SYSTEM FOR USE IN TREATMENT OF VERTEBRAL FRACTURES

• US 20100082033A1
• Filed: 09/30/2009
• Published: 04/01/2010
• Est. Priority Date: 09/30/2008
• Status: Active Grant

• Current Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Original Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Inventors: GERMAIN, Aaron
• Granted Patent: US 8,663,226 B2
• Time in Patent Office: Days
• US Class Current: 606/79
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1642 for producing a curved bore
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• 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 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• 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 2017/003 Steerable
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts

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 device for treating a vertebral body, comprising:

a handle having an actuating portion;

a shaft comprising a first sleeve located concentrically within a second sleeve and a third sleeve located concentrically about the 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; and

a sharp tip located at a distal tip of the working end, the sharp tip adapted to penetrate bone within the vertebral body.

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 affixed to the third sleeve at the working end.

4. 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.

6. 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.

8. The medical device of claim 1, wherein the second configuration comprises a plurality of articulated configurations.

9. The medical device of claim 1, where the third sleeve ends at an intermediate portion of the tool to limit torque or rotational forces generated by the handle mechanism.

10. The medical device of claim 1, where the third sleeve extends to the handle portion.

11. The medical device of claim 1, where the slots or notches on the third sleeve are located 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.

12. 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.

13. 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.

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

15. The medical device of claim 14, where wherein the sharp tip is solid and where the lumen terminated proximal to the sharp tip.

16. The medical device of claim 14, 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.

17. The medical device of claim 16, 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.

18. The medical device of claim 14, wherein the lumen includes a surface comprising a lubricous polymeric material.

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

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29. A kit comprising:

a medical device comprising;

a handle having an actuating portion;

a shaft comprising a first sleeve located concentrically within a second sleeve and a third sleeve located concentrically about the 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; and

a sharp tip located at a distal tip of the working end, the sharp tip adapted to penetrate bone within the vertebral body; and

a bone filler material.

30. 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 and a third sleeve located concentrically about the 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;

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

moving the working end in the curved configuration within the bone to create a cavity therein.

31. The method of claim 30, 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.

32. The method of claim 30, where causing the working end to move from the linear configuration to the curved configuration comprises causing the working end to move through a plurality of curved configurations.

33. The method of claim 30, wherein causing the working end to move from a linear configuration to the curved configuration comprises actuating a handle mechanism to move the working end from the linear configuration to the curved configuration.

34. The method of claim 33, where the third sleeve ends at an intermediate portion of the tool to limit torque or rotational forces generated by the handle mechanism.

35. The method of claim 33, where actuating of the handle mechanism causes movement of the working end to the first curved configuration without torquing the third sleeve.

37. The method of claim 30, wherein causing the working end to move from the linear configuration to the curved configuration comprises applying a driving force to the elongate tool wherein penetration in the bone moves the working end from the linear configuration to the curved configuration.

38. The method of claim 30, where the slots or notches on the third sleeve are located 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.

39. The method of claim 30, where causing the working end to move from the linear configuration to the curved configuration comprises limiting an amount of force applied to bone by the working end by providing a force-limiting structure within the tool to limit the amount of force applied to the bone.

41. The method of claim 30, where advancing the working end through vertebral bone comprises advancing the working end through cancellous or cortical bone.

43. The method of claim 30, where causing the working end to move from the linear configuration to the curved configuration comprises applying an impact force to the tool to allow resistance of the bone at the sharp tip to move the working end from linear configuration to the curved configuration.

45. The method of claim 30, further comprising inserting the tool through a cannula such that the working end remains in the linear configuration while in the cannula and moves to the curved configuration after being advanced out of the cannula.

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