Transdermal intraosseous device

• US 8,512,416 B2
• Filed: 01/28/2011
• Issued: 08/20/2013
• 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: Porter, Joshua R., Hershberger, Troy W.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Hoffman, Marcia
• Application Number:
  US13/016,766
• Publication Number:
  US 20110190907A1
• Time in Patent Office: 935 Days
• Field of Search: 623/27, 623/32, 623/38, 623/53, 623/16.11, 623/23.46, 623/23.55, 623/23.57
• 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 configured for connection to an external prosthetic device and configured for use with a bone, the transdermal adapter including;

a metal dome-shaped portion configured for transcutaneous implantation;

a polished metal 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 polished metal external shaft and configured for engagement with a dermis layer of a 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;

a first transitional surface treatment layer and a second transitional surface treatment layer both between a sidewall of the polished external shaft and the porous metal dome-shaped structure, the first and second layers aligned along the longitudinal axis of the polished metal external shaft;

the first transitional surface treatment layer roughened by blasting and configured for direct engagement with the dermis layer upon implantation of the device; and

the second transitional surface treatment layer roughened by a combination of blasting treatment and acid-etching treatment and configured for direct engagement with the dermis layer upon implantation of the device; and

a bone fixator including a tapered distal portion received into a tapered bore of the dome-shaped portion of the transdermal adapter via a taper-to-taper connection, a proximal portion configured for anchoring into the bone and a skirt-shaped collar between the distal portion and the proximal portion;

wherein the first transitional surface treatment layer is contiguous with the porous metal dome-shaped structure and is between the porous metal dome-shaped structure and the second transitional surface treatment layer, which abuts the sidewall of the polished metal external shaft; and

wherein the first and the second transitional surface treatment layers provide a gradual transition from the polished metal external shaft to a rough surface of the porous metal dome-shaped structure through the first and the second transitional surface treatment layers, the first transitional surface treatment layer has a greater roughness than the second transitional surface treatment layer.

2. 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.

3. The transdermal intraosseous device of claim 1, wherein the bone fixator includes a compliant biasing member within a bore formed 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.

4. The transdermal intraosseous device of claim 1, wherein the blasting treatment is selected from ceramic bead blasting, sand blasting and grit blasting.

5. The transdermal intraosseous device of claim 1, further comprising a centering sleeve having an outer surface engageable with a bore in the bone and an inner surface receiving the proximal portion of the bone fixator.

6. The transdermal intraosseous device of claim 1, wherein an outer surface of a centering sleeve is patient-specific and configured to mate with a bore of the bone based on a preoperative plan for the patient.

7. The transdermal intraosseous device of claim 1, wherein the porous metal dome-shaped structure has an average porosity of about 67 percent.

8. The transdermal intraosseous device of claim 1, wherein the porous metal dome-shaped structure has pore size ranging from about 100 to about 600 microns.

9. The transdermal intraosseous device of claim 1, wherein the porous metal dome-shaped structure has average pore size of about 300 microns.

10. The transdermal intraosseous device of claim 1, wherein the first and second transitional surface treatment layers extend annularly about the polished metal external shaft.

11. The transdermal intraosseous device of claim 1, wherein the first and second transitional surface treatment layers are each configured to align with the dermis layer.