# US 10,369,348 B2 · Reusable aseptic fluid couplings

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- Number: US 10,369,348 B2
- Document ID: US10369348B2
- Status: Granted
- Kind: B2
- Application number: 15/288,162
- Filed: 2016-10-07
- Published: 2017-04-13
- Granted: 2019-08-06
- Earliest claimed: 2015-10-08
- Assignees: Colder Products Company
- Applicants: Colder Products Company
- Inventors: Loi Trong Truong; Randall Scott Williams
- Web page: https://patentgrep.com/patent/US10369348B2

## CPC

- A61M 39/1011: {Locking means for securing connection; Additional tamper safeties (A61M39/16 takes precedence)}
- A61M 39/105: {Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes (multi-channel connectors in general F16L37/56)}
- A61M 39/16: having provision for disinfection or sterilisation {(A61M39/143 takes precedence)}
- A61M 39/18: Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
- A61M 39/26: Valves closing automatically on disconnecting the line and opening on reconnection thereof {(check valves A61M39/24)}
- F16L 37/35: at least one of the valves having an axial bore communicating with lateral apertures
- A61M 2039/1027: {Quick-acting type connectors}
- A61M 2039/263: {where the fluid space within the valve is decreasing upon disconnection}
- F16L 2201/44: sterile
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- F16L: PIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL

## Abstract

Some fluid coupling devices described herein are configured for use in fluid systems for purposes of providing a repeatable, aseptic fluid coupling system. Such repeatable, aseptic fluid coupling systems are configured to facilitate multiple connection and disconnection cycles while repeatably establishing a sterile fluid pathway through the coupling system. The repeatable, aseptic fluid coupling systems can repeatably establish a sterile fluid pathway through the coupling system even though the coupling system may be used in a non-sterile environment.

## Claims

### Claim 1

An aseptic fluid coupling system comprising:
a first coupling portion comprising:
a first valve body defining a first longitudinal axis and a first end port;
a first valve member disposed within the first valve body; and
a cap that is releasably coupleable to the first valve body, the cap enclosing at least a portion of the first valve body while the cap is coupled to the first valve body; and
a second coupling portion configured to releasably couple with the first coupling portion, comprising:
a housing;
a second valve body coupled with the housing, the second valve body defining a second longitudinal axis and a second end port;
a second valve member disposed within the second valve body;
a connection member configured to releasably couple with the first coupling portion, the connection member movably coupled with the housing between a first position and a second position; and
a flexible member coupled to the housing and to the connection member, around an outer periphery of the connection member such that the flexible member acts as a seal to provide a sterility barrier between an interior region of the second coupling portion and all regions external to the second coupling portion.

### Claim 2 (depends on 1)

The aseptic fluid coupling system of claim 1, wherein the second valve body is slidable along the second longitudinal axis.

### Claim 3 (depends on 1)

The aseptic fluid coupling system of claim 1, wherein the connection member is slidable between the first position and the second position along a path that is transverse to the second longitudinal axis.

### Claim 4 (depends on 1)

The aseptic fluid coupling system of claim 1, wherein, while the connection member is in the first position and the first coupling portion is coupled to the connection member, the first longitudinal axis is spaced apart from the second longitudinal axis and parallel to the second axis.

### Claim 5 (depends on 1)

The aseptic fluid coupling system of claim 1, wherein the flexible member reconfigures while the connection member is moved between the first position and the second position, and wherein the flexible member maintains the sterility barrier while the first coupling portion is coupled with the connection member and the connection member is moved between the first position and the second position.

### Claim 6 (depends on 1)

The aseptic fluid coupling system of claim 1, wherein while: (i) the first coupling portion is coupled with the connection member, (ii) the connection member is in the first position, and (iii) the cap is coupled with the first valve body, the connection member is prevented from moving toward the second position.

### Claim 7 (depends on 1)

The aseptic fluid coupling system of claim 1, wherein while: (i) the first coupling portion is coupled with the connection member, (ii) the connection member is in the first position, and (iii) the cap is uncoupled from the first valve body, the connection member is free to be moved toward the second position.

### Claim 8 (depends on 1)

The aseptic fluid coupling system of claim 1, wherein while: (i) the first coupling portion is coupled with the connection member and (ii) the connection member is in the second position, the first longitudinal axis is coincident with the second longitudinal axis, and a fluid flow path from the first end port to the second end port can be opened by a displacement of the second valve body in relation to the housing and toward the first valve body.

### Claim 9 (depends on 1)

The aseptic fluid coupling system of claim 1, further comprising a counter mechanism configured for tracking a number of times the aseptic fluid coupling system has been reconfigured between: (i) an uncoupled configuration in which the first coupling portion is separated from the second coupling portion and (ii) an operative configuration in which the first coupling portion is coupled with the second coupling portion such that a sterile fluid flow path through the aseptic fluid coupling system is open.

### Claim 10

An aseptic fluid coupling system comprising:
a first coupling portion comprising:
a first valve body defining a first longitudinal axis and a first end port;
a first valve member disposed within the first valve body; and
a cap that is releasably coupleable to the first valve body, the cap enclosing at least a portion of the first valve body while the cap is coupled to the first valve body; and
a second coupling portion to releasably couple with the first coupling portion, the second coupling portion comprising:
a housing;
a second valve body coupled with the housing, the second valve body defining a second longitudinal axis and a second end port;
a second valve member disposed within the second valve body;
a connection member configured to releasably couple with the first coupling portion; and
a flexible member attached to the housing and around an outer periphery of the connection member to act as a seal to provide a sterility barrier between an interior region of the second coupling portion and all regions external to the second coupling portion,
wherein, while the first coupling portion is coupled with the connection member, the cap can by uncoupled from the first valve body by a cap movement comprising a translation of the cap along the first longitudinal axis.

### Claim 11 (depends on 10)

The aseptic fluid coupling system of claim 10, wherein the connection member is movably coupled with the housing and movable between a first position and a second position, and wherein the connection member is slidable between the first position and the second position along a path that is transverse to the second longitudinal axis.

### Claim 12 (depends on 11)

The aseptic fluid coupling system of claim 11, wherein the flexible member is coupled to the housing and to the connection member, wherein the flexible member reconfigures while the connection member is moved between the first position and the second position, and wherein the flexible member is configured to maintain the sterility barrier while the connection member is moved between the first position and the second position.

### Claim 13 (depends on 10)

The aseptic fluid coupling system of claim 10, wherein while the cap is coupled to the first valve body, a first seal exists between the cap and the first valve body, and wherein the first seal is configured to maintain sterility of a first sterile space enclosed within the cap and adjacent to the first valve member, and wherein while the cap is uncoupled from the first valve body after the first coupling portion is coupled with the connection member, the sterility of the first sterile space is maintained.

### Claim 14 (depends on 13)

The aseptic fluid coupling system of claim 13, wherein the second coupling portion is sealed so as to maintain sterility of a second sterile space adjacent to the second valve member, and wherein, while the connection member is in the second position, the first sterile space is in fluid communication with the second sterile space.

### Claim 15 (depends on 14)

The aseptic fluid coupling system of claim 14, wherein, while the connection member is in the second position, the second valve body is slidable along the second longitudinal axis such that the first valve member can become engaged with the second valve member to thereby open a fluid pathway between the first and second end ports, and wherein the fluid pathway is a sterile fluid pathway.

### Claim 16

A method of using a reusable, aseptic fluid coupling system, the method comprising:
connecting a first coupling portion of the aseptic fluid coupling system to a second coupling portion of the aseptic fluid coupling system, wherein the first coupling portion comprises: (i) a first valve body defining a first longitudinal axis and a first end port; (ii) a first valve member disposed within the first valve body; and (iii) a cap that is releasably coupled to the first valve body, wherein the second coupling portion comprises: (a) a housing; (b) a second valve body coupled with the housing, the second valve body defining a second longitudinal axis and a second end port; (c) a second valve member disposed within the second valve body; (d) a connection member releasably coupled with the first coupling portion and disposed at a first position in relation to the housing; and (e) a flexible member attached to the housing and around an outer periphery of the connection member to act as a seal to provide a sterility barrier between an interior region of the second coupling portion and all regions external to the second coupling portion;
moving the connection member, with the first coupling portion coupled thereto, to a second position in relation to the housing; and
engaging the first valve member with the second valve member to open a fluid pathway between the first and second end ports.

### Claim 17 (depends on 16)

The method of claim 16, wherein the first valve member and the second valve member are each sterile, wherein the fluid pathway is a sterile fluid pathway, and further comprising, after opening the sterile fluid pathway, disengaging the first valve member from the second valve member to close the fluid pathway between the first and second end ports.

### Claim 18 (depends on 17)

The method of claim 17, further comprising:
after disengaging the first valve member from the second valve member, disconnecting the first coupling portion from the second coupling portion, wherein the first valve member and the second valve member each remain sterile; and
after disconnecting the first coupling portion from the second coupling portion, reconnecting the first coupling portion to the second coupling portion and re-opening the sterile fluid pathway, wherein the first valve member and the second valve member each remain sterile.

### Claim 19 (depends on 18)

The method of claim 18, further comprising, prior to the disconnecting the first coupling portion from the second coupling portion: (i) reconnecting the cap to the first valve body and (ii) after reconnecting the cap to the first valve body, actuating a coupling unlatching mechanism that prevents disconnection of the first coupling portion from the second coupling portion until actuated.

### Claim 20 (depends on 17)

The method of claim 17, further comprising, prior to the disengaging the first valve member from the second valve member, actuating a valve body unlatching mechanism that prevents disengagement of the first valve member from the second valve member until actuated.
