EP1233724A4 - Flexible sealed coil-like devices - Google Patents
Flexible sealed coil-like devicesInfo
- Publication number
- EP1233724A4 EP1233724A4 EP00978657A EP00978657A EP1233724A4 EP 1233724 A4 EP1233724 A4 EP 1233724A4 EP 00978657 A EP00978657 A EP 00978657A EP 00978657 A EP00978657 A EP 00978657A EP 1233724 A4 EP1233724 A4 EP 1233724A4
- Authority
- EP
- European Patent Office
- Prior art keywords
- coating
- covering
- cyclohexanone
- group
- ethanol
- 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.)
- Withdrawn
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
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
- A61L29/16—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
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/08—Materials for coatings
-
- 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
- A61L29/08—Materials for coatings
- A61L29/085—Macromolecular materials
-
- 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
-
- 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
- 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
- A61F2/07—Stent-grafts
- A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
-
- 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
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/606—Coatings
Definitions
- the present invention relates to insertable medical devices with modified surface
- vascular and other stents are also examples of insertable medical devices.
- the typical vascular stent configuration includes metal screen-like scaffolds which are inserted in a
- U.S. Patent No. 5,383,928 issued to Scott et al. describes a stent which is at least partially covered with a sleeve which contains one or more drugs, and which removably
- Thin coatings of TEFLON ® also have been used on coil guide wires. Although such
- coatings can be flexible, they require baking at very high temperatures ( ⁇ 370°C), and adhering
- the present invention comprises a medical device comprising an insertable substrate, an elastic polymeric covering adherent to the substrate, and a polymeric coating adherent to
- the covering such that the coating and covering possess desirable surface characteristics
- devices include but are not limited to guide wires, forceps, trochars, stents and catheters.
- polymeric covering and coating is designed to be sufficiently flexible to allow the substrate
- the substrate may be a relatively rigid structure such as a vascular stent, in which case the flexible polymeric covering and coating is designed to be capable of
- the covering and coating are designed to provide a lubricious surface.
- Other devices require non-lubricious surfaces in order to ensure that they remain in place once inserted.
- the coating is designed to provide such a non -lubricious surface.
- invention contemplates a stent design which has a flexible elastic plastic coating permanently
- the coating expands with the stent and retains its integrity
- the substrate can be composed of a variety
- suitable coatings preferably include a variety of
- hydrogels comprising one or more components selected from the group consisting of polyvinylpyrrolidone, epoxy resin, acrylic polymer, acrylic resin, and aliphatic polyisocyanate.
- a binding layer or precoat can be applied to the substrate to enhance the binding
- Such precoats can contain polymers including but not limited
- these coatings can be any coatings which enhance adhesion onto substrates.
- these coatings can be any coatings which enhance adhesion onto substrates.
- these coatings can be any coatings which enhance adhesion onto substrates.
- crosslinking agents including but not limited to melamine resins, isocyanates,
- agents such as antibiotics, anticoagulants, antiplatelet agents, antineoplastic agents, anti-oxidants
- angiogenic agents and angiogenic agents are incorporated into the coating.
- angiogenic agents and angiogenic agents are incorporated into the coating.
- the coating may contain one or more drugs to, for example, prevent thrombus formation
- the present invention also includes a method of modifying the surface properties of
- the invention also incorporates physiologically or
- insertable medical devices is dependent to varying degrees on the surface properties of the
- a surface that is lubricious can permit the easier, safer and less uncomfortable
- a device that has a non-lubricious surface can be more securely fixed in a desired location, providing added safety and ease of use, and the inclusion
- Such modifications include, but are not limited to, stylets, guide wires, flexible forceps used
- the present invention provides a surface to such medical devices such that improved
- the medical devices can be provided to such medical devices.
- the medical devices are configured to provide surface characteristics to such medical devices.
- contemplated in this invention comprise a substrate, a covering and a coating.
- the substrate is a substrate, a covering and a coating.
- the substrate is
- Such a substrate often has physical
- the polymeric covering is
- adherent to the substrate surface is flexible, such that it can be bent and flexed repeatedly
- the covering preferably is elastic, and able to
- the covering preferably is elastic and flexible when applied to devices such as endoscopic forceps or guide wires.
- the covering can be applied in one or
- Covering the polymeric covering is a polymeric coating, which provides the desired
- the coating can be of the same composition as
- the covering or can be of a different composition.
- the coating also has the properties of flexibility and elasticity, and optionally can be hydrophobic, hydrophilic or of intermediate
- the coating can be applied with one or more layers which may have the same or different composition, is one layer thick or optionally can be several layers thick. Together,
- the covering and the coating are preferably less than 100 ⁇ m thick, and more preferably less
- the polymeric covering and coating preferably are sufficiently flexible so
- the flexible polymeric layer(s) preferably also are
- the coating and covering preferably are applied to the substrate optionally by
- Coating preferably is performed optionally by spraying or by
- the stent comprises a rigid but expandable framework.
- coating and covering of the present invention preferably is sufficiently adherent, flexible and elastic such that when the stent is expanded, the coating and covering forms an adherent sheath that is attached to the struts of the stent and stretches between them, providing a greatly
- coating is non-lubricious, aiding in maintaining the stent in a desired location once the stent
- agents include, but are not
- antibiotics include antibiotics, anticoagulants, anti-platelet agents, antineoplastic agents, thrombogenic
- one or more bonding layers can be used as a primer for the substrate
- the bonding layers preferably are less than
- the substrate of the device can be composed of a variety of materials. Examples include, but are not limited to, metals such as titanium, silver, gold, platinum, aluminum,
- chromium chromium, stainless steel or tantalum, and shape memory materials, including but not limited
- nickel/titanium alloys copper/zinc alloys, and nickel/aluminum alloys.
- Other examples are possible.
- polymeric materials including but not limited to biodegradable materials such as
- polyurethanes silicones, polyamides, polyimides, cellulose esters, cellulose ethers,
- Examples of compounds that are used for the covering include but are not limited to
- polyurethane polyvinyl acetals, acrylate polymers and copolymers, vinyl acetate polymers and
- the covering is comprised of a hybrid polymer mixture, an example of which includes, but is not limited to, polyurethane
- the covering is applied by dipping the covering
- the concentration of the polyurethane polymer is from about 10% to about 30% w/w.
- covering preferably is oven cured such as at about 85°C for from about 30 minutes to about
- a bonding layer can be applied to the substrate as a precoat before the
- a prefe ⁇ ed layer that can be used comprises a composition comprising
- cyclohexanone from about 3% to about 4% w/w polyurethane resin, from about 2.5 % to
- the coating layer of the present invention is preferably a hydrogel.
- used to form the hydrogel preferably comprise a mixture of at least one and more preferably
- At least two, components selected from the group consisting of ethanol, polyvinylpyrrolidone, benzyl alcohol, cyclohexanone, tetrahydrofuran, xylene, epoxy resin, acrylic resin or polymer,
- a prefe ⁇ ed hydrogel composition comprises from about 10% to about
- Another prefe ⁇ ed composition comprises from about 10%> to about 20%> w/w ethanol, from
- tetrahydroafuran from about 2% to about 3% w/w xylene, from about 0.5% to about 1.5%>
- hydrogel composition comprises from about 35%> to about 45%> w/w ethanol, from about 20%
- One embodiment of the present invention incorporates physiologic and/or
- the coating comprises an outer layer comprised of a composition comprised of
- tetrahydrofuran from about 12% to about 20% w/w cyclohexanone, from about 10% to about
- the present invention includes a method of providing desirable surface properties to
- the method comprises applying one or more layers of the
- compositions disclosed herein to the substrate surface in order to provide the appropriate surface for the function of the medical device.
- Epotuf 38-505 (Reichold, Research Triangle Park, NC) is an epoxy resin.
- Paraloid ® AT-63 (Rohm and Haas, Co., Philadelphia, PA) is a crosslinkable acrylic polymer
- the sample was tested for adhesion under both wet and dry conditions.
- the sample was dipped in Genti an Violet, Huckers Gram Stain Solution [(CH 3 ) 2 NC 6 H 4 ] 2 C:C 6 H 4 :N(CH 3 ) 2 C1; VWR, West Chester, PA , Cat No. VW3567-1] for 5 - 10
- the tape was easy to see visually because it was stained with the blue dye.
- the tape was
- the coating passed the wet and dry adhesion tests.
- the sample was lubricious when wet.
- the coated sample was oven dried at 85°C for about 60 minutes, and tested as
- Example 1 The sample was very flexible and the coating passed the wet and dry adhesion tests. The sample was lubricious when wet.
- the coated sample was oven cured for about one hour at 75 °C.
- the sample then was
- Example 4 tested as described n Example 1. The sample and passed the wet and dry adhesion tests. The sample was moderately lubricious when wet. Example 4
- a stainless steel mandril was dipped in the precoat solution below for 20 seconds.
- coated sample was dried for about 45 minutes at 75°C.
- Paraloid ® AT-746 (Rohm and Haas, Co., Philadelphia, PA) is a crosslinkable acrylic polymer
- Example 3 was coated over the polyurethane layers as described in Example 1. The sample
- Example 5 was tested as described in Example 1 , and exhibited good flexibility and good wet and dry adhesion, and showed moderate wet lubricity.
- Example 3 The sample was cured at 65 °C for 20 minutes after each coating
- Example 2 The sample was dipped in the following hydrogel solution using the method of Example 1 :
- Paclitaxel 1.0 %(w/w)
- HBAC Benzalkonium heparinate
- the sample was oven dried for one hour at 75°C.
- the sample passed the wet and dry
- Example 4 As in Example 4, The sample was oven dried for 20 minutes at 60°C after each coating
- the sample was oven dried for one hour at 75 °C.
- the sample was tested for adhesion
- a stainless steel madril was dipped in a Precoat having the following composition for 20 seconds and then withdrawn at 30 mm/second.
- Example 6 solution of Example 6 was coated over the polyurethane layers as described in Example 6.
- Example 2 The sample was tested as described in Example 1 and was flexible and had good wet and dry adhesion. The sample was moderately lubricious when wet.
Abstract
Description
Claims
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US44289199A | 1999-11-18 | 1999-11-18 | |
US442891 | 1999-11-18 | ||
PCT/US2000/031314 WO2001036008A2 (en) | 1999-11-18 | 2000-11-15 | Medical devices coated with elastic polymeric material |
Publications (2)
Publication Number | Publication Date |
---|---|
EP1233724A2 EP1233724A2 (en) | 2002-08-28 |
EP1233724A4 true EP1233724A4 (en) | 2004-03-10 |
Family
ID=23758557
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP00978657A Withdrawn EP1233724A4 (en) | 1999-11-18 | 2000-11-15 | Flexible sealed coil-like devices |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP1233724A4 (en) |
AU (1) | AU1609701A (en) |
WO (1) | WO2001036008A2 (en) |
Families Citing this family (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES2278747T3 (en) | 2000-04-11 | 2007-08-16 | Polyzenix Gmbh | POLY-TRI-FLUORO-ETOXIPOLIFOSFACENO FILMS TO COVER MEDICAL DEVICES. |
US9080146B2 (en) | 2001-01-11 | 2015-07-14 | Celonova Biosciences, Inc. | Substrates containing polyphosphazene as matrices and substrates containing polyphosphazene with a micro-structured surface |
DE10202467A1 (en) * | 2002-01-23 | 2003-07-24 | Polyzenix Gmbh | Device, useful as an artificial implant, comprises a substrate based on nitinol having at least a partial coating of a phosphazene polymer. |
US7771468B2 (en) | 2001-03-16 | 2010-08-10 | Angiotech Biocoatings Corp. | Medicated stent having multi-layer polymer coating |
ATE340551T1 (en) | 2001-08-17 | 2006-10-15 | Polyzenix Gmbh | DEVICE BASED ON NITINOL WITH POLYPHOSPHAZENE COVER |
US20040111144A1 (en) * | 2002-12-06 | 2004-06-10 | Lawin Laurie R. | Barriers for polymeric coatings |
US9114162B2 (en) | 2004-10-25 | 2015-08-25 | Celonova Biosciences, Inc. | Loadable polymeric particles for enhanced imaging in clinical applications and methods of preparing and using the same |
US20210299056A9 (en) | 2004-10-25 | 2021-09-30 | Varian Medical Systems, Inc. | Color-Coded Polymeric Particles of Predetermined Size for Therapeutic and/or Diagnostic Applications and Related Methods |
US9107850B2 (en) | 2004-10-25 | 2015-08-18 | Celonova Biosciences, Inc. | Color-coded and sized loadable polymeric particles for therapeutic and/or diagnostic applications and methods of preparing and using the same |
PT2089071E (en) | 2006-10-10 | 2012-03-09 | Celonova Biosciences Inc | Bioprosthetic heart valve with polyphosphazene |
EP3984568A1 (en) | 2016-07-14 | 2022-04-20 | Hollister Incorporated | Hygienic medical devices having hydrophilic coatings and methods of forming the same |
CN110180038A (en) * | 2019-06-21 | 2019-08-30 | 西南大学 | Has the kirsite vascular stent material of drug slow release function superhigh-flexibility coating |
CN110694118A (en) * | 2019-09-23 | 2020-01-17 | 江苏理工学院 | Antibacterial and anticoagulant ventricles and abdominocentesis shunt tube silica gel tube body and preparation method and application thereof |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0379156A2 (en) * | 1989-01-17 | 1990-07-25 | UNION CARBIDE CHEMICALS AND PLASTICS COMPANY INC. (a New York corporation) | Improved hydrophilic lubricious coatings |
EP0380102A1 (en) * | 1989-01-26 | 1990-08-01 | Advanced Cardiovascular Systems, Inc. | Vascular catheter with durable lubricious coating |
EP0592320A2 (en) * | 1992-10-09 | 1994-04-13 | Terumo Kabushiki Kaisha | Catheter balloon for vasodilation |
US5772609A (en) * | 1993-05-11 | 1998-06-30 | Target Therapeutics, Inc. | Guidewire with variable flexibility due to polymeric coatings |
DE19713214A1 (en) * | 1997-03-28 | 1998-12-10 | Ruebben Alexander Dr Med | Covered stent, e.g. for treating vascular stenosis or aneurysms |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5464650A (en) * | 1993-04-26 | 1995-11-07 | Medtronic, Inc. | Intravascular stent and method |
US5804318A (en) * | 1995-10-26 | 1998-09-08 | Corvita Corporation | Lubricious hydrogel surface modification |
-
2000
- 2000-11-15 AU AU16097/01A patent/AU1609701A/en not_active Abandoned
- 2000-11-15 WO PCT/US2000/031314 patent/WO2001036008A2/en not_active Application Discontinuation
- 2000-11-15 EP EP00978657A patent/EP1233724A4/en not_active Withdrawn
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0379156A2 (en) * | 1989-01-17 | 1990-07-25 | UNION CARBIDE CHEMICALS AND PLASTICS COMPANY INC. (a New York corporation) | Improved hydrophilic lubricious coatings |
EP0380102A1 (en) * | 1989-01-26 | 1990-08-01 | Advanced Cardiovascular Systems, Inc. | Vascular catheter with durable lubricious coating |
EP0592320A2 (en) * | 1992-10-09 | 1994-04-13 | Terumo Kabushiki Kaisha | Catheter balloon for vasodilation |
US5772609A (en) * | 1993-05-11 | 1998-06-30 | Target Therapeutics, Inc. | Guidewire with variable flexibility due to polymeric coatings |
DE19713214A1 (en) * | 1997-03-28 | 1998-12-10 | Ruebben Alexander Dr Med | Covered stent, e.g. for treating vascular stenosis or aneurysms |
Non-Patent Citations (1)
Title |
---|
See also references of WO0136008A3 * |
Also Published As
Publication number | Publication date |
---|---|
AU1609701A (en) | 2001-05-30 |
WO2001036008A3 (en) | 2001-12-13 |
WO2001036008A2 (en) | 2001-05-25 |
EP1233724A2 (en) | 2002-08-28 |
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Legal Events
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Inventor name: WHITBOURNE, RICHARD, J. Inventor name: COPENHAGEN, DONALD M. Inventor name: HULLIHEN, DANIEL, G., JR. Inventor name: SCHOTT, RACHEL, L. |
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A4 | Supplementary search report drawn up and despatched |
Effective date: 20040127 |
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Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN |
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