EP1168983A2 - Utilisation de membranes promotrices d'os en orthopedie - Google Patents

Utilisation de membranes promotrices d'os en orthopedie

Info

Publication number
EP1168983A2
EP1168983A2 EP00919041A EP00919041A EP1168983A2 EP 1168983 A2 EP1168983 A2 EP 1168983A2 EP 00919041 A EP00919041 A EP 00919041A EP 00919041 A EP00919041 A EP 00919041A EP 1168983 A2 EP1168983 A2 EP 1168983A2
Authority
EP
European Patent Office
Prior art keywords
bone
membrane
use according
layer
injury
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.)
Withdrawn
Application number
EP00919041A
Other languages
German (de)
English (en)
Inventor
Gordon Blunn
David Southampton Gen. Hospital BARRETT
Sarah Muirhead-Allwood
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.)
University College London
Original Assignee
University College London
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 University College London filed Critical University College London
Publication of EP1168983A2 publication Critical patent/EP1168983A2/fr
Withdrawn legal-status Critical Current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
    • A61F2/30—Joints
    • A61F2/30721—Accessories
    • A61F2/30742—Bellows or hose-like seals; Sealing membranes
    • 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
    • A—HUMAN NECESSITIES
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    • 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
    • A61F2/28—Bones
    • A61F2/2846—Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects
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    • 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
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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    • 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
    • A61F2/30—Joints
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
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    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A61F2002/2817—Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
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    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
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    • 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
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    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
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    • 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
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    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30448—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30462—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements retained or tied with a rope, string, thread, wire or cable
    • A—HUMAN NECESSITIES
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    • 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
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    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30589—Sealing means
    • A—HUMAN NECESSITIES
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    • 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
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    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
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    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite

Definitions

  • This invention relates to the use of osseo-promotive membranes in regeneration of bone where the bone has been injured by disease, accident or surgery.
  • the present invention provides for use of an occlusive or semi-occlusive membrane in the manufacture of a device for the promotion of bone ingrowth in orthopaedic surgery, wherein a bone injury is sealed by closing said injury with a membrane which is substantially inert to body fluids and is adapted to prevent ingrowth of fibrous tissues into said injury.
  • the membrane is a polymer of a fluorinated monomer and may be totally non-porous to body fluids or may be semi-permeable.
  • the pore sizes should not exceed 250 microns and, preferably, should not exceed 200 microns.
  • a suitable range of pore sizes is from 0.5 micron to 200
  • the membrane should be bio-compatible and essentially inert to body fluids.
  • Preferred materials are fluorinated olefins, especially perfluorinated olefins, e.g. perfluorinated ethylene and propylene.
  • Polytetrafluoroethylene is currently preferred. Where the membrane is semi-permeable, an expanded polytetrafluoroethylene is preferred.
  • the membrane is a laminate of at least two layers of material.
  • One of the layers may have a pore size which is large enough to be penetrated by soft, fibrous tissue cells, e.g. at a size greater than 250 microns.
  • An adjacent layer may be totally occlusive or have much smaller pore openings so that fibrous soft tissue cells cannot penetrate the second layer.
  • the membrane whether a single sheet or a laminate, may be up to about 1 to 1.5 mm thick, preferably from about 300 to 1000 microns thick.
  • the occlusive or semi-occlusive layer having small particle sizes is positioned adjacent the bone injury so that soft fibrous cells cannot penetrate into the space created and sealed off by the membrane.
  • the laminate comprises at least three layers, the layer adjacent the bone injury is occlusive or contains only pore openings having an average size less than 250 microns, preferably less than 200 microns.
  • a three-layer laminate in which the control layer has the smaller pore size is preferred, since it is symmetrical and can be used reversibly.
  • multi-layer laminates in which the outer layers are of the same or similar larger pore sizes are also advantageous.
  • the layers are preferably welded together. While the membranes can be sutured to bone or tissue to seal off the injured site, the inventors have discovered that one effective procedure is to adhesively bond the edges of the membrane around the perimeter of the injury. Suitable adhesives include medical grade cyanoacrylate polymers (commonly known as super glues), and the adhesive material sold under the trade mark "Histoacryl blue" by B. Braun Melsache A.G. is currently preferred.
  • Another method of sealing the ends of the membrane is to pass a ligature, such as a loop of metal wire, around the bone and to tighten the loop around the base.
  • a ligature such as a loop of metal wire
  • Alternative methods of fixing the membrane to the bone include staples or pins. Of course, a combination of these fixing methods may be employed.
  • Figure 1 A shows a section through a hip prosthesis inserted in a femur
  • Figure IB shows a similar view with a membrane fitted over and sealing the gap between the prosthesis and the hole formed to receive the bone;
  • Figure 2A shows a bone which has suffered a severe fracture
  • Figure 2B depicts the invasion of soft tissue into the fracture hindering bone
  • Figure 2C illustrates bone formation promoted by fitting of a membrane around
  • Figure 3A illustrates bone defect caused by surgery to remove a tumour in
  • Figure 3B illustrates the use of a membrane to promote bone growth.
  • FIG 4A illustrates the situation where an intramedullary rod has been
  • Figure 4B illustrates the use of a membrane to prevent fibrous tissue ingrowth.
  • hip replacement prosthesis has been inserted into a femur (2) leaving a jimction (3)
  • the membranes used in accordance with the present invention may be any membrane used in accordance with the present invention.
  • edges of the membrane are preferably
  • an adhesive preferably a
  • the membrane (11) may be sealed to its self and to the upper and lower portions of the bone to prevent ingress of fibrous tissue material into the fracture site.
  • the membrane will confine growth factors present in the bone and other bone-inducible agents or materials such as an altograft or autograft to the defect site and in the vicinity of the healing bone.
  • growth factors present in the bone and other bone-inducible agents or materials such as an altograft or autograft to the defect site and in the vicinity of the healing bone.
  • FIGs 3A and 3B illustrate the application of the invention to surgical treatment of bone tumour.
  • a bone (20) has been cut away to remove the tumour and a replacement implant (21) fitted into the healthy bone.
  • the implant (21) having a fixing stem (21a) may be fitted into the healthy bone using a bone cement (22), and the implant may be provided with a surface treatment of hydroxy-apatite, especially to the stem, to promote bonding of the bone to the surface of the implant.
  • a blood clot may form or be artificially induced at the junction (23) between the implant and the bone and this area is sealed as shown in Figure 3B by wrapping the area with a membrane (24).
  • the membrane (24) is fixed as by gluing to the implant and to the bone to create a space (25) within which bone growth is promoted to bond the healthy bone to the implant.
  • the membrane may be sealed around the bone by positioning wires (101) & (102) around the ends of the membrane and tensioning the wires to form seals between the membrane and the bone or implant.
  • Figures 4 A and 4B illustrate a similar use of the membranes in accordance with the invention in which an intramedullary rod having an hydroxy apatite coated collar (31) having a fixing stem (31a) is introduced into a damaged bone (30) using a bone cement (32). Again, a blood clot material (33) is formed or induced around the junction between the intramedullary rod and the bone and this area is wrapped with a membrane (34) in accordance with the invention.

Landscapes

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

Abstract

L'invention concerne l'utilisation d'une membrane occlusive ou semi-occlusive, permettant de favoriser la croissance osseuse dans une chirurgie orthopédique, une lésion osseuse étant refermée à l'aide d'une membrane sensiblement inerte aux fluides corporels, et conçue de façon à empêcher l'interposition de tissu fibreux dans ladite lésion. La membrane est, de préférence, un stratifié possédant au moins deux couches, qui comprend une première couche dotée d'ouvertures dont la taille permet au tissu mou fibreux de les pénétrer, et d'une seconde couche non poreuse ou possédant des pores trop petits pour que le tissu mou les pénètre, cette seconde couche étant conçue de façon à être adjacente à la lésion osseuse.
EP00919041A 1999-04-15 2000-04-10 Utilisation de membranes promotrices d'os en orthopedie Withdrawn EP1168983A2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB9908638.1A GB9908638D0 (en) 1999-04-15 1999-04-15 Use of osseo-promotive membranes in orthopaedics
GB9908638 1999-04-15
PCT/GB2000/001349 WO2000062707A2 (fr) 1999-04-15 2000-04-10 Utilisation de membranes promotrices d'os en orthopedie

Publications (1)

Publication Number Publication Date
EP1168983A2 true EP1168983A2 (fr) 2002-01-09

Family

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Family Applications (1)

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EP00919041A Withdrawn EP1168983A2 (fr) 1999-04-15 2000-04-10 Utilisation de membranes promotrices d'os en orthopedie

Country Status (5)

Country Link
EP (1) EP1168983A2 (fr)
AU (1) AU3979700A (fr)
CA (1) CA2370358A1 (fr)
GB (1) GB9908638D0 (fr)
WO (1) WO2000062707A2 (fr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7592017B2 (en) 2000-03-10 2009-09-22 Mast Biosurgery Ag Resorbable thin membranes
US20030097180A1 (en) * 2001-11-20 2003-05-22 Pertti Tormala Joint prosthesis
CA2419831A1 (fr) * 2002-02-28 2003-08-28 Macropore Biosurgery, Inc. Methodes de determination de la croissance osseuse
CA2494230C (fr) 2002-07-31 2012-03-06 Macropore Biosurgery, Inc. Appareil et procede de prevention d'adhesions entre un implant et les tissus environnants
US8048444B2 (en) 2002-07-31 2011-11-01 Mast Biosurgery Ag Apparatus and method for preventing adhesions between an implant and surrounding tissues
US7704520B1 (en) 2002-09-10 2010-04-27 Mast Biosurgery Ag Methods of promoting enhanced healing of tissues after cardiac surgery
JP4529410B2 (ja) * 2003-10-23 2010-08-25 株式会社ジェイ・エム・エス 培養担体、該培養担体を使用した培養物と培養物の作製方法

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Publication number Priority date Publication date Assignee Title
SE392582B (sv) 1970-05-21 1977-04-04 Gore & Ass Forfarande vid framstellning av ett porost material, genom expandering och streckning av en tetrafluoretenpolymer framstelld i ett pastabildande strengsprutningsforfarande
GB9321700D0 (en) * 1993-10-21 1993-12-15 Barrett David Bone implants
DE4414675C1 (de) * 1994-04-27 1995-09-28 Kirsch Axel Abdeckeinrichtung für Knochendefektstellen und Verfahren zu deren Herstellung
JPH09512198A (ja) * 1995-02-14 1997-12-09 ダブリュ．エル．ゴア アンド アソシエイツ，インコーポレイティド 補てつ関節アセンブリーを磨耗屑片から保護するための装具と方法
DE19520866C2 (de) * 1995-06-08 1998-04-16 Kirsch Axel Vorrichtung zum Behandeln einer Knochenausnehmung

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO0062707A2 *

Also Published As

Publication number Publication date
WO2000062707A3 (fr) 2001-01-25
CA2370358A1 (fr) 2000-10-26
WO2000062707A2 (fr) 2000-10-26
GB9908638D0 (en) 1999-06-09
AU3979700A (en) 2000-11-02

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