SURGICAL FLUID MANAGEMENT SYSTEM WITH PRESSURE AND/OR FLOW CONTROL

• US 20100228222A1
• Filed: 03/09/2010
• Published: 09/09/2010
• Est. Priority Date: 03/09/2009
• Status: Active Grant

• Current Assignee: Stryker Corporation
• Original Assignee: Thermedx, LLC (Stryker Corporation)
• Inventors: Williams, Jeffrey B., Carr, Douglas L., Pyles, Kenneth R.
• Granted Patent: US 8,444,592 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61M 1/72 Cassettes forming partially or totally the fluid circuit
• 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 2205/123 with incorporated reservoirs
• CPC Class Codes: A61M 2205/127 with provisions for heating or cooling
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/368 by electromagnetic radiation, e.g. IR waves
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 3/0201 Cassettes therefor
• CPC Class Codes: A61M 3/0202 with electronic control means or interfaces
• CPC Class Codes: A61M 3/0208 before use
• CPC Class Codes: A61M 3/0216 Pressure
• CPC Class Codes: A61M 3/022 Volume; Flow rate
• CPC Class Codes: A61M 3/0245 Containers therefor, e.g. with heating means or with storage means for cannula
• CPC Class Codes: A61M 3/0258 by means of electric pumps
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/36 : with means for eliminating or preventing injection or infusion of air into body dialysis systems, blood oxygenators A61M1/14; haemofiltration equipment A61M1/34; automatic tube cut-off A61M39/281
• CPC Class Codes: A61M 5/44 : having means for cooling or heating the devices or media
• CPC Class Codes: G01G 17/04 : for weighing fluids, e.g. gases, pastes
• CPC Class Codes: G01G 19/414 : using electronic computing means only

Abstract

Surgical fluid management systems and methods of operating surgical fluid management systems which may provide one or more functions associated with suction, irrigation, distention, deficit monitoring, infusion, fluid warming, and the like. Some example embodiments may include infra-red lamps arranged to heat fluid flowing through a disposable cartridge. Some example embodiments may provide a three-dimensional fluid path through the cartridge and/or multi-stage heating capabilities. Some example fluid management systems may be selectable between pressure control and flow control modes.

Claims

1. A surgical fluid management system comprising:

a pump configured to deliver a fluid to a surgical site; and

a control system, the control system being user-selectable between a pressure control mode and a flow control mode;

wherein the pressure control mode includes controlling the pump to deliver the fluid to the surgical site at approximately a target pressure; and

wherein the flow control mode includes controlling the pump to deliver the fluid to the surgical site at approximately a target flow rate.

2. The surgical fluid management system of claim 1,

further comprising at least one pressure sensor configured to generate a pressure signal associated with a pressure of the fluid;

wherein the control system is configured to control the pump in the pressure control mode based at least in part upon the pressure signal.

3. The surgical fluid management system of claim 2, wherein the at least one pressure sensor comprises at least a first pressure sensor and a second pressure sensor, the first pressure sensor and the second pressure being configured to generate respective pressure signals associated with the pressure of the fluid.

4. The surgical fluid management system of claim 3,

wherein the control system is configured to compare the first pressure signal and the second pressure signal;

and

wherein the control system is configured such that if the first pressure signal and the second pressure signal differ by an amount in excess of an acceptable tolerance band, the control system automatically stops the pump.

5. The surgical fluid management system of claim 1,

wherein the pump includes a positive displacement pump;

wherein a fluid flow rate through the pump is substantially directly related to a speed of operation of the pump; and

wherein the control system is configured to control the pump in the flow control mode based at least in part upon a flow rate calculated based upon the speed of the pump.

6. The surgical fluid management system of claim 1, further comprising a heater assembly configured to heat the fluid between a fluid supply container and the surgical site.

7. The surgical fluid management system of claim 1,

further comprising a touch screen interface configured to display at least one operating parameter and to receive at least one command;

wherein the control system is selectable between the pressure control mode and the flow control mode using the touch screen.

8. The surgical fluid management system of claim 7, wherein the touch screen is configurable with respect to at least one of content and layout.

9. A surgical fluid management device comprising:

a pump configured to propel fluid from a fluid supply container to a surgical site;

a heater assembly configured to heat the fluid as it is propelled from the fluid source to the surgical site; and

a control system operatively connected to the pump and the heater assembly;

wherein the control system is configured to control the pump and the heater assembly in at least a distention mode and an irrigation mode;

wherein the distention mode includes operation of the pump to maintain a fluid pressure within a predetermined pressure band;

wherein the irrigation mode includes operation of the pump to provide a fluid flow rate within a predetermined flow rate band; and

wherein the control system is configured to control the heater to maintain a temperature of the fluid delivered to the surgical site within a predetermined temperature band in at least the distention mode and the irrigation mode.

10. The surgical fluid management device of claim 9, wherein the distention mode includes calculation of a fluid deficit associated with a difference between a volume of fluid delivered to the surgical site and a volume of fluid returned from the surgical site.

11. The surgical fluid management device of claim 10, further comprising at least one load cell configured to generate an electrical signal associated with a weight of a fluid supply container and at least one load cell configured to generate an electrical signal associated with a weight of a fluid collection container, wherein the control system is operative to calculate a difference between an initial total system weight including an initial weight of the fluid supply container and an initial weight of the fluid collection container and current total system weight including the current weight of the fluid supply container and the current weight of the fluid collection container.

12. The surgical fluid management device of claim 9,

wherein the control system is operative to control the pump and the heater in an infusion mode;

and

wherein the infusion mode includes operating the pump to infuse the fluid at a desired flow rate while monitoring at least one bubble detector, the bubble detector being operatively connected to the control system such that detection of a bubble results in stopping the pump.

13. The surgical fluid management device of claim 9, further comprising a tubing and cartridge set, the tubing and cartridge set including

a cartridge configured to be received within the heater assembly, the cartridge including an internal fluid path,

a first section of tubing extending at least partway from the source of fluid to the cartridge, and

a second section of tubing extending from the cartridge at least partway to the surgical site.

14. The surgical fluid management device of claim 9, wherein the pump includes a positive displacement pump.

15. The surgical fluid management device of claim 14, wherein the positive displacement pump includes a peristaltic pump configured to receive at least a portion of the first section of tubing.

16. A surgical fluid management system comprising:

a pump configured to deliver fluid to a surgical site;

a heater configured to heat the fluid prior to delivery to the surgical site; and

a control system operatively connected to the pump and the heater, the control system being configured to control the pump to deliver the fluid to the surgical site at least one of a desired flow rate and a desired pressure, and to control the heater to warm the fluid to a desired temperature.

17. The surgical fluid management system of claim 16, wherein the control system is configurable to control the pump by adjusting a speed of the pump to maintain the desired flow rate.

18. The surgical fluid management system of claim 16, wherein the control system is configured to control the heater by adjusting the heater to maintain the desired fluid temperature based on an inlet fluid temperature, an outlet fluid temperature, and the flow rate.

19. A disposable tubing and cartridge set for a surgical fluid management, the tubing and cartridge set comprising:

a connector adapted to couple with a fluid supply container;

a heating cartridge configured to be received within a heater assembly of a surgical fluid management system;

a trumpet valve;

an upstream irrigation tubing section fluidicly coupling the connector and the heating cartridge;

a downstream irrigation tubing section fluidicly coupling the heating cartridge and the trumpet valve; and

a suction tubing section fluidicly coupled to the trumpet valve and including an end configured for coupling to a fluid collection container.

20. The tubing and cartridge set of claim 19, wherein the trumpet valve includes a tip configured for suction and irrigation.

21. The tubing and cartridge set of claim 20, wherein the probe comprises an electrosurgical tip.

22. A surgical fluid management system comprising:

a pump configured to deliver fluid to a body cavity for distention of the body cavity;

a remote pressure sensor configured for placement in the body cavity; and

a control system operatively connected to the pump and the remote pressure sensor, the control system being configured to receive, from the remote pressure sensor, a signal associated with a pressure of the fluid within the body;

wherein the control system is configured to adjust a speed of the pump to maintain a desired fluid pressure based at least in part upon the signal from the remote pressure sensor.

23. The surgical fluid management system of claim 22, wherein the control system is configured to receive at least one of a pneumatic signal and an electrical signal from the remote pressure sensor.

24. A method for operating a surgical fluid management system, the method comprising:

delivering fluid from a fluid supply container to a surgical site via a tubing set;

sensing a system fluid pressure in the tubing set between the fluid supply container and the surgical site;

sensing a surgical site fluid pressure using a remote pressure sensor disposed approximate the surgical site; and

controlling a pressure of the fluid delivered to the surgical site based at least in part upon at least one of the sensed system fluid pressure and the sensed surgical site fluid pressure.

25. The method of claim 24, wherein controlling the pressure of the fluid delivered to the surgical site is based at least in part upon both the sensed system fluid pressure and the sensed surgical site fluid pressure.

26. The method of claim 24, wherein the tubing set comprises a disposable tubing set including a pressure relief valve.

27. A suction container support assembly comprising

a suction container support including a plurality of openings, each of the plurality of openings being configured to receive an individual suction container therein;

and

a base comprising at least three spaced-apart load cells, the suction container support being substantially supported by the at least three spaced-apart load cells;

wherein the plurality of openings are arranged such that individual centers of mass of the suction containers received within the openings are disposed inwardly with respect to the spaced-apart load cells.

28. The suction container support assembly of claim 27,

wherein the base includes four substantially symmetrically spaced-apart load cells;

and

wherein the suction container support includes four substantially symmetrically arranged openings.

29. The suction container support assembly of claim 27, wherein individual ones of the plurality of openings are independently adjustable to receive suction containers of a plurality of sizes.

30. The suction container support assembly of claim 29, further comprising, for each of the plurality of openings, a generally radially slidable adjuster, the adjusting being selectively securable in a desired position by a respective knob.

31. A method of operating a surgical fluid management system, the method comprising:

delivering fluid to a surgical site using a pump; and

controlling operation of the pump based at least in part upon a pressure trend, the pressure trend including a current measured pressure as compared to a set point pressure and a previous measured pressure as compared to the set point pressure.

32. The method of claim 31, wherein controlling operation of the pump includes

classifying the previous measured pressure as compared to the set point pressure as corresponding to one of a plurality of zones;

and

classifying the current measured pressure as compared to the set point pressure as corresponding to one of the plurality of zones.

33. The method of claim 32, wherein the plurality of zones includes a first zone less than a lowest value of a set point tolerance band, a second zone between the lowest value of the set point tolerance band and the set point, a third zone between the set point and the highest value of the set point tolerance band, a fourth zone between the highest value of the set point tolerance band and a high pressure alarm level, and a fifth zone above the high pressure alarm level.

34. The method of claim 33, wherein controlling operation of the pump includes selecting one of a plurality of control modes based at least in part upon the zone corresponding to the current measured pressure and the zone corresponding to the previous measured pressure.

35. The method of claim 34, wherein the plurality of control modes includes at least one of

a slope mode, the slope mode including calculating a desired rate of pressure change, and adjusting operation of the pump to achieve the desired rate of pressure change;

an integral control mode, the integral control mode including calculating an integral of a pressure error over time, the pressure error being determined by subtracting a respective measured pressure from the set point pressure, and adjusting operation of the pump to incrementally adjust a fluid flow rate based at least in part upon the integral of the pressure error;

a coast mode, the coast mode including substantially maintaining a speed of the pump;

a reduction mode, the reduction mode including, if the current measured pressure is less than the previous measure pressure, substantially maintaining the speed of the pump, and, if the current measured pressure is not less than the previous measured pressure, reducing the speed of the pump; and

a reverse mode, the reverse mode including reversing operation of the pump until a subsequent measured pressure is below a desired pressure level.

36. The method of claim 35, wherein, in the integral control mode, adjusting operation of the pump to incrementally adjust the fluid flow rate includes adjusting operation of the pump to change the fluid flow rate in increments of about ±

1 ml/min.

37. The method of claim 35, wherein, in the reduction mode, if the current measured pressure is not less than the previous measured pressure, reducing the speed of the pump based at least in part upon a difference between the current measured pressure and the set point pressure.

38. The method of claim 35, wherein selecting one of the plurality of control modes based at least in part upon the zone corresponding to the current measured pressure and the zone corresponding to the previous measured pressure includes

if the current measured pressure corresponds to the second zone and the previous measured pressure corresponds to the first zone, selecting the slope control mode;

if the current measured pressure corresponds to the third zone and the previous measured pressure corresponds to the second zone, selecting the integral control mode;

if the current measured pressure corresponds to the fourth zone and the previous measured pressure corresponds to the third zone and if the fluid flow rate is greater than 0, selecting the reduction mode;

if the current measured pressure corresponds to the fourth zone and the previous measured pressure corresponds to the third zone and if the fluid flow rate is not greater than 0, selecting the reverse mode;

if the current measured pressure corresponds to the fifth zone and the previous measured pressure corresponds to the fourth zone and if the fluid flow rate is not greater than 0, selecting the reduction mode;

if the current measured pressure corresponds to the fifth zone and the previous measured pressure corresponds to the fourth zone and if the fluid flow rate is not greater than 0, selecting the reverse mode;

if the current measured pressure corresponds to the fourth zone and the previous measured pressure corresponds to the fifth zone and if the fluid flow rate is not greater than 0, selecting the reduction mode;

if the current measured pressure corresponds to the fourth zone and the previous measured pressure corresponds to the fifth zone and if the fluid flow rate is not greater than 0, selecting the reverse mode;

if the current measured pressure corresponds to the third zone and the previous measured pressure corresponds to the fourth zone or the fifth zone, selecting the coast mode;

if the current measured pressure corresponds to the second zone and the previous measured pressure corresponds to the third zone, selecting the integral control mode; and

if the current measured pressure corresponds to the second zone and the previous measured pressure corresponds to the fourth zone or the fifth zone, selecting the slope mode.

39. A method of operating a surgical fluid management system, the method comprising:

delivering fluid to a surgical site using a pump; and

controlling operation of the pump including

selecting one of a plurality of pressure control modes based at least in part upon measured conditions, and

adjusting operation of the pump using the selected control mode.

40. The method of claim 39, wherein the plurality of pressure control modes includes at least one of

a slope mode, the slope mode including calculating a desired rate of pressure change, and adjusting operation of the pump to achieve the desired rate of pressure change;

an integral control mode, the integral control mode including calculating an integral of a pressure error over time, the pressure error being determined by subtracting a respective measured pressure from the set point pressure, and adjusting operation of the pump to incrementally adjust a fluid flow rate based at least in part upon the integral of the pressure error;

a coast mode, the coast mode including substantially maintaining a speed of the pump;

a reduction mode, the reduction mode including, if the current measured pressure is less than the previous measure pressure, substantially maintaining the speed of the pump, and, if the current measured pressure is not less than the previous measured pressure, reducing the speed of the pump; and

a reverse mode, the reverse mode including reversing operation of the pump until a subsequent measured pressure is below a desired pressure level.

41. The method of claim 40, wherein, in the integral control mode, adjusting operation of the pump to incrementally adjust the fluid flow rate includes adjusting operation of the pump to change the fluid flow rate in increments of about ±

1 ml/min.

42. The method of claim 40, wherein, in the reduction mode, if the current measured pressure is not less than the previous measured pressure, reducing the speed of the pump based at least in part upon a difference between the current measured pressure and the set point pressure.

43. The method of claim 40, wherein selecting the one of the plurality of pressure control modes based at least in part upon measured conditions includes

classifying a previous measured pressure as compared to a set point pressure as corresponding to one of a plurality of zones;

classifying a current measured pressure as compared to the set point pressure as corresponding to one of the plurality of zones; and

selecting the one of the plurality of pressure control modes based at least in part upon the zone corresponding to the current measured pressure and the zone corresponding to the previous measured pressure.

44. The method of claim 43, wherein the plurality of zones includes a first zone less than a lowest value of a set point tolerance band, a second zone between the lowest value of the set point tolerance band and the set point, a third zone between the set point and the highest value of the set point tolerance band, a fourth zone between the highest value of the set point tolerance band and a high pressure alarm level, and a fifth zone above the high pressure alarm level.

45. The method of claim 44, wherein selecting the one of the plurality of pressure control modes includes

if the current measured pressure corresponds to the second zone and the previous measured pressure corresponds to the first zone, selecting the slope control mode;

if the current measured pressure corresponds to the third zone and the previous measured pressure corresponds to the second zone, selecting the integral control mode;

if the current measured pressure corresponds to the fourth zone and the previous measured pressure corresponds to the third zone and if the fluid flow rate is greater than 0, selecting the reduction mode;

if the current measured pressure corresponds to the fourth zone and the previous measured pressure corresponds to the third zone and if the fluid flow rate is not greater than 0, selecting the reverse mode;

if the current measured pressure corresponds to the fifth zone and the previous measured pressure corresponds to the fourth zone and if the fluid flow rate is not greater than 0, selecting the reduction mode;

if the current measured pressure corresponds to the fifth zone and the previous measured pressure corresponds to the fourth zone and if the fluid flow rate is not greater than 0, selecting the reverse mode;

if the current measured pressure corresponds to the fourth zone and the previous measured pressure corresponds to the fifth zone and if the fluid flow rate is not greater than 0, selecting the reduction mode;

if the current measured pressure corresponds to the fourth zone and the previous measured pressure corresponds to the fifth zone and if the fluid flow rate is not greater than 0, selecting the reverse mode;

if the current measured pressure corresponds to the third zone and the previous measured pressure corresponds to the fourth zone or the fifth zone, selecting the coast mode;

if the current measured pressure corresponds to the second zone and the previous measured pressure corresponds to the third zone, selecting the integral control mode; and

if the current measured pressure corresponds to the second zone and the previous measured pressure corresponds to the fourth zone or the fifth zone, selecting the slope mode.