Osteosynthetic shape memory material intramedullary bone stent and method for treating a bone fracture using the same

• US 9,283,006 B2
• Filed: 09/21/2012
• Issued: 03/15/2016
• Est. Priority Date: 09/22/2011
• Status: Active Grant

• Current Assignee: Arthrex Incorporated
• Original Assignee: MX Orthopedics Corp
• Inventors: Fonte, Matthew
• Primary Examiner(s): Hammond, Ellen C
• Assistant Examiner(s): Bray, Stuart S
• Application Number:
  US13/624,643
• Publication Number:
  US 20130123785A1
• Time in Patent Office: 1,271 Days
• Field of Search: 606 62- 68
• US Class Current: 1/1
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/7208 Flexible pins, e.g. ENDER pins
• CPC Class Codes: A61B 17/7216 for bone lengthening or compression A61B17/7258 takes precedence
• CPC Class Codes: A61B 17/7225 for bone compression
• CPC Class Codes: A61B 17/7266 with fingers moving radially outwardly
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/00867 shape memory effect

Abstract

A method for providing stabilization and compression of a bone fracture, the method comprising: providing an intramedullary prosthesis sized for insertion into the intramedullary canal of a bone and having a distal end, a proximal end and a porous structure therebetween, wherein (i) in a first state, the prosthesis is longitudinally expanded and radially contracted, and (ii) in a second state, the prosthesis is longitudinally contracted and radially expanded, conforms to the shape of the adjacent bone and exerts forces on the adjacent bone; and positioning the intramedullary prosthesis within the intramedullary canal of a bone so that the intramedullary prosthesis spans the bone fracture, whereby to provide stabilization and compression of the bone fracture.

Claims

1. A method for providing stabilization and compression of a bone fracture, the method comprising:

providing an intramedullary prosthesis sized for insertion into the intramedullary canal of a bone, the intramedullary prosthesis consisting of a metallic mesh structure having a round cannulated mesh body terminating in a distal end and a proximal end, and at least two barbs projecting from the round cannulated mesh body;

positioning the intramedullary prosthesis within the intramedullary canal of the bone so that the round cannulated mesh body spans the bone fracture, with at least one of the at least two barbs being disposed on one side of the bone fracture and at least one of the at least two barbs being disposed on the other side of the bone fracture; and

radially expanding and longitudinally contracting the round cannulated mesh body so that the at least two barbs grip the side wall of the intramedullary canal on either side of the bone fracture and pull the bone segments on either side of the bone fracture together, whereby to provide stabilization and compression of the bone fracture.

2. A method according to claim 1 wherein the intramedullary prosthesis comprises a porous structure.

3. A method according to claim 2 wherein the porous structure comprises a stent.

4. A method according to claim 3 wherein the stent comprises Z struts.

5. A method according to claim 3 wherein the stent comprises W struts.

6. A method according to claim 3 wherein the stent comprises Z struts and W struts.

7. A method according to claim 1 wherein the intramedullary prosthesis is self-expanding.

8. A method according to claim 7 wherein the intramedullary prosthesis comprises a shape memory alloy.

9. A method according to claim 8 wherein the shape memory alloy comprises Nitinol.

10. A method according to claim 1 wherein, when the intramedullary prosthesis is in a radially expanded and longitudinally contracted state, the intramedullary prosthesis applies hoop stress radially to the side wall of the intramedullary canal and applies compressive force longitudinally to the side wall of the intramedullary canal so as to close the gap across the bone fracture.

11. A method according to claim 10 wherein the hoop stress is generated by the radial expansion of the intramedullary prosthesis and the compressive force is generated by the foreshortening of the intramedullary prosthesis.

12. A method according to claim 1 wherein the intramedullary prosthesis has a modulus of elasticity which is similar to that of bone.

13. A method according to claim 1 wherein the intramedullary prosthesis has a modulus of elasticity within the range of 1-15 GPa.

14. A method according to claim 1 wherein the intramedullary prosthesis is configured to accommodate bone in-growth.

15. A method according to claim 1 wherein the intramedullary prosthesis is spring-like and oscillates and vibrates so as to cause mechanical loading and catalyze fracture healing.

16. A method according to claim 1 wherein the intramedullary prosthesis is non-self-expanding.

17. A method according to claim 16 wherein the intramedullary prosthesis comprises stainless steel.

18. A method according to claim 1 wherein the intramedullary prosthesis is radially expanded and longitudinally contracted via superelasticity.

19. A method according to claim 1 wherein the intramedullary prosthesis is radially expanded and longitudinally contracted via temperature transition.

20. A method according to claim 1 wherein the intramedullary prosthesis is radially expanded and longitudinally contracted via an expanding balloon.

21. A method for providing stabilization and compression across a dividing line between two bone segments, the method comprising:

providing an intramedullary prosthesis sized for insertion into the intramedullary canal of a bone, the intramedullary prosthesis consisting of a metallic mesh structure having a round elongated mesh body having an axial bore formed therein, and at least two barbs projecting from the round elongated mesh body;

positioning the intramedullary prosthesis within the intramedullary canal of the bone so that the round elongated mesh body spans the dividing line, with at least one of the at least two barbs being disposed on one side of the dividing line and at least one of the at least two barbs being disposed on the other side of the dividing line; and

radially expanding and longitudinally contracting the round elongated mesh body so that the at least two barbs grip the side wall of the intramedullary canal on either side of the dividing line and pull the bone segments on either side of the dividing line together, whereby to provide stabilization and compression across the dividing line.