Reservoir assembly for providing cardioplegic solution containing bicarbonate ion, and method for manufacturing the same

A reservoir assembly for providing a cardioplegic solution, comprising a multi-chamber reservoir;

• a gas-impermeable outer package packaging the multi-chamber reservoir;
• and an oxygen detection agent and a deoxygenation agent in a space part between the multi-chamber reservoir and the outer package,
• wherein
• the multi-chamber reservoir comprises at least a first chamber, a second chamber, a third chamber, a first separator wall that separates the first chamber and the second chamber, and a second separator wall that separates the second chamber and the third chamber,
• the first chamber holds a first medical liquid including sodium ions of 108.9±10 mEq/L, potassium ions of 21.1±2 mEq/L, calcium ions of 3.4±0.3 mEq/L, and magnesium ions of 45.7±5 mEq/L, the first medical liquid having an osmotic pressure of 275 to 300 mOsm/kg,
• the second chamber holds a second medical liquid including sodium ions of 146±10 mEq/L, potassium ions of 4±0.4 mEq/L, and bicarbonate ions of 33.3±3 mEq/L, the second medical liquid having an osmotic pressure of 275 to 300 mOsm/kg,
• the volume ratio of the first medical liquid to the second medical liquid is 7:3,
• the cardioplegic solution is provided by mixing the first medical liquid and the second medical liquid, the cardioplegic solution including sodium ions of 110 to 130 mEq/L, potassium ions of 14 to 17 mEq/L, calcium ions of 2 to 3 mEq/L, magnesium ions of 30 to 35 mEq/L, and bicarbonate ions of 8 to 12 mEq/L,
• the cardioplegic solution has a pH of 7.6 to 8 and osmotic pressure of 275 to 300 mOsm/kg, and
• the deoxygenation agent includes a cross-linked polymer having carbon-carbon unsaturated bonds.

A method for manufacturing a reservoir assembly for providing a cardioplegic solution, comprising:

• sterilizing a multi-chamber reservoir comprising at least a first chamber that holds a first medical liquid, a second chamber that holds a second medical liquid containing bicarbonate ions, and a first separator wall that separates the two chambers;
• packaging the multi-chamber reservoir, an oxygen detection agent, and a deoxygenation agent in a gas-impermeable outer package, wherein the deoxygenation agent neither generates nor absorbs carbon dioxide;
• filling carbon dioxide into the outer package;
• and
• sealing the outer package after filling carbon dioxide;
• wherein
• one or both of the first medical liquid and the second medical liquid contains potassium ions,
• the cardioplegic solution is provided by mixing the first medical liquid and the second medical liquid, and
• the cardioplegic solution contains bicarbonate ions of 5 to 20 mEq/L and potassium ions of 5 to 35 mEq/L.