Classifications

• • 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
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K33/00—Medicinal preparations containing inorganic active ingredients
• • 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

Definitions

• This invention relates to dialysis cartridges containing solid sodium bicarbonate.
• the inventors have discovered that the problem is probably caused by conta ⁇ iination 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, however, difficult and expensive to produce a sodium bicarbonate powder, which is not contaminated with sodium carbonate.
• the inventors have found that the problem can be relatively simply solved by modifying the contents of the cartridge.
• the present invention relates to 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.
• the cartridge additionally contains an acid, or acid anhydride in solid form, or carbon dioxide gas.
• 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.
• 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 acceptability.
• the cartridge may contain at least 0.2g of acid, or acid anhydride per lOOOg of sodium bicarbonate; preferably at least 0.5g per lOOOg and most preferably at least lg per lOOOg.
• the preferred embodiment contains 2.7g per lOOOg.
• Fig 1. is a side elevation of a cartridge according to the invention, shown partly in cross-section;
• Fig 2. is a diagrammatic illustration of the cartridge of fig 1 connected in a haemodialysis machine.
• 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 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, 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 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 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 chloride, sodium chloride and an osmotic agent, such as dextrose.
• a dialysis solution such as calcium and magnesium chloride, sodium chloride and an osmotic agent, such as dextrose.
• 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 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 bicarbonate and 2g citric acid, both in granular, crystalline form. A similar weight ratio could be used with different amounts of sodium bicarbonate.
• 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.

Landscapes

• Health & Medical Sciences (AREA)
• Urology & Nephrology (AREA)
• Heart & Thoracic Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Engineering & Computer Science (AREA)
• Hematology (AREA)
• Biomedical Technology (AREA)
• Anesthesiology (AREA)
• Vascular Medicine (AREA)
• Emergency Medicine (AREA)
• Chemical & Material Sciences (AREA)
• Inorganic Chemistry (AREA)
• Medicinal Chemistry (AREA)
• Pharmacology & Pharmacy (AREA)
• Epidemiology (AREA)
• External Artificial Organs (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Priority Applications (11)

Applications Claiming Priority (2)

Publications (1)

Family

ID=11381684

Family Applications (1)

Country Status (18)

Cited By (4)

Families Citing this family (2)

Citations (9)

• 1999
  • 1999-01-29 IT IT1999MI000176A patent/IT1307734B1/it active
• 2000
  • 2000-01-07 BR BR0008194-9A patent/BR0008194A/pt not_active IP Right Cessation
  • 2000-01-07 CA CA002361641A patent/CA2361641A1/en not_active Abandoned
  • 2000-01-07 JP JP2000595720A patent/JP2002535092A/ja active Pending
  • 2000-01-07 PL PL00349853A patent/PL349853A1/xx unknown
  • 2000-01-07 TR TR2001/02179T patent/TR200102179T2/xx unknown
  • 2000-01-07 CN CN00803275A patent/CN1338952A/zh active Pending
  • 2000-01-07 WO PCT/EP2000/000130 patent/WO2000044418A1/en not_active Application Discontinuation
  • 2000-01-07 KR KR1020017009573A patent/KR20020008115A/ko not_active Application Discontinuation
  • 2000-01-07 AU AU21073/00A patent/AU757226B2/en not_active Ceased
  • 2000-01-07 MX MXPA01007712A patent/MXPA01007712A/es unknown
  • 2000-01-07 IL IL14449400A patent/IL144494A0/xx unknown
  • 2000-01-07 EP EP00901084A patent/EP1146921A1/en not_active Withdrawn
  • 2000-01-27 AR ARP000100356A patent/AR022441A1/es not_active Application Discontinuation
  • 2000-02-18 TW TW089102863A patent/TW483764B/zh active
• 2001
  • 2001-07-27 NO NO20013702A patent/NO20013702L/no not_active Application Discontinuation
  • 2001-08-28 ID IDW00200101858A patent/ID30559A/id unknown
• 2002
  • 2002-08-06 HK HK02105734.8A patent/HK1044125A1/zh unknown

Patent Citations (9)

Non-Patent Citations (1)

Also Published As

Similar Documents

Legal Events