Formed in place fixation system with thermal acceleration
View Patent ↗A subcutaneously formed in place orthopedic fixation device is provided, such as for fixation of the spine or other bone or bones. The device comprises an inflatable member, such as a tubular balloon. A heat source is provided in thermal communication with the interior of the balloon. The balloon is positioned at a treatment site while in a flexible, low crossing profile configuration. The balloon is thereafter inflated with a hardenable media, and heated to accelerate hardening of the media. Methods and delivery structures are also disclosed.
1. An orthopedic fixation device, comprising:
an elongate, flexible tubular body having a distal end and a proximal end, said body forming a central lumen;
a manifold at the proximal end of the tubular body comprising at least one port;
an inflatable member having a proximal end, a distal end, and an interior, removably attached to the distal end of the tubular body;
a heat source in thermal communication with the interior of the inflatable member; and
a valve, provided at the proximal end of the inflatable member;
wherein the inflatable member has a predetermined inflated profile with an inflated length and an inflated diameter, the ratio of the inflated length to the inflated diameter being at least about 4:1.
2. The device of claim 1 , further comprising a hardenable media for inflating said inflatable member.
3. The device of claim 2 , wherein said hardenable media comprises a rapid setting, liquid polymer.
4. The device of claim 3 , wherein said polymer is a light activated polymer.
5. The device of claim 1 , wherein said central lumen comprises an inflation lumen.
6. The device of claim 1 , wherein said central lumen comprises a stiffening wire lumen.
7. The device of claim 1 , wherein said elongate tubular body comprises an inner sleeve and an outer sleeve, forming an annular lumen between said inner sleeve and said outer sleeve.
8. The device of claim 7 , wherein said annular lumen comprises an inflation lumen.
9. The device of claim 1 , wherein said inflatable member comprises a balloon.
10. The device of claim 1 , wherein the heat source comprises a resistive heating element.
11. The device of claim 1 , wherein the heat source comprises a circulating loop for circulating a heated media.
12. The device of claim 1 , wherein the heat source comprises an RF antenna.
13. The device of claim 1 , wherein the heat source comprises an ultrasound transducer.
14. The device of claim 1 , wherein the heat source comprises a microwave antenna.
15. The device of claim 1 , wherein the heat source comprises a waveguide.
16. The device as in claim 1 , wherein the ratio of the inflated length to the inflated diameter is at least about 6:1.
17. The device as in claim 1 , wherein the inflated diameter is within a range of about 5 cm to about 2 cm.
18. The device as in claim 1 , wherein the inflated length is within a range of about 2 cm to about 12 cm.
19. The device as in claim 1 , wherein the inflated length is within a range of about 10 cm to about 20 cm.
20. An orthopedic fixation device, comprising:
an elongate, flexible tubular body having a distal end and a proximal end, said body forming a central lumen;
a manifold at the proximal end of the tubular body comprising at least one port;
an inflatable member having a proximal end, a distal end, and an interior, removably attached to the distal end of the tubular body;
a heat source in thermal communication with the interior of the inflatable member;
a valve, provided at the proximal end of the inflatable member;
a hardenable media for inflating the inflatable member;
wherein, when the hardenable media is hardened, the inflatable member and the hardenable media form a fixation rod that exhibits a static compression bending value that is greater than about 100 lbs.
21. The device of claim 20 , wherein the fixation rod exhibits a static compression bending value that is greater than about 150 lbs.
22. The device of claim 20 , wherein said polymer is a light activated polymer.
23. The device of claim 20 , wherein said central lumen comprises an inflation lumen.
24. The device of claim 20 , wherein said central lumen comprises a stiffening wire lumen.
25. The device of claim 20 , wherein said elongate tubular body comprises an sleeve and an outer sleeve, forming an annular lumen between said inner sleeve and said outer sleeve.
26. The device of claim 25 , wherein said annular lumen comprises an inflation lumen.
27. The device of claim 20 , wherein said inflatable member comprises a balloon.
28. The device of claim 20 , wherein the heat source comprises a resistive heating element.
29. The device of claim 20 , wherein the heat source comprises a circulating loop for circulating a heated media.
30. The device of claim 20 , wherein the heat source comprises an RF antenna.
31. The device of claim 20 , wherein the heat source comprises an ultrasound transducer.
32. The device of claim 20 , wherein the heat source comprises a microwave antenna.
33. The device of claim 20 , wherein the heat source comprises a waveguide.
34. The device of claim 20 , wherein the inflatable member has a predetermined inflated profile having an inflated length and an inflated diameter, the ratio of the inflated length to the inflating diameter being at lea t bout 4:1.
35. The device as in claim 34 , wherein the ratio of the inflated length to the inflated diameter is at least about 6:1.
36. The device as in claim 34 , wherein the inflated diameter is within a range of about 0.5 cm to about 2 cm.
37. The device as in claim 34 , wherein the inflated length is within a range of about 2 cm to about 12 cm.
38. The device as in claim 34 , wherein the inflated length is within a range of about 10 cm to about 20 cm.