Device, system and methods for measurement of pressures in the urinary tract

Abstract

A catheter for measuring pressure in the urinary tract of a patient includes a catheter body having a proximal and distal end. A plurality of lumens is formed in the catheter body, and an adaptor is coupled to the proximal end of the catheter body. The adaptor includes a port for each lumen. A first pressure sensor, typically including a balloon, is fluidically coupled to a first lumen and is configured and positioned to measure pressure in a urethra of the patient. A second pressure sensor, also typically including a balloon, is fluidically coupled to a second lumen and is configured and positioned on the catheter body to measure pressure in a bladder of the patient. An expandable retention member, which may be coupled to a third lumen, is positioned on the catheter body between the first and second expandable pressure sensors so that the catheter body may be retained at a selected location in the urinary tract to properly position the fluid pressure sensors in the bladder and urethra, respectively.

What is claimed is: 
     
         1 . A catheter for simultaneously measuring pressure at multiple locations in the urinary tract of a patient, the catheter comprising:
 a catheter body having a proximal and distal end and a plurality of lumens including at least a first, second and third lumen; the plurality of lumens configured so as to minimize an effect of a pressure change in one lumen of the plurality lumens on a pressure in another lumen of the plurality;   an adaptor coupled to the proximal end of the catheter body, the adaptor including a plurality of ports including at least a first, second and third port for fluidic coupling to the plurality of lumens;   a first pressure sensor fluidically coupled to the first lumen, the first pressure sensor configured and positioned on the catheter body to be positioned and measure pressure in a urethra of the patient;   a second pressure sensor fluidically coupled to the second lumen, the second pressure sensor configured and positioned on the catheter body to be positioned and measure pressure in a bladder of the patient; and   an expandable retention member fluidically coupled to the third lumen and positioned on the catheter body between the first and second expandable pressure sensors, the expandable retention member configured when in an expanded state to retain the catheter body at selected location in the urinary tract in response to a physiological force exerted on at least a portion of the catheter.   
     
     
         2 . The catheter of  claim 1 , wherein the at least a portion of the catheter includes at least one of the retention member, the catheter body, or the bladder pressure sensor. 
     
     
         3 . The catheter of  claim 1 , wherein the physiological force corresponds to a hydrostatic pressure from fluid in the patient's bladder. 
     
     
         4 . The catheter of  claim 1 , wherein the physiological force corresponds to a force resulting from a contraction of at least of the patient's bladder or urethral sphincter. 
     
     
         5 . The catheter of  claim 1 , wherein the retention member is configured to retain the catheter body in a selected position in the urinary tract during a contraction of at least one of the bladder or the urethra. 
     
     
         6 . The catheter of  claim 1 , wherein the retention member is configured to retain the catheter body in a selected position in the urinary tract to keep the bladder pressure sensor positioned in the bladder and the sphincter sensor positioned in the sphincter in response to hydraulic pressure exerted on at least a portion of the catheter. 
     
     
         7 . The catheter of  claim 1 , wherein the expandable retention member comprises an expandable balloon. 
     
     
         8 . The catheter of  claim 1 , wherein at least one of the bladder pressure sensor or the sphincter pressure sensor comprises an expandable member having an expanded and a non-expanded state, wherein the at least sensor is configured to be advanced into the urinary tract in the non-expanded state and then deployed to the expanded state to measure pressure in at least of the sphincter or the bladder. 
     
     
         9 . The catheter of  claim 8 , wherein the expandable member comprises an expandable balloon. 
     
     
         10 . The catheter of  claim 9 , wherein the expandable balloon comprises at least of an elastomer, silicone or polyurethane. 
     
     
         11 . The catheter of  claim 8 , wherein the expandable member is configured to retain the at least one sensor in the ureteral or bladder when in the expanded state. 
     
     
         12 . The catheter of  claim 1 , wherein at least one of the bladder pressure sensor or the sphincter comprises a strain gauge, a MEMS-fabricated sensor or a manometer. 
     
     
         13 . The catheter of  claim 1 , wherein the first pressure sensor comprises a first section and a second section, the first section positioned to measure pressure at first location in the urethra and the second section positioned to measure pressure at a second location in the urethra. 
     
     
         14 . The catheter of  claim 13 , wherein the first location corresponds to an internal urethral sphincter and the second location corresponds to an external urethral sphincter. 
     
     
         15 . The catheter of  claim 1 , wherein the catheter is adapted to be positioned in a male urinary tract. 
     
     
         16 . The catheter of  claim 15 , wherein the second sensor has a length of about 2 cms and is configured to be positioned on either side of a male urinary sphincter. 
     
     
         17 . The catheter of  claim 1 , wherein the catheter is adapted to be positioned in a female urinary tract. 
     
     
         18 . The catheter of  claim 17 , wherein the second sensor has a length of about 1.5 cms and is configured to be positioned on either side of a female urinary sphincter. 
     
     
         19 . The catheter of  claim 1 , wherein at least one of the plurality of ports is configured to be coupled to a manometer. 
     
     
         20 . The catheter of  claim 1 , wherein the catheter includes a fourth lumen fluidically coupled to a fourth port for measurement of a temperature in the urinary tract. 
     
     
         21 . The catheter of  claim 1 , wherein the catheter includes a fourth lumen fluidically coupled to a fourth port for flow of irrigation fluid. 
     
     
         22 . The catheter of  claim 1 , wherein the catheter includes a fourth lumen fluidically coupled to a fourth port for drainage of the bladder. 
     
     
         23 . The catheter of  claim 22 , wherein the catheter includes a fifth lumen coupled to a fifth port for flow of irrigation fluid. 
     
     
         24 . The catheter of  claim 1 , wherein the catheter body comprises an elastomer, silicone, or polyurethane, PTFE, polyethylene or PET. 
     
     
         25 . The catheter of  claim 1 , wherein each lumen of the plurality of lumens has sufficient radial rigidity or hoop strength so as to minimize the effect of the pressure change in one lumen of the plurality on a pressure in another lumen of the plurality. 
     
     
         26 . The catheter of  claim 25 , wherein the radial rigidity of each lumen of the plurality of lumens is in the range of about 20 to 100 N/mm. 
     
     
         27 . The catheter of  claim 26 , wherein the radial rigidity of each lumen of the plurality of lumens is in the range of about 50 to 100 N/mm. 
     
     
         28 . A method for measuring pressure at multiple locations in the urinary tract of a patient to facilitate a treatment for urinary incontinence, the method comprising:
 advancing a catheter having a first and second pressure sensor into the urinary tract of a patient so as position the first sensor at a first location in a urethra of the patient and the second pressure sensor at a second location in a bladder of the patient;   expanding an expandable retention member so as retain the first sensor at the first location and the second sensor at the second location during exertion of a physiological force on the catheter; and   measuring pressures at the first location and the second location in response to an external stimulus.   
     
     
         29 . The method of  claim 28 , wherein the pressures at the first and second location are measured substantially simultaneously. 
     
     
         30 . The method of  claim 28 , wherein the pressures at the first and second location are measured sequentially. 
     
     
         31 . The method of  claim 28 , wherein the external stimulus comprises an electrical signal. 
     
     
         32 . The method of  claim 31 , wherein the electrical signal comprise a neuromodulation signal generated by an electrode electrically coupled to a nerve innervating the bladder. 
     
     
         33 . The method of  claim 28 , wherein the external stimulus comprises adding fluid to the bladder from outside the body. 
     
     
         34 . The method of  claim 28 , wherein the physiological force corresponds to a hydrostatic pressure from fluid in the patient's bladder. 
     
     
         35 . The method of  claim 28 , wherein the physiological force corresponds to a force resulting from a contraction of at least of the patient's bladder or urethral sphincter. 
     
     
         36 . The method of  claim 28 , wherein the at least one of the first or second sensors comprises an expandable member, the method further comprising expanding at least of the first or second pressure sensors.