CA2246455A1 - Reservoir for preparing dialysates - Google Patents
Reservoir for preparing dialysates Download PDFInfo
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- CA2246455A1 CA2246455A1 CA002246455A CA2246455A CA2246455A1 CA 2246455 A1 CA2246455 A1 CA 2246455A1 CA 002246455 A CA002246455 A CA 002246455A CA 2246455 A CA2246455 A CA 2246455A CA 2246455 A1 CA2246455 A1 CA 2246455A1
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- Prior art keywords
- reservoir
- fluid
- dialysis
- inner chamber
- powder material
- 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.)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
- A61M1/1666—Apparatus for preparing dialysates by dissolving solids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
- A61M1/1668—Details of containers
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Urology & Nephrology (AREA)
- Anesthesiology (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Emergency Medicine (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- External Artificial Organs (AREA)
Abstract
The present invention relates to a reservoir for storage and supply of a soluble powder material for use in a haemodialysis, haemofiltration or haemodiafiltration procedure, the reservoir having a fluid inlet means adapted to be releasably connected to a fluid supply line and a fluid outlet means adapted to be releasably connected to a fluid discharge line via which a dialysis solution comprising a solution of the soluble powder material in a fluid supplied in the fluid supply line is supplied to a dialysis apparatus during a haemodialysis, haemofiltration or haemodiafiltration procedure;
characterised in that the reservoir has at least one openable and securely reclosable access port through which, when open, the soluble powder material may be supplied to or removed from the reservoir.
characterised in that the reservoir has at least one openable and securely reclosable access port through which, when open, the soluble powder material may be supplied to or removed from the reservoir.
Description
RESERVOIR FOR PREPARING DIALYSATES
The present invention relates to a reusable reservoir for use in a haemodialysis. haemofiltration or haemodiafiltration procedure.
Haemodialysis is a method of cleansing the blood of patients whose kidney function is impaired. In haemodialysis procedures, the patient's blood is supplied to one side of a permeable membrane located in a dialysis apparatus. Dialysis membranes are usually formed ~om polyacrylonitrile or polysulphone. To the otherside ofthe membrane is supplied a dialysis fluid Cont~ining an electrolyte solution.
In a dialysis procedure, the patient's blood is pumped against the membrane, m~int~ining a controlled low positive blood-to-dialysate pressure ~radient. By reverse osmosis waste products in the blood diffuse through the membrane into the dialysis fluid.
Haemodiafliltration and haemofiltration procedures also take advantage of permeable filter membranes to remove blood waste products. In both procedures, a more perrneable filter is used than in haemodialysis and the consequent blood fluid loss is greater than in haemodialysis. Normally, this fluid must be replaced at least in part, for exannple by one of the methods described above. Haemodialysis, haemodiafiltration and haemofiltration procedures all require the use of an electrolyte-cont~ining fluid either as a dialysis fluid or as a fluid replacement fluid, or both. Historically, different electrolyte mixtures have been used, the choice being influenced by a large number of technical considerations such as the type of apparatus available, the effects of any given elec$rolyte and also the chemical stability of certain electrolyte-containing solutions. For example, when artificial kidney rnachines were first used in the l~50's and 19601s, dialysis fluid cont~ining as its principal component sodium bicarbonate was prepared in large batches prior to use in a number of treatment sessions. Sodium bicarbonate was a natural choice because of its inherent buffering capacity. However. technical difficulties wer.e encountered especiallv with regard to unwanted precipitation of calcium and ma~nesium carbonates in the pre-formed batches. To prevent this unwanted precipitation. it was necessary to bubble carbon dioxide gas through the solution continuQusly, a costly and inconvenient procedure.
Durin~ the 1 960's sodium acetate was used in preference to sodium WO 971:29796 PCT/GB97/00460 bicarbonate. Sodium acetate was perceived to have a number of advantages over sodium bicarbonate. These inc}uded an absence of problems with precipitation of insoluble salts in the dialysis solution. Sodium acetate was also perceived to have advantageous metabolic properties in that acetate is easily metabolised by the 5 patient s liver.
A major advantage of using sodium acetate was that it became possible to prepare dialysis liquids from single liquid concentrates. Typically, one part of such a concentrate would be diluted 3 5 times with water before being used in a dialysis procedure. This simple preparative procedure is not available when using 10 bicarbonate buffers because of the immediate precipitation of insoluble carbonates when all the necessary salts, including bicarbonate, are mixed together in one concentrate. -The use of sodium acetate as a buffer meant that dialysis liquid could be prepared simply and conveniently at the patient's bedside.
During the 1970's however, it emerged that, whilst sodium acetate had many 15 preparative advantages over sodium bicarbonate, it had, at least in some patients, undesirable side effects. In particular, it was demonstrated that acetate in dialysis f~uid was linked with vascular instability and arterial hypotension in certain patients.
When large surface dialysers were used, too much acetate was transferred into the blood and p~tient~ ~ur~ed a number of undesirable symptoms. It became clear that, 20 for all its ~l~ative disadvantages, sodium bicarbonate was much the better dialysis buf~er, in medical terms. than sodium acetate.
The preferred use of sodium bicarbonate as a dialysis buffer combined with the ~ n-l~nt stability problems of that material in pre-use liquid concentrate form has led to a growth in dialysis systems which utilise cartridges of powdered solid ~5 sodium bicarbonate. Such cartridges are manufactured as sealed units cont~ining suff1cient sodium bicarbonate for a single dialysis procedure. The cartridge is attached to a dialysis apparatus comprising a water supply line. A portion of water flowing in the supply line is diverted through the cartridge and subsequently reunited with the original water stream under carefully controlled conditions to provide a final 30 ~luid for supply to the dialvsis membrane, the fluid havin~ a pre-determined quantity of sodium bicarbonate dissolved therein. Sirnilar systems have also been used generally in the field of dru~ deliverv. Thus, for example, WO-A-86/034 16 teaches a drug deLivery apparatus preventing local and systemic to,~;icity ~vhich enables the passive delivery of a drug to the intravenous system of a patient. The apparatus of WO-A-g6/03~16 comprises a cl1~mber for receiving a beneficial a~ent such as a drug, the chamber havin~ a fluid path~vay therethrough for effecting a regulated5 supply of the beneficial a~ent intravenously to a patient.
One commercial system currently in use is described in EP-A-0~78100. This discloses a system for preparing a fluid for a medical procedure by mi.~;ing of at least one concentrate in po~der form ~vith water. The system contains a cartridge containing a soluble powder material. When used as a dialysis system ~vater is 10 supplied by a first fluid conducting means to the dialysis membrane. An adjustable portion of the fluid thus su~plied is diverted through the po~vder-containing cartridge. If the po-vder is sodium bicarbonate then the dialysis may be effected using a solution of sodium bicarbonate at a controlled concentration, ~-hich solution results after recombination under controlled conditions of the diverted and 15 undiverted portions of ~he ~vater in the fluid conducting means.
The system of EP-A-0'~78100 and other conventional commercial systems suffer from a number of disadvantages, including the constant need of the user to replace cartridges after a single use thereof.
EP-A-0~3664~ discloses a method for making available at a dialysls machine ~0 the bicarbonate solution required for bicarbonate haemodialysis in which a quantity of solid bicarbonate sufficient for one or more dialysis treatments is provided in a container ~vhich can be cleaned, sterilised and refilled after use.
According to the present invention there is provided a reservoir for storage and supply of a soluble powder material for use in a haemodialysis, haemofiltration ~5 or haemodiafiltration procedure comprising:
an outer chamber;
an inner chamber;
a fluid inlet means adapted to be releasably connected to a fluid supply line;
a fluid outlet means adapted to be releasably connected to a fluid dischar~e ~0 line via ~hich a dialysis solution comprising a solution of the solub~e powder material in a fluid supplied in the fluid supply line is supplied to a dialysis apparatus during a haemodialysis, haemofiltration or haemodiafiltration procedure;
~'Nn~ FET
CA 022464~ 1998-08-14 at le~st one openable and securely reclosable access port through ~ hich. ~ hen open, the soluble po-vder material may be supplied to the reservoir;
the inner chamber being a longitudinal chamber cornmunicating ~ ith the ~luid inlet means and protrudin~ in-vardly into the outer chamber of tl-e reservoir characterised in that the inner chamber is closed at its protruding end but has a p~urality of lateral orifices arran_ed to distribute fluid over the surface of the soluble po~vder material in use of the reservoir.
The provision of an openable and securely reclosable access port provides significant advantages over conventional disposable cartridges used in dialysis 10 procedures. The purchase of disposable cartridges represents a significant financial cost in the running of dialysis units and cost savings will be made by any unit choosingJ to switch to the reusable reservoir of the invention. Conventional cartridges are ~vastefi 11 of their powder contents because they generally contain more po~vder than is necessary for one procedure. This is particularly the case when a 15 patient requires only a short dialysis because a full cartridge must nevertheless be used and cannot be re-used because of the danger of infection.
The purpose of the inner chamber lateral orifices is to ensure even distribution of the inlet fluid over the inlet end of the outer chamber containin~, the dialysis powder. Thls has the advantage of conserving po~vder by ensuring as much 20 ~vetting as possible of the powder contained in the outer chamber.
A plurality of lateral orifices are provided in the first inner chamber to enhance the even distribution of inlet fluid over the powder by providing a ';sprinklin(J,~' action.
Substantially any number of lateral orifices may be employed in a cartrid,~e 25 according, to the invention. Preferably, at least three up to about 1 or more, even more preferably four lateral orifices are employed. In one preferred embodiment,four lateral orifices a~-e employed and are located symmetrically around the first inner chamber. The first inner chamber may be of substantially any shape, for e.~ample of hexagonal or rectangular cross section, although often a cylindrical shape 30 ~vill be used for ease of construction. In its simplest aspect, the purpose of the inner chamber and lateral orifices is to enable a fluid supplied to the reservoir via the fluid inlet means to be distributed over the surface of any soluble po~vder material All~AEND~D SitFET
CA 022464~ 1998-08-14 contained ~vithin the outer chamber of the reservoir when the reservoir is in use. The ~Ise of a plurality of lateral orll'ices tends to improve the even distribution of fluid over the inlet end of the reservoir.
There is no limitation either on the number of lateral orifices or their location 5 or on the shape and/or size of the inner chamber provided that the inner chamber serves the purpose for which it was designed, which is to direct fluid supplied from the fluid inlet means onto a polvvder located in the outer chamber. One advantage of the sprinkling function of the inner chamber is that channelling of fluid through the powder in the outer chamber ofthe reservoir is substantially avoided. The avoidance 10 of channelling improves the reliability of the reservoir. Another advantage of the inner chamber of a reservoir according to the present invention is that the smoothness of flow of fluid through the reservoir ~vhen in use is less susceptible than conventional cartridges to sli~ht chanoes in pressure of the fluid supplied via the fluid inlet means.
1~In a preferred embodiment of the invention, the fluid inlet means comprises a nipple protruding from the reservoir to which nipple a fluid supply line may be connected. Conveniently, the fluid outlet means also comprises a protruding nipple to which a fluid outlet line may be connected. The shape and/or size of such nipples mav be chosen to f1t a range of commercially available dialysis machines.
~0An openable port is required in the reservoir for supplying or removing a soluble powder material such as sodium bicarbonate therethrough. Con- eniently and for ease of construction and maintenance, it is preferred that the reservoir be _ openable in the region of a fluid inlet end and/or in the region of a fluid outlet end.
In one preferred embodiment the reservoir is openable both in the region of its fluid inlet end and in the region of its fluid outlet end. Conveniently, in one embodiment, the reservoir is constructed of a hollow tube which is threaded at both its fluid inlet end and its fluid outlet end. In ihis case, t~vo threaded caps, a fluid inlet cap and a fluid outlet cap, are provided. The fluid inlet cap attaches to the fluid inlet end of the reservoir and the fluid outlet cap attaches to the fluid outlet end of the reservoir. The 30 lluid inlet cap in this case is provided on its inner face with the first inner chamber of the reservoir and on its outer face ~vith the fluid inlet means. The fiuid outlet cap is provided on its outer face with the fluid outlet means. Conveniently, both caps are A~ D~ S~E~
CA 022464~ 1998-08-14 fitted ~ ith a resilient 'O' ring, for e.~ample of natural or synthetic rubber, to ensure sealing e-ificiency against the hollo~v tube. In addition, the fluid outlet cap may be fitte(l ~vith a filtration device to prevent egress of undissolved po~vder material from the reser~,oir ~vhen in use.
The fluid outlet end of the reservoir is conveniently constructed ~vith a stepped portion ~hich may be arranged to be seated in a cartrid~e cradle in a range of commercially available dialysis units.
In one preferred embodiment of the invention, the reservoir is tapered towards its fluid outlet end. Such tapering ensures smoother flo~v of the fluid through the powder. In one embodiment, the tapering is achieved by means of a tapered sleevewhich may be inserted in a close fit arrangement ~vith the reservoir.
In come cases it may be necessary to provide an adaptor bet~veen the reservoir and the commercial dialysis machine. Accordingly, the invention further providesa reservoir for storage and supply of a soluble powder material for use in a 1~ haemodialysis, haemofiltration or haemodiaf1ltration procedure comprising:
an outer chamber;
a fluid inlet means adapted to be releasably connected to a fluid supplv line;
a fluid outlet means adapted to the releasably connected to a fluid discharge line via ~vhich a dialysis solution comprising a solution of the soluble powder ~0 material in a fluid supplied in the fluid supply line is supplied to a dialysis apparatus during a haemodialvsis, haemofiltration or haemodiafiltration procedure;
characterisea in that the reservoir has a first inner chamber communicating between the fluid inlet means and the outer chamber;
a second inner chamber communicating between the fluid outlet means and ~5 the outer chamber;
at least one openable and securely recloseable access port through which, when open, the soluble po~vder material may be supplied to the reservoir;
and an adaptor comprising a plug portion for insertion into the corresponding socket of a dialysis machine, the plug portion having t~vo openings and means, optionally in combination ~vith the socket, for ensuring non-communication bet~veen said openings, the adaptor further comprising means for supplying via the first of said t~!o openings a fluid for supply to the reservoir and means for recovering via the t~OÇ ;~
CA 022464~ 1998-08-14 second of said t~vo openings a solution of powder from the reservoir for use in a dial~ sis procedure.
Preferably, filtration means are provided in the second inner chamber to prevent e~Jress of undissolved po-vder from the reservoir.
In order that the invention may be clearly understood and fillly carried into effect, t-vo embodiments thereof ~vill no-v be more particularly described with reference to the accompanying drawings, in which:
Figure 1 is a vertical cross-section of a reservoir desi2ned in accordance ~vitha first embodiment of the present invention;
Figure 2 is a vertical cross-section of a reservoir designed in accordance with a second embodiment of the invention;
Figure 3 is a cross-section throu_h an adaptor for use with the reservoir of Figure 2; and Figure 4 is a plan vie~v from above of the adaptor of Figure 3.
Referring to Figure 1, there is shown a reservoir (1 ) for the storage and supply of a soluble powder material such as sodium bicarbonate (not shown) for use in ahaemodialysis, haemofiltration or haemodiafiltration procedure.
The reservoir ( 1 ) comprises an outer chamber (2) which is a hollow cylindrical acrylic tube manufactured by an injection moulding process. Outer ~0 chamber (2) has screw-threaded portions (3) at its upper and lower ends respectively.
At the upper end of reservoir (1) is shown removable cap (4) ~vhich is secured to chamber (2) by means of scre~v-threaded portions (5) on cap (~). Fluid tight engagement of cap (4) and chamber (~) is assisted by a resilient ~O' rin, (6) ofnatural or synthetic rubber. Cap (4) is injection moulded from polycarbonate and has a central orifice (7). Orifice (7) cornrnunicates at its upper end ~vith fluid inlet nipple (8) and at its lo~ver end with inner chamber (9). Inner chamber (9) is provided with four orifices ( 10) evenly spaced around the circumference of first inner chamber (9).
Nipple (8) is shaped to be securable to a fluid inlet line from a commercially available dialysis machine such as the Gambro AK-10 system or the COBE C~RX
,0 system.
At the lo~ver end ofthe chamber (~) can be seen bottom cap (11) secured to chamber (~) by a scre~v-threaded portion generally indicated by reference numeral .
.
CA 022464~ 1998-08-14 . .
7~
( 12). Fluid tio~ht engagement of cap (l 1) and chamber (~) is assisted by a resilient ~O' ring (13) of natural or synthetic rubber. Cap (11) is con~eniently injectionmoulded from po~ycarbonate. Cap (l l) has an instepped portion (l~) in ~vhich sits a filter ( 15). The purpose of filter ( 15) is to prevent small particles of undissolved 5 material escapin~ from reservoir (l) when the reservoir is in use. Any convenient filter material such as a nylon mesh may be used. Conveniently, the mesh size isfrom about ~5 micrometers to about 50 micrometers.
Cap (11) is formed integrally with nipple (16) which is shaped to receive a fluid outlet line from any commercial dialysis system. Cap (11) is also provided10 with a stepped portion ( 17) which may serve to seat the reservoir ( I ) in a corresponding cradle of a commercial dialysis system.
Seated within the lower end of chamber (2) is tapered sleeve (18) which is a moulded polycarbonate sleeve arrarged to fit slidably into chamber (2) and to direct the flow of fluid through chamber (2) towards a central region of the bottom end of 15 chamber (2).
~At~
The dimensions of a t~pical reservoir in accordance with the invention and suitable for use with the Gambro AK-10 system are as follows:
chamber ~) is cylindrical with an external diameter of 3.150 inches (8.001cm) and a len~th of 6.788 inches (17.241cm), threaded portions (3) on chamber (2) extend 5/8 inches ( 1 .588cm) from each end of chamber (2);
fluid inlet cap (4) and fluid outlet cap ~1 1 ) each have an external diameter of 4 inches (10.16cm) and an internal diameter (circumferenced by screw threaded portions (~) and (12) respectively~ of 3.360 inches (8.534cm);
nipples (8) and (16) are sli_htly chamfered at their respective protruding ends; each protmdes ~om a respective external face of cap (4) or cap ( 11 ) by 9/16 inches ( 1 .429cm) and each has an external diameter of 3/8 inches (0.953cm3 at its respective protruding end, not including any chamfered portion of the end;
stepped portion 17 on fluid outlet cap (11~ has a diameter of 2.1 inches (~.33cm) and a depth of 0.5 inches (1.27cm);
the total l~n~inl~lin~l distance between respective ends of nipples (8) and (16)when the reservoir is assembled is 9.1 inches (23 . lcm).
In use, the reservoir is partially filled with a guantity of sodium bicarbonate,optionally in conjunction with other materials, useful in dialysis. Typically, the 20 reservoir is charged with a mass of 500g sodium bicarbonate in readiness for a single dialysis treatment. The reservoir is then connected at its fluid inlet end and at its fluid outlet end to a suitable dialysis apparatus such as the Gambro AK- 10 or the COBE C2E;~X and a dialysis tre~ttnent is carried out in accordance with methods which are well known to those skilled in the art.
Thus, in a dialysis procedure using a cartridge according to the invention, the cartrid e is connected to apparatus comprising a first fluid conrlllcting means having a first end for communicating with a source of water to withdraw water into the first fluid conducting means and a second end for delivering a prepared solution: second fluid conductin_ means having a first end for cornrnunicating with a source of water 30 and a second end communicating with the fluid inlet end of the reservoir for introducing water into the reservoir to produce a concentrate fluid containin~
dissolved powder concentrate in water: third fluid con~-lcting means comrnunicating -CA 022464.?.? 1998 - 08 - 14 with the outlet end of the reservoir and with a mixing point in the first fluid conductin._ means intermediate said first and second ends for conducting the concentrate fluid f~om the reservoir into the first fluid con(hlctin~ means to be mixed wi~h fluid being conducted throu_h the first fluid conducting means thereby to produce a preparèd solution in the first fluid conducting means for delivery to the second end of the first fluid con~llcting means.
Conveniently, the apparatus will comprise measuring means in the first fluid conducting means downstream of the mixing point for measuring the composition of the prepared solution obtained by the mixing of the concentrate fluid and water 10 in the first fluid conducting means. The apparatus may further comprise flow rePulating means in the third fluid Contll~Cting means responsive to said measuring means for controlling the flow of the concentrate fluid from the reservoir.
When a dialysis treatment lltili~ing a reservoir according to the invention has been completed, the reservoir may be ~et~rhç~l from the dialysis a~aldllls and, after 15 a~lu~liate sterilising treatment, may be charged once again with sodium bicarbonate in readiness for a further dialysis tre~tment Stçrili~tton ofthe reservoir in between treatrnents may be effected by any of a number of methods which are well known to those skilled in the art. One convenient method of sterilisation is tû
rinse excess sodium bicarbonate from the reservoir with water before soaking the20 resevoir in a solution of sodium dichlorisocyanurate (SanichlorTM) at a suitable concentratIon.
Referring to Figure 2, there is shown a reservoir (101) which is suitable for use with the commercially available Fresenius 4008E dialysis machine. Reservoir ~101) comprises comprises an outer chamber (102) which is a hollow cylindrical ~5 acrylic tube manufactured by an injection moulding process. Outer chamber (102) has a screw-threaded portion ( 103) at its upper end. At the upper end of reservoir ( 101 ) is shown removable cap ( 104) which is secured to chamber ( 102) by means of screw-threaded portions ( 105) on cap ( 104). Fluid tight engagement of cap ( 104) and c~amber (lQ~) is assisted by a resilient ~O? ring (106) of natural or synthetic ,0 rubber. Cap (104) is injection moulded from polycarbonate and has two orifices ( 107 and 1 07a). Orifice ( 107) communicates at its upper end with lluid inlet nipple ~108j and at itS lower end with first inner chamber (109). First irmer chamber (109) . CA 022464=,=, 1998-08-14 . .
orifice ( l l O) at one end of first inner chamber ( lO9).
Second inner chamber (lll) communicates at its lo~ver end ~ h outer chamber 102 and at its upper end with fluid outlet nipple (112).
In use of reservoir (101), the reservoir is f1lled with a suitable quantity of s sodium bicarbonate and lines are taken from each of fluid inlet nipple ( l O~) and fluid outlet nipple ( l 12) for connection to an adaptor suitable for use with the Fresenius machine refe~Ted to above. The adaptor is shown in Figures 3 and ~ and comprises a plug portion (113) for insertion into the corresponding socket (not shown) of a Fresenius machine and a receiving portion (11~) for receiving lines from the fluid inlet nipple (108) and the fluid outlet nipple (112). Plug portion (113) comprises three concentric cylindrical ~valls (115, 116 and 117) of polyethylene standing up from a base portion (118). Standing down from base portion (l l~) is a chamber ( 1 19) ~hich communicates via orifice (120) wi~h the fluid suppl~v line of the dialysis machine (not shown) and via orifice (121) with a line (not shown) taken from fluid inlet nipple (108). The chamber (119) is traversed by a conduit (122) lrvhich has an opening (123) at its upper end communicating with the fluid intake line of the dialysis machine (not shown) and an opening (124) at its lower end communicating with a line (not sho~vn) taken from fluid outlet nipple ( l 12) of reservoir ( 101).
Fluid is supplied to a powder, such as sodium bicarbonate, contained in outer ~0 chamber (102) and a solution of the po~vder is drawn into second inner chamber ( 1 1 l ) via filter ( 125) by the action of a pump in the dialysis machine (not shown).
As with the reservoir of Figure 1, at the end of a dialysis procedure, reservoir (101) m~y simply be detached from the dialysis machine and prepared for re-use.
Thus, the reservoir (101) is opened by removing cap (104), excess powder is rinsed ~5 from the reservoir and the reservoir is sterilised by a suitable procedure prior to recharging with po~der for further use.
The present invention relates to a reusable reservoir for use in a haemodialysis. haemofiltration or haemodiafiltration procedure.
Haemodialysis is a method of cleansing the blood of patients whose kidney function is impaired. In haemodialysis procedures, the patient's blood is supplied to one side of a permeable membrane located in a dialysis apparatus. Dialysis membranes are usually formed ~om polyacrylonitrile or polysulphone. To the otherside ofthe membrane is supplied a dialysis fluid Cont~ining an electrolyte solution.
In a dialysis procedure, the patient's blood is pumped against the membrane, m~int~ining a controlled low positive blood-to-dialysate pressure ~radient. By reverse osmosis waste products in the blood diffuse through the membrane into the dialysis fluid.
Haemodiafliltration and haemofiltration procedures also take advantage of permeable filter membranes to remove blood waste products. In both procedures, a more perrneable filter is used than in haemodialysis and the consequent blood fluid loss is greater than in haemodialysis. Normally, this fluid must be replaced at least in part, for exannple by one of the methods described above. Haemodialysis, haemodiafiltration and haemofiltration procedures all require the use of an electrolyte-cont~ining fluid either as a dialysis fluid or as a fluid replacement fluid, or both. Historically, different electrolyte mixtures have been used, the choice being influenced by a large number of technical considerations such as the type of apparatus available, the effects of any given elec$rolyte and also the chemical stability of certain electrolyte-containing solutions. For example, when artificial kidney rnachines were first used in the l~50's and 19601s, dialysis fluid cont~ining as its principal component sodium bicarbonate was prepared in large batches prior to use in a number of treatment sessions. Sodium bicarbonate was a natural choice because of its inherent buffering capacity. However. technical difficulties wer.e encountered especiallv with regard to unwanted precipitation of calcium and ma~nesium carbonates in the pre-formed batches. To prevent this unwanted precipitation. it was necessary to bubble carbon dioxide gas through the solution continuQusly, a costly and inconvenient procedure.
Durin~ the 1 960's sodium acetate was used in preference to sodium WO 971:29796 PCT/GB97/00460 bicarbonate. Sodium acetate was perceived to have a number of advantages over sodium bicarbonate. These inc}uded an absence of problems with precipitation of insoluble salts in the dialysis solution. Sodium acetate was also perceived to have advantageous metabolic properties in that acetate is easily metabolised by the 5 patient s liver.
A major advantage of using sodium acetate was that it became possible to prepare dialysis liquids from single liquid concentrates. Typically, one part of such a concentrate would be diluted 3 5 times with water before being used in a dialysis procedure. This simple preparative procedure is not available when using 10 bicarbonate buffers because of the immediate precipitation of insoluble carbonates when all the necessary salts, including bicarbonate, are mixed together in one concentrate. -The use of sodium acetate as a buffer meant that dialysis liquid could be prepared simply and conveniently at the patient's bedside.
During the 1970's however, it emerged that, whilst sodium acetate had many 15 preparative advantages over sodium bicarbonate, it had, at least in some patients, undesirable side effects. In particular, it was demonstrated that acetate in dialysis f~uid was linked with vascular instability and arterial hypotension in certain patients.
When large surface dialysers were used, too much acetate was transferred into the blood and p~tient~ ~ur~ed a number of undesirable symptoms. It became clear that, 20 for all its ~l~ative disadvantages, sodium bicarbonate was much the better dialysis buf~er, in medical terms. than sodium acetate.
The preferred use of sodium bicarbonate as a dialysis buffer combined with the ~ n-l~nt stability problems of that material in pre-use liquid concentrate form has led to a growth in dialysis systems which utilise cartridges of powdered solid ~5 sodium bicarbonate. Such cartridges are manufactured as sealed units cont~ining suff1cient sodium bicarbonate for a single dialysis procedure. The cartridge is attached to a dialysis apparatus comprising a water supply line. A portion of water flowing in the supply line is diverted through the cartridge and subsequently reunited with the original water stream under carefully controlled conditions to provide a final 30 ~luid for supply to the dialvsis membrane, the fluid havin~ a pre-determined quantity of sodium bicarbonate dissolved therein. Sirnilar systems have also been used generally in the field of dru~ deliverv. Thus, for example, WO-A-86/034 16 teaches a drug deLivery apparatus preventing local and systemic to,~;icity ~vhich enables the passive delivery of a drug to the intravenous system of a patient. The apparatus of WO-A-g6/03~16 comprises a cl1~mber for receiving a beneficial a~ent such as a drug, the chamber havin~ a fluid path~vay therethrough for effecting a regulated5 supply of the beneficial a~ent intravenously to a patient.
One commercial system currently in use is described in EP-A-0~78100. This discloses a system for preparing a fluid for a medical procedure by mi.~;ing of at least one concentrate in po~der form ~vith water. The system contains a cartridge containing a soluble powder material. When used as a dialysis system ~vater is 10 supplied by a first fluid conducting means to the dialysis membrane. An adjustable portion of the fluid thus su~plied is diverted through the po~vder-containing cartridge. If the po-vder is sodium bicarbonate then the dialysis may be effected using a solution of sodium bicarbonate at a controlled concentration, ~-hich solution results after recombination under controlled conditions of the diverted and 15 undiverted portions of ~he ~vater in the fluid conducting means.
The system of EP-A-0'~78100 and other conventional commercial systems suffer from a number of disadvantages, including the constant need of the user to replace cartridges after a single use thereof.
EP-A-0~3664~ discloses a method for making available at a dialysls machine ~0 the bicarbonate solution required for bicarbonate haemodialysis in which a quantity of solid bicarbonate sufficient for one or more dialysis treatments is provided in a container ~vhich can be cleaned, sterilised and refilled after use.
According to the present invention there is provided a reservoir for storage and supply of a soluble powder material for use in a haemodialysis, haemofiltration ~5 or haemodiafiltration procedure comprising:
an outer chamber;
an inner chamber;
a fluid inlet means adapted to be releasably connected to a fluid supply line;
a fluid outlet means adapted to be releasably connected to a fluid dischar~e ~0 line via ~hich a dialysis solution comprising a solution of the solub~e powder material in a fluid supplied in the fluid supply line is supplied to a dialysis apparatus during a haemodialysis, haemofiltration or haemodiafiltration procedure;
~'Nn~ FET
CA 022464~ 1998-08-14 at le~st one openable and securely reclosable access port through ~ hich. ~ hen open, the soluble po-vder material may be supplied to the reservoir;
the inner chamber being a longitudinal chamber cornmunicating ~ ith the ~luid inlet means and protrudin~ in-vardly into the outer chamber of tl-e reservoir characterised in that the inner chamber is closed at its protruding end but has a p~urality of lateral orifices arran_ed to distribute fluid over the surface of the soluble po~vder material in use of the reservoir.
The provision of an openable and securely reclosable access port provides significant advantages over conventional disposable cartridges used in dialysis 10 procedures. The purchase of disposable cartridges represents a significant financial cost in the running of dialysis units and cost savings will be made by any unit choosingJ to switch to the reusable reservoir of the invention. Conventional cartridges are ~vastefi 11 of their powder contents because they generally contain more po~vder than is necessary for one procedure. This is particularly the case when a 15 patient requires only a short dialysis because a full cartridge must nevertheless be used and cannot be re-used because of the danger of infection.
The purpose of the inner chamber lateral orifices is to ensure even distribution of the inlet fluid over the inlet end of the outer chamber containin~, the dialysis powder. Thls has the advantage of conserving po~vder by ensuring as much 20 ~vetting as possible of the powder contained in the outer chamber.
A plurality of lateral orifices are provided in the first inner chamber to enhance the even distribution of inlet fluid over the powder by providing a ';sprinklin(J,~' action.
Substantially any number of lateral orifices may be employed in a cartrid,~e 25 according, to the invention. Preferably, at least three up to about 1 or more, even more preferably four lateral orifices are employed. In one preferred embodiment,four lateral orifices a~-e employed and are located symmetrically around the first inner chamber. The first inner chamber may be of substantially any shape, for e.~ample of hexagonal or rectangular cross section, although often a cylindrical shape 30 ~vill be used for ease of construction. In its simplest aspect, the purpose of the inner chamber and lateral orifices is to enable a fluid supplied to the reservoir via the fluid inlet means to be distributed over the surface of any soluble po~vder material All~AEND~D SitFET
CA 022464~ 1998-08-14 contained ~vithin the outer chamber of the reservoir when the reservoir is in use. The ~Ise of a plurality of lateral orll'ices tends to improve the even distribution of fluid over the inlet end of the reservoir.
There is no limitation either on the number of lateral orifices or their location 5 or on the shape and/or size of the inner chamber provided that the inner chamber serves the purpose for which it was designed, which is to direct fluid supplied from the fluid inlet means onto a polvvder located in the outer chamber. One advantage of the sprinkling function of the inner chamber is that channelling of fluid through the powder in the outer chamber ofthe reservoir is substantially avoided. The avoidance 10 of channelling improves the reliability of the reservoir. Another advantage of the inner chamber of a reservoir according to the present invention is that the smoothness of flow of fluid through the reservoir ~vhen in use is less susceptible than conventional cartridges to sli~ht chanoes in pressure of the fluid supplied via the fluid inlet means.
1~In a preferred embodiment of the invention, the fluid inlet means comprises a nipple protruding from the reservoir to which nipple a fluid supply line may be connected. Conveniently, the fluid outlet means also comprises a protruding nipple to which a fluid outlet line may be connected. The shape and/or size of such nipples mav be chosen to f1t a range of commercially available dialysis machines.
~0An openable port is required in the reservoir for supplying or removing a soluble powder material such as sodium bicarbonate therethrough. Con- eniently and for ease of construction and maintenance, it is preferred that the reservoir be _ openable in the region of a fluid inlet end and/or in the region of a fluid outlet end.
In one preferred embodiment the reservoir is openable both in the region of its fluid inlet end and in the region of its fluid outlet end. Conveniently, in one embodiment, the reservoir is constructed of a hollow tube which is threaded at both its fluid inlet end and its fluid outlet end. In ihis case, t~vo threaded caps, a fluid inlet cap and a fluid outlet cap, are provided. The fluid inlet cap attaches to the fluid inlet end of the reservoir and the fluid outlet cap attaches to the fluid outlet end of the reservoir. The 30 lluid inlet cap in this case is provided on its inner face with the first inner chamber of the reservoir and on its outer face ~vith the fluid inlet means. The fiuid outlet cap is provided on its outer face with the fluid outlet means. Conveniently, both caps are A~ D~ S~E~
CA 022464~ 1998-08-14 fitted ~ ith a resilient 'O' ring, for e.~ample of natural or synthetic rubber, to ensure sealing e-ificiency against the hollo~v tube. In addition, the fluid outlet cap may be fitte(l ~vith a filtration device to prevent egress of undissolved po~vder material from the reser~,oir ~vhen in use.
The fluid outlet end of the reservoir is conveniently constructed ~vith a stepped portion ~hich may be arranged to be seated in a cartrid~e cradle in a range of commercially available dialysis units.
In one preferred embodiment of the invention, the reservoir is tapered towards its fluid outlet end. Such tapering ensures smoother flo~v of the fluid through the powder. In one embodiment, the tapering is achieved by means of a tapered sleevewhich may be inserted in a close fit arrangement ~vith the reservoir.
In come cases it may be necessary to provide an adaptor bet~veen the reservoir and the commercial dialysis machine. Accordingly, the invention further providesa reservoir for storage and supply of a soluble powder material for use in a 1~ haemodialysis, haemofiltration or haemodiaf1ltration procedure comprising:
an outer chamber;
a fluid inlet means adapted to be releasably connected to a fluid supplv line;
a fluid outlet means adapted to the releasably connected to a fluid discharge line via ~vhich a dialysis solution comprising a solution of the soluble powder ~0 material in a fluid supplied in the fluid supply line is supplied to a dialysis apparatus during a haemodialvsis, haemofiltration or haemodiafiltration procedure;
characterisea in that the reservoir has a first inner chamber communicating between the fluid inlet means and the outer chamber;
a second inner chamber communicating between the fluid outlet means and ~5 the outer chamber;
at least one openable and securely recloseable access port through which, when open, the soluble po~vder material may be supplied to the reservoir;
and an adaptor comprising a plug portion for insertion into the corresponding socket of a dialysis machine, the plug portion having t~vo openings and means, optionally in combination ~vith the socket, for ensuring non-communication bet~veen said openings, the adaptor further comprising means for supplying via the first of said t~!o openings a fluid for supply to the reservoir and means for recovering via the t~OÇ ;~
CA 022464~ 1998-08-14 second of said t~vo openings a solution of powder from the reservoir for use in a dial~ sis procedure.
Preferably, filtration means are provided in the second inner chamber to prevent e~Jress of undissolved po-vder from the reservoir.
In order that the invention may be clearly understood and fillly carried into effect, t-vo embodiments thereof ~vill no-v be more particularly described with reference to the accompanying drawings, in which:
Figure 1 is a vertical cross-section of a reservoir desi2ned in accordance ~vitha first embodiment of the present invention;
Figure 2 is a vertical cross-section of a reservoir designed in accordance with a second embodiment of the invention;
Figure 3 is a cross-section throu_h an adaptor for use with the reservoir of Figure 2; and Figure 4 is a plan vie~v from above of the adaptor of Figure 3.
Referring to Figure 1, there is shown a reservoir (1 ) for the storage and supply of a soluble powder material such as sodium bicarbonate (not shown) for use in ahaemodialysis, haemofiltration or haemodiafiltration procedure.
The reservoir ( 1 ) comprises an outer chamber (2) which is a hollow cylindrical acrylic tube manufactured by an injection moulding process. Outer ~0 chamber (2) has screw-threaded portions (3) at its upper and lower ends respectively.
At the upper end of reservoir (1) is shown removable cap (4) ~vhich is secured to chamber (2) by means of scre~v-threaded portions (5) on cap (~). Fluid tight engagement of cap (4) and chamber (~) is assisted by a resilient ~O' rin, (6) ofnatural or synthetic rubber. Cap (4) is injection moulded from polycarbonate and has a central orifice (7). Orifice (7) cornrnunicates at its upper end ~vith fluid inlet nipple (8) and at its lo~ver end with inner chamber (9). Inner chamber (9) is provided with four orifices ( 10) evenly spaced around the circumference of first inner chamber (9).
Nipple (8) is shaped to be securable to a fluid inlet line from a commercially available dialysis machine such as the Gambro AK-10 system or the COBE C~RX
,0 system.
At the lo~ver end ofthe chamber (~) can be seen bottom cap (11) secured to chamber (~) by a scre~v-threaded portion generally indicated by reference numeral .
.
CA 022464~ 1998-08-14 . .
7~
( 12). Fluid tio~ht engagement of cap (l 1) and chamber (~) is assisted by a resilient ~O' ring (13) of natural or synthetic rubber. Cap (11) is con~eniently injectionmoulded from po~ycarbonate. Cap (l l) has an instepped portion (l~) in ~vhich sits a filter ( 15). The purpose of filter ( 15) is to prevent small particles of undissolved 5 material escapin~ from reservoir (l) when the reservoir is in use. Any convenient filter material such as a nylon mesh may be used. Conveniently, the mesh size isfrom about ~5 micrometers to about 50 micrometers.
Cap (11) is formed integrally with nipple (16) which is shaped to receive a fluid outlet line from any commercial dialysis system. Cap (11) is also provided10 with a stepped portion ( 17) which may serve to seat the reservoir ( I ) in a corresponding cradle of a commercial dialysis system.
Seated within the lower end of chamber (2) is tapered sleeve (18) which is a moulded polycarbonate sleeve arrarged to fit slidably into chamber (2) and to direct the flow of fluid through chamber (2) towards a central region of the bottom end of 15 chamber (2).
~At~
The dimensions of a t~pical reservoir in accordance with the invention and suitable for use with the Gambro AK-10 system are as follows:
chamber ~) is cylindrical with an external diameter of 3.150 inches (8.001cm) and a len~th of 6.788 inches (17.241cm), threaded portions (3) on chamber (2) extend 5/8 inches ( 1 .588cm) from each end of chamber (2);
fluid inlet cap (4) and fluid outlet cap ~1 1 ) each have an external diameter of 4 inches (10.16cm) and an internal diameter (circumferenced by screw threaded portions (~) and (12) respectively~ of 3.360 inches (8.534cm);
nipples (8) and (16) are sli_htly chamfered at their respective protruding ends; each protmdes ~om a respective external face of cap (4) or cap ( 11 ) by 9/16 inches ( 1 .429cm) and each has an external diameter of 3/8 inches (0.953cm3 at its respective protruding end, not including any chamfered portion of the end;
stepped portion 17 on fluid outlet cap (11~ has a diameter of 2.1 inches (~.33cm) and a depth of 0.5 inches (1.27cm);
the total l~n~inl~lin~l distance between respective ends of nipples (8) and (16)when the reservoir is assembled is 9.1 inches (23 . lcm).
In use, the reservoir is partially filled with a guantity of sodium bicarbonate,optionally in conjunction with other materials, useful in dialysis. Typically, the 20 reservoir is charged with a mass of 500g sodium bicarbonate in readiness for a single dialysis treatment. The reservoir is then connected at its fluid inlet end and at its fluid outlet end to a suitable dialysis apparatus such as the Gambro AK- 10 or the COBE C2E;~X and a dialysis tre~ttnent is carried out in accordance with methods which are well known to those skilled in the art.
Thus, in a dialysis procedure using a cartridge according to the invention, the cartrid e is connected to apparatus comprising a first fluid conrlllcting means having a first end for communicating with a source of water to withdraw water into the first fluid conducting means and a second end for delivering a prepared solution: second fluid conductin_ means having a first end for cornrnunicating with a source of water 30 and a second end communicating with the fluid inlet end of the reservoir for introducing water into the reservoir to produce a concentrate fluid containin~
dissolved powder concentrate in water: third fluid con~-lcting means comrnunicating -CA 022464.?.? 1998 - 08 - 14 with the outlet end of the reservoir and with a mixing point in the first fluid conductin._ means intermediate said first and second ends for conducting the concentrate fluid f~om the reservoir into the first fluid con(hlctin~ means to be mixed wi~h fluid being conducted throu_h the first fluid conducting means thereby to produce a preparèd solution in the first fluid conducting means for delivery to the second end of the first fluid con~llcting means.
Conveniently, the apparatus will comprise measuring means in the first fluid conducting means downstream of the mixing point for measuring the composition of the prepared solution obtained by the mixing of the concentrate fluid and water 10 in the first fluid conducting means. The apparatus may further comprise flow rePulating means in the third fluid Contll~Cting means responsive to said measuring means for controlling the flow of the concentrate fluid from the reservoir.
When a dialysis treatment lltili~ing a reservoir according to the invention has been completed, the reservoir may be ~et~rhç~l from the dialysis a~aldllls and, after 15 a~lu~liate sterilising treatment, may be charged once again with sodium bicarbonate in readiness for a further dialysis tre~tment Stçrili~tton ofthe reservoir in between treatrnents may be effected by any of a number of methods which are well known to those skilled in the art. One convenient method of sterilisation is tû
rinse excess sodium bicarbonate from the reservoir with water before soaking the20 resevoir in a solution of sodium dichlorisocyanurate (SanichlorTM) at a suitable concentratIon.
Referring to Figure 2, there is shown a reservoir (101) which is suitable for use with the commercially available Fresenius 4008E dialysis machine. Reservoir ~101) comprises comprises an outer chamber (102) which is a hollow cylindrical ~5 acrylic tube manufactured by an injection moulding process. Outer chamber (102) has a screw-threaded portion ( 103) at its upper end. At the upper end of reservoir ( 101 ) is shown removable cap ( 104) which is secured to chamber ( 102) by means of screw-threaded portions ( 105) on cap ( 104). Fluid tight engagement of cap ( 104) and c~amber (lQ~) is assisted by a resilient ~O? ring (106) of natural or synthetic ,0 rubber. Cap (104) is injection moulded from polycarbonate and has two orifices ( 107 and 1 07a). Orifice ( 107) communicates at its upper end with lluid inlet nipple ~108j and at itS lower end with first inner chamber (109). First irmer chamber (109) . CA 022464=,=, 1998-08-14 . .
orifice ( l l O) at one end of first inner chamber ( lO9).
Second inner chamber (lll) communicates at its lo~ver end ~ h outer chamber 102 and at its upper end with fluid outlet nipple (112).
In use of reservoir (101), the reservoir is f1lled with a suitable quantity of s sodium bicarbonate and lines are taken from each of fluid inlet nipple ( l O~) and fluid outlet nipple ( l 12) for connection to an adaptor suitable for use with the Fresenius machine refe~Ted to above. The adaptor is shown in Figures 3 and ~ and comprises a plug portion (113) for insertion into the corresponding socket (not shown) of a Fresenius machine and a receiving portion (11~) for receiving lines from the fluid inlet nipple (108) and the fluid outlet nipple (112). Plug portion (113) comprises three concentric cylindrical ~valls (115, 116 and 117) of polyethylene standing up from a base portion (118). Standing down from base portion (l l~) is a chamber ( 1 19) ~hich communicates via orifice (120) wi~h the fluid suppl~v line of the dialysis machine (not shown) and via orifice (121) with a line (not shown) taken from fluid inlet nipple (108). The chamber (119) is traversed by a conduit (122) lrvhich has an opening (123) at its upper end communicating with the fluid intake line of the dialysis machine (not shown) and an opening (124) at its lower end communicating with a line (not sho~vn) taken from fluid outlet nipple ( l 12) of reservoir ( 101).
Fluid is supplied to a powder, such as sodium bicarbonate, contained in outer ~0 chamber (102) and a solution of the po~vder is drawn into second inner chamber ( 1 1 l ) via filter ( 125) by the action of a pump in the dialysis machine (not shown).
As with the reservoir of Figure 1, at the end of a dialysis procedure, reservoir (101) m~y simply be detached from the dialysis machine and prepared for re-use.
Thus, the reservoir (101) is opened by removing cap (104), excess powder is rinsed ~5 from the reservoir and the reservoir is sterilised by a suitable procedure prior to recharging with po~der for further use.
Claims (9)
1. A reservoir (1) for storage and supply of a soluble powder material for use in a haemodialysis, haemofiltration or haemodiafiltration procedure comprising:
an outer chamber (2);
an inner chamber (9);
a fluid inlet means (8) adapted to be releasably connected to a fluid supply line;
a fluid outlet means (16) adapted to be releasably connected to a fluid discharge line via which a dialysis solution comprising a solution of the soluble powder material in a fluid supplied in the fluid supply line is supplied to a dialysis apparatus during a haemodialysis, haemofiltration or haemodiafiltration procedure;
at least one openable and securely recloseable access port through which, when open, the soluble powder material may be supplied to the reservoir;
the inner chamber (9) being a longitudinal chamber communicating with the fluid inlet means and protruding inwardly into the outer chamber (2) of the reservoir characterised in that the inner chamber is closed at its protruding end but has a plurality of lateral orifices (10) arranged to distribute fluid over the surface of the soluble powder material in use of the reservoir.
an outer chamber (2);
an inner chamber (9);
a fluid inlet means (8) adapted to be releasably connected to a fluid supply line;
a fluid outlet means (16) adapted to be releasably connected to a fluid discharge line via which a dialysis solution comprising a solution of the soluble powder material in a fluid supplied in the fluid supply line is supplied to a dialysis apparatus during a haemodialysis, haemofiltration or haemodiafiltration procedure;
at least one openable and securely recloseable access port through which, when open, the soluble powder material may be supplied to the reservoir;
the inner chamber (9) being a longitudinal chamber communicating with the fluid inlet means and protruding inwardly into the outer chamber (2) of the reservoir characterised in that the inner chamber is closed at its protruding end but has a plurality of lateral orifices (10) arranged to distribute fluid over the surface of the soluble powder material in use of the reservoir.
2. A reservoir according to claim 1, characterised in that the lateral orifices of the inner chamber of the reservoir are arranged symmetrically around the inner chamber.
3. A reservoir according claim 1 or claim 2, characterised in that the fluid inlet means comprises a nipple upstanding from the reservoir
4. A reservoir according to any one of claims 1 to 3, characterised in that the fluid outlet means comprises a nipple protruding from the reservoir
5. A reservoir according to any one of claims 1 to 4, characterised in that the reservoir includes a filtration device to prevent egress of undissolved powder material from the reservoir when in use.
6. A reservoir according to any one of claims 1 to 5, characterised in that an exterior face of the reservoir adjacent fluid outlet means therefore comprises astepped portion adapted to be seated in a cartridge cradle of a dialysis apparatus.
7. A reservoir according to any one of claims 1 to 6, characterised in that it includes an interior tapered portion tapering towards the fluid outlet means of the reservoir.
8. A reservoir (101) for storage and supply of a soluble powder material for usein a haemodialysis, haemofiltration or haemodiafiltration procedure comprising:
an outer chamber (102);
a fluid inlet means (108) adapted to be releasably connected to a fluid supply line;
a fluid outlet means (112) adapted to be releasably connected to a fluid discharge line via which a dialysis solution comprising a solution of the soluble powder material in a fluid supplied in the fluid supply line is supplied to a dialysis apparatus during a haemodialysis, haemofiltration or haemodiafiltration procedure;
characterised in that the reservoir has a first inner chamber (109) communicating between the fluid inlet means (108) and the outer chamber (102);
a second inner chamber (111) communicating between the fluid outlet means (112) and the outer chamber (102);
at least one openable and securely recloseable access port through which, when open, the soluble powder material may be supplied to the reservoir;
and an adaptor comprising a plug portion for insertion into the corresponding socket of a dialysis machine, the plug portion having two openings and means, optionally in combination with the socket, for ensuring non-communication between said openings, the adaptor further comprising means for supplying via the first of said two openings a fluid for supply to the reservoir and means for recovering via the second of said two openings a solution of powder from the reservoir for use in adialysis procedure.
an outer chamber (102);
a fluid inlet means (108) adapted to be releasably connected to a fluid supply line;
a fluid outlet means (112) adapted to be releasably connected to a fluid discharge line via which a dialysis solution comprising a solution of the soluble powder material in a fluid supplied in the fluid supply line is supplied to a dialysis apparatus during a haemodialysis, haemofiltration or haemodiafiltration procedure;
characterised in that the reservoir has a first inner chamber (109) communicating between the fluid inlet means (108) and the outer chamber (102);
a second inner chamber (111) communicating between the fluid outlet means (112) and the outer chamber (102);
at least one openable and securely recloseable access port through which, when open, the soluble powder material may be supplied to the reservoir;
and an adaptor comprising a plug portion for insertion into the corresponding socket of a dialysis machine, the plug portion having two openings and means, optionally in combination with the socket, for ensuring non-communication between said openings, the adaptor further comprising means for supplying via the first of said two openings a fluid for supply to the reservoir and means for recovering via the second of said two openings a solution of powder from the reservoir for use in adialysis procedure.
9. A reservoir according to claim 8, wherein filtration means are provided in the second inner chamber to prevent egress of undissolved powder from the reservoir.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB9603468.1 | 1996-02-19 | ||
| GBGB9603468.1A GB9603468D0 (en) | 1996-02-19 | 1996-02-19 | Reservoir |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2246455A1 true CA2246455A1 (en) | 1997-08-21 |
Family
ID=10789018
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002246455A Abandoned CA2246455A1 (en) | 1996-02-19 | 1997-02-19 | Reservoir for preparing dialysates |
Country Status (10)
| Country | Link |
|---|---|
| EP (1) | EP0883412A1 (en) |
| JP (1) | JP2001500748A (en) |
| AU (1) | AU1884897A (en) |
| CA (1) | CA2246455A1 (en) |
| EE (1) | EE9800241A (en) |
| GB (1) | GB9603468D0 (en) |
| HU (1) | HUP9900948A2 (en) |
| NO (1) | NO983773L (en) |
| PL (1) | PL328498A1 (en) |
| WO (1) | WO1997029796A1 (en) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP4607862B2 (en) * | 2003-04-07 | 2011-01-05 | ガンブロ・ルンディア・エービー | Cartridge filter, cartridge, method of using filter in cartridge, and chemical preparation system for medical treatment |
| US20060204405A1 (en) * | 2003-04-07 | 2006-09-14 | Ragnar Tryggvason | Device for use in a cartridge, and a cartridge |
| EP1613371B1 (en) | 2003-04-07 | 2008-08-20 | Gambro Lundia AB | A device, cartridge and method for solving powder in liquid, when manufacturing a dialysis fluid |
| DE102011016167A1 (en) * | 2011-04-05 | 2012-12-27 | Ritter Gmbh | Plastic containers for dialysis |
| CN107537073B (en) * | 2017-08-01 | 2018-07-31 | 浙江济民制药股份有限公司 | The online dry powder bucket of haemodialysis |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2569560B3 (en) * | 1984-09-06 | 1987-01-23 | Grange Serge | PACKAGING PACKAGING OF HEMODIALYSIS PRODUCTS AND DEVICE FOR MAKING CONCENTRATE FOR HEMODIALYSIS |
| JPH07114809B2 (en) * | 1990-07-30 | 1995-12-13 | 日機装株式会社 | Dissolution device for dialysate preparation agent |
| FR2666739B1 (en) * | 1990-09-13 | 1998-01-02 | Soludia Sa | DEVICE FOR THE EXTEMPORANEOUS AND CONTINUOUS PREPARATION OF DIALYSATE. |
| DE9111524U1 (en) * | 1991-09-15 | 1991-12-05 | Zaunbauer, Peter, Dr., 3000 Hannover | Cartridge of a medical device, in particular a dialysis machine |
| EP0536645A3 (en) * | 1991-10-11 | 1993-11-03 | Saueressig Ulrich | Preparation on a dialysis apparatus of the necessary bicarbonate solution for bicarbonate dialysis |
| EP0575970B1 (en) * | 1992-06-26 | 1999-09-08 | Fresenius Medical Care Deutschland GmbH | Bag containing a concentrate |
-
1996
- 1996-02-19 GB GBGB9603468.1A patent/GB9603468D0/en active Pending
-
1997
- 1997-02-19 WO PCT/GB1997/000460 patent/WO1997029796A1/en not_active Application Discontinuation
- 1997-02-19 EP EP97905223A patent/EP0883412A1/en not_active Withdrawn
- 1997-02-19 EE EE9800241A patent/EE9800241A/en unknown
- 1997-02-19 PL PL97328498A patent/PL328498A1/en unknown
- 1997-02-19 CA CA002246455A patent/CA2246455A1/en not_active Abandoned
- 1997-02-19 HU HU9900948A patent/HUP9900948A2/en unknown
- 1997-02-19 AU AU18848/97A patent/AU1884897A/en not_active Abandoned
- 1997-02-19 JP JP09529132A patent/JP2001500748A/en active Pending
-
1998
- 1998-08-18 NO NO983773A patent/NO983773L/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| JP2001500748A (en) | 2001-01-23 |
| EP0883412A1 (en) | 1998-12-16 |
| EE9800241A (en) | 1998-12-15 |
| PL328498A1 (en) | 1999-02-01 |
| WO1997029796A1 (en) | 1997-08-21 |
| NO983773L (en) | 1998-10-16 |
| HUP9900948A2 (en) | 1999-07-28 |
| GB9603468D0 (en) | 1996-04-17 |
| NO983773D0 (en) | 1998-08-18 |
| AU1884897A (en) | 1997-09-02 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |