Shape memory metal emboli trap

• US 9,724,112 B2
• Filed: 03/06/2014
• Issued: 08/08/2017
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Gaerke, Brian, Sudlow, Clay, Cunnane, Connor, McLain, Cameron, Hopkins, Marie
• Primary Examiner(s): Miles, Jonathan
• Assistant Examiner(s): Rwego, Kankindi
• Application Number:
  US14/199,447
• Publication Number:
  US 20140276922A1
• Time in Patent Office: 1,251 Days
• Field of Search: 606200
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61F 2002/016 made from wire-like elements

Abstract

An embolus trap device is provided. The embolus trap device consists of an outer catheter, an inner catheter, a plurality of filter baskets, and a plurality of basket collapse wires. The filter baskets are of different radius and are positioned along the inner catheter in order of increasing radius from the proximal to the distal end. The filter baskets increase in radius so that any embolic fragment that flows past each basket has a chance to be caught and secured by a filter basket distal to it. The filter baskets are separately collapsible by the plurality of collapse wires and are collapsed in proximal-to-distal fashion with the largest basket being closed last in order to capture embolic fragments that may emerge from the smaller baskets because of disruptions as they are closed.

Claims

1. An embolus trap device having a proximal end and a distal end comprising:

an outer catheter having an interior lumen;

an inner catheter disposed within the interior lumen of the outer catheter;

a plurality of basket fixture points spaced along a length of the inner catheter;

a plurality of filter baskets disposed at the basket fixture points of the inner catheter, the filter baskets comprising a plurality of struts and a mesh disposed about the plurality of struts, the mesh having a plurality of openings formed therethrough, the filter baskets having a closeable mouth portion having an inner diameter, the filter baskets being placed at the basket fixture points in order of increasing size of the inner diameter of the mouth portions from the proximal end to the distal end of the embolus trap device;

and a plurality of collapse wires, each of the collapse wires being fixedly attached at a distal end of the collapse wire to a distal end of one of the filter baskets.

2. The embolus trap device of claim 1 further comprising an embolus disruption tip.

3. The embolus trap device of claim 2 in which the collapse wires conform the device to a collapsed state when pulled and conform the device to an expanded state when slackened, the collapse wires being operable independent of each other.

4. The embolus trap device of claim 3 in which the collapse wires are identifiably marked so that it is clear which basket each operates and that the inner catheter has at least one wire retraction slot, through which a proximal portion of at least one of the collapse wires is guided into the inner catheter, the at least one wire retraction slot being proximal from the filter, to which the at least one of the collapse wires is attached.

5. The embolus trap device of claim 4 in which the struts of the filter baskets are made of a shape memory alloy having a remembered state.

6. The embolus trap device of claim 5 in which the remembered state of the shape memory alloy is the expanded state.

7. The embolus trap device of claim 6 wherein the shape memory alloy is NITINOL.

8. The embolus trap device of claim 7 further comprising an inflatable balloon portion.

9. The embolus trap device of claim 7 further comprising a delivery sleeve movable with respect to the filter baskets between a delivery position and a non-delivery position, the delivery position comprising the sleeve being disposed about at least a portion of the filter baskets so that the filter is in a collapsed state, and the delivery sleeve being located distal to the filter when in the non-delivery position so as to allow the filter to open into an expanded state.

10. The embolus trap device of claim 9 further comprising a sleeve release wire coupled with the delivery sleeve to control the position thereof.

11. The embolus trap device of claim 7 wherein the openings formed through the mesh are substantially the same size across all filter baskets.

12. The embolus trap device of claim 7 in which the mesh is integral with the struts.

13. The embolus trap device of claim 12 in which the mesh and struts comprise woven NITINOL.

14. The embolus trap device of claim 7 wherein the openings formed through the mesh are substantially smaller in each basket than the openings formed through the mesh of the basket proximal to it.

15. A method of collecting embolic debris comprising:

providing an embolus trap device having a proximal and a distal end comprising;

an outer catheter having an interior lumen;

an inner catheter disposed within the interior lumen of the outer catheter;

a plurality of basket fixture points along length of the inner catheter;

a plurality of filter baskets disposed at the basket fixture points of the inner catheter, the filter baskets comprising a plurality of struts and a mesh disposed about the plurality of struts, the mesh having a plurality of openings formed therethrough, the filter baskets having a closeable mouth portion having an inner diameter, the filter baskets being placed at the basket fixture points in order of increasing size of the inner diameter of the mouth portions from the proximal to the distal end of the embolus trap device;

and a plurality of collapse wires, one of the plurality of collapse wires being attached to each of the filter baskets and having a distal end fixedly attached to the filter basket at a distal base portion of the filter basket;

deploying the embolus trap device percutaneously into a vessel or cavity of a patient'"'"'s body;

moving the inner catheter through the embolic mass;

opening the plurality of filter baskets to deploy the device in its expanded state;

filling the filter baskets with debris as the embolus disintegrates;

closing the filter baskets by the collapse wires to return the device to its collapsed state; and

retracting the embolus trap device from the patient'"'"'s body.

16. The method of claim 15 wherein the step of closing comprises sequentially closing the filter baskets relative to the basket fixture points, wherein the filter basket disposed on the most proximal basket fixture is closed first.

17. An embolus trap device having a proximal and a distal end comprising:

an outer catheter having an interior lumen;

an inner catheter disposed within the interior lumen of the outer catheter and having a breakage cone at its distal end;

a plurality of basket fixture points along length of the inner catheter;

a plurality of filter baskets having an exterior surface, a closed state and an expanded state, and comprising a body portion made of woven NITINOL and a closeable mouth portion having an inner diameter comprising a NITINOL ring, the filter baskets being placed at the basket fixture points in order of increasing size of the inner diameter of the mouth portions from the proximal to the distal end of the embolic protection device;

and a plurality of collapse wires disposed about the exterior surfaces of the filter baskets in both the closed state and the expanded state, the collapse wires being configured to constrict the filter baskets when pulled toward the proximal end of the embolic protection device.