Devices and methods for minimally invasive kidney stone removal by combined aspiration and irrigation

Abstract

Disclosed herein are systems, devices, and methods for the removal of objects from the body. The device may be a urethral catheter configured to aspirate kidney stones from the urinary tract through one or more aspiration ports at the distal face or along a lateral side of the catheter. The catheter may include one or more irrigation ports at the distal face or along the lateral side of the catheter for dislodging kidney stones. The device may be steerable. The spatial arrangement of the one or more irrigation ports with respect to the one or more aspiration ports may vary. The device may include an irrigation tube and/or a shield member configured to spatially confine the kidney stones adjacent the catheter. Various temporal patterns of aspiration and irrigation are disclosed for optimizing removal of kidney stones.

1 - 36 . (canceled) 
     
     
         37 . A method of removing kidney stones from a kidney of a patient, the method comprising:
 inserting a steerable catheter through the urethra, bladder, and ureter and into the kidney of the patient, the catheter comprising a vacuum lumen and an irrigation lumen, wherein the vacuum lumen has an inner diameter greater than 2 mm, wherein the vacuum lumen and irrigation lumen have openings at a distal end of the catheter, and wherein the irrigation lumen is in fluid communication with a fluid source and the vacuum lumen is in fluid communication with a vacuum source;   inserting, a distal portion of the catheter into a first calyx of the kidney,   providing fluid communication between the vacuum lumen and ambient air outside of the patient;   while fluid communication is provided between the vacuum lumen and ambient air outside of the patient, continuously providing irrigation fluid through the irrigation lumen and out of the irrigation lumen distal end into the first calyx until irrigation fluid returns through the vacuum lumen to outside of the patient;   after the irrigation fluid returns through the vacuum lumen to outside of the patient, terminating the fluid communication between the vacuum lumen and ambient air outside of the patient such that the vacuum source provides negative pressure to the vacuum lumen;   bending the distal portion of the catheter within the first calyx in a first bending direction by manipulating a steering member outside of the patient;   removing one or more kidney stones from the first calyx to outside of the patient by aspiration of the kidney stone through the vacuum lumen;   after removing the one or more kidney stones from the first calyx, reestablishing fluid communication between the vacuum lumen and ambient air outside of the patient;   removing the distal portion of the catheter from the first calyx and inserting it into a second calyx of the kidney without use of a guidewire or endoscope and without removing the catheter from the patient;   providing irrigation fluid through the irrigation lumen and out of the irrigation lumen distal end into the second calyx;   terminating the fluid communication between the vacuum lumen and ambient air outside of the patient such that the vacuum source provides negative pressure to the vacuum lumen while the distal portion of the catheter is in the second calyx; and   bending the distal portion of the catheter within the second calyx by manipulating the steering member outside of the patient.   
     
     
         38 . The method of  claim 37 , wherein all of said steps are conducted without any direct visualization from within the kidney. 
     
     
         39 . The method of  claim 38 , wherein one or more of the steps are conducted with indirect visualization from outside the patient. 
     
     
         40 . The method of  claim 39 , wherein the indirect visualization comprises fluoroscopy. 
     
     
         41 . The method of  claim 37 , wherein irrigation fluid is continuously provided through the irrigation lumen while the distal portion of the catheter is removed from the first calyx and inserted into the second calyx. 
     
     
         42 . The method of  claim 37 , comprising:
 after inserting the distal portion of the catheter into the second calyx, continuously providing irrigation fluid through the irrigation lumen and out of the irrigation lumen distal end into the second calyx until irrigation fluid returns through the vacuum lumen to outside of the patient; and   wherein the step of terminating the fluid communication between the vacuum lumen and ambient air outside of the patient when the distal portion of the catheter is in the second calyx is performed after the irrigation fluid returns from the second calyx through the vacuum lumen to outside of the patient.   
     
     
         43 . The method of  claim 42 , further comprising:
 inserting the distal portion of the catheter into one or more additional calyces;   providing irrigation fluid through the irrigation lumen and out of the irrigation lumen distal end into the one or more additional calyces;   terminating the fluid communication between the vacuum lumen and ambient air outside of the patient such that the vacuum source provides negative pressure to the vacuum lumen while the distal portion of the catheter is in the one or more additional calyces; and   bending the distal portion of the catheter within the one or more additional calyces by manipulating the steering member outside of the patient.   
     
     
         44 . The method of  claim 43 , wherein the first calyx, second calyx, or one or more additional calyces includes a calyx within the lower pole of the kidney. 
     
     
         45 . The method of  claim 37 , comprising, after bending the distal portion of the catheter within the first calyx and while the vacuum source provides negative pressure to the vacuum lumen:
 rotating the catheter in a first rotation direction;   bending the distal portion of the catheter within the first calyx in a second bending direction opposite the first bending direction; and   rotating the catheter in a second rotation direction opposite the first rotation direction.   
     
     
         46 . The method of  claim 45 , wherein rotating the catheter in the first direction comprises rotating the catheter approximately 180 degrees in the first direction, wherein bending the distal portion of the catheter in the second bending direction comprises bending the catheter such that a distal tip of the catheter is returned to approximately the same position it was in before rotating the catheter in the first direction, and wherein rotating the catheter in the second direction comprises rotating the catheter approximately 180 degrees in the second direction such that the distal tip of the catheter has traced a substantially circular trajectory. 
     
     
         47 . The method of  claim 37 , comprising removing one or more kidney stones front the second calyx to outside of the patient by aspiration of the kidney stone through the vacuum lumen. 
     
     
         48 . The method of  claim 37 , wherein removing the distal portion of the catheter from the first calyx is performed while terminating the fluid communication between the vacuum lumen and ambient air outside of the patient such that the vacuum source provides negative pressure to the vacuum lumen. 
     
     
         49 . A method of removing kidney stones from a kidney of a patient, the method comprising:
 inserting a steerable catheter through the urethra, bladder, and ureter and into the kidney of the patient, the catheter comprising a vacuum lumen and an irrigation lumen, wherein the vacuum lumen and irrigation lumen have openings at a distal end of the catheter, and wherein the irrigation lumen is in fluid communication with a fluid source and the vacuum lumen is in fluid communication with a vacuum source;   inserting a distal portion of the catheter into a first calyx of the kidney;   providing fluid communication between the vacuum lumen and ambient air outside of the patient;   while fluid communication is provided between the vacuum lumen and ambient air outside of the patient, continuously providing irrigation fluid through the irrigation lumen and out of the irrigation lumen distal end into the first calyx;   terminating the fluid communication between the vacuum lumen and ambient air outside of the patient such that the vacuum source provides negative pressure to the vacuum lumen;   removing one or more kidney stones from the first calyx to outside of the patient by aspiration of the kidney stone through the vacuum lumen;   after removing the one or more kidney stones from the first calyx, reestablishing fluid communication between the vacuum lumen and ambient air outside of the patient;   removing the distal portion of the catheter from the first calyx and inserting it into a second calyx of the kidney without use of a guidewire or endoscope and without removing the catheter from the patient;   providing irrigation fluid through the irrigation lumen and out of the irrigation lumen distal end into the second calyx; and   terminating the fluid communication between the vacuum lumen and ambient air outside of the patient such that the vacuum source provides negative pressure to the vacuum lumen while the distal portion of the catheter is in the second calyx.   
     
     
         50 . The method of  claim 49 , comprising continuing to provide irrigation fluid through the irrigation lumen while terminating the fluid communication between the vacuum lumen and ambient air outside of the patient. 
     
     
         51 . The method of  claim 49 , comprising ceasing to provide irrigation fluid through the irrigation lumen while terminating the fluid communication between the vacuum lumen and ambient air outside of the patient. 
     
     
         52 . The method of  claim 50 , wherein terminating the fluid communication between the vacuum lumen and ambient air outside of the patient is continuously sustained for a period from 0.5 s to 3 s. 
     
     
         53 . The method of  claim 52 , wherein from 5 cc to 15 cc of irrigation fluid is provided through the irrigation lumen into the first calyx. 
     
     
         54 . The method of  claim 53 , further comprising bending the distal portion of the catheter within the first calyx in a first bending direction by manipulating a steering member outside of the patient. 
     
     
         55 . The method of  claim 54 , further comprising bending the distal portion of the catheter within the second calyx by manipulating a steering member outside of the patient. 
     
     
         56 - 249 . (canceled) 
     
     
         250 . The method of  claim 54 , wherein the distal portion of the catheter is bent to an angle of greater than about 170 degrees.