Bone treatment systems and methods

• US 8,348,955 B2
• Filed: 05/24/2010
• Issued: 01/08/2013
• 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: Truckai, Csaba, Shadduck, John H.
• Primary Examiner(s): Stewart, Alvin
• Assistant Examiner(s): CARTER, TARA ROSE E
• Application Number:
  US12/786,362
• Publication Number:
  US 20100280520A1
• Time in Patent Office: 960 Days
• Field of Search: 606 92- 94, 606/105, 623/17.11, 623/17.12
• US Class Current: 606/94
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61B 17/8827 with filtering, degassing, venting or pressure relief means
• 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: A61B 2017/564 Methods for bone or joint treatment
• 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 vertebral compression fractures. More particularly, embodiments of the invention relate to instruments and methods for controllably restoring vertebral body height by controlling the flow of bone cement into the interior of a vertebra and the application of forces causes by the cement flow. An exemplary system utilizes Rf energy in combination a conductive bone cement for selectively polymerizing the inflow plume to increase the viscosity of the cement. In one aspect of the invention, the system utilizes a controller to control bone cement flow parameters to either, allow or disallow cement interdigitation into cancellous bone. A method of the invention includes pulsing the flows of bone cement wherein high acceleration of the flow pulses can apply expansion forces across the surface of the cement plume to reduce a vertebral fracture.

Claims

1. A method of treating an abnormal vertebra comprising:

providing a flow source for providing a bone cement flow into a vertebral body through an introducer, a controller for control of the bone cement flow and an energy source for heating the bone cement; and

flowing bone cement into the vertebral body wherein the controller adjusts a cement delivery parameter in response to a measured characteristic of the bone cement;

wherein the controller controls aspiration parameters within an aspiration channel in communication with an interior of the vertebra.

2. The method of treating an abnormal vertebra of claim 1, wherein the measured characteristic is pressure of the bone cement flow.

3. The method of treating an abnormal vertebra of claim 1, wherein the measured characteristic is a temperature of the bone cement flow.

4. The method of treating an abnormal vertebra of claim 1, wherein the flow of bone cement reduces a fracture.

5. The method of treating an abnormal vertebra of claim 1, wherein the flow of bone cement moves at least one of cortical bone and cancellous bone.

6. The method of treating an abnormal vertebra of claim 1, wherein the flow of bone cement prophylactically treats the vertebra.

7. The method of treating an abnormal vertebra of claim 1, wherein the controller adjusts at least one of pressure, applied energy from the energy source, velocity of the cement flow and acceleration of the cement flow.

8. The method of treating an abnormal vertebra of claim 1, wherein the controller pulses the cement flow.

9. The method of treating an abnormal vertebra of claim 1, wherein the controller adjusts energy in response to at least one of pressure, temperature, impedance and viscosity of the cement flow.

10. A method of treating an abnormal vertebra comprising:

providing a flow source for providing a bone cement flow into a vertebral body through an introducer, a controller for control of the bone cement flow and an energy source for heating the bone cement; and

flowing bone cement into the vertebral body wherein the controller adjusts a cement delivery parameter in response to a measured characteristic of the bone cement;

wherein the controller adjusts at least one of electromagnetic energy and ultrasound energy delivered from the energy source to an emitter adjacent the cement flow.

11. The method of treating an abnormal vertebra of claim 10, wherein the measured characteristic is pressure of the bone cement flow.

12. The method of treating an abnormal vertebra of claim 10, wherein the measured characteristic is a temperature of the bone cement flow.

13. The method of treating an abnormal vertebra of claim 10, wherein the flow of bone cement reduces a fracture.

14. The method of treating an abnormal vertebra of claim 10, wherein the flow of bone cement moves at least one of cortical bone and cancellous bone.

15. The method of treating an abnormal vertebra of claim 10, wherein the flow of bone cement prophylactically treats the vertebra.

16. The method of treating an abnormal vertebra of claim 10, wherein the controller further adjusts at least one of pressure, velocity of the cement flow and acceleration of the cement flow.

17. The method of treating an abnormal vertebra of claim 10, wherein the controller pulses the cement flow.

18. The method of treating an abnormal vertebra of claim 10, wherein the controller adjusts energy in response to at least one of pressure, temperature, impedance and viscosity of the cement flow.

19. A method of treating an abnormal vertebra comprising:

providing a flow source for providing a bone cement flow into a vertebral body through an introducer, a controller for control of the bone cement flow and a radiofrequency (Rf) energy source for heating the bone cement; and

flowing bone cement into the vertebral body wherein the controller adjusts a cement delivery parameter in response to a measured characteristic of the bone cement;

wherein the controller adjusts radiofrequency (Rf) energy delivered from the Rf energy source to the emitter.

20. The method of treating an abnormal vertebra of claim 19, wherein the measured characteristic is pressure of the bone cement flow.

21. The method of treating an abnormal vertebra of claim 19, wherein the measured characteristic is a temperature of the bone cement flow.

22. The method of treating an abnormal vertebra of claim 19, wherein the flow of bone cement reduces a fracture.

23. The method of treating an abnormal vertebra of claim 19, wherein the flow of bone cement moves at least one of cortical bone and cancellous bone.

24. The method of treating an abnormal vertebra of claim 19, wherein the flow of bone cement prophylactically treats the vertebra.

25. The method of treating an abnormal vertebra of claim 19, wherein the controller further adjusts at least one of pressure, velocity of the cement flow and acceleration of the cement flow.

26. The method of treating an abnormal vertebra of claim 19, wherein the controller pulses the cement flow.

27. The method of treating an abnormal vertebra of claim 19, wherein the controller adjusts energy in response to at least one of pressure, temperature, impedance and viscosity of the cement flow.