Modulated drug delivery

• US 10,864,323 B2
• Filed: 01/22/2018
• Issued: 12/15/2020
• Est. Priority Date: 03/01/2011
• Status: Active Grant

• Current Assignee: Sanovas Intellectual Property, LLC
• Original Assignee: Sanovas Intellectual Property, LLC
• Inventors: Gerrans, Lawrence J.
• Primary Examiner(s): Flick, Jason E
• Application Number:
  US15/877,061
• Publication Number:
  US 20180140773A1
• Time in Patent Office: 1,058 Days
• Field of Search: 604 9601
• CPC Class Codes: A61B 1/00172 with means for scanning
• CPC Class Codes: A61B 1/00183 for variable viewing angles
• CPC Class Codes: A61B 1/04 combined with photographic or television appliances
• CPC Class Codes: A61B 1/06 with illuminating arrangements
• CPC Class Codes: A61B 1/3137 for examination of the interior of blood vessels
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/0285 Measuring or recording phase velocity of blood waves
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/032 Spinal fluid pressure
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/30 : Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/50 : Temperature
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 5/007 : for contrast media
• CPC Class Codes: A61M 5/16836 : by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247
• CPC Class Codes: A61M 5/16854 : by monitoring line pressure
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

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

1. 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.

2. The system of claim 1, wherein said at least one fluid dynamic characteristic of the subject comprises at least one of diastolic pressure and systolic pressure.

3. The system of claim 1, wherein said at least one fluid dynamic characteristic of the subject comprises a lymphatic fluid dynamic characteristic.

4. The system of claim 1, wherein said at least one fluid dynamic characteristic of the subject comprises a blood dynamic characteristic.

5. The system of claim 1, wherein said at least one fluid dynamic characteristic of the subject comprises cerebrospinal fluid dynamic characteristic.

6. The system of claim 1, wherein said at least one fluid dynamic characteristic of the subject comprises an interstitial fluid dynamic characteristic.

7. The system of claim 1, wherein said at least one fluid dynamic characteristic of the subject comprises an intracellular fluid dynamic characteristic.

8. The system 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.

9. The system of claim 1, further comprising a fluid source, wherein the at least one first sensor is positioned at said fluid source.

10. The system of claim 1, wherein the at least one first sensor is positioned in a catheter lumen.

11. The system of claim 1, 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.

12. The system of claim 1, 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.

13. The system of claim 12, wherein the at least one first sensor is positioned inside the chamber between the proximal and distal balloons.

14. The system of claim 12, wherein the processor adjusts the delivery of the therapeutic and/or diagnostic agent by increasing or decreasing volumetric pressure inside said chamber.

15. The system of claim 12, 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.

16. The system of claim 12, wherein said catheter further comprises an outflow lumen that allows fluid to escape said chamber.

17. 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.

18. 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.