Method and device for treating and enlarging body lumens

• US 5,342,348 A
• Filed: 12/04/1992
• Issued: 08/30/1994
• Est. Priority Date: 12/04/1992
• Status: Expired due to Term

• Current Assignee: Aaron V. Kaplan
• Original Assignee: Aaron V. Kaplan
• Inventors: Kaplan, Aaron V.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): ELGART, VANITHA M
• Application Number:
  US07/985,382
• Time in Patent Office: 634 Days
• Field of Search: 604/96, 604/97, 604/104, 604/132, 604/133, 604/891.1, 606/191, 606/198, 623/1, 623/11, 623/12, 623/13, 623/900
• US Class Current: 604/891.1
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• 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: C08L 31/04 Homopolymers or copolymers of vinyl acetate
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 83/00 Compositions of macromolecular compounds obtained by reactions forming in the main chain of the macromolecule a linkage containing silicon with or without sulfur, nitrogen, oxygen or carbon only; Compositions of derivatives of such polymers

Abstract

The present invention relates generally to stents having delivery matrices which provide for the controlled release of bioactive substances. The delivery matrices comprise porous and erodible filaments, and multiple filaments may be employed in order to release different bioactive substances and/or the same bioactive substance at different delivery rates. The stents are particularly useful for preventing restenosis of dilated body lumens, such as blood vessels. Methods for preventing stenosis of dilated body lumens or locally delivering bioactive compounds to tissue are also provided.

Claims

1. An endovascular stent comprising:

a tubular structure having an initial diameter, said structure being composed of a first material expandable from the initial diameter to an enlarged diameter;

a delivery matrix including at least one filament which is interlaced with the tubular structure and expandable therewith from said initial diameter to said enlarged diameter; and

a bioactive substance releasably contained within the filament of the delivery matrix, wherein the filament is composed of a second material which is porous and/or which will degrade over time in a vascular environment to release the bioactive substance.

2. The endovascular stent as in claim 1, wherein said tubular structure is composed of an elastic material, whereby the tubular structure may be constrained to said initial diameter and thereafter released to said enlarged diameter.

3. The endovascular stent as in claim 1, wherein said tubular structure is composed of a non-elastic material, whereby the tubular structure may be expanded from said initial diameter to said enlarged diameter.

4. The endovascular stent as in claim 1, wherein said tubular structure includes at least one helically wound strand, and wherein the filament of the delivery matrix is counter-woven with said helically wound strand.

5. The endovascular stent as in claim 1, wherein said tubular structure includes at least one helically wound strand, and wherein the filament of the delivery matrix is laminated over at least a portion of said helically wound strand.

6. The endovascular stent as in claim 1, wherein said tubular structure includes a perforated cylinder, and wherein the filament is interwoven through the perforations in said cylinder.

7. The endovascular stent as in claim 1, wherein the filament is composed of a material which is biodegradable within a physiologic environment whereby the bioactive substance is released as the filament erodes within a blood vessel.

8. The endovascular stent as in claim 7, wherein the filament material is composed of at least one polymer system selected from the group consisting of lactic acid/glycolic copolymer, carbophenoxy propane/sebacic acid, polycaprolactones, polyanhydride and poly ortho-esters.

9. The endovascular stent as in claim 1, wherein the filament is composed of a material which is substantially biodegradable within a physiologic environment and elutes bioactive substances.

10. The endovascular stent as in claim 9, wherein the material is composed of at least one polymer selected from the group consisting of silicone, ethylene-vinyl acetate copolymer, poly (vinylalcohol).

11. The endovascular stent as in claim 1, wherein the bioactive substance is selected from the group consisting of organic molecules, proteins, peptides, nucleotides, carbohydrates, polysaccharides, mucopolysaccharides, simple sugar, glycoaminoglycans and steroids.

12. The endovascular stent as in claim 1, wherein the first material is non-degradable in the vascular environment.

13. The endovascular stent as in claim 12, wherein the first material is selected from the group consisting of stainless steel, tantalum, gold, titanium, tungsten, platinum, polyether sulfone, polyamide, polycarbonate, polypropylene, high molecular weight polyethylene, and carbon fiber.

14. An endovascular stent comprising:

a tubular structure having an initial diameter, said structure being composed of a metal and being expandable from an initial diameter to an enlarged diameter;

a delivery matrix including at least one first filament and at least one second filament, which first and second filaments are composed of a polymeric material and interlaced with the tubular structure and expandable therewith from said initial diameter to said enlarged diameter; and

a bioactive substance releasably contained within both the first and second filaments wherein at least one of the first and second filaments is composed of a polymer material which will degrade over time in a vascular environment to release the bioactive substance and wherein the first and second filaments are composed of different materials.

15. The endovascular stent as in claim 14, wherein the first filament is composed of a first material selected to degrade and release the bioactive substance over a first time period and wherein the second filament is composed of a second material selected to degrade and release the bioactive substance over a second time period.

16. The endovascular stent as in claim 14, wherein the at least one filament material is composed of a least one polymer selected from the group consisting of lactic acid/glycolic copolymer, carbophenox propane/sebacic acid, polycaprolactones, polyanhydride and poly ortho-esters.

17. The endovascular stent as in claim 16, wherein both the first and second filaments are composed of the at least one polymer.

18. The endovascular stent as in claim 14, wherein one of the first and second filaments is composed of a material which is substantially non-biodegradable within a vascular environment which elutes substances.

19. The endovascular stent as in claim 18, wherein the non-biodegradable material is composed of at least one polymer selected from the group consisting of ethylene-vinyl acetate copolymer, styrene-divinyl benzene copolymer, and methyl methacrylate-ethylene glycol copolymer.

20. A method for treating body lumens said method comprising:

inserting into the body lumen a stent comprising (i) a tubular structure composed of a first material having an initial diameter, (ii) a delivery matrix including at least one filament interlaced with the tubular structure, and (iii) a bioactive substance releasably contained within said filament;

an d

expanding the stent at a location within the body lumen selected to be treated wherein the filament releases the bioactive substance from within under the conditions present the immediate environment.

21. The method as in claim 20, wherein the body lumen is a blood vessel and the selected location is a region of stenosis.

22. The method as in claim 21, wherein the bioactive substance is selected from the group consisting of organic molecules, proteins, peptides, nucleotides, carbohydrates, polysaccharides, mucopolysaccharides, simple sugar, glycoaminoglycans, and steroids.

23. The method as in claim 20, wherein the first material is non-degradable in the vascular environment.

24. The method as in claim 23, wherein the first material is non-degradable in the vascular environment.