Medical connector with automatic valves and volume regulator

• US 8,454,579 B2
• Filed: 03/23/2010
• Issued: 06/04/2013
• Est. Priority Date: 03/25/2009
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Fangrow, Thomas F. Jr.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US12/730,074
• Publication Number:
  US 20100249723A1
• Time in Patent Office: 1,169 Days
• Field of Search: 604/533, 604/536, 604/537, 604/539
• US Class Current: 604/539
• 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 medical connector for use in a fluid pathway, the connector comprising:

a housing having a proximal female end with a proximal opening and a distal male end with a distal opening;

a first valve member positioned substantially within the housing, the first valve member being configured to selectively seal the proximal opening; and

a second valve member positioned within the housing, the second valve member being configured to selectively seal within the housing in a distal direction from the first valve member, wherein;

the second valve member automatically opens or remains open, independent of connecting or disconnecting the medical connector at the distal end, to permit fluid flow in a first direction when the pressure in a proximal region within the connector is greater than the pressure in a distal region within the connector by a first threshold value, the first direction being from the proximal end portion to the distal end portion;

the second valve member automatically opens or remains open, independent of connecting or disconnecting the medical connector at the distal end, to permit fluid flow in a second direction when the pressure in the distal region within the connector is greater than the pressure in the proximal region within the connector by a second threshold value, the second direction being from the distal end portion to the proximal end portion, and the second threshold value being greater than the first threshold value; and

a dynamic regulator comprising a flexible material, the dynamic regulator being configured to buckle, flex, or move so as to reduce the internal volume from a first internal volume to a second internal volume when the first valve member is open and the second valve member is closed, and a pressure change occurs at the proximal end, thereby diminishing the pressure change within the proximal region of the connector.

2. The medical connector of claim 1 further comprising a flow diverter configured to change the direction of at least a portion of fluid flowing through the connector from a generally longitudinal direction to a more lateral direction.

3. The medical connector of claim 1 wherein the second threshold value is substantially greater than the first threshold value.

4. The medical connector of claim 1 wherein the dynamic regulator and the second valve member comprise a single unitary structure.

5. The medical connector of claim 1 wherein the connector substantially prevents negative flow upon disconnection of a medical device from the proximal end of the connector.

6. The medical connector of claim 5 wherein the connector is a neutral flow connector.

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

8. The medical connector of claim 1 wherein the dynamic regulator is spaced from the first and second valve members.

9. The medical connector of claim 1 wherein a proximal end surface of the first valve member is adjacent to the proximal end of the housing in a closed state to facilitate swabbing to maintain sterility.

10. The medical connector of claim 1 wherein the connector substantially prevents negative flow upon connection of a medical device to the proximal end of the connector.

11. The medical connector of claim 1 wherein the connector substantially prevents negative flow upon both connection and disconnection of a medical device to the proximal end of the connector.

12. The medical connector of claim 11 wherein the connector is a neutral flow connector during both connection and disconnection of a medical device to the proximal end of the connector.

13. The medical connector of claim 11 wherein the connector resists negative flow into the distal end of the connector induced by pressure changes outside of the connector.