Luer activated device with valve element under tension

• US 8,221,363 B2
• Filed: 10/18/2006
• Issued: 07/17/2012
• Est. Priority Date: 10/18/2006
• Status: Expired due to Fees

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.)
• Inventors: Jepson, Steven C.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): HAYMAN, IMANI N
• Application Number:
  US11/550,589
• Publication Number:
  US 20080172005A1
• Time in Patent Office: 2,099 Days
• Field of Search: 604246-256
• US Class Current: 604/256
• CPC Class Codes: A61M 2039/0036 characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
• 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 2206/20 having means for promoting or enhancing the flow, actively or passively
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24

Abstract

A luer activated device includes an inlet adapted to receive a male luer, an outlet associable with a fluid flow system, and a fluid flow path therebetween. The flow path is defined by an elastomeric flow controller extending between the inlet and outlet and maintained in a tensioned state. When a male luer is inserted into the inlet, some of the tension in the flow controller is relieved, allowing the flow path to deform and change in volume. The flow path is adapted such that the change in volume results in no net fluid displacement or minimal positive fluid displacement when the male luer is inserted into the inlet. Other aspects include tensioned flow controllers having a plurality of sealing layers for the inlet and methods of manufacturing valves having a tensioned fluid flow controller.

Claims

1. A medical valve for the bi-directional transfer of fluid comprising:

a valve housing having an inlet adapted for receiving a male luer, an outlet and a passageway therethrough; and

a fluid flow controller received within the valve housing, said fluid flow controller having

a valve element fixedly attached to said inlet, said valve element having a resealable aperture for receiving the male luer and sealing the inlet, and

an extending portion extending away from the valve element and fixedly attached to said outlet, said extending portion defining (i) a fluid flow path in communication with said aperture and said outlet (ii) a generally tubular wall, and (iii) a bulge,

wherein (a) said fluid flow controller is maintained in a tensioned state within the valve housing, (b) the bulge has a radius larger than a radius of the tubular wall in an untensioned state, and substantially the same radius as the radius of the tubular wall in the tensioned state, and (c) insertion of the male luer into the inlet (1) decreases the tension in at least a portion of the fluid flow controller, (2) changes a volume of said fluid flow controller, and (3) causes the bulge to radially expand to define a fluid reservoir.

2. The medical valve of claim 1, wherein said change in volume results in substantially no fluid displacement when the male luer is inserted or removed from the inlet.

3. The medical valve of claim 1, wherein said change in volume results in a positive displacement of fluid as the male luer is inserted into the inlet.

4. The medical valve of claim 1, wherein the valve element of the fluid flow controller includes a first seating layer defining a first aperture, a second sealing layer defining a second aperture, and a channel therebetween and in communication with said apertures, wherein said channel is substantially closed in a tensioned state and open in an untensioned state.

5. The medical valve of claim 1 in which at least a portion of the fluid flow controller is overmolded onto the valve housing.

6. The medical valve of claim 1 in which at least a portion of the fluid flow controller is mechanically attached to the valve housing.

7. The medical valve of claim 1, further including a restrictor member that resiliently closes a section of the fluid flow path, said restrictor member adapted to open said section of the fluid flow path to open when the male luer is inserted into the fluid flow controller.

8. The medical valve of claim 7 in which the restrictor member compresses the extending portion to close the section of the fluid flow path.

9. The medical valve of claim 8 in which the restrictor member includes an opening and said extending portion of the fluid controller extends through said opening.

10. A medical valve comprising:

a valve housing having

(i) an inlet adapted for receiving a male luer,

(ii) an upper housing portion, and

(iii) a lower housing portion, the lower housing portion defining an outlet; and

a fluid flow controller associated with the valve housing, the fluid flow controller having

(i) an extending portion defined by a generally tubular wall and a bulge, the extending portion fixedly attached to the outlet in a tensioned state, and

(ii) a valve element fixedly attached to said inlet in the tensioned state,

wherein (a) the extending portion defines a fluid flow path, and (b) the bulge has a larger radius than a radius of the tubular wall in an untensioned state and substantially the same radius as the radius of the tubular wall in the tensioned state,

said valve element having

(i) a first sealing layer defining a first resealable aperture,

(ii) a second sealing layer defining a second resealable aperture,

wherein (a) a portion of the second sealing layer is compressed between the upper housing portion and the lower housing portion to attach the second sealing layer to the housing, (b) the extending portion extends away from the second sealing layer, and (c) the fluid flow path is in communication with the second aperture and the outlet, and

(iii) a channel therebetween and in communication with said apertures, wherein said channel is substantially closed in the tensioned state and open in the untensioned state,

wherein insertion of the male luer into the inlet (a) changes a volume of the fluid flow path, and (b) causes the bulge to radially expand to define a fluid reservoir.

11. The medical valve of claim 10 in which the tension in the channel causes at least one of the first and second sealing layers to have a concave configuration.

12. The medical valve of claim 10 in which the first sealing layer is attached to the valve housing by an interference fit.

13. The medical valve of claim 10 in which the first sealing layer includes a downwardly extending skirt adapted to form a friction fit with the valve housing to attach the first sealing layer to the housing.

14. The medical valve of claim 10, wherein said change in volume results in substantially no fluid displacement when the male luer is inserted or removed from the inlet.

15. The medical valve of claim 10, wherein said change in volume results in a positive displacement of fluid as the male luer is inserted into the inlet.