# US 10,864,323 B2 · Modulated drug delivery

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- Number: US 10,864,323 B2
- Document ID: US10864323B2
- Status: Granted
- Kind: B2
- Application number: 15/877,061
- Filed: 2018-01-22
- Published: 2018-05-24
- Granted: 2020-12-15
- Earliest claimed: 2011-03-01
- Assignees: Sanovas Intellectual Property, LLC
- Applicants: Sanovas Intellectual Property, LLC
- Inventors: Lawrence J. Gerrans
- Web page: https://patentgrep.com/patent/US10864323B2

## CPC

- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61B 5/0215: by means inserted into the body
- A61B 5/4839: {combined with drug delivery}
- A61B 5/6853: {with a balloon}
- A61M 5/16854: {by monitoring line pressure}
- A61M 25/1011: {Multiple balloon catheters}
- A61B 1/00172: {with means for scanning}
- A61B 1/00183: {for variable viewing angles}
- A61B 1/04: combined with photographic or television appliances
- A61B 1/06: with illuminating arrangements
- A61B 1/3137: {for examination of the interior of blood vessels}
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/02158: {provided with two or more sensor elements}
- A61B 5/0285: Measuring or recording phase velocity of blood waves
- A61B 5/03: Measuring fluid pressure within the body other than blood pressure, e.g. cerebral pressure {; Measuring pressure in body tissues or organs (determining bladder or urethral pressure A61B5/205)}
- A61B 5/032: {Spinal fluid pressure}
- 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}
- A61M 5/007: {for contrast media}
- A61M 5/16836: {by sensing tissue properties at the infusion site, e.g. for detecting infiltration}
- A61M 2005/1726: {the body parameters being measured at, or proximate to, the infusion site}
- A61M 2025/0002: {with a pressure sensor at the distal end}
- A61M 2025/0003: {having an additional lumen transmitting fluid pressure to the outside for measurement}
- A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes}
- A61M 2025/1052: {for temporarily occluding a vessel for isolating a sector}
- A61M 2205/3306: Optical measuring means
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/50: with microprocessors or computers
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2230/005: Parameter used as control input for the apparatus
- A61M 2230/30: Blood pressure (A61M2230/04 takes precedence)
- A61M 2230/50: Temperature
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

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

### Claim 7 (depends on 1)

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

### Claim 8 (depends on 1)

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.

### Claim 9 (depends on 1)

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

### Claim 10 (depends on 1)

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

### Claim 11 (depends on 1)

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.

### Claim 12 (depends on 1)

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.

### Claim 13 (depends on 12)

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

### Claim 14 (depends on 12)

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.

### Claim 15 (depends on 12)

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.

### Claim 16 (depends on 12)

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

### Claim 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.

### Claim 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.
