Lubricious flow directed catheter

• US 5,538,512 A
• Filed: 07/08/1994
• Issued: 07/23/1996
• Est. Priority Date: 02/25/1993
• Status: Expired due to Term

• Current Assignee: Target Therapeutics, Inc. (Boston Scientific Corporation)
• Original Assignee: Target Therapeutics, Inc. (Boston Scientific Corporation)
• Inventors: Hergenrother, Robert, Chee, Uriel H., Zenzon, Wendy J., Eder, Joseph C.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): VANOVER, PERRY
• Application Number:
  US08/272,209
• Time in Patent Office: 746 Days
• Field of Search: 604/96, 604/53, 604/265, 604/280-282, 604/93, 604/95, 604/264, 128/658
• US Class Current: 604/508
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 29/041 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/14 Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 29/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0125 Catheters carried by the bloodstream, e.g. with parachutes; Balloon catheters specially designed for this purpose

Abstract

This invention relates to infusion catheters that are used in cardiovascular and endovascular procedures to deliver diagnostic, therapeutic or vasoocclusive agents to a target site (the target site being accessible by a tortuous path through the vasculature). In particular, the invention relates to flow-directed catheters which have been coated on their interior or exterior surfaces with a cross-linkable lubricious polymer and to the method of making those catheters. The invention also relates to the process of using the infusion catheter.

Claims

1. A catheter that can be guided by the blood flow within a vessel, said catheter comprising an elongate tubular member having proximal and distal ends, an inner lumen extending between these ends, and an outer surface;

said tubular member comprising a flexible and strong distal segment having a burst pressure of at least about 195 psi and is made of a material which will show a force of about 10⁴ pounds or less when ten centimeters of the material is deflected 10°

from horizontal; and

said tubular member having a polymeric, lubricious coating on at least a portion of the outer surface, which coating has been covalently bonded to the catheter in-situ with irradiation.

2. The catheter of claim 1 wherein at least a portion of the inner lumen is coated with a polymeric, lubricious coating.

3. The catheter of claim 2 wherein the whole of the inner lumen is coated with a polymeric, lubricious coating.

4. The catheter of claim 1 where the whole of the exterior surface of the distal segment is coated with a polymeric, lubricious coating.

5. The catheter of claim 1 in which the coating is a polymer or oligomer comprising monomers selected from at least one of ethylene oxide;

2-vinyl pyridine;

N-vinylpyrrolidone;

polyethylene glycol acrylates, 2-hydroxyethylmethacrylate, glycerylmethacrylate;

acrylic acid and its salts, acrylamide and acrylonitrile;

acrylamidomethylpropane sulfonic acid and its salts;

cellulose, cellulose derivatives such as methyl cellulose ethyl cellulose, carboxymethyl cellulose, cyanoethyl cellulose, cellulose acetate, polysaccharides including amylose, pectin, amylopectin, alginic acid, and cross-linked heparin.

6. The catheter of claim 1 in which the coating is a polymer or oligomer comprising monomers selected from mono-alkoxy polyethylene glycol mono(meth) acrylates, including mono-methoxy triethylene glycol mono (meth) acrylate, mono-methoxy tetraethylene glycol mono (meth) acrylate, polyethylene glycol mono (meth) acrylate.

7. The catheter of claim 1 wherein the burst pressure of the distal segment is between about 195 and 220 psi.

8. The catheter of claim 1 wherein the distal section is made of a material that further will show an additional force of about 10^-5 pounds or less for each 1°

of deflection of the material from horizontal.

9. The catheter of claim 1 additionally comprising a proximal segment which proximal segment is made of a polymeric material selected from the group consisting of nylon, polyvinyl chloride, polyethylene terephthalate or other polyester elastomer or of a polymer outer core with a metallic mesh inner core.

10. The catheter of claim 1 wherein the distal segment is made of a polymeric material selected from the group consisting of polyurethane, a block copolymer of polyamide, polyvinyl chloride, silicone and blends thereof.

11. The catheter of claim 1 wherein the polymeric material of the distal segment is doped with a metallic material selected from the group consisting of barium sulfate, bismuth trioxide, bismuth subcarbonate, tungsten, and tantalum.

12. The catheter of claim 1 additionally comprising a transition section located proximally of said distal section and which transition is made of a polymeric material selected from the group consisting of polyurethane, a block copolymer of polyamide, polyvinyl chloride, and silicone.

13. The catheter of claim 12 wherein the polymeric material of the transition section is doped with a metallic material selected from the group consisting of barium sulfate, bismuth trioxide, bismuth subcarbonate, tungsten, and tantalum.

14. The catheter of claim 1 wherein the distal segment is in an S-shaped configuration.

15. The catheter of claim 1 additionally comprising a guidewire located within the inner lumen.

16. A method for accessing a target site, said method comprising:

(a) inserting a guiding catheter into the vasculature;

(b) inserting the infusion catheter of claim 1 into the guiding catheter; and

(c) pushing the infusion catheter out of the guiding catheter into the vasculature such that the blood flow in the vessel directs the infusion catheter to the target site.

17. The method of claim 16 which further comprises inserting a stylet into the infusion catheter in order to insert the catheter into the guiding catheter and further removing the stylet prior to pushing the infusion catheter out of the guiding catheter and into the vasculature.

18. The method of claim 17 wherein the stylet is a teflon-coated stainless steel stylet.

19. A method for delivering a diagnostic, therapeutic or vasoocclusive agent to a target site within the vasculature, said method comprising:

(a) inserting a guiding catheter into the vasculature;

(b) inserting the infusion catheter of claim 1 into the guiding catheter;

(c) pushing the infusion catheter out of the guiding catheter into the vasculature such that the blood flow in the vasculature directs the infusion catheter to the target site; and

(d) injecting the diagnostic, therapeutic or vasoocclusive agent through the catheter lumen and into the target site.

20. The method of claim 19 which further comprises inserting a stylet into the infusion catheter in order to insert the catheter into the guiding catheter and further removing the stylet prior to pushing the infusion catheter out of the guiding catheter and into the vasculature.

21. The method of claim 19 wherein the vasoocclusive agent is n-butylcyanoacrylate and the target site is an arteriovenous malformation.

22. The method of claim 19 wherein the vasoocclusive agent is polyvinylacetate dissolved in dimethylsulfoxide and the target site is an arteriovenous malformation.

23. The method of claim 19 wherein the vasoocclusive agent is a vasoocclusive coil.