Stent reducing system and device

• US 7,284,401 B2
• Filed: 01/12/2004
• Issued: 10/23/2007
• Est. Priority Date: 01/12/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Gunderson, Richard C., Jagger, Karl A., Larson, Karen, Gerdts, Michael
• Primary Examiner(s): Crane; Daniel C
• Application Number:
  US10/755,752
• Publication Number:
  US 20050154450A1
• Time in Patent Office: 1,380 Days
• Field of Search: 724/02, 72 44- 46, 724/63, 72/57, 72/58, 72/54
• US Class Current: 72/44
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9524 Iris-type crimpers

Abstract

A system for reducing the diameter of a stent comprises a stent contracting assembly and a fluid source. The assembly comprises a plurality of contracting members that define a diameter reduction chamber for receiving a stent. When the chamber is in a pre-reduction configuration the stent has a first diameter and when the chamber is in a reduced configuration the stent has a second diameter. The second diameter is less than the first diameter. The fluid source is in fluid communication with the chamber and is constructed and arranged to inject a fluid therein. The fluid forms a fluid bearing between the contracting members and the stent which prevents the contracting members from contacting the stent in the reduced diameter configuration.

Claims

1. A system for reducing the diameter of a stent comprising:

a stent contracting assembly, the stent contracting assembly comprising a plurality of moveable contracting members, the plurality of contracting members defining a diameter reduction chamber, the chamber having a reduced diameter configuration and a pre-reduction diameter configuration, the contracting assembly constructed and arranged to receive a stent into and through the chamber, wherein when the chamber is in the pre-reduction diameter configuration the stent has a first diameter and when the chamber is in the reduced diameter configuration the stent has a second diameter, the second diameter being less than the first diameter, wherein the chamber defines a first end opening and a second end opening, the stent being moveable through the chamber from the first end opening to the second end opening, the stent contracting assembly further comprising a housing, the plurality of moveable contracting members being mechanically engaged to the housing, the stent contracting assembly further comprising at least one seal member, the at least one seal member engaged to a portion of the housing adjacent to at least one of the first end opening and the second end opening of the chamber, the at least one seal member providing a fluid tight seal to the at least one of the first end opening and the second end opening;

a fluid source, the fluid source in fluid communication with the chamber, the fluid source constructed and arranged to provide a fluid bearing between the contracting members and the stent which prevents the contracting members from contacting the stent in the reduced diameter configuration;

wherein the stent contracting assembly defines at least one fluid injection port, the at least one fluid injection port in fluid communication with the chamber and the fluid source.

2. The system of claim 1 wherein the plurality of moveable contracting members are adjacent one another, adjacent contracting members defining a space therebetween, each space in fluid communication with the fluid source and the chamber.

3. The system of claim 2 wherein the plurality of moveable contracting members are positioned longitudinally adjacent one another.

4. The system of claim 2 wherein the plurality of moveable contracting members are positioned radially adjacent one another.

5. The system of claim 1 wherein at least one of the plurality of moveable contracting members defines a space the space in fluid communication with the fluid source and the chamber.

6. The system of claim 1, wherein in the reduced diameter configuration the diameter of the chamber in the first end region and the diameter of the chamber second end region are different.

7. The system of claim 6 wherein the diameter of the chamber in the second end region is greater than the diameter of the chamber in the first end region.

8. The system of claim 7 wherein the second end region is constructed and arranged to removably receive a portion of a catheter therein, the stent being loaded on to the catheter by advancing the stent through the chamber.

9. The system of claim 1, wherein at least one seal member comprises a first seal member and a second seal member, the first seal member engaged to a portion of the housing adjacent to the first end opening of the chamber and the second seal member engaged to a portion of the housing adjacent to the second end opening of the chamber.

10. The system of claim 1, wherein the at least one seal member comprises a removable fluid tight seal.

11. The system of claim 1, wherein the at least one seal member comprises a labyrinth.

12. The system of claim 1, wherein the at least one seal member comprises an adjustable valve.

13. The system of claim 1, further comprising a mandrel, in the reduced configuration the mandrel is constructed and arranged to be advanced through the chamber to expel the stent therefrom.

14. The system of claim1 13 wherein the mandrel has a diameter at least as great as that of the second diameter of the stent.

15. The system of claim 13 wherein the mandrel defines a stent mounting region, the stent being disposed about at least a portion of the stent mounting region.

16. The system of claim 15 wherein the mandrel further comprises a first end region and a second end region, the stent mounting region positioned between the first end region of the mandrel and the second end region of the mandrel, at least one of the first end region of the mandrel and the second end region of the mandrel having a diameter at least as great as the second diameter of the stent.

17. The system of claim 16 wherein the first end region of the mandrel is external and immediately adjacent to the first end opening of the chamber and the second end region of the mandrel is external and immediately adjacent to the second end opening of the chamber.

18. The system of claim 17 wherein the first end region of the mandrel is sealingly engaged to the first open end of the chamber.

19. The system of claim 17 wherein the second end region of the mandrel is sealingly engaged to the second open end of the chamber.

20. The system of claim 17 wherein the first end region of the mandrel is sealingly engaged to the first open end of the chamber and the second end region of the mandrel is sealingly engaged to the second open end of the chamber.

21. The system of claim 16 wherein at least a portion of the at least one of the first end region of the mandrel and the second end region of the mandrel are tapered.

22. The system of claim 15 wherein the mandrel defines a fluid injection lumen, a second fluid being injected into the fluid injection lumen.

23. The system of claim 22 wherein the second fluid is a coolant.

24. The system of claim 23 wherein the second fluid is substantially the same as the fluid from the fluid source.

25. The system of claim 22 wherein the at least a portion of the stent mounting region of the mandrel defines at least one perfusion port, the at least one perfusion port in fluid communication with the fluid injection lumen.

26. The system of claim 1 wherein the fluid is selected from a member of the group consisting of air, water, carbon dioxide, nitrous oxide, nitrogen gas and any combination thereof.

27. The system of claim 26 wherein the fluid is cooled to a temperature of about −

60°

Celsius to about −

80°

Celsius.

28. The system of claim 1 wherein at least a portion of the stent is coated with at least one therapeutic agent.

29. The system of claim 28 wherein the at least one therapeutic agent is at least one non-genetic therapeutic agent selected from at least one member of the group consisting of:

anti-thrombogenic agents such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethylketone);

anti-proliferative agents such as enoxaprin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid;

anti-inflammatory agents such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine;

antineoplastic/antiproliferative/anti-miotic agents such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin and thymidine kinase inhibitors;

anesthetic agents such as lidocaine, bupivacaine and ropivacaine;

anti-coagulants such as D-Phe-Pro-Arg chloromethyl keton, an RGD peptide-containing compound, heparin, antithrombin compounds, platelet receptor antagonists, anti-thrombin antibodies, anti-platelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors and tick antiplatelet peptides;

vascular cell growth promoters such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translational promoters, vascular cell growth inhibitors such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin;

bifunctional molecules consisting of an antibody and a cytotoxin;

cholesterol-lowering agents;

vasodilating agents; and

agents which interfere with endogenous vascoactive mechanisms, and any combinations thereof.

30. The system of claim 28 wherein the at least one therapeutic agent is at least one genetic therapeutic agent selected from at least one member of the group consisting of:

anti-sense DNA and RNA;

DNA coding for anti-sense RNA, tRNA or rRNA to replace defective or deficient endogenous molecules;

angiogenic factors including growth factors such as acidic and basic fibroblast growth factors, vascular endothelial growth factor, epidermal growth factor, transforming growth factor α and

β

, platelet-derived endothelial growth factor, platelet-derived growth factor, tumor necrosis factor α

, hepatocyte growth factor and insulin like growth factor;

cell cycle inhibitors including CD inhibitors, thymidine kinase (“

TK”

) and other agents useful for interfering with cell proliferation;

at least one of the family of bone morphogenic proteins (“

BMP'"'"'s”

) such as BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 (Vgr-1), BMP-7 (OP-1), BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, and BMP-16, Any of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 and BMP-7;

dimeric proteins such as homodimers, heterodimers, or combinations thereof, alone or together with other molecules;

molecules capable of inducing an upstream or downstream effect of a BMP such as “

hedgehog”

proteins, or the DNA'"'"'s encoding them and any combinations thereof.

31. The system of claim 28 wherein the at least one therapeutic agent is at least one type of cellular material selected from at least one member of the group consisting of:

cells of human origin (autologous or allogeneic);

cells of non-human origin (xenogeneic) and any combination thereof.

32. The system of claim 31 wherein the cellular material is selected from at least one member of the group consisting of:

side population cells;

lineage negative cells;

lineage negative CD34⁻

cells;

lineage negative CD34⁺cells;

lineage negative cKit⁺cells;

mesenchymal stem cells;

cord blood bells;

cardiac or other tissue derived stem cells;

whole bone marrow;

bone marrow mononuclear cells;

endothelial progenitor cells;

satellite cells;

muscle derived cells;

go cells;

endothelial cells;

adult cardiomyocytes;

fibroblasts;

smooth muscle cells;

cultures of mesenchymal stem cells with 5-aza forces differentiation into cardiomyocytes;

adult cardiac fibroblasts +5-aza;

genetically modified cells;

tissue engineered grafts;

MyoD scar fibroblasts;

Pacing cells;

embryonic stem cell clones;

embryonic stem cells;

fetal or neonatal cells;

immunologically masked cells;

tissue engineered grafts;

genetically modified cells;

teratoma derived cells and any combinations thereof.

33. The system of claim 28 wherein the at least one therapeutic agent comprises at least one polymer coating, the at least one coating selected from at least one member of the group consisting of:

polycarboxylic acids;

cellulosic polymers, including cellulose acetate and cellulose nitrate;

gelatin;

polyvinylpyrrolidone;

cross-linked polyvinylpyrrolidone;

polyanhydrides including maleic anhydride polymers;

polyamides;

polyvinyl alcohols;

copolymers of vinyl monomers such as EVA;

polyvinyl ethers;

polyvinyl aromatics;

polyethylene oxides;

glycosaminoglycans;

polysaccharides;

polyesters including polyethylene terephthalate;

polyacrylamides;

polyethers;

polyether sulfone;

polycarbonate;

polyalkylenes including polypropylene, polyethylene and high molecular weight polyethylene;

halogenated polyalkylenes including polytetrafluoroethylene;

polyurethanes;

polyorthoesters;

proteins;

polypeptides;

silicones;

siloxane polymers;

polylactic acid;

polyglycolic acid;

polycaprolactone;

polyhydroxybutyrate valerate and blends and copolymers thereof coatings from polymer dispersions such as polyurethane dispersions (BAYHDROL®

, etc.), fibrin, collagen and derivatives thereof polysaccharides such as celluloses, starches, dextrans, alginates and derivatives;

hyaluronic acid;

squalene emulsions;

polyacrylic acid, a copolymer of polylactic acid and polycaprolactone;

medical-grade biodegradable materials such as PGA-TMC, Tyrosine-Derived Polycarbonates and arylates;

polycaprolactone co butyl acrylate and other co polymers;

Poly-L-lactic acid blends with DL-Lactic Acid;

Poly(lactic acid-co-glycolic acid);

polycaprolactone co PLA;

polycaprolactone co butyl acrylate and other copolymers;

Tyrosine-Derived Polycarbonates and arylate;

poly amino acid;

polyphosphazenes;

polyiminocarbonates;

polydimethyltrimethylcarbonates;

biodegradable CA/PO₄ '"'"'s;

cyanoacrylate;

50/50 DLPLG;

polydioxanone;

polypropylene fumarate;

polydepsipeptides;

macromolecules such as chitosan and Hydroxylpropylmethylcellulose;

surface erodible material;

maleic anhydride copolymers;

zinc-calcium phosphate;

amorphous polyanhydrides;

sugar;

carbohydrate;

gelatin;

biodegradable polymers; and

polymers dissolvable in bodily fluids;

A block copolymers;

B block copolymers and any combinations thereof.