Bone treatment systems and methods

• US 8,192,442 B2
• Filed: 07/13/2009
• Issued: 06/05/2012
• 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, Luzzi, Robert, Carlson, Grace A., Rappleye, C. Travis, Shadduck, John H.
• Primary Examiner(s): Robert, Eduardo C
• Assistant Examiner(s): CARTER, TARA ROSE E
• Application Number:
  US12/502,163
• Publication Number:
  US 20090275995A1
• Time in Patent Office: 1,058 Days
• Field of Search: 606/86.R, 606 92- 94, 606/105, 623 1711- 1716, 623/23.19, 623/23.62
• US Class Current: 606/92
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• 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. A method of treating bone includes injecting a volume of fill material into a bone and selectively modifying a viscosity 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 via an energy emitter in the introducer.

Claims

1. A method for treating a vertebral fracture, comprising:

controllably applying energy from an energy source to a bone cement in an injector system via a heating element disposed in the injector system, at least a portion of the injector system having an outlet port positionable within cancellous bone, the applied energy selectively increasing the viscosity of the bone cement;

injecting a volume of bone cement having the selectively increased viscosity into the cancellous bone; and

controlling the viscosity of the cement injected through the injector system via the controlled application of energy so that the bone cement flows into cancellous bone along a flow path between the outlet port and a periphery of the volume, and so at least a portion of the flow path comprises bone cement interdigitated with the cancellous bone.

2. The method of claim 1 wherein the injecting step includes injecting the bone cement at a predetermined flow rate into the cancellous bone.

3. The method of claim 1, wherein controlling the viscosity of the cement includes applying a first level of energy to the bone cement to achieve a first desired change in bone cement viscosity, and applying a second level of energy different from the first level to the bone cement to achieve a second desired change in bone cement viscosity.

4. The method of claim 1, further comprising monitoring a parameter of the bone cement.

5. The method of claim 4, wherein the parameter comprising at least one of temperature and impedance.

6. The method of claim 1, further comprising modulating the application of energy with a controller.

7. The method of claim 6, wherein the modulation is in response to a monitored parameter of the bone cement.

8. The method of claim 1, wherein the energy source comprising at least one of a radio frequency source, a resistive heat source, a laser source, a microwave source, a magnetic source and an ultrasound source.

9. A method for treating a vertebral body, comprising:

controllably applying energy from an energy source to a bone cement wherein the application of energy selectively increases the viscosity of the bone cement; and

injecting a volume of the bone cement having the selectively increased viscosity into cancellous bone of the vertebral body wherein the viscosity of the volume of bone cement is controlled by the controlled application of energy;

wherein the injected volume of bone cement flows along a flow path that interdigitates and permeates the cancellous bone, the volume of bone cement being injected without previously compacting the cancellous bone.

10. The method of claim 9, wherein the bone cement follows a natural flow path through the cancellous bone.

11. The method of claim 9, wherein the bone cement follows a flow path through the cancellous bone having an outer region that completely surrounds interdigitated cancellous bone.

12. The method of claim 9, wherein applying energy includes applying energy to selected portions of the volume of bone cement.

13. The method of claim 9, wherein the bone cement forms a flow impermeable surface on at least a portion of the bone cement.

14. The method of claim 9, further comprising applying sufficient energy to the bone cement to substantially accelerate polymerization of the bone cement.

15. The method of claim 9, wherein the viscosity of the bone cement is selectively increased so as to inhibit extravasation in the vertebral fracture.

16. A method for treating a vertebral body, comprising:

controllably applying energy from an energy source to a bone cement via a heating element in an injector system, the applied energy selectively increasing viscosity of the bone cement; and

injecting a volume of the bone cement through an outlet port of the injector system into cancellous bone of the vertebral body wherein the viscosity of the volume of bone cement is controlled by the controlled application of energy;

wherein the injected volume of the bone cement flows along a flow path interdigitating and permeating the cancellous bone, an outer region of the flow path surrounding interdigitated cancellous bone located in the flow path between the outer region and the outlet port.

17. The method of claim 16, further comprising injecting an additional volume of bone cement into the cancellous bone of the vertebral body.

18. The method of claim 17, wherein injecting the additional volume of bone cement expands at least a portion of a surface of the initial volume defined by the outer region.

19. The method of claim 17, wherein injecting the additional volume supports or moves cortical bone.