FLUID MANAGEMENT SYSTEM AND METHODS

• US 20150119795A1
• Filed: 01/30/2014
• Published: 04/30/2015
• Est. Priority Date: 10/28/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: IoGyn, Inc. (Boston Scientific Corporation)
• Inventors: Germain, Aaron, Klein, Kyle
• Granted Patent: US 9,943,639 B2
• Time in Patent Office: Days
• US Class Current: 604/28
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00607 Coagulation and cutting with the same instrument
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 1/777 Determination of loss or gain of body fluids due to suction-irrigation, e.g. during surgery
• CPC Class Codes: A61M 2202/0429 Red blood cells; Erythrocytes
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/7545 for solid matter, e.g. microaggregates
• CPC Class Codes: A61M 2210/1433 Uterus
• CPC Class Codes: A61M 3/0208 before use
• CPC Class Codes: A61M 3/0212 : after use
• CPC Class Codes: A61M 3/022 : Volume; Flow rate
• CPC Class Codes: A61M 3/0229 : Devices operating in a closed circuit, i.e. recycling the irrigating fluid

Abstract

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.

Claims

1. A method of fluid management in an endoscopic procedure, comprising:

providing a re-circulating fluid management system including a saline source, a pump system for providing fluid inflow and outflows, a controller and control algorithms, and a filter system having selected characteristics for filtering the outflows that return to the source;

wherein the control algorithms provide an inflow into a uterine cavity and an outflow at a selected outflow rate, and wherein the filter characteristics and outflow rate are selected to substantially prevent hemolysis of filtered red blood cells; and

performing a diagnostic or therapeutic procedure in the uterine cavity in the presence of the saline.

2. The method of claim 1 wherein the control algorithms control the outflow rate to thereby limit pressure at the filter to a maximum of 100 psi or less.

3. The method of claim 1 wherein a filter system characteristic comprises hollow filter fibers with a total lumen surface area of at least 0.5 m².

4. The method of claim 1 wherein a filter system characteristic is a filtration capacity of at least 40 ml of blood.

5. The method of claim 1 wherein a filter system characteristic is a flow-through capacity of at least 500 ml/min.

6. The method of claim 1 wherein a filter system characteristic comprises hollow fibers having a nominal molecular weight limit (NMWL) of 50 kDa or less.

7. The method of claim 1 wherein a filter system characteristic consists of back pressure at the filter of 5 psi or less.

8. The method of claim 1 wherein the filter system characteristics and outflow rate are selected to prevent hemolysis of greater than 5% of filtered red blood cells.

9. The method of claim 1 wherein the filter system characteristics are further selected to insure that a filtrate causes no substantial effect on an extrinsic coagulation pathway as verified by a Prothrombin Time assay.

10. The method of claim 1 wherein the filter system characteristics are further selected to insure that filtrate causes no substantial effect on an intrinsic coagulation pathway as verified by an Unactivated Partial Thromboplastic Time assay.

11. The method of claim 1 wherein the filter system characteristics are further selected to insure that filtrate causes substantially no activation of an immune system pathway as verified by a Complement Activation assay evaluating at least one of the protein complements C3A and C5b.

12. The method of claim 1 wherein the filter system characteristics are further selected to insure that filtrate causes no substantial effect on platelet aggregation as verified by a Platelet Aggregation assay.

13. The method of claim 1 wherein a filter system characteristic is a filtration capacity of at least 60 ml of blood or at least 80 ml of blood.

19. The method of claim 1 wherein a filter system characteristic comprises hollow fibers having a nominal molecular weight limit (NMWL) of 50 kDa or less.

20. The method of claim 1 wherein a filter system characteristic consists of back pressure at the filter of 5 psi or less.

14. A method of fluid management in an endoscopic procedure, comprising:

providing a re-circulating fluid management system including a saline source, a pump system for providing saline inflow and outflows, a controller and control algorithms, and a filter system having selected characteristics for filtering the outflows that return to the source;

wherein the control algorithms provide an inflow into a site and an outflow from the site at a selected outflow rate, and wherein the filter characteristics and outflow rate are selected to result in substantially no change in the electrolyte concentration of the filtrate; and

performing a diagnostic or therapeutic procedure in the uterine cavity in the presence of the saline.

15. The method of claim 14 wherein the control algorithms control the outflow rate to thereby limit pressure at the filter to a maximum of 100 psi or less.

16. The method of claim 14 wherein a filter characteristic comprises hollow filter fibers with a total lumen surface area of at least 0.5 m².

17. The method of claim 14 wherein a filter characteristic is a filtration capacity of at least 40 ml of blood.

18. The method of fluid management of claim 16 wherein a filter characteristic is a flow-through capacity of at least 500 ml/min.

21. A fluid management method, comprising:

circulating a distention fluid from a source in an inflow to a treatment site and an outflow from the site through a filter resulting in a flow of a filtrate back to the source;

wherein the circulating step includes filtering the outflow under filtering parameters that provide a filtrate that causes no substantial effect on an extrinsic or intrinsic coagulation pathway as verified by Prothrombin Time and Unactivated Partial Thromboplastic Time assays; and

performing a diagnostic or therapeutic procedure in the site.

22. A fluid management method, comprising:

circulating a distention fluid from a source in an inflow to a treatment site and an outflow from the site through a filter resulting in a flow of a filtrate back to the source;

wherein the circulating step includes filtering the outflow under filtering parameters that provide a filtrate that causes substantially no activation of an immune system pathway as verified by a Complement Activation assay evaluating at least one of the protein complements C3A and C5b; and

performing a diagnostic or therapeutic procedure in the site.