System for use in treatment of vertebral fractures

Patent metadata

Field	Value
Publication number	US-10058336-B2
Application number	US-201113083411-A
Country	US
Kind code	B2
Filing date	Apr 8, 2011
Priority date	Apr 8, 2010
Publication date	Aug 28, 2018
Grant date	Aug 28, 2018

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.

First claim

What is claimed is:

1. A medical device for treating a tissue body, comprising:
a handle configured to withstand an impact force used to drive the device into bone, the handle comprising 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 configured to move 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 to limit articulation of the working end to a single plane;
a sharp tip located at a distal tip of the working end, where the shaft and sharp tip have sufficient column strength such that application of the impact force on the handle causes the distal portion of the shaft and the distal tip to drive into the tissue body, the sharp tip having an offset point where the offset point is offset from an axis of the shaft toward a direction of the articulated configuration such that when driven into the tissue body the offset point assists in deflecting the working end toward the articulated configuration;
a force-limiting assembly coupled between the actuating portion and the first sleeve such that upon reaching a threshold force, the actuating portion disengages and then re-engages the first sleeve; and
wherein the distal portion of the shaft carries an expandable structure proximally spaced from the sharp tip and configured to expand orthogonally to the single plane, wherein the expandable structure is fluidly coupled to an inflation tube concentrically disposed within the first sleeve.

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

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

4. The medical device of claim 3 , where the fluid connector is positioned to allow delivery of the impact force on the handle.

5. The medical device of claim 3 , where the fluid connector is coupled to the inflation tube which is fluidly coupled to the expandable structure.

6. The medical device of claim 3 , where the fluid expandable balloon comprises a thin wall polymer outer wall and a thin wall polymer inner wall that covers the series of slots or notches in the second sleeve where fluid expands the thin wall polymer outer wall away from the thin wall polymer inner wall.

7. The medical device of claim 3 , where the fluid expandable balloon comprises a non-compliant balloon.

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

9. The medical device of claim 8 , where the protective structure is selected from a group consisting of a knit wire, a woven wire, a braided wire, and a slotted structure.

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

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

12. The medical device of claim 11 , where the axially translatable sleeve comprises a metal sleeve.

13. The medical device of claim 11 , where the axially translatable sleeve comprises a plurality of at least partially circumferential slots.

14. The medical device of claim 11 , where the axially translatable sleeve comprises a plurality of fully circumferential slots.

15. 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.

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

17. The medical device of claim 16 , where the third sleeve ends at an intermediate portion of the shaft to limit torque or rotational forces generated by the handle.

18. The medical device of claim 17 , 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 articulated configuration such that an interior surface of the articulated configuration is solid.

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

20. The medical device of claim 17 , where the second sleeve is affixed to the third sleeve at the working end.

21. The medical device of claim 1 , wherein the force-limiting assembly is adapted to limit the force applied to bone when moving the working end from the linear configuration toward the articulated configuration.

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

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

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

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

26. The medical device of claim 25 , where the first and second sleeves comprise a non-circular cross-sectional shape.

27. The medical device of claim 25 , where one of the first or second sleeves comprises a key and where the other of the first or second sleeves comprises a keyway.

28. The medical device of claim 1 , wherein the actuating portion is an angularly rotatable actuating portion and comprises a ball bearing assembly disposed between a flange of the shaft and a surface of the handle, wherein the angular rotation of the angularly rotatable actuating portion lifts the first sleeve.

29. The medical device of claim 1 , wherein the force-limiting assembly comprises a collar attached to the second sleeve and a ball member within the handle, wherein the ball is pushed into a notch of the collar to place the medical device into a locked position.

Assignees

• Truckai Csaba
• Germain Aaron
• Shadduck John H
• Dfine Inc

Inventors

• Truckai Csaba
• Germain Aaron
• Shadduck John H

Classifications

• A61B17/1642

  for producing a curved bore · CPC title

• A61B17/1626

  Control means; Display units · CPC title

• A61B17/8805

  for introducing fluid filler into bone or extracting it (A61B17/7097, A61B17/8833 take precedence) · CPC title

• A61B2090/031

  torque limiting · CPC title

• A61B17/3472

  for bones, e.g. intraosseus injections · CPC title