US2020237975A1PendingUtilityA1

Method of Removing Excess Fluid from a Patient with Venous Congestion

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Assignee: STRATACA SYSTEMS LTDPriority: Jul 20, 2015Filed: Apr 16, 2020Published: Jul 30, 2020
Est. expiryJul 20, 2035(~9 yrs left)· nominal 20-yr term from priority
A61M 1/90A61M 25/04A61M 1/75A61M 1/84A61M 1/80A61M 1/743A61M 1/73A61M 1/74A61M 2205/3368A61M 27/008A61M 2202/0496A61M 39/12A61M 2025/0213A61M 2210/1089A61M 25/1025A61M 2230/65A61M 25/0023A61M 2230/00A61M 2210/1085A61M 2230/207A61M 2205/52A61M 2210/1082A61M 25/0017A61M 2230/50A61M 25/0026A61M 1/0031A61M 1/0025A61M 1/008A61M 1/0035A61M 1/0066A61M 1/0037
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Claims

Abstract

A method for increasing urine output rate from a patient having venous congestion is provided. The method includes: deploying a urinary 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 an edema value of the patient; and if the measured edema value is less than or equal to Grade 1 in which the depth of indentation is less than about 2 mm after about 10 seconds, ceasing the application of the negative pressure to the ureter and/or kidney.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for increasing urine output rate from a patient having venous congestion, the method comprising:
 deploying a urinary 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 examining a leg of the patient to determine the extent of peripheral edema; and   if the peripheral edema is less than or equal to Grade 1, in which a depth of an indentation in the leg of the patient is about 2 mm or less after tissue perfusion time of 3 seconds, ceasing the application of the negative pressure to the ureter and/or kidney.   
     
     
         2 . The method according to  claim 1 , wherein the patient has a central venous pressure greater than 6 mm Hg, or greater than about 8 mm Hg, prior to application of the method. 
     
     
         3 . The method according to  claim 1 , wherein the urinary catheter comprises (a) a proximal portion; and (b) a distal portion, the distal portion comprising a retention portion that comprises at least one drainage hole(s), port(s) or perforation(s) and is configured to establish an outer periphery that inhibits mucosal tissue from occluding the at least one drainage hole(s), port(s) or perforation(s) upon application of the negative pressure through the catheter. 
     
     
         4 . The method according to  claim 1 , wherein the urinary catheter comprises a drainage lumen comprising a proximal portion configured to extend outside of the patient's body, and a distal portion configured to be positioned in a patient's kidney, renal pelvis and/or in the ureter adjacent to the renal pelvis, the distal portion comprising a retention portion, the retention portion comprising at least one drainage hole(s), port(s) or perforation(s) on a sidewall of the 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 drainage hole(s), port(s) or perforation(s). 
     
     
         5 . The method according to  claim 4 , wherein the at least one drainage hole(s), port(s) or perforation(s) is on an inwardly facing side of the sidewall of the retention portion. 
     
     
         6 . The method according to  claim 1 , wherein the urinary catheter comprises a drainage lumen comprising a proximal portion configured to extend outside of the patient's body, and a distal portion configured to be positioned in a patient's kidney, renal pelvis and/or in the ureter adjacent to the renal pelvis, the distal portion comprising a retention portion, the retention portion comprising at least one coil(s). 
     
     
         7 . The method according to  claim 6 , wherein the retention portion comprises at least two coils, each of the at least two coils comprising a radially inwardly facing side comprising at least one of the drainage hole(s), port(s) or perforation(s) and an outwardly facing side which is essentially free or free of drainage hole(s), port(s) or perforation(s). 
     
     
         8 . The method according to  claim 7 , wherein the at least two coil(s) comprises at least a first coil having a first diameter; and at least a second coil having a second diameter, the first diameter being less than the second diameter, the second coil being closer to an end of the distal portion of the drainage lumen than the first coil. 
     
     
         9 . The method according to  claim 7 , wherein the radially inwardly facing side of at least one of the at least two coils comprises at least one of the drainage hole(s), port(s) or perforation(s). 
     
     
         10 . The method according to  claim 7 , wherein a total surface area of drainage hole(s), port(s) or perforation(s) on the radially inwardly facing side of at least one of the at least two coils is greater than a total surface area of drainage port(s) hole(s), port(s) or perforation(s) on the outwardly facing side of the same at least one of the at least two coils. 
     
     
         11 . The method according to  claim 1 , further comprising deploying a bladder catheter in the patient's bladder for receiving urine which passes through the ureter and enters the bladder. 
     
     
         12 . The method according to  claim 1 , further comprising ceasing application of negative pressure when a total volume of fluid extracted from the patient and collected from the urinary catheter exceeds a predetermined fluid volume. 
     
     
         13 . The method according to  claim 12 , wherein excess fluid is provided to the patient during a fluid resuscitation procedure performed for the patient. 
     
     
         14 . The method according to  claim 13 , wherein removing the excess fluid from the patient is provided as a treatment for systemic fluid volume management associated with acute heart failure or as a treatment provided to the patient during a coronary graft bypass procedure.

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