Systems, Kits and Methods for Inducing Negative Pressure to Increase Renal Function

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.

1 : A method for removing fluid from a patient, the method comprising:
 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.   
     
     
         2 : The method of  claim 1 , further comprising deploying a second ureteral stent or second ureteral catheter into a second ureter of the patient to maintain patency of fluid flow between a second kidney and the bladder of the patient. 
     
     
         3 : The method of  claim 1 , wherein the ureteral catheter comprises a drainage lumen 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 sidewall extending therebetween; and a retention portion extending radially outwardly from a portion of the distal end of the drainage lumen, 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. 
     
     
         4 : The method of  claim 3 , wherein the retention portion of the ureteral catheter comprises at least one coil. 
     
     
         5 : The method of  claim 3 , 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. 
     
     
         6 : The method of  claim 3 , 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. 
     
     
         7 : The method of  claim 3 , wherein a proximal portion of the drainage lumen is essentially free of or free of perforations. 
     
     
         8 : The method of  claim 3 , wherein a proximal portion of the drainage lumen is free of perforations. 
     
     
         9 : The method of  claim 4 , wherein one or more perforations are disposed on a radially inwardly facing side of the at least one coil and the outwardly facing side of the at least one coil is essentially free of one or more perforations. 
     
     
         10 : The method of  claim 1 , wherein the ureteral catheter comprises a tube comprising a drainage lumen and a retention portion comprising a helical arrangement with multiple coils when deployed, the retention portion comprising one or more perforations. 
     
     
         11 : The method of  claim 3 , wherein the retention portion of the ureteral catheter comprises a funnel-shaped support. 
     
     
         12 : The method of  claim 1 , wherein the ureteral catheter comprises: a drainage lumen comprising a proximal portion and a distal portion configured to be positioned in at least one of a portion of a patient's ureter adjacent to the renal pelvis, renal pelvis or kidney, the distal portion comprising a coiled retention portion, the coiled retention portion comprising: 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; and one or more perforations on a sidewall of the coiled retention portion of the distal portion of the drainage lumen for permitting fluid flow into the drainage lumen, wherein the proximal portion of the drainage lumen is essentially free of or free of perforations. 
     
     
         13 : The method 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 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. 
     
     
         14 : The method of  claim 13 , wherein the retention portion of the bladder catheter comprises at least one coil. 
     
     
         15 : The method of  claim 14 , 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. 
     
     
         16 : The method of  claim 13 , 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. 
     
     
         17 : The method of  claim 16 , wherein a proximal portion of the drainage lumen of the bladder catheter is essentially free of or free of perforations. 
     
     
         18 : The method of  claim 17 , wherein the proximal portion of the drainage lumen of the bladder catheter is free of perforations. 
     
     
         19 : The method of  claim 13 , wherein the retention portion of the bladder catheter comprises a funnel-shaped support. 
     
     
         20 : The method of  claim 1 , wherein the ureteral stent or ureteral catheter is deployed and remains in the patient's body for at least 24 hours. 
     
     
         21 : The method of  claim 1 , wherein the ureteral stent or ureteral catheter is deployed and remains in the patient's body for at least 30 days or longer. 
     
     
         22 : The method of  claim 1 , wherein the bladder catheter is replaced more often that the ureteral stent or ureteral catheter. 
     
     
         23 : The method of  claim 1 , wherein multiple bladder catheters are placed and removed during the indwell time for a single set of ureteral stents or ureteral catheters. 
     
     
         24 : The method of  claim 1 , wherein the negative pressure is provided by a negative pressure source. 
     
     
         25 : The method of  claim 24 , wherein the negative pressure source comprises a pump. 
     
     
         26 : The method of  claim 25 , wherein the pump provides an accuracy of about 10 mmHg or less. 
     
     
         27 : The method of  claim 1 , wherein the negative pressure is provided within a range of about 2 mmHg to about 150 mmHg. 
     
     
         28 : The method 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. 
     
     
         29 : The method of  claim 28 , wherein the vacuum source is selected from the group consisting of a wall suction source, vacuum bottle, and manual vacuum source. 
     
     
         30 : The method of  claim 24 , wherein the negative pressure received from the negative pressure source is controlled manually, automatically, or combinations thereof. 
     
     
         31 : The method of  claim 30 , comprising alternating between providing negative pressure and providing positive pressure. 
     
     
         32 : The method 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. 
     
     
         33 : The method of  claim 32 , wherein the one or more physiological sensors comprise an analyte and/or capacitance sensor associated with an extracorporeal blood system associated with the patient. 
     
     
         34 : The method of  claim 32 , 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. 
     
     
         35 : The method of  claim 34 , wherein the at least one physical parameter of blood composition comprises one or more of hematocrit ratio, analyte concentration, protein concentration, or creatinine concentration. 
     
     
         36 : The method of  claim 34 , wherein the at least one physical parameter of blood flow comprises one or more of blood pressure or blood flow velocity. 
     
     
         37 : The method of  claim 32 , 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. 
     
     
         38 : A kit comprising:
 a plurality of disposable bladder catheters, each bladder catheter comprising 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 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;   instructions for deploying the bladder catheter; and   instructions for connecting the proximal end of the bladder catheter to a pump and for operating the pump to draw urine through the drainage lumen of the bladder catheter.