Fluid therapy method

• US 10,639,419 B2
• Filed: 07/11/2018
• Issued: 05/05/2020
• Est. Priority Date: 03/17/2014
• Status: Active Grant

• Current Assignee: Reprieve Cardiovascular, Inc. (Reprieve Cardiovascular LLC)
• Original Assignee: PLC Medical Systems, Inc. (Viveve Medical, Inc.)
• Inventors: Halpert, Andrew V., Tauscher, Mark, Gelfand, Mark, Levin, Howard
• Primary Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US16/032,453
• Publication Number:
  US 20180326151A1
• Time in Patent Office: 664 Days
• CPC Class Codes: A61M 2202/0496 Urine
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A fluid therapy method for an ADHF patient includes setting a urine output rate desired threshold, setting one or more desired negative net gain rates, and optionally setting a total fluid loss goal. The urine output of the patient is monitored and fluid is automatically administered to the patient at increasing rates to equal to or approximately match the patient'"'"'s increasing urine output rates until the patient'"'"'s urine output rate reaches the set urine output rate desired threshold. Thereafter, fluid is administered to the patient at rates to achieve the set desired negative net gain rate until the fluid loss goal is reached. Thereafter, until the end of therapy, fluid is administered to the patient at rates equal to or approximately equal to the monitored urine output rates.

Claims

1. A fluid therapy method comprising:

setting a urine output rate desired threshold by inputting the urine output rate desired threshold into an input section of a console;

setting one or more desired negative net gain rates by inputting one or more desired negative net gain rates into the input section of the console;

monitoring the urine output of a patient using a microcontroller;

the microcontroller automatically administering a fluid to the patient at increasing rates to equal to or approximately match the patient'"'"'s increasing urine output rates until urine output rate reaches the set urine output rate desired threshold;

upon the urine output rate reaching the set urine output rate desired threshold the microcontroller automatically thereafter administering the fluid to the patient at rates to achieve the set desired negative net gain rate.

2. The method of claim 1 further including setting a desired total fluid loss goal by inputting the desired total fluid loss goal into the input section of the console and wherein fluid is automatically administered to the patient by the microcontroller at said rates to achieve the set desired negative net gain until said set desired fluid loss goal is reached and thereafter, until the end of therapy, automatically administering the fluid to the patient at rates equal to or approximately equal to the monitored urine output rates.

3. The method of claim 1 in which monitoring the urine output rates includes collecting urine in a urine collection bag and weighing the urine collection bag as a function of time.

4. The method of claim 1 in which administering fluid to the patient includes pumping fluid from a fluid bag into the patient using a fluid pump that is controlled by the microcontroller.

5. The method of claim 4 including utilizing the controller to monitor the operation of the fluid pump over time and/or to weight the fluid bag as a function of time to determine the rate of fluid infusion.

6. The method of claim 1 in which the fluid is saline or an osmotic solute.

7. The method of claim 1 further including administering to the patient a bolus of fluid during therapy.

8. The method of claim 1 further including administering to the patient a diuretic during the therapy.

9. The method of claim 8 in which the diuretic is administered at the start of therapy.

10. The method of claim 8 in which the diuretic is administered automatically by the microcontroller.

11. The method of claim 8 in which the diuretic is administered during the therapy when fluid is administered by the microcontroller to the patient at rates less than the monitored urine output rates according to the set desired negative net gain rate.

12. The method of claim 1 in which the urine output rate desired threshold and the desired negative net gain rate are set via stored default values in a memory of a controller.

13. The method of claim 1 in which the desired negative net gain changes during therapy as a function of time.

14. The method of claim 1 in which the microcontroller informs the user automatically when the urine rate desired threshold is met.

15. The method of claim 1 in which the microcontroller informs the user automatically when the total fluid loss goal is met.

16. The method of claim 1 in which the infusion fluid is hypertonic saline.

17. The method of claim 16 in which the hypertonic saline infusion is adjusted based on a urine or serum sodium sensor.

18. A fluid therapy method comprising:

setting one or more desired negative net gain rates by inputting the negative net gain rates into an input section of a console that includes a memory for storing values and information;

setting a desired fluid loss goal by inputting the desired fluid loss goad into the input section of the console;

monitoring the urine output of a patient using a microcontroller;

administering a diuretic to the patient;

the microcontroller automatically administering a fluid to the patient to achieve a set desired negative net gain rate until the desired fluid loss goal is reached; and

thereafter, until the end of therapy, the microcontroller automatically administering fluid to the patient at rates equal to or approximately equal to monitored urine output rates.

19. A method comprising:

setting a desired negative net gain rate by inputting the desired negative net gain rate into an input section of a console that includes a memory for storing values and information

monitoring the urine output of a patient to determine the urine output rate by utilizing a microcontroller;

the microcontroller automatically administering a fluid to the patient at rates equal to or approximately equal to the monitored urine output rate until the urine output rate reaches a desired threshold that is inputted into the input section of the console; and

the microcontroller automatically thereafter administering the fluid to the patient to achieve the set desired negative net gain rate to take off fluid.

20. The method of claim 19 further including, after a total fluid loss goal is reached, until the end of therapy, the microcontroller automatically administering fluid to the patient at rates equal to or approximately equal to the monitored urine output rate.

21. A method of treating a patient having excess fluid, the method comprising:

inputting a urine output rate desired threshold into an input section of a console, the console including a microcontroller and a memory to store values and information;

inputting a negative net fluid gain rate into the input section of the console;

inputting a desired total fluid loss goal into the input section of the console;

administering a diuretic to the patient to induce urine output;

for a first therapy period after beginning the diuretic administration, the microcontroller driving the urine output rate of the patient to a higher level matching or exceeding the set urine output rate desired threshold by automatically controlling a pump in the console to infuse fluid into the patient at rates which match or closely match the patient'"'"'s urine output rates resulting in little or no total fluid loss; and

for a second therapy period after the set urine output rate desired threshold is reached, the microcontroller inducing fluid loss at said set negative net fluid gain rate by automatically controlling the pump to decrease the amount of fluid infused and infusing fluid at rates which are less than but a function of the patient'"'"'s urine output rates until said set desired total fluid loss goal is reached.

22. The method of claim 21 further including a third therapy period wherein fluid is automatically infused by the pump controlled by the microcontroller at rates equal to or approximately equal to the patient'"'"'s urine output rates after the desired total fluid loss goal is reached and until the end of therapy resulting in little or no total fluid loss during the third therapy period to prevent patient dehydration.

23. The method of claim 21 further including administering a diuretic to the patient during the second therapy period.

24. The method of claim 23 wherein the diuretic is administered automatically via the microcontroller.

25. The method of claim 21 in which monitoring the urine output rates includes collecting urine in a urine collection bag and weighing the urine collection bag as a function of time.

26. The method of claim 21 in which administering fluid to the patient includes pumping fluid from a fluid bag into the patient using a fluid pump controlled by the microcontroller and automatically controlling the operation of the fluid pump.

27. The method of claim 26 including monitoring the operation of the fluid pump over time with the microcontroller and/or weighing the fluid bag as a function of time to determine the rate of fluid infusion.

28. The method of claim 21 in which the fluid infused is saline or an osmotic solute.

29. The method of claim 21 further including automatically administering to the patient a bolus of fluid during therapy via the microcontroller.

30. The method of claim 21 further including automatically administering to the patient the diuretic via the microcontroller.

31. The method of claim 21 in which the urine output rate desired threshold, the desired negative net gain rate, and the desired total fluid loss goal are set via stored default values in the memory of the console.

32. A fluid therapy method comprising:

administering a diuretic to the patient to induce urine output;

automatically monitoring the patient'"'"'s urine output rates using a microcontroller that utilizes information and stored values from a memory;

for a first therapy period after administration of the diuretic, driving the urine output rate of the patient to a higher level by configuring the microcontroller to automatically control an infusion pump to infuse fluid into the patient at rates which match or closely match the monitored patient'"'"'s urine output rates until a set urine output rate threshold is reached resulting in little or no total fluid loss during the first therapy period; and

for a second therapy period after the set urine output rate threshold is reached, inducing fluid loss at a set negative net fluid gain rate by configuring the microcontroller to automatically control the infusion pump to decrease the amount of fluid infused and control the infusion pump to infuse fluid at rates which are less than but a function of the patient'"'"'s urine output rates until a set desired total fluid loss goal is reached during the second therapy period.

33. The method of claim 32 further including a third therapy period wherein the infusion pump is controlled via the microcontroller to infuse fluid at rates equal to or approximately equal to the patient'"'"'s urine output rates after the set desired total fluid loss goal is reached and until the end of therapy resulting in little or no total fluid loss during the third therapy period to prevent patient hydration.

34. The method of claim 32 further including storing in a memory in the console at least one of a urine output rate desired threshold, a negative net fluid gain rate, or a desired total fluid loss goal.

35. A method of treating a patient having excess fluid, the method comprising:

utilizing programmable controller electronics in a console to receive inputs from an input section of the console, to read inputs, to store values and information in a memory, and to;

set, via the input section of the console, a negative net fluid gain rate;

administer a diuretic to the patient to induce urine output; and

induce fluid loss at said set negative net fluid gain rate by utilizing the programmable controller electronics to automatically control a pump to decrease the amount of fluid infused and infusing fluid at input or stored rates which are less than, but a function of, the patient'"'"'s urine output rates; and

utilizing the programmable controller electronics to display on the console, in response to inputs, stored values and information, a urine output rate desired threshold, the negative fluid gain rate, and a desired total fluid loss goal.

36. The method of claim 35, further including administering a diuretic to the patient during a first therapy period and during a second therapy period.

37. The method of claim 36, further including utilizing the programmable controller electronics to administer the diuretic automatically.

38. The method of claim 37, further including for a third therapy period, utilizing the programmable controller electronics to control the pump to automatically infuse fluid into the patient at rates equal to or approximately equal to the patient'"'"'s urine output rates after a desired total fluid loss goal is reached and until the end of therapy resulting in little or no total fluid loss during the third therapy period to prevent patient dehydration.

39. The method of claim 35, including monitoring the urine output rates by collecting urine in a urine collection bag and weighing the urine collection bag as a function of time.

40. The method of claim 39, including utilizing the programmable controller electronics to monitor the operation of the pump over time and/or weighing an infusion fluid bag as a function of time and utilizing the programmable controller electronics to determine the rate of fluid infusion.

41. The method of claim 35, in which the fluid infused is saline or an osmotic solute.

42. The method of claim 35, further including utilizing the programmable controller electronics to automatically administer a bolus of fluid to the patient.

43. The method of claim 35, further including utilizing the programmable controller to automatically administer the diuretic to the patient.

44. The method of claim 35, further including utilizing the programmable controller electronics to set the urine output rate desired threshold, the desired negative net gain rate, and the desired total fluid loss goal via stored default values.

45. The method of claim 35, further including utilizing the programmable controller electronics to set the urine output rate desired threshold and, for a first therapy period after beginning diuretic administration, driving the urine output rate of the patient to a higher level matching or exceeding the set urine output rate desired threshold by utilizing the programmable controller electronics to automatically control the pump in the console to infuse fluid into the patient at input or stored rates which match or closely match the patient'"'"'s urine output rates resulting in little or no total fluid loss.

46. The method of claim 35, further including utilizing the programmable controller electronics to set the desired total fluid loss goal and to control the pump to stop decreasing the amount of fluid infused and to infuse fluid in an amount equal to the patient'"'"'s urine output rates for balanced hydration.