CA1312017C - Method and apparatus for peritoneal dialysis using a "y" tubing set - Google Patents

Abstract

ABSTRACT
An apparatus for carrying out peritoneal dialysis on a patient having a catheter ending in a patient connector, includes a tubing set in a "Y" configuration, including a first, second and third arm. Each arm has a clamp and terminates in a connector. Along with the "Y"
tubing set are also provided a cover for covering and protecting the patient connector after the tubing set has been disconnected, and a closure for sealing a dialysate container after it has been emptied, so that it can be used in a subsequent procedure as a drain bag.

Description

~ 3 ~ J~

M~HOD ~ND APP~RA~U~_FQR P~RX~ON~ DIAL~SI~
A ~ SÆT
This invention relates to a new llyll tubing set Por use in peritoneal dialysis trsatment. Its major purposes are to reduce infection rate, to simpli~y operational procedure and to provide physical well-being to patients maintained on peritoneal dialysis.
~CRGROUND O~ ~IS INV~IÇ~
The peritoneal dialysis (PD) modality was introduced before Hemodialysis. However, because of the high in~ection rates associated with RD treatment, Hemodialysis has become the major modality used for life support of End-Stage-Renal-Failure. This i5 true for both chronic and acute patients.
Hemodialy~is is a direct treatment of blood using an extracorporeal system with an artificial membrane (kidney). PD uses the principles of osmosis and diffu~ion across the peritoneal membrane to indirectly remove ~oxic waste and substances from the blood, thereby correcting certain electrolyte and fluid imbalance~. By the nature of the operation, PD is a slower but more gentle dialysis technique. The extracorporeal hemodialy~is i~ used more often when rapid and ef~icient dialysi~ i~ nece~sary because of excessive patient load and~or severs renal ~ailure or drug intoxication.
Technically, hemodialysi is more demanding and restrictive for patients than PD. These along with other medical, ec~no~ical and social reasons have re~ulted in steadily increasing use of the simpler PD.
As more attention is paid to PD, new technical improvements are also in~roduced. The current advances in PD have led to an increasing number of patients using PD at home. Some of these advances have introduced dif~erent PD techniques and others have helped to reduce ~ 3 ~ PI

the peritonitis (infection) rate. Peritonitis i5 by far the most serious complication limiting the growth of PD.
The automated PD techniques such as Intermit ent Peritoneal Dialysis (IPD), and Continuous Cyclic Peritoneal Dialysis (CCPD) have proven to reduce thP
risk of peritonitis. However, sincs Continuous Ambulatory Peritoneal Dialysis (CAPD~ is a simpl~r form o~ home PD treatment, the majority of PD patients are trained in this therapy.
With CAPD the patient manually performs four to six fluid exchanges using sterile packaged dialysate.
Between exchanges the patient carries the dialysate in the peritoneal cavity for four or more hours. Of all the PD techniques CAPD has the highest peritonitis rate.
Repeated peritonitis may cause scarring of the peritoneal membrane and may reduce membrane permeability and hence dialysis ef~iciency. These may also lead to premature termination of P~ ther~py for the patient.
Hence the severity and frequency of peritonitis have led to many technical advances and techniques all directed for use with CAPD.
The "povidone-iodine clamp" is supposed to preven bacterial penetration through the catheter lumen. The " W XD Ultraviolet Germicidal Sy~teml' is supposed to reduce bacterial counts during the bag exchan~e. The "Sterile Connection Device" provides sterile ~Iheat-weld~
between the patient line and dialysate solution bag.
The "Peridex CAPD Filter Set" is meant to prevent bacteria from enteriny the peritoneal cavity.
Unfortunately, none of these special devices has proven capable of significantly reducing the peritonitis rate in any controlled studies, and the search has continued for a device or technique which will remove this impediment from the PD population.
The recent application of the "~" tubing set has exhibited a major promise of peritonitis rate reduction 131~

in CAPD. Howevar~ the complexitie~ and unre~ined procedure of the "Y" set have not made ~Iy~ set operation friendly to the patients. Hence, poor patient complianc~, which leads to poor aseptic technique, has mask~d any great beneficial contri~ution o~ the "Y" set to reduction of the peritonitis rate.
Two recent developments of the l~yl~ set will be described subsequently in thi3 disclosure, along with their shortcomingsO This description will be made with reference to the drawings.
GE~ERAL D~5~ lL~Ln~ 5~ A~J~5~
In view of the drawbacks ~f conventional approaches to PD at the present time, as described both previously and subsequently, it is an aim of on~ aspect of this invention to provide an apparatu~ and a method for carrying out peritoneal dialysis, in such a way ~hat the patient does not need to carry the "Y'~ tubing set on his person between treatment~, and such that temporary disconnection ~rom th~ l~yl~ tubing set during PD can be accomplished without significant risk of infeotion.
More particularly, this invention prsvide~ an apparatus for carrying out peritoneal dialysis on a patient wbose peritoneal cavity is in communication, via a tubular pathway, with a patient connector, the apparatu~ comprising:
a tubing set having first, second and third tubing arms, each tubinq arm having a ~irst end and a second end, the irst end of each tubing arm being connected to and in communication with the ~irst ends of the other two arms, first connecting means on the second end of the first tubing arm, said first connecting means being adapted to be connected to said patient connector, second connecting means on the second end of the second tubing arm, said second connecting means being adapted to be connected to a fresh dialysate container ~ 3 ~ 1 2 ~ ~ , third connecting means on the second end of the third tubing arm, said third connecting means being adapt2d to be connected to a drain bag, clamping means at an intermediate loc~tion of each tubing arm, co~er means for covering and protecting the patient connector after the tubing set has been u~ed and disconnected, and closure means ~or sealing a dialysate container after it has been emptied.
Furthermore, this invention provides a method for carrying out peritoneal dialysis on a patient who~
peritoneal cavity i~ in communication, via a tubular pathway, with a patient connector, utilizing an apparatus comprising:
a tubing set having first, second and third tubing arms, each tubing arm having a first end and a second end, the first end of each tubing arm being connected to and in communication with the ~irst ~nds o~ the other two arm~, first connecting mean~ on the second ~nd of the first tubing arml said first connecting means being adapted to be connected to said patient connector, second connecting mean~ on the second end of the second t~bing arm, said ~econd connecting means being adapted to ba connected to a ~resh dialysate container, third connecting mean~ on tha second end of the third tubing arm, said third connscting means being adapted to be connected to a drain bag, clamping means at an intermediate location o~ each tubing arm, cover means for covering and protecting the patient connector after the tubing set has been used and clisconnected, and closure means for sealing a dialysate container a~ter it has been emptied, ~ 3 ~ 2 ~
j said method comprising the steps:
a) closing all said clamping means, then in any order:
b3 connecting the ~irst connecting means to the patient connector, c) connecting the second connecting means to a fresh dialysate container, d~ connecting the third connecting means to a drain bag, in consecutive order:
e) opening the clamping means on the second and third tubing arm~, ~ ) allowing sufficient time for dialysate from said container to 10w through the second an~ third ~ubing arms and into the drain bag, thus flushing the second and third tubing arms, g) closing the clamping means on the second tubing arm, h3 opening tha clampin~ means on the fir~t tubing arm, i) allowing dialysate in the patient's peritoneal cavity to drain into the drain bag, j) closing the clamping means on ~aid third tubing arm, k) opening the clamping meanR on the second tubing arm and allowing dialysate to flow from th~
container into the patient's peritoneal cavity, 1) closing the clampiny means on the second tubing arm, m) clo~ing the remaininy clamping means.
GEN~L DESC~IpTIO~ OF TH~ D~AWINGS
Two embodiments o~ this invention are illustrated in the accompanying drawings, in which like numeral3 denote like parts throughout the several view, and in which:

~ 3~ 7;~

Figure 1 i5 perspectiYe view of a first embodiment o~ this invention, and is also use~ul for an understanding o~ the prior art;
Figure 2 is a perspective view oP a cover means and its associated cap ~or use in associatiQn with the tubing set forming part o this invention;
Figure 3 is a blind spike useful in carrving out one form of this invention;
Figure 4 is a perspective view o~ a dif~erent "Y"
tubing set forming the second embodiment of this invention;
Figure 5 is a partial axial sectional view of the item shown in Figure 2;
Figure 6 is a perspective view of an optional tray which can be used to facilitate the method of this invention;
Figure 7 i5 a perspective view o~ one end o~ a patient trans~er set; and Figure 8 i~ an e~ploded per~pective view of a cartridge for use in a variant o~ this invention.
D~TAIL~D ~ESCRI~TIO~ OF T~ DRAWING5 Attention i~ first directed to Figur~s 1 and 5, which show an integral cover 10 which includes a substantially cylindrical central probe 12 with a leading end 14. The probe 12 i~ hollow, as can be seen at 16 in Figure 5, the hollow interior o~ the probe 12 communicating with a reces~ed cham~er 18. It will be seen that the chamber 18, including the hollow interior 16 o~ the probe 12, i~ blind at the rightward end in Figure 5, and opens only through the leading end 14 of the probe 12. The cover 10 ~urther includes a cylindrical portion 20 which is substantially coaxial with the probe, and has an internal thread 22, the purpose of which will become clear in what ~ollows.
The cover 10 further defines an additional chamber IL312~ .

24 o~ annular configuration lying outside of the probe 12 and inside the cylindrical portion 20.
The cover which is illustrated at 10 in Figure 5 is adapted to close a connector shown at 26 in Figure 7, and shown partly in sertion in Figure 5.
Looking at Figure 7, the connector 26 has a rearward portion 28 exhibiting two ~lats at 29 for ease of handling, and having a standard tubular portion adapted to connect to a flexible tubing 30 which may be either the patisnt's catheter or the tube of a transfer set which in turn is connected to the patient's catheter. In Figure 7, the le~tward end o~ the connector 26 i5 covered by a resilient sleeve member 32 which is shown in broken lines in Figure 5. The slPeve 15 member 32 covers and protects a ne¢k portion 34 ~se2 Figure 5) having an open central pas~ageway 36, and having an external thread 38. A~ can be seen in Figure 5, the external thread 38 engages ~he internal thread 32, and at the same time the leading end 14 of th~ probe 20 12 enters the passageway 36. The probe 12 i~ sized to be snugly received in tha passageway 36.
The Figure~ show that the remainder of the cover lO
(the portion to the right in Figure 5) iæ shaped to define two ~lats 40, on oppo~ite ~ides, to ~acilitate manipulation.
In Figure 7, a conventional clamp is ~hown at 42.
Figur~ 7 can also be taken to represent the condition of a typical tran~er set, as packaged. In accordance with one aspect o~ this invention, the packaged trans~er set (ready to be connected to the patient's catheter and then to the tubing set) would include a cover 10 exactly as described above. I~hen the connector 26 (Figure 7) is ready to be connected to the tubing set, ~he cover 10 shown in Figure 7 (i.e. the original cover closing the connector 26 of a transfer ~L3~2~

set in the packaged condition) is removed by rotating counterclockwise a~d then is discard~d.
The connector 26 shown in Figure 7 i~ then ready to be connected to the tubing set leading to one or more dialysate bagæ and one or more drain bags or the equivalent.
The Prior Art Earlier in this specification mention was made of recent developments involving "Y" tubing 5et5. In actual fact, ~Y~ tubing set~ have been used ~or manual PD treatment for many years be~ore CAPD wa5 developed.
The major difference i~ that the CAPD 7Iyl1 set is much simplified, with no sampling port or drip chambers.
The conventional CAPD ~yl~ set is represented in Figure l. It i5 COmpOSQd oP a stem CB, and two arms AB
and B~. The stem CB i~ identified by the numeral 50, and the arms AB and BD are represented by the numerals 52 and 54, respectively. The arm A~ (52), intended for connection to the dialysis solution container, is normally longer than the drain arm BD (54~. The stem CB
(50j is connected to the patient oonnector, shown at 26 in Figure 7. It should be noted that the connect4r 26 can be placed at the snd o~ the catheter itself, or more commonly constitutes one end o~ a trans~er set, which is a shor tubular item which is in turn connected to the patient's catheter. In the remainder o~ thi~
disclosure and th~ appended claims, the item 26 shown in Fiyure 7 will be re~erred to as the patient connector, whether that connector i~ on a transfer set or directly on the patient catheter.
Generally, the "Y" set described above is replaced once a month because of the danger of in~ection arising if the "Y" is removed. As a result, the CAPD patients have to wear the "Y" set between dialysis fluid exchanges. In order to maintain the integrity of the ~3~2~ ~ J) "Y" set, ~he arms AB and BD of the set, when not being used, are filled with disinfectant and then capped of~.
To perform fluid exchangeO the arm AB is connected to a new dialysate container. The tip of arm BD is suspend~d over a drain container. The two arms are then unclamped. A small amount of the fresh dialysate is used to rinse out the di3infectant from the arms AB and BD, whereupon the arm AB i again clamped. Ths tube CB
is unclamped and the patient drains out the spent dialysate from the peritoneal cavity into the drain container along CB and ~D.
At the end of the drain, the line BD is closed and line AB is opened again. The rest o~ the fresh dialysate is passed into the patient. ~hen the dialysats container is emptied, the stem c~ is clamped and the arm AB i5 removed from the empty container.
Then, the two arms ~B and BD are completely filled with disinfectant and capped off. The patient roll~ up the whole "Y" set, stores it in a special bag and carries it on the body until the next exchange.
rrh~ main shortcoming~ of the above-described current "~" set procedure ara:
(i) The bulkiness of the tubing set that the patient~ have to carry with them at all times.
(ii) The risk of a¢cidental infusion of disin~ectant into the peritoneum cavity. This is known to cause "chemical'l peritonitis which may cause scarring of the peritone~l membrane. Above all it is a painful incident, eRpecially if the disinfectant used is ~muchina.
(iii) The operation is long, complicat~d and requires many containers and bottles. Hence the exchange procedure is preferably carrled on at one set location each time.
Some attempts have been made to reduce the above-mentioned deficiencie~ o~ the "Y" set. The second-7 ~1 3 :~L 2 ~ :~! PJ

generation llylt sets are meant to be non wea~ables. They are generally in the same ~orm as shown in Figure 1, but they include a drain bag attached to the drain arm DB.
During operation of the second generation "Y" set, the spent dialysate is collecte~ in the drain bag. When the fresh dialysate is completely emptied into the patient, the l-y-l set is discarded. A special connector covsr is used to cap of~ the patient connector.
Because the second-generation l~yl7 set comes with a drain bag, the co~t o~ thi~ set i5 unfortunately high.
Since the procedure is done four to six times a day, seven days a wPek, the annual operational cost per patient is very high indeed.
The Pre~ent Invention The pre~ent "Y" set invention eliminates the shortcomings of all the other "Y" sets so far in~roduced into the PD modality. Above all, this "Y" se could be used for both manual PD and C~PD treatment~.
One ~orm of thi~ invention i5 con~titu ed by a package which contains the "Y" set shown in Figure 1, the item shown in Figure 2, and optionally the item sho~n in Figure 3. All o~ thQse are supplied in sterile condition in a single P~ package.
The conne~tQr 60 mate~ with the patient~s catheter ~5 connector or transfer ~et connector. I~ a trans~er set i~ used, th~ trans~er set is attached to the patient's PD catheter and the transfer s~t i~ changed either once a month or once every six months or more. The connector to which the connector 60 is attached is referred to in th2 claims a~ the "patient connector". The connectors and clamps are preferably colour coded for easy identification. Th~ patient connector 60 and clamp 61 may be white, the fill connector 6~ and clamp 65 may be colored red, and the drain connector 6~ and clamp 6g may be blue. The connector~ 6~ and 68 are identical and have the conventional "spike" shape. They are protected ~ 312 9 ~
by conventional covers 71, which are removed prior to a treatment. The ~ill line is connscted to a fresh dialysate container by means of the red connector A.
The drain line is connected to an empty dralnage bag by means of the blue connector 68. The empty drainage bag is obtained by utilizing the empty ~resh dialysate bag at th~ end of the previous ~luid exchange.
The type of "Y" set connectors and accessories required will depend on the type of fresh dialysate containers in use. The "Y" set used ~or fresh dialysate bags which accept spikes, has connectors 64 and 68 as red and blue spikes respecti~ely (using the color kay suggested above). The set is also packaged with connector cover 10 and cap 53 (pre~illed with disinfectant), and optionally a blua closed spik~ 70 seen in Figure 3. The spike 70 is identical externally to the connectors 6~ and ~8, the only di~ference beinq that the internal passageway 71 is closed by an internal partition (not visible).
During dialysate exchange the patient closes all clamps and connects the "Y" set to the patient connector. The red connector 64 is connected to a fresh dialysate bag. A closed blue spike like that in Figure 3 i~ removed ~ro~ the empty dialysate bag saved from the ~5 previous exchange. The blue connector ~8 o~ th~ "Y" is ins~rted into the empty dialysate bag. Thi~ bag now becomes th~ 2~pty drain bag.
To per~or~ Flush-Be~ore-Fill, which is v~r,v important, the white clamp 61 remains closed while the red fill clamp 65 and the blu~ drain clamp sa are opened for approximately five second~. This causes the lines AB and ~D to be flushed with ~resh dialysate. Next, the red clamp 65 on fill line AB is closed and the white clamp 61 on the patient line CB is opened. The spent dialysate drains out ~rom the patien~ into the drain bag along CB and BD. At the end of the drain phase, the ~ 3 ~

blue clamp 69 on the drain line BD i5 closed. The line AB (red clamp 65) is opened again to allow fresh dialysate to fill ~he patient.
When the dialysate bay is empty, all the line clamps 61, 65 and 69 are closed. Tha '~Y'9 sQt is disconnected ~rom the transfer set (the patient connector). The main body of the connector cover 10 is used to cap-off and protect the patient connector (e.g.
the connector leading to ~he patient's catheter). The red fill spike 64 is removed ~rom the empty dialysate bag. In its place, the sterile closed blue spike 70 is inserted into the empty bag and æafely kept for the next fluid exchange. This bag will serve as the empty drainage bag for the next exchangeO
The l~y~ set used for ~uer Lock dialysat~ solution bags ~uch as Travenol (trade mark) System II bag~), comes wi~h r~d and blue ~emale Luer connectors 6~a and 68a respectively. See Figure 4. Thi "Y" set version is packaged with only the connector cover 10. The blue closed spike 70 is not included because it is not used here.
During exchange the l-y-' ubiny set of ~igure 4 is applied in the same mann2r a~ described above with respect ~o Figure 1. The only diP~rence is the disconnection proc2dure from the transf~r set. The first step is to re~ove the lly-' set rom the transfer set ~patient conn~ctor). The male body o~ the connector cover 10 is used to cover and prot~ct the patient (trans~er set) connector. The empty dialysate bag is disconnected ~rom the red fill connector 6~a.
Then the blue female cap 53 o~ the cover 10 is used to close the empty dialysate bag. This closed empty bag is saved to be used as a drainage bag during the next fluid exchange .
A second version 9~ this invention is such that the '~Y" set has multiple "arms" A~ (52) with a corresponding 13 ~ ~3~
numb~r of fill connectors 64 or 64a. These multiple arms make it possible to connect the '~Y" ~et to many dialysis solution containers at the same time. The second version of the "Y" ~et could be used in many ways for peritoneal dialysis trea~ent. How~ver the two major applications are:
(~) for setting up a CAPD syste~ ~or a patient unable to perform his/her own ~olution containex connection (i.e. very old patient~, blind pati2nts and children) and (b) for initiating peritonitis treatment protocols.
When using this second ver3ion for regular peritoneal dialysis a multiple of fresh dialysate containers would be set up only once under controlled aseptic conditions. The patient then connects his cathet~r or transfer set (the patient connector) to the "Y" set for fluid exchange, For each fluid exchange, only one fresh dialysate container is used. The other fresh dialysate container~ remain closed up. After each ~ill the patiant disconnects completely from th~ system u~ing the connector cover 10 to cap-of~, protect and disinfect the patient connector. The cap 53 of cover 10 is used to cap-o~ protect and di~infect th~ "Y" set connector 60~
To reconnect th~ patient back to th~ syste~, the cover 10 i5 rsmoved from the patient COnnQCtor~ the cap is r~moved ~rom connector 60 of the '~Y" set, and immediately the patient connector is reconnect~d to connector 60.
When using the second version ~or peritonitis treatment protocol, a number o~ ~resh dialysate containers are set up at the same time. The antibiotic doses are added to the required number of dialysate containers. The containers o~ fresh dialysate without antibiotic are first used to quickly ~lush the peritoneum cavity. Then the dialysate con~ainers with l ~c~

an~iblotic are used one by one to provide treatmQnt to the patient.
This l-y'- set invention therefore is functionally superior to the other l-yl' set~ currently in use.
(i) The patients do not have to wear the bulky set between dialysate exchange: it is a non-wearable set.
(ii) No disinfectant of the '~Y" arms is neces ary, which therefore lo (a) eliminates accidental infusion o~ disinfectant into patients, (b) eliminates accidental bleaching of patient's clothing (c) shortens fluid exchange time, and (d) requires no bulky disinfectant containers or disinfectant applicator~ to be carried around.
tiii) Th~ cover 10 (supplied prefilled with disinfectant) enables easy and ~uick cap-o~ of the patient connector.
(iv) The two parts of the connector 10 are functionally useful, thus reducing cost.
(v) The saving of the empty dialysate bag (or container) to be u~ed as tha next drainage bag reduce~
the C09t of tha system.
(vi) Color~coded connectors and clamp~ provide easy identific~tion of lines, ensure a short training period and eliminate operational errors.
(vii) The absencs 9f a fixed bag on the drain line ~acilitate~
(a) the collection o~ an effluent sample for te~ting;
(b) the draining o~ excess fluid from the patient;

(c) open draining into any receptacle if so desired by patisnt~, and (d) the reduction of costsO

15 i ~ 2~
A special "Y" set organizer 76 is also provided ~Figure 6). During fluid exchanges the lly~t set and accessories are arranged in an orderly fashion on the org~nizer 76. It simplifies material handling and ensures systematic operation o~ the procedure~
Looking at Figure 6, the orga~izer 76 is in the form of a horizontal plate which can b~ clamped to an upright pole 78 by means of a clamp 80. The organizer 76 provides 3 slot9 82, ~3 and 84, along wikh two lo recesses 86 and 88. The connectors 64, 60 and 68 ar~
shown to be received in the slots 82, 83 and 84, respectively, while the co~r lo an~ its associated cap 53 is received in the recess 86. The other xeces~ 88 allows storage of cap 53 when removed from the cover lo.
It will be useful hexe to recapitulate the variou~
process steps involving hook-up, drainage o~ previou~
dialysate fro~ the patient, and filling the patient with new dialysate~
The first operation is to connect the "Y" tubing set to the new dialy~ate bag, to the drainag~ bag, and to the patient connector (typically a connector on the end oP ~h~ patient's transfer set). For this operation the organizer 7G shown in Figure 6 is u~eful.
Before connecting these various connectors, all o~
the clamps 61, 65 and 69 are clos~d. Then, in any order, the ~ollowing i~ done: 1) the connector 60 i5 connected to the patient connector; 2) the connector 54 is connected to a fresh dialy~ate container or bag; and 3) the connector 6~ is connected to a drain bag.
The clamps 65 and ~9 on khe arms 52 and 54 are then opened, so that dialysate from the container of fresh dialysate can flow through the second and third tubing a~ms 52 and 54 and into the drain bag. This procedure takes about five seconds, and accomplishe~ the flushing out of the second tubing a~ms 52 and 54.

1~
The clamp ~5 on arm 52 is then closed, and the clamp 61 on the ~irst tubing ar~ 50 is opened. Any clamp on the patient's catheter or transfer set ~hould also be opened at this point. Since the tubing arm 50 and 54 are now open, dialysate in the patient' 5 peritoneal cavity can drain into the drain bag. Once this has been accomplished, the clamp 69 on the tubing arm 54 is closed.
By now opening the clamp 65 on the tubing arm 52, dialysate can Plow fro~ th~ container of ~resh dialysat~
into the patient'~ peritoneal cavity. A~tex this s~ep has been completed, all remaining clamps are closed.
In the event that the patient needs to tempor~rily disconnect from the tubing ~et (and reconnect to i~ at a later time), the procedure is as ~ollows:
1) the patient conn~ctor is disconnected from the connector 60 after all clamp~ have been closed;

2) the cap 53 is then removed ~rom the cover 10 and, in any order:

3) the cover 10 is connected to the patient connector, and 4~ the cap 53 i5 ~onnected to the connector ~0.
The patient can then go to ~o~ other part o~ the hospital ~or tests, etc., u~a the wa~hroom, or whatever, and then return to the dialysi~ apparatu~ and reGonnect the patient co~nector ~-o the connector 60. Because both o~ these joined elements have heen in contact with di~in~ectant, the risk of infecting the patient's peritoneal cavity is virtually non-exi~tent.
In Figure 8 is illustrat~d a cartridge 73 and a cap 75 therefor. The cartridga 73 is sized to snugly receive the end of the spike 64, and i~ useful in the event that the user wishe~ to re-use a llyll tubing set for several dialysis treatments (rather ~han being thrown away after a single treatment). ~he cartridge is capped and filled with liquid di~infectant, when D

initially provided. At the end o~ a treatment, the spike 64 is removed rom the dialysate bag and i~
inserted into a cartridge 73. This will maintain the spike 64 in an antiseptic condition between sequential uses of the "Y" tubing set. To re use the tubing set, the cartridge 73 is removed and the spik~ 64 i~ inserted into the next dialysate bag.
While several embodiments o~ thi invention have been illustrated in the accompanying drawings and des~ribed hereinabove, it will be evident to those skillPd in the art that changes and modifications may be made therein without department from the essence of this invention, as set ~orth in the appended claims.

Claims (10)

1. An apparatus for carrying out peritoneal dialysis on a patient whose peritoneal cavity is in communication, via a tubular pathway, with a patient connector, the apparatus comprising:
a tubing set having first, second and third tubing arms, each tubing arm having a first and and a second end, the first end of each tubing arm being connected to and in communication with the first ends of the other two arms, first connecting means on the second end of the first tubing arm, said first connecting means being adapted to be connected to said patient connector, second connecting means on the second end of the second tubing arm, said second connecting means being adapted to be connected to a fresh dialysate container, third connecting means on the second end of the third tubing arm, said third connecting means being adapted to be connected to a drain bag, clamping means at an intermediate location of each tubing arm, cover means for covering and protecting the patient connector after the tubing set has been used and disconnected, and closure means for sealing a dialysate container after it has been emptied.

2. The apparatus claimed in claim 1, in which the cover means, as initially provided, is closed by a cap, both the cover means and the cap being filled with disinfectant, said cap being adapted to seal said first connecting means after disconnection of the tubing set from the patient connector, while the cover means closes and protects the patient connector, in order to allow the patient to completely disconnect from the tubing set for a lengthy time before reconnecting back to the same set to continue with the treatment.

3. The apparatus claimed in claim 1, in which the cover means, as initially provided, is closed by a cap, both the cover means and the cap being filled with disinfectant, said cap constituting said closure means for sealing a dialysate container after it has been emptied.

4. The apparatus claimed in claim 1, in which the closure means is a closed spike, said second connecting means being an open spike.

5. The apparatus claimed in claim 1, in which the tubing set further comprises at least one additional arm, each additional arm communicating with said first and third tubing arms and having intermediate clamping means, each additional arm having an additional connecting means, each additional connecting means being adapted for connection to a different container of fresh dialysate.

6. The apparatus claimed in claim 5, in which the cover means, as initially provided is closed by a cap, both the cover means and the cap being filled with disinfectant, said cap being adapted to seal said first connecting means after disconnection of the tubing set from the patient connector, while the cover means closes and protects the patient connector, in order to allow the patient to completely disconnect from the tubing set for a lengthy time before reconnecting back to the same set to continue with the treatment.

7. A method for carrying out peritoneal dialysis on a patient whose peritoneal cavity is in communication, via a tubular pathway, with a patient connector, utilizing an apparatus comprising:
a tubing set having first, second and third tubing arms, each tubing arm having a first end and a second end, the first end of each tubing arm being connected to and in communication with the first ends of the other two arms, first connecting means on the second end of the first tubing arm, said first connecting means being adapted to be connected to said patient connector, second connecting means on the second end of the second tubing arm, said second connecting means being adapted to be connected to a fresh dialysate container, third connecting means on the second end of the third tubing arm, said third connecting means being adapted to be connected to a drain bag, clamping means at an intermediate location of each tubing arm, cover means for covering and protecting the patient connector after the tubing set has been used and disconnected, and closure means for sealing a dialysate container after it has been emptied, said method comprising the steps:
a) closing all said clamping means then in any order:
b) connecting the first connecting means to the patient connector, c) connecting the second connecting means to a fresh dialysate container, d) connecting the third connecting means to a drain bag, in consecutive order:
e) opening the clamping means on the second and third tubing arms, f) allowing sufficient time for dialysate from said container to flow through the second and third tubing arms and into the drain bag, thus flushing the second and third tubing arms, g) closing the clamping means on the second tubing arm, h) opening the clamping means on the first tubing arm, i) allowing dialysate in the patient's peritoneal cavity to drain into the drain bag, j) closing the clamping means on said third tubing arm, k) opening the clamping means on the second tubing arm and allowing dialysate to flow from the container into the patient's peritoneal cavity, l) closing the clamping means on the second tubing arm, m) closing the remaining clamping means.

8. The method claimed in claim 7, in which said cover means is initially closed by a cap, both the cover means and its cap being filled with disinfectant, and in which the patient is able to temporarily disconnect from the tubing set and reconnect at a later time by n) disconnecting the patient connector from said first connecting means, o) removing the cap from the cover means,then in any order:
p) connecting the cover means to the patient connector, and q) connecting the cap to said first connecting means.

9. The method claimed in claim 7, in which, after all of the dialysate has been transferred to the patient's peritoneal cavity, the original dialysate container is re-used as a drain bag.

10. The method claimed in claim 7, in which the apparatus includes at least one cartridge containing disinfectant, the cartridge being adapted to close and disinfect said second connecting means, whereby the tubing set can be used for more than a single dialysis treatment.