CA2397654A1 - Expanded ptfe drug delivery graft - Google Patents

Expanded ptfe drug delivery graft Download PDF

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Publication number
CA2397654A1
CA2397654A1 CA002397654A CA2397654A CA2397654A1 CA 2397654 A1 CA2397654 A1 CA 2397654A1 CA 002397654 A CA002397654 A CA 002397654A CA 2397654 A CA2397654 A CA 2397654A CA 2397654 A1 CA2397654 A1 CA 2397654A1
Authority
CA
Canada
Prior art keywords
graft
porous
drug delivery
hollow tubing
drug
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
CA002397654A
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
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 CA2397654A1 publication Critical patent/CA2397654A1/en
Application granted granted Critical
Publication of CA2397654C publication Critical patent/CA2397654C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

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
    • A61L31/14—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
    • 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
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L31/04—Macromolecular materials
    • A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • 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
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • 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
    • 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

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.
CA2397654A 2000-01-20 2001-01-18 Expanded ptfe drug delivery graft Expired - Lifetime CA2397654C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/488,625 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 CA2397654A1 (en) 2001-07-26
CA2397654C CA2397654C (en) 2010-03-16

Family

ID=23940445

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2397654A Expired - Lifetime CA2397654C (en) 2000-01-20 2001-01-18 Expanded ptfe drug delivery graft

Country Status (8)

Country Link
US (2) US6355063B1 (en)
EP (3) EP2301592B1 (en)
JP (1) JP4969752B2 (en)
CA (1) CA2397654C (en)
DE (1) DE60035404T2 (en)
ES (3) ES2642111T3 (en)
MX (1) MXPA02007107A (en)
WO (1) WO2001052914A1 (en)

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EP1121945A1 (en) 2001-08-08
DE60035404T2 (en) 2008-03-06
US20020091440A1 (en) 2002-07-11
EP1767229A2 (en) 2007-03-28
EP1767229A3 (en) 2011-03-30
US6355063B1 (en) 2002-03-12
EP2301592B1 (en) 2015-10-14
MXPA02007107A (en) 2003-01-28
WO2001052914A1 (en) 2001-07-26
EP1767229B1 (en) 2017-08-16
JP2003520106A (en) 2003-07-02
JP4969752B2 (en) 2012-07-04
ES2550807T3 (en) 2015-11-12
EP2301592A1 (en) 2011-03-30
CA2397654C (en) 2010-03-16
DE60035404D1 (en) 2007-08-16
EP1121945B1 (en) 2007-07-04
ES2288462T3 (en) 2008-01-16
ES2642111T3 (en) 2017-11-15

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