US2022265972A1PendingUtilityA1

Devices, systems, and related methods for delivery of fluid to tissue

Assignee: BOSTON SCIENT SCIMED INCPriority: Sep 1, 2011Filed: May 10, 2022Published: Aug 25, 2022
Est. expirySep 1, 2031(~5.1 yrs left)· nominal 20-yr term from priority
A61M 2025/1013A61M 2025/1086A61M 2025/105A61M 25/1011A61M 37/0015A61M 2037/0023A61M 2037/003A61M 2037/0046
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Claims

Abstract

A fluid delivery system including a first balloon and a second balloon at least partially positioned within the first balloon, wherein the second balloon has an inner surface, an outer surface, and at least one micro-needle extending outwardly from the outer surface of the second balloon. The delivery system can further include a fluid source in communication with at least one of the micro-needles of the second balloon.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A system for delivering a therapeutic material to a target tissue of a patient, the system comprising:
 a first expandable balloon; and   a second expandable balloon at least partially positioned within the first balloon, wherein the second balloon comprises an inner surface, an outer surface, and at least one micro-needle extending outwardly from the outer surface of the second balloon, wherein the at least one micro-needle is in fluid communication with an inner volume of the second balloon.   
     
     
         2 . The system of  claim 1 , further comprising a fluid source in communication with at least one micro-needle of the second balloon. 
     
     
         3 . The system of  claim 1 , wherein the second balloon is expandable to cause penetration of the first balloon by at least one of the micro-needles. 
     
     
         4 . The system of  claim 1 , wherein each of the micro-needles comprises an inner lumen in communication with the inner volume of the second balloon. 
     
     
         5 . The system of  claim 1 , further comprising a fluid supply system that comprises a main supply tube and at least one fluid delivery tube, wherein each of the delivery tubes terminates at a proximal end of one of the micro-needles. 
     
     
         6 . The system of  claim 1 , further comprising a fluid supply system that comprises a main supply tube and at least one fluid delivery tube, wherein each of the delivery tubes has a distal end in fluid communication with a proximal end of multiple micro-needles. 
     
     
         7 . The system of  claim 1 , wherein the first expandable balloon has an outer surface configured to come in contact with an inner surface of a bladder wall, an inner surface of a vaginal wall, an inner surface of an anal canal, an inner surface of a rectum, an inner surface of an anus, or an inner surface of a uterine wall. 
     
     
         8 . The system of  claim 1 , wherein the first balloon comprises a material thickness and wherein each of the at least one micro-needles comprises a length that is greater than the material thickness of the first balloon. 
     
     
         9 . The system of  claim 8 , wherein the length of each of the micro-needles is at least as large as a combination of the thickness of the first balloon and a desired penetration depth into the target tissue. 
     
     
         10 . The system of  claim 1 , wherein the second balloon further comprises at least one biodegradable layer covering an opening of at least one of the micro-needles to at least temporarily block fluid communication between the an inner volume of the second balloon and a lumen extending through each of the micro-needles. 
     
     
         11 . The system of  claim 10 , wherein the at least one biodegradable layer is spaced distally from a proximal end of the at least one micro-needle. 
     
     
         12 . The system of  claim 1 , wherein at least one of the micro-needles comprises a textured outer surface. 
     
     
         13 . A system for delivering a therapeutic material to a target tissue of a patient, the system comprising:
 an expandable balloon comprising an inner surface, an outer surface, and at least one micro-needle extending outwardly from the outer surface of the balloon, wherein the at least one micro-needle is in fluid communication with an inner volume of the balloon; and   a catheter operatively engaged with the expandable balloon such that as the balloon is expanded within a bladder, fluid is forced from the bladder into a lumen of the catheter.   
     
     
         14 . A method of delivering fluid to a target tissue of a patient, the method comprising the steps of:
 positioning a fluid delivery system adjacent to a pelvic area of a patient, the fluid delivery system comprising a first expandable balloon and a second expandable balloon at least partially positioned within the first balloon, wherein the second balloon comprises an inner surface, an outer surface, and at least one micro-needle extending outwardly from the outer surface, wherein the at least one micro-needle is in fluid communication with an inner volume of the second balloon;   inserting the fluid delivery system into a pelvic area passageway of a patient until it reaches the target tissue;   expanding the first balloon until an outer surface of the first balloon contacts the target tissue;   expanding the second balloon until at least one of the micro-needles penetrates the first balloon and the target tissue; and   providing fluid to a proximal end of at least one of the micro-needles and forcing the fluid through a length of at least one of the micro-needles to its distal end and into the target tissue.   
     
     
         15 . The method of  claim 14 , wherein the step of providing fluid to at least one micro-needle comprises adding pressurized fluid to the inner volume of the second balloon. 
     
     
         16 . The method of  claim 14 , wherein the fluid delivery system further comprises a fluid supply system that comprises a main supply tube and at least one fluid delivery tube, wherein each of the delivery tubes terminates at a proximal end of one of the micro-needles, and wherein the step of providing fluid to at least one of the micro-needles comprises forcing fluid through the main supply tube to the at least one fluid delivery tube. 
     
     
         17 . The method of  claim 14 , wherein the first balloon comprises a material thickness and wherein each of the at least one micro-needles comprises a length that is greater than the material thickness of the first balloon. 
     
     
         18 . The method of  claim 14 , wherein the length of each of the micro-needles is at least as large as a combination of the thickness of the first balloon and a desired penetration depth into the target tissue. 
     
     
         19 . The method of  claim 14 , wherein the fluid delivery system further comprises a catheter, and wherein the step of expanding the first balloon further comprises forcing a fluid into a distal end of the catheter to move the fluid toward a proximal end of the catheter. 
     
     
         20 . The method of  claim 14 , wherein each of the micro-needles comprises an inner lumen extending from a proximal end to a distal end of the micro-needle, wherein each inner lumen is in fluid communication with the inner volume of the second balloon.

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