WO1984004668A1 - Dispositif protecteur pour prothese implantable - Google Patents

Dispositif protecteur pour prothese implantable Download PDF

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Publication number
WO1984004668A1
WO1984004668A1 PCT/US1984/000769 US8400769W WO8404668A1 WO 1984004668 A1 WO1984004668 A1 WO 1984004668A1 US 8400769 W US8400769 W US 8400769W WO 8404668 A1 WO8404668 A1 WO 8404668A1
Authority
WO
WIPO (PCT)
Prior art keywords
prosthesis
tissue
bone
body portion
biological tissue
Prior art date
Application number
PCT/US1984/000769
Other languages
English (en)
Inventor
Aws S Nashef
Original Assignee
American Hospital Supply Corp
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 American Hospital Supply Corp filed Critical American Hospital Supply Corp
Publication of WO1984004668A1 publication Critical patent/WO1984004668A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • 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
    • A61F2/28—Bones
    • 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
    • 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
    • A61F2/30728—Collars; Bone edge protectors
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30907—Nets or sleeves applied to surface of prostheses or in cement
    • 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
    • A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
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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
    • A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • A61F2/4241—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for hands, e.g. fingers
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/30—Nerves; Brain; Eyes; Corneal cells; Cerebrospinal fluid; Neuronal stem cells; Neuronal precursor cells; Glial cells; Oligodendrocytes; Schwann cells; Astroglia; Astrocytes; Choroid plexus; Spinal cord tissue
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    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
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    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/34—Muscles; Smooth muscle cells; Heart; Cardiac stem cells; Myoblasts; Myocytes; Cardiomyocytes
    • A—HUMAN NECESSITIES
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    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/48—Reproductive organs
    • A61K35/50—Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
    • 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
    • A61F2/0095—Packages or dispensers for prostheses or other implants
    • 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
    • A61F2/30723—Plugs or restrictors for sealing a cement-receiving space
    • 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
    • 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
    • A61F2002/30069—Properties of materials and coating materials elastomeric
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/3011—Cross-sections or two-dimensional shapes
    • A61F2002/30112—Rounded shapes, e.g. with rounded corners
    • A61F2002/30125—Rounded shapes, e.g. with rounded corners elliptical or oval
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/3011—Cross-sections or two-dimensional shapes
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    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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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
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    • 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
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30563—Special structural features of bone or joint prostheses not otherwise provided for having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
    • 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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    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30565—Special structural features of bone or joint prostheses not otherwise provided for having spring elements
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    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
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    • 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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    • A61F2/02—Prostheses implantable into the body
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    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0008—Rounded shapes, e.g. with rounded corners elliptical or oval
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0019—Angular shapes rectangular
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical

Definitions

  • Rheumatoid arthritis is an inflammatory disease of the soft tissues that causes severe destruction of the joint tissues. Inter alia, the disease weakens the capsule and ligament of the joint, causing the fingers to become displaced.
  • resection arthroplasty and a procedure known as fusion were the only alternatives to either relieve pain and to restore functional range of motion to the affected areas.
  • Resection arthroplasty merely removed the joint capsule which allowed the space to fill in with a new surface of fibrous tissue, providing a false joint. Fusion caused a bond union across the joint, provided stability and relief of pain, but did not allow for motion in the fused joint.
  • Implant resection arthroplasty is a surgical procedure performed to correct finger-joint deformation in patients with severe destruction of joints caused by progressive rheumatoid arthritis.
  • a flexible elastomeric implant preferably of silicone rubber, is the most commonly used adjunct to this arthroplasty procedure.
  • Examples of such prosthetic joints include those disclosed in U.S. Patent Nos.: 3,462,765; 3,593,342; 3,681,786; 3,818,513; 3,875,594; 3,879,767; 3,886,600; and 4,178,640.
  • the protective device is a sleeve adapted to fit within the intramedullary canal, wherein the sleeve is made of medical grade material such as porous polytetrafluoroethylene or high density polyethylene, which permits the bone to grow into its exterior surface.
  • the protective device is a curvilinear shield adapted to conform to the upper portion of the prosthesis outer surface, wherein the shield is made of highly polished stainless steel which permits relative sliding, reciprocating motion between the prosthesis and the protective device .
  • a device for protecting surgically implantable prostheses used to repair resected bone or to replace bone joints wherein the pros ⁇ thesis has a body portion and at least one outwardly-directed stem portion, and the protective device is a piece of fixed, soft bio- logical tissue having a means therein for passage of the prosthesis stem portion, and having overall dimensions sufficient to cover at
  • OMPI least a portion of the outer surface of the prosthesis body portion adjacent the stem portion such that a prosthesis-to-bone interface is provided between at least a portion of the exposed resected bone and a portion of the prosthesis when the prosthesis is implanted.
  • FIG. 1 is a cross-section of the human hand showing the protective device in accordance with one embodiment of the present invention
  • FIG. 2 is an enlarged perspective view of the device shown in FIG. 1 , having the bone partially sectioned to show the intramedullary canals;
  • FIG. 3 is an exploded front elevational view of a surgical implantable prosthesis used to replace bone joints and the protec ⁇ tive device of the present invention
  • FIG. 4 is a perspective view of the proximal protective device in accordance with one embodiment of the present invention.
  • FIG. 5 is a perspective view of the distal protective device in accordance with one embodiment of the present invention.
  • FIG. 6 is an elevational view of an alternate protective device in accordance with the present invention.
  • FIG. 7 is an elevational view of an alternate embodiment of the present invention.
  • FIG. 8 is an elevational view of an alternate protective device of the present invention having a portion for extending into the intramedullary canals .
  • the prosthesis may be of the type used for finger, toe , wrist, trapezium, carpal scaphoid, carpal lunate, and radial head implants , and may be a flexible elastomeric joint implant as described in U. S . Patent Nos. 4, 198 ,713 ; 4 , 158 , 893 ; 3 ,875 ,594; 3 ,462 ,765 ; 3 ,593 , 342 ; 3 , 681,786; .
  • the prosthesis may be of the type used in bone amputation , or any other bodily area where resected bone may grow in a jagged, irregular way, in the form of sharp edges that can cut the elastomeric surfaces of the prosthesis.
  • an implantable finger joint prosthesis is generally shown at 10 in FIGS . 1.3.
  • the prosthesis is ordinarily made of flexible elastomeric material such as silicone rubber and sold under the trademark Silastic by Dow Corning Corporation , Midland, Michigan.
  • the prosthesis comprises a hinge-like flexible body portion 12 having a substantially rigid distal stem portion 14 directed outwardly from the body portion, and an outwardly- directed proximal stem portion 16 extending in a direction subs- tantially opposite from that of the distal stem portion. It is to be understood that the stem portions 14 and 16 may project outwardly from the central body portion 12 at various angles depending on the exact configuration required to adapt the prosthesis to various implant sites.
  • the prosthesis may comprise a body portion 13 having a single stem portion 15 extending outwardly therefrom for insertion into the ends of amputated bones as show in FIG. 7.
  • the protective device in accordance with one embodiment of the present invention is shown at 18 and 18' as a generally oval web conforming to the major portion of the prosthesis body surface 12 that comes in contact with the resected bone surface 20 when fully implanted.
  • the protective device is preferably constructed of fixed, soft biological tissue having overall dimensions sufficient to cover at least a portion of the outer surface 22 of the prosthesis body portion adjacent the stem portion 14 , 15 , or 16 such that a prosthesis-to-bone interface is provided between at least a portion of the prosthesis when the prosthesis is inserted into the intramedullary canal.
  • the protective device may be used in conjunction with any intermedullary stemmed flexible prosthetic implant where a resected bone-implant interface occurs .
  • these areas include wrist , toe , and the finger implants shown in FIG. 1.
  • the normal joint of a bone 23 is partially, surgically severed or resected leaving an exposed bone surface 20; and the intramedullary canals 24 and 25 are bored to receive the stem portions 14 and 16 of the prosthesis 10.
  • sharp , jagged edges of bone normally develop particulary at the resected bone surface 20 which eventually initiate a crack in the flexible implant.
  • the protective device 18 and 18' is interposed between the exposed resected bone surface and the prosthetic implant 10 and acts as a barrier or interface therebetween to promote relatively smooth remodeling or reshaping of the bone surface into a regular edge and shield the implant from sharp bone spurs .
  • the protective device 18 and 18' is generally disc-shaped as generally shown at 26 in FIGS . 4 and 5.
  • the external dimensions of the said tissue are sufficient to cover substantially the entire outer surface 22 of the prosthesis body portion 12 adjacent the stem portion such that a prosthesis-to-bone interface is provided between substantially all of the resected bone surface 20 and the body portion 22 of the prosthesis when the implant is inserted into the intramedullary canal 24 and 25.
  • the external dimensions of the tissue 26 will be dependent upon the size of the prosthesis which, in turn, is dependent upon the type of joint replacement and site at which the joint is replaced.
  • a web in accordance with one the present invention is a piece of shaped biological tissue having generally planar faces 27 defining an area which has lateral dimensions relatively larger than the thickness of the tissue.
  • the external dimensions of said tissue are sufficient to cover at least a portion of the stem portion adjacent the prosthetic body portion in addition to covering the body portion as described above and at 38 such that a prosthesis-to-bone interface is additionaly provided between a portion of the exposed resected bone in the intra ⁇ medullary canal and a portion of the stem portion.
  • the protective device is of biological tissue cut in a generally rectilinear shape 28 as shown in FIG. 6 having a major axis (f) of from about 0.31 to about 0.73 inches and a minor axis (g) of from about 0.16 to about 0.53 inches.
  • An aperture 30 is cut through the center of the face 27 of the tissue for passage of the prosthe ⁇ sis stem portion.
  • the aperture has a major axis (h) of from about 0.13 to about 0.39 inches, and a minor axis (i) of from 0.12 to about 0.27 inches.
  • the biological tissue is cut in a generally oval shape as shown in FIGS. 4 and 5.
  • the proximal device 18 depicted in FIG. 4 has a major axis (a) of from about 0.32 to about 0.73 inches , and a minor axis (b) of from about 0.16 to about 0.53 inches.
  • the tissue which is approximately 0.016 inches in depth (e) , has a pair of intersecting slits 32 and 32' cut through its face 27 for
  • the intersecting slits are generally X-shaped, and describe an area from end-to- end having lateral dimensions (c) of from about 0.10 to about 0.29 inches and (d) of from about 0.10 to about 0.29 inches .
  • the distal device 18' depicted in FIG. 5 is generally similar to the proximal web 18 ; however , it has a truncated side portion 34.
  • the tissue has a major axis (a 1 ) of from 0.32 to about 0.73 inches , a minor axis (b') of from 0.15 to about 0.52 inches , and intersecting slits 32 and 32' describing an area from end-to-end having lateral dimensions of (c') from about 0.10 to about 0.29 inches , and (d ⁇ ) from about 0.08 to about 0.25 inches , and a thickness (e') of approximately 0.016 inches.
  • the biological tissue is either naturally occurring biological tissue derived from various animal sources including but not limited to bovine , porcine , horse , sheep , kangaroo , or rabbit; and can be obtained from various parts of the anatomy as described hereinbelow .
  • the biological tissue can be composed of collagen or reconstituted collagen substitutes including but not limited to collagen-fabric films , collagen-membranes , reconstituted collagen on Dacron mesh, tanned collage sponge grafts and the like.
  • the soft biological tissue provides a moist lubricious , flexible interface between the bone and implant; and also promotes the even, remodeling of resected bone resulting in a smooth bone surface.
  • the biological tissue is stable when implanted into the body. It is well under ⁇ stood that soft biological tissue differs from hard biological tissue found in bone , teeth , and the like.
  • tissue naturally occur ⁇ ring biological tissue is removed from its host, defatted if neces ⁇ sary and processed in one of several well-known procedures used to prepare the tissue for implantation into humans.
  • the tissue is fixed (tanned) conventionally in from about 0.2 to about 0.6
  • tissue handling conditions as conventionally known are not considered part of the present invention unless otherwise stated.
  • tissue may be sterilized in about 0.625 percent glutaraldehyde or from about 4 to about 5 percent formaldehyde.
  • Naturally occurring biological tissue in accordance with the present invention includes, but is not limited to epithelial and fibrous connective tissue such as pericardia! tissue, dura mater, facialata, amnion, tendon, ligament , cartilage , and the like.
  • the epithelial tissues such as dura mater, amnion, facialata, and percardium generally comprise two layers each; a fibrious, proteinaceous layer and a relatively smooth membranous layer.
  • the rough, fibrous layer of the tissue is placed against the resected bone to provide better anchoring to the bone surface, while the smooth, membranous layer is positioned to contact the prosthesis surface and provide a more lubricious interface.
  • pericardial tissue is preferred.
  • the natural biological tissue is treated prior to implanta- tion to render it substantially resistant to calcification.
  • This advantageously maintains the biological tissue in a more flexible state than calcified tissue, allowing the tissue to conform better to the uneven surface of the resected bone.
  • Calcification mitigation treatments of biological tissue are not considered part of the invention but can be found in copending U. S . patent applications Serial Nos. 445 ,345 filed November 29 , 1982; 377 ,747 filed May 13, 1982; and 441,023 filed November 12 , 1982; and in U. S . Patent No. 4 ,323 ,358.
  • the protective device 18 and 18' is intended to minimize the potential for
  • OMPI prosthetic implant fracture by acting as a spacer between the joint implant 10 and the resected bone surface 20.
  • Studies conducted in rabbits show that when the protective device 18 and 18' is placed in contact with resected bone , the bone healing process results in a smooth bone surface with minimal inflammation and no necrosis.
  • the rabbit knee was used as the experimental model because the size of the rabbit's knee joint is comparable in size to that of the human finger joint.
  • the animal study consisted of two groups .
  • the control group animals received the prosthetic implant without the protective device, and the experimental group received the prosthetic implant with the protective device .
  • the implants were retrieved from the rabbits and examined for wear and cellular activity. Histology was performed on the bone protective device interface and on the capsule sur ⁇ rounding the joint space to determine host cellular reaction to the protective device and the implant.
  • the silicone joint implant showed pathological evidence of wear debris as is common in many prosthetic materials .
  • the amount of silicone debris was not only related to the length of time the implant was in place , but more importantly to stress factors . The most important factors appeared to be related to sharp bone edges at the ostial opening and to fibro-osseous "humps" which formed in the surgical channel in which the prosthesis was placed. Abrasions and gouges were most prominent on the tibial side of the implant , particularly in the control animals.
  • the silicone debris resulted in predominantly a mononuclear histiocyte response and a mild to moderate multinucleate histiocyte response , generally mild to moderate chronic inflammation and eventually fibrosis, most always in direct proportion to the amount of debris.
  • the control animals showed significantly greater amounts of silicone debris than did the experimental animals , which would be expected when the device minimizes wear.
  • the biological tissue when it covered the ostial surface, the entrance edge of bone, and the upper channel into the bone significantly reduced silicone wear.
  • the tissue caused little histiocytic reaction or chronic inflammation. There was no acute inflammation or necrosis caused by either the tissue or the silicone debris in any experimental time period even as early as two weeks .
  • the tissue was being bound down on its lateral deep edges by living rabbit fibroblasts and incorporated as Sharp ey's. like fibers into rabbit cartilage with no adverse tissue reaction.
  • the following table shows the comparison of the implants in the control animals with those using biological tissue as a protec ⁇ tive device.
  • the protective device 18 and 18' in accordance with the present invention , can be placed around the stem portion 14 and 16 of a surgically implantable prosthesis 10 and sold in a fully assembled manner , or they may be packaged in a sterile sealed package (jar) separately from a prosthesis such that the physician or surgeon can place the device on the prosthesis just prior to implantation.
  • a distal 18' and proximal 18 device may be contained in a sterile package .
  • the webs Prior to insertion of the implant into the intramedullary canal 24 and 23 of the resected joint bone , the webs are placed on the stems 14 and 16 of the implant with the smooth side of the tissue facing the body portion of the prosthesis .
  • the fibrous , textured side is directed away from the prosthesis and toward the surface of the resected bone.
  • the distal web is placed on the distal stem of the prosthesis with the truncated 34 edge facing toward the palmar surface.
  • the web has a pair of slits 32 and 32' in its face 27 that form flaps 36 to cover a portion of the stem adjacent the body of the prosthesis. These flaps 36 preferably fit snugly and squarely around the stem of the prosthesis.
  • the implant is flexed so tht the distal stem can easly be inserted into the proximal phalanx with the flaps carefully tucked into the bone canal.
  • the webs should preferably be flat against the midsection of the implant and not restrict its movement or function.

Abstract

Dispositif protecteur (18) pour prévenir tout endommagement causé à des prothèses (12) implantables chirurgicalement par des bords d'os irréguliers et tranchants de l'os résecté. Les dispositifs protecteurs (10) ont généralement une forme de disque possédant des faces essentiellement planaires (27) où une ouverture (30) est découpée à travers le centre de la face (37) pour permettre l'insertion des parties broches (14, 16) afin de former une interface entre l'os résecté et la surface de la prothèse (12).
PCT/US1984/000769 1983-05-24 1984-05-21 Dispositif protecteur pour prothese implantable WO1984004668A1 (fr)

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EP (1) EP0147431A4 (fr)
JP (1) JPS60501396A (fr)
AU (1) AU2969384A (fr)
CA (1) CA1229203A (fr)
IT (1) IT1179175B (fr)
WO (1) WO1984004668A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2763835A1 (fr) * 1997-05-30 1998-12-04 Michel Lahille Implant carpometacarpien
WO2004017861A3 (fr) * 2002-08-24 2004-10-21 Grampian Univ Hospitals Dispositif
WO2005110291A1 (fr) * 2004-05-07 2005-11-24 Wright Medical Technology, Inc. Implant pour le trapèze du pouce et méthode
FR2900045A1 (fr) * 2006-04-21 2007-10-26 Tornier Sas Prothese d'epaule ou de hanche
FR2927529A1 (fr) * 2008-02-14 2009-08-21 Pfaifer Patrick Prothese d'articulation pour articulation inter-phalangienne ou phalango-metacarpienne ou phalango-metatarsienne
EP2323593A2 (fr) * 2008-05-27 2011-05-25 Smith & Nephew, Inc. Enveloppe pour cupule servant à prévenir un impact sur les tissus mous

Families Citing this family (2)

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Publication number Priority date Publication date Assignee Title
GB0700396D0 (en) * 2007-01-10 2007-02-14 Rolls Royce Plc Temperature indicating paint
JP5285227B2 (ja) * 2007-02-26 2013-09-11 京セラメディカル株式会社 生体用補綴体

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US4158893A (en) * 1976-10-12 1979-06-26 Swanson Alfred B Protective sleeve for implantable prosthesis and method of protecting the prosthesis
US4400833A (en) * 1981-06-10 1983-08-30 Kurland Kenneth Z Means and method of implanting bioprosthetics
US4402697A (en) * 1982-08-25 1983-09-06 Extracorporeal Medical Specialties, Inc. Method for inhibiting mineralization of natural tissue during implantation

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DE2502884A1 (de) * 1975-01-24 1976-07-29 Juergen J Dipl Phy Hildebrandt Mittel zur biologischen implantation von knochen- und gelenkersatz

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Publication number Priority date Publication date Assignee Title
US4158893A (en) * 1976-10-12 1979-06-26 Swanson Alfred B Protective sleeve for implantable prosthesis and method of protecting the prosthesis
US4400833A (en) * 1981-06-10 1983-08-30 Kurland Kenneth Z Means and method of implanting bioprosthetics
US4402697A (en) * 1982-08-25 1983-09-06 Extracorporeal Medical Specialties, Inc. Method for inhibiting mineralization of natural tissue during implantation

Non-Patent Citations (1)

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2763835A1 (fr) * 1997-05-30 1998-12-04 Michel Lahille Implant carpometacarpien
WO2004017861A3 (fr) * 2002-08-24 2004-10-21 Grampian Univ Hospitals Dispositif
US7842091B2 (en) 2002-08-24 2010-11-30 Grampian University Hospitals Nhs Trust Implantable replacement joint
WO2005110291A1 (fr) * 2004-05-07 2005-11-24 Wright Medical Technology, Inc. Implant pour le trapèze du pouce et méthode
FR2900045A1 (fr) * 2006-04-21 2007-10-26 Tornier Sas Prothese d'epaule ou de hanche
WO2007122327A3 (fr) * 2006-04-21 2008-03-13 Tornier Sa Prothese d'epaule ou de hanche et methode de pose d'une telle prothese
FR2927529A1 (fr) * 2008-02-14 2009-08-21 Pfaifer Patrick Prothese d'articulation pour articulation inter-phalangienne ou phalango-metacarpienne ou phalango-metatarsienne
EP2323593A2 (fr) * 2008-05-27 2011-05-25 Smith & Nephew, Inc. Enveloppe pour cupule servant à prévenir un impact sur les tissus mous
EP2323593A4 (fr) * 2008-05-27 2013-10-02 Smith & Nephew Inc Enveloppe pour cupule servant à prévenir un impact sur les tissus mous

Also Published As

Publication number Publication date
JPS60501396A (ja) 1985-08-29
IT8448244A0 (it) 1984-05-23
EP0147431A1 (fr) 1985-07-10
CA1229203A (fr) 1987-11-17
EP0147431A4 (fr) 1987-04-15
AU2969384A (en) 1984-12-18
IT1179175B (it) 1987-09-16

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