CA1155725A - Solution container for continuous ambulatory peritoneal dialysis - Google Patents

Solution container for continuous ambulatory peritoneal dialysis

Info

Publication number
CA1155725A
CA1155725A CA000339221A CA339221A CA1155725A CA 1155725 A CA1155725 A CA 1155725A CA 000339221 A CA000339221 A CA 000339221A CA 339221 A CA339221 A CA 339221A CA 1155725 A CA1155725 A CA 1155725A
Authority
CA
Canada
Prior art keywords
connector
luer lock
luer
tubular member
lock connector
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA000339221A
Other languages
French (fr)
Inventor
T. Michael Dennehey
Ludwig Wolf, Jr.
Richard J. Greff
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxter International Inc
Original Assignee
Baxter Travenol Laboratories Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Baxter Travenol Laboratories Inc filed Critical Baxter Travenol Laboratories Inc
Priority to CA000409716A priority Critical patent/CA1158511A/en
Application granted granted Critical
Publication of CA1155725A publication Critical patent/CA1155725A/en
Expired legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A61M1/285Catheters therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/221Frangible or pierceable closures within tubing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1033Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1066Tube connectors; Tube couplings having protection means, e.g. sliding sleeve to protect connector itself, shrouds to protect a needle present in the connector, protective housing, isolating sheath

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Emergency Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Vascular Medicine (AREA)
  • Pulmonology (AREA)
  • External Artificial Organs (AREA)
  • Quick-Acting Or Multi-Walled Pipe Joints (AREA)

Abstract

ABSTRACT OF THE DISCLOSURE

Equipment for continuous ambulatory peritoneal dialysis in which a solution container is coupled via flexible tubing to a patient's tube that communicates with the patient's peritoneal cavity. The equipment includes a flexible, foldable plastic dialysis solution container having a transfer port. A flexible tube having a luer connector at its distal end extends from the transfer port, for connecting to a luer connector carried by the patient's tube. The flexible tube carries a frangible member which normally blocks fluid flow but permits fluid flow after the frangible member is broken. A particulate filter and a manually-operable clamp are in series with the flexible tube.
Peritoneal dialysis is accomplished by connecting the luer connector from a fresh dialysis solution bag to the patient's tube luer connector, breaking the frangible member, and opening the clamp on the flexible tubing. After the dialysis solution is introduced into the patient's peritoneal cavity and remains there for a predetermined time, the solution is drained back into the flexible bag, the luer connectors are disconnected and the foregoing steps are repeated. If desired, once the dialysis solution has been introduced into the patient's peritoneal cavity, the luer connections may be disconnected and the patient's tube luer connector may be capped.

Description

BACXGROUND OF THE INVENTION
-This invention concerns equipment for continuous ambu-latory peritoneal dialysis and, more particularly, a novel solu-tion container for continuous ambulatory peritoneal aialysis and a novel luer lock assembly for use therewith and for use in other medical applications.
The present invention is particularly suited for use in continuous ambulatory peritoneal dialysis in which a dialysis solution is introduced to the peritoneal cavity of the patient, allowed to remain there for several hours and then drained from the patient's peritoneal cavity with this process being repeate~
on a substantially continuous basis. One manner of achieving this type of dialysis incl~des the steps of connecting a dialysis solution container to a catheter connected to the patient's peritoneal cavity, uncla~.ping the tubing between the dialysis solution container and the patient's peritoneal cavity so as to allow the dialysis solution to flow from the container to the peritoneal ca~ity, thereafter reclamping the tubing, allowing the dialysis solution to remain within the patient's peritoneal cavity for several hours, for example, four hours, unclamping the tubing and draining the solution from the patient's peritoneal cavity back to the dialysis solution container, disconnecting the dialysis solution container from the catheter tube and connecting to the catheter tube a fresh dialysis solution container, and repeating the aforementioned steps.
We have discovered that the aforesaid process can be enhanced with the patient having greater freedom of movement if the dialysis solution container is in bag form, partlcularly a flexible, foldable plastic bag. In this manner, once the dialysis solution has exited the dialysis solution bag, the bag can be
-2-~ 155725 olded and carried about by the patient. A very effective connection and disconnection system between the dialysis solu-tion bag and the patient's catheter tube can be achieved by using a luer lock connector system. In this manner, the transfer tube extending from the dialysis solution bag c~rries a first luer connector and the catheter tube extending from the patient's peritoneal cavity carries a complementary luer lock connector.
The desirability of achieving, in the absence of liquid, and maintaining an uncontaminated connection at the luer connector is apparent and is achieved by means of the present invention.
It has been found desirable for the luer lock connector which is carried by the patient to be of a relatively permanent type, while the cooperating luer lock connector which is carried by the tubing extending from the solution container may be relatively disposable. Further, it is necessary that the luer lock connection be secure and that leakage be prevented in order to prevent contamination which could result in peritonitis.
Where ~he dialysis solution bag is such that it carries a transfer tube extending therefrom, which transfer tube couples to the patient's catheter tube, it may be desirable to prevent the dialysis solution within the dialysis solution bag from flowing into the transfer tube carried by the dialysis solution bag. By utilizing a frangible connector in series with the dialysis solution bag tubing, the flow of dialysis solution from the dialysis solution bag into the tubing can be prevented until the frangible connector is broken.
It is an object of the present invention to provide a novel solution container for continuous ambulatory peritoneal dialysis, which container is constructed so as to permit significant freedom of movement for the patient.
Another object of the present invention is to provide novel means for preventing the solution within the dialysis solution container from flowing into the transfer tubing of the lialysis solution container until a frangible mem~er is broken thereby allowing the connection to be made in the absence of ]iquid.
A further object of the present invention is to provide a novel luer lock connector which maintains the integrity of the connection and alleviates contamination.
Another object of the present invention is to provide a luer lock connection device which includes a seal-type engagement between the male and female luer lock connectors thus preventing leakage and maintaining a water tight bacteria barrier at the connection.
A still further object of the present invention is to provide a luer lock connection device in which one of the luer lock connectors is relatively permanent while the other luer lock connector may be relatively disposable.
Another object of the present invention is to provide a novel solution container for continuous ambulatory peritoneal dialysis having a particulate filter and clamping means in series with the transfer tube extending from the solution container so as to provide a simple but highly effective tubing set carried by the solution container, with the solution container being formed of a flexible, foldable plastic material.
Other objects and advantages of the present invention will become apparent as the description proceeds.

SUMMARY OF THE INVENTION

In accordance with the invention, equipment is provided for continuous ambulatory peritoneal dialysis in which a solution container is coupled via flexible tubing to a patient's tube that communicates with the patient's peritoneal cavity. The equipment comprises a flexible, foldable plastic dialysis solution container having a transfer port extending therefrom. A flexible tube extends from the transfer port and has a luer connection at its distal end for connecting to a luer connection carried by the patient's tube.
In the illustrative embodiment, a frangible member is provided in the flexible tube. The frangible member normally blocks fluid flow in the flexible tube but permits fluid flow after the frangible member is broken.
In the illustrative embodiment, a particulate filter is connected in series with the flexible tube. In addition, a manually-operable clamp is connected in series with the flexible tube.
In the illustrative embodiment, ~he flexible tube has a luer connector at its distal end for connecting to a luer connector carried by the patient's tube. The luer connector at the distal end and the patient's tube luer connector comprise a cooperating male luer lock connector and a female luer lock connector. The male luer connector has a central tubular portion defining an axial bore with at least a portion of the central tubular portion being enclosed by an outer sheath having a generally circular cross-sectional configuration. The outer sheath is internally threaded.
The female luer connector comprises a main tubular member having an outwardly radially extending flange adjacent its distal end. This flange is dimensioned to threadedly cooperate with the internal threads of the male luer connector's outer sheath.
In one illustrative embodiment, an elastomeric member is carried by the female luer connector and is dimensioned and operable for providing a pressure seal-like engagement with the internal wall of the rigid outer sheath of the male connector to aid in maintaining a water tight bacteria barrier at the luer lock connection. Further, the elastomeric member may be swabbed or the chamber defined by the outer sheath filled with a 1 15~725 sterilizing agent by the patient, whi~h would aid in preventing contamination of the system.
Alternatively, in a second illustrative embodiment the female luer connector may have a rigid outer wall portion that is operable with the internal wall of an elas'omeric outer sheath of the male connector for providing the pressure seal-like engagement.
In the second illustrative embodiment, the outer wall portion is contiguous with the external surface of the main tubular member and has a rearwardly extending outer taper. In this manner, the pressure engagement of the internal wall of the outer sheath and the outer wall portion will increase as the male and female connectors are threaded together.
In the second illustrative embodiment, the male and female luer lock connectors are each formed in an integral one-piece construction, and the female luer ~ock connector is formed of stainless steel or titanium to provide a more permanent construction while the male luer lock connector is formed of a resilient plastic material which is readily disposable. It is, of course, apparent that a variety of materials may be used without departir.g from the scope of the present invention.
A more detailed explanation of the invention is provided in the following description and claims, and is illustrated in the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGURE 1 is a view of a solution container for continuous ambulatory peritoneal dialysis, constructed in accordance with the principles of the present invention;
FIGURE 2 is a rear view of a male luer loc~ connector constructed in accordance with the principles of the present invention;

1 ~55725 FIGURE 3 is an elevational view of a male luer loc~
connector constructed in accordance with the principles of the present invention, with portions broken away for clarity;
FIGURE 4 is a front view thereof;
FIGURE 5 is a front view of a female luer lock connector constructed in accordance with the principles of the present invention;
FIGURE 6 is an elevational view thereof, with portions broken away for clarity;
FI~U~E 7 is a greatly enlarged view of a portion of the female luer lock connector of FIGURE 6;
FI~URE 8 is an elevational view, with portions broken away for clarity, of a device for capping the female luer lock connector of FIGURE 6;
FIGURE 9 is an elevational view, with portions broken away for clarity, of a capping device for the male luer lock connector of FIGURE 3;
FIGURE 10 is an elevational view, with portions broken away for clarity, of another embodiment of a female luer loc~
connector constructed in accordance with the principles of the present invention; and FIGURE 11 is an enlarged view of the cooperating portions of the male luer lo~ connector and the female luer loc~
connector of FIGU~E 10.

~ETAIrr~ DESCRIPTION OF
ILLUSTRATIVE EMBODIMENT

Referring to FIGURE 1, a dialysis solution bag 10 is shown therein having ports 12 and 14 extending from one side 16 of the bag 10. Port 14 is capped with an injection site 20 in the illustrative em~odiment.

Solution container 10 is preferably formed of flexible sheet plastic material that is heat sealed at its edges to form a solution bag. Flexible plastic tubing 22 extends from transfer port 12 and is coupled to the inlet 24 of a particulate filter 26, the outlet 28 of which is coupled to flexible tubing 30 carrying a manually operable clamp 32 in series therewith and having a male luer lock connector 34 at its distal end.
Male luer lock connector 34 is connected to a female luer lock connector 36 which is carried at the distal end of a patient's catheter tube 38 which extends into the patient's peritoneal cavity. Additional details concerning the construction of the novel luer lock connection system formed by male luer lock connector 34 and female luer lock connector 36 are set forth below and are illustrated in FIGU~ES 2-9.
A frangible member 40 is positioned in series with transfer port 12 and tubing 22, within the bore defined by the port and tubing. Frangible member 40 blocks fluid flow from transfer port 12 to tubing 22 until the frangible member 40 is broken.
Frangible member 40 is preferably formed of a plastic material which fills the flow path of transfer port 12 and tubing 22, but define~ a central bore through the plastic material which is sealed by a breakoff member 42. When member 42 is manually broken, the dialys~s solution contained by solution bag 10 can flow through the frangible member 40 and thence through tubing 22 and downstream with respect thereto. In this manner, the dialysis solution within solution bag 10 is maintained adjacent transfer port 12 until frangible member 40 is bro~en, and not until the breaking of frangible member 40 can the solution contained within solution bag 10 flow downstream of the frangible member 40.

The filter 26 is a particulate type filter, having a pore size of approximately 5 microns and having a relatively large surface area. It is preferred that the surface area be at least 4 square centimeters and most desirably, ~bout 7 square centimeters.
It is also preferred that filter 26 comprise a hydrophilic membrane filter utilizing air venting by hydropho~ic membranes.
Clamp 32 may be any type of flexible tubing clamp as is well-known in the art, with it preferably being a type of clamp which may be manually engaged and disengaged, using the thumb and forefinger.
U~der certain circumstances, it is believed that certain peritoneal dialysis patients prefer a connection system with respect to the solution container and the patient's catheter tube that does not require the insertion and retraction of a spi~e connector adjacent the solution container. Unless a spike connector is utilized properly, it is possible that the spike may cause contamination resulting in peritonitis. It has thus been discovered that under certain circumstances the use of the luer connection system of the present invention is advantageous, and achieves a connection that is less likely to be contaminated.
Male luer connector 34 is illustrated in detail in Figures 2-4. Referring to these Figures, the male luer connector 34 comprises a central tubular portion 50 defining an axial bore 52, and with the central tubùlar portion 50 extending rearwardly to ~orm a circular insert 50a. ~nsert 50a is solven~ bonded within flexible tubing 30 and extends outwardly by means of a plurality of shoulders 54 to provide an outer sheath 56 which surrounds central tubular portion 50. Outer sheath 56 has a knurled manually-graspable portion 58 and carries first means 66 for co-operative locking with a femal luer connector. First means 60 is illustrated in the form of internal threads 60. The outer sheath 56 aids in preventing touch contamination duringlockinq and/or unlocking of the luer lock connection system and r~
~ _g_ ~erves to carry the threads 60 which are engaqed by second means 62 (Figure 6) for coopera~ive locking with thread 60. Second means 62 comprises a flange 62 (Figure 6) carried by female luer lock connec-tor 36.
Referring to FIGURES 5-7 in which the female luer lock connector 36 is shown in detail, it can be seen that connector 36 comprises a main tubular member 64 having outwardly radially extending flange 62 adjacent its distal end 66. A manually graspable ring 68 surrounds main tubular me~ber 64 and is preferably formed integral therewith, with ring 68 also being formed integrally with a barbed rearward extension 70 for bonded connection within the bore of the patient's catheter tu~e 38. A
knurled portion 72 is provided on the e~ternal surface of ring 68 to aid in manually grasping the same. Rearward extension 70 is coupled to ring 68 by means of a plurality of shoulders 74, and the central tubular member 64 and rearwardly extending member 70 define a common axial bore 76.
The flange 62 is shaped and dimensioned so that when male luer lock connector 34 is engaged with female luer loc~
connector 36, central tubular portion 50 of connector 34 will enter bore 76, and flange 62 will be threaded along threads ~0 to form a locking connection.
The diameter of bore 76 tapers inwardly from distal end 76, to a diameter that is smaller than the external diameter of central tubular portion 50, whereby an engagement will result between the external surface of central tubular member 5Q and the internal wall of tubular member 64.
Referring to FIGURES 6 and 7 in particular, it is seen that a number of projections or rings 78 are carried by tubular mem~er 64 and an elastomeric member 80 surrounds the tubular mem~er 64 and overlies the projections 78. Elastomeric member 80 is has an outwardly extending annular bead 82 utilized for sealing 1 ~55725 urposes. Thus when male connector 34 and female connector 36 are engaged, e~astomeric member 80 will enter outer sheath 56 and a sealing action will occur as a result of annular bead ~2 engaging the internal wall of outer sheath 56. In addition to providing an effective seal to prevent contamination, elastomeric member 80 also acts to provide a water tight bacteria barrier which maintains the integrity of the locking connection thus preventing contamination of the luer connection.
If desired, elastomeric member 80 could be swabbed or the chamber defined by the outer sheath 56 could be filled~by the patient with a s~erilizing agent, such as Betadiné. rt is preferred that the female luer connector 36, with the exception of elastomeric member 80, be formed in a one-piece integral injection molding construction, and that elastomeric member 80 be formed in a subsequent step in the injection molding process during manufacture of the luer connector. Likewise, in this embodiment, it is preferred that the entire male luer connector 34 be formed in a one-piece unitary molded construction.
Referring to FIGURES 10 and 11, an alternative female luer lock connector 202 is illustrated with identical reference numerals indicating the portions of female luer lock connector 202 and male luer lock connector 210 which are identical to portions of female luer lock connector 36 and male luer lock connector 34 respectively.
It can be seen that connector 202 comprises a main tu~ular member 64 having outwardly radially extending flange 62 adjacent its distal end. Main tubular member 64 is contiguous with a manually graspable rin~ 204 which extends contiguously rearwardly from the main tubular member 64, with ring 204 also being formed integrally with a barbed rearward extension 70 for bonded connection with a flexible plastic tube, such as within the bore of the patient's catheter tube in Fontinuous ambulatory 1 155~25 ~eritoneal dialysis. A knurled portion 72 is provided on the rear external surface of ring 204 to aid in manually grasping the same. Rearward extension 70 is coupled to ring 204, and the main tubular member 64 and rearwardly extending member 70 define a coaxial bore 76.
The male luer lock connector 210 used with the female luer lock connector 202 shown in FIGURE 10, is identical to the male luer lock connector 34 shown in FIGUR~ 3 with the exception that the front end 211 of the o~ter sheath 213 or the entire outer sheath 213 is formed of an elastomeric material. This may be accomplished by separately molding the outer sheath 213 and then attaching it to a male luer connector or by providing a unitary member formed of the elastomeric material desired.
Outer wall portion 204 of female luer lock connector 202 has a rearwardly extending outward taper 206 so that the pressure engagement of the internal wall 212 of outer sheath 213 of the male luer connector 210 and outer wall portion 204 will increase as the male and female connectors are threaded together.
The flange 62 is shaped and dimensioned so that when male luer lock connector 210 is engaged with female luer lock connector 202, central tubular portion 50 of connector 30 will enter bore 76 and flange 62 will be ~hreaded along threads 60 to form a locking connection. The internal wall 212 of outer sheath 213 will engage tapered surface 206 of outer wall 204 snugly, and the engagement will become ti~hter as the luer connectors are threadedly closed tighter. In this manner, the cooperation of the internal wall of the outer sheath 213 and surface 206 of outer wall 204 is operable for providing a pressure seal-like engagement to prevent leakage and to aid in maintaining a water tight bacteria barrier.
If female luer lock connector 202 is coupled to a catheter tube which extends to the patient's peritoneal cavity, it 1~55725 is desirable that luer lock connector 202 be formed or a more permanent material. To this end, a stainless steel or titanium connector 202 would be satisfactory.
Under certain circumstances, the patient may desire to disconnect the luer lock connection once the dialysis solu-tion has been introduced into the patient's peritoneal cavity.
For this purpose, a cap 90 (FIGURE 8) for capping the female luer connector is provided which includes a closed top portion 92 and a downwardly extending sidewall portion 94. Sidewall portion 94 defines a bore 96 which has an identical diameter to the opening defined by outer sheath 56, and the internal wall of sidewall portion 94 carries threads 98 which are identical in size and configuration to threads 60. A central tubular portion 50b is also provided. A knurled portion 100 is provided for enabling manual grasping of the cap 90.
Referring to FIGURE 9, a cap 102 for capping t~e male luer connector is provided that is similar in configuration to female luer connector 36 except that it does not include rear tubular connector 70. Identical reference numerals have been used on the FIGURE 9 cap to represent the portions of cap 102 which are identical to portions of female luer connector 36.
It can be seen that instead of bore 76 extending continuously, the bore 76 is capped at its end 104. It should also be realized that male luer lock connector 34 may be carried by the patient's cathe~er tubing 38 with the female luer lock connector 36 being connected at the distal end of tube 30.
As a result of the cooperation of outer sheath 56 and elastomeric member 80, and as a result of the cooperation of outer sheath 211 and outer taper 206, the luer loc~ connection system has a touch-contamination prevention feature and also utilizes a sealed closure device when connected to provide a water tight bacteria barrier, thereby further preventing contamination.

1 ~5~725 Although _wo illustrative embodiments have been shown and described, it is to be understood that various modifications and substitutions may be made by those skilled in the art without departing from the novel spirit and scope of the present invention.

Claims (33)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. Equipment for continuous ambulatory peritoneal dialysis in which a solution container is coupled via flex-ible tubing to a patient's tube that communicates with the patient's peritoneal cavity, which comprises:
a flexible, foldable plastic dialysis solution container having a transfer port extending therefrom;
a flexible tube extending from said transfer port and having a luer connector at its distal end for connecting to a luer connector carried by the patient's tube, said luer connector comprising a cooperating male luer connector and female luer connector, said male luer connector having a central tubular portion defining an axial bore with at least a portion of said central tubular portion being enclosed by an outer sheath having a generally circular cross-sectional configuration, said outer sheath having first means for cooperative locking with a female luer connector; and a female luer connector comprising a main tubular member, said male luer central tubular portion and said female luer main tubular member being cooperative to provide a first liquid seal, said female luer connector having second means for cooperative locking with said first cooperative locking means, and a sealing means for providing a second liquid seal with the internal wall of said outer sheath when the male and female connectors are connected and said first and second cooperative locking means are engaged, to aid in maintaining a water-tight bacteria barrier at the luer lock connection.
2. Equipment as described in Claim 1, said first cooperative locking means comprising an internally threaded wall and said second cooperative locking means comprising an outwardly extending flange adjacent the distal end of the female luer connector.
3. Equipment as described in Claim 1, wherein said sealing means comprises an elastomeric member carried by said female luer connector; said elastomeric member being dimensioned and operable to provide said second liquid seal with said outer sheath.
4. Equipment as described in Claim 1, wherein said sealing means comprises said female luer connector having a rigid outer wall portion that is dimensioned to provide said second liquid seal with the internal wall of said outer sheath; said male luer lock connector being formed of a resilient plastic material.
5. Equipment as described in Claim 2, wherein said flange comprises a single annular member adjacent said distal end.
6. Equipment as described in Claim 2, wherein said flange comprises external threads.
7. Equipment as described in Claim 6, further comprising a particulate filter in series with said flexible tube, and a manually-operable clamp in series with said flexible tube.
8. A luer lock connection device which comprises:
a cooperating male luer connector and a female luer connector;
said male luer connector having a central tubular portion defining an axial bore with at least a portion of said central tubular portion being enclosed by an outer sheath having a generally circular cross-sectional configura-tion;
said outer sheath having first means for cooperative locking with a female luer connector;
a female luer connector comprising a main tubular member, said male luer central tubular portion and said female luer main tubular member being cooperative to provide a first liquid seal, said female luer connector having second means for cooperative locking with said first cooperative locking means; and a sealing means for providing a second liquid seal with the internal wall of said outer sheath when the male and female connectors are connected and said first and second cooperative locking means are engaged, to aid in maintaining a water-tight bacteria barrier at the luer connection.
9. A luer lock connection device as described in Claim 8, wherein said sealing means comprises an elas-tomeric member carried by said female luer connector; said elastomeric member being dimensioned and operable to provide said second liquid seal with said outer sheath.
10. A luer lock connection device as described in Claim 8, said female luer connector having an annular manually-graspable ring extending radially outwardly there-from, said elastomeric member comprising a ring-like member surrounding said central tubular portion adjacent said manually-graspable ring toward said distal end of said female luer connector.
11. A luer lock connection device as described in Claim 8, wherein said sealing means comprises said female luer connector having a rigid outer wall portion that is dimensioned to provide said second liquid seal with the internal wall of said outer sheath; said male luer lock connector being formed of a resilient plastic material.
12. A luer lock connection device as described in Claim 11, said outer wall portion having a rearwardly ex-tending outward taper whereby a pressure engagement of the internal wall of the outer sheath and said outer wall portion will increase as the male and female connectors are threaded together.
13. The luer lock connection device as described in Claim 12, further comprising a knurled, manually-graspable portion contiguous with said outer wall portion; and tube coupling means extending rearwardly from said knurled por-tion.
14. A luer lock connection device as described in Claim 8, wherein said flange comprises a single annular member adjacent said distal end.
15. A luer lock connection device as described in Claim 8, wherein said flange comprises external threads.
16. The equipment for continuous ambulatory peritoneal dialysis of Claim 1 which includes a first luer connector carried by said transfer port; said outer sheath having a threaded internal wall; said female luer connector having external threads adjacent its distal end, said external threads being dimensioned to threadedly cooperate with the threads on the internal wall of said male luer connector's outer sheath, said sealing means comprising said female luer connector being formed of metal and having a rigid outer wall portion that is dimensioned to provide said second liquid seal with the internal wall of said outer sheath, said male luer lock connector being formed of a resilient plastic material.
17. Equipment as described in Claim 16, in which said first and second luer connectors comprise a cooperating male luer lock connector and female luer lock connector, said male luer lock connector having a central tubular portion defining an axial bore with at least a portion of said central tubular portion being enclosed by an outer sheath having a generally circular cross-sectional configura-tion, said outer sheath having a threaded internal wall, and a female luer connector comprising a main tubular member, said male luer central tubular portion and said female luer main tubular member being cooperative to provide a first liquid seal, said female luer connector having external threads adjacent its distal end, said external threads being dimen-sioned to threadedly cooperate with the threads on the internal wall of said male luer connector's outer sheath, and sealing means for providing a second liquid seal with the internal wall of said outer sheath when the male and female connectors are connected, to aid in maintaining a water-tight bacteria barrier at the luer lock connection.
18. The luer lock connection device of Claim 8 in which the first means for cooperative locking with a female luer connector is a threaded internal wall on the outer sheath and the female luer connector has an outwardly extending flange adjacent its distal and as the second means for cooperative locking, said flange being dimensioned to thread-edly cooperate with the threads on the internal wall of the male luer connector's outer sheath.
19. Equipment as described in Claim 1, further comprising a frangible member in said flexible tube, said frangible member normally blocking fluid flow in said flexible tube but permitting fluid flow after said frangible member is broken.
20. The invention of claim 1 or 8, wherein said female luer lock connector is made of titanium.
21. A luer lock connector for attachment to the end of flexible tubing, which comprises: a main tubular member proportioned to sealingly receive a mating luer lock connector within the bore of said main tubular member, said main tubular member being provided with flange-shaped protrusion means extending radially outwardly, said protrusion means being proportioned to cooperate with a matching thread of the mating luer lock connector for attachment thereto, the outer wall of said main tubular member being provided with an annular area spaced from the ends thereof and also spaced from the protrusion means, said annular area defining an enlarged diameter for annular engagement with the mating connector to form a sealing area.
22. The connector of Claim 21 in which said annular area is made of resiliently deformable material.
23. The luer lock connector of Claim 21 in which said annular area is made of a rigid material.
24. A luer lock connector attached to the end of flexible tubing, which comprises: a main tubular member proportioned to sealingly receive a mating luer lock connector within the bore of said main tubular member, said main tubular member being provided with flange-shaped protrusion means extending radially outwardly, said protrusion means being proportioned to cooperate with a matching thread of the mating luer lock connector for attachment thereto, the outer wall of said main tubular member being provided with an annular area spaced from the ends thereof and also spaced from the protrusion means, said annular area defining an enlarged diameter for annular engagement with the mating connector to form a sealing area, said annular area being an integral part of said luer lock connector, said luer lock connector being made of titanium.
25. The luer lock connector of Claim 24 which is free of an attached sleeve surrounding said protrusion means and main tubular member.
26. The luer lock connector of Claim 21 which is free of an attached sleeve surrounding said protrusion means and main tubular member.
27. A luer lock connector for attachment to the end of flexible tubing, which comprises:
a main tubular member proportioned to sealingly receive a mating luer lock connector within the bore of said main tubular member, said main tubular member being provided with flange-shaped protrusion means extending radially outwardly, said protrusion means being proportioned to cooperate with a matching thread of the mating luer lock connector for attachment thereto, the outer wall of said main tubular member being provided with an annular area spaced from the ends thereof and also spaced from the protrusion means, said annular area being made of resiliently deformable material and defining an enlarged diameter for annular engagement with the mating connector to form a sealing area, said luer lock connector being free of an attached sleeve surrounding said protrusion means and main tubular member.
28. A luer lock connector system which comprises a female luer lock connector in locked relation with a male luer lock connector, said female luer lock connector comprising a main tubular member sealingly receiving said male luer lock connector within the bore of said main tubular member, said main tubular member being provided with flange-shaped protrusion means extending radially outwardly, said protrusion means cooperating with a matching thread of the male luer lock connector for attachment thereto in locked relation; the outer wall of said main tubular member being provided with an annular area spaced from the ends thereof, and also spaced from the protrusion means, said annular area defining an enlarged diameter of resiliently deformable material for annular engagement with the male connector to form a sealing area, said female luer lock connector being free of an integrally attached sleeve surrounding said annular area and main tubular member, said male luer lock connector having a central tubular luer portion defining an axial bore projecting in sealing relation into the bore of the main tubular member, said male luer lock connector also defining an outer sheath which surrounds both said central tubular luer portion and the main tubular member, said outer sheath having a generally circular cross-sectional configuration and defining a free annular end, a portion of said outer sheath defining a threaded internal wall portion in locking engagement with the flange-shaped protrusion means of said luer lock connector, said threaded internal wall portion being spaced from the free annular end of said sheath by a portion of the inner surface of said sheath which defines an annular sealing area free of threads, said annular sealing area surrounding said resiliently deformable annular area of enlarged diameter of the luer lock connector in annular sealing relation thereto.
29. The luer lock connector system of Claim 28 in which the free annular end of the outer sheath is positioned beyond said central tubular luer portion to circumferentially enclose the entire length of said central tubular luer portion within said outer sheath.
30. The luer lock connector system of Claim 28 which is attached to tubing communicating with the peritoneal cavity of a patient.
31. A luer lock connector system which comprises a female luer lock connector in locked relation with a male luer lock connector, said female luer lock connector comprising a main tubular member sealingly receiving said male luer lock connector within the bore of said main tubular member, said main tubular member being provided with flange shaped protrusion means extending radially outwardly, the outer wall of said female tubular member being provided with an annular area spaced from the ends thereof and also spaced from the protrusion means, said annular area defining an enlarged diameter for annular engagement with the male connector to form a sealing area, said female luer lock connector being free of an integrally attached sleeve surrounding said annular area and main tubular member; said male luer lock connector having a central tubular luer portion defining an axial bore projecting in sealing relation into the bore of the main tubular member, said male luer lock connector also defining an outer sheath which surrounds both said central tubular luer portion and the main tubular member and is positioned beyond said central tubular luer portion to circumferentially enclose the entire length of said central tubular luer portion within said outer sheath, said outer sheath having a generally circular cross-sectional configuration and defining a free annular end, a portion of said outer sheath defining a threaded internal wall portion in locking engagement with the flange-shaped protrusion means of the female luer lock connector, said threaded internal wall portion being spaced from the free annular end of said sheath by a portion of the inner surface of said sheath which defines an annular sealing area free of threads, said annular sealing area surrounding said flange-shaped protrusion means in annular sealing relation thereto, said outer sheath being made of a resiliently deformable material and said female luer lock connector being made of rigid material.
32. The luer lock connector system of Claim 34 which is attached to tubing communicating with the peritoneal cavity of a patient.
33. The luer lock connector system of Claim 31 in which said female luer lock connector is made of titanium.
CA000339221A 1979-01-23 1979-11-06 Solution container for continuous ambulatory peritoneal dialysis Expired CA1155725A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA000409716A CA1158511A (en) 1979-01-23 1982-08-18 Solution container for continuous ambulatory peritoneal dialysis

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US574879A 1979-01-23 1979-01-23
US005,748 1979-01-23
US2741979A 1979-04-05 1979-04-05
US027,419 1979-04-05

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CA1155725A true CA1155725A (en) 1983-10-25

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CA000339221A Expired CA1155725A (en) 1979-01-23 1979-11-06 Solution container for continuous ambulatory peritoneal dialysis

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AU (1) AU523278B2 (en)
CA (1) CA1155725A (en)
CH (1) CH648758A5 (en)
DE (2) DE7933323U1 (en)
ES (1) ES8101388A1 (en)
FR (4) FR2447198A1 (en)
GB (2) GB2040379B (en)
IE (1) IE49882B1 (en)
IL (1) IL58694A (en)
IT (1) IT1197456B (en)
NL (1) NL184021C (en)
SE (1) SE449564B (en)

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Also Published As

Publication number Publication date
DE7933323U1 (en) 1982-07-15
DE2947574C2 (en) 1984-12-13
IE49882B1 (en) 1986-01-08
FR2522776B1 (en) 1986-03-21
CH648758A5 (en) 1985-04-15
ES487957A0 (en) 1980-12-16
NL184021C (en) 1989-03-16
NL7908349A (en) 1980-07-25
FR2499857A1 (en) 1982-08-20
DE2947574A1 (en) 1980-10-16
IT8019374A0 (en) 1980-01-22
GB2063684A (en) 1981-06-10
FR2447198B1 (en) 1984-03-16
GB2040379A (en) 1980-08-28
FR2522776A1 (en) 1983-09-09
FR2447198A1 (en) 1980-08-22
GB2063684B (en) 1983-06-08
FR2447199B1 (en) 1984-05-25
FR2499857B1 (en) 1985-11-15
SE449564B (en) 1987-05-11
GB2040379B (en) 1983-08-17
FR2447199A1 (en) 1980-08-22
NL184021B (en) 1988-10-17
AU5275379A (en) 1980-07-31
IE800123L (en) 1980-07-23
ES8101388A1 (en) 1980-12-16
IL58694A (en) 1983-02-23
AU523278B2 (en) 1982-07-22
SE7910644L (en) 1980-07-24
IT1197456B (en) 1988-11-30

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