Percutaneous implant for limb salvage

• US 7,909,883 B2
• Filed: 02/21/2007
• Issued: 03/22/2011
• Est. Priority Date: 02/21/2007
• Status: Active Grant

• Current Assignee: BioMedtrix, LLC
• Original Assignee: Christopher G. Sidebotham
• Inventors: Sidebotham, Christopher G.
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): Woznicki; Jacqueline
• Application Number:
  US11/709,397
• Publication Number:
  US 20080200995A1
• Time in Patent Office: 1,490 Days
• Field of Search: 623/32, 623/23.46, 623/23.55, 623/27, 623/11.11, 623/23.53, 623/16.1
• US Class Current: 623/23.55
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61F 2/2814 Bone stump caps
• CPC Class Codes: A61F 2/30749 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/54 Artificial arms or hands or parts thereof
• CPC Class Codes: A61F 2/66 Feet; Ankle joints
• CPC Class Codes: A61F 2/78 Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30233 Stepped cylinders, i.e. having discrete diameter changes
• CPC Class Codes: A61F 2002/30332 Conically- or frustoconically-shaped protrusion and recess
• CPC Class Codes: A61F 2002/30574 with an integral complete or partial collar or flange
• CPC Class Codes: A61F 2002/30604 modular
• CPC Class Codes: A61F 2002/307 Prostheses for animals
• CPC Class Codes: A61F 2002/30795 Blind bores, e.g. of circular cross-section
• CPC Class Codes: A61F 2002/30827 Plurality of grooves
• CPC Class Codes: A61F 2002/30919 Sleeves
• CPC Class Codes: A61F 2002/30968 Sintering
• CPC Class Codes: A61F 2002/7887 for connecting limb exoprostheses to the stump bone
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00095 : Niobium or Nb-based alloys
• CPC Class Codes: A61F 2310/00131 : Tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00407 : Coating made of titanium or of Ti-based alloys
• CPC Class Codes: A61F 2310/00491 : Coating made of niobium or Nb-based alloys
• CPC Class Codes: A61F 2310/00544 : Coating made of tantalum or Ta-based alloys

Abstract

A percutaneous implant device is biologically attached to bone and soft tissue of a broken limb or amputated limb without longitudinal or lateral movement. Bone and soft tissue in-growth are promoted. The percutaneous implant device has a bio-compatible metal alloy stem member, having an integral tapered fluted section designed to fit into a taper reamed bone canal. A precisely dimensioned cylindrical central core cooperates with a suture ring and an external extension member, facilitating attachment of the percutaneous implant device to a hand or foot prosthesis. A porous metal outer body having a female taper at one end and the capacity to promote growth of bone and soft tissue, is press fitted on the central core contacting suture ring. The assembled implant is inserted into a taper reamed bone cavity until the male taper-reamed bone free end contacts the female taper. Soft skin is extended over the outer surface of the porous metal outer body and the surrounding suture ring.

Claims

1. A percutaneous implant device, comprising:

a. a biologically compatible metal alloy implant stem and a porous metal outer body member adapted for bone and soft tissue in-growth;

b. said implant stem having a male tapered fluted stem portion adapted to be inserted into a female tapered cavity drilled within a bone of a broken limb;

c. said implant stem having a cylindrical inner portion extending from and abutting said male tapered fluted stem portion, the cylindrical inner portion having a cylindrical core diameter adapted for press fitting said porous metal outer body member thereon;

d. said porous metal outer body member having a central aperture with a bore diameter that is smaller than said cylindrical core diameter by an interference amount to integrally mate said porous metal outer body member with said cylindrical inner portion of the implant stem;

e. said implant stem having a suture ring abutting said cylindrical inner portion and located distal from said male tapered fluted stem portion;

f. one end of said porous metal outer body member abutting said suture ring;

g. another end of said porous metal outer body member distal from said suture ring having a female taper abutting said male tapered fluted stem portion and being adapted to fit around and mate with a male taper surgically created on a bone end;

h. said implant stem having an external member integral to said implant stem extending from said suture ring adapted for attachment to a hand of foot prosthesis;

whereby the porous metal outer body is adapted to be press fit over the cylindrical inner portion so that said percutaneous implant device functions as a single unit;

whereby the male tapered fluted stem portion and the female taper of the porous metal outer body are adapted for bone contact, generating bone in-growth;

whereby said suture ring is adapted for suturing soft tissue thereto;

whereby said outer surface of said porous metal body member is adapted to contact soft tissue generating soft tissue in-growth and thereby preventing lateral and longitudinal displacement of said percutaneous implant during healing and promoting bone and soft tissue in-growth.

2. A percutaneous implant device as recited by claim 1, wherein said interference amount for press fitting of said cylindrical inner portion of said implant stem and central aperture of said porous metal body is 0.005 to 0.20 mm.

3. A percutaneous implant device as recited by claim 1, wherein said porous metal outer body comprises sintered beads, sintered wire segments or foam.

4. A percutaneous implant device as recited by claim 1, wherein said male tapered fluted stem portion is adapted to connect to said female tapered bone cavity with interference.

5. A percutaneous implant device as recited by claim 1, wherein said female taper of said porous metal outer body member has a length of about 8 mm (0.351 inches).

6. A percutaneous implant device as recited by claim 1, wherein said porous metal outer body member has a length of 37 mm, and is adapted to provide soft tissue contact for soft tissue in-growth.

7. A percutaneous implant device as recited by claim 1, wherein said suture ring has suture holes adapted for suturing skin surrounding an outer surface of said suture ring.

8. A percutaneous implant device, comprising:

a. a biologically compatible titanium or cobalt-chromium alloy implant stem and a porous tantalum outer body member adapted for bone and soft tissue in-growth;

b. said implant stem having a male tapered fluted stem portion adapted to be inserted into a female tapered cavity drilled within the bone of a broken limb;

c. said implant stem having a cylindrical inner portion extending from and abutting said male tapered fluted stem portion, the cylindrical inner portion having a cylindrical core diameter adapted for press fitting said porous tantalum outer body member thereon;

d. said porous tantalum outer body member having a central aperture with a bore diameter that is smaller than said cylindrical core diameter by an interference amount to integrally mate said porous metal outer body member with said cylindrical inner portion of the implant stem;

e. said implant stem having a suture ring abutting said cylindrical inner portion and located distal from said male tapered fluted stem portion;

f. one end of said porous tantalum outer body member abutting said suture ring;

g. another end of said porous metal outer body member distal from said suture ring having a female taper abutting said male tapered fluted stem portion and being adapted to fit around and mate with a male taper surgically created on a bone end

h. said implant stem having an external member integral to said implant stem extending from said suture ring adapted for attachment to a hand or foot prosthesis;

whereby the porous tantalum outer body is press fitted over the cylindrical inner portion so that said percutaneous implant device functions as a single unit;

whereby said fluted male tapered stem and said female taper of said porous tantalum outer body member are appointed for bone contact for generating bone in-growth;

whereby said suture ring is appointed to be sutured to soft tissue and said porous tantalum body member is appointed to contact soft tissue for generating soft tissue in-growth thereby preventing lateral and longitudinal displacement of said percutaneous implant during healing and promoting bone and soft tissue in-growth.

9. A percutaneous implant device as recited by claim 8, wherein said interference amount for press fitting of said cylindrical inner portion of said implant stem and central aperture of said porous tantalum outer body member is 0.01 to 0.015 mm.

10. A percutaneous implant device as recited by claim 8, wherein said male tapered fluted stem portion is adapted to connect to said female tapered bone cavity with interference.