Microcidal agent releasing catheter with balloon

• US 5,269,770 A
• Filed: 03/13/1992
• Issued: 12/14/1993
• Est. Priority Date: 01/10/1990
• Status: Expired due to Fees

• Current Assignee: Rochester Medical Corporation (Becton, Dickinson & Co)
• Original Assignee: Rochester Medical Corporation (Becton, Dickinson & Co)
• Inventors: Conway, Anthony J., Fryar, Richard D. Jr., Conway, Philip J.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US07/851,983
• Time in Patent Office: 641 Days
• Field of Search: 604/51, 604/54, 604/55, 604/93, 604/96, 604/112, 604/264, 604/265, 604/270, 604/280, 604/282, 427/2
• US Class Current: 604/265
• CPC Class Codes: A61M 2025/0056 provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
• CPC Class Codes: A61M 2025/0062 having features to improve the sliding of one part within another by using lubricants or surfaces with low friction
• 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 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/1036 Making parts for balloon catheter systems, e.g. shafts or distal ends A61M25/1029 takes precedence

Abstract

An elongated catheter having an interior and an exterior surface, wherein the interior surface defines a lumen passing through the catheter. The catheter further including an enclosed cavity between the interior and exterior surfaces which encircles of the lumen. The cavity having an inner wall and an outer wall, the outer wall being a resilient sleeve which can stretch generally independently of the inner wall. The cavity containing an amount of a suitable lubricating substance effective to permit the resilient sleeve to slide along an outer surface of the inner wall while in lubricated contact therewith when stretched independently of the inner wall and including a bactericidal agent, wherein the inner wall and the outer wall are joined together at distal end proximal ends of the enclosed cavity. The resilient sleeve includes a plurality of micropores which permit the bactericidal agent to diffuse into suitable aqueous environments. An automated method for producing the same, including a series of automated dipping steps, is also disclosed. A "Foley" catheter having a balloon portion and a lubricated resilient sleeve, as disclosed above, is also disclosed, as are methods for manufacturing the same.

Claims

1. An elongated catheter comprising an interior surface and an exterior surface, said interior surfaces defining a first lumen passing through said catheter, said catheter further including an enclosed cavity between said interior and exterior surfaces which encircles a portion of said first lumen, said cavity having an inner wall and an outer wall, said outer wall being a resilient sleeve which can stretch generally independently of said inner wall, said cavity containing a bactericidal agent in a carrier substance, wherein the inner wall and the outer wall are joined together at distal and proximal ends of said cavity, and wherein said resilient sleeve includes diffusion permitting means for permitting said bactericidal agent to diffuse out of said cavity when said sleeve is in an aqueous environment, and wherein the volume of the sleeve cavity is sufficient to increase a diameter of the elongated catheter at least about five percent, wherein said catheter further includes a second lumen, an inflatable balloon and a balloon cavity, the second lumen communicating with the balloon cavity, wherein fluid can pass into the balloon cavity from the second lumen so as to inflate the inflatable balloon.

2. The elongated catheter of claim 1 wherein said diffusion permitting means include a plurality of micropores in said resilient sleeve.

3. The elongated catheter of claim 2 wherein said catheter is a "Foley" catheter including self-retaining means for retention of a portion of said catheter within a bladder communicating with a urethral tract of an individual requiring catheterization, said retention means including an expandable balloon portion.

4. The elongated catheter of claim 2 wherein the bactericidal agent is an antibiotic.

5. The elongated catheter of claim 4 wherein the antibiotic is selecting from the group consisting of nitrofurantoin, sulfamethoxazole, trimethoprim and mixtures thereof.

6. The elongated catheters of claim 4 wherein the carrier substance is selected from the group consisting of petrolatum, polyvinyl alcohol lubricating gels, water-soluble soaps and water-soluble bulking agents.

7. An elongated catheter comprising a tube having an inner and outer surface, said inner surface defining a first lumen, said catheter further including an enclosed sleeve cavity and an overcoat layer including resilient sleeve portion encircling the outer surface of the tube, wherein the overcoat layer is fixed to the outer surface at distal and proximal ends of the sleeve cavity, wherein the sleeve cavity is defined by the sleeve portion and a sleeve area of the outer surface proximate the sleeve portion, wherein the sleeve cavity contains a carrier substance including a bactericidal agent, and wherein the volume of the sleeve cavity is sufficient to increase a diameter of the elongated catheter at least about five percent, wherein said catheter further includes a second lumen, an inflatable balloon and a balloon cavity, the second lumen communicating with the balloon cavity, wherein fluid can pass into the balloon cavity from the second lumen so as to inflate the inflatable balloon.

8. The elongated catheter of claim 7 wherein the carrier substance is also a lubricating substance effective to permit said resilient sleeve portion to slide along, and with respect to, the sleeve area of the outer surface while in lubricated contact therewith and when stretched independently thereof, and wherein the lubricating substance is effective to permit respective polymeric surfaces to slide generally evenly with respect to one another when in lubricated contact with each other.

9. The elongated catheter of claim 8 wherein the lubricating substance is selected from the group consisting of petrolatum, polyvinyl alcohol containing water-soluble gels, and water-soluble soaps.

10. The elongated catheter of claim 9 wherein the bactericidal agent is an antibiotic selected from the group consisting nitrofurantoin, sulfamethoxazole, trimethoprim and mixtures thereof.

11. An elongated Foley catheter for insertion into a person'"'"'s body, said elongated catheter having first and second lumens and an expandable retention balloon encircling an expandable balloon cavity, said second lumen communicating with the balloon cavity, said elongated catheter made by a process comprising the steps of:

(a) providing a tube having an inner surface and an outer surface, said inner surface defining a first lumen;

(b) coating a first portion of the outer surface with an amount of a lubricating substance effective to generally prevent bonding tot he first portion of the outer surface and to form a coating of lubricating substance thereon, said lubricating substances including a bactericidal agent effective to reduce bacterial growth in aqueous environments;

(c) coating a second portion of the outer surface and the coating of lubricating substance with a resilient polymeric bonding composition such that a resilient polymeric overcoat layer including a retention balloon is created, wherein a first segment of the overcoat layer proximate the coating of lubricating substance on the first portion of the outer surface forms a resilient sleeve which cooperates with the first portion of the outer surface define an enclosed sleeve cavity, wherein the coating of lubricating substance is contained in the sleeve cavity, and wherein the resilient sleeve can move generally independently of the first portion of the outer surface, wherein the lubricating substance is effective to permit the resilient sleeve to slide along the first portion of the outer surface while in lubricated contact therewith and when stretched independently thereof; and

(d) creating a plurality of micropore in the resilient outer sleeve which permit said bactericidal agent to diffuse out said cavity when said sleeve is in an aqueous environment.

12. The elongated catheter of claim 11 made by a process further comprising the step of stripping the lubricating substance from a third portion of the outer surface following step (b) and prior to step (c), wherein the step of coating the first portion also includes coating the third portion of the outer surface with said lubricating substance, wherein the second and third portions of the outer surface are opposite one another on either side of the first portion thereof, and wherein said overcoat layer created in step (c) is fixed to the outer surface proximate the second and third portions of the outer surface on opposite sides of the sleeve cavity.

13. An elongated catheter for insertion into an internal mammalian passageway, said elongated catheter comprising a tube having an inner and outer surface, said inner surface defining a first lumen, said catheter further comprising a cushioned sleeve wherein the cushioned sleeve includes a resilient sleeve portion and an enclosed sleeve cavity, both of which encircle the outer surface of the tube, wherein the resilient sleeve portion is joined to the outer surface at distal and proximal ends of the sleeve cavity and the sleeve cavity is defined by the sleeve portion and a sleeve area of the outer surface of the tube proximate the sleeve portion, the cushioned sleeve further including a displaceable carrier substance within said sleeve cavity, wherein the sleeve cavity of the cushioned contains an amount of displaceable carrier substance sufficient to enable the cushioned sleeve to deform outwardly along any radius from a central axis of the catheter at least about five percent, wherein said catheter further includes a second lumen, an inflatable balloon and a balloon cavity, the second lumen communicating with the balloon cavity, wherein fluid can pass into the balloon cavity from the second lumen so as to inflate the inflatable balloon.

14. The elongated catheter of claim 13, wherein said catheter further includes a second lumen, an inflatable balloon and a balloon cavity, the second lumen communicating with the balloon cavity, wherein fluid can pass into the balloon cavity from the second lumen so as to inflate the inflatable balloon.

15. The elongated catheter of claim 13 further comprising diffusion permitting means for permitting said bactericidal agent to diffuse out of said sleeve cavity when the cushioned sleeve is in an aqueous environment.

16. The elongated catheter of claim 15 wherein said diffusion permitting means include a plurality of micropores in said resilient sleeve portion.

17. The elongated catheter of claim 15 wherein the bactericidal agent is an antibiotic.

18. The elongated catheter of claim 17 wherein the antibiotic is selected from the group consisting of nitrofurantoin, sulfamethoxazole, trimethoprim and mixtures thereof.

19. An elongated catheter comprising an interior surface and an exterior surface, said interior surface defining a first lumen passing through said catheter, said catheter further including an enclosed sleeve cavity between said interior and exterior surfaces which encircles a portion of said first lumen, said sleeve cavity having an inner wall and an outer wall, said outer wall being a resilient sleeve which can stretch generally independently of said inner wall, said sleeve cavity containing a bactericidal agent in a carrier substance, wherein the inner wall and the outer wall are joined together at distal and proximal ends of said sleeve cavity, and wherein said resilient sleeve includes diffusion permitting means for permitting said bactericidal agent to diffuse out of said cavity when said sleeve is in an aqueous environment;

said catheter further including a second lumen, an inflatable balloon and a balloon cavity, the second lumen communicating with the balloon cavity, wherein fluid can pass into the balloon cavity from the second lumen so as to inflate the inflatable balloon.

20. An elongated catheter comprising a tube having an inner and outer surface, said inner surface defining a first lumen, said catheter further including an enclosed sleeve cavity and an overcoat layer including a resilient sleeve portion encircling the outer surface of the tube, wherein the overcoat layer is fixed to the outer surface at distal and proximal ends of the sleeve cavity, wherein the sleeve cavity is defined by the sleeve portion and a sleeve area of the outer surface proximate the sleeve portion, wherein the sleeve cavity contains a carrier substance including a bactericidal agent;

said catheter further including a second lumen, an inflatable balloon and a balloon cavity, the second lumen communicating with the balloon cavity, wherein fluid can pass into the balloon cavity from the second lumen so as to inflate the inflatable balloon.

21. An elongated catheter for insertion into an internal mammalian passageway, said elongated catheter comprising a tube having an inner and outer surface, said inner surface defining a first lumen, said catheter further comprising a cushioned sleeve, the cushioned sleeve including a resilient sleeve portion and an enclosed sleeve cavity which encircle the outer surface of the tube, wherein the resilient sleeve portion is joined to the outer surface at distal and proximal ends of the sleeve cavity and the sleeve cavity is defined by the sleeve portion and a sleeve area of the outer surface of the tube proximate the sleeve portion, the cushioned sleeve further including a displaceable carrier substance within said sleeve cavity, the carrier substance including a bactericidal agent, the sleeve cavity of the cushioned sleeve containing an amount of displaceable carrier substance sufficient to enable the cushioned sleeve to deform outwardly along any radius form a central axis of the catheter at least about five percent;

said catheter further including a second lumen, an inflatable balloon and a balloon cavity, the second lumen communicating with the balloon cavity, wherein fluid can pass into the balloon cavity from the second lumen so as to inflate the inflatable balloon.

22. The elongated catheter of claim 21 further comprising diffusion permitting means for permitting said bactericidal agent to diffuse out of said sleeve cavity when the cushioned sleeve is in an aqueous environment.

23. The elongated catheter of claim 22 wherein said diffusion permitting means include a plurality of micropores in said resilient sleeve portion.

24. The elongated catheter of claim 23 wherein the bactericidal agent is an antibiotic.

25. The elongated catheter of claim 24 wherein the antibiotic is selected from the group consisting of nitrofurantoin, sulfamethoxazole, trimethoprim and mixtures thereof.

26. The elongated catheter of claim 25 wherein the carrier substance is selected from the group consisting of petrolatum, polyvinyl alcohol lubricating gels, water-soluble soaps and water-soluble bulking agents.