CA2487796A1 - Implantable product with improved aqueous interface characteristics and method for making and using same - Google Patents

Implantable product with improved aqueous interface characteristics and method for making and using same Download PDF

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Publication number
CA2487796A1
CA2487796A1 CA002487796A CA2487796A CA2487796A1 CA 2487796 A1 CA2487796 A1 CA 2487796A1 CA 002487796 A CA002487796 A CA 002487796A CA 2487796 A CA2487796 A CA 2487796A CA 2487796 A1 CA2487796 A1 CA 2487796A1
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CA
Canada
Prior art keywords
aqueous solution
porous membrane
membrane
pva
seconds
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
CA002487796A
Other languages
French (fr)
Other versions
CA2487796C (en
Inventor
Alonzo D. Cook
Warren J. Cutright
Robert C. Krall
William D. Montgomery
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.)
WL Gore and Associates 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 CA2487796A1 publication Critical patent/CA2487796A1/en
Application granted granted Critical
Publication of CA2487796C publication Critical patent/CA2487796C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

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
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/12—Devices for detecting or locating foreign bodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • 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
    • 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
    • A61L31/18—Materials at least partially X-ray or laser opaque
    • 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
    • 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
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0097—Visible markings, e.g. indicia

Abstract

An implantable medical device including a porous membrane of expanded polytetrafluoroethylene that is treated with a hydrophilic polyvinyl alcohol to render said membrane transparent to technology for viewing inside a mammalian body. These technologies include ultrasound echocardiography and video imaging such as that used during laparoscopic procedures.

Claims (24)

1. A device for implantation comprising a porous membrane supported by a support frame forming an implantable device;
the porous membrane containing a hydrophilic substance adapted to rapidly wet-out the porous membrane upon contact with an aqueous solution.
2. The device of claim 1 wherein the device is configured for cardiovascular implantation.
3. The device of claim 1 wherein wet-out occurs within 5 seconds of immersion in an aqueous solution.
4. The device of claim 3 wherein the aqueous solution comprises DI water.
5. The device of claim 3 wherein the aqueous solution comprises human blood.
6. The device of claim 1 wherein the porous membrane comprises an expanded polytetrafluoroethylene.
7. The device of claim 6 wherein the hydrophilic substance comprises polyvinyl alcohol (PVA).
8. The device of claim 7 wherein the PVA is cross-linked in place.
9. The device of claim 7 wherein wet-out occurs within 5 seconds of immersion in an aqueous solution.
10. The device of claim 1 wherein the hydrophilic substance comprises polyvinyl alcohol (PVA).
11. The device of claim 1 wherein the PVA is cross-linked in place.
12. The device of claim 10 wherein wet-out occurs within 5 seconds of immersion in an aqueous solution.
13. The device of claim 1 wherein the device is configured to serve as a septal defect closure device.
14. The device of claim 1 wherein the device is configured to serve as a stent-graft.
15. The device of claim 1 wherein the device is configured to serve as an embolic filter.
16. The device of claim 1 wherein the device is effectively transparent to ultrasound imaging.
17. An implantable device comprising a porous membrane of expanded polytetrafluoroethylene;
a dry hydrophilic treatment applied to the porous membrane comprising a polyvinyl alcohol that is cross-linked in situ;

wherein the porous membrane wets-out within 5 seconds of exposure to an aqueous solution of DI water so that the porous expanded polytetrafluoroethylene membrane becomes entirely translucent.
18. The device of claim 17 wherein the membrane is attached to a frame.
19. The device of claim 18 wherein the device is configured for cardiovascular implantation.
20. The device of claim 19 wherein the device is configured to serve as a septal defect closure device.
21. The device of claim 17 wherein the membrane contains a barrier layer.
22. The device of claim 21 wherein the barrier layer is impervious to fluid transmission.
23. The device of claim 21 wherein the barrier layer allows transmission of ultrasound.
24
CA2487796A 2002-05-31 2003-05-23 Implantable product with improved aqueous interface characteristics and method for making and using same Expired - Lifetime CA2487796C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/159,836 2002-05-31
US10/159,836 US20030225439A1 (en) 2002-05-31 2002-05-31 Implantable product with improved aqueous interface characteristics and method for making and using same
PCT/US2003/016865 WO2003101505A1 (en) 2002-05-31 2003-05-23 Implantable device with porous membrane rendered hydrophilic

Publications (2)

Publication Number Publication Date
CA2487796A1 true CA2487796A1 (en) 2003-12-11
CA2487796C CA2487796C (en) 2011-04-05

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2487796A Expired - Lifetime CA2487796C (en) 2002-05-31 2003-05-23 Implantable product with improved aqueous interface characteristics and method for making and using same

Country Status (7)

Country Link
US (6) US20030225439A1 (en)
EP (1) EP1511523B1 (en)
JP (1) JP2005527330A (en)
AU (1) AU2003238786A1 (en)
CA (1) CA2487796C (en)
DE (1) DE60336391D1 (en)
WO (1) WO2003101505A1 (en)

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US7871659B2 (en) 2011-01-18
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US20080213463A1 (en) 2008-09-04
CA2487796C (en) 2011-04-05
US20030225439A1 (en) 2003-12-04
JP2005527330A (en) 2005-09-15
AU2003238786A1 (en) 2003-12-19
US20130172980A1 (en) 2013-07-04
EP1511523B1 (en) 2011-03-16
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US20110082536A1 (en) 2011-04-07
DE60336391D1 (en) 2011-04-28

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