# US 12,758,294 B2 · Continuous flow balloon catheter systems and methods of use

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- Number: US 12,758,294 B2
- Document ID: US12758294B2
- Status: Granted
- Kind: B2
- Application number: 15/923,140
- Filed: 2018-03-16
- Published: 2018-07-19
- Granted: 2026-10-13
- Earliest claimed: 2015-03-10
- Applicants: PAVmed Inc.
- Inventors: Lishan Aklog; Brian J. deGuzman
- Web page: https://patentgrep.com/patent/US12758294B2

## CPC

- A61B 18/04: by heating (by applying electromagnetic radiation A61B18/18)
- A61B 2018/00023: {closed, i.e. without wound contact by the fluid}
- A61B 2018/0022: {Balloons}
- A61B 2018/00255: {arranged one inside another}
- A61B 2018/00577: {Ablation}
- A61B 2018/00714: {Temperature}
- A61B 2018/00821: {measured by a thermocouple}
- A61B 2018/046: {in liquid form}
- A61M 1/00: Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems (catheters A61M25/00; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; devices for taking samples of blood A61B5/15; filters implantable into blood vessels A61F2/01)
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- A61M 25/1011: {Multiple balloon catheters}
- A61M 2025/1013: {with concentrically mounted balloons, e.g. being independently inflatable}
- A61M 2025/1015: {having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system}
- A61M 25/10181: {Means for forcing inflation fluid into the balloon}
- A61M 25/10182: {Injector syringes}
- A61M 25/10184: {Means for controlling or monitoring inflation or deflation}
- A61M 2025/1059: {having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties}
- A61M 2025/1072: {having balloons with two or more compartments}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)}

## Abstract

Systems and methods for continuous infusion of a fluid, which may be heated, into a balloon catheter. A system for balloon inflation, the system comprising a catheter having an inflow lumen and an outflow lumen, a balloon positioned at a distal end of the catheter, the balloon being in fluid communication with the inflow and the outflow lumen, and an infusion device in fluid communication with the balloon through the inflow and outflow lumens, the infusion device configured for continuously circulating a fluid into and out of the balloon to maintain the balloon at a constant pressure and volume by matching a flow of the fluid into the balloon via the inflow lumen with a flow of the fluid out of the balloon via the outflow lumen in order to keep the balloon volume and pressure constant during an entire infusion.

## Claims

### Claim 1

A system for ablation of a target tissue comprising:
a balloon having an outer surface configured to be placed against the target tissue and a directly opposing inner surface surrounding an interior of the balloon, the balloon having a proximal end opposite a distal end;
a divider within the interior of the balloon configured to separate the interior of the balloon into (i) one or more heated compartments designed to accommodate a heated fluid such that heated fluid accommodated therein directly contacts the inner surface of the balloon and the divider and (ii) at least two insulating compartments designed to accommodate an insulating fluid, the at least two insulating compartments defined by a volumetric heat capacity and thermal conductivity lower than that of surrounding tissues and the heated fluid, wherein a first insulating compartment of the at least two insulating compartments defines a distalmost end of the balloon and a second insulating compartment of the at least two insulating compartments is arranged at the proximal end of the balloon, and wherein the one or more heated compartments extends radially outward between the at least two insulating compartments, such that the one or more heated compartments and the at least two insulating compartments are aligned along a longitudinal axis, and wherein the heated fluid and the insulating fluid are configured such that heat transfer is permitted through the one or more heated compartments and inhibited through the at least two insulating compartments; and
a plurality of lumens, the plurality of lumens collectively being in bidirectional fluid communication with interiors of the at least two insulating compartments, wherein a first lumen and a second lumen of the plurality of lumens are spatially positioned relative to one another so as to manage thermal transfer (i) between the first lumen of the plurality of lumens and the second lumen of the plurality of lumens and (ii) between the plurality of lumens and the target tissue.

### Claim 2 (depends on 1)

The system of claim 1, wherein the divider includes a plurality of septae.

### Claim 3 (depends on 1)

The system of claim 1,
wherein the balloon comprises one heated compartment and the at least two insulating compartments, and
wherein the at least two insulating compartments are designed such that the insulating fluid accommodated therein directly contacts the inner surface of the balloon.

### Claim 4 (depends on 3)

The system of claim 3,
wherein the one heated compartment extends about a circumference of the balloon, and
wherein the at least two insulating compartments are designed such that the insulating fluid accommodated therein directly contacts the inner surface of the balloon.

### Claim 5 (depends on 3)

The system of claim 3, wherein the heated compartment follows a spiral shaped pathway about a circumference of the balloon and a portion of the inner surface of the balloon not forming the heated compartment forms or contacts the at least two insulating compartments.

### Claim 6 (depends on 1)

The system of claim 1, wherein the balloon comprises one heated compartment situated between the at least two insulating compartments.

### Claim 7 (depends on 1)

The system of claim 1, wherein the one or more heated compartments includes a plurality of heated compartments distributed among the at least two insulating compartments.

### Claim 8 (depends on 1)

The system of claim 1,
wherein the one or more heated compartments comprises a plurality of heated compartments, and
wherein the plurality of heated compartments are in fluid communication with one another.

### Claim 9 (depends on 1)

The system of claim 1, further including an inflow lumen wherein the inflow lumen is arranged within a catheter, and wherein the catheter extends distally relative to the distalmost end of the balloon.

### Claim 10

A system for ablation of a target tissue comprising:
an outer balloon;
an elongate structure extending through the outer balloon defining at least two lumens extending through proximately a distal end of the outer balloon and through which a heated fluid is directed towards and away from the outer balloon, in opposite directions; and
an inner balloon attached to the elongate structure and disposed within the outer balloon, wherein the inner balloon is bonded or fused to the outer balloon at one or more discrete area(s) of contact, the area(s) of contact being located within an area comprising less than an entire circumference of the inner wall of the outer balloon, and wherein, when the inner balloon is inflated with the heated fluid from one of the at least two lumens, the inner balloon expands outward from the elongate structure in fewer than all radial directions and
wherein heat transfer from within the inner balloon to the target tissue occurs at the area(s) of contact between the inner balloon and the inner wall of the outer balloon.

### Claim 11 (depends on 10)

The system of claim 10, further comprising a lumen in fluid communication with an interior of the outer balloon for inflating the outer balloon with an insulating fluid, such that one or more areas spanning between the area(s) of contact are insulated from the heated fluid within the inner balloon.

### Claim 12 (depends on 10)

The system of claim 10, wherein the one or more area(s) of contact between the inner balloon and the outer balloon form a strip extending along a length of the outer balloon.

### Claim 13 (depends on 12)

The system of claim 12, wherein the strip extends straight along the length of the outer balloon.

### Claim 14 (depends on 12)

The system of claim 12, wherein the strip extends helically along the length of the outer balloon.
