CA2559747A1 - Multiple drug delivery from a balloon and a prosthesis - Google Patents

Multiple drug delivery from a balloon and a prosthesis Download PDF

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Publication number
CA2559747A1
CA2559747A1 CA002559747A CA2559747A CA2559747A1 CA 2559747 A1 CA2559747 A1 CA 2559747A1 CA 002559747 A CA002559747 A CA 002559747A CA 2559747 A CA2559747 A CA 2559747A CA 2559747 A1 CA2559747 A1 CA 2559747A1
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CA
Canada
Prior art keywords
balloon
beneficial agent
prosthesis
coating
poly
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002559747A
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French (fr)
Other versions
CA2559747C (en
Inventor
John L. Toner
Sandra E. Burke
Keith R. Cromack
Randolf Von Oepen
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Abbott Laboratories
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Individual
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Publication date
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Publication of CA2559747A1 publication Critical patent/CA2559747A1/en
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Publication of CA2559747C publication Critical patent/CA2559747C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61K47/6957—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a device or a kit, e.g. stents or microdevices
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91525—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract

Disclosed is an interventional device for delivery of therapeutic agents from an angioplasty balloon and from a prosthesis such as an intraluminal stent.
The invention also relates to the method of loading the beneficial agents onto the balloon and the device, as well as the method of delivery of the agents from separate surfaces. The invention also relates to an interventional device having a prosthesis surface that is loaded with a first beneficial agent, and a balloon surface loaded with a second beneficial agent. The invention also relates to a method of loading multiple beneficial agents onto the prosthesis surfaces and the balloon surfaces, and to a method of manufacturing an interventional device for the delivery of a first beneficial agent and a second beneficial agent from separate surfaces.

Claims (49)

What is claimed is:
1. A system for delivering a beneficial agent, comprising:
a) a balloon having an outer surface that is at least partially coated with a therapeutically effective amount of a first beneficial agent; and b) a prosthesis that can be delivered or implanted having a surface that is at least partially coated with a therapeutically effective amount of a second beneficial agent wherein the system is useful for the treatment and prevention of vascular diseases.
2. A system according to claim 1, wherein the balloon is an angioplasty balloon.
3. A system according to claim1, wherein the prosthesis is a stent.
4. A system according to claim 3, wherein said prosthesis is crimped onto said balloon.
5. A system according to claim 1, wherein said prosthesis is at least partially retained on said balloon by said coating on said balloon.
6. A system according to claim 3, wherein the stent is a self-extanding stent.
7. A system according to claim 1, wherein the coating on the balloon further comprises a carrier for said first beneficial agent.
8. A system according to claim 6, wherein the carrier is selected from the group consisting of complex sugars (mannitol) starches (cellulose), collagens, and polymeric materials.
9. A system according to claim 1, wherein the coating on the prosthesis further comprises a carrier for said second beneficial agent.
10. A system according to claim 9, wherein said carrier for said second beneficial agent is selected from a group consisting of phosphorylcholine, polycaprolactone, poly-D,L-lactic acid, poly-L-lactic acid, poly(lactide-co-glycolide), poly(hydroxybutyrate), poly(hydroxybutyrate-co-valerate), polydioxanone, polyorthoester, polyanhydride, poly(glycolic acid), poly(glycolic acid-co-trimethylene carbonate), polyphosphoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), polyalkylene oxalates, polyphosphazenes, polyiminocarbonates, and aliphatic polycarbonates, fibrin, fibrinogen, cellulose, starch, collagen, Parylene®, Parylast®, polyurethane, polycarbonate urethanes, polyethylene, polyethylene terephthalate, ethylene vinyl acetate, ethylene vinyl alcohol, silicone polysiloxanes, substituted polysiloxanes, polyethylene oxide, polybutylene terephthalate-co-PEG, PCL-co-PEG, PLA-co-PEG, polyacrylates, polyvinyl pyrrolidone, polyacrylamide, thermoplastic elastomers, polyolefin elastomers, EPDM rubbers, polyamide elastomers, biostable plastic, acrylic polymers, nylon, polyesters, epoxies and derivatives or combinations thereof.
11. A system according to claim 1, further comprising a balloon which is substantially free of a beneficial agent.
12. A system according to claim 1, wherein the first beneficial agent is the same as the second beneficial agent.
I3. A system according to claim 1, wherein a surface of said prosthesis is loaded with therapeutically effective amounts of more than one beneficial agent.
14. A system according to claim 1, wherein the first beneficial agent and the second beneficial agent are individually selected from the group consisting of antithrombotics, anticoagulants, antiplatelet agents, anti-lipid agents, thrombolytics, antiproliferatives, anti-inflammatories, agents that inhibit hyperplasia, smooth muscle cell inhibitors, antibiotics, growth factor inhibitors, cell adhesion inhibitors, cell adhesion promoters, antimitotics, antifibrins, antioxidants, antineoplastics, agents that promote endothelial cell recovery, antiallergic substances, viral vectors, nucleic acids, monoclonal antibodies, antisense compounds, oligonucleotides, cell permeation enhancers, radiopaque agent markers, HMG CoA
reductase inhibitors, pro-drugs and combinations thereof. .
15. A system according to claim 9, wherein said HMG CoA reductase inhibitor is selected from the group consisting of atorvastatin, simvastatin, pravastatin, lovastatin, cerivastatin, fluvastatin.
16. The system according to claim 1, wherein the first and second beneficial agents are individually selected from the group of indomethacin, phenyl salicylate, vinblastine, ABT-627 (atrasentan), ABT-578, testosterone, progesterone, paclitaxel, taxanes, cyclosporin A, vincristine, casvedilol, vindesine, dipyridamole, methotrexate, folic acid, thrombospondin mimetics, estradiol, dexamethasone, metrizamide, iopamidol, iohexol, iopromide, iobitridol, iomeprol, iopentol, ioversol, ioxilan, iodixanol, iotrolan, rapamycin, rapamycin derivatives, pimecrolimus, everolimus, fenofibrate, carvedilol, taxoteres, tacrolimus, peroxisomal proliferator activated receptor .gamma. (PPAR-.gamma.) agonists, paricalcitol, butylated hydroxytoluene, butylated hydroxyanisole, vitamin E, danazol, probucol, tocopherols, tocotrienols and pro-drugs, analogs, derivatives, or combinations thereof.
17. The system according to claim 16, wherein the PPAR-.gamma. agonist is a thiazolidinedione.
18. The system according to claim 1, wherein the beneficial agent is a nucleic acid that encodes a pharmaceutically useful peptide or an anti-sense oligonucleotide used to control a gene of interest in a cell of the patient.
19. A system according to claim 1, further comprising additional prostheses.
20. A system according to claim 1, wherein the coating on the balloon is discontinuous.
21. A system according claim 1, wherein the coating on the balloon forms a pattern.
22. A system according to claim 4, wherein the length of said coating on the balloon extends past the length of said prosthesis crimped on said balloon.
23. A system according to claim 6, wherein said coated balloon is delivered after said stent is implanted to accomplish final sizing of said stent.
24. A system according to claim 1, wherein said first beneficial agent is transferred from said coating on said balloon into said coating on said prosthesis.
25. A system according to claim 1, wherein said coating on said prosthesis comprises a barrier to transfer of said first beneficial agent from said coating on said balloon into said coating on said prosthesis or of said second beneficial agent from said coating on said prosthesis into said coating on said balloon.
26. A system according to claim 25, wherein said barrier is polymeric.
27. The system according to claim 26, wherein the polymeric component is selected from a group consisting of phosphorylcholine, polycaprolactone, poly-D,L-lactic acid, poly-L-lactic acid, poly(lactide-co-glycolide), poly(hydroxybutyrate), poly(hydroxybutyrate-co-valerate), polydioxanone, polyorthoester, polyanhydride, poly(glycolic acid), poly(glycolic acid-co-trimethylene carbonate), polyphosphoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), polyalkylene oxalates, polyphosphazenes, polyiminocarbonates, and aliphatic polycarbonates, fibrin, fibrinogen, cellulose, starch, collagen, Parylene®, Parylast®, polyurethane, polycarbonate urethanes, polyethylene, polyethylene terephthalate, ethylene vinyl acetate, ethylene vinyl alcohol, silicone polysiloxanes, substituted polysiloxanes, polyethylene oxide, polybutylene terephthalate-co-PEG, PCL-co-PEG, PLA-co-PEG, polyacrylates, polyvinyl pyrrolidone, polyacrylamide, thermoplastic elastomers, polyolefin elastomers, EPDM rubbers, polyamide elastomers, biostable plastic, acrylic polymers, nylon, polyesters, epoxies and derivatives or combinations thereof.
28. A method of treating and preventing a vascular disease using the system of claim 1
29. A system according to claim 24, wherein said first beneficial agent is delivered from said coating on said prosthesis into a target site.
30. A system according to claim 1, wherein said coating on said balloon contains multiple beneficial agents.
31. A system according to claim 1, wherein said coating on said prosthesis contains multiple beneficial agents.
32. A method of treating and preventing a vascular disease, comprising the steps of:
a) delivering a balloon having an outer surface that is at least partially coated with a therapeutically effective amount of a first beneficial agent; and b) delivering a prosthesis having a surface that is at least partially coated with therapeutically effective amount of a second beneficial agent.
33. A method according to claim 40, wherein first beneficial agent is not the same as the second beneficial agent.
34. A method according to claim 40, wherein step a and step b are performed simultaneously.
35. A method according to claim 42, wherein said balloon is adhered to said prosthesis by said coating on said balloon.
36. A method according to claim 40, wherein step a and step b are performed in sequence.
37. A method according to claim 40, wherein step a is performed before step b and said balloon is delivered during angioplasty.
38. A method according to claim 40, further comprising the step of using an uncoated balloon.~
39. A method according to claim 40, wherein step b is performed prior to step a.
40. A method according to claim 47, wherein said prosthesis is a self expanding scent.
41. A method according to claim 48, wherein said coated balloon is used for final sizing of said coated stent.
42. A system according to claim 24, wherein said first beneficial agent is delivered from said coating on said prosthesis into a target site.
43. A method of providing a device for treatment and prevention of vascular disease, comprising the steps of:
a) providing a beneficial agent; and b) coating said beneficial agent onto said balloon.
44. A method according to claim 60, wherein said coating step is accomplished by dipping, spraying, layering, painting or jetting.
45. A method according to claim 60, wherein said beneficial agent is coated from a solution.
46. A method according to claim 62, wherein said solution comprises at least one solvent.
47. A method according to claim 63, wherein said at least one solvent is selected from the group consisting of water, alcohols, dichloromethane, dimethylsulfoxide, ethanol, isopropyl alcohol, isobutyl alcohol, tetrahydrofuran, alkanes, dimethylformamide and mixtures thereof.
48. A method according to claim 60, further comprising the step of providing a prosthesis for use in association with said coated balloon.
49. A method according to claim 60, further comprising the step of enhancing retention of said prosthesis by mounting said prosthesis on said coated balloon prior to complete drying or curing of said coating on said balloon.
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US20050246009A1 (en) 2005-11-03
EP1735042A1 (en) 2006-12-27
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AU2005222719B2 (en) 2011-03-24
JP2007529285A (en) 2007-10-25
WO2005089855A1 (en) 2005-09-29
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ATE534424T1 (en) 2011-12-15
EP1735042B1 (en) 2011-11-23

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