VASCULAR PLUGS

• US 20100106178A1
• Filed: 10/29/2009
• Published: 04/29/2010
• Est. Priority Date: 10/29/2008
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Evert, Kathryn, Obermiller, F. Joseph, Hardert, Michael W., Deckard, Michael D.
• Granted Patent: US 8,986,338 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• 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 2017/12054 Details concerning the detachment of the occluding device from the introduction device

Abstract

Certain aspects of the present invention provide devices for occluding vascular vessels. In some preferred forms, these devices are able to move from a first condition to a less compact, second condition in a vascular vessel so as to fully or partially prevent fluid from passing through the vessel. One such device includes a frame and a flexible sheet material. The device also includes an occluding material that is located in an interior region of the frame. The flexible sheet material and frame are associated with one another such that when the device is in the second condition in the vascular vessel, the sheet material is positioned in the vessel lumen so as to block fluid flow through the lumen.

Claims

1. A device for occluding a vascular vessel, comprising:

a frame movable between a first condition suitable for transluminal vascular delivery to a vascular site for providing an occluding device, and an expanded second condition adapted for deployment at the vascular site, the frame having a proximal end and a distal end and including a plurality of elongate arms that emanate from a common centralized region at the proximal end of the frame and extend distally to the distal frame end, the expanded second condition including an expanded frame segment in which the arms are outwardly displaced relative to the common centralized region, the expanded frame segment being spaced distally from the common centralized region;

a flexible sheet material coupled to the frame such that when the frame is in the expanded second condition at the vascular site, the sheet material is positioned in the vascular vessel lumen so as to block fluid flow through the lumen; and

an expandable occluding material located in an interior region of the frame, the expandable material effective to expand at the vascular site so as to provide an expanded material at the vascular site.

2. The device of claim 1, wherein the frame is self-expandable.

3. The device of claim 1, wherein the expandable occluding material is located in the interior region of the frame so as to be effective to at least partially move the frame between the first condition and the expanded second condition upon expansion at the vascular site.

4. The device of claim 1, wherein the sheet material is coupled to the frame so as to include portions located between the expanded frame segment and inner wall surfaces of the vascular vessel when the frame is in the expanded second condition at the vascular site.

5. The device of claim 1, wherein the expandable occluding material is located in the interior region of the frame so as to position the expanded frame segment between the occluding material and inner wall surfaces of the vascular vessel when the frame is in the expanded second condition at the vascular site.

6. The device of claim 1, wherein the expanded frame segment includes a conical portion.

7. The device of claim 1, wherein the expanded frame segment includes a bulbous portion.

8. The device of claim 1, wherein the expandable occluding material is located in the interior region of the frame so as to include portions positioned externally of the frame when the frame is in the expanded second condition at the vascular site.

9. The device of claim 1, wherein the flexible sheet material is coupled to the frame so as to be drawn across at least part of the vascular vessel lumen when the frame moves from the first condition to the expanded second condition at the vascular site.

10. A medical product for delivering an occlusive device to a vascular vessel, comprising:

an endoluminally advanceable delivery device having a lumen; and

an occlusive device removably positioned in the delivery device lumen, the occlusive device being configured for deployment from the delivery device lumen in the vascular vessel for occluding the vessel, the occlusive device comprising;

a frame;

an expandable occluding material located in an interior region of the frame; and

a flexible sheet material coupled to the frame,

wherein the occlusive device is compressible to a compressed first condition for positioning the occlusive device in the delivery device lumen,

and wherein the occlusive device in the compressed first condition is expandable to an expanded second condition upon deployment from the delivery device in the vascular vessel, the expanded second condition including the occluding material and the frame expanded such that the flexible sheet material is positioned across at least part of the vascular vessel so as to block fluid flow through the vessel, and such that the occlusive device contacts inner wall surfaces of the vascular vessel and occludes the vessel, with portions of the frame located between the expanded occluding material and the inner wall surfaces of the vascular vessel.

11. The medical product of claim 10, further including a deployment member translatable through the delivery device lumen for deploying the occlusive device from the delivery device lumen, wherein the deployment member is adapted for coupling to the occlusive device for pulling the occlusive device through the vascular vessel.

12. The medical product of claim 11, wherein the occlusive device further includes a coupling element extending proximally from the proximal end of the frame.

13. The medical product of claim 10, wherein the occlusive device is configured for over-the-wire delivery.

14. A device for occluding a vascular vessel, comprising:

a frame movable between a first condition suitable for transluminal vascular delivery to a vascular site for providing an occluding device, and an expanded second condition adapted for deployment at the vascular site, the expanded second condition including a first frame perimeter having an opening in the vascular vessel lumen when the frame is deployed at the vascular site;

a flexible sheet material coupled to the frame such that when the frame is in the expanded second condition at the vascular site, the sheet material is positioned across the first frame perimeter opening; and

an expandable material located in an interior region of the frame, the expandable material effective to expand at the vascular site so as to provide an expanded material at the vascular site.

15. The device of claim 14, wherein said opening of said first frame perimeter is in communication with the interior region of the frame.

16. The device of claim 15, wherein said opening of said first frame perimeter is located at the distal end of the frame.

17. A device for occluding a vascular vessel, comprising:

a frame movable between a first condition suitable for transluminal vascular delivery to a vascular site for providing an occluding device, and an expanded second condition adapted for deployment at the vascular site, the frame having an interior space that expands as the frame moves from the first condition to the second condition such that the expanded second condition includes an expanded interior space adjacent to a distal frame opening;

an expandable occluding material located in the interior space of the frame and effective to expand at the vascular site so as to provide an expanded material at the vascular site; and

a flexible sheet material coupled to the frame such that when the frame is in the expanded second condition at the vascular site, the sheet material is positioned across the distal frame opening.

18. The device of claim 17, wherein the distal frame opening and at least part of the expanded interior space have essentially the same diameter.

19. The device of claim 17, wherein the flexible sheet material includes a harvested extracellular matrix sheet material.

20. The device of claim 17, wherein the flexible sheet material comprises a synthetic polymeric material.

21. A device for occluding a vascular vessel, the device movable between a first condition suitable for transluminal vascular delivery to a vascular site for providing an occluding device, and an expanded second condition adapted for deployment at the vascular site, the device comprising:

a tube formed with a flexible sheet material, the tube having a first end portion, a second end portion and a wall defining an interior region;

an expandable occluding material located in the interior region of the tube;

a first expandable frame member located at the first end portion of the tube; and

a second expandable frame member located at the second end portion of the tube,

wherein upon deployment of the device at the vascular site the expanded second condition includes the first frame member, the second frame member and the occluding material expanded so as to force the tube into contact with inner wall surfaces of the vascular vessel such that fluid flow through the vessel is blocked.

22. The device of claim 21, wherein the sheet material is remodelable.

23. The device of claim 21, wherein the first expandable frame member and the second expandable frame member each include a plurality of elongate arms extending away from the first end portion and the second end portion of the tube, respectively.

24. The device of claim 23, wherein the plurality of elongate arms in the first expandable frame member and the second expandable frame member extend toward a first common centralized region and a second common centralized region, respectively.

25. The device of claim 21, wherein the first expandable member and the second expandable member are attached to the first end portion and the second end portion of the tube, respectively, along the perimeters of the respective tube end portions.

26. An occlusion device deliverable to a vascular vessel in a compressed condition and thereafter expandable in the vessel to an expanded condition for occluding the vessel, the occlusion device comprising:

a remodelable ECM construct effective to volumetrically expand in the vessel so as to provide a volumetrically expanded mass of remodelable ECM material in the vessel; and

a frame at least partially embedded in the remodelable ECM construct, the frame including a deformable distal frame member, a deformable proximal frame member and a connector extending therebetween to connect the distal frame member to the proximal frame member.

27. The device of claim 26, wherein the frame assembly is essentially fully embedded in the remodelable ECM construct.

28. The device of claim 26, wherein at least one of the distal frame member and the proximal frame member is self-expandable.

29. The device of claim 28, wherein the distal frame member and the proximal frame member are both radially self-expandable.

30. The device of claim 26, wherein at least one of the distal frame member and the proximal frame member is non self-expandable.

31. The device of claim 26, wherein the distal frame member, the proximal frame member and the connector are formed separately from one another.

32. The device of claim 31, wherein the connector includes a spring.

33. The device of claim 26, wherein at least one of the distal frame member and the proximal frame member includes one or more resilient wires that run generally transverse to the connector when the frame assembly is in an unstressed condition.