Title of Invention	A PROCESS FOR MAKING A LUBRICIOUS MEDICAL DEVICE
Abstract	The present invention relates to a process for making a lubricious medical device capable of being detected by magnetic resonance imaging, said process being conducted in the absence of plasma etching and comprising: (a) contacting a surface of the device with (i) a binder polymer; and (ii) a hydrophilic polymer selected from the group consisting of poly(N-vinyl lactams), polysaccharides, polyacrylates, poly(acrylic acid), polyacrylamides, polyalkylene oxides, and copolymers and mixtures thereof; said binder polymer having functionality to promote bonding of the hydrophilic polymer to the medical device substrate, and (b) contacting the surface with a magnetic susceptible agent to cause the surface of the medical device to be detectable by magnetic resonance imaging

Title of Invention

A PROCESS FOR MAKING A LUBRICIOUS MEDICAL DEVICE

Abstract

The present invention relates to a process for making a lubricious medical device capable of being detected by magnetic resonance imaging, said process being conducted in the absence of plasma etching and comprising: (a) contacting a surface of the device with (i) a binder polymer; and (ii) a hydrophilic polymer selected from the group consisting of poly(N-vinyl lactams), polysaccharides, polyacrylates, poly(acrylic acid), polyacrylamides, polyalkylene oxides, and copolymers and mixtures thereof; said binder polymer having functionality to promote bonding of the hydrophilic polymer to the medical device substrate, and (b) contacting the surface with a magnetic susceptible agent to cause the surface of the medical device to be detectable by magnetic resonance imaging

Full Text	The present invention relates to a process for making a lubricious medical device and the device. The device can be detected by magnetic resonance imaging. A variety of lubricious coatings have been proposed for use on the surfaces of medical devices such as, for example, catheters, guide wires, endotracheal tubes and implants. Common materials used in the art to provide lubricious coatings for medical devices include, for example, oil, silicone, and polymeric materials, such as poly(N-vinylpyrrolidone), hydrophilic polyurethanes, Teflon, poly(ethylene oxide) and poly(acrylic acid). Among the most common materials used to provide lubricious coatings are hydrophilic polymers which are covalently bonded to the substrate with a binder polymer having reactive functional groups, e.g., isocyanate, aldehyde, and epoxy groups. Other binder polymers comprise, for example, copolymers containing a vinyl moiety. Details of such coatings are disclosed, for example, in U.S. Patent Nos. 5,091,205 issued February 25, 1992 and 5,731,087 issued March 24, 1998. Medical device coatings that are visible in magnetic resonance imaging (MRI) provide the opportunity to use magnetic resonance to perform therapeutic procedures. The possible uses of image guided therapy otherwise known as interventional MR are extensive. Examples of these applications include monitoring ultrasound and laser ablations, guiding the placement of biopsy needles, endovascular therapy, and visualizing disease, such as tumors, inter-operatively. WE CLAIM: 1. A process for making a lubricious medical device capable of being detected by magnetic resonance imaging, said process being conducted in the absence of plasma etching and comprising: (a) contacting a surface of the device with (i) a binder polymer; and (ii) a hydrophilic polymer selected from the group consisting of poly(N-vinyl lactams), polysaccharides, polyacrylates, poly(acrylic acid), polyacrylamides, polyalkylene oxides, and copolymers and mixtures thereof; said binder polymer having functionality to promote bonding of the hydrophilic polymer to the medical device substrate , and (b) contacting the surface with a magnetic susceptible agent to cause the surface of the medical device to be detectable by magnetic resonance imaging. 2. The process as claimed in claim 1 wherein the surface is contacted with a first liquid medium comprising the binder polymer and subsequently contacted with a second liquid medium comprising the hydrophilic polymer. 3. The process as claimed in claim 2 wherein it comprises drying the surface prior to contacting with the second liquid medium. 4. The process as claimed in claim 2 wherein the magnetic susceptible agent is comprised in at least one of the first liquid medium or the second liquid medium. 5. The process as claimed in claim 2 wherein it comprises contacting the surface with a third liquid medium comprising the magnetic susceptible agent. 6. The process as claimed in claim 1 wherein the surface is contacted with a common liquid medium comprising the binder polymer and the hydrophilic polymer, and optionally the magnetic susceptible agent. 7. The process as claimed in claim 6 wherein it comprises drying the surface after contacting with the common liquid medium. 8. The process as claimed in claim 1 wherein the magnetic susceptible agent is imbibed into the surface of the medical device. 9. The process as claimed in claim 1 wherein the magnetic susceptible agent has a paramagnetic ion. 10. The process as claimed in claim 9 wherein the magnetic susceptible agent has a paramagnetic ion selected from the group consisting of iron, manganese, chromium, cobalt, nickel and gadolinium. 11. The process as claimed in claim 10 wherein the magnetic susceptible agent is an organometallic complex. 12. The process as claimed in claim 11 wherein the magnetic susceptible agent is selected from the group consisting of diethylenetriamine-pentaacetic acid gadolinium (III) dihydrogen salt, tetrazacyclododecane tetraacetic acid gadolinium complex, tetrazacyclotetradecane tetraacetic acid gadolinium complex, and mixtures thereof. 13. The process as claimed in claim 1 wherein the magnetic susceptible agent is selected from the group consisting of superparamagnetic particles and iodine containing contrast agents. 14. The process as claimed in claim 1 wherein the substrate is selected from the group consisting of polyurethane, polyvinyl chloride, polyacrylate, polycarbonate, polystyrene, polyester resins, polybutadiene-styrene copolymers, nylon, polyethylene, polypropylene, polybutylene, silicon, polyvinyl acetate, polymethacrylate, polysulfone, polyisoprene, and copolymers thereof, glass, metal, ceramic and mixtures thereof. 15. The process as claimed in claim 1 wherein the hydrophilic polymer is selected from the group consisting of poly(N-vinyl pyrrolidone), poly(N-vinyl pyrrolidone) copolymers, carboxymethylcellulose, polyacrylic acid, cationically-modified hydroxyethylcellulose, polyethylene oxides, polyacrylamides and copolymers and mixtures thereof. 16. The process as claimed in claim 15 wherein the binder polymer comprises an isocyanate, aldehyde, epoxy, vinyl or carboxylic acid moiety. 17. A process for making a lubricious medical device comprising a molded element capable for being detected by magnetic resonance imaging, said process being conducted in the absence of plasma etching and comprising extruding a polymer in the presence of a magnetic susceptible agent to form the molded element; said molded element having a surface which is detectable by magnetic resonance imaging, and contacting a surface of the molded element with (i) a binder polymer; and (ii) a hydrophilic polymer selected from the group consisting of poly(N-vinyl lactams), polysaccharides, poiyacrylates, poly(acrylic acid), polyacrylamides, polyalkylene oxides, and copolymers and mixtures thereof; said binder polymer having functionality to promote bonding of the hydrophilic polymer to the medical device substrate. 18. A medical device capable of being detected by magnetic resonance imaging and obtainable by the process according to any of claims 1 to 17, said device comprising: (a) a polymeric substrate having a matrix with (i) an internal region comprising a substrate polymer; and (ii) an outer surface; and (b) a layer of a hydrophilic polymer affixed to the outer surface by a binder polymer, said hydrophilic polymer being selected from the group consisting of poly(N-vinyl lactams), polysaccharides, polyacrylates, poly(acrylic acid), polyacrylamides, polyalkylene oxides, and copolymers and mixtures thereof, and said binder polymer having functionality to promote bonding of the hydrophilic polymer to the medical device substrate, wherein at least one of the polymeric substrate or the hydrophilic polymer comprises a magnetic susceptible agent detectable by magnetic resonance imaging. 19. The medical device as claimed in claim 18 wherein hydrophilic polymer layer comprises the magnetic susceptible agent. 20. The medical device as claimed in claim 18 wherein the polymeric substrate comprises the magnetic susceptible agent.

Full Text

The present invention relates to a process for making a lubricious medical device and the device. The device can be detected by magnetic resonance imaging.
A variety of lubricious coatings have been proposed for use on the surfaces of medical devices such as, for example, catheters, guide wires, endotracheal tubes and implants. Common materials used in the art to provide lubricious coatings for medical devices include, for example, oil, silicone, and polymeric materials, such as poly(N-vinylpyrrolidone), hydrophilic polyurethanes, Teflon, poly(ethylene oxide) and poly(acrylic acid). Among the most common materials used to provide lubricious coatings are hydrophilic polymers which are covalently bonded to the substrate with a binder polymer having reactive functional groups, e.g., isocyanate, aldehyde, and epoxy groups. Other binder polymers comprise, for example, copolymers containing a vinyl moiety. Details of such coatings are disclosed, for example, in U.S. Patent Nos. 5,091,205 issued February 25, 1992 and 5,731,087 issued March 24, 1998.
Medical device coatings that are visible in magnetic resonance imaging (MRI) provide the opportunity to use magnetic resonance to perform therapeutic procedures. The possible uses of image guided therapy otherwise known as interventional MR are extensive. Examples of these applications include monitoring ultrasound and laser ablations, guiding the placement of biopsy needles, endovascular therapy, and visualizing disease, such as tumors, inter-operatively.

WE CLAIM:
1. A process for making a lubricious medical device capable of being detected by
magnetic resonance imaging, said process being conducted in the absence of plasma
etching and comprising:
(a) contacting a surface of the device with (i) a binder polymer; and (ii) a hydrophilic polymer selected from the group consisting of poly(N-vinyl lactams), polysaccharides, polyacrylates, poly(acrylic acid), polyacrylamides, polyalkylene oxides, and copolymers and mixtures thereof; said binder polymer having functionality to promote bonding of the hydrophilic polymer to the medical device substrate , and
(b) contacting the surface with a magnetic susceptible agent to cause the surface of the medical device to be detectable by magnetic resonance imaging.

2. The process as claimed in claim 1 wherein the surface is contacted with a first liquid medium comprising the binder polymer and subsequently contacted with a second liquid medium comprising the hydrophilic polymer.
3. The process as claimed in claim 2 wherein it comprises drying the surface prior to contacting with the second liquid medium.
4. The process as claimed in claim 2 wherein the magnetic susceptible agent is comprised in at least one of the first liquid medium or the second liquid medium.
5. The process as claimed in claim 2 wherein it comprises contacting the surface with a third liquid medium comprising the magnetic susceptible agent.

6. The process as claimed in claim 1 wherein the surface is contacted with a common liquid medium comprising the binder polymer and the hydrophilic polymer, and optionally the magnetic susceptible agent.
7. The process as claimed in claim 6 wherein it comprises drying the surface after contacting with the common liquid medium.
8. The process as claimed in claim 1 wherein the magnetic susceptible agent is imbibed into the surface of the medical device.
9. The process as claimed in claim 1 wherein the magnetic susceptible agent has a paramagnetic ion.

10. The process as claimed in claim 9 wherein the magnetic susceptible agent has a paramagnetic ion selected from the group consisting of iron, manganese, chromium, cobalt, nickel and gadolinium.
11. The process as claimed in claim 10 wherein the magnetic susceptible agent is an organometallic complex.
12. The process as claimed in claim 11 wherein the magnetic susceptible agent is selected from the group consisting of diethylenetriamine-pentaacetic acid gadolinium (III) dihydrogen salt, tetrazacyclododecane tetraacetic acid gadolinium complex, tetrazacyclotetradecane tetraacetic acid gadolinium complex, and mixtures thereof.
13. The process as claimed in claim 1 wherein the magnetic susceptible agent is selected from the group consisting of superparamagnetic particles and iodine containing contrast agents.

14. The process as claimed in claim 1 wherein the substrate is selected from the group consisting of polyurethane, polyvinyl chloride, polyacrylate, polycarbonate, polystyrene, polyester resins, polybutadiene-styrene copolymers, nylon, polyethylene, polypropylene, polybutylene, silicon, polyvinyl acetate, polymethacrylate, polysulfone, polyisoprene, and copolymers thereof, glass, metal, ceramic and mixtures thereof.
15. The process as claimed in claim 1 wherein the hydrophilic polymer is selected from the group consisting of poly(N-vinyl pyrrolidone), poly(N-vinyl pyrrolidone) copolymers, carboxymethylcellulose, polyacrylic acid, cationically-modified hydroxyethylcellulose, polyethylene oxides, polyacrylamides and copolymers and mixtures thereof.
16. The process as claimed in claim 15 wherein the binder polymer comprises an isocyanate, aldehyde, epoxy, vinyl or carboxylic acid moiety.
17. A process for making a lubricious medical device comprising a molded element capable for being detected by magnetic resonance imaging, said process being conducted in the absence of plasma etching and comprising extruding a polymer in the presence of a magnetic susceptible agent to form the molded element; said molded element having a surface which is detectable by magnetic resonance imaging, and contacting a surface of the molded element with (i) a binder polymer; and (ii) a hydrophilic polymer selected from the group consisting of poly(N-vinyl lactams), polysaccharides, poiyacrylates, poly(acrylic acid), polyacrylamides, polyalkylene oxides, and copolymers and mixtures thereof; said binder polymer having functionality to promote bonding of the hydrophilic polymer to the medical device substrate.

18. A medical device capable of being detected by magnetic resonance imaging and
obtainable by the process according to any of claims 1 to 17, said device comprising:
(a) a polymeric substrate having a matrix with (i) an internal region comprising a
substrate polymer; and (ii) an outer surface; and (b) a layer of a hydrophilic polymer
affixed to the outer surface by a binder polymer, said hydrophilic polymer being
selected from the group consisting of poly(N-vinyl lactams), polysaccharides,
polyacrylates, poly(acrylic acid), polyacrylamides, polyalkylene oxides, and
copolymers and mixtures thereof, and said binder polymer having functionality to
promote bonding of the hydrophilic polymer to the medical device substrate, wherein
at least one of the polymeric substrate or the hydrophilic polymer comprises a
magnetic susceptible agent detectable by magnetic resonance imaging.
19. The medical device as claimed in claim 18 wherein hydrophilic polymer layer
comprises the magnetic susceptible agent.
20. The medical device as claimed in claim 18 wherein the polymeric substrate
comprises the magnetic susceptible agent.

Documents:

351-chenp-2003-abstract.pdf

351-chenp-2003-assignement.pdf

351-chenp-2003-claims dublicate.pdf

351-chenp-2003-claims original.pdf

351-chenp-2003-correspondnece-others.pdf

351-chenp-2003-correspondnece-po.pdf

351-chenp-2003-description(complete) dublicate.pdf

351-chenp-2003-description(complete) original.pdf

351-chenp-2003-drawings.pdf

351-chenp-2003-form 1.pdf

351-chenp-2003-form 18.pdf

351-chenp-2003-form 26.pdf

351-chenp-2003-form 3.pdf

351-chenp-2003-form 5.pdf

351-chenp-2003-form 6.pdf

351-chenp-2003-pct.pdf

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Patent Number

204316

Indian Patent Application Number

351/CHENP/2003

PG Journal Number

26/2007

Publication Date

29-Jun-2007

Grant Date

13-Feb-2007

Date of Filing

07-Mar-2003

Name of Patentee

M/S. DOW GLOBAL TECHNOLOGIES INC

Applicant Address

WASHINGTON ST, 1790 BUILDING, MIDLAND, MICHIGAN 48674

Inventors:

#	Inventor's Name	Inventor's Address
1	SCHACHTER, Deborah	136 Washington Avenue Edison, NJ 08817
2	FAN, You-Ling	33 Quail Run Warren, NJ 07059
3	RUTAR, Venceslav	5 Stratford Place Flemington, NJ 08822

PCT International Classification Number

A61L29/18

PCT International Application Number

PCT/US01/12458

PCT International Filing date

2001-04-17

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1	60/231,601	2000-09-11	U.S.A.