CA2457129A1 - Expandable medical device for delivery of beneficial agent - Google Patents

Expandable medical device for delivery of beneficial agent Download PDF

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Publication number
CA2457129A1
CA2457129A1 CA002457129A CA2457129A CA2457129A1 CA 2457129 A1 CA2457129 A1 CA 2457129A1 CA 002457129 A CA002457129 A CA 002457129A CA 2457129 A CA2457129 A CA 2457129A CA 2457129 A1 CA2457129 A1 CA 2457129A1
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CA
Canada
Prior art keywords
medical device
expandable medical
opening
beneficial agent
expandable
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
CA002457129A
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French (fr)
Other versions
CA2457129C (en
Inventor
John F. Shanley
Neal L. Eigler
Kinam Park
Elazer R. Edelman
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Innovational Holdings LLC
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Individual
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Publication of CA2457129A1 publication Critical patent/CA2457129A1/en
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Publication of CA2457129C publication Critical patent/CA2457129C/en
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Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • 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
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • 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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
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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
    • 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
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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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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    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
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    • 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
    • A61F2002/91533—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
    • A61F2002/91541—Adjacent bands are arranged out of phase
    • 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
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
    • A—HUMAN NECESSITIES
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    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time
    • A—HUMAN NECESSITIES
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    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
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    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
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    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
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    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
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    • A61L2300/622—Microcapsules

Abstract

An expandable medical device has a plurality of elongated struts joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter. At least one of the plurality of struts includes at least one opening extending at least partially through a thickness of said strut. A beneficial agent is loaded into the opening within the strut in layers to achieve desired temporal release kinetics of the agent. Alternatively, the beneficial agent is loaded in a shape which is configured to achieve the desired agent delivery profile.
A wide variety of delivery profiles can be achieved including zero order, pulsatile, increasing, decrease, sinusoidal, and other delivery profiles.

Claims (48)

1. An expandable medical device comprising:
a plurality of elongated struts, said plurality of elongated struts joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter, said plurality of struts each having a strut width in a circumferential direction and a strut thickness in a radial direction;
at least one opening in at least one of the plurality of struts; and at least one beneficial agent provided in the at least one opening in a plurality of layers.
2. The expandable medical device according to Claim 1, wherein the at least one opening extends at least partially through the thickness of said strut.
3. The expandable medical device according to Claim 1, wherein said at least one opening comprises a plurality of openings.
4. The expandable medical device according to Claim 1, wherein said at least one opening extends through the thickness of said at least one strut, so as to thereby define a through opening.
5. The expandable medical device according to Claim 1, wherein said at least one opening has a depth less than the thickness of said at least one strut, so as to thereby define a recess.
6. The expandable medical device according to Claim 1, wherein said plurality of beneficial agent layers include layers of different chemical compositions.
7. The expandable medical device according to Claim 6, wherein said different chemical compositions include a barrier composition and an active beneficial agent composition.
8. The expandable medical device according to Claim 7, wherein said barrier composition has an opening formed therein.
9. The expandable medical device according to Claim 6, wherein said different chemical compositions include different active beneficial agents.
10. The expandable medical device according to Claim 9, wherein said different active beneficial agents include anti-thrombotic agents and anti-proliferative agents.
11. The expandable medical device according to Claim 1, wherein said plurality of beneficial agent layers include layers of beneficial agent having the same chemical composition in different concentrations.
12. The expandable medical device according to Claim 1, wherein said plurality of beneficial agent layers include a barrier layer at a radially innermost location in the at least one opening.
13. The expandable medical device according to Claim 1, wherein the plurality of beneficial agent layers include a barrier layer between two active beneficial agent layers.
14. The expandable medical device according to Claim 1, wherein said beneficial agent is formulated to be activated by a systemically applied agent.
15. The expandable medical device according to Claim 14, wherein said systemically applied agent is ultrasound.
16. The expandable medical device according to Claim 14, wherein said systemically applied agent is a chemical agent.
17. The expandable medical device according to Claim 1, wherein the beneficial agent is contained in microspheres.
18. The expandable medical device according to Claim 17, wherein said plurality of layers include layers with microspheres of different sizes.
19. The expandable medical device according to Claim 1, wherein the opening has a shape configured to vary the release rate of a beneficial agent over time.
20. The expandable medical device according to Claim 1, wherein the beneficial agent is provided in the opening in a biodegradable carrier.
21. The expandable medical device according to Claim 1, wherein the beneficial agent is configured to diffuse from a carrier in the opening.
22. The expandable medical device according to Claim 1, wherein the beneficial agent layers include a bio-degradable barrier layer configured to terminate a therapy at a predetermined time.
23. The expandable medical device according to Claim 1, wherein the beneficial agent is paclitaxel, or an analogue or derivative thereof.
24. The expandable medical device according to Claim 1, wherein the beneficial agent is rapamycin, or an analogue or derivative thereof.
25. The expandable medical device according to Claim 1, wherein the at least one opening comprises a plurality of openings containing the beneficial agent and a plurality of openings remaining open for anchoring purposes.
26. The expandable medical device according to Claim 1, wherein the plurality of beneficial agent layers are substantially cylindrical.
27. An expandable medical device comprising:
a plurality of elongated struts, said plurality of elongated struts joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter, said plurality of struts each having a strut width in a circumferential direction and a strut thickness in a radial direction;
at least one opening in at least one of the plurality of struts; and at least one beneficial agent provided in the at least one opening, wherein a shape of the beneficial agent is configured to achieve a desired agent delivery profile.
28. The expandable medical device according to Claim 27, wherein said at least one opening comprises a plurality of openings.
29. The expandable medical device according to Claim 27, wherein said at least one opening extends through the thickness of said at least one strut, so as to thereby define a through-opening.
30. The expandable medical device according to Claim 27, wherein said at least one opening has a depth less than the thickness of said at least one strut, so as to thereby define a recess.
31. The expandable medical device according to Claim 27, wherein the at least one beneficial agent is a substantially conical plug configured to achieve an continuously varying agent delivery profile.
32. The expandable medical device according to Claim 27, wherein the at least one beneficial agent is a substantially spherical plug configured to achieve a substantially sinusoidally varying agent delivery profile.
33. The expandable medical device according to Claim 27, wherein the at least one beneficial agent is a plug and a filling material surrounds the plug in the opening.
34. The expandable medical device according to Claim 27, wherein the opening is configured in a non-cylindrical shape to achieve the desired agent delivery profile.
35. The expandable medical device according to Claim 27, wherein the beneficial agent is paclitaxel, or an analogue or derivative thereof.
36. The expandable medical device according to Claim 27, wherein the beneficial agent is rapamycin, or an analogue or derivative thereof.
37. The expandable medical device according to Claim 27, wherein the at least one opening comprises a plurality of openings containing the beneficial agent and a plurality of openings remaining open for anchoring purposes.
38. An expandable medical device for treating cardiac arrhythmias, the device comprising:
an expandable cylindrical device having a plurality of struts;
a plurality of openings in the plurality of struts; and a chemically ablative agent provided in the openings, wherein the openings are configured to deliver the chemically ablative agent to tissue surrounding the expandable cylindrical device without permanently trapping any agent in the openings.
39. The expandable medical device of Claim 38, further comprising a biodegradable barrier layer provided in the opening substantially adjacent an innermost surface of the cylindrical device.
40. An expandable medical device for treating cardiac arrhythmias, the device comprising:
an expandable cylindrical device having a plurality of struts;
a plurality of openings in the plurality of struts; and an anti-arrhythmic drug and a non-biodegradable carrier provided in the openings, wherein the openings are configured to deliver the anti-arrhythmic drug to tissue surrounding the cylindrical device over an extended time period.
41. The expandable medical device of Claim 40, further comprising a non-biodegradable barrier layer provided in the opening substantially adjacent an innermost surface of the cylindrical device.
42. A method of forming an expandable medical device, the method comprising:
providing an expandable medical device with a plurality of struts, said plurality of struts joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter;
forming at least one opening in at least one of the plurality of struts;
and delivering at least one beneficial agent into in the at least one opening in a plurality of layers.
43. The method according to Claim 42, wherein the least one opening extends at least partially through the thickness of said struts.
44. The method according to Claim 42, wherein said at least one opening comprises a plurality of openings.
45. The method according to Claim 42, wherein said at least one opening extends through the thickness of said struts, so as to thereby define a through opening.
46. The method according to Claim 42, wherein said at least one opening has a depth less than the thickness of the struts, so as to thereby define a recess.
47. The method according to Claim 42, wherein the beneficial agent delivered is paxlitaxel, or an analogue or derivative thereof.
48. The method according to Claim 42, wherein the beneficial agent delivered is rapamycin, or an analogue or derivative thereof.
CA2457129A 2001-08-20 2002-06-05 Expandable medical device for delivery of beneficial agent Expired - Lifetime CA2457129C (en)

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EP1477137B1 (en) 2009-01-14
CA2457129C (en) 2010-08-17
EP1477137A3 (en) 2005-01-19
EP1420719B9 (en) 2007-05-09
EP1420719A1 (en) 2004-05-26
DE60230926D1 (en) 2009-03-05
US8206435B2 (en) 2012-06-26
JP4746267B2 (en) 2011-08-10
US20060009838A1 (en) 2006-01-12

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