Balloon expandable cement director and related methods

• US 10,238,442 B2
• Filed: 07/29/2015
• Issued: 03/26/2019
• Est. Priority Date: 12/14/2007
• Status: Active Grant

• Current Assignee: Globus Medical, Inc.
• Original Assignee: Globus Medical, Inc.
• Inventors: Sahatjian, Ronald, Sennett, Andrew R.
• Primary Examiner(s): Coley, Zade
• Assistant Examiner(s): Weiss, Jessica
• Application Number:
  US14/811,878
• Publication Number:
  US 20150335370A1
• Time in Patent Office: 1,336 Days
• Field of Search: 606 63, 606 86 R, 606 92- 94, 606 99, 606105, 604 9601, 60410301-10302, 60410306, 60410307, 60410309, 60410311-10314
• 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 system for treating a vertebral body comprising:

a delivery device comprising a distal end configured for insertion into a vertebral body and a proximal end comprising a handle, wherein the delivery device includes a fill passageway;

an expandable device configured to be releasably coupled to the distal end of the delivery device, the expandable device comprising a mesh structure comprising a plurality of layers including 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 by forming the mesh structure with the austenite layer and a martensite layer, the mesh structure is configured to correspond in shape to an original undeformed shape of the mesh structure prior to collapsing the mesh structure for delivery, the mesh structure provides structural support for the vertebral body upon deployment and prior to cement injection, and

a balloon configured to be coupled at the distal end of the delivery device and adapted to further expand the expandable device from the original undeformed shape of the mesh structure when disposed therein in order to provide an enlarged cavity for cement injection, wherein the balloon is configured to expand upon introduction of balloon expansion material from the fill passageway of the delivery device,

wherein the expandable device is configured to receive bone cement from the fill passageway of the delivery device,

wherein the mesh structure further includes a third layer surrounding the first layer and the second layer,

wherein the mesh structure is configured to expand to a partially expanded shape smaller than the original undeformed shape after deployment and the balloon is configured to expand the mesh structure from the partially expanded shape to an expanded form, and

wherein the mesh structure is configured to maintain the expanded form upon deflation of the balloon and the balloon is configured to be removable from the mesh structure.

2. The system of claim 1 further comprising a push rod adapted to be removably insertable through the delivery device and into the expandable device to hold the expandable device in a collapsed configuration prior to deployment.

3. The system of claim 1 further comprising a sheath adapted to removably extend through the delivery device and over the expandable device to hold the expandable device in a collapsed configuration prior to deployment.

4. The system of claim 1, wherein the mesh structure is generally cylindrical in shape, when expanded, such that an outer diameter along at least a portion of a length of the mesh structure is substantially constant.

5. The system of claim 1, wherein the mesh structure includes at least one region of greater permeability relative to a second region of lesser permeability.

6. The system of claim 5, wherein the region of greater permeability includes a plurality of holes positioned along a length of the mesh structure.

7. The system of claim 1, wherein the third layer is a covering layer.

8. The system of claim 7, wherein the mesh structure includes at least one region of greater permeability relative to a second region of lesser permeability, and the region of greater permeability comprises a region that is not covered by the covering layer.

9. The system of claim 7, wherein the covering layer is impermeable to bone cement.

10. The system of claim 7, wherein the covering layer comprises an elastic material.

11. The system of claim 10, wherein the elastic material is selected from the group consisting of silicone, polyurethane, styrene, isobutylene, polyester, nylon, natural fiber material, and combinations thereof.

12. The system of claim 1, wherein at least one of the first and second shape memory materials comprises nickel titanium.

13. The system of claim 1, wherein the expandable device includes a closed distal end and an open proximal end.

14. The system of claim 13, wherein the open proximal end of the expandable device is configured to be releasably coupled to a distal end of the fill passageway in the delivery device.

15. The system of claim 1 further comprising at least one of a drilling device and a reaming device configured to form a path or a cavity in the vertebral body.

16. A system for treating a vertebral body comprising:

a delivery device comprising a distal end configured for insertion into a vertebral body and a proximal end comprising a handle, wherein the delivery device includes a fill passageway;

an expandable device configured to be releasably coupled to the distal end of the delivery device, the expandable device comprising a mesh structure comprising a plurality of layers including 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 the mesh structure includes at least one region of greater permeability relative to a second region of lesser permeability, and

a balloon configured to be coupled at the distal end of the delivery device and adapted to further expand the expandable device from the original undeformed shape of the mesh structure when disposed therein in order to provide an enlarged cavity for cement injection, wherein the balloon is configured to expand upon introduction of balloon expansion material from the fill passageway of the delivery device,

wherein the expandable device is configured to receive bone cement from the passageway of the delivery device,

wherein the mesh structure further includes a third layer surrounding the first layer and the second layer,

wherein the mesh structure is configured to expand to a partially expanded shape smaller than the original undeformed shape after deployment and the balloon is configured to expand the mesh structure from the partially expanded shape to an expanded form, and

wherein the mesh structure is configured to maintain the expanded form upon deflation of the balloon and the balloon is configured to be removable from the mesh structure.

17. The system of claim 16, wherein the region of greater permeability includes a plurality of holes positioned along a length of the mesh structure.

18. The system of claim 16, wherein the expandable device is collapsible to a collapsed state and expandable to an expanded state by inflating the balloon within the expandable device.

19. The system of claim 16 further comprising a push rod adapted to be removably insertable through the delivery device and into the expandable device to hold the expandable device in a collapsed configuration prior to deployment.

20. The system of claim 16 further comprising a sheath adapted to removably extend through the delivery device and over the expandable device to hold the expandable device in a collapsed configuration prior to deployment.