Medical connectors and methods of use

• US 9,440,060 B2
• Filed: 12/20/2013
• Issued: 09/13/2016
• 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:
  US14/137,732
• Publication Number:
  US 20140107588A1
• Time in Patent Office: 998 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 medical connector that is resistant to retrograde fluid flow comprising:

a base member comprising a male tip protrusion extending in a distal direction, the male tip protrusion comprising an internal proximal opening, a distal opening, and a passageway extending between the proximal and distal openings;

a proximal body member affixed to the base member in a permanent manner, the proximal body member including a proximal end opening;

a proximal seal member with a first position and a second position, the proximal seal member comprising a proximal end surface and a distal end, the proximal end surface being generally even with the proximal end opening of the body member in the first position and being displaced distally from the proximal end opening of the body member in the second position, and the proximal seal member comprising an interior passage with a proximal end and a distal end;

a support member positioned within the medical connector in a fixed position with respect to the base member, the support member comprising a base portion, one or more fluid openings, and an internal fluid passageway; and

a dome valve positioned in a region inside of the medical connector between the base portion of the support member and the internal proximal opening of the male tip protrusion, a portion of the support member extending into an interior region of the dome valve, and the distance from the distal end of the proximal seal member to a proximal end of the dome valve being less than the distance from the internal proximal opening of the male tip protrusion to the distal opening of the male tip protrusion;

wherein the dome valve is configured to open to permit fluid to flow from a proximal side of the dome valve to a distal side of the dome valve under a first fluid pressure differential between a proximal region of the medical connector and a distal region of the medical connector, and the dome valve is configured to open to permit fluid flow from the distal side of the dome valve to the proximal side of the dome valve under a second fluid pressure differential between a distal region of the medical connector and the proximal region of the medical connector that is higher than the first fluid pressure differential, and wherein opening of the dome valve is not functionally dependent on opening of the proximal seal member.

2. The medical connector of claim 1, wherein an elongate portion of the support member penetrates through the proximal end surface of the proximal seal member in the second position of the proximal seal member.

3. The medical connector of claim 2, wherein the elongate portion is tapered.

4. The medical connector of claim 3, wherein a proximal tip of the elongate portion is tapered.

5. The medical connector of claim 2, wherein the one or more fluid openings in the support member is or are located in the elongate portion of the support member.

6. The medical connector of claim 5, wherein the one or more fluid openings in the elongate portion of the support member is or are located on a lateral side of the elongate portion.

7. The medical connector of claim 5, wherein the one or more fluid openings in the elongate portion of the support member is or are located on a proximal end of the elongate portion.

8. The medical connector of claim 1, wherein the support member does not penetrate through the proximal end surface of the proximal seal member in the second position of the proximal seal member.

9. The medical connector of claim 1, wherein the medical connector further comprises a dynamic regulator.

10. The medical connector of claim 1, wherein the medical connector does not comprise a dynamic regulator.

11. The medical connector of claim 1, wherein the permanent attachment between the proximal body member and the distal base member is performed using adhesive, plastic or sonic welds, snap, interference, or press-fit features.

12. The medical connector of claim 1, wherein the proximal opening of the proximal body of the medical connector is configured to receive a luer of a medical implement.

13. The medical connector of claim 12, wherein the male tip protrusion of the base member of the medical connector is a luer.

14. The medical connector of claim 1, wherein the portion of the support member that extends into the interior region of the dome valve is configured to receive a protrusion on the interior region of the dome valve.

15. The medical connector of claim 1, wherein the dome valve has a dome shape when the proximal seal member is in both open and closed positions.

16. The medical connector of claim 1, wherein the dome valve is biased toward a closed position when the proximal seal member is in both open and closed positions.

17. The medical connector of claim 16, wherein the dome valve opens only during fluid flow.

18. The medical connector of claim 1, wherein the connector is configured to prevent retrograde flow of fluid in response to one or more external fluid disturbances.

19. The medical connector of claim 18, wherein the one or more external fluid disturbances is a patient'"'"'s cough or an increase in a patient'"'"'s blood pressure.

20. The medical connector of claim 18, wherein the one or more external fluid disturbances include syringe plunger rebound.

21. The medical connector of claim 18, wherein the one or more external fluid disturbances include connection or disconnection of the medical connector.

22. The medical connector of claim 1, wherein the fluid flow extends in a generally straight path through the connector.

23. A medical connector that is resistant to retrograde fluid flow comprising:

a base member comprising a male tip protrusion extending in a distal direction, the male tip protrusion comprising an internal proximal opening, a distal opening, and a passageway extending between the proximal and distal openings;

a proximal body member affixed to the base member in a permanent manner, the proximal body member including a proximal end opening;

a proximal seal member with a first position and a second position, the proximal seal member comprising a proximal end surface and a distal end, the proximal end surface being generally even with the proximal end opening of the body member in the first position and being displaced distally from the proximal end opening of the body member in the second position, and the proximal seal member comprising an interior passage with a proximal end and a distal end;

a support member positioned within the medical connector in a fixed position with respect to the base member, the support member comprising a distal base portion and an elongate portion with a proximal end and a distal end, the proximal end of the elongate portion being positioned within the proximal seal member, in a proximal region of the interior passage in the first position, the support member further comprising one or more fluid openings, and an internal fluid passageway;

a dynamic regulator; and

a dome valve positioned in a region inside of the medical connector between the distal base portion of the support member and the internal proximal opening of the male tip protrusion, the distance from the distal end of the proximal seal member to a proximal end of the dome valve being less than the distance from the internal proximal opening of the male tip protrusion to the distal opening of the male tip protrusion;

wherein the dome valve is configured to open to permit fluid to flow from a proximal side of the dome valve to a distal side of the dome valve under a first fluid pressure differential between a proximal region of the medical connector and a distal region of the medical connector, and the dome valve is configured to open to permit fluid flow from the distal side of the dome valve to the proximal side of the dome valve under a second fluid pressure differential between a distal region of the medical connector and the proximal region of the medical connector that is higher than the first fluid pressure differential, and wherein opening of the dome valve is not functionally dependent on opening of the proximal seal member.