Balloon expandable cement director and related methods

• US 9,126,023 B1
• Filed: 02/25/2011
• Issued: 09/08/2015
• Est. Priority Date: 12/14/2007
• Status: Active Grant

• Current Assignee: Globus Medical, Inc.
• Original Assignee: Gmedelaware 2 LLC (Globus Medical, Inc.)
• Inventors: Sahatjian, Ronald, Sennett, Andrew R.
• Primary Examiner(s): Ramana, Anu
• Assistant Examiner(s): Weiss, Jessica
• Application Number:
  US13/035,423
• Time in Patent Office: 1,656 Days
• Field of Search: 606/63, 606/86.R, 606 92- 94, 606/99, 606/105, 604/96.01, 60410301-10302, 604/103.06, 604/103.07, 604/103.09, 60410311-10314
• US Class Current: 1/1
• CPC Class Codes: A61B 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61B 17/8802 Equipment for handling bone cement or other fluid fillers
• 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 17/8819 characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula A61B17/8825 takes precedence
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1018 Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/10181 Means for forcing inflation fluid into the balloon

Abstract

The invention relates to a cement director for insertion within a vertebral body or other body structure, and related methods of use. An example method includes creating a cavity in a vertebral body, inserting a collapsible mesh structure into the cavity in a collapsed state, wherein the collapsible mesh structure comprises regions of different permeability to a bone cement, inflating a balloon within the collapsible mesh structure to expand the mesh structure, and injecting a bone cement into the mesh structure, wherein the bone cement flows preferentially out of the mesh structure through at least one region of greater permeability.

Claims

1. A method of treating a vertebral body comprising the steps of:

creating a cavity in a vertebral body;

inserting a collapsible mesh structure into the cavity in a collapsed state, wherein the collapsible mesh structure comprises regions of different permeability to a bone cement;

inflating a balloon within the collapsible mesh structure through a fill passageway with a balloon expansion material to expand the mesh structure having a length; and

injecting a bone cement into the mesh structure, wherein the bone cement flows out of the mesh structure through at least one region of greater permeability relative to a second region of lesser permeability,

wherein the bone cement is injected into the mesh structure through the same fill passageway as the balloon expansion material, and wherein the mesh structure is generally cylindrical in shape, when expanded, such that an outer diameter along at least a portion of the length is substantially constant, and the at least one region of greater permeability includes a plurality of holes positioned along the length of the mesh structure,

wherein the mesh structure comprises;

a first layer comprising a first shape memory material in an austenite phase at body temperature; and

a second layer comprising a second shape memory material in a martensite phase at body temperature,

wherein forming the mesh structure of the austenite layer and the martensite layer enables the balloon to further expand the partially expanded mesh to its fully expanded configuration corresponding to the mesh structure'"'"'s original, undeformed shape prior to collapsing the mesh structure for delivery, the mesh structure providing structural support for the vertebral body upon deployment, and prior to cement injection;

and deflating the inflated balloon, wherein the mesh structure maintains its fully expanded configuration upon removal of the deflated balloon; and

removing the deflated balloon from the fully expanded mesh structure.

2. The method of claim 1, wherein the mesh structure further comprises a covering layer.

3. The method of claim 1, wherein the mesh structure comprises a shape memory material.

4. The method of claim 3, wherein the shape memory material comprises nickel titanium.

5. The method of claim 3, wherein the shape memory material is formed in an austenite phase at body temperature.

6. The method of claim 1, wherein a surface of the mesh structure is covered by a covering layer.

7. The method of claim 6, wherein the covering layer comprises a textile selected from the group consisting of a knitted fabric, a braided fabric, and a woven fabric.

8. The method of claim 6, wherein the at least one region of greater permeability comprises a region that is not covered by the covering layer.

9. The method of claim 6, wherein the covering layer covers at least one of an interior surface and an exterior surface of the mesh structure.

10. The method of claim 6, wherein the covering layer is impermeable to the bone cement.

11. The method of claim 6, wherein the covering layer comprises an elastic material.

12. The method of claim 11, wherein the elastic material is selected from the group consisting of silicone, polyurethane, styrene, isobutylene, polyester, nylon, natural fiber material, and combinations thereof.

13. The method of claim 1, wherein the at least one region of greater permeability comprises at least one hole in a wall of the mesh structure.

14. The method of claim 1, wherein the collapsible mesh structure is at least partially self-expandable from its collapsed state.

15. The method of claim 1, wherein the balloon is inserted into the interior of the mesh structure prior to the mesh structure being inserted into the cavity.

16. The method of claim 1, wherein the balloon is inflated with sufficient pressure to move endplates of the vertebral body apart.

17. The method of claim 1, wherein the mesh structure is expanded to be a size of a boundary of the cavity.