US2016074581A1PendingUtilityA1

Modulated Drug Delivery

54
Assignee: GERRANS LAWRENCE JPriority: Sep 17, 2014Filed: Sep 17, 2014Published: Mar 17, 2016
Est. expirySep 17, 2034(~8.2 yrs left)· nominal 20-yr term from priority
A61B 1/04A61B 1/06A61M 2205/52A61B 5/0275A61M 2205/502A61M 2005/1726A61M 5/16859A61M 5/1723A61B 5/02158A61B 5/032A61B 5/02055A61M 25/1011A61B 5/031A61B 5/6853A61M 5/007A61M 2205/3334A61M 2205/3306A61M 2205/50A61B 1/00183A61B 1/00172A61B 5/01A61M 2025/1052A61M 2230/005A61B 5/03A61B 5/4839A61B 5/0285A61M 2230/50A61M 2025/0003A61M 5/16854A61M 2230/30A61M 2025/0002A61M 5/16836A61B 5/065A61B 1/3137A61M 2025/105A61B 5/0215
54
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Claims

Abstract

A method of delivering a therapeutic and/or diagnostic agent to tissue is provided including the steps of inserting a catheter into a bodily cavity, the catheter having a proximal balloon and a distal balloon, inflating the proximal and distal balloons to create a chamber between the proximal and distal balloons, delivering the therapeutic and/or diagnostic agent to the chamber, measuring fluid pressure in the chamber, measuring at least one fluid dynamic characteristic of a subject, and adjusting the delivery of the therapeutic and/or diagnostic agent based at least in part on the measured volumetric pressure in the chamber and the at least one fluid dynamic characteristic of the subject.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of delivering a therapeutic and/or diagnostic agent to tissue, comprising the steps of:
 inserting a catheter into a bodily cavity, said catheter comprising a proximal balloon and a distal balloon;   inflating the proximal and distal balloons to create a chamber between the proximal and distal balloons;   delivering the therapeutic and/or diagnostic agent to said chamber;   measuring fluid pressure in said chamber;   measuring at least one fluid dynamic characteristic of a subject; and   adjusting the delivery of the therapeutic and/or diagnostic agent based at least in part on said measured fluid pressure in said chamber and said at least one fluid dynamic characteristic of the subject.   
     
     
         2 . The method of  claim 1 , wherein said at least one fluid dynamic characteristic of the subject is measured via at least one sensor positioned on the subject. 
     
     
         3 . The method of  claim 1 , wherein said at least one fluid dynamic characteristic of the subject comprises at least one of diastolic pressure and systolic pressure. 
     
     
         4 . The method of  claim 1 , wherein said at least one fluid dynamic characteristic of the subject comprises at least one of a lymphatic fluid dynamic characteristic, a blood dynamic characteristic, a cerebrospinal fluid dynamic characteristic, an interstitial fluid dynamic characteristic, and an intracellular fluid dynamic characteristic. 
     
     
         5 . The method of  claim 1 , wherein said at least one fluid dynamic characteristic of the subject comprises at least one of fluid velocity, fluid pressure, fluid density, and fluid temperature. 
     
     
         6 . The method of  claim 1 , wherein the step of adjusting the delivery of the therapeutic and/or diagnostic agent comprises increasing or decreasing volumetric pressure inside said chamber. 
     
     
         7 . The method of  claim 6 , wherein the step of decreasing volumetric pressure inside said chamber comprises allowing fluid to escape said chamber via an outflow lumen. 
     
     
         8 . The method of  claim 6 , wherein the catheter further comprises a middle balloon positioned between the proximal and distal balloons and the volumetric pressure inside said chamber is increased or decreased by adjusting the inflation of the middle balloon. 
     
     
         9 . The method of  claim 1 , wherein the step of adjusting the delivery of the therapeutic and/or diagnostic agent comprises increasing or decreasing the pressure at which the agent is delivered to said chamber. 
     
     
         10 . The method of  claim 1 , wherein the step of measuring fluid pressure in said chamber comprises measuring pressure via at least one sensor positioned at a fluid source. 
     
     
         11 . The method of  claim 1 , wherein the step of measuring volumetric pressure in said chamber comprises measuring pressure via at least one sensor positioned inside said chamber. 
     
     
         12 . The method of  claim 1 , wherein the step of measuring volumetric pressure in said chamber comprises measuring pressure via at least one sensor positioned in a catheter lumen. 
     
     
         13 . A method of delivering a therapeutic and/or diagnostic agent to tissue, comprising the steps of:
 inserting a catheter into a bodily cavity;   delivering the therapeutic and/or diagnostic agent to tissue via said catheter;   measuring pressure at which the therapeutic and/or diagnostic agent is delivered to tissue;   measuring at least one fluid dynamic characteristic of a subject; and   adjusting the delivery of the therapeutic and/or diagnostic agent based at least in part on said measured pressure of the agent and said at least one fluid dynamic characteristic of the subject.   
     
     
         14 . The method of  claim 12 , wherein said at least one fluid dynamic characteristic of the subject is measured via at least one sensor positioned on the subject. 
     
     
         15 . The method of  claim 12 , wherein said at least one fluid dynamic characteristic of the subject comprises at least one of diastolic pressure and systolic pressure. 
     
     
         16 . The method of  claim 12 , wherein said at least one fluid dynamic characteristic of the subject comprises at least one of a lymphatic fluid dynamic characteristic, a blood dynamic characteristic, a cerebrospinal fluid dynamic characteristic, an interstitial fluid dynamic characteristic, and an intracellular fluid dynamic characteristic. 
     
     
         17 . The method of  claim 12 , wherein said at least one fluid dynamic characteristic of the subject comprises at least one of fluid velocity, fluid pressure, fluid density, and fluid temperature. 
     
     
         18 . The method of  claim 12 , wherein the step of adjusting the delivery of the therapeutic and/or diagnostic agent comprises increasing or decreasing pressure at which the agent is delivered to tissue. 
     
     
         19 . The method of  claim 12 , wherein the step of measuring pressure at which the therapeutic and/or diagnostic agent is delivered to tissue comprises measuring pressure via at least one sensor positioned at a fluid source. 
     
     
         20 . The method of  claim 12 , wherein the step of measuring pressure at which the therapeutic and/or diagnostic agent is delivered to tissue comprises measuring pressure via at least one sensor positioned in a catheter lumen. 
     
     
         21 . A system for delivering a therapeutic and/or diagnostic agent to tissue, comprising:
 a catheter having a delivery port and a lumen through which a therapeutic and/or diagnostic agent is communicated to the delivery port;   at least one first sensor that measures pressure of the therapeutic and/or diagnostic agent being delivered via said port and generates a signal indicating the pressure;   a processor that receives the signal from said at least one first sensor; and   at least one second sensor that measures at least one fluid dynamic characteristic of a subject and transmits a signal indicating the at least one fluid dynamic characteristic to said processor;   wherein said processor adjusts the delivery of the therapeutic and/or diagnostic agent based at least in part on said measured pressure of the agent and said at least one fluid dynamic characteristic of the subject.   
     
     
         22 . The system of  claim 21 , wherein said at least one fluid dynamic characteristic of the subject comprises at least one of diastolic pressure and systolic pressure. 
     
     
         23 . The system of  claim 21 , wherein said at least one fluid dynamic characteristic of the subject comprises at least one of a lymphatic fluid dynamic characteristic, a blood dynamic characteristic, a cerebrospinal fluid dynamic characteristic, an interstitial fluid dynamic characteristic, and an intracellular fluid dynamic characteristic. 
     
     
         24 . The system of  claim 21 , wherein said at least one fluid dynamic characteristic of the subject comprises at least one of fluid velocity, fluid pressure, fluid density, and fluid temperature. 
     
     
         25 . The system of  claim 21 , further comprising a fluid source, wherein the at least one first sensor is positioned at said fluid source. 
     
     
         26 . The system of  claim 21 , wherein the at least one first sensor is positioned in a catheter lumen. 
     
     
         27 . The system of  claim 21 , wherein the processor adjusts the delivery of the therapeutic and/or diagnostic agent by increasing or decreasing pressure at which the agent is delivered via the delivery port. 
     
     
         28 . The system of  claim 21 , wherein said catheter comprises a proximal balloon and a distal balloon and a fluid source that inflates said proximal and distal balloons by supplying fluid thereto to create a chamber between the proximal and distal balloons, and wherein said delivery port is positioned between the proximal and distal balloons. 
     
     
         29 . The system of  claim 28 , wherein the at least one first sensor is positioned inside the chamber between the proximal and distal balloons. 
     
     
         30 . The system of  claim 28 , wherein the processor adjusts the delivery of the therapeutic and/or diagnostic agent by increasing or decreasing volumetric pressure inside said chamber. 
     
     
         31 . The system of  claim 28 , wherein said catheter further comprises a middle balloon positioned between the proximal and distal balloons and wherein the processor adjusts the delivery of the therapeutic and/or diagnostic agent by adjusting the inflation of the middle balloon. 
     
     
         32 . The system of  claim 28 , wherein said catheter further comprises an outflow lumen that allows fluid to escape said chamber.

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