SYSTEM FOR USE IN TREATMENT OF VERTEBRAL FRACTURES

• US 20110251615A1
• Filed: 04/08/2011
• Published: 10/13/2011
• Est. Priority Date: 04/08/2010
• 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, GERMAIN, Aaron
• Granted Patent: US 10,058,336 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 17/1626 Control means; Display units
• CPC Class Codes: A61B 17/1631 Special drive shafts, e.g. flexible shafts A61B17/1642, A61B17/164 take precedence
• CPC Class Codes: A61B 17/1633 Sleeves, i.e. non-rotating parts surrounding the bit shaft, e.g. the sleeve forming a single unit with the bit shaft A61B17/1644 takes precedence
• CPC Class Codes: A61B 17/1642 for producing a curved bore
• CPC Class Codes: A61B 17/1657 Bone breaking devices
• 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 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855
• CPC Class Codes: A61B 2090/031 torque limiting

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, the shaft having a distal portion comprising a working end capable of moving between a linear configuration and an articulated configuration 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 distal portion of the shaft carrying an expandable structure.

2. The medical device of claim 1, further comprising a sharp tip located at a distal tip the working end working end, the sharp tip adapted to penetrate bone within the vertebral body, 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.

3. The medical device of claim 1, where the expandable member is a mechanically expanded structure.

4. The medical device of claim 1, where the expandable member is a fluid expandable balloon that includes a fluid connector adapted to be fluidly coupled to a pressurized fluid source.

5. The medical device of claim 4, where the fluid connector is positioned to allow delivery of an impact force on the handle.

6. The medical device of claim 4, where the fluid connector is coupled to an inflation tube which is fluidly coupled to the expandable member.

7. The medical device of claim 4, where the fluid expandable balloon comprises a thin wall polymer outer wall and thin wall polymer inner wall that covers slot in the second sleeve where fluid expands the outer wall against the inner wall.

8. The medical device of claim 4, where the fluid expandable balloon comprises a balloon selected from the group consisting of a compliant balloon and a non-compliant balloon.

9. The medical device of claim 1, where the expandable member further comprises an expandable protective structure configured to minimize the expandable member from becoming caught or damaged when expanding against cancellous bone.

10. The medical device of claim 9, where the protective structure is selected from a group consisting of knit wire, a woven wire, a braided wire, and a slotted structure.

11. The medical device of claim 1, further comprising a tear away sheath located over the shaft.

12. The medical device of claim 1, further comprising an axially translatable sleeve configured to extend over the expandable member and is retractable to allow for expansion of the expandable member.

13. The medical device of claim 12, where the axially translatable sleeve comprises a metal sleeve.

14. The medical device of claim 12, where the axially translatable sleeve comprises a plurality of at least partially circumferential slots.

15. The medical device of claim 12, where the axially translatable sleeve comprises a plurality of fully circumferential slots.

16. 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.

17. The medical device of claim 1, further comprising a third sleeve located concentrically about the second sleeve.

18. The medical device of claim 17, where the third sleeve ends at an intermediate portion of the shaft to limit torque or rotational forces generated by the handle.

19. The medical device of claim 18, where the third sleeve extends to the handle.

20. The medical device of claim 18, 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.

21. The medical device of claim 18, where the series of slots or notches on the third sleeve vary in a width.

22. The medical device of claim 18, where the second sleeve is affixed to the third sleeve at the working end.

23. 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.

24. The medical device of claim 23 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.

25. 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.

26. The medical device of claim 25, where the at least one spring element comprises a plurality of spring elements.

27. 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.

28. The medical device of claim 1, further comprising a source of a bone cement material that is fluidly coupled to a lumen in the shaft, where the bone cement material can pass through the lumen to exit at the working end.

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

30. The medical device of claim 1, where at least the series of slots or notches on the second sleeve have a uniform 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 31, where the first and second sleeves are prevented from rotating with respect to one another.

33. The medical device of claim31, where the sleeves comprises a non-circular cross-sectional shape.

34. The medical device of claim 31, 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.