CA2499566A1 - Method and apparatus for loading a beneficial agent into an expandable medical device - Google Patents

Method and apparatus for loading a beneficial agent into an expandable medical device Download PDF

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Publication number
CA2499566A1
CA2499566A1 CA002499566A CA2499566A CA2499566A1 CA 2499566 A1 CA2499566 A1 CA 2499566A1 CA 002499566 A CA002499566 A CA 002499566A CA 2499566 A CA2499566 A CA 2499566A CA 2499566 A1 CA2499566 A1 CA 2499566A1
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CA
Canada
Prior art keywords
medical device
beneficial agent
openings
mandrel
dispensing
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
CA002499566A
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French (fr)
Other versions
CA2499566C (en
Inventor
Stephen Hunter Diaz
John F. Shanley
Kinam Park
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Innovational Holdings LLC
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Individual
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Publication date
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Priority to CA2752146A priority Critical patent/CA2752146C/en
Publication of CA2499566A1 publication Critical patent/CA2499566A1/en
Application granted granted Critical
Publication of CA2499566C publication Critical patent/CA2499566C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • 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
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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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • 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
    • 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
    • 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
    • A61L31/146—Porous materials, e.g. foams or sponges
    • 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
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D1/00—Evaporating
    • B01D1/16—Evaporating by spraying
    • B01D1/18—Evaporating by spraying to obtain dry solids
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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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • 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
    • A61F2002/821—Ostial stents
    • 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
    • A61F2002/91508—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 the meander having a difference in amplitude along the band
    • 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
    • A61F2002/91516—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 the meander having a change in frequency along the band
    • 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
    • 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
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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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
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    • A61F2002/91541—Adjacent bands are arranged out of phase
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    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
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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
    • A61F2250/0058—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
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
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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

Abstract

The present invention relates to method and apparatus for dispensing a beneficial agent into an expandable medical device. The method includes the step of placing an expandable medical device on a mandrel, the medical device forming a cylindrical device having a plurality of openings and dispensing a beneficial agent into the plurality of openings.

Claims (90)

1. A method for dispensing a beneficial agent into an expandable medical device, the method comprising:
placing an expandable medical device on a mandrel, the medical device forming a cylindrical device having a plurality of openings; and dispensing a beneficial agent into the plurality of openings.
2. The method of Claim 1, further comprising dispensing the beneficial agent with a piezoelectric micro jetting dispenser.
3. The method of Claim 2, further comprising moving the dispenser from a first position to a second position to fill the plurality of openings of the medical device with the beneficial agent.
4. The method of Claim 2, further comprising moving the mandrel from a first position to a second position to fill the plurality of openings of the medical device with the beneficial agent.
5. The method of Claim 1, further comprising rotating the mandrel to fill the plurality of openings with the beneficial agent.
6. The method of Claim 1, wherein the plurality of openings have different volumes and the amount of beneficial agent dispensed is adjusted based on the size of the opening.
7. The method of Claim 1, further comprising adjusting an amount of the beneficial agent dispensed into an opening based on an amount of beneficial agent previously dispensed into the opening.
8. The method of Claim 1, wherein the medical device is an expandable intraluminal prosthesis.
9. The method of Claim 1, wherein the medical device is a stent.
10. The method of Claim 1, wherein the mandrel includes a resilient outer surface which seals a bottom side of the openings.
11. The method of Claim 1, further comprising dissolving the beneficial agent in a solvent before dispensing.
12. The method of Claim 1, wherein the beneficial agent comprises a drug.
13. The method of Claim 1, further comprising filling the plurality of openings with a barrier layer comprising a matrix material.
14. The method of Claim 1, further comprising filling the plurality of openings with a cap layer comprising a bioresorbable matrix.
15. The method of Claim 1, further comprising lubricating the medical device and the mandrel and sliding the cylindrical device onto the mandrel.
16. The method of Claim 1, further comprising mapping the medical device on the mandrel to obtain an actual specification of the medical device including locations of the openings.
17. The method of Claim 16, wherein the mapping is performed by a camera.
18. The method of Claim 16, wherein the mapping is performed by a machine vision system.
19. The method of Claim 16, further comprising storing a plurality of coordinates from the mapping of the medical device on a central processing unit.
20. The method of Claim 19, further comprising providing the central processing unit with a plurality of coordinates from a manufacturing specification for the medical device.
21. The method of Claim 20, further comprising comparing the plurality of coordinates of the actual specification to the plurality of coordinates from the manufacturing specification for the medical device.
22. The method of Claim 21, further comprising adjusting the dispensing of the beneficial agent based on a series of adjustments, the series of adjustments comprising comparing the plurality of coordinates of the actual specification to the plurality of coordinates from the manufacturing specification.
23. The method of Claim 1, further comprising an observation system for observing the dispensing of the beneficial agent into the plurality of openings.
24. The method of Claim 1, further comprising an observation system for mapping the medical device on the mandrel.
25. The method of Claim 11, further comprising drying the mandrel to evaporate the solvent and then dispensing an additional beneficial agent into the plurality of openings.
26. The method of Claim 11, further comprising baking the mandrel to evaporate the solvent and then dispensing an additional beneficial agent into the plurality of openings.
27. The method of Claim 1, further comprising verifying the dispensing of the beneficial agent into the plurality of opening of the medical device.
28. The method of Claim 27, wherein the verification step is performed using a refracted light beam.
29. The method of Claim 27, wherein the verification step is performed using a camera.
30. The method of Claim 10, further comprising removing the cylindrical device from the mandrel by inflating the resilient outer surface of the mandrel.
31. The method of Claim 1, further comprising a plurality of bearings, the plurality of bearings providing a means for supporting the mandrel.
32. The method of Claim 1, further comprising repeating the dispensing of the beneficial agent until the plurality of openings in the expandable medical device have been filled with the beneficial agent.
33. A method for loading a beneficial agent in an expandable medical device, the method comprising:
dispensing a beneficial agent through a dispenser into a first opening in an expandable medical device;
providing relative movement between the dispenser and the expandable medical device such that the dispenser is moved from alignment with the first opening in the expandable medical device to alignment with a second opening in the expandable medical device; and dispensing the beneficial agent into the second opening in the expandable medical device.
34. The method of Claim 33, further comprising repeating the relative movement between the dispenser and expandable medical device, and dispensing of the beneficial agent until the plurality of openings in the expandable medical device have been filled with the beneficial agent.
35. The method of Claim 33, further comprising adjusting an amount of the beneficial agent dispensed into each of the openings based on a shape of each of the openings.
36. The method of Claim 33, further comprising adjusting an amount of the beneficial agent dispensed into each of the openings based on a volume of each of the openings or a preprogrammed pattern of the openings.
37. The method of Claim 33, wherein the expandable medical device is an expandable intraluminal prosthesis.
38. The method of Claim 33, wherein the expandable medical device is a stent.
39. The method of Claim 33, further comprising dissolving the beneficial agent in a solvent prior to dispensing.
40. The method of Claim 33, further comprising mapping the expandable medical device on the mandrel to obtain an actual specification of the medical device including locations of the opening.
41. The method of Claim 40, further comprising comparing the plurality of coordinates of the actual specification to the plurality of coordinates from the manufacturing specification.
42. The method of Claim 41, further comprising adjusting the dispensing of the beneficial agent based on a series of adjustments, the series of adjustments comprising comparing the plurality of coordinates of the actual specification to the plurality of coordinates from the manufacturing specification.
43. The method of Claim 33, further comprising an observation system to observe the dispensing of the beneficial agent into the plurality of openings.
44. The method of Claim 33, further comprising a step of blocking a bottom side of the openings prior to dispensing.
45. An apparatus for loading a beneficial agent in an expandable medical device, the apparatus comprising:
a mandrel;
an expandable medical device having a plurality of openings, the expandable medical device mounted on the mandrel; and a dispenser configured to dispense a beneficial agent into the plurality of openings in the expandable medical device.
46. The apparatus of Claim 45, further comprising a plurality of bearings for receiving the mandrel.
47. The apparatus of Claim 45, further comprising a central processing unit for controlling the dispensing of the beneficial agent into the openings of the expandable medical device.
48. The apparatus of Claim 45, further comprising an observation system for dispensing the beneficial agent into the plurality of openings in the expandable medical device.
49. The apparatus of Claim 48, wherein the observation system is used to map the mandrel including a plurality of expandable medical devices fixed thereto.
50. The apparatus of Claim 48, further comprising a monitor for observing the dispensing of the beneficial agent into the plurality of openings of the expandable medical device.
51. The apparatus of Claim 45, wherein an exterior surface of the mandrel is encapsulated with a rubber-like material.
52. The apparatus of Claim 45, wherein the beneficial agent includes a solvent.
53. The apparatus of Claim 45, wherein the dispenser uses vibration to dispense drops on demand.
54. The apparatus of Claim 53, wherein the dispenser is a piezoelectric micro jetting dispenser.
55. The apparatus of Claim 53, wherein the dispenser is an acoustic jetting device.
56. The apparatus of Claim 45, wherein the medical device is an expandable intraluminal prosthesis.
57. The apparatus of Claim 45, wherein the medical device is a stent.
58. A method for loading a stent with a beneficial agent, the method comprising:
providing a stent with a plurality of holes; and dispensing a beneficial agent through a piezo-electric micro-jet into the plurality of holes.
59. The method of Claim 58, further comprising providing the stent on a mandrel and encapsulating the mandrel with a resilient material.
60. An apparatus for loading a beneficial agent in a medical device having a plurality of openings, the apparatus comprising:
a dispenser configured to dispense a beneficial agent into the plurality of openings in the medical device;
an observation system configured to locate and identify the plurality of openings; and a central processing unit for controlling the dispensing of the beneficial agent into the openings of the medical device, wherein an amount and location of droplets of beneficial agent dispensed into each of the openings in the medical device is determined by the central processing unit based on information obtained from the observation system.
61. The apparatus of Claim 60, further comprising a mandrel for mounting a plurality of medical devices.
62. The apparatus of Claim 61, wherein the mandrel includes a resilient outer surface which seals a bottom side of the opening.
63. The apparatus of Claim 60, wherein the plurality of openings have different volumes and the amount of beneficial agent dispensed is adjusted based on the volume of the opening.
64. The apparatus of Claim 60, wherein the beneficial agent comprises a drug.
65. A system for controlling a delivery of a beneficial agent into a plurality of openings of a medical device, the system comprising:
an observation system for mapping a medical device to obtain an actual position of a plurality of openings of the medical device;
a central processing unit for comparing the actual position of the plurality of openings of the medical device to an anticipated position from a manufacturing specification; and a dispenser for dispensing a fluid beneficial agent into the plurality of openings.
66. The system of Claim 65, wherein the central processing unit compares the actual position of the medical device to the manufacturing specifications of the medical device on an opening by opening comparison.
67. The system of Claim 65, wherein the central processing unit compares the actual position of the medical device to the manufacturing specification of the medical device on a medical device by medical device comparison.
68. The system of Claim 65, wherein the medical device is on a mandrel.
69. The system of Claim 65, wherein the fluid beneficial agent is delivered in droplets.
70. The system of Claim 65, further comprising a motor providing relative movement between the dispenser and the medical device, such that the dispenser is moved from alignment with the first opening in the medical device to alignment with a second opening in the medical device.
71. The system of Claim 65, wherein the medical device is an expandable intraluminal prosthesis.
72. The system of Claim 65, wherein the medical device is a stent.
73. A system for controlling a delivery of a beneficial agent into an opening, the system comprising:
a mandrel having a plurality of expandable medical devices;

a dispenser configured to dispense a first layer and a second layer of a beneficial agent into a plurality of openings in the expandable medical device;
and a central processing unit for controlling the dispensing of the beneficial agent into the openings of the expandable medical device.
74. The system of Claim 73, wherein the mandrel includes a resilient outer surface which seals a bottom side of the opening.
75. The system of Claim 73, wherein the plurality of opening have different volumes and the amount of beneficial agent dispensed is adjusted based on the volume of the opening.
76. The system of Claim 73, wherein the beneficial agent comprises a drug.
77. A method of removing stents from a mandrel, the method comprising:
radially expanding the stents by injecting air into at least a portion of the mandrel to inflate the mandrel and expand the stents;
deflating the mandrel; and sliding the expanded stents off the mandrel.
78. The method Claim 77, wherein the stents are radially constrained by a die during the inflation of the mandrel to prevent over expansion.
79. A method for loading a medical device with a beneficial agent, the method comprising:
providing a medical device with a plurality of holes;

dispensing a beneficial agent through a dispenser into the plurality of holes by vibration of a portion of the dispenser to form a plurality of droplets;
and controlling a size of the droplets by controlling parameters of the vibration.
80. The method of Claim 79, further comprising controlling a number and location of the droplets with a central processing unit.
81. The method of Claim 80, further comprising observing the dispensing of the beneficial agent and returning observed data to the central processing unit for use in controlling the location of the droplets.
82. The method of Claim 79, wherein the dispenser uses vibration of a piezoelectric material.
83. The method of Claim 79, wherein the dispenser uses vibration of an acoustic transducer.
84. A method for loading a medical device with a beneficial agent, the method comprising:
providing a medical device to be provided with a therapeutic agent;
providing a dispenser containing a beneficial agent including a therapeutic agent and a volatile solvent;
delivering droplets of the beneficial agent to the medical device with the dispenser; and inhibiting evaporation of the volatile solvent during delivery of the droplets by creating a cloud of vaporized solvent around an exit orifice of the dispenser.
85. The method of Claim 84, wherein the cloud is created by containment of the volatile solvent evaporating from the beneficial agent.
86. The method of Claim 84, wherein the cloud is created by delivery of the volatile solvent around the exit orifice from an auxiliary solvent source.
87. A system for loading a medical device with a beneficial agent, the system comprising:
a mandrel for supporting a medical device;
a dispenser for dispensing a beneficial agent into a plurality of holes in the medical device by vibration of a portion of the dispenser; and a central processing unit for controlling a size of droplets of beneficial agent from the dispenser by controlling parameters of the vibration.
88. The system of Claim 87, wherein the central processing unit controls a number and location of the droplets.
89. The system of Claim 87, wherein the dispenser uses vibration of a piezoelectric material.
90. The system of Claim 87, wherein the dispenser uses vibration of an acoustic transducer.
CA2499566A 2002-09-20 2003-09-22 Method and apparatus for loading a beneficial agent into an expandable medical device Expired - Fee Related CA2499566C (en)

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