Medical connectors and methods of use

• US 9,278,206 B2
• Filed: 04/04/2013
• Issued: 03/08/2016
• Est. Priority Date: 03/25/2009
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Fangrow, Thomas F.
• Primary Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US13/857,019
• Publication Number:
  US 20130226099A1
• Time in Patent Office: 1,069 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2039/1033 Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
• CPC Class Codes: A61M 2039/2406 designed to quickly shut upon the presence of back-pressure
• CPC Class Codes: A61M 2039/2433 Valve comprising a resilient or deformable element, e.g. flap valve, deformable disc
• CPC Class Codes: A61M 2039/262 having a fluid space within the valve remaining the same upon connection and disconnection, i.e. neutral-drawback valve
• CPC Class Codes: A61M 2039/263 where the fluid space within the valve is decreasing upon disconnection
• CPC Class Codes: A61M 2039/266 where the valve comprises venting channels, e.g. to insure better connection, to help decreasing the fluid space upon disconnection, or to help the fluid space to remain the same during disconnection
• CPC Class Codes: A61M 2039/267 having a sealing sleeve around a tubular or solid stem portion of the connector
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/40 Respiratory characteristics
• CPC Class Codes: A61M 39/02 Access sites
• 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 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 39/221 Frangible or pierceable closures within tubing A61M39/14 takes precedence; frangible closures for containers A61J1/14
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24
• CPC Class Codes: Y10T 137/87917 Flow path with serial valves and/or closures
• CPC Class Codes: Y10T 29/494 Fluidic or fluid actuated device making

Abstract

Some embodiments disclosed herein relate to a medical connector having a backflow resistance module configured to prevent fluid from being drawn into the connector when a backflow inducing event occurs. In some embodiments, the backflow resistance module can include a variable-volume chamber configured to change in volume in response to a backflow-inducing event and a check valve configured to resist backflow. In some embodiments, the medical connector can include a fluid diverter configured to direct fluid flowing through the medical connector into the variable volume chamber to prevent fluid stagnation therein. In some embodiments, the medical connector includes a body member, a base member, a seal member, a support member, and a valve member.

Claims

1. A retrograde-flow-resistant needleless medical connector comprising:

a housing comprising a body member and a base member permanently coupled together, and a female luer-receiving proximal region and a male luer distal end, and an internal fluid volume configured to receive medicinal fluid during use;

the proximal region of the housing comprising a proximal closure system with a first stage at which a proximal end of the housing is closed and a second stage at which the proximal end of the housing is open, the proximal closure system being configured to move between the first and second stages such that a proximal surface of the proximal closure system is configured to be displaced in a distal direction when a medical implement is inserted into the proximal end of the housing;

a volume adjuster positioned within the housing that is capable of operating independently of the proximal closure system, the volume adjuster being configured to change the internal fluid volume in the proximal region of the connector automatically in response to changes in fluid pressure within the medical connector; and

an internal closure system positioned in a distal direction from the volume adjuster, the internal closure system being capable of operating independently of the proximal closure system and spaced from the distal male end of the housing, the internal closure system comprising a first stage at which the internal closure system is closed and a second stage at which the internal closure system is open, the internal closure system being capable of being closed when a male luer of the medical implement is seated within the female luer-receiving proximal end, and the proximal closure system is open, to resist retrograde flow of fluid through the distal end of the housing when the proximal end is open.

2. A fluid administration system comprising the retrograde-flow-resistant needleless medical connector of claim 1 and the medical implement.

3. The medical connector of claim 1, wherein the proximal closure system comprises a resilient or elastomeric seal.

4. The medical connector of claim 3, wherein the seal changes from the first stage to the second stage by moving between different states of compression.

5. The medical connector of claim 3, wherein a support member is positioned within an interior of the resilient or elastomeric seal of the proximal closure system.

6. The medical connector of claim 5, wherein the support member comprises an elongate member.

7. The medical connector of claim 6, wherein the elongate member comprises a tapered proximal end.

8. The medical connector of claim 6, wherein the elongate member is configured to penetrate through a portion of the resilient or elastomeric seal in the open stage of the proximal closure system.

9. The medical connector of claim 8, wherein the elongate member comprises one or more fluid openings near a proximal end of the elongate member.

10. The medical connector of claim 5, wherein the support member is stationary.

11. The medical connector of claim 1, wherein retrograde flow of fluid is entirely prevented through the distal end of the housing.

12. The medical connector of claim 1, wherein the medical connector is a neutral flow connector.

13. The medical connector of claim 1, wherein the volume adjuster is made of the same material as a seal in the proximal closure system.

14. The medical connector of claim 13, wherein the volume adjuster is positioned between the proximal closure system and the internal closure system.

15. The medical connector of claim 14, wherein the volume adjuster is formed as a single unit unitary with the internal closure system.

16. The medical connector of claim 15, wherein the volume adjuster operates independently of the internal closure system.

17. The medical connector of claim 14, wherein the volume adjuster operates independently of the internal closure system.

18. The medical connector of claim 13, wherein the volume adjuster is generally cylindrical.

19. The medical connector of claim 18, wherein the volume adjuster comprises a flexible material.

20. The medical connector of claim 1, wherein the internal closure system comprises a generally dome-shaped valve.

21. The medical connector of claim 1, wherein the proximal closure system comprises a slit in a septum in a normally closed state.

22. The medical connector of claim 1, wherein the proximal closure system comprises a slit biased to an open state.

23. The medical connector of claim 1, wherein the proximal region extends from a proximal end of the housing to a distal end of an interior of the internal closure system.

24. The medical connector of claim 23, wherein the distal end of the interior of the internal closure system is closer to the distal end of the housing than to the proximal end of the housing.