Bone treatment systems and methods

• US 9,610,110 B2
• Filed: 04/10/2015
• Issued: 04/04/2017
• 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): Hoffman, Mary
• Assistant Examiner(s): CARTER, TARA ROSE E
• Application Number:
  US14/683,506
• Publication Number:
  US 20150282852A1
• Time in Patent Office: 725 Days
• Field of Search: 606 92- 94, 623 1711- 1712
• 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;

an energy source coupled to a thermal energy emitter configured to apply energy to the bone cement flowing through the flow channel to controllably alter the viscosity of the bone cement within the flow channel;

one or more sensors configured to provide a measurement of a parameter of the bone cement flowing through the flow channel; and

a controller coupleable to the energy source, the controller including algorithms that ramp-up and ramp-down power delivery from the energy source to the thermal energy emitter based at least in part on a measurement from the one or more sensors.

2. The system for treating bone 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.

3. The system for treating bone of claim 2, wherein the insulative interior sleeve comprises a polymer.

4. The system for treating bone of claim 1, wherein the thermal energy emitter comprises spaced apart opposing polarity electrodes.

5. The system for treating bone of claim 1, wherein the thermal energy emitter is disposed about the distal termination of the flow channel.

6. The system for treating bone of claim 1, wherein the controller comprises algorithms for adjusting power delivery based on the volume of the bone cement introduced to the bone.

7. The system for treating bone of claim 1, further comprising a source of bone cement operatively coupleable to said flow channel.

8. The system for treating bone of claim 7, wherein the controller is configured to vary the volume of bone cement introduced into the flow channel.

9. An osteoplasty system comprising:

an introducer assembly with a flow channel extending therethrough for introducing bone cement into a bone;

an electrical source operatively connected to at least one thermal energy emitter configured to apply energy to the bone cement contemporaneously with the bone cement flowing through the flow channel to controllably alter the viscosity of the bone cement within the flow channel; and

a means for electrically adjusting power delivery from the electrical source to the at least one thermal energy emitter based at least in part on algorithms that ramp-up and ramp-down said power delivery based at least in part on a sensed parameter measurement of the bone cement as the bone cement flows through the flow channel.

10. The osteoplasty system of claim 9, wherein the introducer assembly comprises a thermally insulative interior sleeve that at least partially defines the flow channel.

11. The osteoplasty system of claim 10, wherein the insulative interior sleeve comprises a polymer.

12. The osteoplasty system of claim 9, wherein the at least one thermal energy emitter comprises spaced apart opposing polarity electrodes.

13. The osteoplasty system of claim 9, wherein the at least one thermal energy emitter is disposed about a distal termination of flow channel.

14. The osteoplasty system of claim 9, wherein the means for electrically adjusting power delivery comprises algorithms for adjusting power delivery based on the volume of the bone cement introduced to the bone.

15. The osteoplasty system of claim 9, further comprising a pressurizable source of bone cement operatively coupled to said flow channel.

16. The osteoplasty system of claim 15, wherein the means for electrically adjusting power delivery is configured to vary the volume or pressure of bone cement introduced into the flow channel.

17. A system for treating bone, comprising:

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

a thermal energy emitter configured to apply energy to the bone cement flowing through the internal flow channel to controllably alter a property of the bone cement within the internal flow channel;

one or more sensors configured to provide a measurement of a parameter of the bone cement flowing through the internal flow channel; and

a controller coupleable to an energy source, the controller including algorithms that ramp-up and ramp-down power delivery from the energy source to the thermal energy emitter based at least in part on a measurement from the one or more sensors.

18. The system for treating bone of claim 17, further comprising a source of bone cement operatively coupleable to the internal flow channel.

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

20. The system for treating bone of claim 17, wherein the controller comprises algorithms for adjusting power delivery based on the volume of the bone cement introduced to the bone.