Fluid management system and methods
A hysteroscopic fluid management system includes a saline source with an electrolyte concentration, at least one pressure mechanism for circulating saline to and from a targeted site and through a filter having filter characteristics back to the source, and a controller. The controller provides a saline inflow in a first flow path to the site and a saline outflow in a second flow path from the site through the filter and back to the source at a controlled flow rate. A diagnostic or therapeutic procedure is performed at the site in the presence of the saline. The filter characteristics and the controlled flow rate are selected to (1) cause substantially no change in the electrolyte concentration in the saline, (2) to prevent hemolysis of greater than 5% of filtered red blood cells exposed to the saline, and/or (3) to minimize effect on prothrombin time of plasma exposed to the filter.
1. A fluid management system for use in an endoscopic procedure, comprising:
a pump system for providing a fluid inflow from a fluid source to a body cavity of a patient and fluid outflow returning to the fluid source from the body cavity;
a controller and control algorithms; and
a filter system having selected characteristics for filtering blood from the fluid outflow returning to the fluid source;
wherein the filter system characteristics are selected to ensure that a filtrate returning to the fluid source causes no effect on platelet aggregation as verified by a Platelet Aggregation assay.
2. The system of claim 1 , wherein the filter system characteristics and outflow rate of the fluid outflow are selected to result in no change in an electrolyte concentration of the filtrate returning to the fluid source.
3. The system of claim 1 , wherein the filter system characteristics are further selected to ensure that the filtrate causes no effect on an extrinsic coagulation pathway as verified by a Prothrombin Time assay.
4. The system of claim 1 , wherein the filter system characteristics are further selected to ensure that the filtrate causes no effect on an intrinsic coagulation pathway as verified by an Unactivated Partial Thromboplastic Time assay.
5. The system of claim 1 , wherein a filter system characteristic comprises hollow fibers having a nominal molecular weight limit (NMWL) of 50 kDa or less.
6. The system of claim 1 , wherein a filter system characteristic comprises hollow fibers having a nominal molecular weight limit (NMWL) of 20 kDa or less.
7. The system of claim 1 , wherein the control algorithms control an outflow rate of the fluid outflow to thereby limit pressure at the filter system to a maximum of 6.9*10 5 Pa (100 psi) or less.
8. The system of claim 1 , wherein a filter system characteristic comprises hollow filter fibers with a total lumen surface area of at least 0.5 m 2 .
9. The system of claim 1 , wherein a filter system characteristic is a flow-through capacity of at least 500 ml/min.
10. The system of claim 1 , wherein a filter system characteristic comprises back pressure at the filter of 3.5*10 5 Pa (5 psi) or less.
11. The system of claim 1 , wherein a filter system characteristic is a filtration capacity of at least 40 ml of blood.
12. The system of claim 1 , wherein a filter system characteristic is a filtration capacity of at least 60 ml of blood.
13. The system of claim 1 , wherein a filter system characteristic is a filtration capacity of at least 80 ml of blood.
14. The system of claim 1 , wherein the control algorithms are configured to control flow rates through the filter system.
15. The system of claim 14 , wherein the control algorithms are further configured to control pressure at the filter system.