Prefilled sterilant fluid releasable coupling connector apparatus for catheter applications

• US 5,190,534 A
• Filed: 12/07/1990
• Issued: 03/02/1993
• Est. Priority Date: 12/07/1990
• Status: Expired due to Term

• Current Assignee: Delmed, Inc. (Fresenius SE & Co. KGaA)
• Original Assignee: Delmed, Inc. (Fresenius SE & Co. KGaA)
• Inventors: Kendell, Lamar C.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Owens, Kerry
• Application Number:
  US07/624,142
• Time in Patent Office: 816 Days
• Field of Search: 604/905, 604/283, 604/4-6, 604/29, 604/30
• US Class Current: 604/6.16
• CPC Class Codes: A61M 2039/1033 Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
• CPC Class Codes: A61M 39/162 with antiseptic agent incorporated within the connector
• CPC Class Codes: B08B 3/048 Overflow-type cleaning, e.g. tanks in which the liquid flows over the tank in which the articles are placed

Abstract

A releasable coupling connector apparatus for catheter applications is provided wherein the connector is partially filled wtih anti-infective solution during manufacture and capped so that a patient or medical technician does not have the task of opening the fluid pathway and introducing the anti-infective solution at point of use into the connector apparatus. The connector apparatus being partially filled with anti-infective solution and capped during manufacture is further sterilized by Gamma radiation in order to eliminate any organism resistant to the anti-infective solution. The releasable coupling connector apparatus provides the first practical double seal connector means wherein a double seal connector defining dual sterilant liquid containing chambers for use with catheter applications and particularly with CAPD whereby sterilization is assuredly and easily achieved by an impaired, unskilled patient even under adverse conditions.

Claims

1. A luer lock connection device comprising:

a male luer connector member having a central tubular portion outwardly circumscribed by a generally tubular sheath portion and having an open end facing in a first axial direction;

a female luer connector member operatively interconnectable with said male luer connector and having a hollow tubular portion coaxially insertable into said sheath portion to coaxially receive said central tubular portion of said male luer connector member;

cooperating thread means on said male and female luer connector members for releasably holding them in their operatively interconnected orientation; and

means associated with said male and female luer connector members and responsive to their operative interconnection for forming within said sheath portion a sterilant fluid-receiving chamber having;

an inner annular portion coaxially disposed between the outer side surface of said central tubular portion and the inner side surface of said central tubular portion and the inner side surface of said hollow tubular portion of said female luer connector member, said inner annular portion having an annular first end and an annular second end spaced apart therefrom in said first axial direction, and

an outer annular portion coaxially disposed between the outer side surface of said hollow tubular portion of said female luer connector member and the inner side surface of said sheath portion, said outer annular portion having an annular first end, and an annular second end spaced apart therefrom in said first axial direction, said first ends of said inner and outer annular portions communicating with one another; and

seal means, responsive to the operative interconnection of said male and female luer connector members, for forming annular resilient seals around said second ends of said inner and outer annular portions of said sterilant fluid-receiving chamber.

2. The luer lock connection device of claim 1 wherein:

said chamber is filled with a sterilant fluid.

3. The luer lock connection device of claim 2 wherein:

said sterilant fluid contains iodine.

4. The luer lock connection device of claim 1 wherein said seal means include:

a first resilient seal means exteriorly carried by said hollow tubular portion of said female luer connector member, and

a second resilient seal means interiorly carried by said hollow tubular portion of said female luer connector member.

5. The luer lock connector device of claim 4 wherein the first resilient seal means and the second resilient seal means are comprised of O-ring seal members.

6. Connector apparatus for releasably coupling facing end portions of first and second lengths of tubing and communicating their interiors, said connector apparatus comprising:

a first connector member having;

a hollow, generally tubular configuration,

a first end portion,

a second end portion operably connectable to one of said tubing end portions,

a cylindrical cavity extending axially inwardly from the outer end of said first end portion of said first connector member, said cylindrical cavity having an inner end, and

a hollow tubular male connector portion extending coaxially into said cylindrical cavity from said inner end thereof and being laterally circumscribed by an annular portion of said cylindrical cavity;

a second connector member operably connectable to said first connector member and having;

a hollow, generally tubular configuration,

a first end portion coaxially insertable into said cylindrical cavity toward said inner end thereof and configured to coaxially receive said male connector portion, in a radially outwardly spaced relationship therewith, and create within said cylindrical cavity a sterilant fluid-receiving chamber having an inner annular portion coaxially disposed between said male connector portion and the interior side surface of said first end portion of said second connector member, and an outer annular portion coaxially disposed between the inner side surface of said first end portion of said first connector member and the outer side surface of said first end portion of said second connector member, said inner and outer annular portions of said sterilant fluid-receiving chamber having first ends which are communicated adjacent said inner end of said cylindrical cavity, said second ends which are axially spaced apart from said inner end of said cylindrical cavity, and

a second end portion operably connectable to the other of said first and second lengths of tubing;

thread means on said first and second connector members for releasably locking them in their operatively interconnected orientation;

first resilient seal means for creating an annular seal at said second end of said outer annular portion of said sterilant fluid-receiving chamber; and

second resilient seal means for creating an annular seal at said second end of said inner annular portion of said sterilant fluid-receiving chamber.

7. The connector apparatus of claim 6 wherein:

said chamber is filled with a sterilant fluid.

8. The connector apparatus of claim 6 wherein:

said sterilant fluid contains iodine.

9. The connector apparatus of claim 6 comprising said chamber and sterilant fluid is exposed to gamma radiation.

10. The connector apparatus of claim 6 wherein:

said first resilient seal means include a first O-ring seal member, and

said second resilient seal means include a second O-ring seal member.

11. The connector apparatus of claim 6 wherein:

said first O-ring seal member is exteriorly carried by said second connector member, and

said second O-ring seal member is internally carried by said second connector member.

12. In a tubing set for use with equipment for Continuous Ambulatory Peritoneal Dialysis in which a solution container is coupled via the tubing set to a patient'"'"'s tube that communicates with a patient'"'"'s peritoneal cavity, and with the solution container having a transport port carrying a luer connector and the patient'"'"'s tube carrying a luer connector, the improvement comprising:

a male luer connector member having a central tubular portion outwardly circumscribed by a generally tubular sheath portion and having an open end facing in a first axial direction;

a female luer connector member operatively interconnectable with said male luer connector and having a hollow tubular portion coaxially insertable into said sheath portion to coaxially receive said central tubular portion of said male luer connector member;

cooperating thread means on said male and female luer connector members for releasably holding them in their operatively interconnected orientation; and

means associated with said male and female luer connector members and responsive to their operative interconnection for forming within said sheath portion a sterilant fluid-receiving chamber having;

an inner annular portion coaxially disposed between the outer side surface of said central tubular portion and the inner side surface of said central tubular portion and the inner side surface of said hollow tubular portion of said female luer connector member, said inner annular portion having an annular first end and an annular second end spaced apart therefrom in said first axial direction, and

an outer annular portion coaxially disposed between the outer side surface of said hollow tubular portion of said female luer connector member and the inner side surface of said sheath portion, said outer annular portion having an annular first end, and an annular second end spaced apart therefrom in said first axial direction, said first ends of said inner and outer annular portions communicating with one another; and

seal means, responsive to the operative interconnection of said male and female luer connector members, for forming annular resilient seals around said second ends of said inner and outer annular portions of said sterilant fluid-receiving chamber.

13. In a tubing set for use with equipment for Continuous Ambulatory Peritoneal Dialysis in which a solution container is coupled via the tubing set to a patient'"'"'s tube that communicates with a patient'"'"'s peritoneal cavity, and with the solution container having a transport port carrying a luer connector and the patient'"'"'s tube carrying a luer connector, the improvement comprising:

a first connector member having;

a hollow, generally tubular configuration,

a first end portion,

a second end portion operably connectable to one of said tubing end portions,

a cylindrical cavity extending axially inwardly from the outer end of said first end portion of said first connector member, said cylindrical cavity having an inner end, and

a hollow tubular male connector portion extending coaxially into said cylindrical cavity from said inner end thereof and being laterally circumscribed by an annular portion of said cylindrical cavity;

a second connector member operably connectable to said first connector member and having;

a hollow, generally tubular configuration,

a first end portion coaxially insertable into said cylindrical cavity toward said inner end thereof and configured to coaxially receive said male connector portion, ;

n a radially outwardly spaced relationship therewith, and create within said cylindrical cavity a sterilant fluid-receiving chamber having an inner annular portion coaxially disposed between said male connector portion and the interior side surface of said first end portion of said second connector member, and an outer annular portion coaxially disposed between the inner side surface of said first end portion of said first connector member and the outer side surface of said first end portion of said second connector member, said inner and outer annular portions of said sterilant fluid-receiving chamber having first ends which are communicated adjacent said inner end of said cylindrical cavity, said second ends which are axially spaced apart from said inner end of said cylindrical cavity, and

a second end portion operably connectable to the other of said first and second lengths of tubing;

cooperating thread means on said first and second connector members for releasably locking them in their operatively interconnected orientation;

first resilient seal means for creating an annular seal at said second end of said outer annular portion of said sterilant fluid-receiving chamber; and

second resilient seal means for creating an annular seal at said second end of said inner annular portion of said sterilant fluid-receiving chamber.

14. A luer lock connection device comprising:

a male luer connector member having a central tubular portion outwardly circumscribed by a generally tubular sheath portion and having an open end facing in a first axial direction;

a female luer connector member operatively interconnectable with said male luer connector and having a hollow tubular portion coaxially insertable into said sheath portion to coaxially receive said central tubular portion of said male luer connector member;

cooperating thread means on said male and female luer connector members for releasably holding them in their operatively interconnected orientation; and

means associated with said male and female luer connector members and responsive to their operative interconnection for forming within said sheath portion a sterilant fluid-receiving chamber having;

an inner annular portion coaxially disposed between the outer side surface of said central tubular portion and the inner side surface of said central tubular portion and the inner side surface of said hollow tubular portion of said female luer connector member, said inner annular portion having an annular first end and an annular second end spaced apart therefrom in said first axial direction, and

an outer annular portion coaxially disposed between the outer side surface of said hollow tubular portion of said female luer connector member and the inner side surface of said sheath portion, said outer annular portion having an annular first end, and a annular second end spaced apart therefrom in said first axial direction, said first ends of said inner and outer annular portions communicating with one another;

seal means, responsive to the operative interconnection of said male and female luer connector members, for forming annular resilient seals around said second ends of said inner and outer annular portions of said sterilant fluid-receiving chamber; and

the female luer connector member having a hollow tubular end portion remote from the hollow tubular portion coaxially insertable into the sheath portion of the male luer connector wherein the removed hollow tubular end portion is capped by a capping means.

15. A method for avoiding patient catheter fluid inflow contamination in CAPD by providing a connector device having a sterilant fluid receiving chamber comprising:

filling the chamber during manufacture of the male luer connector with an anti-infective solution which when capped by a female luer connector having a capping means on an outer end portion of a hollow tubular portion aligned axially through the female luer connector, with sufficient fluid to fill the chamber formed by the capped female luer connector and the male luer connector; and

maintaining the fluid in a portion of the male luer connector when the capped female luer connector is removed and connecting the fluid containing male luer connector with the patient female luer connector catheter connection redefining the fluid filled sterilant fluid receiving chamber.

16. In a CAPD apparatus in which a solution container is coupled via flexible tubing to a patient'"'"'s tube that communicates with a patient'"'"'s peritoneal cavity, the improvement which comprises:

a male luer connector member having a central tubular portion outwardly circumscribed by a generally tubular sheath portion and having an open end facing in a first axial direction;

a female luer connector member operatively interconnectable with said male luer connector and having a hollow tubular portion coaxially insertable into said sheath portion to coaxially receive said central tubular portion of said male luer connector member;

cooperating thread means on said male and female luer connector members for releasably holding them in their operatively interconnected orientation; and

means associated with said male and female luer connector members and responsive to their operative interconnection for forming within said sheath portion a sterilant fluid-receiving chamber having;

an inner annular portion coaxially disposed between the outer side surface of said central tubular portion and the inner side surface of said central tubular portion and the inner side surface of said hollow tubular portion of said female luer connector member, said inner annular portion having an annular first end and an annular second end spaced apart therefrom in said first axial direction, and

an outer annular portion coaxially disposed between the outer side surface of said hollow tubular portion of said female luer connector member and the inner side surface of said sheath portion, said outer annular portion having an annular first end, and an annular second end spaced apart therefrom in said first axial direction said first ends of said inner and outer annular portions communicating with one another; and

seal means, responsive to the operative interconnection of said male and female luer connector members, for forming annular resilient seals around said second ends of said inner and outer annular portions of said sterilant fluid-receiving chamber.

17. In a CAPD apparatus in which a solution container is coupled via flexible tubing to a patient'"'"'s tube that communicates with a patient'"'"'s peritoneal cavity, the improvement which comprises:

a first connector member having;

a hollow, generally tubular configuration,

a first end portion,

a second end portion operably connectable to one of said tubing end portions,

a cylindrical cavity extending axially inwardly from the outer end of said first end portion of said first connector member, said cylindrical cavity having an inner end, and

a hollow tubular male connector portion extending coaxially into said cylindrical cavity from said inner end thereof and being laterally circumscribed by an annular portion of said cylindrical cavity;

a second connector member operably connectable to said first connector member and having;

a hollow, generally tubular configuration,

a first end portion coaxially insertable into said cylindrical cavity toward said inner end thereof and configured to coaxially receive said male connector portion, in a radially outwardly spaced relationship therewith, and create within said cylindrical cavity a sterilant fluid-receiving chamber having an inner annular portion coaxially disposed between said male connector portion and the interior side surface of said first end portion of said second connector member, and an outer annular portion coaxially disposed between the inner side surface of said first end portion of said first connector member and the outer side surface of said first end portion of said second connector member, said inner and outer annular portions of said sterilant fluid-receiving chamber having first ends which are communicated adjacent said inner end of said cylindrical cavity, said second ends which are axially spaced apart from said inner end of said cylindrical cavity, and

a second end portion operably connectable to the other of said first and second lengths of tubing;

cooperating thread means on said first and second connector members for releasably locking them in their operatively interconnected orientation;

first resilient seal means for creating an annular seal at said second end of said outer annular portion of said sterilant fluid-receiving chamber; and

second resilient seal means for creating an annular seal at said second end of said inner annular portion of said sterilant fluid-receiving chamber.