BONE TREATMENT SYSTEMS AND METHODS

• US 20090149878A1
• Filed: 12/07/2007
• Published: 06/11/2009
• Est. Priority Date: 12/07/2007
• Status: Abandoned Application

• Current Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Original Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Inventors: Shadduck, John H., Truckai, Csaba, Luzzi, Robert
• Application Number:
  US11/952,942
• Publication Number:
  US 20090149878A1
• Time in Patent Office: Days
• US Class Current: 606/186
• CPC Class Codes: A61B 17/1642 for producing a curved bore
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/8836 for heating, cooling or curing of bone cement or fluid fillers
• CPC Class Codes: A61B 2017/00088 using thermistors
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/0084 low friction A61B2017/00853 takes precedence
• CPC Class Codes: A61B 2017/3405 using mechanical guide means

Abstract

The present invention relates in certain embodiments to systems for treating vertebral compression fractures. In one embodiment, a trocar with a flexible tip is provided to create a curved path in cancellous bone. An injector can be introduced into the vertebra in communication with the curved path for delivery of bone fill material into the curved path. Optionally, thermal energy can be applied to the bone fill material prior to injection into the curved path in cancellous bone to alter a property (e.g., viscosity) of the bone fill material.

Claims

1. A method of treating an abnormal vertebra, comprising:

advancing an elongated member transpedicularly into vertebral cancellous bone, a distal end of the elongated member having an angled surface relative a longitudinal axis of the elongated member, at least a distal flex portion of the elongated member being deflectable away from the longitudinal axis; and

creating a curved path in cancellous bone by deflecting at least the distal flex portion of the elongated member via the engagement of said angled surface with bone as the elongated member is advanced into cancellous bone.

2. The method of claim 1, further comprising introducing a bone fill material injector into the vertebra so that the injector is in communication with the curved path and injecting a bone fill material through the injector into the curved path.

3. The method of claim 2, wherein the bone fill material injector is introduced into the vertebra over the elongated member.

4. The method of claim 2, wherein the bone fill material injector is introduced into the curved path after withdrawal of the elongated member from the curved path.

5. The method of claim 2, further comprising applying thermal energy to the bone fill material from an emitter in the injector.

6. The method of claim 5, wherein the application of thermal energy is provided by at least one of an electrical source, a resistive heat source, a light source, a microwave source, and inductive heating source, an Rf source and an ultrasound source.

7. The method of claim 5, wherein the bone fill material is an exothermic bone cement.

8. A bone treatment device, comprising an elongated shaft member extending along a longitudinal axis and configured for insertion into cancellous bone, the shaft having a working end comprising a proximal semi-rigid shaft portion, a medial flexible shaft portion and a distal end having a surface that is angled relative to said axis, wherein at least a portion of the working end of the elongated shaft member is configured to deflect away from the longitudinal axis.

9. The bone treatment device of claim 8, wherein the medial flexible shaft portion has a smaller cross-sectional dimension than the proximal rigid shaft portion.

10. The bone treatment device of claim 8, wherein the medial flexible shaft portion comprises a superelastic material.

11. The bone treatment device of claim 8, wherein the medial flexible shaft portion is off-axis.

12. The bone treatment device of claim 8, wherein the medial flexible shaft portion is non-symmetrical relative to said axis.

13. The bone treatment device of claim 8, wherein the medial flexible shaft portion comprises a single wire-like element.

14. The bone treatment device of claim 8, wherein the medial flexible shaft portion includes at least one wire-like element and a flexible polymer jacket.

15. The bone treatment device of claim 8, wherein the distal end surface is angled between about 10°

and 75°

relative to said axis.

16. The bone treatment device of claim 8, wherein the distal end surface is angled between about 20°

and 50°

relative to said axis.

17. The bone treatment device of claim 8, wherein the medial flexible shaft portion has an axial length ranging between about 1 mm and 20 mm.

18. The bone treatment device of claim 8 wherein the medial flexible shaft portion has an axial length ranging between about 4 mm. and 10 mm.

19. A bone treatment device, comprising an elongated shaft member extending along a longitudinal axis and configured for insertion into cancellous bone, the shaft having a working end comprising a proximal shaft portion, a medial flexible shaft portion and a distal end having a surface that is angled relative to said axis, wherein the medial flexible shaft portion comprises at least one slideable element actuatable to deflect the distal end of the elongated shaft member away from the longitudinal axis.

20. The bone treatment device of claim 19, wherein the slideable element is actuatable from a proximal handle end of the elongated shaft member.

21. The bone treatment device of claim 19, wherein the medial flexible shaft portion comprises two slideable elements, each of the elements actuatable to move axially relative to the proximal shaft portion to deflect the distal end of the elongated shaft member away from the longitudinal axis

22. A system of treating an abnormal vertebra, comprising:

an elongated trocar configured for pedicular insertion into vertebral cancellous bone so as to create a curved path in cancellous bone, a distal end of the elongated trocar having an angled surface relative a longitudinal axis of the elongated trocar, at least a distal flex portion of the elongated trocar configured to deflect away from the longitudinal axis;

an elongated injector configured for insertion into the cancellous bone to deliver a bone fill material into the curved path; and

a thermal energy emitter disposed in the elongated injector and configured to apply energy to the bone fill material prior to delivery of bone fill material into the curved path in cancellous bone.

23. The system of claim 22, wherein the injector is configured for introduction into the vertebra over the elongated trocar.

24. The system of claim 22, wherein the emitter is coupled to an external energy source.

25. The system of claim 24, wherein the external energy source is at least one of an electrical source, a resistive heat source, a light source, a microwave source, and inductive heating source, an Rf source and an ultrasound source.