Y-adaptor manifold with pinch valve for an intravascular catheter

• US 5,395,352 A
• Filed: 01/21/1994
• Issued: 03/07/1995
• Est. Priority Date: 02/24/1992
• Status: Expired due to Term

• Current Assignee: Medline Industries Incorporated (Medline Holdings Incorporated)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Penny, William H.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Bockelman, Mark
• Application Number:
  US08/184,888
• Time in Patent Office: 410 Days
• Field of Search: 604/9, 604/30, 604/34, 604/82, 604/83, 604/86, 604/247, 604/250, 604/256, 604/283-284, 604/905, 604/167, 604/169, 251/4, 251/342, 137/606
• US Class Current: 604/256
• 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 25/1025 Connections between catheter tubes and inflation tubes
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence
• CPC Class Codes: Y10T 137/87684 Valve in each inlet

Abstract

A Y-adaptor manifold assembly includes a main tubular segment adapted to be coupled to an intravascular catheter. A first, tubular side port is joined to the main tubular segment so as to be in fluid communication with a through passage of the main tubular member. The first side port forms an infusion port for radiopaque dye. A second, tubular side port is joined to the main tubular segment so as to be in fluid communication with a through passage of the main tubular member. The second side port and main tubular segment are adapted to receive dilatation catheters. To prevent backbleeding, the second side port and main tubular segment include passive hemostatic valve mechanisms. Each valve mechanism includes a valve member and a disk valve. The valve member has a normally closed, sealed state, an open state and an in-use sealed state. The valve member has an inherent tendency to move to its normally closed, sealed state or its in-use state (wherein the valve member conforms about the dilatation catheter). Application of a compressive radial force moves the valve member to its open state.

Claims

1. A Y-adaptor manifold assembly for use with an intravascular catheter, the manifold assembly comprising:

a body member including;

a main tubular segment having a distal end, a proximal end and a through passage extending between the distal and proximal ends, the distal end of the main tubular segment being adapted to be joined to an intravascular catheter so that the through passage of the main tubular segment is arranged to be in fluid communication with a through lumen of the intravascular catheter;

a valve mechanism having a frame with distal end and a proximal end with the distal end thereof fixed to the proximal end of the main tubular segment with the valve mechanism extending outwardly from the proximal end of the main tubular segment, the valve mechanism including;

a flexible valve member fixed within the valve mechanism frame and having a longitudinal slit defined by opposed sealing wall portions, the sealing wall portions having a normally closed, sealed state that prevents a fluid medium from passing out of the through passage of the main tubular segment through the proximal end thereof, and an open state wherein a medical device can be inserted into the through passage of the main tubular segment through the longitudinal slit of the valve member, the sealing wall portions being movable from the normally closed, sealed state to the open state by way of a pair of opposed, compressive radial force components that are simultaneously applied to the valve member in opposed directions substantially perpendicular to a longitudinal extent of the longitudinal slit; and

a flexible tubular sleeve extending between and fixed within the distal end and the proximal end of the valve mechanism frame with the sleeve extending about the valve member,

wherein the frame of the valve mechanism is configured and arranged to support the valve member and the sleeve and to permit access to the sleeve for application of the opposed radial force components to the valve member through the sleeve; and

a tubular side port joined to the main tubular segment proximally of the distal end of the main tubular segment, the side port having a through passage in fluid communication with the through passage of the main tubular segment.

2. The Y-adaptor manifold assembly of claim 1 wherein the sealing wall portions have an in-use sealed state wherein the sealing wall portions of the longitudinal slit conform about the medical device and a fluid medium is prevented from passing out of the through passageway of the main tubular segment through the proximal end thereof, the sealing wall portions being movable from the open state to the in-use sealed state by removing the compressive radial force components from the valve member and allowing the sealing wall portions to conform about the medical device due to the inherent tendency of the sealing wall portions to move towards their normally closed, sealed state.

3. The Y-adaptor manifold assembly of claim 1, and further including:

a disk valve fixed within the proximal end of the valve mechanism frame proximal to the valve member, the disk valve having a through aperture wherein upon insertion of the medical device into the through passage of the main tubular segment, the medical device passes first through the through aperture of the disk valve before the medical device passes through the valve member in its open state.

4. The Y-adaptor manifold assembly of claim 3 wherein the disk valve has a funnel portion that directs the medical device into the through aperture of the disk valve.

5. The Y-adaptor manifold assembly of claim 1 wherein the valve mechanism frame further includes:

a first annular ring defining the distal end of the valve mechanism and joined to the proximal end of the main tubular segment; and

a second annular ring spaced from and coupled to the first annular ring, the second annular ring defining the proximal end of the valve mechanism and being configured to support the valve member, wherein a distal end of the sleeve is fixed within the first annular ring of the valve mechanism frame and a proximal end of the sleeve is fixed within the second annular ring of the valve mechanism frame.

6. The Y-adaptor manifold assembly of claim 5 wherein the valve mechanism frame further includes a pair of rigid support members joining the second annular ring to the first annular ring, the pair of support members defining a pair of oppositely directed windows to allow the opposed compressive force components to be applied to the valve member through the tubular sleeve.

7. The Y-adaptor manifold assembly of claim 6, and further including:

a disk valve positioned within the second annular ring and proximal to the valve member, the disk valve having a through aperture wherein upon insertion of the medical device into the main tubular segment the medical device passes first through the through aperture of the disk valve before the medical device passes through the valve member in its open state.

8. A Y-adaptor manifold assembly for use with an intravascular guide catheter configured to be introduced into a vascular system of a patient, the manifold assembly comprising:

a body member including;

a main tubular segment having a distal end, a proximal end and a through passage extending between the distal and proximal ends, the distal end of the main tubular segment being adapted to be joined to an intravascular guide catheter so that the through passage of the main tubular segment is arranged to be in fluid communication with a through lumen of the intravascular guide catheter;

a first side port tubular segment having a distal end and a proximal end, the distal end thereof joined to the main tubular segment, the first side port having a through passage in fluid communication with the through passage of the main tubular segment;

a second tubular side port joined to the main tubular segment, the second side port having a through passage in fluid communication with the through passage of the main tubular segment; and

a first valve mechanism having an elongate tubular frame with a distal end and a proximal end, the distal end Of the first valve mechanism frame being fixed to and extending outwardly from the proximal end of the main tubular segment and a second valve mechanism having an elongate tubular frame with a distal end and a proximal end, the distal end of the second valve mechanism frame being fixed to and extending outwardly from the proximal end of the first side port tubular segment, each of the first and the second valve mechanism frames defining a pair of windows and each of the first and second valve mechanisms including;

a flexible valve member fixed within each respective valve mechanism frame and having a longitudinal slit defined by opposed sealing wall portions, the sealing wall portions having a normally closed, sealed state that prevents backbleeding out of the respective through passage, and an open state wherein a medical device can be inserted into the respective through passage through the longitudinal slit of the valve member, the sealing wall portions being movable from the normally closed, sealed state to the open state by way of a pair of opposed, compressive radial force components that are simultaneously applied to the valve member in opposed directions substantially perpendicular to a longitudinal extent of the longitudinal slit; and

a flexible tubular sleeve extending between and fixed within the distal end and the proximal ends of each respective valve mechanism frame with the sleeve extending about the respective valve member, the windows of each respective valve mechanism frame permitting access to each respective sleeve so that the compressive radial force components can be applied to the respective valve member through the respective tubular sleeve.

9. The Y-adaptor manifold assembly of claim 8 wherein the first and second side ports are oriented at an acute angle relative to a longitudinal axis of the main tubular segment.

10. The Y-adaptor manifold assembly of claim 9 wherein the first side port is oriented at an angle between ten and twenty five degrees with respect to the longitudinal axis of the main tubular segment.

11. The Y-adaptor manifold assembly of claim 10 wherein the first side port is oriented at an angle of fifteen degrees with respect to the longitudinal axis of the main tubular segment.

12. The Y-adaptor manifold assembly of claim 9 wherein the second side port is oriented at an angle of thirty degrees with respect to the longitudinal axis of the main tubular segment.

13. The Y-adaptor manifold assembly of claim 8 wherein the sealing wall portions have an in-use sealed state wherein the sealing wall portions of the longitudinal slit conform about the medical device inserted through the slit so as to prevent backbleeding out of the through passage, the sealing wall portions being movable from the open state to the in-use sealed state by removing the compressive radial force components from the valve member and allowing the sealing wall portions to conform about the inserted medical device due to the inherent tendency of the sealing wall portions to move towards their normally closed, sealed state.

14. The Y-adaptor manifold assembly of claim 8 wherein each of the first and the second valve mechanism frames further includes:

a first annular ring defining the distal end of each valve mechanism frame and joined to the proximal end of the respective tubular segment; and

a second annular ring spaced from and coupled to the first annular ring, the second annular ring defining the proximal end of each valve mechanism frame and being configured to support the respective valve member, wherein a distal end of each respective sleeve is fixed within the first annular ring of each respective valve mechanism frame and a proximal end of each respective sleeve is fixed within the second annular ring of each respective valve mechanism frame.

15. The Y-adaptor manifold assembly of claim 14 wherein each valve mechanism frame further includes a pair of rigid support members joining the second annular ring to the first annular ring, the pair of support members defining the pair of windows to allow the opposed compressive force components to be applied to the valve member through the tubular sleeve.

16. The Y-adaptor manifold assembly of claim 15 wherein each valve mechanism frame further includes:

a disk valve positioned within the second annular ring and proximally adjacent to the valve member, the disk valve having a through aperture wherein upon insertion of a medical device into the respective through passage the medical device passes first through the through aperture of the disk valve before the medical device passes through the valve member in its open state.

17. A Y-adaptor manifold assembly for use with an intravascular catheter, the manifold assembly comprising:

a body member including;

a main tubular segment having a distal end, a proximal end and a through passage extending between the distal and proximal ends, the distal end of the main tubular segment being adapted to be joined to an intravascular catheter so that the through passage of the main tubular segment is arranged to be in fluid communication with a through lumen of the intravascular catheter;

a valve mechanism having an elongate tubular frame with a distal end and a proximal end, the distal end of the valve mechanism frame being fixed to the proximal end of the main tubular segment and the frame having a pair of windows formed therein, the valve mechanism including;

a flexible valve member disposed within the frame of the valve mechanism and having a longitudinal slit defined by opposed sealing wall portions, the sealing wall portions having a normally closed, sealed state that prevents a fluid medium from passing out of the through passage of the main tubular segment through the distal end thereof, an open state wherein a medical device can be inserted into the through passage of the main tubular segment through the longitudinal slit of the valve member and an in-use sealed state wherein the sealing wall portions of the longitudinal slit conform about the medical device to prevent the fluid medium from passing out of the through passage of the main tubular segment through its proximal end, the sealing wall portions being movable from the normally closed, sealed state to the open state by way of a pair of opposed, compressive radial force components that are simultaneously applied to the valve member in opposed directions substantially perpendicular to a longitudinal extent of the longitudinal slit, and the sealing wall portions being movable from the open state to the in-use sealed state by removing the compressive radial force components from the valve member to allow the sealing wall portions to conform about the medical device due to the inherent tendency of the sealing wall portions to move toward their normally closed, sealed state; and

a flexible tubular sleeve extending between and fixed within the distal end and the proximal end of the valve mechanism frame and extending about a portion of the valve member, wherein the windows in the frame permit access of the user'"'"'s fingers to the sleeve for manual application of the opposed radial force components to the valve member through the sleeve; and

a tubular side port joined to the main tubular segment proximally of the distal end of the main tubular segment, the side port having a through passage in fluid communication with the through passage of the main tubular segment.

18. A Y-adaptor manifold assembly for use with an intravascular catheter, the manifold assembly comprising:

a body member include;

a main tubular segment having a distal end, a proximal end and a through passage extending between the distal and proximal ends, the distal end of the main tubular segment being adapted to be joined to an intravascular catheter so that the through passage of the main tubular segment is arranged to be in fluid communication with a through lumen of the intravascular catheter;

a valve mechanism having an elongate tubular frame with a distal end and a proximal end with the distal end of the valve mechanism frame fixed to the proximal end of the main tubular segment, the frame having a pair of windows formed therein, the valve mechanism including;

a flexible valve member disposed within the valve mechanism and having a longitudinal slit defined by opposed sealing wall portions, the sealing wall portions having a normally closed, sealed state that prevents a fluid medium from passing out of the through passage of the main tubular segment through the proximal end thereof, and an open state wherein a medical device can be inserted into the through passage of the main tubular segment through the longitudinal slit of the valve member, the sealing wall portions being movable from the normally closed, sealed state to the open state by way of a pair of opposed, compressive radial force components that are simultaneously applied to the valve member in opposed directions substantially perpendicular to a longitudinal extent of the longitudinal slit; and

a flexible tubular sleeve extending between and fixed within the distal end and the proximal end of the valve mechanism frame with the sleeve extending about the valve member, wherein the windows of the frame permit the compressive radial force components to be applied to the valve member through the tubular sleeve;

a disk valve fixed within the valve mechanism proximal to the valve member, the disk valve having a through aperture being adapted to permit insertion of a medical device therethrough;

a tubular side port joined to the main tubular segment proximally of the distal end of the main tubular segment, the side port having a through passage in fluid communication with the through passage of the main tubular segment.

19. A Y-adaptor manifold assembly for use with an intravascular catheter, the manifold assembly comprising:

a body member including;

a main tubular segment having a distal end, a proximal end and a through passage extending between the distal and proximal ends, the distal end of the main tubular segment being adapted to be joined to an intravascular catheter so that the through passage of the main tubular segment is arranged to be in fluid communication with a through lumen of the intravascular catheter;

a valve mechanism including;

a frame having a first annular ring defining a distal end of the valve mechanism and a second annular ring defining a proximal end of the valve mechanism, the second annular ring being coupled to the first annular ring and the distal end of the valve mechanism being fixed to the proximal end of the main tubular segment with the valve mechanism frame extending outwardly from the proximal end of the main tubular segment;

a flexible valve member fixed within the valve mechanism frame and being supported by the second annular ring, the valve member having a longitudinal slit defined by opposed sealing wall portions, the sealing wall portions having a normally closed, sealed state that prevents a fluid medium from passing out of the through passage of the main tubular segment through the proximal end thereof, and an open state wherein a medical device can be inserted into the through passage of the main tubular segment through the longitudinal slit of the valve member, the sealing wall portions being movable from the normally closed, sealed state to the open state by way of a pair of opposed, compressive radial force components that are simultaneously applied to the valve member in opposed directions substantially perpendicular to a longitudinal extent of the longitudinal slit; and

a flexible tubular sleeve having a distal end fixed within the first annular ring of the valve mechanism and a proximal end fixed within the second annular ring of the valve mechanism with the sleeve extending between the first and second annular ring of the valve mechanism, and the sleeve extending about the valve member so that the compressive radial force components can be manually applied to the valve member through the tubular sleeve; and

a tubular side port joined to the main tubular segment proximally of the distal end of the main tubular segment, the side port having a through passage in fluid communication with the through passage of the main tubular segment.

20. The Y-adaptor manifold assembly of claim 19 wherein the valve mechanism further includes:

a pair of rigid support members joining the second annular ring to the first annular ring, the pair of support members defining a pair of oppositely directed windows to allow the opposed radial force components to be applied to the valve member through the tubular sleeve.