Transdermal prosthesis

• US 8,915,970 B2
• Filed: 02/08/2013
• Issued: 12/23/2014
• Est. Priority Date: 02/08/2013
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Porter, Joshua R., Hershberger, Troy W.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): BAHENA, CHRISTIE L.
• Application Number:
  US13/762,744
• Publication Number:
  US 20140228973A1
• Time in Patent Office: 683 Days
• Field of Search: 623/16.11, 623/23.44, 623/27, 623/32, 623/33, 623/54
• US Class Current: 623/32
• CPC Class Codes: A61F 2/2814 Bone stump caps
• 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 2002/7887 for connecting limb exoprostheses to the stump bone

Abstract

A transdermal implant assembly including a transdermal bone fixator configured for anchoring into a bone. The fixator includes a longitudinally extending shaft configured to be received into a recess of the bone, and a spindle defining a cavity. A compliant biasing member is disposed within the cavity and an end cap is removably coupled to the spindle to seal the cavity. The compliant biasing member is accessible for adjustments from the external environment.

Claims

1. A transdermal implant assembly for attaching an external prosthesis to a bone of a patient, the transdermal implant assembly comprising:

a transdermal bone fixator configured for anchoring into a recess of the bone, the transdermal bone fixator including;

a longitudinally extending shaft configured to be received into the recess of the bone;

a spindle defining a cavity, the spindle having a proximal end and a distal end, wherein the distal end extends a distance past a dermis layer of the patient and is exposed to an environment external from the patient;

a compliant biasing member disposed within the cavity; and

an end cap removably coupled to the spindle and configured to seal the cavity;

a prosthesis adapter coupled to the spindle and configured for connection to an external prosthetic device that is operable for use with the bone,

wherein the compliant biasing member is accessible upon removal of the end cap for adjustments from the external environment.

2. The transdermal implant assembly of claim 1, further comprising at least one sensor configured to measure an operational parameter of the transdermal implant.

3. The transdermal implant assembly of claim 2, wherein the at least one sensor comprises a force sensor configured to measure a parameter of the compliant biasing member.

4. The transdermal implant assembly of claim 2, wherein the at least one sensor is responsive to infections in the implant and monitors at least one physiological parameter selected from the group consisting of temperature, pressure, pH, electrical potential, and oxygen saturation.

5. The transdermal implant assembly of claim 2, wherein the at least one sensor is configured to transmit data using wireless communication technology.

6. The transdermal implant assembly of claim 1, further comprising an ingrowth collar disposed between the shaft and the proximal end of the spindle and configured for transcutaneous implantation.

7. The transdermal implant assembly of claim 6, wherein the ingrowth collar comprises porous titanium.

8. The transdermal implant assembly of claim 1, wherein the ingrowth collar comprises a biocompatible coating providing a substantially dome-shaped profile disposed adjacent the dermis layer.

9. The transdermal implant assembly of claim 1, further comprising an anchor fully retained within the recess of the bone and configured to secure the transdermal bone fixator to the bone, the anchor including a stem portion extending through the shaft of the transdermal bone fixator and into the cavity of the spindle.

10. The transdermal implant assembly of claim 9, further comprising an adjustment nut coupled to the stem portion of the anchor and configured to adjust a force exerted by the compliant biasing member.

11. The transdermal implant assembly of claim 10, wherein the end cap is configured to be removed to allow access to the adjustment nut transdermally for adjusting the force after implantation of the transdermal bone fixator.

12. The transdermal implant assembly of claim 1, wherein an exterior of the spindle is tapered and the distal end of the spindle is coupled with a tapered bore defined within the prosthesis adapter.

13. The transdermal implant assembly of claim 1, wherein the shaft, spindle, and ingrowth collar of the transdermal fixator are formed as a monolithic component.

14. The transdermal implant assembly of claim 1, further comprising at least one channel in fluid communication with both the cavity of the spindle and the recess of the bone.

15. The transdermal implant assembly of claim 1, further comprising a centering sleeve having an outer surface configured to engage with the recess in the bone and an inner surface configured to receive the longitudinally extending shaft of the transdermal bone fixator.

16. A transdermal implant assembly for attaching an external prosthesis to a bone of a patient, the transdermal implant assembly comprising:

an anchor disposed in and secured to a recess formed in the bone, the anchor including a longitudinally extending stem;

a transdermal bone fixator coupled to the anchor, the transdermal bone fixator including;

a longitudinally extending shaft configured to be received into the recess formed in the bone;

a spindle defining a cavity, the spindle having a proximal end and a distal end, wherein the distal end extends a distance past a dermis layer of the patient and is exposed to an environment external from the bone of the patient;

a compliant biasing member disposed within the cavity, wherein the compliant biasing member is pre-stressed and configured to provide a compressive force to the bone;

an adjustment member disposed in the cavity and threadably coupled to the longitudinally extending anchor stem, the adjustment member being accessible from the external environment for adjusting the compliant biasing member without removing the spindle;

a prosthesis adapter coupled to the spindle and configured for connection to an external prosthetic device that is operable for use with the bone.

17. The transdermal implant assembly of claim 16, further comprising an end cap removably coupled to the spindle and configured to seal the cavity.

18. The transdermal implant assembly of claim 16, further comprising an adjustment tool configured to engage the adjustment member after the transdermal bone fixator is implanted.

19. The transdermal implant assembly of claim 16, wherein the adjustment tool is configured to be manipulated external to the transdermal bone fixator and engage and move the adjustment member only by removing one member connected to the transdermal bone fixator.

20. A method of implanting a transdermal implant assembly into a patient, the method comprising:

exposing and preparing a bone to receive a transdermal bone fixator;

the transdermal bone fixator comprising;

a longitudinally extending shaft configured to be received into the bone; and

a spindle having a proximal end and a distal end, wherein the distal end is configured to extend a distance past a dermis layer of the patient;

a compliant biasing member disposed within an interior of the spindle;

implanting the shaft of the transdermal bone fixator into the bone;

exposing at least a portion of the spindle to an environment external from the patient;

setting the compliant biasing member to exert a first force;

monitoring the force of the compliant biasing member; and

accessing the interior of the spindle and adjusting the compliant biasing member to exert a second force after the transdermal implant assembly is implanted in the bone of the patient.

21. The method of claim 20, further comprising:

implanting, below the dermis layer of an implantation site, a porous ingrowth member and closing the implantation site, allowing the dermis layer to integrate with the porous ingrowth member prior to exposing and preparing the bone;

resecting an area of the dermis layer adjacent to and including the porous ingrowth member; and

implanting the transdermal bone fixator, wherein at least a portion of the spindle is configured to pass through a bore defined in the porous ingrowth member.

22. The method of claim 21, wherein the bore of the porous ingrowth member and an exterior of the spindle define mating tapered surfaces operable to provide a tapered junction between the bore and spindle, and the method further comprises providing at least one elastomeric sealing member at the tapered junction.

23. The method of claim 20, wherein accessing the interior of the spindle comprises removing an end cap of the transdermal implant assembly.