US4994069A — Vaso-occlusion coil and method

Claim 1

Independent Claim 152 words

A flexible, vaso-occlusive wire designed for occluding a vessel having a selected cross-sectional area, when the wire is released into the vessel from a small-diameter catheter, said wire being characterized by: (a) a relaxed condition in which the wire assumes a folded, convoluted conformation which is adapted to form a substantially space-filling body having a substantially predetermined diameter when the wire is in said released condition, (b) a stretched condition in which the wire has a linear conformation in which the wire can be pushed through said catheter, and (c) a memory which returns the wire from its stretched to its relaxed condition, as the wire is released from said catheter in the vessel, thereby forming a space-filling, vaso-occlusive body which is lodged in the vessel at the site of release, the size of the wire and relaxed shape of the body being such as to occlude the vessel at said site.

Claim 2

Dependent Claim 152 words

A flexible, vaso-occlusive wire designed for occluding a vessel having a selected cross-sectional area, when the wire is released into the vessel from a small-diameter catheter, said wire being characterized by: (a) a relaxed condition in which the wire assumes a folded, convoluted conformation which is adapted to form a substantially space-filling body having a substantially predetermined diameter when the wire is in said released condition, (b) a stretched condition in which the wire has a linear conformation in which the wire can be pushed through said catheter, and (c) a memory which returns the wire from its stretched to its relaxed condition, as the wire is released from said catheter in the vessel, thereby forming a space-filling, vaso-occlusive body which is lodged in the vessel at the site of release, the size of the wire and relaxed shape of the body being such as to occlude the vessel at said site.

Claim 3

Dependent Claim 56 words

The wire of claim 1, which, in its stretched condition, is an elongate helically coiled wire formed by wrappings of a metal thread, and the coiled wire, in its stretched condition, has a length which is at least about 15-20 times the diameter of the space-filling body formed when the wire is in said relaxed condition.

Claim 4

Dependent Claim 25 words

The wire of claim 2, wherein the diameter of the coil is between about 10-30 mils and the metal thread is platinum, tungsten, or gold.

Claim 5

Dependent Claim 12 words

The wire of claim 1, which is formed of a shape-memory polymer.

Claim 6

Dependent Claim 22 words

The wire of claim 4, which is formed of a tubular polymer, and the tube contains a drug intended for slow release.

Claim 7

Dependent Claim 24 words

The wire of claim 4, wherein the polymer is coated with a drug that is released slowly from the polymer within a vessel site.

Claim 8

Dependent Claim 29 words

The wire of claim 2, whose relaxed conformation is characterized by a helical windings of the coiled wire, and a tertiary structure formed by irregular bends in the winding.

Claim 9

Dependent Claim 24 words

The wire of claim 7, wherein the diameter of the helical winding is substantially the same as that of the vessel to be occluded.

Claim 10

Dependent Claim 22 words

The wire of claim 7, wherein the irregularities in the helical winding take the form of angular offsets in the helical axis.

Claim 11

Dependent Claim 26 words

The wire of claim 7, wherein the helical winding has a spiral shape dimensioned to fill the cross sectional area of the vessel to be occluded.

Claim 12

Dependent Claim 47 words

The wire of claim 7, wherein the diameter of the coil is between about 10-30 mils, the diameter of the secondary coiled conformation is substantially the same as that of the vessel to be occluded and the metal thread forming the wire is platinum, gold, or tungsten.

Claim 13

Dependent Claim 27 words

The wire of claim 11, for occlusion of a 0.5-2 mm diameter vessel, wherein the length of the wire, in its stretched condition, is about 3-6 cm.

Claim 14

Dependent Claim 29 words

The wire of claim 11, for occlusion of a vessel about 3-6 mm in diameter, wherein the length of the wire, in its stretched condition, is about 4-9 cm.

Claim 15

Dependent Claim 167 words

A flexible, vaso-occlusive wire designed for occluding a vessel having a selected cross-sectional area, when the wire is released into the vessel from a small-diameter catheter, said wire being characterized by: (a) a stretched, substantially linear condition in which the wire can be pushed through the catheter; (b) a relaxed, substantially convoluted condition formed by a combination of a helical winding in the wire which has a winding diameter substantially that of the vessel to be occluded, and irregularities in the helical winding which cause the wire to assume a substantially random, space filling body when released from a catheter into the vessel, (c) a memory which returns the wire from its stretched to its relaxed condition, as the wire is released from said catheter in the vessel, thereby to form a space-filling, vaso-occlusive body which is lodged in the vessel at the site of release, the size of the wire and relaxed shape of the body being such as to occlude the vessel at said site.

Claim 16

Dependent Claim 167 words

A flexible, vaso-occlusive wire designed for occluding a vessel having a selected cross-sectional area, when the wire is released into the vessel from a small-diameter catheter, said wire being characterized by: (a) a stretched, substantially linear condition in which the wire can be pushed through the catheter; (b) a relaxed, substantially convoluted condition formed by a combination of a helical winding in the wire which has a winding diameter substantially that of the vessel to be occluded, and irregularities in the helical winding which cause the wire to assume a substantially random, space filling body when released from a catheter into the vessel, (c) a memory which returns the wire from its stretched to its relaxed condition, as the wire is released from said catheter in the vessel, thereby to form a space-filling, vaso-occlusive body which is lodged in the vessel at the site of release, the size of the wire and relaxed shape of the body being such as to occlude the vessel at said site.

Claim 17

Dependent Claim 52 words

The wire of claim 14, which is an elongate helically coiled wire formed by wrappings of a metal thread, and the coiled wire, in its stretched condition, has a length which is at least about 15-20 times the diameter of the space-filling body formed when the wire is released into said vessel.

Claim 18

Dependent Claim 29 words

The wire of claim 15, wherein the diameter of the coiled wire is between about 10-30 mils, and the metal thread forming the wire is platinum, gold, or tungsten.

Claim 19

Dependent Claim 180 words

A catheter system for use in occluding a vessel having a selected cross-sectional area, said system comprising: (i) a catheter having a small-diameter inner lumen and designed to access a selected site of occlusion in said vessel, (ii) a flexible vaso-occlusive wire characterized by: (a) a stretched, substantially linear condition in which the wire can be pushed through said catheter; (b) a relaxed, substantially convoluted condition formed by a combination of a helical winding in the wire which has a winding diameter substantially that of the vessel to be occluded, and irregularities in such helical winding which cause the wire to assume a substantially random, space filling body when released from the catheter into the vessel, (c) a memory which returns the wire from its stretched to its relaxed condition, as the wire is released from such catheter in the vessel, thereby to form a space-filling, vaso-occlusive mass which is lodged in the vessel at the site of release, and (d) a pusher for advancing the wire in its stretched condition through the catheter to the selected site of occlusion.

Claim 20

Dependent Claim 180 words

A catheter system for use in occluding a vessel having a selected cross-sectional area, said system comprising: (i) a catheter having a small-diameter inner lumen and designed to access a selected site of occlusion in said vessel, (ii) a flexible vaso-occlusive wire characterized by: (a) a stretched, substantially linear condition in which the wire can be pushed through said catheter; (b) a relaxed, substantially convoluted condition formed by a combination of a helical winding in the wire which has a winding diameter substantially that of the vessel to be occluded, and irregularities in such helical winding which cause the wire to assume a substantially random, space filling body when released from the catheter into the vessel, (c) a memory which returns the wire from its stretched to its relaxed condition, as the wire is released from such catheter in the vessel, thereby to form a space-filling, vaso-occlusive mass which is lodged in the vessel at the site of release, and (d) a pusher for advancing the wire in its stretched condition through the catheter to the selected site of occlusion.

Claim 21

Dependent Claim 56 words

The system of claim 17, wherein the wire is an elongate helically coiled wire formed by wrappings of platinum, gold, or tungsten thread, and the coiled wire, in its stretched condition, has a length which is at least about 15≧20 times the diameter of the space-filling mass formed when the wire is released into the vessel.

Claim 22

Dependent Claim 32 words

The system of claim 17, wherein the pusher has a relatively long, relatively stiff metal wire proximal region, and a relatively short relatively flexible distal region formed of a low-friction polymer tubing.

Claim 23

Dependent Claim 15 words

The system of claim 19, wherein the polymer tubing is an extruded fluorocarbon polymer tubing.

Claim 24

Dependent Claim 30 words

The system of claim 19, wherein the combined diameter of the distal region of the pusher and the vaso-occlusive wire is greater than the inner lumen diameter of the catheter.

Claim 25

Independent Claim 167 words

A method of occluding a selected site in a vessel having an inner lumen diameter of between about 2-4 mm, said method comprising accessing the site with a catheter having a small-diameter lumen, advancing through the catheter, a flexible vaso-occlusive wire characterized by: (a) a stretched, substantially linear condition in which the wire can be pushed through said catheter; (b) a relaxed, substantially convoluted condition formed by a combination of a helical winding in the wire which has a winding diameter substantially that of the vessel to be occluded, and irregularities in such helical winding which cause the wire to assume a substantially random, space filling body when released from a catheter into the vessel, (c) a memory which returns the wire from its stretched to its relaxed condition, as the wire is released from said catheter in the vessel, and releasing the wire from the catheter at the vessel, thereby forming a space-filling, vaso-occlusive body which is lodged in the vessel at the site of release.

Claim 26

Independent Claim 167 words

A method of occluding a selected site in a vessel having an inner lumen diameter of between about 2-4 mm, said method comprising accessing the site with a catheter having a small-diameter lumen, advancing through the catheter, a flexible vaso-occlusive wire characterized by: (a) a stretched, substantially linear condition in which the wire can be pushed through said catheter; (b) a relaxed, substantially convoluted condition formed by a combination of a helical winding in the wire which has a winding diameter substantially that of the vessel to be occluded, and irregularities in such helical winding which cause the wire to assume a substantially random, space filling body when released from a catheter into the vessel, (c) a memory which returns the wire from its stretched to its relaxed condition, as the wire is released from said catheter in the vessel, and releasing the wire from the catheter at the vessel, thereby forming a space-filling, vaso-occlusive body which is lodged in the vessel at the site of release.

Claim 27

Dependent Claim 57 words

The method of claim 22, wherein the wire is an elongate helically coiled wire formed by wrappings of a platinum, gold, or tungsten thread, and the coiled wire, in its stretched condition, has a length which is at least about 15-20 times the diameter of the space-fillig body formed when the wire is released into the vessel.

Claim 28

Dependent Claim 29 words

The method of claim 22, for use in slow-release drug delivery at the vaso-occlusion site, wherein the wire contains a drug adapted for slow release into the vessel site.

Claim 29

Dependent Claim 34 words

The method of claim 22, for use in slow-release drug delivery at the vaso-occlusion site, which further includes injection a bolus of drug-containing vaso-occlusion material immediately upstream of the vaso-occlusion wire in the vessel.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1994-02-18	1994-08-20	1995-02-19	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	1998-02-18	1998-08-20	1999-02-19	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2002-02-18	2002-08-20	2003-02-19	$7700.00	Window Closed / Lapsed

Vaso-occlusion coil and method

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