Delivery apparatus and methods for vertebrostenting

• US 7,909,873 B2
• Filed: 12/14/2007
• Issued: 03/22/2011
• Est. Priority Date: 12/15/2006
• Status: Active Grant

• Current Assignee: Globus Medical, Inc.
• Original Assignee: Soteira, Inc. (Globus Medical, Inc.)
• Inventors: Hamilton, John V., Mugan, John, Tan-Malecki, Francisca, Gallagher, Dion, Ryan, Damien, Cannon, James, Bruggemann, Martin, Sennett, Andrew R., Sahatjian, Ronald, Coyle, James, Farrissey, Liam
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): HAMMOND, ELLEN CHRISTINA
• Application Number:
  US11/957,039
• Publication Number:
  US 20080208320A1
• Time in Patent Office: 1,194 Days
• Field of Search: 623/17.11, 623 111- 112, 606 92- 95, 606/86.R, 606/90, 606/99, 606/105
• US Class Current: 623/17.11
• 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

The invention relates to a method of delivering and deploying a stent into a curvilinear cavity within a vertebral body or other bony or body structure. The invention also relates to devices that may be used to perform the steps to deliver and deploy a stent.

Claims

1. A method of deploying a stent within an enlarged curvilinear void created in a bony structure, the method comprising the steps of:

inserting a distal end of a stent delivery system through a cannula and into a curvilinear void created along a curved pathway in a bony structure;

locking the stent delivery system to the cannula in a correct circumferential orientation with releasable locking means;

deploying a self-expanding cement-directing stent within the curvilinear void, wherein the self-expanding stent is releasably attached to the distal end of the stent delivery system;

attaching a cement injecting syringe to a proximal end of the stent delivery system;

injecting cement through the stent delivery system and into the stent;

terminating the cement injection when the volume of cement injected exceeds an interior volume of the expanded stent; and

releasing the stent from the stent delivery system.

2. The method of claim 1, wherein the self-expanding cement-directing stent comprises a multifilament braided, polymer impregnated, self-expanding, cement-directing stent.

3. The method of claim 1, wherein the stent delivery system comprises a handle and an elongate shaft, and wherein the stent is releasably attached to a distal end of the elongate shaft.

4. The method of claim 3, wherein the stent is released by actuating a user control mechanism on the handle.

5. The method of claim 3, wherein the elongate shaft comprises at least one of an inner shaft, an outer shaft, a tubular sheath, a flexible guidewire, and an internal polymer extrusion.

6. The method of claim 5, wherein prior to the deploying step the self-expanding cement-directing stent is collapsed on a distal end of at least one of the inner shaft, the guidewire, and the polymer extrusion.

7. The method of claim 6, wherein the self-expanding cement-directing stent is deployed by retracting at least one of the inner shaft, the outer shaft, the flexible guidewire, and the polymer extrusion.

8. The method of claim 5, wherein prior to the deploying step the self-expanding cement-directing stent is restrained in a collapsed condition by the tubular sheath.

9. The method of claim 8, wherein the self-expanding cement-directing stent is deployed by slideably retracting the tubular sheath to allow the stent to self-expand within the enlarged curvilinear void.

10. The method of claim 3, wherein the stent is further releasably attached at a distal end thereof.

11. The method of claim 1, wherein the deploying step comprises actuating a rotating cam mechanism.

12. The method of claim 1, wherein the distal end of the stent delivery system comprises a preformed curvature.

13. The method of claim 1, wherein the stent delivery system further comprises means for controlling curvature of the distal end.