CA2450962A1 - Drug delivery devices - Google Patents

Drug delivery devices Download PDF

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Publication number
CA2450962A1
CA2450962A1 CA002450962A CA2450962A CA2450962A1 CA 2450962 A1 CA2450962 A1 CA 2450962A1 CA 002450962 A CA002450962 A CA 002450962A CA 2450962 A CA2450962 A CA 2450962A CA 2450962 A1 CA2450962 A1 CA 2450962A1
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CA
Canada
Prior art keywords
medical device
drug delivery
delivery apparatus
local drug
implantation
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
CA002450962A
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French (fr)
Other versions
CA2450962C (en
Inventor
Gerard H. Llanos
David C. Lentz
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Cardinal Health 529 LLC
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Individual
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Publication of CA2450962A1 publication Critical patent/CA2450962A1/en
Application granted granted Critical
Publication of CA2450962C publication Critical patent/CA2450962C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • AHUMAN NECESSITIES
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    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • A61F2/91Stents 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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    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B17/0644Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
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    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • AHUMAN NECESSITIES
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    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115Staplers for performing anastomosis in a single operation
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    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • A61F2/91Stents 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
    • A61F2/915Stents 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
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/33Heterocyclic compounds
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    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
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    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/727Heparin; Heparan
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    • A61L31/00Materials 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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    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16Biologically active materials, e.g. therapeutic substances
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004Means for attaching suture to needle
    • A61B2017/06028Means for attaching suture to needle by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/064Blood vessels with special features to facilitate anastomotic coupling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • A61F2/91Stents 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
    • A61F2/915Stents 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
    • A61F2002/91533Stents 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
    • A61F2002/91541Adjacent bands are arranged out of phase
    • AHUMAN NECESSITIES
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    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067Means for introducing or releasing pharmaceutical products into the body
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    • A61FFILTERS 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
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    • A61F2310/00389The prosthesis being coated or covered with a particular material
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    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
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    • A61L2300/606Coatings

Abstract

Local drug delivery medical devices are utilized to deliver therapeutic dosages of drugs, agents or compounds directly to the site where needed. The local drug delivery medical devices utilize various materials and coating methodologies to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

Claims (51)

1. A local drug delivery apparatus comprising:
a medical device for implantation into a treatment site of a living organism;
at least one agent in therapeutic dosages releasably affixed to the medical device for the treatment of reactions by the living organism caused by the medical device or the implantation thereof; and a material for preventing the at least one agent from separating from the medical device prior to implantation of the medical device at the treatment site, the material being affixed to at least one of the medical device or a delivery system for the medical device.
2. The local drug delivery apparatus according to Claim 1, wherein the medical device comprises an intraluminal medical device.
3. The local drug delivery apparatus according to Claim 2, wherein the intraluminal medical device comprises a stent.
4. The local drug delivery apparatus according to Claim 1, wherein the at least one agent comprises an anti-proliferative.
5. The local drug delivery apparatus according to Claim 1, wherein the at least one agent comprises an anti-inflammatory.
6. The local drug delivery apparatus according to Claim 1, wherein the at least one agent comprises an anti-coagulant.
7. The local drug delivery apparatus according to Claim 1, wherein the at least one agent comprises an immunosuppressant.
8. The local drug delivery apparatus according to Claim 1, wherein the at least one agent comprises a non-viral gene introducer.
9. The local drug delivery apparatus according to Claim 1, wherein the material for preventing the at least one agent from separating from the medical device comprises a lubricious coating.
10. The local drug delivery apparatus according to Claim 9, wherein the lubricious coating is incorporated onto the medical device.
11. The local drug delivery apparatus according to Claim 9, wherein the lubricious coating is incorporated into the medical device.
12. The local drug delivery apparatus according to Claim 9, wherein the lubricious coating is incorporated onto the delivery system for the medical device.
13. The local drug delivery apparatus according to Claim 9, wherein the lubricious coating comprises a silicone-based material.
14. The local drug delivery apparatus according to Claim 1, wherein the material for preventing the at least one agent from separating from the medical device comprises a water soluble powder.
15. The local drug delivery apparatus according to Claim 14, wherein the water soluble powder is incorporated onto the medical device.
16. The local drug delivery apparatus according to Claim 15, wherein the water soluble powder comprises an anti-oxidant.
17. The local drug delivery apparatus according to Claim 15, wherein the water soluble powder comprises an anti-coagulant.
18. A local drug delivery apparatus comprising:
a medical device for implantation into a treatment site of a living organism;
at least one agent in therapeutic dosages releasably affixed to the medical device for the treatment of reactions by the living organism caused by the medical device or the implantation thereof, the at least one agent being incorporated into a polymeric matrix; and a material for preventing the at least one agent from separating from the medical device prior to implantation of the medical device at the treatment site, the material being affixed to at least one of the medical device or a delivery system for the medical device.
19. The local drug delivery apparatus according to Claim 18, wherein the medical device comprises an intraluminal medical device.
20. The local drug delivery apparatus according to Claim 19, wherein the intraluminal medical device comprises a stent.
21. The local drug delivery apparatus according to Claim 20, wherein the polymeric matrix comprises ethylene-co-vinylacetate and polybutylmethacrylate.
22. The local drug delivery apparatus according to Claim 20, wherein the polymeric matrix comprises ethylene-co-vinylacetate and polybutylmethacrylate.
23. The local drug delivery apparatus according to Claim 20, wherein the material for preventing the at least one agent from separating from the medical device comprises a lubricious coating.
24. The local drug delivery apparatus according to Claim 23, wherein the lubricious coating is incorporated onto the surface of the polymeric matrix.
25. The local drug delivery apparatus according to Claim 23, wherein the lubricious coating is incorporated into the polymeric matrix.
26. The local drug delivery apparatus according to Claim 23, wherein the lubricious coating is incorporated onto the surface of the delivery system for the medical device.
27. The local drug delivery apparatus according to Claim 23, wherein the lubricious coating comprises a silicone-based material.
28. A local drug delivery apparatus comprising:
a medical device for implantation into a treatment site of a living organism;
at least one agent in therapeutic dosages releasably affixed to the medical device for the treatment of reactions by the living organism caused by the medical device or the implantation thereof, the at least one agent being incorporated into a polymeric matrix; and a material for preventing the polymeric matrix from adhering to itself when parts of the medical device make contact with one another.
29. The local drug delivery apparatus according to Claim 28 wherein the medical device comprises an intraluminal medical device.
30. The local drug delivery apparatus according to Claim 29 wherein the intraluminal medical device comprises a stent.
31 31. The local drug delivery apparatus according to Claim 30 wherein the material for preventing the polymeric matrix from adhering to itself comprises a water soluble powder.
32. The local drug delivery apparatus according to Claim 31 wherein the water soluble powder is affixed to the surface of the polymeric matrix.
33. The local drug delivery apparatus according to Claim 32 wherein the water soluble powder comprises an anti-oxidant.
34. The local drug delivery apparatus according to Claim 32 wherein the water soluble powder comprises anti-coagulant.
35. A drug delivery device comprising:
a medical device for implantation into a treatment site of a living organism; and therapeutic dosages of one or more anti-proliferatives, one or more anti-inflammatories, one or more anti-coagulants, and one or more immunosuppressants releasably affixed to the medical device for the treatment of reactions by the living organism caused by the medical device or the implantation of the medical device at the treatment site.
36. The drug delivery device according to Claim 35, further comprising therapeutic dosages of modified genes via one or more non-viral gene introducers releasably affixed to the medical device.
37. The drug delivery device according to Claim 36, further comprising a material for preventing the therapeutic dosages releasably affixed to the medical device from separating from the medical device during delivery and implantation of the medical device at the treatment site, the material being affixed to at least one of the medical device or a delivery system for the medical device.
38 The drug delivery device according to Claim 37, wherein the material for preventing the therapeutic dosages releasably affixed to the medical device from separating from the medical device comprises a lubricious coating.
39. The drug delivery device according to Claim 36, further comprising a polymeric matrix into which the therapeutic dosages are incorporated.
40. The drug delivery device according to Claim 39, further comprising a material for preventing the polymeric matrix from adhering to itself when parts of the medical device make contact with one another.
41. The drug delivery device according to Claim 40, wherein the material for preventing the polymeric matrix from adhering to itself comprises a water soluble powder.
42. A method for maintaining agents on a medical device during implantation into a treatment site of a living organism comprising:
releasably affixing one or more agents in therapeutic dosages to the medical device;
treating one of the medical device or the delivery device with a material for preventing the one or more agents from separating from the medical device during delivery and implantation of the medical device at the treatment site; and loading the medical device into a delivery device.
43. The method for maintaining agents on a medical device during implantation according to Claim 42, wherein the step of releasably affixing one or more agents comprises incorporating the agents in at least one polymer and coating the medical device with the at least one polymer.
44. The method for maintaining agents on a medical device during implantation according to Claim 43, wherein the step of treating one of the medical device or the delivery device comprises coating the at least one polymer with a lubricious material.
45. The method for maintaining agents on a medical device during implantation according to Claim 43, wherein the step of treating one of the medical device or the delivery device comprises coating the delivery device with a lubricious material.
46. The method for maintaining agents on a medical device during implantation according to Claim 43, wherein the step of treating one of the medical device or the delivery device comprises incorporating a lubricious material into the polymer.
47. The method for maintaining agents on a medical device during implantation according to Claim 43, wherein the step of treating one of the medical device or the delivery device comprises coating the at least one polymer with a water soluble powder.
48. A method for maintaining agents on a medical device during implantation into a treatment site of a living organism comprising:
releasably affixing one or more agents in therapeutic dosages to the medical device by incorporating the one or more agents in at least one polymer;
treating the medical device with a material for preventing the polymer from adhering to itself when parts of the medical device make contact; and loading the medical device into a delivery device.
49. The method for maintaining agents on a medical device during implantation according to Claim 48, wherein the step of treating the medical device comprises coating the at least one polymer with a water soluble powder.
50. A method for maintaining agents on a medical device during implantation into a treatment site of a living organism comprising:
coating at least a portion of the medical device with a primer layer;
coating the primer layer with a first polymer layer including cross-linking moieties;
cross-linking the first polymer layer to the primer layer; and releasably affixing one or more agents in therapeutic dosages to the medical device by incorporating the one or more agents in at least one polymer, the polymer being similar in chemical composition to the first polymer.
51. The method for maintaining agents on a medical device during implantation according to Claim 50, wherein the step of releasably affixing one or more agents comprises layering the at least one polymer onto the first polymer layer using a solvent that swells.
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US20020165608A1 (en) 2002-11-07
CA2450962C (en) 2011-01-25
US7261735B2 (en) 2007-08-28
ATE444768T1 (en) 2009-10-15
EP1406682A1 (en) 2004-04-14
DE60233944D1 (en) 2009-11-19
WO2003000308A1 (en) 2003-01-03
US20060235503A1 (en) 2006-10-19
EP1406682B1 (en) 2009-10-07
JP2004531331A (en) 2004-10-14

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