IP Library Granted Patent US 10,980,989
Granted Patent B2
US 10,980,989 · App. 15/879,770 · Granted Apr 20, 2021

Systems, kits and methods for inducing negative pressure to increase renal function

Inventors: John R. Erbey, II (Milton, GA); Jacob L. Upperco (Atlanta, GA); David E. Orr (Piedmont, SC)
A61M27/008A61F2/042A61M1/0031A61M25/0017A61F2002/048A61F2220/0008A61F2230/0091A61M1/008A61M25/007A61M2205/3344A61M2209/06A61M2210/1082A61M2210/1085A61M2210/1089
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Quick Facts
Patent No.
US 10,980,989
App. No.
15/879,770
Granted
Apr 20, 2021
Kind
B2
Abstract

A method for removing fluid from a patient is provided, the method including: deploying a ureteral stent or ureteral catheter into a ureter of a patient to maintain patency of fluid flow between a kidney and a bladder of the patient; deploying a bladder catheter into the bladder of the patient, wherein the bladder catheter comprises a distal end configured to be positioned in a patient's bladder, a drainage lumen portion having a proximal end, and a sidewall extending therebetween; and applying negative pressure to the proximal end of the bladder catheter to induce negative pressure in a portion of the urinary tract of the patient to remove fluid from the patient. Systems and kits related thereto also are provided.

Claims (45)

1. A system for removing fluid from a patient, comprising:

at least one ureteral stent or ureteral catheter for maintaining patency of fluid flow between at least one of a kidney and a bladder of the patient;

a bladder catheter comprising a drainage lumen for draining fluid from the bladder of the patient; and

a negative pressure source in fluid communication with the drainage lumen of the bladder catheter the negative pressure source being configured for inducing positive and/or negative pressure in the bladder catheter to induce negative pressure in a portion of the urinary tract of the patient to remove fluid from the patient.

2. The system of claim 1 , further comprising one or more physiological sensors associated with the patient, the physiological sensors being configured to provide information representative of at least one physical parameter to a controller configured to actuate the pump to apply negative pressure to a proximal end of the bladder catheter to induce negative pressure in at least a portion of the urinary tract of the patient to remove fluid from the patient.

3. The system of claim 2 , wherein the controller is configured to cause the pump to alternate between providing negative pressure and providing positive pressure.

4. The system of claim 2 , wherein the one or more physiological sensors comprise an analyte and/or capacitance sensor associated with an extracorporeal blood system associated with the patient.

5. The system of claim 2 , wherein the at least one physical parameter comprises one or more of volume of urine collected, urine composition, urine protein concentration, blood composition, blood flow or conductance.

6. The system of claim 5 , wherein the at least one physical parameter of blood flow comprises one or more of blood pressure or blood flow velocity.

7. The system of claim 5 , wherein the at least one physical parameter of blood composition comprises one or more of hematocrit ratio, analyte concentration, protein concentration, or creatinine concentration.

8. The system of claim 2 , wherein the one or more physiological sensors comprise one or more of pulse oximetry sensor(s), blood pressure sensor(s), heart rate sensor(s), respiration sensor(s), capnography sensor(s), glucose sensor(s), blood velocity sensor(s), hemoglobin sensor(s), hematocrit sensor(s), protein sensor(s), creatinine sensor(s), sodium sensor, analyte sensor(s), capacitance sensor(s), conductance sensor, optical spectroscopy sensor(s) or combinations thereof.

9. The system of claim 1 , wherein the pump provides an accuracy of about 10 mmHg or less.

10. The system of claim 1 , wherein the negative pressure is provided within a range of about 2 mmHg to about 150 mmHg.

11. The system of claim 1 , wherein the ureteral catheter comprises a drainage lumen portion having a proximal end, a distal end configured to be positioned in at least one of the patient's ureter, renal pelvis or kidney, and a retention portion extending radially outwardly 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.

12. The system of claim 11 , wherein the retention portion of the ureteral catheter comprises at least one coil.

13. The system of claim 12 , wherein the retention portion of the ureteral catheter comprises at least a first coil having a first diameter; at least a second coil having a second diameter, the first diameter being less than the second diameter.

14. The system of claim 13 , wherein the second coil is closer to an end of the proximal portion of the drainage lumen than is the first coil.

15. The system of claim 11 , wherein the retention portion of the ureteral catheter comprises one or more perforations on a sidewall of the retention portion for permitting fluid flow into the drainage lumen.

16. The system of claim 11 , wherein a proximal portion of the drainage lumen is essentially free of or free of perforations.

17. The system of claim 11 , wherein a proximal portion of the drainage lumen is free of perforations.

18. The system of claim 11 , wherein the retention portion of the ureteral catheter comprises a funnel-shaped support.

19. The system of claim 1 , wherein the ureteral stent comprises an elongated body comprising a proximal end, a distal end, a longitudinal axis, and at least one drainage channel that extends along the longitudinal axis from the proximal end to the distal end to maintain patency of fluid flow between a kidney and a bladder of the patient.

20. The system of claim 1 , wherein the bladder catheter comprises a drainage lumen portion having a proximal end, a distal end configured to be positioned in a patient's bladder, 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.

21. The system of claim 20 , wherein the retention portion of the bladder catheter comprises at least one coil.

22. The system of claim 21 , wherein the retention portion of the bladder catheter comprises at least a first coil having a first diameter; at least a second coil having a second diameter, the first diameter being less than the second diameter.

23. The system of claim 22 , wherein the second coil is closer to an end of the distal portion of the drainage lumen than is the first coil.

24. The system of claim 22 , wherein the second coil is closer to an end of the proximal portion of the drainage lumen than is the first coil.

25. The system of claim 20 , wherein the retention portion of the bladder catheter comprises one or more perforations on a sidewall of the retention portion for permitting fluid flow into the drainage lumen.

26. The system of claim 20 , wherein a proximal portion of the drainage lumen is essentially free of or free of perforations.

27. The system of claim 20 , wherein the retention portion of the bladder catheter comprises a funnel-shaped support.

28. The system of claim 1 , wherein the negative pressure source comprises a pump.

29. The system of claim 1 , wherein the negative pressure source comprises a vacuum source external to the patient's body for application and regulation of the negative pressure.

30. The system of claim 29 , wherein the vacuum source is selected from the group consisting of a wall suction source, vacuum bottle, and manual vacuum source.

31. The system of claim 1 , wherein the negative pressure received from the negative pressure source is controlled manually, automatically, or combinations thereof.

32. The system of claim 1 , wherein the ureteral catheter comprises a proximal portion and a distal portion comprising a retention portion configured to be positioned in at least one of the patient's ureter, renal pelvis or kidney, wherein the proximal portion is essentially free of or free of perforations.

33. The system of claim 32 , wherein the proximal portion is free of perforations.

34. A kit for removing fluid from a patient, the kit comprising:

a ureteral stent or ureteral catheter comprising a drainage channel for facilitating flow of fluid from the ureter and/or kidney through the drainage channel of the ureteral stent or ureteral catheter towards the bladder of the patient; and

a pump comprising a controller configured to induce a negative pressure in at least one of the ureter, kidney or bladder of the patient to draw urine through a drainage lumen of a bladder catheter deployed in the patient's bladder.

35. The kit according to claim 34 , further comprising a bladder catheter.

36. The kit according to claim 34 , further comprising instructions for inserting a ureteral stent, a bladder catheter, and operating the pump to draw urine through a drainage lumen of a catheter deployed the patient's bladder.

37. A system for removing fluid from a patient, comprising:

at least one ureteral stent or ureteral catheter for maintaining patency of fluid flow between at least one of a kidney and a bladder of the patient, wherein the ureteral stent or ureteral catheter comprises a drainage lumen portion having a proximal end, a distal end configured to be positioned in at least one of the patient's ureter, renal pelvis or kidney, and a retention portion extending radially outwardly 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 the retention portion of the ureteral catheter comprises at least a first coil having a first diameter; at least a second coil having a second diameter, the first diameter being less than the second diameter, wherein the second coil is closer to an end of the distal portion of the drainage lumen than is the first coil;

a bladder catheter comprising a drainage lumen for draining fluid from the bladder of the patient; and

a negative pressure source in fluid communication with the drainage lumen of the bladder catheter the negative pressure source being configured for inducing positive and/or negative pressure in the bladder catheter to induce negative pressure in a portion of the urinary tract of the patient to remove fluid from the patient.

Assignments (7)
CORRECTIVE ASSIGNMENT TO CORRECT THE RECEIVING PARTY INTERNAL ADDRESS PREVIOUSLY RECORDED AT REEL: 057647 FRAME: 0601. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Feb 22, 2022
From: STRATACA SYSTEMS, LTD.
To: ROIVIOS LIMITED
Reel/Frame 059279/0434 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 29, 2021
From: STRATACA SYSTEMS LTD.
To: ROIVIOS LIMITED
Reel/Frame 057647/0601 →
BILL OF SALE, ASSIGNMENT AND ASSUMPTION AGREEMENT Recorded Jul 14, 2018
From: THE STRATACA GROUP
To: STRATACA SYSTEMS LIMITED
Reel/Frame 046545/0336 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 12, 2018
From: STRATACA SYSTEMS, LLC
To: THE STRATACA GROUP
Reel/Frame 046333/0193 →
MERGER Recorded Jul 12, 2018
From: STRATACA SYSTEMS, LLC
To: THE STRATACA GROUP
Reel/Frame 046332/0909 →
BILL OF SALE, ASSIGNMENT AND ASSUMPTION AGREEMENT WITH THE CONTRIBUTION AGREEMENT EXHIBIT A Recorded Jul 12, 2018
From: THE STRATACA GROUP
To: STRATACA SYSTEMS LIMITED
Reel/Frame 047480/0850 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 6, 2018
From: ERBEY II, JOHN R.; UPPERCO, JACOB L.; ORR, DAVID E.
To: STRATACA SYSTEMS, LLC
Reel/Frame 044839/0829 →
Continuity (16)
Continuation In Part 15687064 · Aug 25, 2017
Continuation In Part 15411884 · Jan 20, 2017
Continuation In Part 15214955 · Jul 20, 2016
Continuation In Part 15879770
Continuation In Part 15687083 · Aug 25, 2017
Continuation In Part 15411884 · Jan 20, 2017
Continuation In Part 15214955 · Jul 20, 2016
Continuation In Part 15879770
Continuation In Part 15745823
Provisional Application 62300025 · Feb 25, 2016
Provisional Application 62278721 · Jan 14, 2016
Provisional Application 62260966 · Nov 30, 2015
Provisional Application 62194585 · Jul 20, 2015
Provisional Application 62489789 · Apr 25, 2017
Provisional Application 62489831 · Apr 25, 2017
Related Publication 20180193618A1 · Jul 12, 2018