INTERNAL OSSEOINTEGRATED IMPLANT FOR TRANSFEMORAL AMPUTEE
20220218488 ยท 2022-07-14
Inventors
Cpc classification
A61F2002/30578
HUMAN NECESSITIES
A61F2002/3092
HUMAN NECESSITIES
A61F2310/00023
HUMAN NECESSITIES
A61F2002/30772
HUMAN NECESSITIES
A61F2310/00005
HUMAN NECESSITIES
A61F2/3609
HUMAN NECESSITIES
A61F2002/30433
HUMAN NECESSITIES
A61F2002/421
HUMAN NECESSITIES
A61B17/17
HUMAN NECESSITIES
International classification
Abstract
The present invention is an internal osseointegrated transfemoral amputee implant device and related methods. The device is designed to restore the enclosed nature of the bone marrow system which is disrupted by amputation, plus provide a pressure tolerant (weight-bearing) surface and mechanical anchoring for the iliotibial band.
Claims
1. An implant device for a person having an amputation, the device comprising: a. a distal, weight bearing head having a substantially convex surface; b. a stem for insertion into a bone of said amputee; and c. a soft tissue attachment member, wherein no portion of said device traverses the skin of said person.
2. The device of claim 1, wherein said substantially convex surface is elongated to prevent lateral movement of the weight bearing head.
3. The device of claim 1, wherein said weight bearing head comprises a thermoplastic material.
4. The device of claim 1, wherein said stem comprises a porous surface operable to become osseointegrated with said bone.
5. The device of claim 1, wherein said stem comprises a protrusion for preventing twisting of the stem in relation to the bone.
6. The device of claim 1, wherein said stem comprises at least one of titanium and a thermoplastic.
7. The device of claim 1, wherein said stem comprises at least one of a tapered shape and an shape complementary to a natural shape of a medullary cavity of said bone.
8. The device of claim 1, wherein said stem comprises a length of about 50 mm or less.
9. The device of claim 1, wherein said bone comprises a femur and said amputation comprises a transfemoral amputation.
10. The device of claim 1, wherein said bone comprises at least one of a tibia, a fibula, a radius, an ulna, and a humerus, and said amputation comprises at least one of a transtibial, a transfibular, a transradial, a transulnar, and a transhumeral amputation.
11. The device of claim 1, wherein said stem is inserted into a medullary cavity of said bone.
12. The device of claim 1, wherein said soft tissue attachment member comprises a tab having a shape complementary to a slot in said weight bearing head, said tab comprising at least one securing device for securing said tab in said slot.
13. The device of claim 12, wherein said securing device comprises a screw.
14. The device of claim 12, wherein said soft tissue attachment member is operable to secure a tendon, a muscle, or another similar type of soft tissue of said person to said weight bearing head.
15. The device of claim 1, further comprising a drilling guide for shaping a surface of said bone such that said surface of said bone is complementary to a shape of said stem.
16. The device of claim 15, wherein said drilling guide comprises a plurality of approaches for shaping said surface of said bone.
17. The device of claim 16, wherein said plurality of approaches comprises a first approach for forming a taper on said surface of said bone, and a second approach for forming a groove in said surface, said groove having a shape complementary to a shape of a protrusion of said stem.
18. The device of claim 15, wherein said drilling guide comprises a central axis substantially parallel with a central axis of said bone.
19. A method of implanting an implant device for a person having an amputation, the method comprising the steps of: a. providing said implant device, said implant device comprising a distal weight bearing head having an elongated, substantially convex shape, and a stem for inserting into a bone of said person, said stem comprising a porous material for osseointegration with said bone; b. inserting said stem into said bone; and c. closing the skin of said patient such that the entire implant device is under said skin.
20. The method of claim 19, further comprising the steps of: a. providing a drilling guide having at least one approach for shaping a surface of said bone; and b. shaping a surface of said bone using said drilling guide such that said surface comprises a shape complementary to a shape of said stem.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0017]
[0018]
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0019] Reference will now be made in detail to certain embodiments of the invention, examples of which are illustrated in the accompanying drawings. While the invention will be described in reference to these embodiments, it will be understood that they are not intended to limit the invention. To the contrary, the invention is intended to cover alternatives, modifications, and equivalents that are included within the spirit and scope of the invention as defined by the claims. In the following disclosure, specific details are given to provide a thorough understanding of the invention. However, it will be apparent to one skilled in the art that the present invention may be practiced without these specific details.
[0020] As shown in
[0021] The weight bearing head may be attached to a stem 101 for insertion into a conditioned medullary cavity B of the amputee. In some embodiments, the stem 101 comprises a porous surface operable to become osseointegrated with the bone A. In some embodiments, the stem 101 comprises at least one of a tapered shape and a shape complementary to a natural shape of a medullary cavity B of the bone. In some embodiments, the stem 101 comprises a length of about 50 mm or less. In some embodiments, the stem 101 comprises a protrusion for preventing twisting of the stem in relation to the bone.
[0022] The device 100 may also include a soft tissue anchoring device 105 for attachment of an iliotibial band of the amputee. In some embodiments, the soft tissue attachment member 105 comprises a tab 106 having a shape complementary to a slot in the weight bearing head, the tab comprising at least one securing device 107 for securing the tab in the slot. In some embodiments, the securing device 107 comprises a screw or pin to secure the tab 106. In some embodiments, the soft tissue attachment member is operable to secure a tendon, a muscle, or another similar type of soft tissue of the person to the weight bearing head. The soft tissue anchoring mechanism may be for tethering the iliotibial band. This is done to provide additional hip abduction torque for the limb.
[0023] In some embodiments, the bone comprises a femur and the amputation comprises a transfemoral amputation. In some embodiments, the bone comprises at least one of a tibia, a fibula, a radius, an ulna, and a humerus, and the amputation comprises at least one of a transtibial, a transfibular, a transradial, a transulnar, and a transhumeral amputation. In some embodiments, the stem is inserted into a medullary cavity of the bone.
[0024] It should be understood that the foregoing descriptions of specific embodiments of the present invention have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed, and obviously many modifications and variations are possible in light of the above teachings. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, and to thereby enable others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated.