Delivery of apparatus and methods for vertebrostenting

• US 9,918,765 B2
• Filed: 01/15/2016
• Issued: 03/20/2018
• Est. Priority Date: 04/15/2004
• Status: Active Grant

• Current Assignee: Globus Medical, Inc.
• Original Assignee: Globus Medical, Inc.
• Inventors: Tan-Malecki, Francisca, Hamilton, John V., Sennett, Andrew R., Sahatjian, Ronald, Coyle, James, Cannon, James, Farrissey, Liam, Mugan, John, Bruggeman, Martin, Gallagher, Dion
• Primary Examiner(s): Hammond, Ellen C
• Application Number:
  US14/996,437
• Publication Number:
  US 20160166302A1
• Time in Patent Office: 795 Days
• CPC Class Codes: A61B 17/16 Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans arthroscopic bone cutters A61B17/320016; dental implant drills potentially for other surgical use A61C8/0089; bone grinders A61F2/4644, A22C17/06; A61B17/1662 takes precedence over all other subgroups except A61B17/17
• CPC Class Codes: A61B 17/1617 with mobile or detachable parts
• CPC Class Codes: A61B 17/1637 Hollow drills or saws producing a curved cut, e.g. cylindrical A61B10/025, A61B17/1695 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 17/88 Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices A61B17/7074 takes precedence
• 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 17/8808 with sealing collar for bone cavity
• 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 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61B 17/885 Tools for expanding or compacting bones or discs or cavities therein A61B17/8805, A61B17/7097 take precedence
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855

Abstract

Systems and methods of delivering and deploying a stent into a curvilinear cavity within a vertebral body or other bony or body structure. In some instances, the system can include an elongate shaft for delivering a self-expanding, cement-directing stent and devices that may be used to perform the steps to deliver and deploy the stent.

Claims

1. A surgical method comprising:

forming a curved pathway in a vertebral body using a curved drill;

cutting an enlarged cavity through the curved pathway;

rotating a handle of a stent delivery system in a first direction in order to collapse a stent having a braided structure and at least one hole;

inserting the collapsed stent via the stent delivery system into the enlarged cavity;

expanding the stent by rotating the handle in a second direction opposite to the first direction, thereby allowing the stent to self-expand; and

injecting a filling material through the stent delivery system and into the expanded stent such that at least some of the bone cement flows out of the at least one hole.

2. The surgical method of claim 1, wherein the at least one hole allows the filling material to enter the inferior and anterior sides of the vertebral body.

3. The surgical method of claim 1, wherein the stent includes at least two holes for providing regions of differing permeability.

4. The surgical method of claim 1, wherein the stent includes a plurality of holes aligned along a single axis.

5. The surgical method of claim 1, wherein injecting the filling material into the stent comprises attaching a syringe to a proximal end of the stent delivery system.

6. The surgical method of claim 1, wherein the filling material comprises bone cement.

7. The surgical method of claim 1, wherein the stent delivery system comprises a shaft and a sliding mechanism to allow for extension and retraction of the stent along the axis of the shaft.

8. A surgical method comprising:

forming a curved pathway in a vertebral body using a curved drill;

cutting an enlarged cavity through the curved pathway;

rotating a handle of a stent delivery system in a first direction in order to collapse a stent having a braided structure and at least one hole;

inserting the collapsed stent via the stent delivery system into the enlarged cavity;

expanding the stent by rotating the handle in a second direction opposite to the first direction, thereby allowing the stent to self-expand, wherein the stent expands on its own within the vertebral body without the use of filling material; and

injecting a filling material through the stent delivery system and into the expanded stent such that at least some of the bone cement flows out of the at least one hole.

9. The surgical method of claim 8, wherein the stent comprises an inlet hole for receiving the filling material therethrough.

10. The surgical method of claim 9, wherein the stent comprises one or more porous regions that allow for controlled or direct distribution of the filling material.

11. The surgical method of claim 10, wherein the total cross-sectional area of the one or more porous regions exceeds that of the cement inlet hole.

12. The surgical method of claim 8, wherein the stent includes a plurality of holes aligned along a single axis.

13. The surgical method of claim 8, wherein the enlarged cavity is created with a curved reamer.

14. A surgical method comprising:

accessing a vertebral body;

forming a curved pathway in the vertebral body;

cutting an enlarged cavity through the curved pathway;

rotating a handle of a stent delivery system in a first direction in order to collapse a stent having a braided structure and at least one hole;

inserting the collapsed stent via the stent delivery system into the enlarged cavity;

expanding the stent by rotating the handle in a second direction opposite to the first direction, thereby allowing the stent to self-expand, wherein the stent expands on its own within the vertebral body without the use of filling material.

15. The surgical method of claim 14, wherein the stent comprises one or more porous regions that allow for controlled or direct distribution of a filling material.

16. The surgical method of claim 14, wherein the stent comprises an inlet hole for receiving filling material therethrough.

17. The surgical method of claim 14 wherein the stent includes a plurality of holes aligned along a single axis.

18. The surgical method of claim 14, wherein the handle is rotated between 90°

and 360°

to collapse and deploy the stent.

19. The surgical method of claim 14, wherein the enlarged cavity is created with a curved reamer.

20. The surgical method of claim 14, wherein the vertebral body is accessed with a posterior pathway to the vertebral body using an extrapedicular or intrapedicular approach.