SYSTEM FOR USE IN TREATMENT OF VERTEBRAL FRACTURES

• US 20120130381A1
• Filed: 11/22/2011
• Published: 05/24/2012
• Est. Priority Date: 11/22/2010
• 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 9,649,116 B2
• Time in Patent Office: Days
• US Class Current: 606/84
• 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 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/00323 Cables or rods

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 method of displacing cancellous bone in a vertebral body comprising:

providing an osteotome with an axially-extending shaft having an articulating working end, wherein the working end comprises a plurality of concentric sleeves with distal portions of at least a first sleeve having a plurality of slots where at least one of the slots has an arcuate shape;

inserting the working end into cancellous bone; and

progressively articulating the working end through toward an increased curvature to progressively apply a displacing force is over said curvature from distal to proximal portions thereof to displace adjacent cancellous bone.

2. The method of claim 1, where progressively articulating the working end comprises closing a space between each of the plurality of slots sequentially from a distal most slot to a proximal most slot.

3. The method of claim 2, where at least one of the plurality of slots comprises a key portion and a mating key receiving portion, where closing the space between each of the plurality of slots comprises closing the space between the slot to move the key portion and key receiving portion together to prevent torsional movement of the sleeve when articulating.

4. The method of claim 3, where each of the plurality of slots comprises the key portion and the mating key receiving portion, where progressively articulating the working end causes each key portion and key receiving portion to move together to prevent torsional movement of the sleeve.

5. The method of claim 1, where each of the plurality of slots on the first sleeve has the arcuate shape.

6. The method of claim 1, where at least one of the plurality of slots on the first sleeve has a radial shape.

7. The method of claim 1, further comprising a second sleeve having a second plurality of slots where at least one of the second plurality of slots has an arcuate shape.

8. The method of claim 7, where each of the second plurality of slots has the arcuate shape.

9. The method of claim 7, where at least one of the second plurality of slots comprises a key portion and a mating key receiving portion.

13. The method of displacing cancellous bone of claim 1 further comprising rotating the working end when in a curved shape, wherein movement together or meshing of the keyed portion and the key receiving portion increases a resistance to deformation of the working end from the predetermined plane or planes.

10. A method of displacing cancellous bone in a vertebral body comprising:

providing an osteotome with a shaft having an axis and an elongate working end capable of articulation between a linear shape and a curved shape, wherein the working end comprises at least one sleeve wall with a series of slots comprising a keyed portion and a key receiving portion, where a resistance to twisting deformation of the sleeve increases when the keyed portion and keyed receiving portion move together;

inserting the working end in the linear shape into cancellous bone; and

progressively articulating the working end from the linear shape toward the curved shape o cause progressive application of a displacing force to bone by axial regions of the elongate working end to displace adjacent cancellous bone.

11. The method of claim 10, wherein progressively articulating the working end articulates the working end into a curve shape in a predetermined plane or planes.

12. The method of displacing cancellous bone of claim 11, wherein said displacing force is applied progressively from distal axial regions of the elongate working end toward proximal axial regions of the elongate working end.

14. The method of claim 10, where at least one of the series of slot comprises a radial oriented slot and at least one of the series of slots comprises an axial oriented slot.

15. A medical osteotome device for treating a vertebral body by mechanically displacing cancellous bone, the medical osteotome device comprising:

a handle including an actuator mechanism;

a shaft coupled to the handle, the shaft having an axis and comprising a plurality of concentric sleeves with distal portions, each sleeve configured with a respective series of slots to provide actuation of the working end between a linear configuration and an articulated configuration;

wherein at least a plurality of slots is configured with substantially radial and axially oriented openings that when closed increase resistance to torsion of the respective sleeve.

16. The medical device of claim 15, wherein the articulated configuration is limited to a single plane.

17. The medical device of claim 16, wherein the working end in the articulated configuration is rotatable in cancellous bone to mechanically displace said cancellous bone.

18. The medical device of claim 17, wherein the working end is rotatable in said bone without substantial deformation of the working end from said single plane.

19. The medical device of claim 17, wherein the working end is rotatable in said bone to apply a force of at least 10 in-lbs to said bone without substantial deformation of the working end from said single plane.

20. The medical device of claim 16, wherein the working end in the articulated configuration is rotatable for mechanically displacing bone;

and wherein the handle includes a handle-shaft torque release mechanism that releases at between 10 in-lbs and 15 in-lbs.

21. The medical device of claim 15, wherein the shaft comprises at least two sleeves.

22. The medical device of claim 15, wherein each sleeve has a wall thickness of at least 0.015″

.

23. A medical osteotome device for treating a vertebral body by mechanically displacing cancellous bone, the medical osteotome device comprising:

a handle including an actuator mechanism; and

a shaft coupled to the handle, the shaft having a working end comprising a plurality of concentric sleeves with a series of slots therein to provide movement of the working end between a linear configuration and an articulated configuration, where at least a plurality of the series of slots are configured to increase a resistance to torsional movement of the sleeves when articulated;

wherein movement of the working end toward the articulated configuration applies at least 30 lbs. force to said bone.

24. The medical osteotome of claim 23, wherein movement of the working end toward the articulated configuration applies at least 50 lbs. force to said bone.

25. A medical osteotome device for treating a vertebral body by mechanically displacing cancellous bone, the medical osteotome device comprising:

a handle including an actuator mechanism;

a shaft coupled to the handle, the shaft having an axis and comprising a plurality of concentric sleeves with distal portions configured with a series of slots allowing actuation of the working end between a linear configuration and an articulated configuration;

wherein a plurality of slots in the sleeves have each have a substantially radially oriented opening and a substantially axially oriented opening, where a dimension of the radially oriented opening is greater than a dimension of the axially oriented opening.

26. The medical device of claim 25, wherein said radial slot portions have a width greater than 0.006″

, 008″

or 0.010″

.

27. The medical device of claim 25, wherein said axial slot portions have a width less than 0.010″

, 008″

or 0.006″

.

28-32. -32. (canceled)