Bone treatment systems and methods

• US 10,172,659 B2
• Filed: 04/03/2017
• Issued: 01/08/2019
• 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): Robert, Eduardo C
• Assistant Examiner(s): Carter, Tara R
• Application Number:
  US15/477,678
• Publication Number:
  US 20170333103A1
• Time in Patent Office: 645 Days
• 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 system for treating bone, comprising:

a bone cement injection assembly having a flow channel extending therethrough for injecting bone cement into an interior of a bone;

a thermal energy emitter coupleable to an energy source and configured to deliver energy to the bone cement as it flows through the flow channel to controllably alter the viscosity of the bone cement within the flow channel; and

a controller coupleable to the energy source, the controller comprising algorithms for adjusting power delivery applied by the energy source, wherein the controller includes algorithms for adjusting power delivery based on at least one of the following;

impedance of the bone cement within the flow channel, temperature of the bone cement within the flow channel, volume of the bone cement within the flow channel, or flow rate of the bone cement within the flow channel.

2. The system of claim 1, 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, or an ultrasound source.

3. The system of claim 2, wherein the energy source is a radiofrequency source.

4. The system of claim 1, wherein the controller includes algorithms for adjusting power delivery based on impedance of the bone cement within the flow channel.

5. The system of claim 1, wherein the controller includes algorithms for adjusting power delivery based on temperature of the bone cement within the flow channel.

6. The system of claim 1, wherein the controller includes algorithms for adjusting power delivery based on flow rate of the bone cement within the flow channel.

7. The system of claim 1, wherein the controller includes algorithms for adjusting power delivery based on volume of the bone cement within the flow channel.

8. The system of claim 1, wherein the controller is configured to adjust power delivery applied by the energy source to alter the bone cement to a viscosity that is sufficient to controllably permeate and interdigitate with cancellous bone.

9. The system of claim 1, further comprising:

a source of bone cement operatively coupleable to the flow channel.

10. The system of claim 9, wherein the controller is configured to vary the volume of bone cement introduced into the flow channel.

11. The system of claim 1, wherein the thermal energy emitter is disposed about a distal termination of the flow channel.

12. The system of claim 1, wherein the thermal energy emitter comprises one or more electrodes.

13. The system of claim 1, wherein the bone cement injection assembly comprises a thermally insulative interior sleeve that defines at least a portion of the flow channel.

14. A system for treating bone, comprising:

a bone cement injection assembly having a flow channel extending therethrough for injecting bone cement into an interior of a bone;

a thermal energy emitter coupleable to an energy source and configured to deliver energy to the bone cement as it flows through the flow channel to controllably alter the viscosity of the bone cement within the flow channel; and

a controller coupleable to the energy source, the controller comprising algorithms for adjusting power delivery applied by the energy source, wherein the controller is configured to adjust power delivery applied by the energy source to alter the bone cement to a viscosity that is sufficient to controllably permeate and interdigitate with cancellous bone.

15. The system of claim 14, 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, or an ultrasound source.

16. The system of claim 15, wherein the energy source is a radiofrequency source.

17. The system of claim 14, further comprising:

a source of bone cement operatively coupleable to the flow channel.

18. The system of claim 17, wherein the controller is configured to vary the volume of bone cement introduced into the flow channel.

19. A system for treating bone, comprising:

a bone cement injection assembly having a flow channel extending therethrough for injecting bone cement into an interior of a bone;

a source of bone cement operatively coupleable to the flow channel;

a thermal energy emitter coupleable to an energy source and configured to deliver energy to the bone cement as it flows through the flow channel to controllably alter the viscosity of the bone cement within the flow channel, 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, or an ultrasound source; and

a controller coupleable to the energy source, the controller comprising algorithms for adjusting power delivery applied by the energy source.

20. The system of claim 19, wherein the energy source is a radiofrequency source.