Fluid management system for arthroscopic surgery

• US 5,800,383 A
• Filed: 07/17/1996
• Issued: 09/01/1998
• Est. Priority Date: 07/17/1996
• Status: Expired due to Fees

• Current Assignee: AVAcore Technologies, Inc.
• Original Assignee: Aquarius Medical Corporation
• Inventors: Cassaday, William, Kane, John, Roundy, James S., Egan, Michael J., Etherington, Roger, Chandler, W. Jeffrey, Phillips, Howard S.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US08/683,745
• Time in Patent Office: 776 Days
• Field of Search: 604/19, 604/35, 604/54, 604/65, 604/66, 604/67, 604/80
• US Class Current: 604/35
• 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 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

An improved fluid management system for irrigation of a body cavity and in particular for use in arthroscopic surgery having a pressurized fluid circuit for supplying irrigation fluid and a vacuum fluid circuit for withdrawing waste fluid from the cavity. In a preferred embodiment there is an uninterrupted fluid supply comprised of a plurality of sterile solution saline bags with an automatic spiker to perforate the bags. The system is processor controlled with numerous safety and design features to automate arthroscopy to the highest degree possible. Some of the features include the monitoring and tracking of cavity pressure and flow rates to predetermined pressure and flow rates, tracking cavity to mean blood pressure, overpressure protection, a plurality of pressure and flow rate baseline settings, monitoring, setting and controlling saline supply, and specialized functions for providing pressure and flow rates for typical surgical procedures such as lavage, clear view, and burr/shaver. One or more vacuum discharge lines may be provided with an automatic self-cleaning feature. The system is compact and optionally employs a number of disposable components, including a novel fluid accumulator.

Claims

1. An improved fluid management system for irrigation of a body cavity comprising:

means for supplying an uninterrupted supply of irrigation fluid;

means for pumping said irrigation fluid from said irrigation fluid supply to a body cavity to create pressure inside said body cavity;

a supply conduit connecting said supply of irrigation fluid to said body cavity;

a fluid discharge conduit leading from said body cavity to withdraw fluid from said body cavity;

means for creating a vacuum in said fluid discharge conduit to create suction inside said body cavity;

pressure sensing means for sensing pressure inside said body cavity; and

means for controlling said suction and pressure inside said body cavity wherein said pumping means is a peristaltic pump, and said means for controlling said suction and pressure comprise a processor controlling the pump speed of said peristaltic pump and the rate of fluid flowing through said supply conduit to said body cavity;

a pressure transducer for sensing the pressure inside the body cavity, said processor communicating with said pressure transducer; and

at least one valve for controlling the rate of fluid flow from said body cavity, said processor controlling said valve;

wherein said processor communicates with a display console and a hand held remote control having a plurality of control buttons for an operator to manually input functions to control said peristaltic pump speed, said pressure inside the body cavity and for the control by said processor of said pump and said valves.

2. The invention according to claim 1, wherein said input functions are functions that involve controlling the pressure and flow of irrigation fluid inside the body cavity and are selected from the group consisting of lavage, clear view, burr, and shaver.

3. The invention according to claim 1, where said input functions are functions that involve controlling the pressure and flow of irrigation fluid inside the body cavity and are selected from the group consisting of pause, run and drain.

4. The invention according to claim 1, wherein said means for controlling further comprises a blood pressure transducer communicating with said processor the mean blood pressure associated with said body cavity, and said processor controlling said pump and said valves to vary the body cavity pressure to track said body cavity mean blood pressure.

5. An improved fluid management system for irrigation of a body cavity comprising:

means for supplying an uninterrupted supply of irrigation fluid;

means for pumping said irrigation fluid from said irrigation fluid supply to a body cavity to create pressure inside said body cavity;

a supply conduit connecting said supply of irrigation fluid to said body cavity;

a fluid discharge conduit leading from said body cavity to withdraw fluid from said body cavity;

means for creating a vacuum in said fluid discharge conduit to create suction inside said body cavity;

pressure sensing means for sensing pressure inside said body cavity;

means for controlling said suction and pressure inside said body cavity, wherein said means for controlling said suction and pressure comprises a processor receiving signals from said pressure sensing means relating to the pressure inside said body cavity, a valve controlling the flow of fluid through said fluid discharge conduit, and said processor controlling the amount of fluid discharged from said body cavity and said pressure inside said body cavity by selectively opening and closing said valve, and further comprising a second fluid discharge conduit leading from said body cavity to withdraw fluid from said body cavity, and a second valve controlling the flow of fluid through said second conduit in said second conduit and controlled by said processor.

6. The invention according to claim 5, wherein said second valve is randomly opened and closed by said controlling means at a predetermined frequency for a preselected period of time during certain predetermined procedures involving the discharge of tissue from said body cavity.

7. The invention according to claim 5, wherein said valve to said fluid discharge conduit and said second valve to said second fluid discharge conduit are variable controlled valves.

8. The invention according to claim 7, second valve is randomly opened and closed by said controlling means at a predetermined frequency for a preselected period of time during said procedures involving the discharge of tissue.

9. The invention according to claim 5, wherein said fluid discharge conduits comprise flexible tubing and said valve to said fluid discharge conduit and said second valve to said second fluid discharge conduit are valves that pinch said flexible tubing either fully closed shut or allow said tubing to be fully open to flow.

10. An improved fluid management system for irrigation of a body cavity comprising:

means for supplying an uninterrupted supply of irrigation fluid;

means for pumping said irrigation fluid from said irrigation fluid supply to a body cavity to create pressure inside said body cavity;

a supply conduit connecting said supply of irrigation fluid to said body cavity;

a fluid discharge conduit leading from said body cavity to withdraw fluid from said body cavity;

means for creating a vacuum in said fluid discharge conduit to create suction inside said body cavity;

pressure sensing means for sensing pressure inside said body cavity;

means for controlling said suction and pressure inside said body cavity, wherein said means for creating said vacuum comprises a vacuum pump connected to a vacuum accumulator tank, with said tank connected to said fluid discharge conduit, further comprising;

a second fluid discharge conduit leading from said body cavity to withdraw fluid from said body cavity, and a second valve controlled by said means for controlling said suction and pressure, to control the fluid flowing through said second fluid discharge conduit;

said second fluid discharge conduit in-line with a waste disposal trap, said second valve opened by said controlling means to allow said second fluid discharge conduit to receive waste fluid from said body cavity during procedures involving the discharge of tissue from said body cavity.

11. The invention according to claim 10, wherein said vacuum pump generates sufficient vacuum in said fluid discharge conduit to achieve a negative pressure in the range of up to 350 mm-Hg of vacuum, and said means for pumping is a positive displacement pump generating sufficient pressure in said supply conduit to achieve a positive pressure in the range of up to 500 mm-Hg of pressure.

12. The invention according to claim 10, wherein said second valve is randomly opened and closed by said controlling means at predetermined frequency for a preselected period of time during said procedures involving the discharge of tissue.

13. An improved fluid management system for irrigation of a body cavity comprising:

means for supplying an uninterrupted supply of irrigation fluid;

means for pumping said irrigation fluid from said irrigation fluid supply to a body cavity to create pressure inside said body cavity;

a supply conduit connecting said supply of irrigation fluid to said body cavity;

a fluid discharge conduit leading from said body cavity to withdraw fluid from said body cavity;

means for creating a vacuum in said fluid discharge conduit to create suction inside said body cavity;

pressure sensing means for sensing pressure inside said body cavity;

means for controlling said suction and pressure inside said body cavity;

an accumulator in fluid communication with said supply conduit and connected between said pumping means and said body cavity, wherein said accumulator has an inlet port, an outlet port, and a vent port to atmosphere, said inlet port receiving irrigation fluid from said pumping means, said outlet port discharging said irrigation fluid to flexible conduits leading to said body cavity, wherein said accumulator is sealed from atmosphere and vents to atmosphere through said vent port, said accumulator receiving pressurized irrigation fluid from said pumping means.

14. The invention according to claim 13, wherein said accumulator contains two fluid level sensors to determine the level of fluid within said accumulator.

15. An improved fluid management system for irrigation of a body cavity comprising:

means for supplying an uninterrupted supply of irrigation fluid;

means for pumping said irrigation fluid from said irrigation fluid supply to a body cavity to create pressure inside said body cavity;

a supply conduit connecting said supply of irrigation fluid to said body cavity;

a fluid discharge conduit leading from said body cavity to withdraw fluid from said body cavity;

means for creating a vacuum in said fluid discharge conduit to create suction inside said body cavity;

pressure sensing means for sensing pressure inside said body cavity;

means for controlling said suction and pressure inside said body cavity, said means for providing an uninterrupted supply of irrigation fluid comprising a plurality of sealed bags each containing a predetermined amount of said irrigation fluid;

each said bag being fixedly mounted on a housing; and

means for spiking each said sealed bag to allow fluid communication with said supply conduit, wherein said means for spiking is controlled by a processor to allow the uninterrupted flow of fluid from said sealed bag to said body cavity.

16. The invention according to claim 15, wherein said means for spiking comprises a trocar mounted on a hollow piston housed in a piston chamber and said trocar being protracted from said housing to spike said sealed bag;

said piston chamber and said hollow piston having fluid ports, said ports in fluid communication when said trocar is protracted, to allow said irrigation fluid from spiked sealed bag to flow into said supply conduit.

17. The invention according to claim 16, wherein said hollow piston is actuated to a protracted position by a linear actuator.

18. The invention according to claim 17, wherein said linear actuator is a pneumatic cylinder.

19. The invention according to claim 15:

wherein said means for spiking said sealed bag is in fluid communication with a portion of said supply conduit;

wherein a plurality of bags are mounted on said housing, each of said plurality of bags having said means for spiking said sealed bag;

further comprising a manifold having a plurality of inlet ports for receiving said portion of said supply conduits from said spiking means, said manifold having at least one outlet port leading to said means for pumping;

a flow interrupt fluid sensor for sensing the absence of irrigation fluid in said manifold;

a processor for receiving signals from said flow interrupt sensor and for controlling said spiking means to spike said bags, wherein said sealed bags are sequentially spiked by said spiking means through control by said processor whenever said flow interrupt fluid sensor indicates the absence of irrigation fluid in said manifold.

20. The invention according to claim 19, further comprising:

a pressurized accumulator chamber having an inlet port, an outlet port, and a vent to atmosphere;

wherein said pumping means comprises a peristaltic pump having a plurality of drive rollers, and said supply conduit is flexible tubing surrounding said peristaltic pump drive rollers;

wherein said pressure sensing means comprise a pressure transducer;

said accumulator inlet port connected to said peristaltic pump to receive pressurized irrigation fluid into said pressurized accumulator chamber, and said outlet port connected to said supply flexible tubing and discharging irrigation fluid to said body cavity.

21. The invention according to claim 20,

wherein said means for controlling comprise said processor, said processor receiving signals from a pressure transducer for sensing pressure inside the body cavity, and controlling a plurality of valves to control the rate of fluid flow through said discharge conduit and said processor controlling the pump speed of said peristaltic pump to control the rate of irrigation fluid flow to said body cavity.

22. The invention according to claim 21, further comprising a fluid level sensor in said accumulator to determine the level of fluid within said accumulator, said fluid level sensor communicating with said processor.

23. An improved fluid management system for irrigation of a body cavity comprising:

means for supplying an uninterrupted supply of irrigation fluid;

means for pumping said irrigation fluid from said irrigation fluid supply to a body cavity to create pressure inside said body cavity;

a supply conduit connecting said supply of irrigation fluid to said body cavity;

a fluid discharge conduit leading from said body cavity to withdraw fluid from said body cavity;

means for creating a vacuum in said fluid discharge conduit to create suction inside said body cavity;

pressure sensing means for sensing pressure inside said body cavity;

means for controlling said suction and pressure inside said body cavity wherein said means for providing said uninterrupted supply of irrigation fluid comprises a plurality of sealed bags containing a predetermined amount of said irrigation fluid;

each said bag is fixedly mounted on a vertical post from a carousel; and

means for spiking each said sealed bag to allow fluid communication with said supply conduit, wherein said means for spiking is controlled by a processor to allow the uninterrupted flow of fluid from said sealed bag to said body cavity.

24. The invention according to claim 23, wherein said means for spiking comprises a trocar mounted on a hollow piston housed in a piston chamber and said trocar being protracted from said housing to spike each said sealed bag;

said piston chamber and said hollow piston having fluid ports, said ports in fluid communication when said trocar is protracted, to allow said irrigation fluid from spiked sealed bag to flow into said supply conduit.

25. The invention according to claim 23, wherein said means for spiking said sealed bag is in fluid communication with a portion of said supply conduit;

further comprising a manifold having a plurality of inlet ports for receiving said portion of said supply conduits from said spiking means, said manifold having at least one outlet port leading to said means for pumping;

a flow interrupt fluid sensor for sensing the absence of irrigation fluid in said manifold;

a processor for receiving signals from said flow interrupt sensor and for controlling said spiking means to spike said bags, wherein said sealed bags are sequentially spiked by said spiking means through control by said processor whenever said flow interrupt fluid sensor indicates the absence of irrigation fluid in said manifold.

26. An improved fluid management system for irrigation of a body cavity comprising:

means for supplying an uninterrupted supply of irrigation fluid;

means for pumping said irrigation fluid from said irrigation fluid supply to a body cavity to create pressure inside said body cavity;

a supply conduit connecting said supply of irrigation fluid to said body cavity;

a fluid discharge conduit leading from said body cavity to withdraw fluid from said body cavity;

means for creating a vacuum in said fluid discharge conduit to create suction inside said body cavity;

pressure sensing means for sensing pressure inside said body cavity;

means for controlling said suction and pressure inside said body cavity wherein said pressure sensing means comprises;

a sense line for sensing pressure in said body cavity;

a branch line of a smaller diameter than said supply line, located outside said body cavity, connecting said supply line to said sense line to allow fluid communication between the lines;

a differential pressure transducer for converting differential fluid pressure into an electrical signal representing fluid pressure, said differential pressure transducer having two ports, each measuring a pressure P1 and P2, with one of said ports in fluid communication with said sense line and the other said port in fluid communication with said supply line;

wherein the differential pressure transducer measures the difference between pressures P1 and P2 for calculating the pressure inside the cavity.

27. The invention according to claim 26, a compensating line operatively connected to one of the two differential pressure transducer ports, said compensating line open at one end to atmosphere and of a substantially small enough diameter that the liquid supplied to the body cavity drips out the compensating line with substantially no pressure loss in said body cavity.

28. An apparatus for irrigation of a body cavity comprising:

means for providing an uninterrupted and continuous supply of fluid for irrigation of a body cavity;

means for pressurizing the irrigation fluid to a body cavity to create pressure inside the body cavity;

a flexible supply conduit inflow line connecting the supply of irrigation fluid to the body cavity;

a fluid discharge conduit outflow line leading from the body cavity to withdraw fluid from the body cavity;

means for creating a vacuum in the fluid discharge conduit outflow line to create suction inside the body cavity; and

means for controlling the suction and pressure inside the body cavity, wherein the containers are flexible bags and wherein the means to sequentially access each of the plurality of containers comprises a hollow piston inserted into the containers by a pneumatic cylinder fired in response to a signal from the processor.

29. The apparatus according to claim 28, wherein the means for providing an uninterrupted and continuous supply of fluid comprise a plurality of flexible bags hanging from an upright position, said bags each containing a predetermined quantity of the irrigation fluid, and spiking means to sequentially spike each of the plurality of containers, the spiking means operatively connected to the flexible conduit.

30. The apparatus according to claim 28, wherein the means for providing an uninterrupted and continuous supply of fluid comprising a plurality of containers each containing a predetermined quantity of the irrigation fluid, and means to sequentially access each of the plurality of containers individually.

31. The apparatus according to claim 28, wherein the means for pressurizing the irrigation fluid is a positive displacement peristaltic pump.

32. The apparatus according to claim 28, wherein the means for creating a vacuum comprises a vacuum pump, wherein the vacuum pump is connected to a vacuum tank, the peristaltic pump pumps irrigation fluid into a pressurized accumulator, and further comprising a pressure sensing means for sensing pressure inside the body cavity.

33. The apparatus according to claim 32, further comprising a valve to control the rate of fluid passing through the outflow line, and wherein the means for controlling the vacuum and pressure inside the body cavity comprises a processor that controls the peristaltic pump and the valve, the processor receiving signals from the pressure sensing means.

34. The apparatus according to claim 33, further comprising a second outflow line substantially in parallel with the outflow line leading from the body cavity, and a second valve to control the rate of fluid passing through the second outflow line, and wherein the processor controls the second valve.

35. An improved fluid management system for irrigation of a body cavity comprising:

a housing;

a supply of irrigation fluid, said supply of irrigation fluid provided by a plurality of bags hanging vertically from a carousel mounted on a post on said housing;

a supply conduit connecting said supply of irrigation fluid to said body cavity;

separate means for spiking each of said bags to allow fluid communication with said supply conduit, whereby more than one bag may be in fluid communication with said supply conduit;

a fluid discharge conduit leading from said body cavity to withdraw fluid from said body cavity;

means for pressurizing said supply of irrigation fluid;

pressure sensing means for sensing pressure inside said body cavity.

36. The improved fluid management system according to claim 35, further comprising:

means for creating a vacuum in said fluid discharge conduit to create suction inside said body cavity; and

means for controlling said suction and pressure inside said body cavity, wherein said means for controlling said suction and pressure comprises a processor.

37. The improved fluid management system according to claim 35, further comprising an accumulator chamber having an inlet port, and an outlet port, said accumulator receiving fluid from said supply of irrigation fluid in said inlet port and discharging fluid to said supply conduit in said outlet port.

38. A auto-accumulating, gravity feed pressure based fluid management apparatus comprising:

a housing;

a supply of irrigation fluid, said supply of irrigation fluid provided by a plurality of bags hanging vertically from a carousel mounted on a post on said housing;

a supply conduit connecting said supply of irrigation fluid to said body cavity;

a fluid discharge conduit leading from said body cavity to withdraw fluid from said body cavity;

pressure sensing means for sensing pressure inside said body cavity;

an accumulator in fluid communication with said supply conduit and connected between said supply of irrigation fluid and said body cavity;

wherein pressure is provided to said irrigation fluid by the gravity head by said plurality of bags.

39. An improved fluid management system for irrigation of a body cavity comprising:

a supply of irrigation fluid;

means for pumping said irrigation fluid from said irrigation fluid supply to a body cavity;

a supply conduit connecting said supply of irrigation fluid to said body cavity;

a fluid discharge conduit leading from said body cavity to withdraw fluid from said body cavity;

an accumulator in fluid communication with said supply conduit and connected between said pumping means and said body cavity,

a post for mounting said accumulator,

wherein said accumulator is raised to a height above said pumping means wherein said accumulator is pressurized with irrigation fluid by said means for pumping and has an inlet port, an outlet port, and a vent port to atmosphere, said inlet port receiving irrigation fluid from said pumping means, said outlet port discharging said irrigation fluid to flexible conduits leading to said body cavity, wherein said accumulator is sealed from atmosphere and vents to atmosphere through said vent port, said accumulator receiving pressurized irrigation fluid from said pumping means, and further comprising a weight sensor mounted on said post for weighing the contents of said accumulator.

40. A fluid management system for the uninterrupted supply of fluid to a body cavity, comprising:

a supply of fluid comprising a plurality of sealed containers each containing a predetermined supply of fluid;

means for pumping said fluid from said fluid supply to a body cavity;

a supply conduit connecting said supply of fluid to said body cavity;

means for spiking each sealed container to allow fluid communication with said supply conduit, wherein said means for spiking comprises a trocar mounted on a hollow piston housed in a piston chamber and said trocar is protracted from said housing to spike said sealed container, said piston chamber and said hollow piston having fluid ports, said ports in fluid communication when said trocar is protracted, to allow said irrigation fluid from the spiked container to flow into said supply conduit.

41. The invention according to claim 40, wherein said hollow piston is actuated to a protracted position by a linear actuator;

a processor controlling said linear actuator, wherein each of said plurality of containers is spiked sequentially by said processor.

42. The invention according to claim 41:

further comprising a manifold having a plurality of inlet ports for receiving a portion of said supply conduits from said spiking means, said manifold having at least one outlet port leading to said means for pumping;

a flow interrupt fluid sensor for sensing the absence of irrigation fluid in said manifold;

a processor for receiving signals from said flow interrupt sensor and for controlling said spiking means to spike said bags, wherein said sealed bags are sequentially spiked by said spiking means through control by said processor whenever said flow interrupt fluid sensor indicates the absence of irrigation fluid in said manifold.

43. A spiker for the spiking of a flexible saline bag comprising:

a trocar mounted on a hollow piston housed in a piston chamber within a housing, said trocar in close proximity to a flexible sealed bag containing fluid having an inlet and fixedly secured with respect to said trocar;

said trocar being protracted from said housing to spike said sealed bag;

said piston chamber and said hollow piston having fluid ports, said ports in fluid communication when said trocar is protracted, to allow said fluid from the spiked sealed bag to flow into a supply conduit, wherein said hollow piston is actuated to a protracted position by a linear actuator.

44. The invention according to claim 43, wherein said linear actuator is a pneumatic cylinder.

45. A fluid accumulator for a peristaltic fluid delivery system in a medical fluid irrigation system comprising:

a peristaltic pump;

an accumulator chamber having an inlet port and an outlet port;

said accumulator inlet port leading into said chamber and connected to said peristaltic pump to receive fluid from said pump, and said outlet port discharging said fluid.

46. The fluid accumulator according to claim 45, further comprising a plurality of sensors in said accumulator chamber to sense the level of said pump fluid in said chamber.

47. The fluid accumulator according to claim 46, wherein said accumulator is sealed to atmosphere and has an inlet port, an outlet port, and a vent to atmosphere.

48. An improved cavity pressure sensing system for measuring pressure in a cavity containing a mixture of air and liquid, comprising:

an inflow line for supplying liquid to a cavity;

a sense line for sensing pressure in the cavity;

a branch line of a smaller diameter than the inflow line, located outside the cavity, connecting the inflow line to the sense line to allow fluid communication between the lines;

a differential pressure transducer for converting differential fluid pressure into an electrical signal representing fluid pressure, the differential pressure transducer having two ports, each measuring a pressure P1 and P2, with one of the ports in fluid communication with the sense line and the other port in fluid communication with the supply line;

a compensating line operatively connected to one of the two differential pressure transducer ports, said compensating line open at one end to atmosphere and of a substantially small enough diameter that the liquid supplied to the cavity drips out the compensating line with substantially no pressure loss in the cavity;

wherein the differential pressure transducer measures the difference between pressures P1 and P2 to calculate the pressure inside the cavity.

49. The method of irrigating a body cavity during arthroscopic surgery with an improved fluid management system comprising the steps of:

supplying an uninterrupted supply of saline solution under pressure, in the range of up to 180 mm-Hg inside a body cavity;

inserting a flexible supply tubing to deliver said pressurized saline solution in a surgical incision site of said body cavity where arthroscopic surgery is to be performed;

inserting flexible discharge tubing in said incision site to withdraw body cavity fluid from said body cavity;

pumping said pressurized saline solution through said flexible supply tubing into said surgical incision site;

withdrawing waste fluid from the body cavity through said flexible discharge tubing through suction, in the range of up to 180 mm-Hg vacuum inside said body cavity;

monitoring and controlling the supply of said saline solution, the pumping of said saline solution and the withdrawal of waste fluid from said body cavity with a processors,

measuring the pressure inside said body cavity with a pressure sensing transducer;

monitoring and controlling the flow of fluid from said body cavity to chance the pressure inside said body cavity and track said pressure according to a predetermined set pressure;

said monitoring and controlling performed by said processor and at least one valve controlled by said processor that selectively opens and closes the flow of waste fluid through said flexible discharge tubing;

attenuating the surges associated with pumping said pressurized saline solution through an accumulator;

supplying said uninterrupted supply of saline solution through a plurality of containers having flexible opening capable of perforation;

automatically perforating said flexible opening of said containers with a trocar, said trocar actuated by a linear actuator that is controlled by said processor.