Transcutaneous implant for skeletal attachment of external prosthetic devices

Abstract

Provided herein are devices and methods for connecting a transcutaneous external prosthetic device to a bone, such as a bone of an amputee. The device is a two-piece transcutaneous implant device to provide reversible connection for ease of implantation, reliability, and relatively easy access for removal, while maximizing tissue ingrowth to reduce risk of infection and attendant adverse outcomes. The devices provided herein comprise a prosthetic interface and a bone anchor. A through-hole that traverses a longitudinal length of the prosthetic interface and at least a longitudinal portion of the bone anchor receives a fastener to reversibly connect the prosthetic interface to the bone anchor implanted in bone. A connector may connect to a failsafe element which, in turn, connects to an external prosthetic device.

1 . (canceled) 
     
     
         2 . A transcutaneous device to anchor an external prosthetic device to a bone, the transcutaneous device comprising:
 a bone anchor implantable into bone and defining a longitudinal length, the bone anchor including a male end configured to extend from the bone along the longitudinal length;   a prosthetic interface configured for implantation external to the bone and configured to receive the male end of the bone anchor to secure the prosthetic interface to the bone anchor; and   a connector releasably securable to the prosthetic interface, the connector configured to optionally connect to a prosthetic and to a failsafe external to the bone and external to soft tissue.   
     
     
         3 . The transcutaneous device of  claim 2 , wherein the prosthetic interface and the bone anchor are configured to mate through a tapered interference fit. 
     
     
         4 . The transcutaneous device of  claim 3 , further comprising:
 a fastener securable to the prosthetic interface and the bone anchor.   
     
     
         5 . The transcutaneous device of  claim 4 , wherein the fastener is configured to reversibly secure the prosthetic interface to the bone anchor and is removable from the bone anchor and the prosthetic interface external to the soft tissue and the bone. 
     
     
         6 . The transcutaneous device of  claim 4 , wherein the fastener is an axial taper bolt positioned beneath the connector. 
     
     
         7 . The transcutaneous device of  claim 2 , wherein the prosthetic interface is configured for soft tissue ingrowth and vascularization after implantation. 
     
     
         8 . The transcutaneous device of  claim 2 , wherein the connector is a pyramid connector. 
     
     
         9 . A transcutaneous assembly to anchor an external prosthetic device to a bone, the transcutaneous assembly comprising:
 a bone anchor implantable into bone and defining a longitudinal length, the bone anchor including a male end configured to extend from the bone along the longitudinal length;   a prosthetic interface configured for implantation external to the bone and configured to receive the male end of the bone anchor to secure the prosthetic interface to the bone anchor; and   a connector releasably securable to the prosthetic interface and optionally releasably couplable to a prosthetic external to the bone and external to soft tissue; and   a failsafe optionally releasably couplable to the connector external to the bone and external to the soft tissue.   
     
     
         10 . The transcutaneous assembly of  claim 9 , wherein the failsafe includes:
 a first clamp connectable to the connector;   a central tube connectable to the first clamp, the central tube configured to fail by bending when a predetermined moment is applied to the central tube; and   a second clamp connectable to the central tube and to the prosthetic, the first clamp and the second clamp configured to rotate with respect to the central tube when a predetermined torque load is applied to at least one of the first clamp or the second clamp.   
     
     
         11 . The transcutaneous assembly of  claim 10 , wherein the failsafe includes:
 a plurality of set screws securable to the first clamp to couple the first clamp to the connector.   
     
     
         12 . The transcutaneous assembly of  claim 9 , wherein the connector is a pyramid connector. 
     
     
         13 . The transcutaneous assembly of  claim 12 , wherein the connector is threadably securable to a threaded interface of a body of the prosthetic interface. 
     
     
         14 . The transcutaneous assembly of  claim 13 , wherein the threaded interface of the body of the prosthetic interface is configured to receive a distraction bolt when the connector is removed. 
     
     
         15 . The transcutaneous assembly of  claim 9 , wherein the prosthetic interface and the bone anchor are configured to mate through a tapered interference fit. 
     
     
         16 . The transcutaneous assembly of  claim 15 , further comprising:
 a fastener securable to the prosthetic interface and the bone anchor.   
     
     
         17 . The transcutaneous assembly of  claim 15 , wherein the fastener is configured to reversibly secure the prosthetic interface to the bone anchor and is removable from the bone anchor and the prosthetic interface external to the soft tissue and the bone. 
     
     
         18 . The transcutaneous assembly of  claim 15 , wherein the fastener is an axial taper bolt positioned beneath the connector. 
     
     
         19 . The transcutaneous assembly of  claim 9 , wherein the prosthetic interface is configured for soft tissue ingrowth and vascularization after implantation. 
     
     
         20 . A transcutaneous device to anchor an external prosthetic device to a bone, the transcutaneous device comprising:
 a bone anchor implantable into bone and defining a longitudinal length, the bone anchor including a male end configured to extend from the bone along the longitudinal length;   a prosthetic interface configured for implantation external to the bone and configured to receive the male end of the bone anchor to secure the prosthetic interface to the bone anchor; and   a pyramid connector releasably securable to the prosthetic interface, the pyramid connector connectable to a prosthetic external to the bone and soft tissue and connectable to a failsafe external to the bone and the soft tissue.   
     
     
         21 . The transcutaneous device of  claim 20 , further comprising:
 a bolt securable to the prosthetic interface and the bone anchor to reversibly secure the prosthetic interface to the bone anchor, the bolt removable from the bone anchor and the prosthetic interface external to the soft tissue and the bone, the bolt positioned beneath the connector.   
     
     
         22 . The transcutaneous device of  claim 21 , wherein the prosthetic interface is configured for soft tissue ingrowth and vascularization after implantation, and wherein the prosthetic interface and the bone anchor are configured to mate through a tapered interference fit.