CA2361641A1 - Cartridge for dialysis containing sodium bicarbonate - Google Patents

Cartridge for dialysis containing sodium bicarbonate Download PDF

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Publication number
CA2361641A1
CA2361641A1 CA002361641A CA2361641A CA2361641A1 CA 2361641 A1 CA2361641 A1 CA 2361641A1 CA 002361641 A CA002361641 A CA 002361641A CA 2361641 A CA2361641 A CA 2361641A CA 2361641 A1 CA2361641 A1 CA 2361641A1
Authority
CA
Canada
Prior art keywords
cartridge
acid
sodium bicarbonate
carbon dioxide
solution
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.)
Abandoned
Application number
CA002361641A
Other languages
French (fr)
Inventor
Giampiero Pesci
Mario Mazza
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxter Biotech Technology SARL
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2361641A1 publication Critical patent/CA2361641A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654Dialysates therefor
    • A61M1/1656Apparatus for preparing dialysates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654Dialysates therefor
    • A61M1/1656Apparatus for preparing dialysates
    • A61M1/1666Apparatus for preparing dialysates by dissolving solids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654Dialysates therefor
    • A61M1/1656Apparatus for preparing dialysates
    • A61M1/1668Details of containers

Abstract

A cartridge (10) is provided containing sodium bicarbonate in solid form. The cartridge (10) is usable in a haemodialysis machine for continuously producing a buffer solution, which is mixed with another solution to produce a dialysis solution. The cartridge (10) also contains a solid acid or acid anhydride, or carbon dioxide gas. This has been found to overcome problems caused by a temporary high pH in the dialysis solution during the early stages of a dialysis operation.

Description

CARTRIDGE FOR DIALYSIS CONTAINING SODIUM
BICARBONATE
This invention relates to dialysis cartridges containing solid sodium bicarbonate.
BACKGROUND
It has long been known to use cartridges containing drugs, or other to substances, in solid form and to pass water or a solution through the cartridge to dissolve the solid substance continuously, e.g. for continuous administration to a patient.
Examples are WO-A-86/03417 and US-A-4432756.
It is also known, as disclosed in EP-A-0278100 to provide sodium is bicarbonate in solid form for use as a buffer in haemodialysis. Sodium bicarbonate is stored separately from the rest of a dialysis solution, which contains calcium and magnesium ions, to prevent calcium and magnesium carbonate precipitation. A cartridge of sodium bicarbonate powder is inserted in a haemodialysis machine and water is passed through the 2o cartridge. The powder is gradually dissolved, so that a solution of sodium bicarbonate is continuously produced. The solution is continuously flowed through the machine, mixing with the rest of the dialysis solution in-line upstream of the dialyzer. There is, therefore, only a short dwell time in the machine after mixing, so that the problem of calcium and 25 magnesium carbonates being precipitated is avoided.
A problem does, however, arise with such cartridges. The pH of the mixed dialysis solution is monitored upstream of the dialyzer. If the pH falls outside a given range, then an alarm is triggered. It has been found that this often happens during the first twenty minutes of flow, 3o when the machine is being set up for operation. After this period, no ~UBSTI~JTE SHEET (RULE 26) problems are encountered. This causes substantial inconvenience to personnel operating haemodialysis machines, since the problem has to be investigated and the machine reset, each time the alarm is triggered.
s The inventors have discovered that the problem is probably caused by contamination of the sodium bicarbonate powder with a small amount of sodium carbonate. The bicarbonate is less soluble than the carbonate, so that a high pH is caused by the dissolution of the carbonate in the early stages. Once the carbonate has dissolved, the problem disappears. It is, io however, difficult and expensive to produce a sodium bicarbonate powder, which is not contaminated with sodium carbonate.
A possible solution to the problem once it was realised that sodium carbonate precipitation was the cause, would be to introduce a further line is upstream of the pH monitoring device to add dilute acid solution to the dialysis solution during the first twenty minutes of use of the cartridge.
This could be done upstream or downstream of the cartridge. This involves, however, modification of the dialysis solution, use of an additional solution and additional operational control.
The inventors have found that the problem can be relatively simply solved by modifying the contents of the cartridge.
SUMMARY OF THE INVENTION
2s The present invention relates to a cartridge having an operable sealed inlet and an operable sealed outlet, for connection in-line in a haemodialysis machine for passage of water, or a solution through the cartridge, the cartridge containing sodium bicarbonate in solid form.
In accordance with the invention, the camidge additionally contains an acid, or acid anhydride in solid form, or carbon dioxide gas.
When the cartridge is mounted in a haemodialysis machine and s water is passed through the cartridge, the acid or acid anhydride (including carbon dioxide) is gradually dissolved, decreasing the pH of the resulting solution to counteract any temporary increase in pH caused by sodium carbonate contamination.
to The amount of acid or acid anhydride provided is preferably predetermined, so that it is leached from the cartridge during the initial 10 to 30 minutes, i.e. during the period that sodium carbonate is also likely to be leached from the cartridge.
15 Carbon dioxide may be added to the cartridge, during manufacture, in solid form, i.e. as dry ice, prior to sealing the cartridge.
Acids which may be used in solid form may be organic acids, e.g.
citric acid, or tartaric acid, citric acid being preferred for clinical 2o acceptability.
The cartridge may contain at least 0.2g of acid, or acid anhydride per 1000g of sodium bicarbonate; preferably at least O.Sg per 1000g and most preferably at least lg per 1000g. The preferred embodiment 2s contains 2.7g per 1000g.
DRAWINGS
The invention is described with reference to the accompanying drawings, wherein:-Fig 1. is a side elevation of a cartridge according to the invention, shown partly in cross-section; and Fig 2. is a diagrammatic illustration of the cartridge of fig 1 connected in a haemodialysis machine.
s PREFERRED EMBODIMENTS
The currently preferred embodiments of the invention are now described. The construction of haemodialysis machines is well known, as is the construction of a sodium bicarbonate cartridge for use in a haemodialysis machine. The machine and the cartridge are not, therefore, described in detail. The cartridge may be of the type sold under the trademark EASYCART by Bieffe Medital S.p.A. of Italy.
The cartridge 10 comprises a body 14, closed by a lid 15 and is defining a chamber 11. The body and lid are injection moulded in polypropylene. The chamber 11 contains sodium bicarbonate in granular, crystalline form, although other solid forms are possible. The lid 15 is sealed to the body 14 by ultrasonic welding. The lid 15 has an inlet 12 and the body had an outlet 13, both sealed closed in the as-moulded state, 2o by integral membranes 17, 18 respectively.
The cartridge 10 is connected in-line in a first line 20 for receiving deionised water at 21 and supplying sodium bicarbonate solution to a main line 22, at 23. The membranes 17, 18 are perforated during clamping of 2s the cartridge into the machine, by piercing means provided on the machine. The main line 22 also receives deionised water at 24. A
container 30, containing a solution of the other ingredients of a dialysis solution, is connected to the main line 22 by a second line 25 at 26. A
final dialysis solution is formed at point 26 and the main line 22 feeds this to a dialyzer 40. A pH detector 50 is connected to the main line 22 downstream of point 26 and upstream of the dialyzer. The detector is connected with a control system (not shown), which produces an alarm, if a pH outside a predetermined range is exceeded. This range is usually 6.8 s to 7.9 pH may be monitored by other means, such as by conductivity measurement.
The solution in the container 30 may contain any of the components usually provided in a dialysis solution, such as calcium and magnesium io chloride, sodium chloride and an osmotic agent, such as dextrose.
In accordance with the present invention, the cartridge contains, in addition to the sodium bicarbonate, an acid or acid anhydride in solid form, or carbon dioxide gas, so as to avoid any sodium carbonate ~5 contamination causing a temporary increase in the pH of the dialysis solution to a degree sufficient to exceed the predetermined threshold and trigger an alarm.
The preferred embodiment of a cartridge contains 750g sodium 2o bicarbonate and 2g citric acid, both in granular, crystalline form. A
similar weight ratio could be used with different amounts of sodium bicarbonate.
Alternatives to citric acid are preferably provided in the same 2s weight ratio.
Tests were carried out using cartridges containing 750g sodium bicarbonate and citric acid, tartaric acid, or carbon dioxide (added as dry ice) respectively. These were compared with similar cartridges, to which no acid or carbon dioxide had been added.
The tests were carried out by running an Integra (trademark) s haemodialysis machine, using the various cartridges. Notes were made of which cartridges produced an alarm signal, due to the pH of the mixed dialysis solution falling outside the predetermined range. The actual maximum pH of each solution was also recorded. "Acid" solutions, ie the solutions carrying the other components of the dialysis solution, were io standard solutions produced by Gambro. In each case, the pH of the water supplied was 6.1. The results are shown in the tables below. There were numerous false alarms with the reference cartridges, but no false alarms with the cartridges according to the invention.
is Table 1 This shows the results using the reference cartridges, containing 750g sodium bicarbonate and no added acid or carbon dioxide.
Sample No. Maximum pH of Alarm dialysis solution Yes/No 1 7.9 No' 2 7.8 No 3 8 Yes 4 8.1 Yes 7.9 No 6 8 Yes 7 8.2 Yes g 8 Yes 9 7.4 No 7.4 No Table 2 This shows the results using cartridges according to the invention, containing 2g citric acid and 750g sodium bicarbonate.
s Sample No. Maximum pH of Alarm dialysis solution Yes/No 11 7.5 No 12 7.5 No 13 7.5 No 14 7.5 No 15 7.4 No 16 7.4 No 17 7.4 No 18 7.4 No 19 7.4 No 20 7.4 No 21 7.4 No Table 3 This shows the results using cartridges according to the invention, to containing 0.5g or lg of carbon dioxide (dry ice) and 750g sodium bicarbonate.
Sample No. Amount of COZ(g) Maximum pH Alarm of dialysis solutionYes/No 22 0.5 7.5 No 23 1.0 7.3 No 24 0.5 7.5 No 25 1.0 7.3 No 26 1.0 7.3 No g Table 4 This shows the results using carnidges according to the invention, containing lg tartaric acid and 750g sodium bicarbonate.
Sample No. Maxiumum pH of Alarm dialysis solution Yes/No 27 7.5 No 2g 7.5 No Other tests were carried out using different "acid" solutions, and water of different pH. In each case, a cartridge according to the invention did not cause any alarm due to either high or low pH.
to

Claims (10)

Claims:
1. A cartridge having an openable, sealed inlet and an openable, sealed outlet for connection in-line in a haemodialysis machine for passage of water or a solution through the cartridge, the cartridge containing sodium bicarbonate in solid form, characterised in chat the cartridge additionally contains an acid or acid anhydride in solid form or carbon dioxide gas in an amount to prevent a temporary increase in pH of a dialysis solution produced utilising the cartridge.
2. A cartridge according to Claim 1, wherein the acid is in powder form.
3. A cartridge according to Claim 1 or Claim 2, wherein the acid is citric acid.
4. A cartridge according to Claim 1 or Claim 2, wherein the acid is tartaric acid, or another organic acid.
5. A cartridge according to any one of the preceding claims containing at least 0.2g of acid, acid anhydride, or carbon dioxide per 1000g of sodium bicarbonate.
6. A cartridge according to Claim 5, wherein the cartridge contains at least 0.5g of acid, acid anhydride, or carbon dioxide per 1000g of sodium bicarbonate.
7. A method of preventing a temporary increase of pH in a dialysis solution being continuously produced in a haemadialysis machine from different component sources including a cartridge containing solid sodium bicarbonate, the method comprising including inn the cartridge an acid or acid anhydride in solid form, or carbon dioxide gas.
8. A method according to Claim 7, wherein the cartridge and its contents are in accordance with any one of Claims 1 to 5.
9. A method of introducing carbon dioxide gas to a cartridge according to Claim 1, wherein the carbon dioxide is introduced as dry ice.
10. A haemodialysis machine comprising a cartridge as claimed is any one of Claims 1 to 6 which is connected in-line.
CA002361641A 1999-01-29 2000-01-07 Cartridge for dialysis containing sodium bicarbonate Abandoned CA2361641A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IT1999MI000176A IT1307734B1 (en) 1999-01-29 1999-01-29 CARTRIDGE FOR DIALYSIS CONTAINING SODIUM BICARBONATE.
ITMI99A000176 1999-01-29
PCT/EP2000/000130 WO2000044418A1 (en) 1999-01-29 2000-01-07 Cartridge for dialysis containing sodium bicarbonate

Publications (1)

Publication Number Publication Date
CA2361641A1 true CA2361641A1 (en) 2000-08-03

Family

ID=11381684

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002361641A Abandoned CA2361641A1 (en) 1999-01-29 2000-01-07 Cartridge for dialysis containing sodium bicarbonate

Country Status (18)

Country Link
EP (1) EP1146921A1 (en)
JP (1) JP2002535092A (en)
KR (1) KR20020008115A (en)
CN (1) CN1338952A (en)
AR (1) AR022441A1 (en)
AU (1) AU757226B2 (en)
BR (1) BR0008194A (en)
CA (1) CA2361641A1 (en)
HK (1) HK1044125A1 (en)
ID (1) ID30559A (en)
IL (1) IL144494A0 (en)
IT (1) IT1307734B1 (en)
MX (1) MXPA01007712A (en)
NO (1) NO20013702L (en)
PL (1) PL349853A1 (en)
TR (1) TR200102179T2 (en)
TW (1) TW483764B (en)
WO (1) WO2000044418A1 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20040037943A (en) 2002-10-31 2004-05-08 엘지.필립스 엘시디 주식회사 Device and fabrication method for polarizer in substrate of lcd
DE102011016167A1 (en) * 2011-04-05 2012-12-27 Ritter Gmbh Plastic containers for dialysis
DE102011106248A1 (en) 2011-07-01 2013-01-03 Fresenius Medical Care Deutschland Gmbh Container, use, dialysis machine or preparation unit and method for producing a concentrate
DE102014119106A1 (en) * 2014-12-18 2016-07-07 B. Braun Avitum Ag Concentrate container for an extracorporeal blood treatment machine, and concentrate delivery system for an extracorporeal blood treatment machine
GR1009075B (en) * 2016-04-20 2017-07-07 Βερμα Ντραγκς - Verma Drugs Abee A sodium bicarbonate-containing bag with added anhydrous citric acid as ph stabilser
GR1009074B (en) * 2016-04-20 2017-07-07 Βερμα Ντραγκς - Verma Drugs Abee A sodium bicarbonate-containing cartridge with added anhydrous citric acid as ph stabiliser

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4432756A (en) 1981-11-27 1984-02-21 Alza Corporation Parenteral controlled therapy
US4655941A (en) * 1984-02-13 1987-04-07 Tomita Pharmaceutical Corp., Ltd. Method of preparing mixed electrolyte powder for bicarbonate dialysis and powder mixture formed
AU591883B2 (en) 1984-12-03 1989-12-21 Baxter International Inc. Housing enabling passive mixing of a beneficial agent with a diluent
US4784495A (en) * 1987-02-06 1988-11-15 Gambro Ab System for preparing a fluid intended for a medical procedure by mixing at least one concentrate in powder form with water
JP2739898B2 (en) * 1989-08-07 1998-04-15 日機装株式会社 Dialysate preparation method and dialysate preparation agent
US5071558A (en) * 1989-08-11 1991-12-10 Nikkiso Co., Ltd. Sodium bicarbonate dialysate
DK0567452T3 (en) * 1990-12-18 1996-10-14 Univ Washington Dialysate production system with dialysate pellets
US5383324A (en) * 1993-04-23 1995-01-24 Baxter International Inc. Method for manufacturing and storing stable bicarbonate solutions
SE504633C2 (en) * 1995-07-03 1997-03-24 Althin Madical Ab Device for dialysis machine

Also Published As

Publication number Publication date
TR200102179T2 (en) 2001-12-21
PL349853A1 (en) 2002-09-23
HK1044125A1 (en) 2002-10-11
WO2000044418A1 (en) 2000-08-03
AU2107300A (en) 2000-08-18
JP2002535092A (en) 2002-10-22
IT1307734B1 (en) 2001-11-19
KR20020008115A (en) 2002-01-29
NO20013702D0 (en) 2001-07-27
MXPA01007712A (en) 2003-07-14
TW483764B (en) 2002-04-21
ITMI990176A1 (en) 2000-07-29
CN1338952A (en) 2002-03-06
AU757226B2 (en) 2003-02-06
AR022441A1 (en) 2002-09-04
ID30559A (en) 2001-12-20
EP1146921A1 (en) 2001-10-24
BR0008194A (en) 2002-02-13
NO20013702L (en) 2001-09-06
IL144494A0 (en) 2002-12-01

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Legal Events

Date Code Title Description
EEER Examination request
FZDE Discontinued