SYSTEMS FOR TREATING A VERTEBRAL BODY

• US 20100211076A1
• Filed: 10/13/2009
• Published: 08/19/2010
• Est. Priority Date: 10/13/2008
• Status: Active Grant

• Current Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Original Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Inventors: TRUCKAI, Csaba, GERMAIN, Aaron
• Granted Patent: US 8,758,349 B2
• Time in Patent Office: Days
• US Class Current: 606/84
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/1631 Special drive shafts, e.g. flexible shafts A61B17/1642, A61B17/164 take precedence
• CPC Class Codes: A61B 17/1642 for producing a curved bore
• CPC Class Codes: A61B 17/1659 Surgical rasps, files, planes, or scrapers
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• 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 17/8819 characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula A61B17/8825 takes precedence
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2018/00101 low, i.e. thermally insulating
• CPC Class Codes: A61B 2018/00339 Spine, e.g. intervertebral disc
• CPC Class Codes: A61B 2018/00565 Bone
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00589 Coagulation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00714 : Temperature
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/1412 : Blade
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2018/1497 : Electrodes covering only part of the probe circumference

Abstract

Methods and devices that displace bone or other hard tissue to create a cavity in the tissue. Where such methods and devices rely on a driving mechanism for providing moving of the device to form a profile that improves displacement of the tissue. These methods and devices also allow for creating a path or cavity in bone for insertion of bone cement or other filler to treat a fracture or other condition in the bone. The features relating to the methods and devices described herein can be applied in any region of bone or hard tissue where the tissue or bone is displaced to define a bore or cavity instead of being extracted from the body such as during a drilling or ablation procedure.

Claims

1. A medical osteotome device for treating a vertebral body by mechanically displacing hard tissue and coupleable to a power supply, the medical osteotome device comprising:

a handle having an actuating portion and a connector for electrically coupling the osteotome device to the power supply;

a shaft comprising a first sleeve located concentrically within a second sleeve, the shaft having a distal portion comprising a working end capable of moving between a linear configuration and an articulated configuration where the articulated configuration is limited to a single plane, and where each sleeve comprises a series of slots or notches to limit deflection of the working end to the articulated configuration, where the respective series of slots or notches are radially offset in adjacent sleeves, where a first conductive portion of the shaft is electrically coupleable to a first pole of the power supply;

a sharp tip located at a distal tip of the first sleeve of the working end, the sharp tip adapted to penetrate bone within the vertebral body, where the distal tip is coupleable to a second pole of the power supply, such that when activated, current flows between a portion of the distal tip and the shaft;

a non-conductive layer electrically isolating the first sleeve from the first conductive portion; and

where the shaft and sharp tip have sufficient column strength such that application of an impact force on the handle causes the distal portion of the shaft and the distal tip to mechanically displace the hard tissue.

2. The medical device of claim 1, where the first sleeve is affixed to the second sleeve at the working end such that relative axial movement of the first and second sleeves causes the working end to assume the articulated configuration.

3. The medical device of claim 1, where the second sleeve is electrically coupleable to the power supply such that the first conductive portion is on the second sleeve.

4. The medical device of claim 1, further comprising a third sleeve located concentrically about the second sleeve and where the third sleeve is electrically coupleable to the power supply such that the first conductive portion is on the third sleeve.

5. The medical device of claim 4, where the third sleeve ends at an intermediate portion of the tool to limit torque or rotational forces generated by the handle mechanism.

6. The medical device of claim 4, where the third sleeve extends to the handle portion.

7. The medical device of claim 4, where the third sleeve further includes slots or notches on an exterior surface of the third sleeve that faces outward from a direction of the curved configuration such that an interior surface of the curved configuration is solid.

10. The medical device of claim 1, where the first sleeve is advanceable out of the shaft.

11. The medical device of claim 1, where a portion of the distal tip of the first sleeve does not contain notches.

12. The medical device of claim 1, where a portion of the distal tip comprises a plurality of openings.

13. The medical device of claim 4, where the second sleeve is affixed to the third sleeve at the working end.

14. The medical device of claim 1, further comprising a force-limiting assembly coupled between the actuating portion and the first sleeve such that upon reaching a threshold force, the actuating portion disengages the first sleeve.

15. The medical device of claim 14, wherein the force-limiting mechanism is adapted to limit force applied to bone when moving the working end from the first configuration toward the second configuration.

16. The medical device of claim 1, further comprising at least one spring element extending through the first sleeve, where the spring element is affixed to the shaft and causes the working end to assume the linear configuration in a relaxed state.

17. The medical device of claim 16, where the at least one spring element comprises a plurality of spring elements.

19. The medical device of claim 1, wherein the first sleeve is coupled to the actuation portion of the handle such that rotation of the actuation portion of the handle causes axial movement of the first sleeve to deform the working end into the articulated configuration.

20. The medical device of claim 1, where the handle is configured to receive an impact force, and where resistance of the sharp tip against bone causes the working end to assume the curved configuration.

21. The medical device of claim 1, further comprising a lumen extending through the shaft and working end.

22. The medical device of claim 21, where wherein the sharp tip is solid and where the lumen terminated proximal to the sharp tip.

23. The medical device of claim 21, further comprising a source of a bone cement material that is fluidly coupled to lumen the bone cement material can pass through the lumen to exit at the working end.

24. The medical device of claim 23, wherein the lumen terminates in a side opening in a wall of the shaft such that bone cement material exits proximal to the distal tip.

25. The medical device of claim 21, wherein the lumen includes a surface comprising a lubricous polymeric material.

27. The medical device of claim 1, where at least the series of slots or notches on the first sleeve have a uniform width.

28. The medical device of claim 1, where at least the series of slots or notches on the second sleeve have a uniform width.

29. The medical device of claim 1, where the series of slots or notches on the first sleeve vary in a width.

30. The medical device of claim 1, where the series of slots or notches on the second sleeve vary in a width.

31. The medical device of claim 1, where the first and second sleeves are prevented from rotating with respect to one another.

32. The medical device of claim 27, where the sleeves comprises a non-circular cross-sectional shape.

33. The medical device of claim 27, where at least one of the first or second sleeves comprises a key and where at least at least one of the first or second sleeves comprises a keyway.

8. (canceled)

9. (canceled)

18. (canceled)

26. (canceled)

34. (canceled)

35. A method of treating a vertebral body, comprising:

providing an elongate tool having a sharp tip configured for penetration into vertebral bone, the tool having an axis extending from a proximal end to a working end thereof, where the working end comprises at least a first sleeve concentrically located within a second sleeve, where each sleeve comprises a series of slots or notches to limit deflection of the working end to a first curved configuration in a single plane and where the respective series of slots or notches are radially offset in adjacent sleeves, where a first conductive portion of the first sleeve is electrically coupled to a first pole of a power supply;

advancing the working end through vertebral bone;

causing the working end to move from a linear configuration to a curved configuration by translating the first sleeve relative to the second sleeve in an axial direction; and

applying energy between the first conductive portion and a return electrode electrically coupled to a second pole of the energy supply to ablate or coagulate a region within the vertebral body.

36. The method of claim 35, further comprising moving the working end in the curved configuration within the bone to by applying an impact force on the handle create a cavity therein by mechanically displacing bone.

37. The method of claim 35, where applying energy comprises advancing an extension portion of the first sleeve distally from the second sleeve such that applying energy comprises causing current to flow between the extension portion of the first sleeve and the return electrode.

38. The method of claim 37, further comprising applying a fluid through the first sleeve through one or more ports in the extension portion of the first sleeve.

40. The method of claim 35, where the return electrode is located on an exterior portion of the second sleeve.

41. The method of claim 35, where translating the first sleeve relative to the second sleeve comprises relatively rotating the first sleeve and the second sleeve to each other to translate in the axial direction.

44. The method of claim 35, further comprising a third sleeve located concentrically about the second sleeve, the third sleeve having a series of slots or notches to limit deflection of the working end to the first curved configuration in the single plane, and where the return electrode is located on an exterior portion of the third sleeve.

45. The method of claim 44, where the third sleeve ends at an intermediate portion of the tool to limit torque or rotational forces generated by the handle mechanism.

39. (canceled)

42. (canceled)

43. (canceled)

46-59. -59. (canceled)