Catheter introducing system

• US 4,960,412 A
• Filed: 04/15/1988
• Issued: 10/02/1990
• Est. Priority Date: 04/15/1988
• Status: Expired due to Fees

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Universal Medical Instrument Corporation
• Inventors: Fink, E. David
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Daley, Kathleen
• Application Number:
  US07/182,138
• Time in Patent Office: 900 Days
• Field of Search: 604/167, 604/169, 604/164, 604/165, 604/168, 604/256, 604/297, 137/230, 137/816, 137/849
• US Class Current: 604/167.04
• CPC Class Codes: A61M 2039/0072 Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0633 the seal being a passive seal made of a resilient material with or without an opening
• CPC Class Codes: A61M 2039/0646 Duckbill-valve
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• CPC Class Codes: A61M 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

A catheter introducer valve assembly of a catheter introducer leading to a blood vessel of a patient for positioning at least one catheter tube through the catheter introducer and its sheath to a blood vessel of a patient. The valve assembly unit has first and second valves, the first valve being for preventing or minimizing the flow of blood from the valve assembly unit when the catheter tube is absent from the catheter introducer and the second valve being for preventing or minimizing the flow of blood when the catheter tube is present in the catheter introducer. The first valve, which is made of a flexible, resilient material, is shaped as a disk having a valve slit, such a duckbill valve, positioned diametrically across the passage of the valve assembly body. The rim surface of the valve disk has a slightly smaller diameter than the diameter of the positioning area of the inner surface of the valve assembly body where the valve disk is located so that a cylindrical space is formed therebetween. A pair of opposed holding bosses connected to the disk rim are located in the cylindrical space transverse to the direction of the valve slit. Pressure against the valve disk by any flow of blood is resisted by the pressure of the holding bosses against the inner surface of the positioning area so that the lips of the valve are kept pressed together to shut off or minimize the flow of blood. Also, the holding bosses help to close the lips of the valve during the withdrawal procedure of the catheter tube from the introducer assembly.

Claims

1. A catheter introducing valve assembly of a catheter introducer including a sheath tube positioning a catheter tube in a blood vessel of a patient, comprising in combination,

a valve assembly including a central passage having opposed inlet and outlet ends, said valve assembly for positioning the catheter tube which is introduced into said valve assembly at said inlet end;

first valve means bearing sealing lips of flexible, resilient material positioned internally across said passage in said valve assembly for sealing off flow of blood during any time the catheter tube is absent from the catheter introducer,

second valve means positioned externally across said passage in said valve assembly and comprising gasket means with an aperture adapted to the diameter of the sheath tube for sealing off flow of blood during the time the catheter tube is positioned in the catheter introducer,

holding means connected to said first valve means and adapted to said valve assembly for keeping said first valve means in a sealed position when the catheter tube is absent,

connector means mounted to said valve assembly at said outlet end for securing the sheath tube to said valve assembly;

said first valve means comprising a first valve body made of a flexible, resilient material, and including a reinforced valve disk having a centrally positioned valve slit extending transversely to said central passage, said valve slit having opposed valve lips; and

said holding means being positioned transversely to said valve slit so as to keep said valve lips together when the catheter tube is absent from the catheter introducer and to close said valve lips during withdrawal of the catheter tube;

and said valve assembly further including a generally cylindrical assembly body having a generally cylindrical compartment area in axial alignment with a central passage having an inner surface, said compartment area having a first diameter;

said reinforced valve disk having a cylindrical disk rim of a second diameter, said second diameter being slightly less than said first diameter, wherein a cylindrical space is defined between said disk rim and said inner surface of said compartment area; and

wherein said holding means includes a pair of diametrically opposed peripheral bosses connected to said disk rim and positioned transversely to said valve slit, said bosses having curved ends conforming to the configuration of and in tight contact with said inner surface of said compartment area, whereby even pressure is exerted against said valve lips, the lips are held together in sealing relationship during the absence of the catheter tube from the catheter tube assembly.

2. The valve assembly according to claim 1, wherein said first valve means comprises a cylindrical positioning ring connected to said first valve means, said positioning ring having a diameter greater than said second diameter, said valve assembly including a cylindrical positioning compartment external to said cylindrical compartment area, said positioning ring being seated in said positioning compartment so as to prevent movement of said first valve means.

3. The valve assembly according to claim 2, wherein said positioning ring is external to said valve disk when seated in the positioning compartment.

4. The valve assembly according to claim 2, wherein said first valve means includes an arced recess which opens toward said inlet end for guiding said catheter tube to said valve slit during the introduction of said catheter tube into said catheter introducer assembly.

5. The valve assembly according to claim 4, wherein said valve disk has opposed inner and outer surfaces facing said outlet and inlet ends, respectively, of said assembly body, said inner end surface being curved in general conformity with said arced recess means so as to define a reinforcing rib diametrically extending to said disk rim in operative association with said pair of bosses.

6. The valve assembly according to claim 2, wherein said inner surface further includes a circumferential ring defined by said valve rim and said arced recess.

7. The valve assembly according to claim 2, wherein said second valve means is positioned in said cylindrical positioning compartment in tight association with and downstream of said first valve body.

8. The valve assembly according to claim 1, wherein said first valve means is a duckbill valve.

9. The valve assembly according to claim 1, wherein said first valve is made of a flexible, resilient material.

10. The valve assembly according to claim 1, wherein said connector means is a flexible connector tube.

11. The valve assembly as in claim 4, wherein the second valve means is in the form of a conical centering gasket.