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Publication Number
US-8969323-B2
Publication Date
2015-03-03
Expiration Date
Abstract
The present invention relates to priming solutions used during cardiopulmonary bypass procedures. In particular, the present invention relates to a cardiopulmonary bypass priming solution comprising a balanced salt solution and a combination of oncotic and non-oncotic dextran molecules. The present invention also relates to the use of the priming solution in a cardiopulmonary bypass method, a method of maintaining oncotic pressure in a patient during a cardiopulmonary bypass procedure, and a combination of cardiopulmonary bypass priming solution and cardiopulmonary bypass apparatus.
Core Innovation
The patent describes maintaining oncotic pressure in a patient during a cardiopulmonary bypass procedure by contacting the patient with a cardiopulmonary bypass priming solution. The priming solution includes a balanced salt solution and a combination of an oncotic dextran and a non-oncotic dextran, and the oncotic dextran provides a functional oncotic pressure corresponding to 35 to 55 g/l of Dextran 40.
The document defines oncotic dextran as having a mean molecular weight greater than 20 kDa and non-oncotic dextran as having a mean molecular weight less than 5 kDa. It further describes a functional hyperoncotic pressure that is maintained after mixing with patient blood, with oncotic Dextran 40 together with non-oncotic Dextran supporting maintenance of oncotic pressure during cardiopulmonary bypass.
The disclosed approach is evaluated for effects on bleeding and hemodynamics in preclinical and clinical settings. A comparison between a PrimeECC-like solution and Ringer-acetate reports higher or maintained oncotic pressure, lower haematocrit, and improved hemodynamics after ECC, without increased ACT or bleeding, and a prospective randomized, user-blind human clinical study reports maintained COP with lower haematocrit during cardiopulmonary bypass.
Claims Coverage
Independent claim clm-00001 covers maintaining oncotic pressure during cardiopulmonary bypass using a priming solution that combines balanced salt solution with both an oncotic dextran and a non-oncotic dextran. The claim includes a functional oncotic pressure requirement corresponding to a specific Dextran 40 equivalent, yielding at least two principal inventive features.
Oncotic pressure maintenance with combined dextran priming solution
Contacting the patient, during the cardiopulmonary bypass procedure, with a cardiopulmonary bypass priming solution comprising a balanced salt solution and a combination of an oncotic dextran and a non-oncotic dextran.
Functional oncotic pressure corresponding to Dextran 40 equivalent range
The oncotic dextran provides a functional oncotic pressure corresponding to 35 to 55 g/l of Dextran 40.
The claim coverage focuses on a cardiopulmonary bypass priming solution that maintains oncotic pressure by combining balanced salt solution with oncotic and non-oncotic dextrans, with the oncotic dextran selected so it provides a functional oncotic pressure equivalent to 35 to 55 g/l of Dextran 40.
Stated Advantages
Avoids dose-dependent bleeding.
Maintains oncotic pressure during cardiopulmonary bypass.
Maintains higher or maintained colloidal oncotic pressure (COP) in the randomized clinical study.
Lowers haematocrit during cardiopulmonary bypass.
Improves hemodynamics, including cardiac output and MAP after ECC.
No increased ACT or bleeding reported in the summarized preclinical comparison.
Improves CPB fluid balance metrics without excessive bleeding.
Documented Applications
Cardiopulmonary bypass procedures (ECC) requiring maintenance of oncotic pressure using a cardiopulmonary bypass priming solution.
Preclinical pig study comparing a PrimeECC-like solution to Ringer-acetate during ECC.
Prospective randomized, user-blind human clinical study during cardiopulmonary bypass comparing PrimeECC to controls.
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