Bidirectional check valve catheter

• US 5,112,301 A
• Filed: 06/19/1991
• Issued: 05/12/1992
• Est. Priority Date: 06/19/1991
• Status: Expired due to Term

• Current Assignee: AngioDynamics, Inc., Rita Medical Systems Incorporated (AngioDynamics, Inc.)
• Original Assignee: Strata Medical Incorporated
• Inventors: Gorman, William J., Fenton, Paul V. Jr., Young, Thomas M.
• Primary Examiner(s): WEHNER, CARY ELLEN
• Application Number:
  US07/717,618
• Time in Patent Office: 328 Days
• Field of Search: 604/30, 604/31, 604/34, 604/35, 604/169, 604/246, 604/247, 604/93, 604/119, 604/320, 137/493, 137/493.7, 251/343, 251/344
• US Class Current: 604/30
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 2025/0076 Unidirectional valves
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

Abstract

A valved catheter is disclosed having an elongated, flexible tubular element defining a lumen extending along an axis substantially parallel to the central axis of the tubular element, and a bidirectional check valve assembly near its distal end which controls fluid flow in the tubular element. The valve assembly includes an aspiration valve offset from the tip of the distal end and an infusion valve formed at the tip of the distal end. The aspiration valve is generally defined by port(s) in the tubular element and a sleeve within the element underlying the ports, where the sleeve normally closes the ports. The aspiration valve permits fluid flow from the bloodstream into the element when the static fluid pressure inside the distal end is lower than the static fluid pressure outside the aspiration valve by an amount sufficient to displace the sleeve to allow fluid flow through the ports. The infusion valve includes a throat formed in the distal end which tapers down to a mouth formed by jaws at the tip. The mouth is essentially closed to fluid inflow from the patient into the tubular element and normally closed to fluid outflow from the tubular element into the patient. The infusion valve permits fluid infusion into the bloodstream when the static fluid pressure inside of the tubular element sidtal end is higher than the static fluid pressure outside of the infusion valve by an amount sufficient to force the mouth open. A bidirectionally valved multiple lumen catheter is also disclosed.

Claims

1. A bidirectionally valved catheter comprising:

at least one elongated, flexible tubular element defining a lumen extending along an axis substantially parallel to the central axis of said tubular element and adapted for selective flow of fluid therein between a proximal end and a distal end of said tubular element, and

a first bidirectional check valve assembly coupled to said lumen and disposed near said distal end of said tubular element, said valve assembly including an aspiration valve for fluid inflow from outside to inside said tubular element and an infusion valve for fluid outflow from inside to outside said tubular element, said aspiration valve including a sleeve valve positioned near said distal end, and said infusion valve including a slit valve at said distal end.

2. The catheter of claim 1 wherein said distal end terminates in a distal tip and wherein said aspiration valve comprises:

A. one or more inflow ports extending through the sidewall of said tubular element near said distal end and displaced from the distal tip of said catheter; and

B. a flexible, tubular sleeve disposed within said tubular element and having an outer surface normally flush against the inner surface of said tubular element in the portion of said tubular element bearing said inflow ports,

whereby substantially no fluid may flow through said inflow ports, and wherein a portion of said sleeve is displaceable to permit fluid inflow through said ports when the static pressure outside of said ports is higher than the static pressure inside said tubular element by an amount sufficient to force a portion of said sleeve away from the portion of said interior wall of said tubular element bearing at least one of said inflow ports, and

wherein said infusion valve comprises;

a flexible valve section defining a tapered interior region contiguous to said lumen and extending from the tip of said distal end and terminating in a normally closed slit formed by opposed edges of said valve section whereby substantially no fluid may flow between said opposed edges, and wherein said opposed edges are displaceable in opposite directions to permit fluid outflow between said opposed edges when the static pressure inside said tapered interior region is higher than the static pressure outside said tip of said distal end by an amount sufficient to displace said opposed edges away from each other.

3. The catheter of claim 2 wherein said valve section is formed by an integral extension of the distal end of said tubular element.

4. The catheter of claim 2 wherein said valve section is formed by an integral extension of said sleeve.

5. The catheter of claim 2 wherein the cross-section of said distal end of said lumen is substantially circular.

6. The catheter of claim 2 wherein the cross-section of said distal end of said lumen is non-circular.

7. The catheter of claim 6 wherein said cross-section is substantially D-shaped.

8. The catheter of claim 2 wherein said valve assembly is nominally disposed to prevent fluid flow in the tubular element when there is substantially no fluid pressure differential across the infusion valve and the aspiration valve.

9. The catheter of claim 2 further comprising at least one additional lumen extending along an axis substantially parallel to said central axis wherein at least one of said additional lumens includes an additional bidirectional check valve assembly coupled thereto.

10. The catheter of claim 9 wherein said additional bidirectional check valve assembly is substantially similar to said first bidirectional check valve assembly.

11. A multiple lumen, bidirectionally valved catheter comprising:

an elongated flexible tubular element defining a plurality of lumens extending along axes substantially parallel to the central axis of said tubular element and adapted for selective flow of fluid therein between a proximal end and a distal end of said tubular element, and

a plurality of bidirectional check valve assemblies, each of said assemblies being associated with one of said lumens and including an aspiration valve for fluid inflow from outside said tubular element to inside said associated lumen and an infusion valve for fluid outflow from inside said associated lumen to outside said tubular element, and being coupled to said associated lumen and disposed near said distal end of said tubular element, wherein for one or more of said valve assemblies, said aspiration valve including a sleeve valve positioned near said distal end, and said infusion valve including a slit valve at said distal end.

12. The catheter of claim 11 wherein said distal end terminates in a distal tip and wherein said aspiration valve comprises:

A. one or more inflow ports extending through the sidewall of said tubular element to its associated lumen near said distal end and displaced from the distal tip of said catheter; and

B. a flexible, tubular sleeve disposed within said tubular element and having an outer surface normally flush against the inner surface of said its associated lumen of said tubular element in the portion of said tubular element bearing said inflow ports whereby substantially no fluid may flow through said inflow ports, and wherein a portion of said sleeve is displaceable to permit fluid inflow through said ports when the static pressure outside of said ports is higher than the static pressure inside said tubular element by an amount sufficient to force a portion of said sleeve away from the portion of said interior wall of said tubular element bearing at least one of said inflow ports, and said infusion valve comprises;

a flexible valve section defining a tapered interior region contiguous to its associated lumen and extending from the tip of said distal end and terminating in a normally closed slit formed by opposed edges of said valve section whereby substantially no fluid may flow between said opposed edges, and wherein said opposed edges are displaceable in opposite directions to permit fluid outflow between said opposed edges when the static pressure inside said tapered interior region is higher than the static pressure outside said tip of said distal end by an amount sufficient to displace said opposed edges away from each other.