Medical valve with positive flow characteristics

• US 6,695,817 B1
• Filed: 07/11/2000
• Issued: 02/24/2004
• Est. Priority Date: 07/11/2000
• Status: Expired due to Term

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Fangrow, Thomas F. Jr.
• Primary Examiner(s): Denion, Thomas
• Assistant Examiner(s): TRAN, BINH Q
• Application Number:
  US09/614,001
• Time in Patent Office: 1,323 Days
• Field of Search: 604/167.01, 604/167.05, 604/167.06, 604/167.02, 604/167.03, 604/167.04, 604/247, 604/249, 285/283, 251/149.1
• US Class Current: 604/167.01
• CPC Class Codes: A61M 2039/0205 for injecting media
• CPC Class Codes: A61M 2039/0258 for vascular access, e.g. blood stream access
• CPC Class Codes: A61M 2039/027 having a particular valve, seal or septum septum A61M2039/0036
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/263 where the fluid space within the valve is decreasing upon disconnection
• CPC Class Codes: A61M 39/02 Access sites
• 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
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24

Abstract

A valve for selectively permitting a fluid flow between first and second medical implements is disclosed. The valve has a housing with an interface suitable for receiving a connector portion of a first medical device such as a catheter, and a seal made of a flexible material. The seal has a first end in fluid communication with the interface, a second end suitable for receiving the second medical device, and at least one slit in fluid communication with the first end and the second end. The slit defines a restricted fluid flow path and a relatively small interior volume when in an undisturbed state, defines an expanded fluid flow path and a larger interior volume upon the introduction of the second medical instrument into the slit, and retracts to define a restricted flow path and a small interior volume upon the withdrawal of the second medical device from the seal.

Claims

1. A medical valve for selectively permitting fluid to flow between a first medical device and a second medical device, the valve comprising:

a housing having an interface suitable for receiving a connector portion of the first medical device; and

a seal made of a flexible material, the seal having a downstream end in fluid communication with the interface, an upstream end suitable for receiving the second medical device, and a normally substantially closed passage in fluid communication with the downstream end and the upstream end,

the seal including a body made of flexible material and having a downstream end and an upstream end opposite the downstream end;

a lead lumen formed in the downstream end of the body and in fluid communication with the passage;

a neck formed at the upstream end of the body; and

a transverse flange at an end of the neck opposite the body, the transverse flange having at least one opening in fluid communication with the passage; and

the passage having a relatively small interior volume when in an undisturbed state and a larger interior volume upon the introduction of the second medical device into the upstream end of the passage, the passage retracting to define a restricted flow path and a relatively small interior volume upon the withdrawal of the second medical device from the seal, the upstream end initially being sealed as the second medical device is withdrawn, so that a fluid occupying the interior volume is forced toward the downstream end as the passage walls collapse.

2. The medical valve defined in claim 1, wherein the lead lumen is centered on an axis substantially parallel to or collinear with a longitudinal axis of the seal.

3. The medical valve defined in claim 1, wherein the seal body comprises a substantially rectangular slab of flexible material and the neck is coplanar with the body.

4. The medical valve defined in claim 1, wherein the passage comprises a slit and the passage opening comprises a slit opening.

5. The medical valve defined in claim 4, wherein the slit comprises:

a relatively thin, substantially planar channel having a varying width;

a region of minimum width; and

a region of larger width on a side of the region of minimum width remote from the slit opening;

wherein the width of the slit tapers from the slit opening to the region of minimum width.

6. The medical valve defined in claim 1, wherein the seal body has first and second lateral portions and the housing further comprises:

a seal holder attached to the interface, the seal holder comprising a hollow cylindrical member that extends from the interface and has an axial opening opposite the interface, and first and second side openings;

a lead cannula attached to and in fluid communication with the interface and extending from the interface toward the axial opening, the lead cannula being centered on an axis substantially parallel to or collinear with a longitudinal axis of the housing;

wherein the seal is disposed within the seal holder such that the lead cannula extends at least partially into the lead lumen, the flange extends across the axial opening, and the first and second lateral portions of the seal body extend into the first and second side openings.

7. The medical valve defined in claim 6, wherein the first and second side openings have top edges that define the portions of the side openings nearest the axial opening, and the first and second lateral portions of the seal body have shoulders that define the extent of the lateral portions nearest the transverse flange, and the top edges of the side openings are sufficiently remote from the axial opening to impart a tensile force to the seal between the transverse flange and the shoulders, thereby causing the perimeter of the transverse flange to bear against the edges of the axial opening and the transverse flange to take on a concave configuration with the slit opening near the deepest portion of the concavity.

8. The medical valve defined in claim 6, wherein at least a portion of the lead cannula is disposed within the lead lumen when the seal is in an undisturbed state and at least a portion of the lead cannula enters the region of the slit nearest the lead lumen upon axial compression of the seal occurring when the second medical device is inserted into the seal.