Bone treatment systems and methods

• US 8,556,910 B2
• Filed: 04/03/2008
• Issued: 10/15/2013
• Est. Priority Date: 04/03/2007
• Status: Active Grant

• Current Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Original Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Inventors: Truckai, Csaba, Luzzi, Robert, Shadduck, John H.
• Primary Examiner(s): BOLES, SAMEH RAAFAT
• Application Number:
  US12/062,345
• Publication Number:
  US 20080255570A1
• Time in Patent Office: 2,021 Days
• Field of Search: 606 92- 94
• US Class Current: 606/94
• 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 17/8836 for heating, cooling or curing of bone cement or fluid fillers
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site

Abstract

Systems and methods for delivering bone cement into a bone can include a handle body defining a flow path, a thermal emitter in the handle body to apply energy to bone cement passing through the flow path, a source of bone cement and an injection cannula. The cannula can be in communication with the flow path such that inserting the cannula into a bone can allow a flow of bone cement therethrough to an opening at a distal end of the cannula. Other systems and methods for delivering bone cement into a bone can include an injector body with a handle portion, and a cannula, a bone cement container, a low pressure drive mechanism configured to effect a flow of bone cement from said container to the injector body and a high pressure drive mechanism configured to effect a flow of bone cement through the injector body into the bone.

Claims

1. A method for treating a bone, comprising:

mixing two-components to form bone cement within a syringe body, the syringe body forming part of a source of bone cement;

inserting at least a portion of an elongated bone cement injector percutaneously through a patient'"'"'s skin into a cancellous bone portion of a bone;

coupling a proximal end of the injector to an outlet of a handle body;

coupling the source of bone cement to an inlet of the handle body;

coupling a first side of a two-sided plunger with the syringe body;

flowing bone cement from the source of bone cement through the handle body and through a bore in the injector into the cancellous bone by hydraulically advancing a second side of the two-sided plunger and thereby advancing the first side of the two-sided plunger within the syringe body; and

applying energy to the bone cement as it flows through the handle body in an amount sufficient to accelerate a setting rate in the bone cement to increase the viscosity of the bone cement so as to reach a selected polymerization endpoint as the bone cement exits the injector and prior to introduction of the bone cement into bone.

2. The method of claim 1, wherein the injector couples to the handle body at a location outside of the patient.

3. The method of claim 1, wherein the selected polymerization endpoint provides a bone cement viscosity that substantially inhibits extravasation of bone cement upon introduction of the bone cement into the bone.

4. The method of claim 1, wherein the applied energy accelerates the setting rate by at least 20%.

5. The method of claim 1, wherein the applied energy accelerates the setting rate by at least 60%.

6. The method of claim 1, further comprising modulating the applied energy via a controller based at least in part on a signal indicative of a temperature of the bone cement that is communicated to the controller.

7. The method of claim 1, further comprising modulating the applied energy via a controller based at least in part on a signal indicative of a flow rate of the bone cement that is communicated to the controller.

8. The method of claim 1, further comprising modulating a rate of flow of the bone cement via a controller.

9. The method of claim 1, wherein applying energy includes delivering energy from an energy source comprising at least one of a radiofrequency source, a resistive heat source, an electrical source, a PTCR constant temperature heat source, a non-coherent light source, a laser source, an LED source, a microwave source, a magnetic source and an ultrasound source.

10. The method of claim 1, further comprising activating the flow of bone cement into the cancellous bone wherein the step of activating can be performed outside of a radiation field created by an imaging system used while treating the bone.

11. The method of claim 1, further comprising controlling the application of energy from an energy source with a computer controller.

12. The method of claim 11, wherein controlling the application of energy from the energy source further comprises controlling the application of energy from the energy source to achieve a generally constant bone cement viscosity at an outlet opening in the bore of the injector.

13. The method of claim 1, wherein applying energy to the bone cement comprises applying energy to the bone cement via a thermal energy emitter disposed in the handle body, the thermal energy emitter comprising a polymeric positive temperature coefficient of resistance (PTCR) material and having spaced apart electrodes on a surface of the thermal energy emitter.

14. The method of claim 13, wherein the electrodes are spaced apart so as to generate substantially uniform heating of the thermal energy emitter along its length.

15. The method of claim 1, wherein applying energy to the bone cement as it flows through the handle body comprises applying energy with a thermal energy emitter surrounding a flow channel in the handle body.

16. The method of claim 15, wherein a lubricious surface layer defines the flow channel in the handle body at the thermal energy emitter.

17. A method of bone cement delivery, comprising:

mixing components of a bone cement to begin polymerization of the bone cement within a bone cement container;

coupling an elongated bone cement injector to an outlet of a handle body, the handle body defining a flow channel extending therethrough from an inlet of the handle body to the outlet of the handle body;

coupling the bone cement container to the inlet of the handle body;

flowing the mixed and polyermizing bone cement from the container into the flow channel in the handle body;

applying energy to the bone cement passing through the flow channel with a thermal energy emitter disposed about the flow channel in the handle body in order to controllably increase the viscosity of the bone cement as it flows therethrough and prior to introduction of the bone cement into bone, a lubricious surface layer defining the flow channel within an interior of the thermal energy emitter;

flowing the mixed and polyermizing bone cement from the flow channel in the handle body and through a bore in the injector into cancellous bone.

18. The method of claim 17, wherein applying energy to the bone cement further comprises applying energy to accelerate a setting rate of the bone cement so as to reach a selected polymerization endpoint as the bone cement exits the injector.

19. The method of claim 17, further comprising controlling the application of energy from an energy source with a computer controller.

20. The method of claim 19, wherein controlling the application of energy from the energy source further comprises controlling the application of energy from the energy source to achieve a generally constant bone cement viscosity at an outlet opening in the bore of the injector.

21. The method of claim 19, further comprising accelerating a polymerization rate of the bone cement by at least 20%.

22. The method of claim 19, further comprising accelerating a polymerization rate of the bone cement by at least 60%.

23. The method of claim 17, further comprising depressing an activation switch to initiate flowing the mixed and polyermizing bone cement from the flow channel in the handle body and through a bore in the injector into the cancellous bone.

24. The method of claim 23, wherein the activation switch is located remotely from the handle body, the injector and the container.

25. The method of claim 17, wherein the thermal energy emitter comprises at least one of a resistive heater, a PTCR constant temperature heater, a fiber optic emitter, a light channel, an LED emitter, an ultrasound transducer, an electrode and an antenna.

26. The method of claim 17, wherein the thermal energy emitter comprises a polymeric positive temperature coefficient of resistance (PTCR) material and has spaced apart electrodes on a surface of the thermal energy emitter.

27. The method of claim 26, wherein the electrodes are spaced apart so as to generate substantially uniform heating of the thermal energy emitter along its length.

28. The method of claim 17, further comprising coupling a first side of a two-sided plunger with the bone cement container.

29. The method of claim 28, wherein flowing the mixed and polyermizing bone cement from the container into the flow channel in the handle body comprises hydraulically advancing a second side of the two-sided plunger and thereby advancing the first side of the two-sided plunger within the bone cement container.