CA2456918A1 - Medical devices comprising nanocomposites - Google Patents

Medical devices comprising nanocomposites Download PDF

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Publication number
CA2456918A1
CA2456918A1 CA002456918A CA2456918A CA2456918A1 CA 2456918 A1 CA2456918 A1 CA 2456918A1 CA 002456918 A CA002456918 A CA 002456918A CA 2456918 A CA2456918 A CA 2456918A CA 2456918 A1 CA2456918 A1 CA 2456918A1
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CA
Canada
Prior art keywords
medical device
nanocomposite
transluminal
catheter
component
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
CA002456918A
Other languages
French (fr)
Other versions
CA2456918C (en
Inventor
Edward Parsonage
Daniel J. Horn
John J. Chen
Paul J. Miller
Douglas A. Devens, Jr.
Jan Weber
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Ltd Barbados
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2456918A1 publication Critical patent/CA2456918A1/en
Application granted granted Critical
Publication of CA2456918C publication Critical patent/CA2456918C/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
    • A61F2/95—Instruments specially adapted for placement or removal of 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
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/0108—Both ends closed, i.e. legs gathered at both ends
    • 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
    • A61F2/02—Prostheses implantable into the body
    • 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
    • A61F2/95—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
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L29/126—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • 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
    • A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L31/125—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • 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
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/018—Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/005—Rosette-shaped, e.g. star-shaped
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/90—Stent for heart valve
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S977/00—Nanotechnology
    • Y10S977/902—Specified use of nanostructure
    • Y10S977/904—Specified use of nanostructure for medical, immunological, body treatment, or diagnosis
    • Y10S977/905—Specially adapted for travel through blood circulatory system

Abstract

The present invention provides medical devices comprising nanocomposite materials. By utilizing nanocomposites in the production thereof, the inventive medical devices can be produced with various advantageous properties. Methods of producing the inventive medical devices are also provided. Inasmuch as the inventive devices are expected to provide certain advantages in their use, there is also provide a method of medical care including methods of treatment or diagnosis, wherein the inventive devices a re brought into therapeutic contact with a body to be treated or diagnosed thereby.

Claims (59)

1. A medical device wherein at least one component thereof is prepared from a nanocomposite material comprising;
a matrix material;
at least one plurality of nanoparticulate filler particles.
2. The medical device of claim 1, wherein the nanocomposite material further comprises a functionalizer, a compatibilizer, a dispersant or combinations thereof.
3. The medical device of claim 1, wherein the device is a transluminal medical device.
4. The medical device of claim 3, wherein the at least one component comprises at least one layer of a multilayered transluminal device.
5. The medical device of claim 4, wherein the at least one component comprises an inner lumen wall of a multilumen catheter.
6. The medical device of claim 4, wherein the at least one component comprises an outer lumen wall of a multilumen catheter.
7. The medical device of claim 4, wherein at least one layer of the multilayered transluminal device is tapered in thickness along a longitudinal axis thereof.
8. The medical device of claim 3, wherein flexibility of the device varies along a longitudinal axis thereof.
9. The medical device of claim 4, wherein the multilayer transluminal medical device comprises at least one nanocomposite layer and at least one non-nanocomposite layer.
10. The medical device of claim 4, wherein the multilayer transluminal medical device comprises at least two nanocomposite layers separated by at least one non-nanocomposite layer.
11. The medical device of claim 4, wherein the multilayer transluminal medical device comprises at least a first and a second nanocomposite layer, wherein the first and second nanocomposite layers are comprised of different nanocomposites.
12. The medical device of claim 4, wherein at least one of the first and second nanocomposite layers further comprises at least a first functionalizer, and are otherwise comprised of the same nanocomposite.
13. The medical device of claim 4, wherein the multilayer transluminal medical device comprises at least a first and a second nanocomposite layer, wherein the first and second nanocomposite layers further comprise at least a first and a second functionalizer respectively, and otherwise are comprised of the same nanocomposite.
14. The medical device of claim 1, wherein the at least one component comprises an expandable balloon comprising at least two layers.
15. The medical device of claim 14, wherein each of at least two layers comprises a different functionalizer and are otherwise comprised of the same nanocomposite material.
16. The medical device of claim 1, wherein the matrix material comprises a thermoset material.
17. The medical device of claim 16, wherein the thermoset material comprises a nitrile butadiene elastomer, a silicone, an epoxy, a isocyanate, EPDM, epichlorohydrin, or a copolymer, block copolymer or polymer blend of these.
18. The medical device of claim 1, wherein the matrix material comprises a thermoplastic material.
19. The medical device of claim 18, wherein the thermoplastic material comprises a polyolefin, a polyamide, a polyester, a polyether, a polyurethane, a polyurea, a polyvinyl, a polyacrylic, a fluoropolymer or a copolymer, block copolymer or blend of any of these.
20. The medical device of claim 19, wherein the thermoplastic material is a nylon.
21. The medical device of claim 20, wherein the nylon is nylon 12.
22. The medical device of claim 19, wherein the thermoplastic material is a polyether amide block copolymer
23. The medical device of claim 1, wherein the filler particles comprise synthetic or natural phyllosilicate, monomeric silicate, carbon or ceramic nanotubes, nanowires or nanofibers, metal or metal oxide powder, magnetic or paramagnetic powder, temperature sensitive polymer, biodegradable polymer, dendrimer or dendrimer metal complex, or a combination of these.
24. The medical device of claim 23, wherein the filler particles comprise one or more phyllosilicates.
25. The medical device of claim 24, wherein the filler particles comprise one or more clays.
26. The medical device of claim 25, wherein at least one of the clays comprises montmorillonite.
27. The medical device of claim 23, wherein the filler particles comprise one or more polyhedral oligomeric silsequioxanes.
28. The medical device of claim 23, wherein the filler particles comprise one or more carbon or ceramic nanotubes, nanowires or nanofibers.
29. The medical device of claim 28, wherein the filler particles comprise one or more carbon nanotubes.
30. The medical device of claim 1, wherein the at least one component comprises a catheter shaft.
31. The medical device of claim 1, wherein the at least one component comprises a balloon.
32. The medical device of claim 1, wherein the medical device is a guide catheter.
33. The medical device of claim 1, wherein the at least one component comprises a stent delivery catheter.
34. A method of making at least a component of a medical device, comprising:
selecting a nanoparticle filler material;
selecting a matrix material;
preparing a nanocomposite from the filler material and the matrix material; and preparing at least a component of the medical device with the nanocomposite.
35. The method of claim 34, wherein the medical device is a transluminal medical device.
36. The method of claim 35, wherein the medical device is a multilayer transluminal medical device.
37. The method of claim 36, wherein the at least one component comprises a length of catheter shafting.
38. The method of claim 37, wherein the step of preparing at least a component of the medical device comprises providing one layer to be tapered in thickness along a longitudinal axis thereof.
39. The method of claim 37, wherein the step of preparing at least a component of the medical device comprises providing a variability in flexibility along a longitudinal axis thereof.
40. The method of claim 37, wherein the filler material comprises a plurality of carbon nanotubes, nanofibers, or nanowires.
41. The method of claim 40, wherein at least a portion of the plurality of carbon nanotubes, nanofibers, or nanowires is functionalized with glucosamine, or carboxylic acid.
42. The method of claim 40, wherein the length of shafting is provided by contacting at least a portion of a first layer of the length of shafting with a solution comprising the carbon nanoparticles and providing the second layer to be deposited over at least a portion of the carbon nanoparticles.
43. The method of claim 40, wherein the solution of carbon nanoparticles further comprises a dispersant.
44. The method of claim 43, wherein the dispersant comprises gum arabic.
45. The method of claim 35, wherein the medical device is a cardiovascular medical device.
46. The method of claim 45, wherein the cardiovascular medical device is a balloon catheter.
47. An apparatus for forming a polymer extrudate, the apparatus comprising:
a polymer extruder, the polymer extruder comprising an extruder head for extruding a polymer melt, the extruder head having at least one ultrasonic transducer functionally engaged thereto, the at least one ultrasonic transducer constructed and arranged to transmit at least one modulated ultrasonic wave to the extruder head, the at least one modulated ultrasonic wave having at least one amplitude and at least one modulation, the at least one amplitude and the at least one modulation of the wave imparting substantially uniform vibrations to at least the entire extruder head.
48. A method of medical care comprising bringing a medical device into therapeutic contact with a body to effectuate a treatment or diagnosis thereof, wherein the medical device comprises at least one nanocomposite material.
49. The method of claim 48, wherein the method of medical care is a method of treatment.
50. The method of claim 49, wherein the medical device is a transluminal medical device.
51. The method of claim 50, wherein the medical device comprises a catheter.
52. The method of claim 51, wherein the medical device comprises a balloon.
53. The method of claim 51, wherein the medical device is a guide catheter.
54. The method of claim 51, wherein the medical device is a stent delivery, catheter.
55. The method of claim 52, wherein the treatment is angioplasty.
56. The method of claim 48, wherein the method of medical care is a diagnostic method.
57. The method of claim 56, wherein the medical device is a transluminal medical device.
58. The medical device of claim 57, wherein the medical device comprises a catheter.
59. The method of claim 58, wherein the diagnostic method is angiography.
CA2456918A 2001-09-28 2002-09-27 Medical devices comprising nanocomposites Expired - Fee Related CA2456918C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US33133201P 2001-09-28 2001-09-28
US60/331,332 2001-09-28
US32762901P 2001-10-05 2001-10-05
US60/327,629 2001-10-05
PCT/US2002/030725 WO2003049795A2 (en) 2001-09-28 2002-09-27 Medical devices comprising nanocomposites

Publications (2)

Publication Number Publication Date
CA2456918A1 true CA2456918A1 (en) 2003-06-19
CA2456918C CA2456918C (en) 2011-02-22

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ID=26985974

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CA2456918A Expired - Fee Related CA2456918C (en) 2001-09-28 2002-09-27 Medical devices comprising nanocomposites
CA2457189A Expired - Fee Related CA2457189C (en) 2001-09-28 2002-09-27 Medical devices comprising nanomaterials and therapeutic methods utilizing the same

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Application Number Title Priority Date Filing Date
CA2457189A Expired - Fee Related CA2457189C (en) 2001-09-28 2002-09-27 Medical devices comprising nanomaterials and therapeutic methods utilizing the same

Country Status (6)

Country Link
US (5) US7591831B2 (en)
EP (4) EP2319453B1 (en)
JP (2) JP2005503865A (en)
AU (2) AU2002360251A1 (en)
CA (2) CA2456918C (en)
WO (2) WO2003049795A2 (en)

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