Bone treatment systems and methods

• US 9,005,210 B2
• Filed: 01/04/2013
• Issued: 04/14/2015
• 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:
  US13/734,829
• Publication Number:
  US 20130190771A1
• Time in Patent Office: 830 Days
• Field of Search: 606 92- 94
• 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. An apparatus for delivering a bone cement into a bone, comprising:

a bone cement injector having an internal flow channel extending therethrough to at least one outlet in a distal end of the injector, wherein an interior surface of the internal flow channel comprises a polymeric layer;

a thermal energy emitter coupleable to an electrical source and configured to deliver energy to the bone cement as it flows through the internal flow channel of the bone cement injector, wherein the interior surface is insulative from the thermal energy emitter; and

a sensor configured to provide a measurement of a parameter of the bone cement as it flows through the internal flow channel.

2. The apparatus of claim 1, wherein the polymeric layer is thermally and electrically insulative.

3. The apparatus of claim 1, wherein the polymeric layer comprises a material selected from the group consisting of PEEK (Polyetheretherketone), Teflon™

, and a polyimide.

4. The apparatus of claim 1, wherein the thermal energy emitter comprises at least one conductor coupled to an electrical source.

5. The apparatus of claim 4, wherein the at least one conductor comprises a resistive heating element.

6. An apparatus for delivering a bone cement into a bone, comprising:

a bone cement injector extending from a proximal end to a distal end and having at least one outlet at the distal end of the injector, at least a portion of the injector being removably positionable in bone the bone cement injector having an internal flow channel extending from the proximal end to the at least one outlet;

a thermal energy emitter operably coupled to the internal flow channel extending through the bone cement injector, the thermal energy emitter coupleable to an electrical source and configured to deliver energy to bone cement flowing through the internal flow channel;

a polymeric layer extending along at least a portion of the internal flow channel, the polymeric layer configured to contact bone cement flowing through the internal flow channel to facilitate the flow of the bone cement through the injector and into the bone, wherein the polymeric layer is insulative from the thermal energy emitter; and

a sensor configured to provide a measurement of a parameter of the bone cement prior to the bone cement flowing through the at least one outlet at the distal end of the injector.

7. The apparatus of claim 6, wherein the polymeric layer is thermally and electrically insulative.

8. The apparatus of claim 6, wherein the polymeric layer comprises a material selected from the group consisting of PEEK (Polyetheretherketone), Teflon™

, and a polyimide.

9. The apparatus of claim 6, wherein the thermal energy emitter comprises at least one conductor coupled to an electrical source.

10. The apparatus of claim 9, wherein the at least one conductor comprises a resistive heating element.

11. An injector system comprising an apparatus for delivering a bone fill material to a vertebra, comprising:

an injector assembly having portion positionable within a bone, the injector having a polymeric surface layer that defines an internal flow channel extending through the injector to at least one outlet opening; and

a thermal energy emitter operatively coupled to the internal flow channel and configured to a ply energy to the bone fill material flowing through the internal flow channel,

wherein the polymeric surface layer is insulative from the thermal energy emitter, a first portion of the polymeric surface layer disposed radially between the thermal energy emitter and the internal flow channel and a second portion of the polymeric surface layer extending downstream from the thermal energy emitter to the at least one outlet opening; and

a sensor configured to provide a measurement of a parameter of bone fill material flowing through the internal flow channel.

12. The system of claim 11, wherein the polymeric surface layer is thermally and electrically insulative.

13. The system of claim 11, wherein the polymeric surface layer comprises a material selected from the group consisting of PEEK (Polyethylethylketone), Teflon™

, and polyimide.

14. The system of claim 11, wherein the thermal energy emitter comprises at least one conductor coupled to an electrical source.

15. The system of claim 14, wherein the at least one conductor comprises a resistive heating element.