Needleless medical connector

• US 8,221,391 B2
• Filed: 07/27/2010
• Issued: 07/17/2012
• 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): Sirmons, Kevin C
• Assistant Examiner(s): GRAY, PHILLIP A
• Application Number:
  US12/844,791
• Publication Number:
  US 20110022031A1
• Time in Patent Office: 721 Days
• Field of Search: 604174-180, 604246-256, 604/96.01, 604/164.01, 604/523
• US Class Current: 604/539
• 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 needleless medical connector having a downstream end for receiving a first medical device and an upstream end for receiving a second medical device, the medical connector comprising:

a housing having an interface configured to receive a connector portion of the first medical device and an axial opening opposite the interface, the housing comprising an upstream end, a downstream end, a cavity extending from the upstream end of the housing to a lower inner surface of the housing, a side inner surface disposed near the upstream end of the housing and defining an offset portion, and a lead cannula extending from the lower inner surface toward the upstream end of the housing; and

a seal element 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, the seal element comprising 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 such that in an undisturbed state the lead cannula extends at least partially into the lead lumen, a neck formed proximal to the upstream end of the body, and a transverse flange proximal to an end of the neck opposite the body and having a lower surface, wherein the transverse flange includes a portion disposed upstream of the axial opening and extending radially beyond the side inner surface of the housing, and wherein the body has first and second lateral portions each having an upper surface;

wherein a lower surface of the offset portion of the housing is sufficiently remote from an upper surface of an edge of the axial opening to impart a tensile force to the seal element between the lower surface of the transverse flange and the upper surfaces of the lateral portions, thereby causing a portion of the lower surface of the transverse flange to bear against a portion of the upper surface of the edge of the axial opening and the transverse flange to take on a concave configuration.

2. The medical connector of claim 1, wherein the lead lumen of the seal element is permitted to slide along an outer surface of the lead cannula and to move toward the lower inner surface of the housing when the second medical device is inserted into the medical connector.

3. The medical connector of claim 1, wherein a first distance is defined by the distance between the upper surface of the edge of the axial opening and the lower surface of the offset portion and a second distance is defined by the distance between the lower surface of the transverse flange and the upper surfaces of the lateral portions, the first distance being greater than the second distance.

4. The medical connector of claim 1, wherein the concave configuration biases the opening of the transverse flange towards a closed position.

5. The medical connector of claim 1, wherein the opening in the transverse flange is disposed near the deepest portion of the concavity of the transverse flange.

6. The medical connector of claim 1, wherein the lead cannula is centered on an axis substantially parallel to or collinear with a longitudinal axis of the housing.

7. The medical connector of claim 1, wherein the lead cannula is substantially rigid.

8. The medical connector of claim 1, wherein the housing comprises at least one side opening.

9. The medical connector of claim 1, wherein the housing comprises a seal holder containing the seal element such that the interface is configured to be mateably coupled to the seal holder.

10. The medical connector of claim 1, wherein the medical connector is configured to selectively permit a substantially unobstructed, smooth flow of fluid therethrough.

11. The medical connector of claim 1, wherein upon removal of the second medical device from the seal element, substantially all fluid in the seal element is urged towards the downstream end of the seal element.