High flow rate needleless medical connector

• US 7,497,849 B2
• Filed: 05/02/2006
• Issued: 03/03/2009
• 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): Tran; Binh Q.
• Application Number:
  US11/416,932
• Publication Number:
  US 20060212002A1
• Time in Patent Office: 1,036 Days
• Field of Search: 604/30, 604/34, 604/167.01, 604/167.02, 604/167.03, 604/167.04, 604/167.05, 604/167.06, 604/246, 604/247, 604/249, 285/283, 251/149.1
• US Class Current: 604/247
• 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
• 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 high flow rate needleless medical connector having a downstream end for receiving a first medical device and an upstream end for receiving a second medical device having a standard medical Luer tip, the medical connector comprising:

a housing having an interface configured to receive a connector portion of the first medical device, the housing comprising a cavity extending from the upstream end of the medical connector to a lower inner surface of the housing, and a lead cannula extending from the lower inner surface toward the upstream end of the medical connector, the lead cannula having a substantially cylindrical outer surface and an inner diameter of the lead cannula being similar in size to an inner diameter of an end of the second medical device; and

a seal element having a downstream end and an upstream end, the seal element comprising;

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

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;

the downstream end of the seal element being in fluid communication with the interface, the upstream end of the seal element being suitable for receiving the second medical device, and a normally substantially closed passage in the seal element being in fluid communication with the downstream end and the upstream end of the seal element such that a substantial portion of the end of the second medical device is permitted to enter the passage when the second medical device is inserted into the medical connector;

wherein the downstream end of the seal element is permitted to move toward the lower inner surface of the housing when the second medical device is inserted into the medical connector, and the downstream end of the seal element is permitted to move away from the lower inner surface of the housing when the second medical device is removed from the medical connector;

wherein at least a portion of the seal element closely fits about the outer surface of the lead lumen proximal an upstream opening in the lead lumen when the second medical device is inserted into the medical connector; and

wherein the upstream end and the downstream end of the medical connector are disposed on substantially the same axis to assist in providing a substantially straight fluid-flow path.

2. 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.

3. The medical connector of claim 1, wherein the housing expands upon insertion of a second medical device having a Luer lock into the seal element.

4. The medical connector of claim 3, wherein the housing comprises two protrusions positioned near the end of the housing opposite the interface and configured to threadably engage the second medical device having the Luer lock.

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

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

7. 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.

8. The medical connector of claim 1, wherein the housing comprises an axial opening at an end opposite the interface and at least one side opening.

9. The medical connector of claim 8, wherein the housing comprises two side openings circumferentially spaced apart at approximately 180 degrees from each other.

10. The medical connector of claim 1, wherein the lead cannula comprises a lumen therethrough, and wherein the downstream end of the seal element is in fluid communication with the lumen of the lead cannula.

11. The medical connector of claim 1, wherein upon insertion of the second medical device into an upstream end of the passage, the distance between the end of the second medical device and an upstream end of the lead cannula is similar in size to the height of the lead cannula.

12. The medical connector of claim 1, wherein upon insertion of the second medical device into an upstream end of the passage, the distance between the end of the second medical device and an upstream end of the lead cannula is less than the height of the lead cannula.

13. The medical connector of claim 1, wherein upon insertion of the second medical device into an upstream end of the passage, the distance between the end of the second medical device and an upstream end of the lead cannula is similar in size to the diameter of the end of the second medical device.

14. The medical connector of claim 1, wherein the housing is substantially rigid.

15. The medical connector of claim 1, wherein the seal element further comprises a substantially planar slit defining a highly restricted flow path in an undisturbed state, and a substantially unobstructed linear flow path when the second medical device is inserted into the passage.

16. The medical connector of claim 1, wherein the seal element comprises a lead lumen formed in the downstream end of the body and in fluid communication with the passage.

17. The medical connector of claim 16, wherein an inner diameter of the lead lumen is about 0.040 inches.

18. The medical connector of claim 1, wherein upon insertion of the second medical device into an upstream end of the passage, the seal element is moved downward onto the lead cannula such that the at least a portion of the lead cannula extends into the passage.

19. The medical connector of claim 1, wherein the seal element is made of silicone rubber.

20. The medical connector of claim 1, wherein the seal element is made of synthetic polyisoprene.

21. The medical connector of claim 1, wherein the housing comprises at least one slit extending generally vertically from an end of the housing opposite the interface toward the interface.

22. The medical connector of claim 21, wherein the slit of the housing permits the housing to expand upon insertion of the second medical device into the seal element.

23. The medical connector of claim 22, wherein the housing expands in a manner that permits the second medical device to be retained in the seal element.

24. The medical connector of claim 23, wherein the second medical device comprises a medical device having a Luer slip connector.

25. The medical connector of claim 21, wherein the housing comprises an axial opening at an end opposite the interface and at least one side opening.

26. The medical connector of claim 25, wherein the at least one slit extends from the axial opening to the at least one side opening.