Bone treatment systems and methods

• US 7,559,932 B2
• Filed: 06/24/2005
• Issued: 07/14/2009
• Est. Priority Date: 12/06/2004
• Status: Active Grant

• Current Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Original Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Inventors: Shadduck, John H., Truckai, Csaba, Luzzi, Robert, Rappleye, C. Travis, Carlson, Grace A.
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): CARTER, TARA ROSE E
• Application Number:
  US11/165,652
• Publication Number:
  US 20060122623A1
• Time in Patent Office: 1,481 Days
• Field of Search: 606 92- 94, 623 1711- 1716, 623/23.19, 623/23.62
• US Class Current: 606/92
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 17/8836 for heating, cooling or curing of bone cement or fluid fillers
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs

Abstract

The present invention relates in certain embodiments to medical devices for treating osteoplasty procedures such as vertebral compression fractures. More particularly, embodiments of the invention relate to instruments and methods for controllably restoring vertebral body height by controlling the geometry of fill material introduced into cancellous bone. An exemplary system utilizes Rf energy in combination a conductive bone fill material for polymerizing the surface of the inflow plume to control the geometry of the fill material and the application of force caused by inflows of fill material. In another embodiment, method of treating bone includes injecting a volume of fill material into a bone and selectively modifying a viscosity of a selected portion of the bone filler to control the direction of flow of the fill material within the bone. A system for treating bone using this method includes an introducer for delivering fill material into the bone and an energy source selectively coupleable to the fill material to alter the viscosity of the fill material as it flows out of the introducer.

Claims

1. A method for treating bone, comprising:

providing a flowable infill material for infill of an interior region of a bone;

loading the infill material into an injector system having a portion positionable within the bone, the injector system comprising a heating element therein and at least one outlet port;

controllably applying energy from an energy source to the infill material via the heating element contemporaneously with flowing of the infill material through the injector system and before introducing the flowable infill material into the bone, the applied energy selectively increasing the viscosity of the infill material; and

introducing the flowable infill material having the selectively increased viscosity into the bone while controlling the viscosity of the flow of infill material through the controlled application of energy, the introduction of flowable infill material being controlled causing flowing of the flowable infill material, along a flow path through cancellous bone and interdigitating with cancellous bone, in the flow path wherein between an outer region of the flow path and the at least one outlet port in the flow path, the flow path comprises flowable infill material interdigitating with cancellous bone.

2. The method of claim 1, further comprising introducing the infill material into the interior region of the bone from a working end of an elongated introducer.

3. The method of claim 1, wherein the applied energy substantially accelerates polymerization of the infill material.

4. The method of claim 1, wherein the applied energy selectively increases the viscosity of infill material by at least 20%.

5. The method of claim 1, wherein the applied energy selectively alters a property selected from the group consisting of Young'"'"'s modulus, percent elongation, surface hardness and durometer.

6. The method of claim 1, wherein the bone is a vertebra.

7. The method of claim 1, wherein the viscosity of the infill material is selectively increased to prevent extravasation in fractured cancellous bone.

8. The method of claim 1, wherein the infill material with increased viscosity has substantially reduced flowability upon being introduced into the bone.

9. The method of claim 1, wherein the infill material with increased viscosity is at least partially elastomeric upon being introduced into the bone.

10. The method of claim 1, wherein the application of energy is modulated by a controller.

11. The method of claim 10, wherein the application of energy is modulated in response to a monitored parameter of the infill material.

12. The method of claim 1, further comprising monitoring a parameter of the infill material.

13. The method of claim 12, wherein the parameter is at least one of temperature and impedance.

14. The method of claim 1, wherein the applied energy is changed over time.

15. The method of claim 1, wherein the energy source consists of at least one of a radiofrequency source, a resistive heat source, a laser source, a microwave source, a magnetic source and an ultrasound source.

16. The method of claim 1, wherein the infill material forms a flow impermeable surface on at least a portion of the infill material.

17. The method of claim 1, wherein introducing the infill material into the bone comprises introducing the infill material directly into the interior region of the bone.

18. The method of claim 17, wherein introducing the infill material directly into the interior region of the bone comprises injecting the infill material so that a majority of the infill material controllably interdigitates with a cancellous bone portion of the bone.

19. The method of claim 18, wherein introducing the infill material directly into the interior region of the bone comprises injecting the infill material so that all of the infill material controllably interdigitates with the cancellous bone portion of the bone.

20. The method of claim 1, wherein introducing the flowable infill material having the selectively increased viscosity into the bone includes introducing the flowable infill material into a bone portion having cancellous bone with marrow and blood vessels in spaces within cancellous bone.

21. A method for treating bone, comprising:

providing a flowable bone fill material;

controllably applying energy from an energy source to the bone fill material, wherein the application of energy selectively increases the viscosity of the bone fill material; and

introducing a volume of the fill material having selectively increased viscosity into an interior of a bone while controlling the viscosity of the flow of flowable bone fill material through the controlled application of energy, the introduction of the volume of the bone fill material being controlled causing flowing of the flowable bone fill material, along a flow path that controllably interdigitates and permeates with a cancellous bone portion of the bone, the fill material being introduced along the flow path without previously creating a cavity which compresses or compacts the cancellous bone portion.

22. The method of claim 21, wherein the application of energy enhances polymerization of the bone fill material.

23. The method of claim 21, where in the application of energy increases the modulus of the fill material.

24. The method of claim 21, wherein the bone is a vertebra.

25. The method of claim 21, wherein the energy source is at least one of a radiofrequency source, a resistive heat source, a laser source, a microwave source, a magnetic source and an ultrasound source.

26. The method of claim 21, further comprising applying sufficient energy to the composition to substantially accelerate polymerization of the fill material.

27. The method of claim 21, wherein introducing the volume of fill material is done at least one of prior to or contemporaneously with the application of energy.

28. The method of claim 21, wherein applying energy includes applying energy to selected portions of the volume of fill material.

29. The method of claim 21, wherein the energy source applies energy to a conductive composition in at least one of a mono-polar manner and a bi-polar manner.

30. The method of claim 21, wherein the fill material includes a polymerizable component.

31. The method of claim 30, wherein the polymerizable component includes at least one of PMMA, monocalcium phosphate, tricalcium phosphate, calcium carbonate, calcium sulfate or hydroxyapatite.

32. The method of claim 21, further comprising contemporaneously controlling the application of energy with a controller.

33. The method of claim 21, wherein applying energy includes maintaining a specific power density in the fill material.

34. The method of claim 21, further comprising monitoring at least one parameter of the fill material.

35. The method of claim 34, wherein monitoring includes at least one of temperature monitoring and impedance monitoring.

36. The method of claim 21, wherein introducing the fill material supports or moves a cortical bone portion of the bone.

37. The method of claim 21, wherein introducing the volume of the fill material into the interior of the bone includes introducing the bone fill material so that a majority of the introduced bone fill material controllably interdigitates with the cancellous bone.

38. The method of claim 37, wherein introducing the fill material into the interior region of the bone comprises injecting the infill material so that all of the introduced fill material controllably interdigitates with the cancellous bone.

39. The method of claim 21, wherein the introduced volume of fill material controllably interdigitates and permeates with a cancellous bone meshwork.

40. A method for treating a vertebral body, comprising:

providing a bone fill material and an injector system having a portion positionable within the vertebral body, the injector system comprising a heating element therein and the bone fill material being loaded in the injector system;

positioning a portion of the injector system within the vertebral body;

controllably applying energy from an energy source to the bone fill material via the heating element before introducing the bone fill material into the bone, the applied energy selectively increasing viscosity of the bone fill material; and

introducing a volume of the bone fill material through an outlet port of the injector system into cancellous bone of the vertebral body while controlling the viscosity of the flow of bone fill material through the controlled application of energy, the introduction of the volume of the bone fill material being controlled causing flowing of the flowable bone fill material along a flow path that, controllably interdigitates with the cancellous bone and follows the flow path interdigitating and permeating through cancellous bone, an outer region of the flow path surrounding interdigitated cancellous bone located in the flow path between the outer region and the outlet port.

41. The method of claim 40, wherein controllably applying energy to the bone fill material increases the viscosity of the bone fill material by at least 100%.

42. The method of claim 40, wherein the viscosity of the infill material is selectively increased so as to inhibit extravasation in fractured cancellous bone.

43. The method of claim 40, wherein the application of energy is modulated by a controller.

44. The method of claim 43, wherein the application of energy is modulated in response to a monitored parameter of the bone fill material.

45. The method of claim 44, wherein the monitored parameter is at least one of temperature and impedance.

46. The method of claim 40, wherein the energy source consists of at least one of a radiofrequency source, a resistive heat source, a laser source, a microwave source, a magnetic source and an ultrasound source.

47. The method of claim 40, wherein introducing the volume of the bone fill material into cancellous bone of the vertebral body includes introducing the bone fill material so that a majority of the introduced bone fill material controllably interdigitates with the cancellous bone.

48. The method of claim 47, wherein introducing the fill material into the interior region of the bone comprises injecting the infill material so that all of the introduced fill material controllably interdigitates with the cancellous bone.

49. The method of claim 40, wherein the energy is applied to the bone fill material contemporaneously with the bone fill material flowing from the injector system into the cancellous bone.

50. The method of claim 40, wherein introducing the infill material directly into the interior region of the bone comprises injecting the infill material so that all of the infill material controllably interdigitates with the cancellous bone portion of the bone.

51. The method of claim 40, wherein introducing the fill material into the interior region of the bone comprises injecting the infill material so that all of the introduced fill material controllably interdigitates with the cancellous bone.