Catheter having lubricated outer sleeve and methods for making and using same

• US 5,098,379 A
• Filed: 03/01/1990
• Issued: 03/24/1992
• Est. Priority Date: 01/10/1990
• Status: Expired due to Term

• 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 J.
• Application Number:
  US07/487,422
• Time in Patent Office: 754 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: 604/523
• 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 coatings A61M2025/0046
• 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, wherein the inner wall and the outer wall are joined together at distal end proximal ends of the enclosed cavity. 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 surface 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 enclosed 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 enclosed cavity containing an amount of a suitable lubricating substance effective to permit said sleeve to slide along an outer surface of the inner wall while in lubricated contact therewith when stretched independently of said inner wall, wherein the inner wall and the outer wall are joined together at distal and proximal ends of said enclosed cavity;

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.

2. The elongated catheter of claim 1 wherein the inner wall has a greater thickness than the outer wall.

3. The elongated catheter of claim 2 wherein said catheter is made of a flexible elastomeric material, and wherein the lubricating substance is enclosed within the cavity.

4. The elongated catheter of claim 3 wherein the outer wall is easier to stretch than the inner wall.

5. The elongated catheter of claim 1 wherein the lubricating substance is any biocompatible lubricating substance which is effective to permit respective polymeric surfaces to slide generally evenly with respect to one another when in lubricated contact with each other.

6. The elongated catheter of claim 5 wherein the lubricating substance is petrolatum.

7. An elongated catheter comprising an interior surface defining a first lumen, an expandable balloon having an expandable balloon cavity a second lumen in communication with the expandable balloon cavity, an exterior surface, and an enclosed sleeve cavity located between the respective interior and exterior surfaces and encircling the first lumen in a position removed from the expandable balloon cavity, said catheter further comprising a resilient sleeve portion encircling the first lumen and said sleeve cavity, said sleeve cavity containing a lubricating substance.

8. The elongated catheter of claim 7 wherein the lubricating substance is any biocompatible lubricating substance which 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 petrolatum.

10. An elongated catheter comprising a tube having an inner surface and an outer surface, said inner surface defining a first lumen, said catheter further comprising 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 an enclosed sleeve cavity defined by an interior surface of the sleeve portion and a sleeve area of the outer surface proximate the sleeve portion, wherein the sleeve cavity contains 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, said elongated catheter further comprising a second lumen and a inflatable balloon portion removed from the sleeve portion, said balloon portion including an expandable balloon cavity in communication with said second lumen.

11. The elongated catheter of claim 10 wherein the lubricating substance is any biocompatible lubricating substance which is effective to permit respective polymeric surfaces to slide generally evenly with respect to one another when in lubricated contact with each other.

12. The elongated catheter of claim 11 wherein the lubricating substance is petrolatum.

13. An elongated catheter comprising a tube and an overcoat layer, said tube having an inner surface and an outer surface, said inner surface defining a first lumen, said overcoat layer including a resilient sleeve encircling the outer surface of the tube proximate a first portion of the outer surface, said overcoat layer being fixed to said outer surface proximate second and third portions of said outer surface which are located opposite one another in respect to and on either side of said first portion, said resilient sleeve of said overcoat layer and said first portion of said outer surface cooperating to define a sleeve cavity, wherein the sleeves cavity contains a lubricating substance effective to permit said resilient sleeve to slide along and in respect said first portion of the outer surface while in lubricated contact therewith and when stretched independently thereof;

said tube having a second lumen and a first lumen access opening in a fourth portion of said outer surface removed from the first portion thereof, said overcoat layer further including a resilient balloon proximate said fourth portion, wherein said balloon and said fourth portion of the outer surface cooperate to define a balloon cavity, wherein said balloon cavity communicates with said first lumen via said first lumen access opening, and wherein said overcoat layer is fixed to said outer surface proximate a fifth portion of said outer surface, wherein said fifth portion and said third portion of the outer surface are located opposite one another in respect to and on either side of said fourth portion.

14. The elongated catheter of claim 13 wherein the lubricating substance is any biocompatible lubricating substance which is effective to permit respective polymeric surfaces to slide generally evenly with respect to one another when in lubricated contact with each other.

15. The elongated catheter of claim 14 wherein the lubricating substance is petrolatum.

16. 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 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 inner and outer walls being provided with friction reducing means for reducing friction between surfaces of the inner and outer wall which cooperate to define the cavity, wherein said friction reducing means are effective to permit surfaces of said inner and outer walls to slide evenly with respect to one another when contacting each other, wherein the inner wall and outer wall are jointed together at distal and proximal ends of said cavity, 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.

17. The elongated catheter of claim 16 wherein the inner wall has a greater thickness than the outer wall.

18. The elongated catheter of claim 17, said friction reducing means including a suitable lubricating substance effective to permit said sleeve to slide along an outer surface of the inner wall while in lubricated contact therewith when stretched independently of said inner wall.

19. The elongated catheter of claim 18 wherein the lubricating substance is any biocompatible lubricating substance which is effective to permit respective polymeric surfaces to slide generally evenly with respect to one another when in lubricated contact with each other.

20. The elongated catheter of claim 19 wherein the lubricating substance is petrolatum.

21. 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 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 substance which is effective to provide for a separation between said inner wall and said outer wall and cushion the outer wall from impacting against the inner wall, where as the cavity has a volume which can increase the outside diameter of the catheter proximate the sleeve at least about 10 percent over the outside diameter of the catheter if the cavity was empty, 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. A method of catheterizing a person having an internal passageway defined by internal walls within the person'"'"'s body, said method comprising the steps of:

(a) providing an elongated catheter including an interior surface and an exterior surface, said interior surface defining a lumen passing through said catheter, said catheter further including an enclosed cavity between said interior and exterior surfaces which encircles a portion of said 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, wherein the cavity contains an amount of an appropriate substance which is sufficient to provide a separation between the inner wall and the outer wall; and

(b) inserting the catheter into the passageway such that a portion of the exterior surface proximate the sleeve is in contact with at least one internal wall, and wherein the inner wall can move within the passageway without moving the portion of the exterior surface of the catheter proximate the sleeve in contact with the at least one internal wall.

23. A method of catheterizing a person having an internal passageway defined by internal walls within the person'"'"'s body, said method comprising the steps of:

(a) providing an elongated catheter including an interior surface and an exterior surface, said interior surface defining a lumen passing through said catheter, said catheter further including an enclosed cavity between said interior and exterior surfaces which encircles a portion of said lumen, said cavity having an inner wall and an outer wall, wherein the outer wall is a conformable sleeve having a surface which generally conforms to surfaces of the adjacent inner wall with which it comes into contact, wherein the cavity contains an amount of an appropriate, displaceable substance which is sufficient to provide a separation between the inner wall and the outer wall which cushions the inner wall from impacts on the outer wall; and

(b) inserting the catheter into the passageway such that a portion of the exterior surface proximate the sleeve is in contact with at least one internal wall.

24. An elongated catheter comprising a tube and an overcoat layer, said tube having an inner surface and an outer surface, said inner surface defining a first lumen, said overcoat layer including a resilient sleeve encircling the outer surface of the tube proximate a first portion of the outer surface, said overcoat layer being fixed to said outer surface proximate second and third portions of said outer surface which are located opposite one another in respect to and on either side of said first portion, said resilient sleeve of said overcoat layer and said first portion of said outer surface cooperating to define an enclosed sleeve cavity, wherein the sleeve cavity contains a complaint substance which allows the resilient sleeve to conform to adjacent surfaces with which it comes into contact and permits said resilient sleeve to slide along and in respect said first portion of the outer surface while in lubricated contact therewith and when stretched independently thereof;

said tube having a second lumen and a first lumen access opening in a further portion of said outer surface removed from the first portion thereof, said overcoat layer further including a resilient balloon proximate said fourth portion, wherein said balloon and said fourth portion of the outer surface cooperate to define a balloon cavity, wherein said balloon cavity communicates with said first lumen via said first lumen access opening, and wherein said overcoat layer is fixed to said outer surface proximate a fifth portion of said outer surface, wherein said fifth portion and said third portion of the outer surface are located opposite one another in respect to and on either side of said fourth portion.

25. The elongated catheter of claim 24, wherein the compliant substance is a lubricating substance effective to permit said resilient sleeve to slide along and in respect said first portion of the outer surface while in lubricated contact therewith.

26. The elongated catheter of claim 25, wherein the lubricating substance is petrolatum.

27. An elongated catheter comprising an interior surface defining a first lumen, a second lumen in communication with an expandable balloon cavity, an exterior surface, and an enclosed sleeve cavity located between the respective interior and exterior surfaces and encircling the first lumen in a position removed from the balloon cavity, said catheter further comprising a resilient sleeve portion encircling the first lumen and said sleeve cavity and an expandable balloon portion encircling the expandable balloon cavity and located in a position removed from said sleeve portion and contiguous with an outer surface of the resilient sleeve portion, and said sleeve cavity containing a compliant substance which allows the resilient sleeve portion to conform to adjacent surfaces with which it comes into contact.

28. The elongated catheter of claim 27 wherein the compliant substance is a biocompatible lubricating substance which is effective to permit the resilient sleeve portion to slide along, and with respect to, said inner wall while in lubricated contact therewith.

29. The elongated catheter of claim 28 wherein the biocompatible lubricating substance is petrolatum.