Fluid delivery system for hysteroscopic endometrial ablation

• US 5,437,629 A
• Filed: 04/14/1994
• Issued: 08/01/1995
• Est. Priority Date: 04/14/1994
• Status: Expired due to Term

• Current Assignee: Minerva Surgical, Inc.
• Original Assignee: BEI Medical Systems Company
• Inventors: Goldrath, Milton H.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): VANOVER, PERRY
• Application Number:
  US08/227,724
• Time in Patent Office: 474 Days
• Field of Search: 604/21, 604/27-28, 604/55, 604/96, 606/27-28, 606/96, 606/113-114, 606/191-192, 607/105, 128/4, 128/736, 128/766
• US Class Current: 604/21
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/046 in liquid form
• 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 2205/3393 by weighing the reservoir
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• 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 3/0241 the liquid being supplied by gravity
• CPC Class Codes: A61M 3/0245 Containers therefor, e.g. with heating means or with storage means for cannula

Abstract

Apparatus for and method of recirculating fluid used in performing hysteroscopic endometrial ablation. The fluid preferably circulates through a closed loop, fluid delivery system, including a heater for heating the fluid, and passes through a chamber of known volume having graduated markings disposed thereon so that the amount of fluid circulating within the closed loop system can be continuously monitored. The apparatus is connected to the inlet and outlet ports of a hysteroscopic sheath positioned within the uterine cavity of a patient. Any drop of fluid level within the marked chamber will indicate to the surgeon that the patient is undesirably absorbing fluid so that the procedure may be swiftly terminated before adverse consequences occur.

Claims

1. A fluid delivery apparatus for use in performing hysteroscopic endometrial ablation, said system comprising:

a chamber of known volume having graduated markings indicative of a plurality of fluid levels;

a container of physiologically compatible solution in fluid communication with said chamber;

a first valve for controlling the flow of physiologically compatible solution into said chamber from said container;

a heater disposed downstream of said chamber for heating a flow of fluid passing therethrough;

a first conduit disposed between said chamber and said heater;

a hysteroscopic sheath capable of introducing heated physiologically compatible solution into the uterine cavity of a patient and being provided with an inlet port and an outlet port;

a fill tube connecting said heater and said sheath inlet port;

a discharge tube from said sheath outlet port;

collection means connected to said discharge tube such that fluid discharged from said sheath collects therein;

fluid pumping means in fluid communication with said collection means;

a second conduit between said pump and said chamber to form a closed loop circulation system;

a collection bottle containing a quantity of physiologically compatible solution disposed in fluid communication with said second conduit;

a second valve disposed in said second conduit between said collection bottle and said chamber for controlling the flow of fluid into said chamber; and

a third valve for controlling the flow of fluid from said collection bottle into said second conduit.

2. The system of claim 1 further comprising a temperature monitor disposed in operative association with said heater for monitoring the temperature of fluid flowing into said hysteroscopic sheath.

3. The system of claim 1 wherein said fluid pumping means is a peristaltic pump.

4. The system of claim 1 wherein said collection means is a second chamber angles downwardly from an upper end disposed proximate said discharge tube to a lower end proximate said pumping means.

5. The system of claim 4 wherein said chamber is disposed three to four feet above the level of said patient.

6. The system of claim 1 wherein said chamber is provided with an air valve.

7. The system of claim 6 wherein said air valve and said first, second and third valve comprise a single rotary valve for synchronous operation.

8. The system of claim 1 wherein said first and second conduits, said fill and discharge tubes and said collection means is formed of insulated tubing.

9. The system of claim 1 further including a sensor disposed in said chamber for sensing the level of fluid therewithin and producing a signal when said fluid level falls below a preset minimum.

10. The system of claim 9 further comprising a switch in communication with said sensor for receiving said signal and terminating operation of said system.

11. A method of recirculating and heating fluid used in performing hysteroscopic endometrial ablation, said method comprising:

providing a recirculating system including;

a chamber of known volume having graduated markings indicative of a plurality of fluid levels, said chamber being provided with an air valve;

a container of physiologically compatible solution in fluid communication with said chamber;

a first valve for controlling the flow of physiologically compatible solution into said chamber from said container;

a heater disposed downstream of said chamber for heating a flow of fluid passing therethrough;

a first conduit disposed between said upper chamber and said heater;

a hysteroscopic sheath capable of introducing heated physiologically compatible solution into the uterine cavity of a patient and being provided with an inlet port and an outlet port;

a fill tube connecting said heater and said sheath inlet port;

a discharge tube from said sheath outlet port;

collection means connected to said discharge tube such that fluid discharged from said sheath collects therein;

fluid pumping means in fluid communication with said collection means;

a second conduit between said pump and said chamber to form a closed loop circulation system;

a collection bottle containing a quantity of physiologically compatible solution disposed in fluid communication with said second conduit;

a second valve disposed in said second conduit between said collection bottle and said chamber for controlling the flow of fluid into said chamber; and

a third valve for controlling the flow of fluid from said collection bottle into said second conduit;

closing said air valve in said chamber and said second valve, and opening said first and third valves;

allowing physiologically compatible solution to flow from said container into said chamber, said first conduit, and said heater;

operating said heater to heat solution flowing therethrough;

allowing said heated solution to fill said hysteroscopic sheath and circulate into said uterine cavity, and exit through said outlet port;

allowing said discharged solution to drain into said collection means so that it is collected therein;

operating said pumping means to draw said collected fluid from said collection means and pump it into said second conduit;

allowing said pumped liquid to flow into said collection bottle until said system and said uterine cavity are totally filled with said physiologically compatible solution; and

closing said first and third valves and opening said second valve and said air valve in said chamber to allow pumped solution to flow into said chamber for subsequent recirculation through said system.

12. The method of claim 11 comprising the further step of monitoring the level of liquid in said chamber to assure that said level remains relatively constant.

13. The method of claim 12 comprising the further step of stopping the circulation of solution through the system when the level of solution in said upper chamber begins to decline so as to prevent absorption of said solution by said patient.

14. A system for recirculating physiologically compatible solution used in performing hysteroscopic endometrial ablation, said system comprising:

a fluid conduit having a first end and a second end, said first end being attached to an inlet port of a hysteroscopic sheath and said second end being attached to an outlet port of said hysteroscopic sheath to form a closed loop fluid system;

a source of physiologically compatible solution;

a chamber for containing a portion of said physiologically compatible solution in fluid communication with said source and with said conduit at a location upstream of said hysteroscopic sheath;

a heater disposed in said conduit medial said chamber and said sheath;

a pumping means disposed in said conduit downstream of said sheath;

a collection bottle in fluid communication with said conduit at a location medial of said pumping means and said chamber; and

first, second and third valve means for controlling, respectively, fluid flow between said source and said chamber, said pump and said chamber, and said collection bottle and said conduit.

15. The system of claim 14 wherein said fluid conduit is formed of insulated tubing.

16. A fluid delivery system for use in hysteroscopic procedures requiring the delivery of a fluid to the uterine cavity of a patient, said system comprising:

a first conduit for introducing a first stream of physiologically compatible fluid of a known magnitude into a uterine cavity of a patient;

a second conduit for drawing away a second stream of said fluid from said uterine cavity;

means for measuring the magnitude of said second stream of fluid and determining a differential between said magnitude of said second stream and said known magnitude of said first stream; and

means for terminating the flow of said first stream when said differential exceeds a preset value.

17. The system of claim 16 further comprising means for heating the first stream of liquid.