Transdermal intraosseous device

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.

1 - 20 . (canceled) 
     
     
         21 . A transdermal intraosseous device comprising:
 a transdermal adapter comprising:
 a dome-shaped portion for transcutaneous implantation, the dome shaped portion including a porous metal dome-shaped structure configured to engage a dermis layer of a patient; and 
 a shaft extending from the dome-shaped portion along a longitudinal axis, the shaft comprising:
 a polished portion configured to extend external of the dermis layer; and 
 a dermal transition structure extending axially along the shaft distally from the porous metal dome-shaped structure to the polished external shaft portion, the dermal transition structure including a first surface treatment layer contiguous to a second surface treatment layer, each of the first and second transitional surface treatment layers configured to directly contact the dermis layer of the patient, the first transitional surface treatment layer having a first roughness greater than a second roughness of the second transitional surface treatment layer to provide a controlled roughness gradient from the polished portion through the first and second transitional surface treatment layers and to the dome-shaped portion. 
 
   
     
     
         22 . The transdermal intraosseous device of  claim 21 , further comprising:
 a bone fixator including a distal portion couplable to the transdermal adapter and including a proximal portion configured to anchor in the bone.   
     
     
         23 . The transdermal intraosseous device of  claim 21 , wherein the external shaft and the dome-shaped portion of the transdermal adapter are monolithically coupled. 
     
     
         24 . The transdermal intraosseous device of  claim 21 , wherein the polished external shaft portion extends directly distal of the dermal transition structure along the longitudinal axis. 
     
     
         25 . The transdermal intraosseous device of  claim 24 , wherein the first transitional surface treatment layer is a roughness treatment of the external shaft. 
     
     
         26 . The transdermal intraosseous device of  claim 25 , 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, and 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. 
     
     
         27 . The transdermal intraosseous device of  claim 21 , wherein the porous metal dome-shaped structure has an average porosity of 67 percent. 
     
     
         28 . The transdermal intraosseous device of  claim 21 , wherein the porous metal dome-shaped structure has a pore size ranging from 100 to 600 microns. 
     
     
         29 . A transdermal intraosseous device comprising:
 a transdermal adapter comprising:
 a dome-shaped portion for transcutaneous implantation, the dome shaped portion including a porous metal dome-shaped structure configured to engage a dermis layer of a patient; and 
 a shaft extending from the dome-shaped portion along a longitudinal axis, the shaft comprising:
 a polished portion configured to extend external of the dermis layer; and 
 a dermal transition structure extending axially along the shaft distally from the porous metal dome-shaped structure to the polished external shaft portion, the dermal transition structure including a first surface portion and a second surface portion configured to directly contact the dermis layer of the patient, the first surface portion having a first roughness greater than a second roughness of the second surface portion. 
 
   
     
     
         30 . The transdermal intraosseous device of  claim 29 , further comprising:
 a bone fixator including a distal portion couplable to the transdermal adapter and including a proximal portion configured for anchoring into the bone.   
     
     
         31 . The transdermal intraosseous device of  claim 30 , wherein the dome-shaped portion includes an internal bore configured to receive the distal portion of the bone fixator therein. 
     
     
         32 . The transdermal intraosseous device of  claim 31 , wherein the bone fixator includes a compliant biasing member within a bore in the distal portion of the bone fixator, and wherein the compliant biasing member is pre-stressed and configured to provide a compressive force to the bone. 
     
     
         33 . The transdermal intraosseous device of  claim 32 , further comprising:
 a centering sleeve including an outer surface configured to be engageable with a bore in the bone and including an inner surface configured to receive the proximal portion of the bone fixator.   
     
     
         34 . The transdermal intraosseous device of  claim 29 , further comprising:
 a connector securable to an intermediate portion of the bone fixator and securable to the transdermal adapter.   
     
     
         35 . The transdermal intraosseous device of  claim 34 , wherein the transdermal adapter includes an extension extending proximally from the dome shaped portion and configured to extend toward the bone, the extension defining a circumferential groove. 
     
     
         36 . The transdermal intraosseous device of  claim 35 , wherein the connector is securable to the circumferential groove of the extension. 
     
     
         37 . The transdermal intraosseous device of  claim 36 , wherein the connector is a two-piece split locking nut. 
     
     
         38 . A transdermal intraosseous device comprising:
 a transdermal adapter comprising:
 a dome-shaped portion for transcutaneous implantation, the dome shaped portion including a porous metal dome-shaped structure configured to engage a dermis layer of a patient; and 
 a shaft extending from the dome-shaped portion along a longitudinal axis, the shaft comprising:
 a polished portion configured to extend external of the dermis layer; and 
 a dermal transition structure extending along the shaft distally from the porous metal dome-shaped structure to the polished external shaft portion, the dermal transition structure including a first surface portion and a second surface portion adjacent to the first surface portion, the first surface portion and the second surface portion configured to directly contact the dermis layer of the patient, the first surface portion having a first roughness greater than a second roughness of the second surface portion. 
 
   
     
     
         39 . The transdermal intraosseous device of  claim 38 , further comprising:
 a bone fixator including a distal portion coupled to the transdermal adapter and a proximal portion configured for anchoring into the bone.   
     
     
         40 . The transdermal intraosseous device of  claim 39 , 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, wherein the dome-shaped portion includes an internal bore receiving the distal portion of the bone fixator with a taper connection therebetween,
 and 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.