Intravascular hydrogel implant

• US 5,258,042 A
• Filed: 12/16/1991
• Issued: 11/02/1993
• Est. Priority Date: 12/16/1991
• Status: Expired due to Term

• Current Assignee: Henry Ford Health System
• Original Assignee: Henry Ford Health System
• Inventors: Mehta, Bharat
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/809,265
• Time in Patent Office: 687 Days
• Field of Search: 623/1, 623/2, 623/12, 623/66, 623/500, 623/901, 604/96, 604/51-54, 606/108, 606/153
• US Class Current: 600/36
• 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 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/945 hardenable, e.g. stents formed in situ
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: C08L 29/04 Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids
• CPC Class Codes: Y10S 623/921 Blood vessel

Abstract

A vascular structure, including an artery, vein or vessel, with a peripheral wall defining a cavity and having a localized abnormal wall is treated by inserting a device of a hydrogel material into the cavity; and then hydrating and expanding the hydrogel material until the device occludes the localized abnormal wall, sealing it from the cavity of the vascular structure.

Claims

1. A method of treating a vascular structure, the vascular structure being at least one selected from the group consisting of artery, vein and vessel, the vascular structure having an inner surface and a peripheral wall defining a cavity and having a localized abnormal wall, comprising:

a) placing a tubular stent in the cavity, the stent having an outer surface and an inner surface, such that the outer surface of the stent spans the localized abnormal wall, the stent consisting essentially of a hydrogel in a less than fully hydrated condition, said hydrogel being formed of a polymer with a degree of polymerization sufficient to form a three dimensional network of polymer crystallites with interspaces between the polymer crystallites, and when fully hydrated, water in an amount up to about 99% by weight of the hydrogel, with at least a portion of the water occupying the interspaced; and

b) hydrating and expanding the tubular, hydrogel stent to thereby cause the outer surface of the stent to abut the inner surface of the vascular structure at a sealing edge encircling a peripheral extent of the localized abnormal wall, such that a suitable passage is provided through the stent and across the localized abnormal wall.

2. The method according to claim 1, wherein the localized abnormal wall comprises an arteriovenous fistula, and the sealing edge of the stent encircles the peripheral extent of the fistula to seal the fistula from the cavity.

3. The method according to claim 1, wherein the localized abnormal wall comprises an aneurysm with a neck opening into the cavity of the vascular structure and the stent having the outer surface occluding the peripheral extent to the neck opening.

6. The method according to any one of claims 1, 2, 3, 4 and 5 wherein the hydrogel is a porous poly(vinyl alcohol) hydrogel which has a tensile strength greater than about 10 kg/cm², water content of 50 to 98% by weight and is prepared by dissolving poly(vinyl alcohol) in a mixed solvent consisting of water and an organic solvent, followed by crystallization of poly(vinyl alcohol) at temperatures lower than room temperature.

4. A method of treating a vascular structure, the vascular structure being at least one selected from the group consisting of artery, vein and vessel, the vascular structure having a localized abnormal wall, the localized abnormal wall comprising an aneurysm with a neck opening into the cavity of the vascular structure,

a) placing a hydrogel plug in the neck opening to occlude the opening, said plug consisting essentially of a hydrogel in a less than fully hydrated condition, the hydrogel formed of a polymer with a degree of polymerization sufficient to form a three dimensional network of polymer crystallites with interspaces between the polymer crystallites, and when fully hydrated, water in an amount up to about 99% by weight of the hydrogel, with at least a portion of the water occupying the interspaces;

and

b) hydrating and expanding the hydrogel plug to thereby cause the hydrogel plug to occlude the neck opening such that the localized abnormal wall is sealed from the cavity of the vascular structure.

5. A method of treating a vascular structure, the vascular structure being at least one selected from the group consisting of artery, vein and vessel, the vascular structure having a localized abnormal wall, the localized abnormal wall comprising an arteriovenous fistula,

a) placing a hydrogel plug in the fistula, said plug consisting essentially of a hydrogel in a less than fully hydrated condition, the hydrogel formed of a polymer with a degree of polymerization sufficient to form a three dimensional network of polymer crystallites with interspaces between the polymer crystallites, and when fully hydrated, water in an amount up to about 99% by weight of the hydrogel, with at least a portion of the water occupying the interspaces;

and

b) hydrating and expanding the hydrogel plug to thereby cause the hydrogel plug to occlude the fistula.