CA1195574A - Continuous ambulatory peritoneal dialysis clamping system - Google Patents

Continuous ambulatory peritoneal dialysis clamping system

Info

Publication number
CA1195574A
CA1195574A CA000418962A CA418962A CA1195574A CA 1195574 A CA1195574 A CA 1195574A CA 000418962 A CA000418962 A CA 000418962A CA 418962 A CA418962 A CA 418962A CA 1195574 A CA1195574 A CA 1195574A
Authority
CA
Canada
Prior art keywords
spike
tube
housing
section
shoulder
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
CA000418962A
Other languages
French (fr)
Inventor
Arthur Lueders
Marc Bellotti
James Fitzgerald
Larry C. Taylor
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
Application granted granted Critical
Publication of CA1195574A publication Critical patent/CA1195574A/en
Expired legal-status Critical Current

Links

Classifications

    • 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
    • A61M39/1011Locking means for securing connection; Additional tamper safeties
    • 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
    • A61M39/16Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • 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
    • A61M39/28Clamping means for squeezing flexible tubes, e.g. roller clamps
    • A61M39/286Wedge clamps, e.g. roller clamps with inclined guides
    • A61M39/287Wedge formed by a slot having varying width, e.g. slide clamps
    • 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
    • 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
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S604/00Surgery
    • Y10S604/905Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

CONTINUOUS AMBULATORY PERITONEAL
DIALYSIS CLAMPING SYSTEM

ABSTRACT OF THE DISCLOSURE
A system is provided for connection of a transfer spike on the end of a tube with another tube, in which the connection portions may be ultraviolet sterilized prior to connection. Both the spike and the tube for connection communicate with a housing member having a tubular, collapsible sheath member which is ultra-violet transparent. Also, a clamping system may be provided for closing flow through the system.

Description

CONTINUOUS AMBULATORY PERITONEAL
DIALYSIS CLAMPING SS{STEM

BACKGROIJMD OF THE INVENTION
_ This invention relates to a connector system, and more particularly, to a system for use in peritoneal dialysis generally.
Specifically, continuous an~ulatory peritoneal dialysis (CAP~ is an increasingly popular form of dialysis. CAPD employs a bag of sterile peritoneal dialysis solution which is opened through a pierceable membrane. The bag is connected to a pa~ient ' 5 peri-toneal cavity through a tubing set whish includes a membrane-piercing spike. In order to perform dialysis, fresh solution in the bag is drained into the peritoneal . 15 cavity and remains in the cavity for the dialysis or ; dwell period, usually four to six hours. ~t the end of that period, spent dialysis solution i5 drained from the cavity back to the bag. Then a second bag of fresh solution is exchanged for the bag of spent solu-tion, is connected to the tubing set, and the cavity : is filled with fresh solution and the dialysis process ; repeated.
One of the principal areas of concern in peritoneal dialysis generally is that the connection between the ~ubing set and the dialysis solution bag must be kept sterile, particularly when the bag memhrane is pierced in order to drain the solution from the bag to fill the peritoneal cavity.
Ultraviolet (W) sterilization is a desirable form ~ ~ 30 of sterilization for use in a peritoneal dialysis pro-3 ~ cedure, particularly CAPD.
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It is an object of this invention to provide such a connector which can be UV-sterilized and easily used by a patient.
This and other objects will become apparent from the following description and appended claims.

SUMMARY OF INVENTION
In accordance with this invention a connector sys~em is provided for use in peritoneal dialysis, and particularly CAPD applications, to connect the patient's catheter to a supply of dialysis solution through a tubing set having a transfer spike and catheter coupler.
The connector may comprise an ultraviolet trans-parent, longitudinally expansible and collapsible housiny member which can receive the transfer spike at one end and which receives a tube from a solution con-tainer at the other end. Clamp means are also provided to permit closing of flow through the solution container tube. When the housing member is in its extended posi-tion, the spike is spaced from a pierceable sealing membrane within the tube of the solution container. When the housing member is in its collapsed position, the spike penetrates the tube of the solution container.
A casing may also be provided to retain the spike and bag tubing in either its position spaced from the pierceable membrane or its position in which it extends through the pierceable membrane.
At least portions of the housing member ar-e desirably ultraviolet transparent, so that after connec~ion of the spike and the ~ubing within the housing member, but before penetration of the pierceable membrane, the in-terior of the housing member can be sterilized hy appli-cation of ultraviolet light from the exterior.
More specifically, the housing member includes a tubular, collapsible sheath m~mber having a collapsible tubular, ultraviolet~transparent, spike-receiving section with a spike-receiving opening on one end, and an inte-gral housing portion at the other end of the spike-receivlng sec~ion.
The housing portion has a tube-receiving opening aligned with the spike-receiving section for receiving a dial~sis solution bag delivery tube typically closed with a pierceable membrane. l'he housing portion also has a transverse slide clamp-receiving slot~
A slide clamp is associated with the housing por tion slo~, the clamp having a tube-grasping slo , and being carried and movable within the housing slot be-tween tube closing and tube opening positions, r~ferring to the dialysis solution bag delivery tube.
As the result of this, the dialysis solution bag delivery tube may be inserted into the sheath through the housing end, and held in a piercing position by moving the slide clamp to the closing position. The transverse spike may be inserted into the sheath at the other end and held for application of ultraviolet light.
After the ultraviolet application, for antibacterial effect within the sheath, the spike is thrust into the dialysis solution bag delivery tube to pierce the mem-brane which closes it, to provide a steril~ connection between the spike and the tube so that the liquid can flow between the solution container and the peritoneal cavity of a patient.
The casing member which retains the transfer spike either in piercing or nonpiercing position may comprise a pair of hinged halves having grooves at each end which are proportioned to grasp clamping shoulders or flanges positioned at opposed ends of the collapsible sheath member, to hold the sheath member in an open position, or alternatively to grasp one end of the collapsible sheath membex and a flange or clamping shoulder on the 5~
'I

spike, to hold the system in collapsed, membrane~
piercing relation.
Various aspects of the invention are as follows:
A connector system for use in peritoneal dialysis applications and the like to connect a patient's catheter to the delivery tube of a supply of dialysis solution through a tube set having a transfer spike and a catheter coupler at opposite ends thereof;
said connector comprising a housing member which includes a tube-like, collapsible sheath member having a hollow, accordion-like ultraviolet transparent splke-receiving section having a spike-receiving-opening at one end of said section and an integral housing section at the other end of said spike-receiving-section, said sheath member also having a pair of shoulder formations~ the first shoulder formation being adjacent the spike-receiving opening and the second shoulder formation being adjacent the housinq, said housing section having a tube-receiving-opening aligned with the spike-receiving section for receiving said delivery tube, and a transverse slide clamp-receiving slot, said slot extending through said housing so as to provide slide clamp-receiving openings at either end;
a bifurcated slide clamp cooperatively associated with said slot, said clamp having a tube grasping slot and being movable within said housing slot between tube closing and tube opening positions;
removable retention casing means having a pair of spaced, shoulder-grasping ends fixedly spaced ~rom one another, said ends being proportioned to grasp said ; pair of shoulder formations for positioning said transfer spike in a spaced position relative to a pierceable membrane in said delivery tube positioned in said opening by preventing collapsing of said sheath member;
whereby said delivery tube may be inserted into said sheath through said housing end and held in a piercing position by moving said slide clamp to said 4a grasping position and whereby said -transfer spike may be inserted into said sheath at the other end and retrained in spaced relation from the pierceable membrane and thereafter thrust toward said tube so as to pierce the membrane associated therewith after removal of the retention casing means.
A connector system for llse in perltoneal dialysis applications and the like to connect a patient~s catheter to a supply of dialysis solution through a tube set having a transfer spike and catheter couple.r, said connection system comprising:
a housing member which includes a tubular, collapsible sheath member having a collapsible tubular ultraviolet-transparent, spike-receiving section with a spike receiving opening at one end, an integral housing portion at the other end of the spike-receiving section, said housing portion having a tube-receiving opening aligned with said spike-receiving section for receiving a dialysis solution container delivery tube closed with a pierceable membrane, and also a transverse, clamp-receiving slot;
a slide clamp cooperatively associated with said housing portion in said slot, said clamp defining a tube-grasping slot and carried and movable within said housing slot between delivery tube closing and delivery tube opening positions;
casing means provided for alternatively retaining a transfer spike in piercing and non-piercin-g positions relative to the anticipated position of the pierceable membrane, said casing means defining slots at opposed ends thereof, and a pair of first and second shoulder formations defined on the spike-receiving, collapsible sheath member whereby said shoulder formations can fit into the slots of the casing to prevent collapse of the sheath member, and said delivery tube may be inserted into said sheath member through the tube-receiving opening and held in position by moving said slide clamp to said closing position, and also a transfer spike may -3 be inserted into said sheath member at the other end ., ~b and held spaced rom the tube end for ultraviolet treatment, and then thrust into said tube end to pierce the membralle associated therewithO
A connector system for connecting a delivery tube, which is normally closed by a pierceable membrane, in flow communication with a tube set, said connector system comprising:
a transfer spike attachable to the tube set, a housing having opposite ends and including:
a Eirst section at one end of said housing releasably attachable to the delivery tube, a second section aligned with said first section at the other end of said housing for releasably inserting said transfer spike, a collapsible section between said first and second sections for moving said housing between an uncollapsed position, in which said spike, when releasably inserted into said first section, is held away from the delivery tube, when releasably attached to said second section, and a collapsed position, in which said inserted spike pierces the membrane of the attached delivery tube, thereby opening flow communication between the deli~ery tube and the tube set, and means defining a first shoulder on said first section and a second shoulder on said second section, and means releasably attachable to said first and second shoulders of said housing for retaining said housing i.n said uncollapsed position during insertion of said spike into said second section.
Other details of the invention are shown in the :~ drawings and specification below.
~, BRIEF DESCRIPTION OF THE DRAWINGS
FIGURE 1 is a diagramma-tic v:iew showing the solution bag, the connector/ the tubing set, the catheter, and the patient;
FIGURE 2 is an exploded perspective view showiny the spike and the connector of Figure l;
FIGURE 3 is a sectional view showing the connector with the spike of Figure l in the non-piercing sterilization position;
FIGURE 4 is a sectional view similar to Figure 3 showing the connector with the spike in the pierced position;
EIGURE 5 is a sectional view taken along line 5-5 of Figure 3 and showing the slide clamp grasping the tube end;
FIGURE 6 is a fragmentary transverse sectional view taken along line 6-6 showing the slide clamp in the non~grasping position:
FIGURE 7 is a perspective view of the slide clamp showing notch-like surface recesses for folding of the : upper clamp section relative to the lower clamp ; section; and : FIGURE 8 is a side elevational view of the clamp in the folded position with the "clamshell" retainer in pOsition.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring now to Figure l, peritoneal dialysis solution bag 10 which has a short delivery tube 11, is shown coupled to a patient 12 through catheter 14, tubing t;~L

set 16, and connector 18. The tubing set 16, which is replaced perhaps once a month~ includes a length of tubing 19, a catheter coupler 20 for connecting the tube set to the catheterl and a transfer spike 25. If so desired, a filter may be included in the tubing set.
The transfer spike 24 and connector system 18, which includes sheath and housing member 26 and slide clamp 28, are shown in Figure 2. Spike member 24 has a central bore 29, a tubing set connecting end 30, a round clamping shoulder 32; a handle or grasping center section 34 which includes a round disc-like member 36;
and a hollow piercing or spiking point 38 having liquid flow ports 40 which communicate with bore 29O
The sheath and housing member 26 includes a hollow spike~receiving sheath mem~er 42, and a slide-receiving housing 44. The spike~receiving section 42 is hollow and tubular, having an accordion-like shape, and is collapsible. Section 42 includes a spike~receiving aperture 46, hexagonal clamping shoulder 48, and convoluted, collapsible, ultraviolet transparent section 50. Second tubular section 52 and second hexa--gonally-~hap2d clamping shoulder 54 are also provided.
Collapsible section 50 may be made of an ultraviolet transpar~nt plastic such as polyethylene or other desired plastic, preferably selected and formed so that at leas~
15 percent of the ultraviolet radiation to which it is exposed passes into its interior for sterilization therein.
Slide housing 44 may be integral with sheath member 42, being connected thereto adjacent to clamping shoulder 54. Housing 44 may be rectangularly shaped, having a transversely oriented slide-receiving slot 56 extending through its central portion, and a pair o stepped stop ledges 58, 60. Slide clamp 28 is preferably insertable into slide housing 44 from either end of slot 56, with leg 67 on either the right or left side of slot 56. Housing ; 44 includes a delivery tube-receiving opening 61 which is ' , aligned with tubular member 52 and is best seen in Figure 4.
Slide member 28 is a bifurcated, fork-like member having a bight or head section 62 that includes a down-ward movement-limiting shoulders 64 which cooperate wi.th the stops 58, 60 in limiting the movement of the slide member relative to th0 housing. A pair of mirror image shaped legs 66, 67 extend from the head section 62. The outer surface of each leg 66 and 67 includes outwardly tapering, shoulder-like intermediate portions 68, and limit shoulder of hooks 70 for limiting upward movement of the slide clamp. The legs 66, 67 are shaped so as to form a thin slot 72 extending from head section 62 downwardly toward an enlarged tube-receiving opening 74. A tapered tube-guiding section 76 connects slot 72 and enlarged opening 74. It will be noted that the shoulder portions 68 are positioned slightly above opening 74, and this provides some spring bias to the slide clamp so as to maintain its position in the hous-ing when the slide is in an upper position where limitshoulders 70 engage the slide housing.
Each of limit shoulders or hooks 70 may define tapering ramp section 70a which permits insertion of the slide into slot 56. Hooks 70 can engage the lower edges of the housing 44 so as to limit upward movement of the slide clamp. ~ooks 70 also can provide alig~ment of opening 74 with housing aperture 61 and sheath tube 52 when they engage the lower edges of housing 44.
A "clamshell" retention casing 78 is provided for positioning spike 24 relative to clamp 28. Casing 78 has two hingedly-connected half sec~ions 80, 82 which may be substantially identical, except that section 80 includes tongue like members 84 and section 82 includes latch-like members 86 for locking cooperation with members 34. Each section includes end wall formations r 87, 88, that de~ine grooves 90, 92, which can receive hexagonally-shaped clamping shoulders 48, 54 on the sheath, and round shoulder 32 on ~he spike to immovably retain the system in connected relation.
Referring now to Figure 3, spike member 24 is shown in a non-piercing st~riliza~ion position. A5 can he seen, casing 78 is shown holding the collapsible portion 50 of the sheath in an expanded posi~ion, with shoulders 48, 54 being held in grooves g2 and 90 of the casing 78, respecti~ely. With this arrangement, pierc-ing spike 24 can be inserted i.nto the sheath/ but it cannot pierce the delivery~tube membrane lla that pre vents flow through tube 11 of bag 10, which is inserted into tube 52 at one end. Tube 11 i5 shown being held in position by slide clamp 28, which has been pressed downwardly so as to grasp and close tube 11 in 510~ 72.
As shown in Figure 3~ pieroeable membrane lla is still sealed. The piercing or transfer spike 24 is inserted into sheath member 50, but by virtue of the casing 78 it is prevented from piercing the membrane 11_.
Figure 5 shows tubing clamp 28 holding tubing 11 in the grasping position shown in Figure 4.
After connection of the parts, clamshell casing 78 can be removed, and sheath section 42, carrying tube end 11, membrane lla, and spike 24 may be placed in an ultra~iolet sterilizer. After appropriate steriliza-tion with ultraviolet light, spike 24 is then thrust through membrane lla so as to pierce the membrane, to permit fluid flow fxom bag 10 through spike 24 and from there to the patient.
~ eferring now to Figure 4, hollow point 38 of spike 24 is shown thrust through membrane lla, and slide clamp 28 .is then raised to the non-grasping, flow permitting position shown in Figure 6.

Once spike 24 has been thrust through member lla, casing 78 is then reapplied to hexagonal shoulder 54, and round shoulder 32 on spike 24 as in Figure 4. This holds the spike in a fluid flow position so that fresh S solution can 10w from the bag throuyh the spike to the patient with hollow point 38 holding tubing 11 in position by friction. After the peritoneal cavity is filled, clamp 28 is moved to its sealing, grasping posi-tion to close o~f tube 11. Casiny 78 can remain attached and clamp 28 can remain in closed position throughout t.he dwell period of the dialysis solution in the perito-neal cavity until it i5 time to drain the cavity of spent solution and to exchange solution bags.
Referring now to Figures 7 and 8, slide clamp 28 includes a pair of transverse lines of folding weakness 65 which permit folding of the clamp to minimi~e its size and facilitate its concealment by the patient dur-ing useO As seen in Figure 7, the lower section 28a of clamp 28 may be folded transversely along the fold lines 65 to a position at right angle with the upper section 28b. I'he folding relative to clampshell casing 78 is shown in Figure 8, wi~h section 28a being bent over toward casing 78, and with tube 11 in cloæed, no-flow position. This folding feature may be used in the solution dwell portion of dialysis.
Integral flexihle strap 96 on clamp 28 limits the spreading of legs 66, 67 to assure the sealing~of tube 11 when placed in slot 72. In operation, slide clamp 28 is inserted into slide housing 44 by aligning clamp 28 with housing slot 56 and then pushing clamp 28 down-wardly.
The clamp entrance ramps 70a engage the edges of slot 56 to biaæ the clamp legs inwardly and permit them to enter the housing. Clamp 28 is pushed downwardly until the hooks 70 emerge from ~he other end of the slot 56, and legs 66 and 67 then snap outwardly and engage the inside walls of the slot. Hooks 70, in coop-eration with the housing provide an upward movement limiting means with clamp opening 74 being aligned with sheath opening 61.
In use, delivery tube lL of a bag 10 is inserted into housing 44, and clamp 28 is then pushed down-wardly to grasp and close tube 11 in slot 7~. The down-ward movement of clamp 28 is limited by the engagementof clamp shoulders 64 with housing ledges 58, 60. Next, casing 78 may be applied to flanges 48, 54 and spike 24 may then be inserted into sheath 42. The spike, sheath and tube end are then sterilized by ultraviolet radia-tion after preferably removing casing 78. During ultra-violet sterilization, spike 24 remains spaced from membrane lla so that the sterile seal has not been pierced.
After sterilization, the spike 24 i5 grasped in one hand, housing 44 i5 ~rasped in the other hand, and 20 the spike is thrust into tube 11 to puncture membrane lla. Thereafter casing 78 is positioned about ~he sheath and spike so as to grasp shoulders 32 and 54 r to hold spike 24 in the piercing position.
Then, clamp 28 is retracted to its open position, so that dialysis solution can flow from bag 10 to the pa~ient. Af~er bag 10 is emptied, clamp 28 is-thrust downward to again grasp and close tube 11, to close the bag during dialysis solution dwell.
During the dwell phase with solution residing in the peritoneal cavity, the bag and connector may be carried ~y the patient about his waist. In order to minimi~e bulk, clamp 28 can be folded about the fold lines as seen in Figures 7 and 8.

t~

When it i5 necessary to drain the peritoneal cavity, clamp 28 i.s folded open and slid outwardly so that spent dialysis solution can be drain~d from the cavity into bag 10. Thereafter, a bag of fresh solu-~ion can be exchanged for the bag of spent solution,and the above procedure repeated.
Spike 24 and especially hollow piercing point 38 are preferably made of an ultraviolet-transparent mater ial to permit antimicrobial effect within bore or lumen 29 upon irradiation by a source of ultraviolet light, for example poly(methylpentene), a polyolefin such as polye~hylene or polypropylene, EEA(poly(ethylene-ethyl acetate)) or poly(chlorotrifluoroethylene).
Sheath and housing member 26 may be made as a separate item from bag 10 and spike ~4, and may be made of a polyolefin such as polyethylene, or other flexible, ultraviolet transparent material such as EEA. Thus the sheath and housing member may be used with different formulations of peritoneal dialysis solution and types of bags, for example. Also, sheath and housing member 26 may be used with currently available bags of peritoneal dialysis sol~tion.
When shoulders 48, 54 are polygonal in shape, and slots 90, 92 in casing 78 are of matching polygonal shape, casing 78 grips member 26 in fixed manner, pre-venting relative rotation therebetween. This facilitates the installation and removal of tube 11 of container 10 into and rom the system, and protects bellows 50.
The above has been offered for illustrative pur-poses only, and is not intended to limit the scope of theinvention of this application, which is as defined in the claims below.

Claims (17)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS
FOLLOWS:
1. A connector system for use in peritoneal dialysis applications and the like to connect a patient's catheter to the delivery tube of a supply of dialysis solution through a tube set having a transfer spike and a catheter coupler at opposite ends thereof;
said connector comprising a housing member which includes a tube-like, collapsible sheath member having a hollow, accordion-like ultraviolet transparent spike-receiving section having a spike-receiving-opening at one end of said section and an integral housing section at the other end of said spike-receiving-section, said sheath member also having a pair of shoulder formations, the first shoulder formation being adjacent the spike-receiving opening and the second shoulder formation being adjacent the housing, said housing section having a tube-receiving-opening aligned with the spike-receiving section for receiving said delivery tube, and a transverse slide clamp-receiving slot, said slot extending through said housing so as to provide slide clamp-receiving openings at either end;
a bifurcated slide clamp cooperatively associated with said slot, said clamp having a tube grasping slot and being movable within said housing slot between tube closing and tube opening positions;
removable retention casing means having a pair of spaced, shoulder-grasping ends fixedly spaced from one another, said ends being proportioned to grasp said pair of shoulder formations for positioning said transfer spike in a spaced position relative to a pierceable membrane in said delivery tube positioned in said opening by preventing collapsing of said sheath member;
whereby said delivery tube may be inserted into said sheath through said housing end and held in a piercing position by moving said slide clamp to said grasping position and whereby said transfer spike may be inserted into said sheath at the other end and retrained in spaced relation from the pierceable membrane and thereafter thrust toward said tube so as to pierce the membrane associated therewith after removal of the retention casing means.
2. A connector system for use in peritoneal dialysis applications and the like to connect a patient's catheter to a supply of dialysis solution through a tube set having a transfer spike and catheter coupler, said connection system comprising:
a housing member which includes a tubular, collapsible sheath member having a collapsible tubular ultraviolet-transparent, spike-receiving section with a spike-receiving opening at one end, an integral housing portion at the other end of the spike-receiving section, said housing portion having a tube-receiving opening aligned with said spike-receiving section for receiving a dialysis solution container delivery tube closed with a pierceable membrane, and also a transverse, clamp-receiving slot;
a slide clamp cooperatively associated with said housing portion in said slot, said clamp defining a tube-grasping slot and carried and movable within said housing slot between delivery tube closing and delivery tube opening positions;
casing means provided for alternatively retaining a transfer spike in piercing and non-piercing positions relative to the anticipated position of the pierceable membrane, said casing means defining slots at opposed ends thereof, and a pair of first and second shoulder formations defined on the spike-receiving, collapsible sheath member whereby said shoulder formations can fit into the slots of the casing to prevent collapse of the sheath member, and said delivery tube may be inserted into said sheath member through the tube-receiving opening and held in position by moving said slide clamp to said closing position, and also a transfer spike may be inserted into said sheath member at the other end and held spaced from the tube end for ultraviolet treatment, and then thrust into said tube end to pierce the membrane associated therewith.
3. The connector system of claim 2 in which said transfer spike carries a third shoulder formation adapted for fitting in an end slot of said casing, whereby the collapsible, tubular, spike-receiving section may be held in collapsed position with one slot of the casing engaging the first shoulder formation and the other slot of the casing engaging the third shoulder formation of the transfer spike.
4. The connector system of claim 3 in which said slide clamp defines a pair of leg sections connected at one end to a head section, said leg sections defining between them a grasping slot into which the delivery tube of the solution container can be placed to close said tube and to grasp it, said slot also defining a tube-receiving opening more remote from the head section than said grasping slot through which the delivery tube can extend in a manner permitting fluid flow therethrough.
5. The connector system of claim 4 in which said casing comprises a pair of casing halves connected together in hinged relation.
6. The connector system of claim 1 in which said transfer spike is transparent to ultraviolet light.
7. The connector system of claim 6 in which said transverse spike is made of poly(methylpentene).
8. The connector system of claim 3 in which said transfer spike is transparent to ultraviolet light.
9. The connector system of claim 8 in which said transverse spike is made of poly(methylpentene).
10. The connector system of claim 1 in which said first and second shoulder formations are of a shape to prevent relative rotation of said tube-like collapsible sheath member with respect to the retention casing means.
11. The connector system of claim 10 in which said retention casing means is proportioned to grasp the first shoulder formation on the sheath member adjacent said housing portion and a third shoulder formation on the transverse spike after advancement of the spike member.
12. The connector system of claim 1 in which said spaced first and second shoulder formations are of a shape to prevent relative rotation of said tube-like collapsible sheath member with respect to the retention casing means.
13. The connector member of claim 12 in which said retention casing means is proportioned to grasp the first shoulder formation on the sheath member adjacent said housing portion and a third shoulder formation on the transverse spike after advancement of the spike member.
14. A connector system for connecting a delivery tube, which is normally closed by a pierceable membrane, in flow communication with a tube set, said connector system comprising:
a transfer spike attachable to the tube set, a housing having opposite ends and including:
a first section at one end of said housing releasably attachable to the delivery tube, a second section aligned with said first section at the other end of said housing for releasably inserting said transfer spike, a collapsible section between said first and second sections for moving said housing between an uncollapsed position, in which said spike, when releasably inserted into said first section, is held away from the delivery tube, when releasably attached to said second section, and a collapsed position, in which said inserted spike pierces the membrane of the attached delivery tube, thereby opening flow communication between the delivery tube and the tube set, and means defining a first shoulder on said first section and a second shoulder on said second section, and means releasably attachable to said first and second shoulders of said housing for retaining said housing in said uncollapsed position during insertion of said spike into said second section.
15. A system as in claim 14 wherein said transfer spike includes means defining a shoulder on said spike, and wherein said retention means is further releasably attachable to said first housing shoulder and said spike shoulder for retaining said housing in said collapsed position.
16. A system as in claim 14 or 15 and further including means defining a slide clamp carried in said first housing section operative for movement transversely of the attached delivery tube between an unclamped position on the attached delivery tube and a clamped position on the attached delivery tube.
17. A system as defined in claim 14 or 15 wherein said collapsible section is made of a material transparent to sterilizing radiation, and whereby, after insertion into said second section, and while said housing is in said uncollapsed position, said spike can be exposed to sterilizing radiation and then later thrust into the delivery tube by movement of said housing toward its collapsed position to pierce the membrane.
CA000418962A 1982-01-11 1983-01-06 Continuous ambulatory peritoneal dialysis clamping system Expired CA1195574A (en)

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US06/338,712 US4473369A (en) 1982-01-11 1982-01-11 Continuous ambulatory peritoneal dialysis clamping system
US338,712 1982-01-11

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JP (1) JPS58502187A (en)
AU (1) AU555682B2 (en)
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CA (1) CA1195574A (en)
DE (1) DE3279563D1 (en)
ES (1) ES8407397A1 (en)
IL (1) IL67507A (en)
IT (1) IT1159814B (en)
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Also Published As

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ES518900A0 (en) 1984-09-16
IT1159814B (en) 1987-03-04
EP0098282A4 (en) 1985-07-30
IT8319023A0 (en) 1983-01-06
DE3279563D1 (en) 1989-04-27
AU1108383A (en) 1983-07-28
US4473369A (en) 1984-09-25
JPS58502187A (en) 1983-12-22
WO1983002395A1 (en) 1983-07-21
EP0098282A1 (en) 1984-01-18
IL67507A0 (en) 1983-05-15
IL67507A (en) 1985-09-29
AU555682B2 (en) 1986-10-02
ES8407397A1 (en) 1984-09-16
BR8208013A (en) 1983-11-08
EP0098282B1 (en) 1989-03-22

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