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CA2397654A1 - Expanded ptfe drug delivery graft - Google Patents

Expanded ptfe drug delivery graft

Info

Publication number
CA2397654A1
CA2397654A1 CA 2397654 CA2397654A CA2397654A1 CA 2397654 A1 CA2397654 A1 CA 2397654A1 CA 2397654 CA2397654 CA 2397654 CA 2397654 A CA2397654 A CA 2397654A CA 2397654 A1 CA2397654 A1 CA 2397654A1
Authority
CA
Grant status
Application
Patent type
Prior art keywords
graft
drug
porous
hollow
tubing
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
CA 2397654
Other languages
French (fr)
Other versions
CA2397654C (en )
Inventor
Robert W. Calcote
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.)
Bard Peripheral Vascular Inc
Original Assignee
Robert W. Calcote
Impra, Inc. A Subsidiary Of C.R. Bard, Inc.
Bard Peripheral Vascular, Inc.
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

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/16Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/04Macromolecular materials
    • A61L31/048Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • 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
    • A61F2250/0068Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus

Abstract

An improved ePTFE-based delivery graft is intended to dispense a bioactive agent such as a drug into the blood stream. A hollow tubing is infused with the agent from a source such as a drug delivery pump mechanism. The spiral hollow tubing is wrapped in a helical fashion around, or otherwise brought into contact with an outer wall of a porous ePTFE graft and adhered thereto.
The agent is delivered to the lumen of the graft by infusing the agent through the porous interstices of the graft wall. Thus, the bioactive agent is conducted by the hollow tubing from a source to the outer surface of an ePTFE
graft where it is released to diffuse into the graft to influence biological processes along both the inner and outer surfaces of the graft. The present invention allows the bioactive agent or drug to be renewed or changed after implant of the graft. In addition the present invention can be implanted in the same fashion as regular vascular grafts.

Claims (25)

1. A drug delivery graft comprising:
a graft having a lumen and a porous wall; and a hollow tubing having a bore, running along an exterior surface of said graft in fluid communication with said porous wall of said graft, wherein a drug can be infused into said bore of said hollow tubing to penetrate into said lumen of said graft through said porous wall.
2. The drug delivery graft of Claim 1 further comprising a drug source attached to one end of said hollow tubing.
3. The drug delivery graft of Claim 1, wherein said hollow tube is wrapped helically around the outer surface of said graft.
4. The drug delivery graft of Claim 1, wherein said hollow tube is arranged substantially parallel to a longitudinal axis of said graft.
5. The drug delivery graft of Claim 1, wherein said graft comprises ePTFE.
6. The drug delivery graft of Claim 1, wherein said hollow tubing comprises a cutaway portion in contact with said porous wall of said graft.
7. The drug delivery graft of Claim 1, wherein said hollow tubing comprises perforations communicating said bore of said hollow tubing with said porous wall of said graft.
8. The drug delivery graft of Claim 1, wherein said hollow tubing comprises a porous wall allowing fluid communication with said porous wall of said graft.
9. The drug delivery graft of Claim 2, wherein said drug source further comprises a drug delivery pump.
10. The drug delivery graft of Claim 2, wherein said drug is selected to prevent restenosis of a blood vessel.
11. The drug delivery graft of Claim 10, wherein said drug is selected from the group consisting of a growth factor, a growth factor inhibitor, growth factor receptor antagonist, a transcriptional repressor, a translational repressor, an antisense nucleic acid, a replication inhibitor, an anti-microtubule agent, an inhibitory antibody, an antibody directed against a growth factor, a bifunctional molecules comprising a growth factor and a cytotoxin, and a bifunctional molecule comprising an antibody and a cytotoxin.
12. A drug delivery device comprising:
porous graft means for replacing a natural tissue conduit; and hollow tubing means in contact with an outer surface of said porous graft means for delivering a drug to said porous graft means via areas in contact with said porous graft means.
13. The drug delivery device of Claim 12, wherein the hollow tubing means is wrapped helically about said porous graft means.
14. The drug delivery device of Claim 12 further comprising drug infusing means for infusing said drug into said hollow tubing means.
15. The drug delivery device of Claim 12, wherein said areas in communication with said porous graft means comprise a cutaway section.
16. The drug delivery device of Claim 12, wherein said areas in communication with said porous graft means comprise perforations on said hollow tubing means.
17. The drug delivery device of Claim 12, wherein said areas in communication with said porous graft means comprise a porous region on said hollow tubing means.
18. A drug delivery system manufactured by a process comprising the steps of:
providing a porous graft;
providing a small diameter hollow tubing having defined porous areas;
bringing said small diameter hollow tubing into contact with said porous graft such that said defined porous areas are secured against an outer surface of the porous graft; and connecting an end of the small diameter beading to a drug source so that a drug from the drug source enters said small diameter hollow tubing and passes through the porous areas into said porous graft.
19. The drug delivery system of Claim 18, wherein said small diameter hollow tubing is wrapped helically about said porous graft.
20. The drug delivery system of Claim 18, wherein said defined porous areas of said small diameter hollow tubing comprise cut away sections of said small diameter hollow tubing.
21. The drug delivery system of Claim 18, wherein said process further comprises the step of using a cutting device to cut said defined porous areas into said small diameter hollow tubing.
22. The drug delivery system of Claim 18, wherein said defined porous areas of said small diameter hollow tubing further comprise perforations on said small diameter hollow tubing.
23. The drug delivery system of Claim 18, wherein said connecting step further comprises connecting said unsealed end of said small diameter hollow tubing to a drug infusion pump.
24. A method of preventing restenosis of a blood vessel comprising the steps of:
providing a porous graft ;
providing a small diameter hollow tubing in contact with said graft and having a porous region in fluid communication with an outer surface of said porous graft;
connecting an end of said small diameter hollow tubing to an anti-restenosis agent source;
delivering said anti-restenosis agent to said blood vessel via said small diameter hollow tubing and said porous graft.
25. The method of Claim 24, wherein said anti-restenosis agent is selected from the group consisting of a growth factor, a growth factor inhibitor, growth factor receptor antagonist, a transcriptional repressor, a translational repressor, an antisense nucleic acid, a replication inhibitor, an anti-microtubule agent, an inhibitory antibody, an antibody directed against a growth factor, a bifunctional molecules comprising a growth factor and a cytotoxin, and a bifunctional molecule comprising an antibody and a cytotoxin.
CA 2397654 2000-01-20 2001-01-18 Expanded ptfe drug delivery graft Active CA2397654C (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US09488625 US6355063B1 (en) 2000-01-20 2000-01-20 Expanded PTFE drug delivery graft
US09/488,625 2000-01-20
PCT/US2001/002061 WO2001052914A1 (en) 2000-01-20 2001-01-18 Expanded ptfe drug delivery graft

Publications (2)

Publication Number Publication Date
CA2397654A1 true true CA2397654A1 (en) 2001-07-26
CA2397654C CA2397654C (en) 2010-03-16

Family

ID=23940445

Family Applications (1)

Application Number Title Priority Date Filing Date
CA 2397654 Active CA2397654C (en) 2000-01-20 2001-01-18 Expanded ptfe drug delivery graft

Country Status (7)

Country Link
US (2) US6355063B1 (en)
EP (3) EP2301592B1 (en)
JP (1) JP4969752B2 (en)
CA (1) CA2397654C (en)
DE (2) DE60035404T2 (en)
ES (3) ES2550807T3 (en)
WO (1) WO2001052914A1 (en)

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Also Published As

Publication number Publication date Type
ES2642111T3 (en) 2017-11-15 grant
EP1767229B1 (en) 2017-08-16 grant
EP1121945B1 (en) 2007-07-04 grant
JP2003520106A (en) 2003-07-02 application
EP2301592A1 (en) 2011-03-30 application
EP1121945A1 (en) 2001-08-08 application
EP2301592B1 (en) 2015-10-14 grant
CA2397654C (en) 2010-03-16 grant
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