ES2245989T3 - Soporte subcutaneo intramuscular para un implante transcutaneo rigido. - Google Patents

Soporte subcutaneo intramuscular para un implante transcutaneo rigido.

Info

Publication number
ES2245989T3
ES2245989T3 ES01947292T ES01947292T ES2245989T3 ES 2245989 T3 ES2245989 T3 ES 2245989T3 ES 01947292 T ES01947292 T ES 01947292T ES 01947292 T ES01947292 T ES 01947292T ES 2245989 T3 ES2245989 T3 ES 2245989T3
Authority
ES
Spain
Prior art keywords
flexible
support
implant
sleeve
bellows
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.)
Expired - Lifetime
Application number
ES01947292T
Other languages
English (en)
Inventor
Hans Grundei
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.)
Eska Implants GmbH and Co KG
Original Assignee
Eska Implants GmbH and Co KG
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 Eska Implants GmbH and Co KG filed Critical Eska Implants GmbH and Co KG
Application granted granted Critical
Publication of ES2245989T3 publication Critical patent/ES2245989T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
    • 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
    • A61F2/2814—Bone stump caps
    • 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
    • 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
    • A61F2/30749—Fixation appliances for connecting prostheses to the body
    • 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
    • A61F2002/2825—Femur
    • 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
    • A61F2002/30004—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
    • A61F2002/30014—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 elasticity, stiffness or compressibility
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
    • A61F2002/30332—Conically- or frustoconically-shaped protrusion and recess
    • A—HUMAN NECESSITIES
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    • 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
    • A61F2002/30316—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
    • A61F2002/30331—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
    • A61F2002/30332—Conically- or frustoconically-shaped protrusion and recess
    • A61F2002/30339—Double cones, i.e. connecting element having two conical connections, one at each of its opposite ends
    • 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
    • A61F2002/30316—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
    • A61F2002/30433—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
    • 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
    • A61F2002/30316—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
    • 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
    • A61F2002/30316—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
    • 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
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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
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30574—Special structural features of bone or joint prostheses not otherwise provided for with an integral complete or partial collar or flange
    • 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
    • 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
    • A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
    • 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
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • A61F2002/30784—Plurality of holes
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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
    • 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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    • 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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    • A61F2/30907—Nets or sleeves applied to surface of prostheses or in cement
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    • A61F2/02—Prostheses implantable into the body
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    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
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    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0041—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels or rivets, e.g. connecting screws
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    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
    • A61F2310/00407—Coating made of titanium or of Ti-based alloys

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  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
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  • Heart & Thoracic Surgery (AREA)
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  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
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  • Orthopedic Medicine & Surgery (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Soporte subcutáneo intramuscular (1) para un implante transcutáneo rígido (2), que se puede anclar intracorpóreamente a un muñón óseo (10) y que presenta un dispositivo de acoplamiento extracorpóreo (18) para una pieza estándar exoprotética, constituido por un material flexible y que presenta un manguito de introducción (7) que rodea distal y firmemente el implante (2), caracterizado por un manguito de cierre (3) dispuesto intracorpóreamente en forma de un fuelle flexible que está unido proximalmente con un collarín (4) ajustado herméticamente al manguito de introducción (7), de tal manera que entre la pared interna del fuelle y la pared externa del manguito de introducción (7) queda libre un hueco con una anchura mínima (s), habiéndose dispuesto en el fuelle distalmente una malla cuadriculada flexible (5) a la que se une por el lado distal otra malla cuadriculada (6) con un módulo de elasticidad superior al de la malla cuadriculada flexible (5).

Description

Soporte subcutáneo intramuscular para un implante transcutáneo rígido.
La presente invención se refiere a un soporte subcutáneo intramuscular para un implante transcutáneo rígido que ha de ser anclado intracorpóreamente en un muñón óseo y que presenta un dispositivo de acoplamiento extracorpóreo para una pieza estándar exoprotética.
Un implante de este tipo para colocación en un paciente con amputación de muslo se describe detalladamente, por ejemplo, en el documento DE-19826638. Según este documento, se inserta en el muñón femoral amputado un implante en forma de adaptador con un vástago en la región intramedular. Al vástago se le une una pieza intermedia que sale por la hendidura de penetración del muñón del muslo. Lo que aquí resulta problemático es el aislamiento hermético del muñón del miembro, pues es necesario mantener la hendidura de penetración aséptica. Otro punto crítico es la adaptación de la pieza intermedia rígida a la región muscular del muñón del muslo así como a la piel. En una situación ideal, la piel y el tejido muscular y conjuntivo han de permanecer móviles con relación al implante rígido. Por supuesto, este requisito complica el intento de mantener aséptica la hendidura de penetración.
Del documento US4158895 se conoce el soporte subcutáneo intramuscular anteriormente mencionado, que está constituido por un material flexible y presenta un manguito de introducción que encierra firme y distalmente el implante. Este soporte no proporciona la movilidad de las partes blandas que rodean al soporte con relación al implante rígido.
Otro aspecto importante es que un soporte subcutáneo debe formar una barrera firme contra la invasión de gérmenes.
En vista de esto, el objetivo de la presente invención es variar el soporte subcutáneo genérico de tal manera que puedan moverse las partes blandas con respecto al implante rígido sin que esto constituya un mayor riesgo de inflamación para la hendidura de penetración de la parte del muñón corporal.
Este objetivo se ha conseguido mediante el soporte subcutáneo intramuscular con las características distintivas de la reivindicación 1. De las reivindicaciones subordinadas se derivan variantes ventajosas.
Según estas, se prevé que el soporte subcutáneo intramuscular conforme a la invención presente un manguito de cierre dispuesto intracorpóreamente en forma de un fuelle flexible. Este fuelle va unido de forma proximal con un collarín ajustado herméticamente al manguito de introducción y de tal forma que entre la pared interna del fuelle y la pared externa del manguito de introducción quede libre un hueco con una anchura mínima "s" de 1 mm, habiéndose dispuesto en el fuelle distalmente una malla cuadriculada flexible a la que se une por el lado distal otra malla cuadriculada con un módulo de elasticidad superior al de la malla cuadriculada flexible.
El manguito de introducción queda firmemente unido a la pieza del implante en cuestión y está, por ejemplo, pegado a este de forma homogénea, de tal manera que la ubicación del manguito de introducción en la pieza del implante está protegida frente a los gérmenes. En esta región va adaptado el manguito de cierre en forma de fuelle que puede estar fabricado con el manguito de introducción de una sola pieza, por ejemplo, de silicona.
La conformación del manguito de cierre en forma de fuelle proporciona una movilidad óptima de las partes blandas que rodean al soporte frente al implante rígido.
La mencionada malla cuadriculada flexible se fija distalmente al muelle que, asimismo, puede estar fabricado preferentemente de silicona y, dado el caso, estar integrado junto con el fuelle en una sola pieza. Esta malla cuadriculada flexible se encarga de proporcionar con el tiempo, después de la implantación, una estrecha unión con los músculos circundantes.
A la malla cuadriculada flexible se le une distalmente la otra malla cuadriculada anteriormente mencionada, la cual se fabrica con especial preferencia con una lana metálica de titanio tejida o fieltrada. De este modo esta lana de titanio contrae en el muñón corporal un vínculo estrecho con la piel del paciente, es decir, la piel interpenetra el trenzado de titanio.
Todo el soporte queda alojado en el muñón corporal. Únicamente el implante rígido sobresale del manguito de introducción del soporte y presenta allí el dispositivo de acoplamiento para una pieza estándar exoprotética.
El muñón óseo no podrá ser invadido por gérmenes ni partículas de suciedad, sino que estos serán retenidos en el hueco del soporte formado por el fuelle.
Con la conformación según la invención del soporte subcutáneo intramuscular es posible proporcionarle a un paciente de forma permanente un implante en el muñón óseo sin tener que temer complicaciones graves causadas por septicemia. Debido al entrecrecimiento de la piel con el trenzado de titanio y al entrecrecimiento del tejido muscular con la malla cuadriculada de silicona se construye en el muñón corporal una barrera natural extremadamente eficaz contra la invasión de gérmenes, etc.
La invención se ilustra con más detalle mediante un ejemplo de realización de acuerdo con la única figura gráfica.
En ella se representa un muñón de muslo 14 con el muñón femoral 10. En el muñón femoral 10 tubular se ha introducido un vástago 13 del implante 2. Fijado distalmente a este se halla un manguito de cierre, que encierra una pieza intermedia 12 en forme de cono doble. Esta pieza intermedia es la pieza de unión entre el interior del muñón del muslo y el entorno extracorpóreo. Por lo tanto, penetra a través de la piel 11 del muñón del muslo 14. En su segmento que está ubicado en el exterior se ha acoplado un dispositivo de acoplamiento extracorpóreo 18, que sirve para recibir una pieza estándar exoprotética (no represen-
tada).
El soporte 1 con disposición completamente intracorpórea, es decir, subcutánea e intramuscular, en el muñón del muslo 14 está constituido aquí esencialmente por un tubo interno cilíndrico o manguito de introducción 7, firmemente unido al implante 2 y pegado aquí de forma homogénea con la pieza intermedia 12 a su zona de transición cilíndrica. El punto de adhesión forma una barrera protegida frente a gérmenes y suciedad. Mediante un collarín 4 adaptado al manguito de introducción 7 se ha dispuesto el manguito de cierre 3 en forma de un fuelle. La anchura mínima "s" entre la pared externa del manguito de introducción 7 y la pared interna del manguito de cierre 3 es de, al menos, 1 mm y puede ser, por ejemplo, de hasta 10 mm.
Por el lado distal el manguito de cierre 3 de una sola pieza pasa a ser una malla cuadriculada flexible 5 con un gran número de perforaciones 21, las cuales, con el tiempo, después de la operación, serán interpenetradas por tejido muscular.
Por el lado distal se une a la malla cuadriculada 5 otra malla cuadriculada 6, que presenta un módulo de elasticidad mayor y está constituida, con especial preferencia, por una lana metálica de fibras de titanio. Con el paso del tiempo esta malla cuadriculada 6 será interpenetrada, después de la operación, de tejido cutáneo.
Por lo demás, el adaptador de cierre 15 está provisto en su periferia de una estructura reticular tridimensional 20 de malla cuadriculada abierta, en la que penetran partículas óseas, formando así en el lado óseo otra barrera adicional contra la invasión de gérmenes.
Por lo demás, el vástago 13 del implante 2 lleva una superficie parecida en el interior del canal óseo.
En este punto hay que mencionar todavía el extremo proximal 19 del vástago 13, que aquí está configurado en forma de cono de inserción y que podría servir como adaptador para un vástago de una prótesis de cadera.

Claims (6)

1. Soporte subcutáneo intramuscular (1) para un implante transcutáneo rígido (2), que se puede anclar intracorpóreamente a un muñón óseo (10) y que presenta un dispositivo de acoplamiento extracorpóreo (18) para una pieza estándar exoprotética, constituido por un material flexible y que presenta un manguito de introducción (7) que rodea distal y firmemente el implante (2), caracterizado por
un manguito de cierre (3) dispuesto intracorpóreamente en forma de un fuelle flexible que está unido proximalmente con un collarín (4) ajustado herméticamente al manguito de introducción (7), de tal manera que entre la pared interna del fuelle y la pared externa del manguito de introducción (7) queda libre un hueco con una anchura mínima (s), habiéndose dispuesto en el fuelle distalmente una malla cuadriculada flexible (5) a la que se une por el lado distal otra malla cuadriculada (6) con un módulo de elasticidad superior al de la malla cuadriculada flexible (5).
2. Soporte (1) según la reivindicación 1, en el que la anchura mínima "s" asciende a 1 mm.
3. Soporte (1) según la reivindicación 1 ó 2, compuesto por silicona.
4. Soporte (1) según una de las reivindicaciones 1 a 3, en el que la malla cuadriculada flexible (5) está compuesto por silicona.
5. Soporte (1) según una de las reivindicaciones 1 a 4, en el que la otra malla cuadriculada (6) está compuesta por una lana metálica tejida o fieltrada.
6. Soporte (1) según la reivindicación 5, en la que la lana metálica está formada por fibras de titanio.
ES01947292T 2000-08-15 2001-05-18 Soporte subcutaneo intramuscular para un implante transcutaneo rigido. Expired - Lifetime ES2245989T3 (es)

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DE10040590A DE10040590C2 (de) 2000-08-15 2000-08-15 Subkutanes, intramuskuläres Lager für ein starres transkutanes Implantat

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US6843808B2 (en) 2005-01-18
US20030109878A1 (en) 2003-06-12
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EP1309294A1 (de) 2003-05-14
EP1309294B1 (de) 2005-07-27
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DE10040590A1 (de) 2002-03-07
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