Needleless medical connector

• US 8,444,628 B2
• Filed: 07/16/2012
• Issued: 05/21/2013
• Est. Priority Date: 07/11/2000
• Status: Expired due to Fees

• 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:
  US13/550,154
• Publication Number:
  US 20120283702A1
• Time in Patent Office: 309 Days
• Field of Search: 604/284, 604246-256, 604/905
• US Class Current: 604/533
• 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, and a cavity extending from the upstream end of the housing to a lower inner surface of the housing, wherein at least a portion of the housing defines a first side opening and a second side opening; and

a seal having a downstream end in fluid communication with the interface, an upstream end configured to receive the second medical device, and a normally substantially closed passage, the seal comprising a body and a transverse flange, the body made of flexible material and having a downstream end and an upstream end opposite the downstream end wherein the body has first and second lateral portions each having an upper surface, and the transverse flange disposed proximal to the upstream end of the seal and having a lower surface;

wherein the seal is disposed within the housing such that the transverse flange extends across the axial opening, and the first lateral portion of the body extends into the first side opening and the second lateral portion of the body extends into the second side opening;

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 configured to engage the top edges of the first and second side openings, 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.

2. The medical connector of claim 1, wherein the seal body comprises a generally flat slab.

3. The medical connector of claim 1, wherein the first lateral portion of the seal body generally opposes the second lateral portion of the seal body.

4. The medical connector of claim 1, wherein the side openings are circumferentially spaced apart at approximately 180 degrees from each other.

5. The medical connector of claim 1, wherein the first lateral portion of the seal body extends through the first side opening and the second lateral portion of the seal body extends through the second side opening.

6. The medical connector of claim 1, wherein the transverse flange takes on a concave configuration.

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

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

9. The medical connector of claim 1, wherein the interface of the housing comprises a Luer lock interface.

10. The medical connector of claim 1, wherein the seal further comprises a neck formed proximal to an upstream end of the seal body.

11. The medical connector of claim 10, wherein the seal body, neck, and transverse flange form an integral unit.

12. The medical connector of claim 1, wherein the housing further comprises a lead cannula extending from the lower inner surface toward the upstream end of the housing.

13. The medical connector of claim 12, wherein at least a portion of the lead cannula has a substantially cylindrical outer surface.

14. The medical connector of claim 12, wherein the seal further comprises a lead lumen formed in the downstream end of the body and in fluid communication with the passage.

15. The medical connector of claim 14, wherein the lead lumen of the seal 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.

16. The medical connector of claim 15, wherein the lead cannula is centered on an axis substantially parallel to or collinear with a longitudinal axis of the housing.