Transdermal intraosseous device

• US 10,166,125 B2
• Filed: 12/18/2015
• Issued: 01/01/2019
• 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): Watkins, Marcia
• Application Number:
  US14/974,636
• Publication Number:
  US 20160100961A1
• Time in Patent Office: 1,110 Days
• 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 use with a bone of a patient, the transdermal adapter including;

a dome-shaped portion for transcutaneous implantation,

a porous metal dome-shaped structure at least partially overlaying the dome-shaped portion,

an external shaft extending from the dome-shaped portion, the external shaft including a polished external shaft portion, and

a dermal transition structure extending axially from the porous metal dome-shaped structure to the polished external shaft portion, the dermal transition structure including a first transitional surface treatment layer contiguous to a second transitional surface treatment layer such that a common border of the first and second transitional surface treatment layers is located along the longitudinal axis and each of the first and second transitional surface treatment layers extends along the external shaft distal of the dome-shaped portion, each of the first and second transitional surface treatment layers configured to directly contact a dermis layer of the patient for infection control upon implantation thereof, the first transitional surface treatment layer having a greater roughness than the second transitional surface treatment layer to provide a controlled roughness gradient from the external shaft to the dome-shaped portion for controlling infection at the dermis layer of the patient, wherein a first surface treatment of the first transitional surface treatment layer is different than a second surface treatment of the second transitional surface treatment layer; 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 external shaft and the dome-shaped portion of the transdermal adapter are monolithically coupled.

3. The transdermal intraosseous device of claim 1, wherein the polished external shaft portion extends directly distal of the dermal transition structure along the longitudinal axis.

4. The transdermal intraosseous device of claim 3, wherein the first transitional surface treatment layer is a roughness treatment of the external shaft.

5. The transdermal intraosseous device of claim 4, wherein the roughness treatment of the first transitional surface treatment layer is selected from the group consisting of ceramic bead blasting, sand blasting and grit blasting.

6. The transdermal intraosseous device of claim 4, wherein the second transitional surface treatment layer comprises a combination of blasting treatment and acid etching to configure the second transitional surface treatment layer for contact with the dermis layer of the patient.

7. The transdermal intraosseous device of claim 6, wherein the dome-shaped portion includes an internal bore receiving the distal portion of the bone fixator with a taper connection therebetween.

8. The transdermal intraosseous device of claim 7, 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.

9. The transdermal intraosseous device of claim 8, 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.

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

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

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

13. A transdermal intraosseous device comprising:

a transdermal adapter including a longitudinal axis and configured for connection to an external prosthetic device for use with a bone of a patient, the transdermal adapter including;

a dome-shaped portion for transcutaneous implantation;

a porous metal dome-shaped structure at least partially surrounding and overlaying the dome-shaped portion of the transdermal adapter; and

an external shaft extending from the dome-shaped portion, the external shaft including;

a first transitional surface treatment layer adjacent the porous metal dome-shaped structure, the first transitional surface treatment layer contiguous to a second transitional surface treatment layer, each of the first and second transitional surface treatment layers extending along the external shaft distal of the dome-shaped portion; and

a polished external shaft portion contiguous to the second transitional surface treatment layer; and

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

wherein the porous metal dome-shaped structure has a greater roughness than the first transitional surface treatment layer, the first transitional surface treatment layer has a greater roughness than the second transitional surface treatment layer, and the second transitional surface treatment layer having a greater roughness than the polished external shaft portion, and wherein the first and second transitional surface treatment layers and the porous metal dome-shaped structure are configured to create a roughness gradient from the porous metal dome-shaped structure to the polished external shaft portion with each layer of the roughness gradient being configured to directly contact a dermis layer of the patient for infection control upon implantation thereof.