Devices and methods for fracture reduction

• US 10,588,646 B2
• Filed: 05/08/2017
• Issued: 03/17/2020
• Est. Priority Date: 06/17/2008
• Status: Active Grant

• Current Assignee: Globus Medical, Inc.
• Original Assignee: Globus Medical, Inc.
• Inventors: Sennett, Andrew R., Beyreis, Randall J., Williams, Brett A.
• Primary Examiner(s): Coley, Zade
• Application Number:
  US15/589,287
• Publication Number:
  US 20170238943A1
• Time in Patent Office: 1,044 Days
• CPC Class Codes: A61B 17/1617 with mobile or detachable parts
• 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 17/1671 for the spine
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons

Abstract

Methods of creating a curvilinear cavity within a vertebral body or other bony structure and devices that may be used to perform the steps to create the curvilinear cavity. In one embodiment, a method of forming a curvilinear void in bony structure may include the steps of accessing a bony structure with a cannula, inserting a distal end of a drill device through the cannula and into the bony structure, manipulating the distal end of the drill device to create a curvilinear void in the bony structure, enlarging the void by expansion of a balloon element mounted to the drill device, and deflating the balloon element and removing the drill device from the cannula.

Claims

1. An apparatus for forming a curvilinear void in bony structure, comprising:

a curvilinear drilling device, comprising a handle and a flexible drill shaft assembly extending from a distal end of the handle, wherein the flexible drill shaft assembly includes a cutting tip located at a distal end of the flexible drill shaft assembly, a flexible rotatable drive shaft coupled to the tip, and a flexible, moveable and non-rotatable housing, wherein the distal end of the flexible drill shaft assembly includes a plurality of slots configured to allow the distal end to bend; and

a multi-lumen balloon assembly having a hollow shaft and an expandable balloon element mounted on a distal portion of the hollow shaft,

wherein the curvilinear drilling device is configured to be slidably inserted through the hollow shaft of the multi-lumen balloon assembly, and

wherein the curvilinear drilling device and the multi-lumen balloon assembly are configured to be positioned within a vertebral body.

2. The apparatus of claim 1, wherein the balloon element is expanded by injection of a fluid into an interior portion thereof.

3. The apparatus of claim 1, further comprising a lumen in fluid communication with the balloon element.

4. The apparatus of claim 1, further comprising a pull wire band, wherein the pull wire band provides an anchor for a distal end of the expandable balloon element.

5. The apparatus of claim 1, wherein the cutting tip is adapted to form the curvilinear void by simultaneous rotation and curvilinear translation of the cutting tip.

6. The apparatus of claim 1, wherein the balloon element is located substantially proximate to a distal end of the flexible, moveable and non-rotatable housing.

7. The apparatus of claim 1, wherein the balloon element is mounted to a multi-lumen assembly mounted to the drilling device.

8. The apparatus of claim 7, wherein the multi-lumen assembly comprises:

a first lumen adapted to surround an elongate shaft of the drilling device; and

a second lumen in fluid communication with the balloon element.

9. The apparatus of claim 7, wherein the multi-lumen assembly is removably mounted onto the drilling device.

10. The apparatus of claim 7, wherein the multi-lumen assembly is fixedly mounted onto the drilling device.

11. The apparatus of claim 1, wherein the drilling device further comprises a slotted tube.

12. The apparatus of claim 11, wherein the slotted tube is non-rotatable.

13. The apparatus of claim 1, wherein walls of the shaft of the multi-lumen balloon assembly is thin to allow the assembly to remain flexible and/or steerable.

14. The apparatus of claim 1, further comprising a wire tensioner connected to a distal end of the multi-lumen balloon catheter assembly.

15. The apparatus of claim 1, further comprising a feedscrew integrated with a key component and the key component is adapted to mate with a slot in a cannula to ensure correct orientation of the drilling device.

16. The apparatus of claim 15, wherein at least a portion of the multi-lumen balloon assembly passes through the feedscrew.

17. The apparatus of claim 16, wherein a balloon lumen of the multi-lumen balloon assembly passes through the feedscrew.

18. The apparatus of claim 1, wherein the drilling device includes a curved distal end that is induced to curve by a spring loaded pull wire.

19. The apparatus of claim 18, wherein the drilling device includes an axial stiffening wire independent from the pull wire, wherein the stiffening wire extends in a helical pattern axially along the drilling device.

20. An apparatus for forming a curvilinear void in bony structure, comprising:

a handle assembly;

a curvilinear drilling device, wherein the drilling device comprises a feedscrew assembly including a feedscrew having a threaded mating with the handle assembly configured to provide rotational and axial driving motion and a key component configured to movably couple the drilling device to the handle assembly to ensure a desired circumferential orientation between the drilling device and the handle assembly, wherein a distal end of the drilling device includes a plurality of slots configured to allow the distal end to bend; and

a multi-lumen balloon assembly having a hollow shaft and an expandable balloon element mounted on a distal portion of the hollow shaft,

wherein the curvilinear drilling device is configured to be slidably inserted through the hollow shaft of the multi-lumen balloon assembly,

wherein the drilling device further comprises a flexible drill shaft assembly extending from a distal end of the handle, wherein the flexible drill shaft assembly includes a cutting tip located at a distal end of the flexible drill shaft assembly, a flexible rotatable drive shaft coupled to the tip, and a flexible, moveable and non-rotatable housing, and

wherein the curvilinear drilling device and the multi-lumen balloon assembly are configured to be positioned within a vertebral body.