Self expanding cardiovascular occlusion device, method of using and method of making the same

• US 5,733,294 A
• Filed: 02/28/1996
• Issued: 03/31/1998
• Est. Priority Date: 02/28/1996
• Status: Expired due to Term

• Current Assignee: Scion Medical Ltd. (Siemens AG)
• Original Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Inventors: Forber, Simon John, Noddin, Richard Alan
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US08/608,110
• Time in Patent Office: 762 Days
• Field of Search: 606/200, 606/151, 606/198, 606/213
• US Class Current: 606/151
• 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 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• 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: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A self-expanding cardiovascular occlusion apparatus including a predetermined pattern of wire and three collinear bands, whereby pushing the bands together causes the two exposed braided or helical sections between them to flatten to two disk-like shapes. The disks are then forced outward relative to the middle band, causing the exposed braided or wound pattern to invaginate. The final shape is similar to two cones attached end to end. The device is heat treated to maintain this configuration. In use, the device is straightened to its cylindrical form, installed in the distal end of a device pusher which is advanced through a small diameter catheter installed in a blood vessel When the device is expelled from the device pusher, it returns to its expanded shape and lodges in a blood vessel, for example. Once lodged in the vessel, the device will initiate thrombus formation which will occlude the vessel. The final in-situ form of the device with cone-like ends has the ability to adapt to a range of vessel sizes. The wire loops formed when the braid or helical pattern is invaginated can move relative to one another. The result is that each end of the device can conform independently to the shape of the vessel. Since the device returns to the dual-cone shape, it will resist movement in either direction when placed in a vessel. The high number of wires exposed to blood flow help increase the rate of thrombosis and help center the device within the vessel lumen. The configuration of the device also ensures that it occupies a specific predictable length when placed in a vessel, which facilitates site specific embolization Although the primary use of the device is in embolotherapy to occlude a site in the vasculature, it may be used generally to close other sites in the cardiovascular system such as a septal defect. Methods of making and using the apparatus are also disclosed.

Claims

1. A cardiovascular occlusion device, comprising:

(a) three bands linearly spliced a predetermined distance from each other and defining a first end and a second end, said bands located at said first and second ends being end bands, said band disposed between said end bands being a middle band; and

(b) a plurality of wires disposed around said bands and attached to said bands so that each wire contacts all of said bands, terminates at said end bands, and forms wire segments between said bands,

(c) wherein the device has the following states;

(i) a relaxed state wherein said wire segments are longer than said distance between said bands so that said wires form a set of loops between any two adjacent bands, wherein said set of loops has a first outer dimension, and wherein said set of loops forms two conical shapes, each of said conical shapes having an apex at said middle band and an invaginated base attached to one of said end bands; and

(ii) a stretched state wherein the device has a tubular configuration having a second outer dimension which is less than said first outer dimension; and

(d) wherein said wires have memory whereby the device returns from said stretched state to said relaxed state.

2. The cardiovascular occlusion device of claim 1, wherein each said band comprises an inner member and an outer member.

3. The cardiovascular occlusion device of claim 1 further comprising a multiplicity of filaments which:

(a) are disposed inside all of said bands;

(b) are attached to and span said end bands; and

(c) have lengths between said bands which splay out inside of a shaped formed by said set of loops.

4. A cardiovascular occlusion device of claim 1 wherein said wires are disposed in a braided pattern and said loops intertwine.

5. A cardiovascular occlusion device of claim 1 wherein said wires are disposed in a helical pattern and said loops intertwine.

6. A cardiovascular occlusion device of claim 1 wherein said bands are constructed of platinum-iridium and wherein said wires are constructed of Nitinol.

7. A methodology of using the device of claim 1 to occlude a selected site in a vessel comprising the steps of:

(a) installing a small diameter catheter in a blood vessel so that said catheter accesses the site at which said device will be deployed;

(b) causing said device to go into its stretched state;

(c) installing said device, while in its stretched state, into a tubular device pusher, said device pusher having an outer diameter small enough to slide inside said catheter and an inner diameter small enough so that said device cannot return to its relaxed state while inside said device pusher, but large enough so that said device can slide inside said device pusher;

(d) advancing said device pusher through said catheter;

(e) partially discharging said device out said device pusher at the selected site for deployment until said device partially deploys and contacts the vessel; and

(f) retracting said device pusher slightly while simultaneously pushing said device the same distance out the end of said device pusher until said device is entirely deployed and in contact with said blood vessel.

8. A methodology of using the device of claim 1 to occlude a selected site in a vessel comprising the steps of:

(a) installing a small diameter catheter in a blood vessel so that said catheter accesses the site at which said device will be deployed;

(b) causing said device to go into its stretched state;

(c) installing said device, while in its stretched state, into a tubular device pusher, said device pusher having an .outer diameter small enough to slide inside said catheter and an inner diameter small enough so that said device cannot return to its relaxed state while inside said device pusher, but large enough so that said device can slide inside said device pusher;

(d) advancing said device pusher through said catheter; and

(e) maintaining a position of said device relative to said blood vessel while retracting said device pusher until said device is deployed and in contact with said blood vessel.

9. A self expanding cardiovascular occlusion device comprising:

(a) two end bands with a distance between them;

(b) a middle band disposed along a line between said end bands and approximately equidistant from both end bands;

(c) a plurality of wires disposed around and attached to said bands, with said wires disposed among themselves in a braided pattern and with each wire contacting all three of said bands, terminating at said end bands, and spanning sequentially from one end band, to the middle band and then to the other end band, thereby forming wire segments between said bands;

(d) wherein said device has the following states;

(i) a relaxed state in which said wire segments are longer than a distance between said middle band and either of said end bands so that said wires form two sets of intertwining loops, with each set of loops disposed generally between said middle braid and one of said end bands and disposed with relatively uniform spacing around an axis formed by said bands, and where each set of loops forms a cone shape having a first outer diameter, and wherein said cone shape has an apex at said middle band and an invaginated base attached to one of said end bands;

(ii) a stretched state in which said device has a tubular configuration having a second outer diameter which is less than said first outer diameter and wherein said second outer diameter is small enough to enable said device to be pushed through a small diameter device pusher, said device pusher being of tubular configuration and small enough to be pushed through a small diameter catheter;

(e) a multiplicity of fibers disposed inside all three bands wherein said fibers are attached to said end bands and splay out inside each of said cone shapes when said device is in its relaxed state; and

(f) said wires having memory which returns said device from its stretched state to its relaxed state as said device is released from said device pusher thereby lodging said device in tissue at the site of release.

10. A method of making a cardiovascular occlusion device comprising the steps of:

(a) attaching a plurality of bands at spaced intervals onto a core;

(b) attaching a plurality of wires to said bands so that said wires span any two adjacent bands and so that said wires are disposed at circumferentially spaced intervals around said bands;

(c) applying a force to said bands to displace said bands relative to one another on said core so as to cause each of said wires to form a loop shape between any two adjacent bands wherein said loop shapes together form a three dimensional shape generally disposed between any two adjacent bands;

(d) deforming said loop shapes so that said three dimensional shape has an invaginated end;

(e) treating said wires so they will maintain their said loop shape after said force displacing said bands is removed; and

(f) removing said core from said bands.

11. The method of claim 10 wherein said treating of said wires comprises a thermal treatment.

12. The method of claim 10 wherein said deforming of said loop shapes is done by installing said device in a tubular die having an internal wall which contacts said loops and thereby deforms said loops.

13. The method of claim 10 further comprising the steps of:

(a) displacing said bands back to their original position relative to one another after said wires have been treated to maintain their loop shape;

(b) threading a yarn comprising a multiplicity of filaments through the inside of said bands so that filaments are substantially collimated; and

(c) attaching said yam to each end band of said device.