FOAM OCCLUSION DEVICE

• US 20150305750A1
• Filed: 04/28/2015
• Published: 10/29/2015
• Est. Priority Date: 04/28/2014
• Status: Abandoned Application

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Hadley, Rick, Isch, Andrew P., Hadley, Rita
• Application Number:
  US14/698,189
• Publication Number:
  US 20150305750A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12163 having a string of elements connected to each other
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/12095 Threaded connection

Abstract

An occlusion device comprising a plurality of expandable hydrophilic foam elements is described. When the device is deployed to a body vessel or a body cavity, it expands radially due to uptake of liquid from the body fluids with which it is in contact. The device may optionally have a surrounding meshwork, an inner spring, and a screw-type deployment mechanism. A method of deploying the device is also provided.

Claims

1. A device for occlusion of a body vessel, the device comprising:

a coil spring having a proximal end and a distal end, defining a longitudinal axis;

a proximal collet disposed to the proximal end and a distal collet to the distal end;

at least one expandable element disposed radially about a portion of the coil spring; and

a covering disposed on the proximal collet about the proximal end, the covering extending from the proximal collet about the coil spring and the at least one expandable element, the covering being disposed on the distal collet about the distal end.

2. The device of claim 1 wherein the hydrophilic foam elements are substantially disc-shaped.

3. The device of claim 1 wherein the covering comprises a mesh.

4. The device of claim 1 further comprising a threaded capture element extending proximally from the proximal collet substantially along the longitudinal axis.

5. The device of claim 1 wherein the coil spring defines a lumen formed therethrough along the longitudinal axis, each of the proximal collet and the distal collet comprising an opening formed along the longitudinal axis and in fluid communication with the lumen of the coil spring.

6. The device of claim 5 further comprising a tapered tip extending distally from the distal collet substantially along the longitudinal axis.

7. The device of claim 3 wherein the covering comprises a shape memory metal.

8. The device of claim 7 wherein the mesh further comprises a polyester.

9. The device of claim 8 wherein the shape memory metal and the polyester are present as strands, the strands being woven together to form the mesh, the shape memory metal strands and polyester strands being positioned in alternating fashion.

10. The device of claim 1 further comprising a radiopaque member embedded in the hydrophilic expandable foam member.

11. The device of claim 1 comprising at least two hydrophilic expandable foam members.

12. The device of claim 1 wherein the coil spring comprises:

a proximal coil spring half having a first end and a second end, the first end being attached to the proximal collet, the second end having a threaded member attached thereto and extending distally and substantially along the longitudinal axis; and

a distal coil spring half having a third end and a fourth end and defining a lumen formed therethrough, the fourth end of the distal coil spring being attached to the distal collet, the third end having a diameter such that the threaded member can enter the lumen threadedly.

13. An assembly for occlusion of a body vessel, the assembly comprising:

an outer sheath having a tubular body comprising an open end, the tubular body including a lumen formed through the open end;

an inner member disposed within the sheath lumen and movable rotationally and longitudinally relative to the outer sheath; and

an occlusion device comprising;

a coil spring having a proximal end and a distal end, defining a longitudinal axis;

a proximal collet disposed to the proximal end and a distal collet to the distal end;

at least one expandable element disposed radially about a portion of the coil spring; and

a covering disposed on the proximal collet about the proximal end, the covering extending from the proximal collet about the coil spring and the at least one expandable element, the covering being disposed on the distal collet about the distal end;

the occlusion device being disposed within the lumen and removably coupled to the distal end of the inner member and deployable through the open end of the outer sheath.

14. The kit of claim 13 further comprising a crimping device for crimping the occlusion device to a size to fit within the sheath lumen.

15. The kit of claim 13 further comprising a wire guide, and wherein the coil spring defines a lumen formed therethrough along the longitudinal axis, each of the proximal collet and the distal collet comprising an opening formed along the longitudinal axis and in fluid communication with the lumen of the coil spring, such that the wire guide can be passed through the lumen.

16. The kit of claim 13 wherein the device comprises a threaded capture element extending proximally from the proximal collet substantially along the longitudinal axis and the distal part of the outer sheath comprises a threaded receiving portion to threadedly engage the threaded capture element of the device.

17. A method of occluding a body vessel comprising:

wetting an occlusion device, the occlusion device comprising;

a coil spring having a proximal end and a distal end, defining a longitudinal axis;

a proximal collet disposed to the proximal end and a distal collet to the distal end;

at least one expandable element disposed radially about a portion of the coil spring; and

a covering disposed on the proximal collet about the proximal end, the covering extending from the proximal collet about the coil spring and the at least one expandable element, the covering being disposed on the distal collet about the distal end;

crimping the expandable element of the occlusion device to dispose the occlusion device within a lumen;

loading the occlusion device into the lumen;

introducing the delivery assembly percutaneously into the body vessel; and

delivering the occlusion device to the body vessel.

18. The method of claim 17 wherein delivering the occlusion device comprises advancing an inner member of a delivery assembly distally and rotating the inner member to release the occlusion device.

19. The method of claim 17 further comprising the steps of retracting the occlusion device back into the lumen, repositioning the lumen, and redeploying the occlusion device in the body vessel to be occluded.

20. The method of claim 18 wherein advancing the inner member precedes rotating the inner member.