Bone treatment systems and methods

• US 8,070,753 B2
• Filed: 08/02/2005
• Issued: 12/06/2011
• 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): Robert, Eduardo C
• Assistant Examiner(s): CARTER, TARA ROSE E
• Application Number:
  US11/196,045
• Publication Number:
  US 20060122624A1
• Time in Patent Office: 2,317 Days
• Field of Search: 606 92- 94, 606/90, 606/105, 623/17.11, 623/17.12
• US Class Current: 606/94
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61B 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• 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 17/8836 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: A61F 2/44 for the spine, e.g. vertebrae, spinal discs

Abstract

The present invention relates in certain embodiments to medical devices for treating osteoplasty procedures such as vertebral compression fractures. More particularly, embodiments of the invention relate to instruments and methods for controllably restoring vertebral body height by controlling the geometry of fill material introduced into cancellous bone. An exemplary system utilizes Rf energy in combination a conductive bone fill material for polymerizing the surface of the inflow plume to control the geometry of the fill material and the application of force caused by inflows of fill material. In another embodiment, method of treating bone includes injecting a volume of fill material into a bone and selectively modifying a viscosity of a selected portion of the bone filler to control the direction of flow of the fill material within the bone. A system for treating bone using this method includes an introducer for delivering fill material into the bone and an energy source selectively coupleable to the fill material to alter the viscosity of the fill material as it flows out of the introducer.

Claims

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;

a source of bone cement coupled to said flow channel;

an energy source coupled to a thermal energy emitter in the flow channel configured to apply energy to the bone cement to controllably increase the viscosity of the bone cement within the flow channel;

a sensor that provides a measurement of a parameter of the bone cement within the flow channel, wherein the parameter is selected from the group consisting of impedance, temperature, viscosity, and volume; and

a controller detachably coupled to the thermal energy emitter, the controller including algorithms that adjust power delivery from the energy source to the thermal energy emitter based at least in part on measurements from the sensor, wherein the controller controls the energy source to alter the bone cement to a viscosity in a range of at least about 1,000,000 cps sufficient to controllably permeate and interdigitate with cancellous bone.

2. The system for treating bone 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 and an ultrasound source.

3. The system for treating bone of claim 1, wherein the energy source is detachably coupled to the thermal energy emitter.

4. The system for treating bone of claim 1, wherein the source of bone cement is detachably coupled to the injector.

5. The system for treating bone of claim 1, wherein the fill bone cement further includes an in-situ polymerizable component for causing hardening of the bone cement.

6. The system for treating bone of claim 5, wherein the polymerizable component includes at least one of PMMA, monocalcium phosphate, tricalcium phosphate, calcium carbonate, calcium sulphate or hydroxyapatite.

7. The system for treating bone of claim 1 further comprising at least one electrode carried in the flow channel.

8. The system for treating bone of claim 1, further comprising a monitoring means coupled to the controller for monitoring at least one parameter of the bone cement.

9. The system for treating bone of claim 8, wherein the monitoring means includes at least one of temperature monitoring means and impedance monitoring means.

10. The system for treating bone of claim 1, wherein the energy source is capable of accelerating polymerization of the fill material.

11. The system for treating bone of claim 1, wherein the controller is capable of modulating energy delivery from the energy source.

12. The system for treating bone of claim 1, wherein the controller is capable of modulating a flow parameter of a flow of bone cement from the source of bone cement.

13. The system for treating bone of claim 1, wherein the energy source is capable of modifying at least one of a viscosity, a Young'"'"'s modulus, a surface hardness and a durometer of the bone cement.

14. The system for treating bone of claim 1, wherein the energy source is capable of increasing a viscosity of the bone cement by at least 20% on or before injection of the bone cement into the bone.

15. The system for treating bone of claim 1, wherein the energy source is capable of increasing a viscosity of the bone cement by at least 100% on or before injection of the bone cement into the bone.

16. The system for treating bone of claim 1, wherein the energy source is capable of increasing a viscosity of the bone cement by at least 500% on or before injection of the bone cement into the bone.

17. The system of claim 1 wherein the energy source is further configured to apply energy directly to the bone cement.

18. The system of claim 1 wherein the energy source is further configured to apply energy to the bone cement contemporaneously with the bone cement flowing through the flow channel.

19. The system of claim 1, wherein the controls to alter the viscosity increase the viscosity by about 10% to 1000%.

20. An osteoplasty system comprising:

an elongated introducer with a flow channel extending therethrough for introducing bone cement to a bone portion;

a pressurizable source of bone cement coupled to said flow channel;

an electrical source operatively connected to at least one thermal energy emitter proximate to the flow channel for delivering thermal energy to the bone cement within the flow channel contemporaneously with the bone cement flowing through the flow channel, the electrical source configured to deliver thermal energy to the bone cement to controllably increase the viscosity of the bone cement; and

means for electrically adjusting power delivery from the electrical source to the at least one thermal energy emitter based at least in part on a sensed parameter measurement of the bone cement within the flow channel, said parameter selected from the group consisting of impedance, temperature, viscosity, and volume, said means being detachably connectable to the electrical source and at least one thermal energy emitter;

wherein the means for electrically adjusting power delivery controls the energy source to alter the bone cement to increase the viscosity of the bone cement flow by between about 10% and 1000% sufficient to controllably permeate and interdigitate with cancellous bone.

21. The osteoplasty system of claim 20, wherein the means for electrically adjusting power delivery comprising an electronic controller to control the pressure of the source of bone cement.

22. The osteoplasty system of claim 20, wherein the means for electrically adjusting power delivery comprising a controller to control the volume of the fill bone cement introduced to the bone portion.

23. The osteoplasty system of claim 20, wherein the means for electrically adjusting power delivery comprising a controller to control the flow rate of the bone cement.

24. The osteoplasty system of claim 20, wherein the means for electrically adjusting power delivery comprising a controller including algorithms for adjusting power delivery based on electrical impedance between electrodes proximate to the flow channel.

25. The osteoplasty system of claim 20, wherein the means for electrically adjusting power delivery comprising a controller including algorithms for adjusting power delivery based on the volume of the bone cement introduced to the bone portion.

26. The osteoplasty system of claim 20, wherein the means for electrically adjusting power delivery comprising a controller including algorithms for adjusting power delivery based on temperature of the bone cement introduced to the bone portion.

27. The osteoplasty system of claim 20, further comprising a temperature sensor within the flow channel operatively coupled to a controller.

28. The osteoplasty system of claim 20, further comprising means for pressurizing the source of bone cement including at least one of a piston pump, a screw pump and a hydraulic pump.

29. The osteoplasty system of claim 20, wherein the increase in viscosity comprises an increase to a viscosity of at least about 1,000,000 cps.