Hybrid stent and method of making

• US 9,649,210 B2
• Filed: 08/10/2016
• Issued: 05/16/2017
• Est. Priority Date: 04/01/2002
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Prabhu, Santosh
• Primary Examiner(s): Simone, Catherine A
• Application Number:
  US15/233,585
• Publication Number:
  US 20160346102A1
• Time in Patent Office: 279 Days
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0032 differing in radiographic density
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 31/727 Heparin; Heparan
• CPC Class Codes: A61L 2300/236 Glycosaminoglycans, e.g. heparin, hyaluronic acid, chondroitin
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 31/022 : Metals or alloys
• CPC Class Codes: A61L 31/048 : obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 31/18 : Materials at least partially X-ray or laser opaque
• CPC Class Codes: B23K 2103/42 : Plastics B23K2103/16 takes precedence
• CPC Class Codes: B23K 2103/50 : Inorganic material, e.g. metals, not provided for in B23K2103/02 – B23K2103/26
• CPC Class Codes: B23K 2103/54 : Glass
• CPC Class Codes: B23K 26/38 : by boring or cutting
• CPC Class Codes: B23K 26/402 : involving non-metallic material, e.g. isolators
• CPC Class Codes: B29C 41/08 : Coating a former, core or other substrate by spraying or fluidisation, e.g. spraying powder spray-up of reinforcing fibres B29C70/305
• CPC Class Codes: B29C 41/14 : Dipping a core B29C41/10 takes precedence
• CPC Class Codes: B29C 41/20 : incorporating preformed parts or layers, e.g. moulding inserts or for coating articles
• CPC Class Codes: B29C 41/22 : Making multilayered or multicoloured articles
• CPC Class Codes: B29C 65/16 : Laser beams
• CPC Class Codes: B29C 65/68 : using auxiliary shrinkable elements
• CPC Class Codes: B29K 2027/18 : PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: B29L 2031/7534 : Cardiovascular protheses
• CPC Class Codes: Y10T 29/49906 : Metal deforming with nonmetallic bonding
• CPC Class Codes: Y10T 428/139 : Open-ended, self-supporting conduit, cylinder, or tube-type article
• CPC Class Codes: Y10T 428/1393 : Multilayer [continuous layer]

Abstract

A stent is formed by encasing or encapsulating metallic rings in an inner polymeric layer and an outer polymeric layer. At least one polymer link connects adjacent metallic rings. The stent is drug loaded with one or more therapeutic agent or drug, for example, to reduce the likelihood of the development of restenosis in the coronary arteries. The inner and outer polymeric materials can be of the same polymer or different polymer to achieve different results, such as enhancing flexibility and providing a stent that is visible under MRI, computer tomography and x-ray fluoroscopy.

Claims

1. A stent, comprising:

a metallic body having an undulating pattern including a plurality of longitudinally spaced-apart peaks and a plurality of longitudinally spaced-apart valleys;

a polymeric material encasing the metallic body; and

a plurality of links made from the polymeric material which extend between the longitudinally spaced-apart peaks and the longitudinally spaced-apart valleys, wherein each link has a first end and a second end, the first end of each link being attached to a peak or valley of the metallic body and the second end being attached to an adjacent peak or valley of the metallic body.

2. The stent of claim 1, wherein the polymeric material is radiopaque.

3. The stent of claim 1, wherein the polymeric material is taken from the group of polymers consisting of polyetheretherketone (PEEK), ethyl vinyl alcohol (EVOH), polyetherketone, polymethylmethacrylate, polycarbonate, polyphenylenesulfide, polyphenylene, polyvinylfluoride, polyvinylidene fluoride, polypropylene, polyethylene, poly(vinylidene fluoride-co-hexafluoropropylene), poly(ethylene-co-hexafluoropropylene), poly(tetrafluoroethyelene-co-hexafluoropropylene), poly(tetrafluoroethyelene-co-ethylene), polyethyleneterephthalate, polyimides, polyetherimide, ePTFE, polyurethanes, polyetherurethanes, polyesterurethanes, silicone, thermoplastic elastomer, polyether-amide thermoplastic elastomer, fluoroelastomers, fluorosilicone elastomer, styrene-butadiene-styrene rubber, styrene-isoprene-styrene rubber, polybutadiene, polyisoprene, neoprene, ethylene-propylene elastomer, chlorosulfonated polyethylene elastomer, butyl rubber, polysulfide elastomer, polyacrylate elastomer, nitrile rubber, a family of elastomers composed of styrene, ethylene, propylene, aliphatic polycarbonate polyurethane, polymers augmented with antioxidants, polymers augmented with image enhancing materials, polymers having a proton (H+) core, butadiene and isoprene and polyester thermoplastic elastomer and a di-block co-polymer of PET and caprolactone.

4. The stent of claim 1, wherein the metallic body is formed from a metal taken from the group of metals consisting of stainless steel, titanium, tantalum, nickel-titanium, cobalt-chromium, and tungsten.

5. The stent of claim 1, wherein the polymeric material is loaded with a therapeutic drug.

6. The stent of claim 5, wherein the therapeutic drug is taken from the group of drugs including one or more of everolimus, rapamycin, actinomycin D (ActD), or derivatives and analogs thereof;

synonyms of actinopmycin D including dactinomycin, actinomycin IV, actinomycin l1, actinomycin X1, and actinomycin C1;

antiproliferative substances including antineoplastic, antinflammatory, antiplatelet, anticoagulant, antifibrin, antithomobin, antimitotic, antibiotic, antioxidant substances, taxol (paclitaxel and docetaxel), anticoagulants, antifibrins, sodium heparin, low molecular weight heparin, hirudin, argatroban, forskolin, vapiprost, prostacyclin and prostacyclin analogs, dextran, D-phe-pro-arg-chloromethylketone (synthetic antithrombin), dipyridamole, glycoprotein, llb/llla platelet membrane receptor antagonist, recombinant hirudin, thrombin inhibitor methotrexate, azathioprine, vincristine, vinblastine, fluorouracil, adriamycin, mutamycin;

angiopeptin, angiotensin converting enzyme inhibitors;

calcium channel blockers;

colchicine fibroblast growth factor (FGF) antagonists;

fish oil (omega 3-fatty acid);

histamine antagonist;

monoclonal antibodies (such as PDGF receptors);

nitroprusside;

phosphodiesterase inhibitors;

prostaglandin inhibitor (a PDGF antagonist);

serotonin blockers;

steroids;

thioprotease inhibitors;

triazolopyrimidine (a PDGF antagonist); and

nitric oxide.

7. The stent of claim 1, wherein the stent is configured so that it is visible under any of x-ray fluoroscopy, computer tomography, or MRI.

8. A stent, comprising:

a stent body made from a metallic material, the stent body having crowns extending circumferentially to create open spaces on the stent body; and

a polymeric material encasing the stent body and forming polymeric links which extend within the open spaces formed on the metallic body, wherein each link has a first end and a second end, the first end being attached to a crown and the second end being attached to an adjacent crown.

9. The stent of claim 8, wherein the polymeric links are formed from the polymeric material encasing the stent body.

10. The stent of claim 8, wherein the metallic body is formed from a metal taken from the group of metals consisting of stainless steel, titanium, tantalum, nickel-titanium, cobalt-chromium, and tungsten.

11. The stent of claim 8, wherein the polymeric material is loaded with a therapeutic drug.

12. The stent of claim 11, wherein the therapeutic drug is taken from the group of drugs including one or more of everolimus, rapamycin, actinomycin D (ActD), or derivatives and analogs thereof;

synonyms of actinopmycin D including dactinomycin, actinomycin IV, actinomycin l1, actinomycin X1, and actinomycin C1;

antiproliferative substances including antineoplastic, antinflammatory, antiplatelet, anticoagulant, antifibrin, antithomobin, antimitotic, antibiotic, antioxidant substances, taxol (paclitaxel and docetaxel), anticoagulants, antifibrins, sodium heparin, low molecular weight heparin, hirudin, argatroban, forskolin, vapiprost, prostacyclin and prostacyclin analogs, dextran, D-phe-pro-arg-chloromethylketone (synthetic antithrombin), dipyridamole, glycoprotein, llb/llla platelet membrane receptor antagonist, recombinant hirudin, thrombin inhibitor methotrexate, azathioprine, vincristine, vinblastine, fluorouracil, adriamycin, mutamycin;

angiopeptin, angiotensin converting enzyme inhibitors;

calcium channel blockers;

colchicine fibroblast growth factor (FGF) antagonists;

fish oil (omega 3-fatty acid);

histamine antagonist;

monoclonal antibodies (such as PDGF receptors);

nitroprusside;

phosphodiesterase inhibitors;

prostaglandin inhibitor (a PDGF antagonist);

serotonin blockers;

steroids;

thioprotease inhibitors;

triazolopyrimidine (a PDGF antagonist); and

nitric oxide.

13. The stent of claim 8, wherein the stent is configured so that it is visible under any of x-ray fluoroscopy, computer tomography, or MRI.

14. A stent, comprising:

a stent body made from a metallic material and having a longitudinal stent axis, the stent body including an undulating structural support extending circumferentially along the longitudinal stent axis to create discrete open spaces longitudinally along the longitudinal stent axis;

a polymeric material encasing the stent body; and

polymeric links connecting adjacent portions of the structural support together, each polymeric link being sized and shaped to create areas devoid of any polymeric material in the discrete open spaces formed on the stent body.

15. The stent of claim 14, wherein the polymeric links are formed from the polymeric material encasing the stent body.

16. The stent of claim 14, wherein the metallic body is formed from a metal taken from the group of metals consisting of stainless steel, titanium, tantalum, nickel-titanium, cobalt-chromium, and tungsten.

17. The stent of claim 14, wherein the polymeric material is loaded with a therapeutic drug.

18. The stent of claim 17, wherein the therapeutic drug is taken from the group of drugs including one or more of everolimus, rapamycin, actinomycin D (ActD), or derivatives and analogs thereof;

synonyms of actinopmycin D including dactinomycin, actinomycin IV, actinomycin l1, actinomycin X1, and actinomycin C1;

antiproliferative substances including antineoplastic, antinflammatory, antiplatelet, anticoagulant, antifibrin, antithomobin, antimitotic, antibiotic, antioxidant substances, taxol (paclitaxel and docetaxel), anticoagulants, antifibrins, sodium heparin, low molecular weight heparin, hirudin, argatroban, forskolin, vapiprost, prostacyclin and prostacyclin analogs, dextran, D-phe-pro-arg-chloromethylketone (synthetic antithrombin), dipyridamole, glycoprotein, llb/llla platelet membrane receptor antagonist, recombinant hirudin, thrombin inhibitor methotrexate, azathioprine, vincristine, vinblastine, fluorouracil, adriamycin, mutamycin;

angiopeptin, angiotensin converting enzyme inhibitors;

calcium channel blockers;

colchicine fibroblast growth factor (FGF) antagonists;

fish oil (omega 3-fatty acid);

histamine antagonist;

monoclonal antibodies (such as PDGF receptors);

nitroprusside;

phosphodiesterase inhibitors;

prostaglandin inhibitor (a PDGF antagonist);

serotonin blockers;

steroids;

thioprotease inhibitors;

triazolopyrimidine (a PDGF antagonist); and

nitric oxide.

19. The stent of claim 14, wherein each polymeric link has a first end and a second end, the first end being attached to an undulation of the undulating structural support and the second end being attached to a longitudinally adjacent undulation of the structural support.

20. The stent of claim 14, wherein the stent is configured so that it is visible under any of x-ray fluoroscopy, computer tomography, or MRI.