Ureteral and Bladder Catheters and Methods of Inducing Negative Pressure to Increase Renal Perfusion

Abstract

A method is provided for facilitating urine output from the kidney, including: (a) inserting a catheter including: a drainage lumen including a distal portion configured to be positioned in a patient's kidney, renal pelvis and/or in the ureter adjacent to the renal pelvis and a proximal portion, the distal portion including a retention portion including a funnel support including at least one sidewall, wherein the funnel support includes a first diameter and a second diameter, the first diameter being less than the second diameter, the second diameter being closer to an end of the distal portion of the drainage lumen than the first diameter, wherein the proximal portion of the drainage lumen is essentially free of or free of openings; and (b) applying negative pressure to the proximal portion of the drainage lumen for a period of time to facilitate urine output from the kidney.

What is claimed is: 
     
         1 . A ureteral catheter, comprising:
 a drainage lumen comprising a distal portion configured to be positioned in a patient's kidney, renal pelvis and/or in the ureter adjacent to the renal pelvis and a proximal portion, the distal portion comprising a retention portion comprising a funnel support comprising at least one sidewall, wherein the funnel support comprises at least one opening in the sidewall, wherein the funnel support comprises a first diameter and a second diameter, the first diameter being less than the second diameter, the second diameter being closer to an end of the distal portion of the drainage lumen than the first diameter, wherein the proximal portion of the drainage lumen is essentially free of or free of openings.   
     
     
         2 . The ureteral catheter according to  claim 1 , wherein the flow of urine from the ureter and/or kidney is not prevented by occlusion of the ureter and/or kidney by the catheter. 
     
     
         3 . The ureteral catheter according to  claim 1 , wherein the funnel support has a generally conical shape. 
     
     
         4 . The ureteral catheter according to  claim 1 , wherein the funnel support has a generally hemispherical shape. 
     
     
         5 . The ureteral catheter according to  claim 1 , wherein the funnel support comprises a base portion adjacent to the distal portion of the drainage lumen, the base portion comprising at least one opening aligned with an interior of the proximal portion of the drainage lumen for permitting fluid flow into the interior of the proximal portion of the drainage lumen. 
     
     
         6 . The ureteral catheter according to  claim 5 , wherein the at least one opening of the base portion has a diameter ranging from about 0.05 mm to about 4 mm. 
     
     
         7 . The ureteral catheter according to  claim 1 , wherein the at least one sidewall of the funnel support has a height along a central axis of the funnel support. 
     
     
         8 . The ureteral catheter according to  claim 7 , wherein the height of the at least one sidewall of the funnel support ranges from about 1 mm to about 25 mm. 
     
     
         9 . The ureteral catheter according to  claim 7 , wherein the ratio of the height to the second diameter of the at least one sidewall of the funnel support ranges from about 1:25 to about 5:1. 
     
     
         10 . The ureteral catheter according to  claim 5 , wherein the at least one opening of the base portion has a diameter ranging from about 0.05 mm to about 4 mm, a height of the at least one sidewall of the funnel support ranges from about 1 mm to about 25 mm, and the second diameter of the funnel support ranges from about 5 mm to about 25 mm. 
     
     
         11 . The ureteral catheter according to  claim 1 , wherein the at least one sidewall of the funnel support is discontinuous along the height of the at least one sidewall. 
     
     
         12 . The ureteral catheter according to  claim 1 , wherein the at least one opening has an area ranging from about 0.002 mm 2  to about 100 mm 2 . 
     
     
         13 . The ureteral catheter according to  claim 1 , wherein the at least one sidewall of the funnel support comprises at least a first coil having a first diameter and a second coil having a second diameter, the first diameter being less than the second diameter. 
     
     
         14 . The ureteral catheter of  claim 13 , wherein the diameter of the coils increases toward a distal end of the drainage lumen, resulting in a helical structure having a tapered or partially tapered configuration. 
     
     
         15 . The ureteral catheter according to  claim 1 , wherein the at least one sidewall of the funnel support comprises mesh, the mesh having a plurality of the at least one openings therethrough for permitting fluid flow into the drainage lumen, wherein the maximum area of an opening is up to about 100 mm 2 . 
     
     
         16 . The ureteral catheter according to  claim 1 , wherein the at least one opening on the sidewall of the drainage lumen permits fluid flow by negative pressure into the drainage lumen. 
     
     
         17 . The ureteral catheter according to  claim 1 , wherein the retention portion of the drainage lumen further comprises an open distal end for permitting fluid flow into the drainage lumen. 
     
     
         18 . The ureteral catheter according to  claim 1 , wherein the funnel support comprises a third diameter, the third diameter being less than the second diameter, the third diameter being closer to an end of the distal portion of the drainage lumen than the second diameter. 
     
     
         19 . The ureteral catheter according to  claim 1 , wherein one or more openings are circular. 
     
     
         20 . The ureteral catheter according to  claim 1 , wherein one or more openings are non-circular. 
     
     
         21 . The ureteral catheter according to  claim 1 , wherein the at least one sidewall of the funnel support is convex. 
     
     
         22 . The ureteral catheter according to  claim 1 , wherein the at least one sidewall of the funnel support is concave. 
     
     
         23 . The ureteral catheter according to  claim 1 , wherein a central axis of the funnel support is offset with respect to a central axis of the drainage lumen. 
     
     
         24 . The ureteral catheter according to  claim 1 , wherein the distal end of the retention portion of the funnel support comprises a plurality of generally rounded edges. 
     
     
         25 . The ureteral catheter according to  claim 1 , wherein the at least one sidewall of the funnel support comprises a plurality of lobe-shaped longitudinal folds. 
     
     
         26 . The ureteral catheter according to  claim 25 , wherein at least one lobe-shaped longitudinal fold comprises at least one longitudinal support member. 
     
     
         27 . The ureteral catheter according to  claim 25 , wherein a distal end of the at least one lobe-shaped longitudinal fold comprises at least one support member. 
     
     
         28 . The ureteral catheter according to  claim 1 , wherein the at least one sidewall of the funnel support comprises an inner sidewall and an outer sidewall, the inner sidewall comprising the at least one opening for permitting the fluid flow therethrough into the interior of the proximal portion of the drainage lumen. 
     
     
         29 . The ureteral catheter according to  claim 1 , wherein the funnel support comprises a porous material positioned within the interior of the sidewall. 
     
     
         30 . The ureteral catheter according to  claim 1 , wherein the funnel support comprises a porous liner positioned adjacent to the interior of the sidewall. 
     
     
         31 . The ureteral catheter according to  claim 1 , wherein the catheter is transitionable between a contracted configuration for insertion into the patient's ureter and a deployed configuration for deployment within the ureter. 
     
     
         32 . The ureteral catheter according to  claim 1 , wherein the drainage lumen is formed, at least in part, from one or more of copper, silver, gold, nickel-titanium alloy, stainless steel, titanium, polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, and silicone. 
     
     
         33 . A system for inducing negative pressure in a portion of a urinary tract of a patient, the system comprising:
 at least one ureteral catheter according to  claim 1 ; and   a negative pressure source in fluid communication with the proximal portion of the drainage lumen, the negative pressure source being configured for inducing a negative pressure in a portion of the urinary tract of the patient to draw fluid through the drainage lumen of the ureteral catheter.   
     
     
         34 . The system according to  claim 33 , wherein the negative pressure source comprises a pump. 
     
     
         35 . The system according to  claim 33 , wherein the negative pressure source comprises a vacuum source external to the patient's body for application and regulation of the negative pressure. 
     
     
         36 . The system according to  claim 35 , wherein the vacuum source is selected from the group consisting of a wall suction source, vacuum bottle, and manual vacuum source. 
     
     
         37 . The system according to  claim 33 , wherein the negative pressure received from the negative pressure source is controlled manually, automatically, or combinations thereof. 
     
     
         38 . The system according to  claim 33 , further comprising a controller configured to cause the negative pressure source to provide negative pressure or positive pressure. 
     
     
         39 . The system according to  claim 33 , further comprising one or more physiological sensors configured to detect at least one physical parameter of the patient. 
     
     
         40 . The system according to  claim 39 , wherein the one or more physiological sensors comprise an analyte and/or capacitance sensor associated with an extracorporeal blood system associated with the patient. 
     
     
         41 . The system according to  claim 39 , 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. 
     
     
         42 . The system according to  claim 39 , wherein the at least one physical parameter of blood composition comprises one or more of hematocrit ratio, analyte concentration, protein concentration, or creatinine concentration. 
     
     
         43 . The system according to  claim 41 , wherein the at least one physical parameter of blood flow comprises one or more of blood pressure or blood flow velocity. 
     
     
         44 . The system according to  claim 39 , 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. 
     
     
         45 . A method for facilitating urine output from the kidney, comprising:
 (a) inserting a catheter according to  claim 1  into at least one of a patient's kidney, renal pelvis or in the ureter adjacent to the renal pelvis; and   (b) applying negative pressure to the proximal portion of the drainage lumen for a period of time to facilitate urine output from the kidney.