Method of removing excess fluid from a patient with hemodilution

• US 10,512,713 B2
• Filed: 01/20/2017
• Issued: 12/24/2019
• Est. Priority Date: 07/20/2015
• Status: Active Grant

• Current Assignee: Roivios Limited
• Original Assignee: Strataca Systems Limited
• Inventors: Erbey, II, John R., Upperco, Jacob L., Fisher, Michael Allen, Strane, Patrick William, Black, Lance Michael, Orr, David E.
• Primary Examiner(s): Marcetich, Adam
• Application Number:
  US15/411,884
• Publication Number:
  US 20170128639A1
• Time in Patent Office: 1,068 Days
• CPC Class Codes: A61M 1/73 comprising sensors or indicators for physical values
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/743 by changing the cross-section of the line, e.g. flow regulating valves A61M1/7413 takes precedence
• CPC Class Codes: A61M 1/75 Intermittent or pulsating suction A61M1/63, A61M1/772 take precedence
• CPC Class Codes: A61M 1/80 Suction pumps A61M1/64, A61M1/71, A61M60/00 take precedence
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 1/90 Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
• CPC Class Codes: A61M 2025/0213 where the catheter is attached by means specifically adapted to a part of the human body
• CPC Class Codes: A61M 2202/0496 Urine
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2210/1082 Kidney
• CPC Class Codes: A61M 2210/1085 Bladder
• CPC Class Codes: A61M 2210/1089 Urethra
• CPC Class Codes: A61M 2230/00 Measuring parameters of the user
• CPC Class Codes: A61M 2230/207 hematocrit
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 2230/65 Impedance, e.g. conductivity, capacity
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0026 : Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/1025 : Connections between catheter tubes and inflation tubes
• CPC Class Codes: A61M 27/008 : pre-shaped, for use in the urethral or ureteral tract
• CPC Class Codes: A61M 39/12 : for joining a flexible tube to a rigid attachment

Abstract

A method for removing excess fluid from a patient with hemodilution is provided. The method includes: deploying a urinary tract catheter into the patient such that flow of urine from the ureter and/or kidney is transported within a drainage lumen of the catheter; applying negative pressure to the ureter and/or kidney through the drainage lumen of the catheter to extract urine from the patient; periodically measuring a hematocrit value of the patient; and if the measured hematocrit value is greater than a predetermined threshold value, ceasing the application of the negative pressure to the ureter and/or kidney. A system for removing excess fluid from a patient with hemodilution including a ureteral catheter and a pump is also provided.

Claims

1. A method for increasing urine output rate from a patient with hemodilution having a Glomerular Filtration Rate (GFR) of at least 30 ml/min/1.73m² prior to treatment with the method, the method comprising:

deploying a urinary tract catheter into the patient such that flow of urine from a ureter and/or kidney is transported within a drainage lumen of the catheter;

applying negative pressure to the ureter and/or kidney through the drainage lumen of the catheter to extract urine from the patient;

periodically measuring a hematocrit value of the patient; and

if the measured hematocrit value exceeds a predetermined minimum threshold value, providing feedback to a user or controller to determine whether to adjust or cease the application of negative pressure to the ureter and/or kidney.

2. The method of claim 1, wherein the urinary tract catheter comprises a ureteral catheter comprising a tube defining a drainage lumen and comprising a helical retention portion comprising a helical arrangement with multiple coils when deployed and a plurality of drainage ports.

3. The method of claim 2, wherein deploying the ureteral catheter comprises expanding the helical retention portion at a fluid collection position in a renal pelvis of the patient'"'"'s kidney.

4. The method of claim 2, further comprising deploying a bladder catheter in the patient'"'"'s bladder for receiving urine which passes through the ureter and enters the bladder.

5. The method of claim 4, wherein a proximal portion of the ureteral catheter is positioned within a drainage lumen of the bladder catheter.

6. The method of claim 4, wherein the bladder catheter comprises a seal for sealing an opening to the urethra for preventing passage of urine from the bladder to the urethra outside of the drainage lumen of the bladder catheter.

7. The method of claim 1, wherein the urinary tract catheter is introduced to one of a patient'"'"'s bladder, ureter, and kidney through the urethra of the patient.

8. The method of claim 1, further comprising collecting fluid extracted from the patient through the urinary tract catheter to determine a total volume of extracted fluid.

9. The method of claim 8, further comprising ceasing application of negative pressure when the determined total volume of extracted fluid exceeds a predetermined fluid volume.

10. The method of claim 9, wherein the predetermined value is based on an amount of fluid provided to the patient from a fluid resuscitation procedure.

11. The method of claim 1, wherein excess fluid is provided to the patient from a fluid resuscitation procedure performed for the patient.

12. The method of claim 11, wherein increasing urine output rate from the patient is provided as one of a treatment for systemic fluid volume management associated with acute heart failure and as a treatment provided to the patient from a coronary graft bypass procedure.

13. The method of claim 1, wherein the predetermined hematocrit value is between 25% and 40%.

14. The method of claim 1, wherein the patient has Stage 2 kidney disease.

15. The method of claim 1, wherein the patient has a GFR ranging from 60 ml/min/1.73 m² to 89 ml/min/1.73 m² prior to application of the method.

16. The method of claim 1, wherein the patient has Stage 3 kidney disease.

17. The method of claim 1, wherein the patient has a GFR ranging from 30 ml/min/1.73 m² to 59 ml/min/1.73 m² prior to application of the method.

18. The method of claim 1, wherein the patient has a GFR ranging from greater than 30 ml/min/1.73 m² to 59 ml/min/1.73 m² prior to application of the method.

19. The method of claim 1, wherein the patient has a urine output rate ranging from at least about 0.05 ml/min to about 3 ml/min.

20. The method of claim 1, wherein if the received hematocrit value exceeds a predetermined minimum threshold value, feedback is provided to a user or controller to cease the application of the negative pressure to the ureter and/or kidney.

21. A system for increasing urine output rate from a patient with hemodilution having a Glomerular Filtration Rate (GFR) of at least 30 ml/min/1.73 m² prior to treatment with the method, comprising:

a urinary tract catheter comprising;

a drainage lumen portion comprising a proximal end, a distal end configured to be positioned in a patient'"'"'s urinary tract, and a sidewall extending therebetween; and

a retention portion extending radially outward from a portion of the distal end of the drainage lumen portion, and being configured to be extended into a deployed position in which a diameter of the retention portion is greater than a diameter of the drainage lumen portion, wherein at least one of the drainage lumen portion or the retention portion comprises at least one drainage port to permit fluid flow into the drainage lumen; and

a pump in fluid communication with a drainage lumen defined by the drainage lumen portion of the urinary tract catheter, the pump comprising a controller configured to;

actuate the pump to cause the pump to induce a negative pressure in a ureter and/or kidney of the patient to draw urine through the drainage lumen of the urinary tract catheter;

periodically receive information representative of a hematocrit value of the patient; and

if the received hematocrit value exceeds a predetermined minimum threshold value, providing feedback to a user or controller to determine whether to adjust or cease the application of the negative pressure to the ureter and/or kidney.

22. The system of claim 21, wherein the predetermined threshold value comprises a hematocrit value for a healthy patient.

23. The system of claim 21, wherein the predetermined threshold value is between 25% and 40%.

24. The system of claim 21, further comprising a bladder catheter for deployment within the patient'"'"'s bladder, the bladder catheter comprising:

a drainage lumen portion defining a drainage lumen and comprising a proximal end, a distal end configured to be positioned in the patient'"'"'s bladder, and a sidewall extending therebetween; and

a deployable anchor portion comprising a seal configured to contact a proximal portion of a bladder wall to seal a urethral opening,

wherein at least one of the drainage lumen portion or the anchor portion comprises at least one drainage port for permitting fluid flow into the drainage lumen for expelling urine from the bladder.

25. The system of claim 21, further comprising one or more physiological sensors associated with the patient, the physiological sensors being configured to provide the information representative of the hematocrit value to the controller.

26. The system of claim 25, wherein the one or more physiological sensors comprise an analyte and/or capacitance sensor associated with an extracorporeal blood system associated with the patient.

27. The system of claim 21, wherein, prior to ceasing application of the negative pressure, the controller is further configured to adjust an operating parameter of the pump based, at least in part, on the measured hematocrit value.

28. The system of claim 27, wherein adjusting an operating parameter of the pump based on the measured hematocrit value comprises reducing applied negative pressure when a downward trend in the measured hematocrit value is identified.

29. The system of claim 21, wherein the pump provides an accuracy of 10 mmHg or less.

30. The system of claim 21, wherein the controller is configured to cause the pump to alternate between providing negative pressure and providing positive pressure.

31. The system of claim 30, wherein the negative pressure is provided within a range of 5 mmHg to 50 mmHg, and wherein the positive pressure is provided within a range of 5 mmHg to 20 mmHg.

32. The system of claim 21, wherein excess fluid is provided to the patient from a fluid resuscitation procedure.

33. The method of claim 21, wherein the patient has a urine output rate ranging from at least about 0.05 ml/min to about 3 ml/min.

34. The method of claim 21, wherein if the received hematocrit value exceeds a predetermined minimum threshold value, feedback is provided to a user or controller to cease the application of the negative pressure to the ureter and/or kidney.