Transdermal Intraosseous Device

• US 20110190907A1
• Filed: 01/28/2011
• Published: 08/04/2011
• Est. Priority Date: 02/01/2010
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Hershberger, Troy W., Porter, Joshua R.
• Granted Patent: US 8,512,416 B2
• Time in Patent Office: Days
• US Class Current: 623/32
• CPC Class Codes: A61B 17/60 for external osteosynthesis, e.g. distractors, contractors
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• 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 2/78 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
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2250/0023 differing in porosity
• CPC Class Codes: A61F 2250/0025 differing in roughness
• CPC Class Codes: B24C 1/04 for treating only selected parts of a surface, e.g. for carving stone or glass

Abstract

A transdermal intraosseous device includes a transdermal adapter for an external prosthetic device for a bone of a patient and a bone fixator including a distal portion coupled to the transdermal adapter and a proximal portion for anchoring into the bone. The transdermal adapter includes a dome-shaped portion for transcutaneous implantation and an external shaft extending from the dome-shaped portion. A dermal transition structure is configured to include a controlled roughness gradient from the external shaft to the dome-shaped portion and configured for use in infection control at a dermis layer of the patient.

Claims

1. A transdermal intraosseous device comprising:

a transdermal adapter having a longitudinal axis and configured for connection to an external prosthetic device for a bone of a patient, the transdermal adapter including a dome-shaped portion for transcutaneous implantation, an external shaft extending from the dome-shaped portion, and a dermal transition structure configured to include a controlled roughness gradient from the external shaft to the dome-shaped portion and configured for use in infection control at a dermis layer of the patient; and

a bone fixator including a distal portion coupled to the transdermal adapter and a proximal portion configured for anchoring into the bone.

2. The transdermal intraosseous device of claim 1, wherein the dermal transition structure includes a porous metal dome-shaped structure surrounding and overlaying the dome-shaped portion of the transdermal adapter.

3. The transdermal intraosseous device of claim 2, wherein the external shaft and the dome-shaped portion of the transdermal adapter are monolithically coupled.

4. The transdermal intraosseous device of claim 2, wherein the external shaft is metallic and polished.

5. The transdermal intraosseous device of claim 4, wherein the dermal transition structure includes a first transitional surface treatment layer at the external shaft extending directly above the porous metal dome-shaped structure along the longitudinal axis and surrounding a contiguous portion of the external shaft and configured for direct contact with the dermis layer of the patient at the interface between the transdermal adapter and the dermis.

6. The transdermal intraosseous device of claim 5, wherein the first transitional surface treatment layer is a roughness treatment of the contiguous portion of the external shaft.

7. The transdermal intraosseous device of claim 6, wherein the roughness treatment of the first transitional surface treatment layer is selected from ceramic bead blasting, sand blasting and grit blasting.

8. The transdermal intraosseous device of claim 6, wherein the dermal transition structure includes a second transitional surface treatment layer contiguous to the first transitional surface treatment layer at the interface between the transdermal adapter and the dermis layer along the longitudinal axis, the second transitional layer comprising a combination of blasting treatment and acid etching configured for contact with the dermis layer of the patient

9. The transdermal intraosseous device of claim 8, wherein the dome-shaped portion includes an internal bore receiving the distal portion of the bone fixator with a taper connection therebetween.

10. The transdermal intraosseous device of claim 9, wherein the bone fixator includes a compliant biasing member within a bore in the distal portion of the bone fixator, wherein the compliant biasing member is pre-stressed and configured to provide a compressive force to the bone.

11. The transdermal intraosseous device of claim 10, further comprising a centering sleeve having an outer surface configured to be engageable with a bore in the bone and an inner surface receiving the proximal portion of the bone fixator.

12. The transdermal intraosseous device of claim 11, wherein the outer surface of the centering sleeve is patient-specific and configured to mate with the bore of the bone based on a preoperative plan for the patient.

13. The transdermal intraosseous device of claim 1, wherein the dome shaped portion of the transdermal adapter includes an extension with a circumferential groove coupled to a redundant connector between the bone fixator and the transdermal adapter.

14. The transdermal intraosseous device of claim 2, wherein the porous metal dome-shaped structure has an average porosity of about 67 percent.

15. The transdermal intraosseous device of claim 2, wherein the porous metal dome-shaped structure has pore size ranging from about 100 to about 600 microns.

16. The transdermal intraosseous device of claim 2, wherein the porous metal dome-shaped structure has average pore size of about 300 microns.

17. The transdermal intraosseous device of claim 8, wherein the first transitional surface treatment layer has a greater roughness than the second transitional surface treatment layer.

18. A transdermal intraosseous device comprising:

a transdermal adapter configured for connection to an external prosthetic device for a bone, the transdermal adapter including;

a metal dome-shaped portion configured for transcutaneous implantation;

a polished external shaft having a longitudinal axis and extending from the metal dome-shaped portion; and

a dermal transition structure defining a controlled roughness gradient from the dome-shaped portion of the transdermal adapter to the external shaft and configured for engagement with a dermis layer of the patient for infection control, the dermal transition structure including a porous metal dome-shaped structure surrounding and overlaying the dome-shaped portion of the transdermal adapter and first and second transitional surface treatment layers between the polished external shaft and the porous metal dome-shaped structure along the longitudinal axis, the first transitional surface treatment layer roughened by blasting and configured for contact with the dermis layer and the second transitional surface treatment layer roughened by a combination of blasting treatment and acid-etching treatment and configured for contact with dermis layer; and

a bone fixator including a distal portion coupled to the transdermal adapter and a proximal portion configured for anchoring into the bone.

19. The transdermal intraosseous device of claim 18, wherein the bone fixator includes a compliant biasing member within a bore in the distal portion of the bone fixator, wherein the compliant biasing member is pre-stressed and configured to provide compressive force to the bone.

20. The transdermal intraosseous device of claim 18, wherein the blasting treatment is selected from ceramic bead blasting, sand blasting and grit blasting.

21. The transdermal intraosseous device of claim 18, further comprising a centering sleeve having an outer surface configured engageable with a bore in the bone and an inner surface receiving the proximal portion of the bone fixator.

22. The transdermal intraosseous device of claim 18, wherein the porous metal dome-shaped structure has an average porosity of about 67 percent.

23. The transdermal intraosseous device of claim 18, wherein the porous metal dome-shaped structure has pore size ranging from about 100 to about 600 microns.

24. The transdermal intraosseous device of claim 18, wherein the porous metal dome-shaped structure has average pore size of about 300 microns.

25. The transdermal intraosseous device of claim 18, wherein the first transitional surface treatment layer has a greater roughness than the second transitional surface treatment layer.

26. A method for forming a controlled roughness gradient transition between an external prosthetic device for a bone of a patient and the corresponding dermis of the patient, the method comprising:

positioning a porous metal dome-shaped structure around a metal dome-shaped portion of a transdermal adapter;

roughening a first portion of an external shaft extending from the dome-shaped portion of the transdermal adapter by blasting to a first roughness, the first portion extending above the porous metal dome-shaped structure along a longitudinal axis of the external shaft; and

roughening a second portion of the external shaft by a combination of blasting and acid etching to a second roughness, the second portion extending above the first portion along the longitudinal axis of the external shaft,

wherein the porous metal dome-shaped portion and the first and second portions of the external shaft are configured to contact the dermis for infection control

27. The method of claim 26, wherein the porous metal dome-shaped structure has an average porosity of about 67 percent.

28. The method of claim 26, wherein the porous metal dome-shaped structure has pore size ranging from about 100 to about 600 microns.

29. The method of claim 26, wherein the porous metal dome-shaped structure has average pore size of about 300 microns.

30. The method of claim 26, wherein the first portion of the external shaft has a greater roughness than the second portion.