Bone treatment systems and methods

• US 8,696,679 B2
• Filed: 12/10/2007
• Issued: 04/15/2014
• Est. Priority Date: 12/08/2006
• 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): LAWSON, MATTHEW JAMES
• Application Number:
  US11/953,800
• Publication Number:
  US 20080154273A1
• Time in Patent Office: 2,318 Days
• Field of Search: 623 1711- 1716, 623 2361- 2362, 606 92- 94, 604 23- 24, 604/113, 604/131, 604144-147, 604/150, 604 82- 92, 523113-116, 433/32, 433/80, 433 89- 90, 2221461-1464, 239 8- 9
• US Class Current: 606/94
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• 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 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00544 pneumatically

Abstract

The present invention relates in certain embodiments to methods, systems, and devices for treating vertebral compression fractures. In one embodiment, a bone cement injector is advanced into bone and injects a bone cement flow through the injector and a vapor flow from at least one vapor outlet in the injector. In another embodiment, the bone treatment system comprises an elongated member having a flow passageway, a bone fill material source, and a vapor source coupleable to the flow passageway. Still another embodiment describes a vapor injection device having an elongated member with a flow passageway, the elongated member configured for insertion into a bone and for delivering a bone fill material through the flow passageway, and having at least one vapor channel in communication with the flow passageway to deliver a vapor into the flow passageway to heat a bone fill material flow.

Claims

1. A method of treating bone, comprising:

providing bone cement injector system with a distal portion positioned in a bone, wherein the distal portion of the injector system comprises an introducer having an interior channel;

providing a bone cement flow through the injector system; and

introducing vapor into the bone cement flow from at least one vapor outlet in the interior channel of the introducer of the injector system, wherein the vapor provides thermal energy sufficient to heat the bone cement flow prior to its ejection from the distal portion of the injector system and to accelerate polymerization of the bone cement.

2. The method of claim 1, wherein the vapor has a heat of vaporization of greater that about 60°

C.

3. The method of claim 1, wherein the vapor is generated from one or more of water, saline, Ringer'"'"'s solution, hypertonic saline and alcohol.

4. The method of claim 1, wherein the vapor elevates the temperature of the bone cement flow thereby increasing its viscosity.

5. The method of claim 1, wherein the vapor undergoes a phase change upon interaction with the bone cement.

6. The method of claim 1, wherein introducing the vapor includes ejecting the vapor from a plurality of vapor outlets communicating with a flow passageway in the injector system.

7. The method of claim 1, wherein introducing the vapor is controlled by a controller.

8. The method of claim 1, wherein providing the bone cement flow is controlled by a controller.

9. The method of claim 1, wherein the bone is a vertebra.

10. The method of claim 1, wherein introducing the vapor creates a bone cement emulsion.

11. The method of claim 1, wherein the bone cement comprises at least in part PMMA.

12. A method of treating bone, comprising:

providing bone cement injector system with a distal portion positioned in a bone, wherein the distal portion of the injector system comprises an introducer having an interior channel;

providing a bone cement flow through the injector system; and

introducing vapor into the bone cement flow from at least one vapor outlet in the interior channel of the introducer of the injector system, wherein the vapor heats the bone cement flow prior to its ejection from the distal portion of the injector system, wherein the vapor is adapted to accelerate polymerization of the bone cement, and wherein introducing vapor into the bone cement flow includes introducing vapor via an annular channel in the introducer, the annular channel disposed about the interior channel of the introducer.

13. A method of treating bone, comprising:

inserting at least a distal portion of an introducer of a bone cement injector system into a bone, wherein the introducer comprises an interior channel;

delivering a bone cement flow through the interior channel of the introducer into the bone; and

introducing vapor into the bone cement flow via at least one vapor outlet in the interior channel of the introducer of the injector system, wherein the vapor provides thermal energy sufficient to heat the bone cement flow prior to its ejection from the distal portion of the introducer and to accelerate polymerization of the bone cement.

14. The method of claim 13, wherein the vapor has a heat of vaporization of greater that about 60°

C.

15. The method of claim 13, wherein the vapor is generated from one or more of water, saline, Ringer'"'"'s solution, hypertonic saline and alcohol.

16. The method of claim 13, wherein the vapor elevates the temperature of the bone cement flow thereby increasing its viscosity.

17. The method of claim 13, wherein the vapor undergoes a phase change upon interaction with the bone cement.

18. The method of claim 13, wherein introducing the vapor includes ejecting the vapor from a plurality of vapor outlets communicating with a flow passageway in the injector system.

19. The method of claim 13, wherein introducing the vapor is controlled by a controller.

20. The method of claim 19, wherein the controller controls one or more of vapor pressure, vapor temperature, vapor quality, vapor flow rate, and vapor flow intervals.

21. The method of claim 13, wherein delivering a bone cement flow is controlled by a controller.

22. The method of claim 21, wherein the controller controls one or more of bone cement flow pressure, bone cement flow rates, and bone cement flow intervals.

23. The method of claim 13, wherein the bone is a vertebra.

24. The method of claim 13, wherein introducing the vapor creates a bone cement emulsion.

25. The method of claim 13, wherein the bone cement comprises at least in part PMMA.