Systems for delivering bone fill material

• US 8,066,712 B2
• Filed: 09/01/2006
• Issued: 11/29/2011
• Est. Priority Date: 09/01/2005
• 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
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): HARVEY, JULIANNA NANCY
• Application Number:
  US11/469,752
• Publication Number:
  US 20070191858A1
• Time in Patent Office: 1,915 Days
• Field of Search: 606 92- 94
• US Class Current: 606/93
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• 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
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity

Abstract

The disclosure relates in certain embodiments to medical devices, systems and methods for use in osteoplasty procedures, such as vertebral compression fractures. One system for delivering a bone fill material to a bone includes an elongated introducer configured for insertion into a bone and having a channel sized to allow a flow of bone fill material therethrough. The introducer has at least one outlet opening in communication with the channel for delivering the bone fill material into the bone. A thermal energy emitter is coupled to the introducer and configured to apply thermal energy to the bone fill material flowing through the introducer. A sensor and a computer controller can be used to measure data about the bone fill material and to control certain aspects of the flow of bone fill material. A hydraulic pressure source may also be operatively coupled to the introducer and configured to apply a force on the bone fill material to provide a pressurized flow of bone fill material through the introducer. In certain embodiments, the system for use in osteoplasty procedures can include a cooling system that can be used to cool the bone fill material.

Claims

1. A system for delivering a bone fill material to a vertebra, comprising:

an in-situ hardenable bone fill material comprising a two-part curable polymer;

an elongated introducer configured for insertion into a vertebral body and delivery of bone fill material through a channel of the introducer into the vertebral body;

a container of bone fill material coupleable to the introducer;

a thermal energy emitter coupled to the introducer and configured to apply thermal energy to the bone fill material flowing through the introducer;

a hydraulic pressure source coupled to the container and configured to apply a force on the bone fill material in the container to eject bone fill material from the container into the introducer;

a sensor for providing data relating to the bone fill material, the data being a measured parameter of the bone fill material and comprising at least one of temperature, impedance, capacitance, conductivity, pressure, viscosity, a flow parameter, volume, reflectance, an optical parameter, and an acoustical parameter; and

a computer controller configured to receive the data from the sensor and to control, based at least in part on the data,

     1) the thermal energy applied to the flow of bone fill material and

     2) the force from the hydraulic pressure source applied to the bone fill material, the computer controller thereby configured to control both the increase in viscosity of the bone fill material and the flow of bone fill material.

2. The system of claim 1, further comprising a flexible tube and a piston, wherein the hydraulic pressure source couples to the container via the flexible tube and is configured to selectively drive the piston disposed in the container to eject bone fill material from the container.

3. The system of claim 2, wherein the piston is a floating piston configured to move within the container between a proximal end coupled to the flexible tube and a distal end coupled to the introducer, the container having a larger diameter than the introducer, the flexible tube comprising a hydraulic line, the piston driven hydraulically by a liquid within the hydraulic line toward the distal end of the container to drive bone fill material from the container into the introducer.

4. The system of claim 1, wherein the thermal energy emitter is selected from the group consisting of an electromagnetic energy emitter, a radiofrequency energy emitter, a resistive heat emitter, a light energy emitter, a microwave emitter, an inductive heat emitter and an ultrasound emitter.

5. The system of claim 1, wherein the thermal energy emitter is disposed in the channel of the introducer proximal at least one opening of the introducer.

6. The system of claim 5, further comprising an insulative layer between the thermal energy emitter and a wall of the introducer.

7. The system of claim 1, wherein the thermal energy emitter is a resistive heat emitter.

8. The system of claim 7, wherein the resistive heat emitter has an axial configuration.

9. The system of claim 7, wherein the resistive heat emitter has a helical configuration.

10. The system of claim 7, wherein the thermal energy emitter is configured to raise a temperature of the bone fill material flowing through the channel to at least about 45°

C.

11. The system of claim 7, wherein the resistive heat emitter comprises a positive temperature coefficient (PTC) material configured to provide a generally uniform temperature from the emitter.

12. The system of claim 7, further comprising an electrical source coupled to the resistive heat emitter, the electrical source configured to provide a current to the resistive heat emitter.

13. The system of claim 1, further comprising a cooling system configured to cool the bone fill material within the container prior to ejection into the introducer and prior to the application of thermal energy within the introducer.

14. The system of claim 1, wherein the sensor is configured to measure a parameter of the bone fill material within the container of bone fill material.

15. A system for delivering a bone fill material to a bone, comprising:

an elongated introducer configured for insertion into a bone, the introducer defining a channel sized to allow a flow of a bone fill material therethrough, the introducer having at least one opening in communication with the channel for delivering the bone fill material into the bone;

a thermal energy emitter configured to apply thermal energy to the bone fill material within the introducer; and

a hydraulic pressure source operatively coupled to the introducer and configured to apply a force on the bone fill material to provide a pressurized flow of bone fill material through the introducer;

a sensor for providing data relating to the bone fill material, the data being a measured parameter of the bone fill material and comprising at least one of temperature, impedance, capacitance, conductivity, pressure, viscosity, a flow parameter, volume, reflectance, an optical parameter, and an acoustical parameter; and

a computer controller configured to receive the data from the sensor and to control the flow rate of the bone fill material to thereby control application of thermal energy from the thermal energy emitter to the bone fill material at least in response to the data from the sensor to thereby controllably increase the viscosity of the bone fill material injected into the bone.

16. The system of claim 15, wherein the hydraulic pressure source is configured to apply force through a flexible tube.

17. The system of claim 16, further comprising a piston, wherein the hydraulic pressure source is configured to selectively drive the piston to eject bone fill material from the introducer.

18. The system of claim 17, wherein the piston is a floating piston.

19. The system of claim 16, further comprising a cooling system configured to cool the bone fill material.

20. The system of claim 15, wherein the thermal energy emitter is selected from the group consisting of an electromagnetic energy emitter, a resistive heat emitter, a radiofrequency energy emitter, a light energy emitter, a microwave emitter, an inductive heat emitter and an ultrasound source.

21. The system of claim 15, wherein the thermal energy emitter is disposed in the channel of the introducer proximal at least one opening of the introducer.

22. The system of claim 15, wherein the sensor is configured to measure a parameter of the bone fill material that is within the system.

23. A system for delivering a bone cement into a bone, comprising:

an in-situ hardenable bone cement;

a cement introducer system having an introducer configured for insertion into a bone, the introducer defining a channel for carrying the bone cement, the introducer having at least one opening in communication with the channel for delivering the bone cement into the bone;

a thermal energy emitter configured to apply thermal energy to the bone cement within the cement introducer system;

a cooling system configured to cool the bone cement within the cement introducer system, wherein the cooling system is configured to cool the bone cement in a first section of the cement introducer system and the thermal energy emitter is configured to apply thermal energy to the bone cement in a second section of the cement introducer system separate from the first section;

a sensor for providing data relating to the bone cement, the data being a measured parameter of the bone cement and comprising at least one of temperature impedance, capacitance, conductivity, pressure, viscosity, a flow parameter, volume, reflectance, an optical parameter, and an acoustical parameter; and

a computer controller configured to receive the data from the sensor and to control the application of thermal energy from the thermal energy emitter to the bone cement flowing through the introducer system into the bone at least in response to the data from the sensor and to control the flow of bone cement to thereby controllably increase the viscosity of the bone cement injected into the bone.

24. The system of claim 23, wherein the controller is further configured to control the operation of the cooling system.

25. The system of claim 23, wherein the thermal energy emitter and the cooling system are configured such that the bone cement can be cooled during mixing and storage of the bone cement and heated during delivery through the introducer.

26. The system of claim 23, further comprising a hydraulic pressure mechanism comprising a hydraulic line and a floating piston, coupled to the cement introducer system and configured to hydraulically drive the piston by a liquid within the hydraulic line to apply a force on the bone cement and to eject bone cement from the cement introducer system.

27. The system of claim 23, wherein the cooling system comprises a thermoelectric system with at least one Peltier element in contact with a thermally conductive wall portion of the first section of the cement introducer system.

28. The system of claim 23, wherein the cooling system comprises at least one of a chilled fluid circulation system, and a Freon system.

29. The system of claim 23, wherein the cooling system is a passive cooling system.

30. The system of claim 29, wherein the passive cooling system comprises an open cell graphite structure for conducting heat away from the first section of the cement introducer system to a heat exchanger component.

31. The system of claim 23, wherein the sensor is configured to measure a parameter of the bone fill material within the cement introducer system.

32. The system of claim 31, wherein the sensor is configured to measure a parameter of the bone fill material within the first section of the cement introducer system.