SURGICAL FLUID MANAGEMENT SYSTEM HEATER ASSEMBLY AND CARTRIDGE

• US 20100228223A1
• 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: Torer, Steven J., Donath, Edward R., Williams, Jeffrey B., Pyles, Kenneth R.
• Granted Patent: US 8,790,303 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 tubing and cartridge set for a surgical fluid management system configured to receive fluid from a fluid supply container and to deliver the fluid to a surgical instrument, the tubing and cartridge set comprising:

a heating cartridge configured to be releasably received in a heater assembly, the heating cartridge including a three-dimensional fluid path therethrough;

an upstream tubing section fluidicly interposing a fluid supply container and the heating cartridge; and

a downstream tubing section fluidicly interposing the heating cartridge and a surgical instrument.

2. The tubing and cartridge set of claim 1,

wherein the three-dimensional fluid path includes

a first fluid channel oriented in a first direction,

a second fluid channel oriented in a second direction, the second direction being substantially opposite the first direction, and

a port fluidicly connecting the first fluid channel to the second fluid channel;

wherein the first fluid channel is disposed on a first side of a main body of the heating cartridge;

wherein the second fluid channel is disposed on a second side of the main body of the heating cartridge;

wherein the first fluid channel faces outwardly from the first side of the heating cartridge; and

wherein the second fluid channel faces outwardly from the second side of the heating cartridge.

3. The tubing and cartridge set of claim 2, wherein the three-dimensional fluid path includes a third fluid channel on the second side of the main body and generally adjacent to the second fluid channel, the third fluid channel being oriented generally in the first direction;

wherein the three-dimensional fluid path includes a fourth fluid channel on the first side of the main body and generally adjacent to the first fluid channel, the fourth fluid channel being oriented generally in the second direction;

wherein the third fluid channel faces outwardly from the second side of the heating cartridge; and

wherein the fourth fluid channel faces outwardly from the first side of the heating cartridge.

4. The tubing and cartridge set of claim 3,

wherein the heating cartridge includes a first side sheet affixed to the first side of the main body and a second side sheet affixed to the second side of the main body;

wherein the first side sheet at least partially defines outwardly facing aspects of the first fluid channel and the fourth fluid channel, the first fluid channel and the fourth fluid channel being disposed substantially against the first side sheet; and

wherein the second side sheet at least partially defines outwardly facing aspects of the second fluid channel and the third fluid channel, the second fluid channel and the third fluid channel being disposed substantially against the second side sheet.

5. The tubing and cartridge set of claim 1,

further comprising a fitting configured to releasably couple with a corresponding fitting associated with the heater assembly upon insertion of the heating cartridge into the heater assembly;

wherein the fitting is fluidicly connected to the fluid path.

6. The tubing and cartridge set of claim 5, further comprising a hydrophobic filter fluidicly interposing the fitting and the fluid path, the hydrophobic filter being operative to prevent fluid from flowing from the fluid path through the fitting.

7. The tubing and cartridge set of claim 1, wherein the heating cartridge includes at least one bubble trap configured to vent gas from the fluid path.

8. The tubing and cartridge set of claim 7, wherein the bubble trap includes an umbrella valve arranged to allow the gas to escape the fluid path without allowing air to enter the fluid path.

9. A cartridge for a surgical fluid management system, the cartridge comprising:

an internal fluid path including

a first channel extending along a first side of the cartridge,

a first through-port to a second side of the cartridge,

a second channel extending along the second side of the cartridge,

a turn section,

a third channel extending along the second side of the cartridge,

a second through-port to the first side of the cartridge, and

a fourth channel extending along the first side of the cartridge.

10. The cartridge of claim 9, wherein the first channel, the second channel, the third channel, and the fourth channel have generally flattened shapes.

11. The cartridge of claim 10, wherein the first channel, the second channel, the third channel, and the fourth channel have lengths and heights which are substantially greater than their thicknesses.

12. The cartridge of claim 9, further comprising

an inlet fitting fluidicly connected to the first channel, and

an outlet fitting fluidicly connected to the fourth channel.

13. The cartridge of claim 12, further comprising a first bubble trap between the inlet fitting and the first channel.

14. The cartridge of claim 13, further comprising a second bubble trap between the fourth channel and the outlet fitting.

15. The cartridge of claim 14,

wherein at least one of the first bubble trap and the second bubble trap includes a hydrophobic membrane;

and

wherein the hydrophobic membrane is disposed within the cartridge such that the hydrophobic membrane is canted with respect to vertical when the cartridge is in use, the hydrophobic membrane being canted towards a fluid-contacting side.

16. The cartridge of claim 9, further comprising a substantially rigid main body and two relatively flexible side sheets, the main body and the side sheets defining the first channel, the second channel, the third channel, and the fourth channel.

17. The cartridge of claim 16,

wherein the main body includes molded polycarbonate;

wherein the side sheets are constructed from polycarbonate; and

wherein the side sheets are welded to the main body.

18. The cartridge of claim 9,

further comprising a pressure sensor fitting configured to couple with a corresponding fitting in a heater assembly upon insertion of the cartridge into the heater assembly;

wherein the pressure sensor fitting is fluidicly connected to the internal fluid path.

19. The cartridge of claim 18, further comprising a hydrophobic filter fluidicly interposing the pressure sensor fitting and the internal fluid path, the hydrophobic filter being operative to prevent fluid from flowing through the pressure sensor fitting.

20. The cartridge of claim 19,

further comprising a pressure sensor fluid path fluidicly connecting the internal fluid path and the hydrophobic filter;

wherein the pressure sensor fluid path is configured to retain a volume of gas adjacent to the hydrophobic filter.

21. A heater assembly for a surgical fluid management device, the heater assembly comprising:

a slot configured to receive a cartridge slidably therein;

a first infrared lamp mounted adjacent a first side of the slot;

a second infrared lamp mounted adjacent the first side of the slot;

a third infrared lamp mounted adjacent a second side of the slot; and

a fourth infrared lamp mounted adjacent the second side of the slot;

wherein the first infrared lamp is substantially elongated and is configured to heat fluid within a first flow channel of the cartridge, the second infrared lamp is substantially elongated and is configured to heat fluid within a second flow channel of the cartridge, the third infrared lamp is substantially elongated and is configured to heat fluid within a third flow channel of the cartridge, and the fourth infrared lamp is substantially elongated and is configured to heat fluid within a fourth flow channel of the cartridge; and

wherein at least one of the first infrared lamp, the second infrared lamp, the third infrared lamp, and the fourth infrared lamp is mounted generally parallel with a respective one of the first flow channel, the second flow channel, the third flow channel, and the fourth flow channel.

22. The heater assembly of claim 21,

wherein the first infrared lamp and the second infrared lamp are operatively connected to be controlled as a pair;

wherein the third infrared lamp and the fourth infrared lamp are operatively connected to be controlled as a pair; and

wherein fluid flows through the cartridge from the first flow channel to the second flow channel, from the second flow channel to the third flow channel, and from the third flow channel to the fourth flow channel.

23. The heater assembly of claim 22,

further comprising an inlet temperature sensor, an intermediate temperature sensor, and a outlet temperature sensor;

wherein the first flow channel and the second flow channel are fluidicly between the inlet temperature sensor and the intermediate temperature sensor, and the third flow channel and the fourth flow channel are fluidicly between the intermediate temperature sensor and the outlet temperature sensor;

wherein a level of power applied to the first infrared lamp and the second infrared lamp is determined at least in part by a signal from the inlet temperature sensor; and

wherein a level of power applied to the third infrared lamp and the fourth infrared lamp is determined at least in part by a signal from the outlet temperature sensor.

24. The heater assembly of claim 21, further comprising

a first reflector associated with the first infrared lamp and arranged to direct infrared energy emitted by the first infrared lamp onto the first flow channel,

a second reflector associated with the second infrared lamp and arranged to direct infrared energy emitted by the second infrared lamp onto the second flow channel,

a third reflector associated with the third infrared lamp and arranged to direct infrared energy emitted by the third infrared lamp onto the third flow channel, and

a fourth reflector associated with the fourth infrared lamp and arranged to direct infrared energy emitted by the fourth infrared lamp onto the fourth flow channel.

25. The heater assembly of claim 24, wherein at least a portion of at least one of the first reflector, the second reflector, the third reflector, and the fourth reflector is shaped, in cross-section, generally as at least a portion of an ellipse.

26. The heater assembly of claim 25,

wherein one of the first infrared lamp, second infrared lamp, third infrared lamp, and fourth infrared lamp is located proximate a first foci of the ellipse, and

wherein at least a portion of at least one of the first flow channel, the second flow channel, the third flow channel, and the fourth flow channel is located proximate a second foci of the ellipse.

27. A surgical fluid management system comprising:

a heater assembly including elongated infrared lamps located adjacent to a slot;

a heating cartridge incorporating a three-dimensional fluid path including a plurality of fluid channels, the heating cartridge being receivable within the slot such that the elongated infrared lamps are disposed generally adjacent to the fluid channels; and

a control system operatively connected to the elongated infrared lamps, the control system being configured to adjust power to the elongated infrared lamps based on fluid temperature and flow rate to heat the fluid to a desired temperature.

28. The surgical fluid management system of claim 27, wherein the control system is operative to adjust power to the elongated infrared lamps using pulse width modulation.

29. The surgical fluid management system of claim 27, wherein the heater assembly includes an individual elongated infrared lamp located generally adjacent to each of the fluid channels.

30. The surgical fluid management system of claim 29, wherein each individual elongated infrared lamp is mounted generally parallel to its respective fluid channel.

31. The surgical fluid management system of claim 27, wherein the control system is configured to supply different levels of power to different lamps, thereby applying different levels of power to different fluid channels in response to fluid temperature and flow rate conditions.

32. The surgical fluid management system of claim 27, further comprising at least one reflector arranged to direct infrared energy emitted by at least one of the elongated infrared lamps towards at least one of the fluid channels.

33. The surgical fluid management system of claim 32, wherein the at least one reflector is arranged to minimize exposure of portions of the heating cartridge other than the fluid channels.

34. The surgical fluid management system of claim 32, wherein the at least one reflector is integrated with the elongated lamp.

35. The surgical fluid management system of claim 32, wherein the at least one reflector includes a reflector shroud mounted generally adjacent to the elongated infrared lamp.

36. A surgical fluid management system comprising:

a heater assembly including

a slot including a first side and a second side,

a first elongated infrared lamp mounted generally adjacent to the first side of the slot,

a second elongated infrared lamp mounted generally adjacent to the second side of the slot,

a third elongated infrared lamp mounted generally adjacent to the second side of the slot,

a fourth elongated infrared lamp mounted generally adjacent to the first side of the slot;

a heating cartridge receivable within the slot and including a first fluid channel and a second fluid channel, wherein, when the heating cartridge is received within the slot, the first fluid channel is disposed between the first elongated infrared lamp and the second elongated infrared lamp, and wherein, when the heating cartridge is received within the slot, the second fluid channel is disposed between the third elongated infrared lamp and the fourth elongated infrared lamp; and

a control system configured to independently control at least a first group including the first elongated infrared lamp and the second elongated infrared lamp and a second group including the third infrared lamp and the fourth infrared lamp, so as to selectively apply different levels of power to the first fluid channel and the second fluid channel.

37. The surgical fluid management system of claim 36, wherein the control system is operative to selectively apply different levels of power to the first fluid channel and the second fluid channel based at least in part upon fluid temperature and flow rate.

38. A heating cartridge for a surgical fluid management system, the heating cartridge comprising:

a three-dimensional fluid path including a plurality of fluid channels, each of the plurality of fluid channels being exposed to an exterior of the heating cartridge to receive infrared energy therein;

wherein a first one of the fluid channels is disposed adjacent to a second one of the fluid channels to permit heat transfer from the first fluid channel to the second channel through an interposing wall.

39. A heating cartridge for a surgical fluid management system, the heating cartridge comprising:

a substantially rigid main body at least partially defining at least one fluid channel; and

a substantially flexible side sheet affixed to the main body, the side sheet at least partially defining the at least one fluid channel, such that the main body and side sheet together define the at least one fluid channel.

40. The heating cartridge of claim 39, wherein the side sheet is sufficiently flexible to substantially dampen pulsatile fluid flow through the fluid channel.

41. The heating cartridge of claim 40, wherein the side sheet is sufficiently flexible to substantially dampen pulsatile fluid flow produced by at least one of a peristaltic pump and a piston pump.

42. A surgical fluid management system comprising:

a heater assembly including a slot and a heater assembly pressure sensor fitting;

a heater cartridge receivable within the slot, the heater cartridge including a heater cartridge pressure sensor fitting configured to couple with the heater assembly pressure sensor fitting upon insertion of the heater cartridge into the heater assembly, the heater cartridge pressure sensor fitting being fluidicly connected to at least one fluid channel within the heater cartridge; and

at least one fluid pressure sensor fluidicly connected to the heater assembly pressure sensor fitting, the pressure sensor being operative to measure a pressure of a column of air trapped between fluid in the at least one fluid channel and the pressure sensor.

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

delivering fluid to a surgical site via a heater assembly, the heater assembly including at least a first heater and a second heater, the fluid flowing past the first heater and then flowing past the second heater;

supplying power to the first heater based at least in part upon an estimated power requirement, the estimated power requirement being substantially proportional to a flow rate of the fluid and a total desired temperature change of the fluid; and

supplying power to the second heater, including

if a current outlet temperature is less than a set point outlet temperature by greater than a predetermined threshold, supplying power to the second heater based upon a first heater control algorithm, and

if the current outlet temperature is less than the set point outlet temperature by less than a predetermined threshold, supplying power to the second heater based upon a second heater control algorithm.

44. The method of claim 43, wherein supplying power to the first heater includes supplying power to the first heater based at least in part upon a load factor multiplied by the estimated power requirement.

45. The method of claim 43, wherein supplying power to the second heater includes cutting off power to the second heater if a predetermined threshold rate of pressure increase is reached.

46. The method of claim 43, wherein the first heater control algorithm includes a proportional control algorithm, the proportional control algorithm including multiplying the estimated power requirement by a proportional control factor, the proportional control factor varying with the temperature error, the temperature error being a difference between a set point outlet temperature and a current outlet temperature.

47. The method of claim 46, wherein the proportional control factor is given by

48. The method of claim 43, wherein the second heater control algorithm includes an integral control algorithm, the integral control algorithm including

calculating an integral of the temperature error over time, the temperature error being a difference between a set point outlet temperature and a current outlet temperature,

if the integral of the temperature error over time is less than a predetermined negative value, incrementally reducing the power supplied to the second heater,

if the integral of the temperature error over time is greater than a predetermined positive value, incrementally increasing the power supplied to the second heater, and

if the integral of the temperature error over time is between the predetermined negative value and the predetermined positive value, maintaining the power supplied to the second heater.

49. The method of claim 48, wherein incrementally reducing the power supplied to the second heater and incrementally increasing the power supplied to the second heater include adjusting the power supplied to the second heater in increments of about 1% of a maximum power of the second heater.

50. The method of claim 48, wherein supplying power to the second heater based upon the integral control algorithm includes applying a reduction factor to the power supplied to the second heater, the reduction factor decreasing from about 1.0 to about 0 as the current outlet temperature increases to reach and exceed the set point outlet temperature.