the legs move apart. Moreover the retaining element would lose it efficacy once the staple has loosened from the bone. A further disadvantage is that the retaining member cannot engage the transverse arm on account of the radiused juction between the latter and the legs.
  • a bone staple comprises at least two legs arranged in spaced relation and connected by a cross member, and securing means extending between said legs and adapted to be moveable in use between the first position wherein an article to be secured by the staple may be inserted between the cross member and securing means and the second positio adjacent to the cross member wherein said article is secure between said member and said means.
  • Th staple is preferably arranged to prevent free movement of th securing means from said second position.
  • the legs of the staple are preferably received in apertures i the securing means. This arrangement prevents release of th securing means if the legs of the staple separate for example b becoming splayed.
  • a dimension of a sai aperture is less than a corresponding dimension of the respectiv leg.
  • the diameter of a circular aperture may be les than the cross-sectional diameter of the leg in one or mor directions .
  • the leg is an interference fit within th aperture or is slightly oversized so that it must be deformed a it is hammered through it.
  • the legs ar rectangular, square or otherwise polygonal and the apertures an circular. Use of square legs is preferred since the faces of th legs may be barbed, corrugated or otherwise roughened to imped withdrawal from the bone, without decreasing the engagemen between the apices of the legs and the aperture walls.
  • the frictional engagement between the legs and the apertures i sufficient to lock the bar in a desired position to secure th ligament.
  • the friction can be overcome by sharp blows t the cross member as it is being driven home, so that the bar wil gradually move along the legs of the cross member until i reaches the second position.
  • the legs of the staple and surface of the apertures may be serrated to allow relative movement i one direction but to resist movement in the other direction.
  • the securing means ar arranged to engage the cross member along the entire lengt thereof.
  • the cross member and securing means ma have linear abutting surfaces, the junction between the legs an cross member being sharply perpendicular.
  • the distance between the apertures is preferbly greater than th distance between the legs, further enhancing the frictiona engagement between these two components.
  • the components of the staple are preferably composed of identica materials, to avoid any electrolytic interaction in the presenc of physiological fluids.
  • Figure 1 illustrates a bone staple in accordance with thi invention
  • Figure 2 is a section of XX of Figure 1 illustrating the stapl inserted into the bone
  • Figure 3 is a plan view of the staple
  • FIG. 4 illustrates an alternative staple
  • FIGS 5 to 7 illustrate installation of the staple.
  • the staple (1) comprises two legs (2, 3) arranged in space relation.
  • a cross member (4) extends between the ends of th legs to form the head of the staple. The ends of the legs remot from the head of the staple are centrally pointed (22. 23).
  • Th cross member (4) is straight and the junctions with the legs (2 3) are sharply perpendicular.
  • Securing means (5) extends betwee and engages the legs of the staple (2, 3).
  • the securing mean may take the form of a liner bar having apertures (6, 7 dimensioned to form a friction fit with the legs of the staple
  • the apertures (6, 7) are arranged with a dimension which is les than the corresponding dimension of the respective leg.
  • the staple legs ar square and the diameters of the apertures (6, 7) are less tha the diagonal widths of the square legs.
  • the legs may be rectangular triangular, hexagonal or otherwise shaped- Alternatively th legs may be circular, being disposed within square or otherwis polygonal apertures.
  • the relative dimensions of the aperture and legs are selected so that the securing member may be driv along the legs towards the head of the staple as the staple i driven into a bone.
  • the staple legs may be an interference fit may be barbed or otherwise serrated, being arranged to b deformed during passge through the apertures (6, 7).
  • the uppe surface (24) of the securing member and corresponding lowe surface (25) of the cross member are arranged to engage closel when the securing member is driven against the head of th staple. Both may be linear. Alternatively the surface (24) ma have a cylindrical indentation, arranged to receive a cylindrica cross member (4) .
  • a natural or artificial ligament (8) may b inserted between the legs (2, 3) , cross member (5) and head (4).
  • Driving of the staple into a bone causes the securing member (5) to pass up the legs of th staple towards the cross member (4).
  • the ligament (8) is the trapped between the securing member and cross member. Release o the ligament is prevented by frictional engagement of the member (4, 5). Loosening of the staple, for example in growth of th bone, does not release the ligament.
  • the ⁇ epartion between the apertures (6, 7) may be selected to b slightly less than the separation between the legs (2. 3), further enhancing the frictional engagement between thes components.
  • Figure 4 illustrates an alternative embodiment of the inventio which finds application in securing a looped end (10) of ligament.
  • the staple is provided with a third leg (11) whic extends substantially parallel to the legs (2, 3) but is muc shorter.
  • the third leg (11) may be located centrally between th legs (2, 3).
  • the securing member (5) is provided with a aperture (12) to receive the third leg (11).
  • two o more legs, spikes or other projections may extend between th securing member (5) and head of the staple (4).
  • Thes projections may extend from either of the latter components, apertures or recesses to receive them being provided in the other component .
  • the legs of the staple may be tapered, increasing in thickness towards the head of the staple. This has the advantage that the securing member may mo comparatively easily over the lower portions of the legs, b tightly engages the portions adjacent the head. resulting i secure attachment of the ligament.
  • a staple in accordance with this invention confers t advantage of the ease of use of a simple staple, but with t security of attachment of the ligament which may be achiev with a more complex arrangement.
  • the staple may be driven short distance into the bone, the ligament inserted undernea the securing means and the staple driven further into the bo with the ligament held under tension until it is trapped betwe the securing means and the bone. This affords a sufficie retaining force to maintain the tension in the ligament whi the latter is threaded between the securing means and cro menmber and the staple then completely driven into the bon The need for use of three hands (to hold the staple, ligame and hammer) is avoided.
  • FIGS 5 to 7 illustrate the method of use of the staple.
  • the staple having legs " (30), cross member (33) and securing mea (31) is first driven a short distance into the bone (35).
  • T ligament (32) may be threaded between the legs (30) , securi means (31) and bone (35) and maintained under tension while t staple is driven further into the bone as shown in Figure Trapping of the ligament between the securing means (31) and bo (35) maintains the tension in the ligament while the free end threaded between the securing means (31) and cross member (33
  • the staple may then be driven fully into the bone as shown Figure 7. This affords a secure attachment of the ligame bone.
  • a comparative test was carried out to evaluate the retention an artificial ligament by the staple driven into a piece wood- An In ⁇ tron tensile test instrument was used. T instrument was arranged to apply the set displacement of 0.5 mm per second for 5 seconds. Force-displacement figures were determined for each test.
  • a ligament secured to the wood by a conventional staple withstood a maximum tensile force of 220 Newtons before slippage occurred.
  • the staple in accordance with this invention was driven into the wood and was then prised out of the wood by 3 mm so that there was no compressive force on the ligament against the wood. This served to simulate loosening of the staple in use. A conventional staple would offer no retaining force under these conditions.
  • the staple of this invention resisted a maximum tensile force of 620 Newtons before slippage.
  • Typical forces acting on cruciate ligaments have been estimated at 200 to 500 Newtons.
  • a conventional staple does not therefore serve to retain the ligament even for normal walking.
  • the staple of the present invention affords an adequate retaining force, even if the staple has become loosened, for example during growth of the bone.

Landscapes

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

Abstract

Une agrafe pour os comporte deux branches parallèles (2, 3) reliées par un élément transversal (4). Une traverse (5) possède des ouvertures (6, 7) dimensionnées pour recevoir sans jeu les branches (2, 3). Un ligament (8) placé entre l'élément de fixation et la tête de l'agrafe est assujetti après enfoncement de l'agrafe, même si celle-ci se desserre par rapport à l'os.
PCT/GB1989/000750 1988-07-06 1989-07-04 Agrafe pour os Ceased WO1990000370A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB8816083.3 1988-07-06
GB888816083A GB8816083D0 (en) 1988-07-06 1988-07-06 Improvements in & relating to staples

Publications (1)

Publication Number Publication Date
WO1990000370A1 true WO1990000370A1 (fr) 1990-01-25

Family

ID=10639958

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1989/000750 Ceased WO1990000370A1 (fr) 1988-07-06 1989-07-04 Agrafe pour os

Country Status (3)

Country Link
AU (1) AU3980989A (fr)
GB (1) GB8816083D0 (fr)
WO (1) WO1990000370A1 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991006249A1 (fr) * 1989-11-03 1991-05-16 Bahaa Botros Seedhom Dispositif de fixation de ligaments
WO1994002073A1 (fr) * 1992-07-24 1994-02-03 Laboureau Jacques Philippe Agrafe-plaque d'osteosynthese pour osteotomie
EP0592000A3 (en) * 1992-10-08 1994-05-18 United States Surgical Corp Surgical fastening apparatus with suture array
EP0703758A4 (fr) * 1993-06-04 1997-07-23 Hip Dev Pty Ltd Vis et rondelle chirurgicales
US5682597A (en) * 1995-06-15 1997-10-28 International Business Machines Corporation Hybrid video-on-demand based on a near-video-on-demand system
US5724646A (en) * 1995-06-15 1998-03-03 International Business Machines Corporation Fixed video-on-demand
FR2754169A1 (fr) * 1996-10-04 1998-04-10 Ugmed Dispositif de blocage d'au moins un fil de suture sur un element-support ancre dans une substance dure
AU697490B2 (en) * 1993-06-04 1998-10-08 Smith & Nephew, Inc. Surgical staple and washer
EP1532930A1 (fr) * 1998-04-21 2005-05-25 Tornier SA Ancre de suture à expansion réversible

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0033641A2 (fr) * 1980-02-01 1981-08-12 Howmedica Inc. Combinaison d'un implant pour os et d'un élément pour retenir le tissu
US4592346A (en) * 1985-04-08 1986-06-03 Jurgutis John A Orthopedic staple
EP0202090A2 (fr) * 1985-05-13 1986-11-20 Ethicon, Inc. Procédé de fabrication d'un dispositif d'attache chirurgicale

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0033641A2 (fr) * 1980-02-01 1981-08-12 Howmedica Inc. Combinaison d'un implant pour os et d'un élément pour retenir le tissu
US4592346A (en) * 1985-04-08 1986-06-03 Jurgutis John A Orthopedic staple
EP0202090A2 (fr) * 1985-05-13 1986-11-20 Ethicon, Inc. Procédé de fabrication d'un dispositif d'attache chirurgicale

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991006249A1 (fr) * 1989-11-03 1991-05-16 Bahaa Botros Seedhom Dispositif de fixation de ligaments
WO1994002073A1 (fr) * 1992-07-24 1994-02-03 Laboureau Jacques Philippe Agrafe-plaque d'osteosynthese pour osteotomie
US5662655A (en) * 1992-07-24 1997-09-02 Laboureau; Jacques Philippe Osteosynthesis plate-staple
EP0592000A3 (en) * 1992-10-08 1994-05-18 United States Surgical Corp Surgical fastening apparatus with suture array
EP0703758A4 (fr) * 1993-06-04 1997-07-23 Hip Dev Pty Ltd Vis et rondelle chirurgicales
AU697490B2 (en) * 1993-06-04 1998-10-08 Smith & Nephew, Inc. Surgical staple and washer
US5961521A (en) * 1993-06-04 1999-10-05 Smith & Nephew, Inc. Surgical screw and washer
EP1038503A3 (fr) * 1993-06-04 2000-10-11 Smith & Nephew, Inc. Dispositif de fixation chirurgical
US5682597A (en) * 1995-06-15 1997-10-28 International Business Machines Corporation Hybrid video-on-demand based on a near-video-on-demand system
US5724646A (en) * 1995-06-15 1998-03-03 International Business Machines Corporation Fixed video-on-demand
FR2754169A1 (fr) * 1996-10-04 1998-04-10 Ugmed Dispositif de blocage d'au moins un fil de suture sur un element-support ancre dans une substance dure
EP1532930A1 (fr) * 1998-04-21 2005-05-25 Tornier SA Ancre de suture à expansion réversible

Also Published As

Publication number Publication date
AU3980989A (en) 1990-02-05
GB8816083D0 (en) 1988-08-10

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