System and method for cooling a spinal correction device comprising a shape memory material for corrective spinal surgery

• US 8,348,952 B2
• Filed: 01/26/2006
• Issued: 01/08/2013
• Est. Priority Date: 01/26/2006
• Status: Active Grant

• Current Assignee: Depuy International Limited (Johnson & Johnson)
• Original Assignee: Depuy International Limited (Johnson & Johnson)
• Inventors: Bonnema, Thomas Allard Xander, Firkins, Paul John, Sanders, Marc M., Amesbury, Kevin Michael
• Primary Examiner(s): Barrett, Thomas
• Assistant Examiner(s): LAWSON, MATTHEW JAMES
• Application Number:
  US11/340,259
• Publication Number:
  US 20070191831A1
• Time in Patent Office: 2,539 Days
• Field of Search: 606/80, 606/102, 606/86.A, 606/86.B, 606/86.R, 606/279, 606246-247, 606251-257, 606261-262, 623 1711- 1716
• US Class Current: 606/86.R
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/7002 Longitudinal elements, e.g. rods
• CPC Class Codes: A61B 17/7043 with a longitudinal element fixed to one or more transverse elements which connect multiple screws or hooks
• CPC Class Codes: A61B 17/8863 Apparatus for shaping or cutting osteosynthesis equipment by medical personnel
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/564 Methods for bone or joint treatment

Abstract

A device and method of correcting a spinal defect in a patient employs the use of shape memory material in a spinal correction device. The shape memory material may be transitioned between a flexible martensitic state to allow shaping of the spinal correction device and a rigid austenitic state to apply corrective forces to the spine. The shape memory material may be transitioned to the flexible martensitic by applying a coolant, such as cold gas, directly or indirectly to the shape memory material to transfer heat away from the material. The cooling device and method may allow for in-vivo shaping of the spinal correction device while inserted in the body and attached to bone anchors by cooling the spinal correction device after insertion.

Claims

1. A method of cooling a spinal correction device comprising a shape memory material, comprising the steps of:

inserting in a body of a patient a spinal correction device comprised at least partially of a shape memory material;

applying a cold gas to the spinal correction device when implanted in the body of the patient to transition at least a portion of the shape memory material from an austenitic state to a martensitic state;

sensing a temperature of the shape memory material of the spinal correction device where the cold gas is applied; and

adjusting the applying the cold gas to the spinal correction device based on the sensed temperature of the shape memory material;

adjusting a shape of the spinal correction device transitioned to the martensitic state to match a spinal deformity of the patient;

inserting the shaped spinal correction device in receiving portions fixed to vertebrae of the patient; and

heating the spinal correction device inserted in the receiving portions to transition the spinal correction device from the martensitic state into the austenitic state and to apply corrective forces to the vertebrae of the patient, wherein the spinal correction device has a corrected shape of the vertebrae in the austenitic state.

2. The method of claim 1, wherein the cold gas comprises one of liquid nitrogen, carbon dioxide and nitrous oxide.

3. The method of claim 1, wherein the step of applying the cold gas comprises inserting the spinal correction device in an insulated device having a compartment, and injecting the cold gas into the compartment.

4. The method of claim 1, wherein the step of applying the cold gas to the spinal correction device comprises circulating the cold gas through a jacket coupled to the spinal correction device.

5. The method of claim 1, wherein the step of applying the cold gas comprises releasing gas from a pressurized canister.

6. The method of claim 1, wherein the cold gas is applied to a portion of the spinal correction device.

7. The method of claim 1, wherein the cold gas is applied along the length of the spinal correction device.

8. The method of claim 1, further comprising the step of adjusting the shape of the spinal correction device while in the body.

9. The method of claim 1, wherein the cold gas is applied directly to the spinal correction device and then evaporates.

10. The method of claim 1, wherein the cold gas is circulated through a system to draw heat away from the spinal correction device.

11. The method of claim 10, wherein the system also selectively transfers heat to the spinal correction device to heat the shape memory material to an austenitic state.

12. The method of claim 1, wherein the shape memory material comprises a shape memory metal.

13. The method of claim 1, wherein the shape memory material comprises nitinol.

14. A method of correcting a spinal deformity, comprising the steps of:

implanting a spinal correction device in a body of a patient, wherein the spinal correction device includes a spinal rod having a square cross-section to provide torsional correction and stability during correction of the spinal deformity, the spinal rod includes a first portion and a second portion each formed of a shape memory material, and the first portion and the second portion are insulated by an insulation portion; and

cooling the spinal correction device after implantation in the body to maintain the shape memory material in a martensitic state, wherein the step of cooling comprises cooling the first portion of the spinal correction device separately from the second portion of the spinal correction device so that the first portion is transitioned from an austenitic state to the martensitic state while the second portion remains in the austenitic state.

15. The method of claim 14, further comprising the step of adjusting the shape of the spinal correction device while in the body.

16. The method of claim 14, wherein the step of cooling comprises applying a cold gas to the spinal correction device.

17. The method of claim 16, wherein the cold gas is directly applied to the shape memory material.

18. The method of claim 16, wherein the cold gas is circulated through a fluid path adjacent to the spinal corrective device to draw heat from the shape memory material.

19. A method of cooling a spinal correction device comprising a shape memory alloy, comprising the steps of:

implanting and isolating a first shape memory portion from a second shape memory portion in a spinal correction device by including an insulation portion between the first shape memory portion and the second shape memory portion, each of the first shape memory portion and the second shape memory portion including a shape memory alloy, wherein the spinal correction device includes a spinal rod having a square cross-section to provide torsional correction and stability during correction of a spinal deformity;

cooling the first shape memory portion of the implanted and isolated spinal correction device without affecting the temperature of the second shape memory portion of the spinal correction device so that the first shape memory portion is transitioned from an austenitic state to a martensitic state while the second shape memory portion remains in an austenitic state; and

heating the spinal correction device to transition from the martensitic state into the austenitic state to apply corrective forces to the spine, wherein the spinal correction device has a shape of a corrected spine in the austenitic state.

20. The method of claim 19, wherein the step of cooling the portion of the spinal corrective device comprises applying a cold gas to the segment.

21. The method of claim 20, wherein the cold gas comprises one of liquid nitrogen, carbon dioxide and nitrous oxide.

22. The method of claim 19, wherein the step of cooling a portion of the spinal correction device comprises circulating a coolant through a jacket coupled to the portion of the spinal correction device.

23. The method of claim 19, wherein the step of cooling a portion of the spinal correction device comprises releasing a pressurized cooling gas from a pressurized canister and directing the released gas to the segment.