BONE TREATMENT SYSTEMS AND METHODS

• US 20080249530A1
• Filed: 04/03/2008
• Published: 10/09/2008
• 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: Shadduck, John H., Truckai, Csaba, Luzzi, Robert, Poser, Robert D.
• Granted Patent: US 8,523,871 B2
• Time in Patent Office: Days
• 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 system for delivering bone fill material into a bone, comprising

an injector body comprising a handle portion and an elongated cannula attached to the handle portion, at least a portion of the cannula percutaneously insertable into a bone;

a flow control mechanism disposed in the injector body and configured to generate a flow rate signal of bone fill material flowing through the injector body;

a thermal energy emitter disposed in the injector body and configured to apply energy to the bone fill material flowing through the injector body; and

a controller configured to receive the flow rate signal from the flow control mechanism and configured to modulate at least one of the flow rate of bone fill material through the injector body and the energy applied by the thermal energy emitter to the bone fill material based at least in part on the flow rate signal.

2. The system of claim 1, wherein the flow rate signal corresponds to a measured electrical parameter of a PTCR or NTCR material that responds to heat transfer from the bone fill material flow to the PTCR or NTCR material to thereby determine the flow rate of the bone fill material flow.

3. The system of claim 2, wherein the electrical parameter is impedance.

4. The system of claim 1, wherein the flow control mechanism is disposed in the handle portion.

5. The system of claim 1, wherein the thermal energy emitter is disposed in the handle portion.

6. The system of claim 1, wherein the thermal energy emitter is disposed in the cannula.

7. The system of claim 1, wherein the flow control mechanism comprises a flowmeter chosen from the group consisting of an impeller flowmeter, a gear flowmeter, a positive displacement flowmeter, an oval gear flowmeter, a sliding vane flowmeter, a nutating disc flowmeter, an oscillating piston flowmeter, a helical screw flowmeter, a Pelton wheel flowmeter, an ultrasonic flowmeter, and a thermal mass flowmeter.

8. The system of claim 1, wherein the flow control mechanism comprises a flow drive mechanism chosen from the group consisting of a peristaltic pump, a reciprocating piston pump, a rotary vane pump, a diaphragm pump, a rotodynamic pump, and a positive displacement pump.

9. The system of claim 1, wherein the thermal energy emitter is coupled to one of an electrical source, a light source, a microwave source, a resistive heat source, an Rf source, an ultrasound source, or an inductive heat source.

10. The system of claim 1, wherein the thermal energy emitter is a PTCR heater.

11. The system of claim 10, wherein the flow rate signal comprises a measured impedance value and wherein the controller further comprises at least one control algorithm configured to maintain a constant energy level applied to the thermal energy emitter and to modulate the flow rate based on the measured impedance value so as to maintain the measured impedance value within a desired range.

12. The system of claim 1, wherein the flow drive mechanism is configured to provide a continuous flow of bone fill material.

13. The system of claim 1, wherein the flow drive mechanism and controller are configured to provide a flow of bone fill material of between around 0.1 cc/min to 10 cc/min.

14. The system of claim 1, further comprising a power source removably coupled to the flow drive mechanism, and a remote hand-held switch operatively coupled to at least one of the injector body, the power source and the controller.

15. The system of claim 14, wherein the hand-held switch is configured to actuate the thermal energy emitter.

16. The system of claim 14, wherein the hand-held switch is configured to actuate the flow drive mechanism.

17. The system of claim 1, wherein the controller comprises at least one control algorithm configured to modulate the flow rate of the bone fill material and the application of energy in order to provide a substantially constant bone fill material viscosity at a distal end of the injector body.

18. A method for injecting bone cement into a bone, comprising:

inserting at least a portion of an injector body into a bone, the injector body comprising a flow control mechanism configured to generate a flow rate signal of bone cement flowing through the injector body;

flowing bone cement through the injector body into the bone;

generating a flow rate signal corresponding to the flow of bone cement through the injector body; and

modulating the application of thermal energy to the bone cement flowing through the injector body based at least in part on the flow rate signal.

19. The method of claim 18, wherein flowing bone cement through the injector body comprises actuating a flow drive mechanism coupled to the injector body.

20. The method of claim 18, wherein flowing bone cement through the injector body comprises hydraulically actuating a flow of bone cement.

21. The method of claim 18, wherein flowing bone cement comprises providing pulsed cement flow.

22. The method of claim 18, wherein flowing bone cement comprises providing a bone cement flow ranging from about 0.1 cc/min to about 10 cc/min.

23. The method of claim 18, wherein the bone cement flow ranges from about 0.1 cc/min to about 5 cc/min.

24. The method of claim 18, wherein generating a flow rate signal comprises measuring an electrical parameter of a PTCR or NTCR material in response to heat transfer from the bone cement flow to the PTCR or NTCR material to thereby determine the flow rate of the bone cement flow.

25. The method of claim 25, wherein the electrical parameter is impedance.

26. A method of delivering bone fill material into a bone, comprising:

inserting at least a portion of an injector body into a bone, the injector body comprising a PTCR or NTCR material;

flowing a bone fill material through the injector body into the bone; and

measuring an electrical parameter of the PTCR or NTCR material in response to heat transfer from the flow of bone fill material to the PTCR or NTCR material to thereby determine a selected parameter of the bone fill material flow.

27. The method of claim 26, wherein measuring an electrical parameter comprises measuring an impedance value.

28. The method of claim 26, wherein the selected parameter is a flow rate of the bone fill material.

29. The method of claim 26, wherein the selected parameter is a temperature of the bone fill material.

30. The method of claim 26, wherein the selected parameter is a viscosity of the bone fill material.

31. The method of claim 26, further comprising modulating the flow rate of the bone fill material in response, at least in part, to determining the selected parameter.

32. The method of claim 26, further comprising applying energy to the bone fill material flow via a thermal energy emitter disposed in a handle portion of the injector body.

33. The method of claim 32, further comprising modulating the application of energy from the energy emitter to the bone fill material flow in response, at least in part, to determining the selected parameter of the bone fill material flow.

34. The method of claim 32, further comprising modulating at least one of the flow rate of the bone fill material flow and energy application to the bone fill material to maintain a substantially constant impedance of the PTCR or NTCR material over a desired injection interval.

35. The method of claim 34, wherein the injection interval is at least 1 minute.

36. The method of claim 34, wherein the injection interval is at least 5 minutes.

37. The method of claim 34, wherein the injection interval is at least 10 minutes.

38. The method of claim 32, further comprising modulating at least one of the flow rate of the bone fill material flow and energy application to the bone fill material to maintain a substantially constant viscosity of the bone fill material flow ejected from the injector body over a desired injection interval.

39. The method of claim 26, further comprising applying a selected level of energy to the bone fill material flow via the PTCR or NTCR material.