Bone treatment systems and methods

• US 20060122624A1
• Filed: 08/02/2005
• Published: 06/08/2006
• 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: Shadduck, John H., Truckai, Csaba, Luzzi, Robert, Carlson, Grace A.
• Granted Patent: US 8,070,753 B2
• Time in Patent Office: Days
• 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:

an elongated introducer having a working end with a flow channel extending therethrough for injecting fill material into an interior of a bone;

a source of fill material coupled to said flow channel, wherein the fill material includes a composition that has at least one of an energy-absorbing property and an energy-transmitting property; and

an energy source configured to apply energy to the energy-absorbing or energy-transmitting composition to modify at least one of the fill material and a bone structure proximate the injected fill material.

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 composition is at least one of an electrically conductive media, a chromophore, a ferromagnetic composition, a thermally conductive composition and a radiosensitive composition.

4. The system for treating bone of claim 2, wherein the energy source is operatively connected to an energy emitter within the flow channel.

5. The system for treating bone of claim 2, wherein the energy source is operatively connected to an energy emitter on an exterior of the working end.

6. The system for treating bone of claim 2, wherein the energy source is operatively connected to an energy emitter carried by a working end of a second introducer.

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

8. The system for treating bone of claim 7, wherein the polymerizable component includes at least one of PMMA, monocalcium phosphate, tricalcium phosphate, calcium carbonate, calcium sulphate or hydroxyapatite.

9. The system for treating bone of claim 1 further comprising at least one electrode carried in said working end.

10. The system for treating bone of claim 9, wherein the at least one electrode is carried in the flow channel.

11. The system for treating bone of claim 1, further comprising a controller for controlling the application of energy from the energy source.

12. The system for treating bone of claim 11, further comprising a monitoring means coupled to the controller for monitoring at least one parameter of the fill material.

13. The system for treating bone of claim 12, wherein the monitoring means includes at least one of temperature monitoring means and impedance monitoring means.

14. 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 fill material.

15. The system for treating bone of claim 1, wherein the energy source is capable of increasing a viscosity of the fill material by at least 20%.

16. The system for treating bone of claim 1, wherein the energy source is capable of increasing a viscosity of the fill material by at least 100%.

17. The system for treating bone of claim 1, wherein the energy source is capable of increasing a viscosity of the fill material by at least 500%.

18. The system for treating bone of claim 1, wherein the energy source is capable of modifying bone structure including at least one of sealing, coagulating, shrinking and ablating the structure.

19. An osteoplasty system comprising:

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

a pressurizable source of fill material coupled to said flow channel, wherein the fill material includes an electrically conductive filler; and

a radiofrequency (Rf) source operatively connected to at least one electrode in a working end of the introducer for delivering Rf energy to the fill material.

20. The osteoplasty system of claim 19, further comprising a controller to control the pressure of the source of fill material.

21. The osteoplasty system of claim 19, further comprising a controller to control the amount of Rf energy delivered to the fill material.

22. The osteoplasty system of claim 19, further comprising a controller to control the volume of the fill material introduced to the bone portion.

23. The osteoplasty system of claim 19, further comprising a controller including algorithms for adjusting power delivery based on impedance of the fill material introduced to the bone portion.

24. The osteoplasty system of claim 19, further comprising a controller including algorithms for adjusting power delivery based on the volume the fill material introduced to the bone portion.

25. The osteoplasty system of claim 19, further comprising a controller including algorithms for adjusting power delivery based on temperature of the fill material introduced to the bone portion.

26. The osteoplasty system of claim 19, further comprising a temperature sensor at the working end operatively coupled to the controller.

27. The osteoplasty system of claim 19, further comprising first and second introducers with respective working ends that carry at least one electrode.

28. The osteoplasty system of claim 19, further comprising a projecting thread structure in the working end for gripping bone.

29. The osteoplasty system of claim 19, further comprising an expandable structure in the working end for expanding a cross-section thereof for gripping bone.

30. The osteoplasty system of claim 19, further comprising a barb structure in the working end for gripping bone.

31. The osteoplasty system of claim 19, further comprising means for pressurizing the source of fill material including at least one of a piston pump and a screw pump.

32. The osteoplasty system of claim 19, further including a detachment mechanism for detaching a working end of the introducer from a proximal portion thereof.