IP Library Granted Patent US 11,026,734
Granted Patent B2
US 11,026,734 · App. 16/241,494 · Granted Jun 8, 2021

Bone treatment systems and methods

Inventors: Csaba Truckai (Saratoga, CA); John H. Shadduck (Menlo Park, CA)
Assignee: DFine, Inc.
A61B17/8805A61B17/8822A61B17/8827A61B17/8836A61B17/70A61B2017/00022A61B2017/00026A61B2017/00084A61B2017/564A61F2/44
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Quick Facts
Patent No.
US 11,026,734
App. No.
16/241,494
Granted
Jun 8, 2021
Kind
B2
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 (30)

1. A system for treating bone, comprising:

a bone cement injector having a flow channel extending therethrough for injecting bone cement into an interior of a bone, the bone cement injector comprising a metallic shaft having a polymeric layer disposed on an inner surface thereof, the polymeric layer terminating at an end of the metallic shaft, wherein the polymeric layer defines the flow channel and insulates the metallic shaft from the flow channel;

an energy emitter coupleable to an energy source and configured to deliver energy to the bone cement to controllably alter the viscosity of the bone cement within the system; 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 system, temperature of the bone cement within the system, volume of the bone cement within the system, or flow rate of the bone cement within the system.

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 energy source is a remote energy source.

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

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 system.

7. 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.

8. The system of claim 1 , wherein the polymeric layer is at least one of thermally or electrically insulative.

9. The system of claim 1 , wherein the polymeric layer comprises a material selected from the group consisting of PEEK (polyetheretherketone), PTFE (polytetrafluoroethylene), Teflon™, and a polyimide.

10. The system of claim 9 , wherein the polymeric layer comprises PTFE.

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

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

13. A system for treating bone, comprising:

a bone cement injector having a flow channel extending therethrough for injecting bone cement into an interior of a bone, the bone cement injector comprising a metallic shaft having a polymeric layer disposed on an inner surface thereof, the polymeric layer terminating at an end of the metallic shaft, wherein the polymeric layer defines the flow channel and insulates the metallic shaft from the flow channel;

an energy emitter coupleable to an energy source and configured to deliver energy to the bone cement as it flows through the system to controllably alter the viscosity of the bone cement within the system; 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.

14. The system of claim 13 , 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.

15. The system of claim 14 , wherein the energy source is a radiofrequency source.

16. The system of claim 13 , wherein the polymeric layer is at least one of thermally or electrically insulative.

17. The system of claim 13 , wherein the polymeric layer comprises a material selected from the group consisting of PEEK (polyetheretherketone), PTFE (polytetrafluoroethylene), Teflon™, and a polyimide.

18. The system of claim 17 , wherein the polymeric layer comprises PTFE.

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, the bone cement injection assembly comprising a metallic shaft having a polymeric layer disposed on an inner surface thereof, the polymeric layer terminating at an end of the metallic shaft, wherein the polymeric layer defines the flow channel and insulates the metallic shaft from the flow channel, wherein the polymeric layer comprises a material selected from the group consisting of PEEK (polyetheretherketone), PTFE (polytetrafluoroethylene), Teflon™, and a polyimide;

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

an energy emitter coupleable to a remote 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 polymeric layer comprises PTFE.

Assignments (2)
SECURITY INTEREST Recorded Jan 5, 2021
From: DFINE, INC.
To: WELLS FARGO BANK, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT
Reel/Frame 054814/0021 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 7, 2019
From: TRUCKAI, CSABA; SHADDUCK, JOHN H.
To: DFINE, INC.
Reel/Frame 047921/0276 →
Continuity (10)
Continuation 15477678 · Apr 3, 2017
Continuation 14683506 · Apr 10, 2015
Continuation 13734829 · Jan 4, 2013
Continuation 12786362 · May 24, 2010
Continuation 11209035 · Aug 22, 2005
Continuation In Part 11208448 · Aug 20, 2005
Continuation In Part 11196045 · Aug 2, 2005
Continuation In Part 11165652 · Jun 24, 2005
Provisional Application 60633509 · Dec 6, 2004
Related Publication 20190209221A1 · Jul 11, 2019
Cited By (14)
US 12,193,719 US 12,303,166 US 12,329,412 US 12,433,668 US 12,458,428 US 12,465,373 US 12,496,094 US 12,502,182 US 12,508,037 US 12,573,045 US 12,605,199 US 12,642,555 US 12,670,596 US 12,708,437