# US 2025/0082912 A1 · Balloon catheter methods of use

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- Number: US 2025/0082912 A1
- Document ID: US20250082912A1
- Status: Published application
- Kind: A1
- Application number: 18/464,859
- Filed: 2022-03-14
- Published: 2025-03-13
- Earliest claimed: 2021-03-12
- Applicants: Hope Medical
- Inventors: Andrew GEORGILIS; Paul IMAOKA; Brandon VERWIJST
- Web page: https://patentgrep.com/patent/US20250082912A1

## CPC

- A61M 25/1018: {Balloon inflating or inflation-control devices}
- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61M 25/0009: {Making of catheters or other medical or surgical tubes}
- A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- A61M 25/1011: {Multiple balloon catheters}
- A61M 25/1027: {Making of balloon catheters}
- A61M 25/002: {Packages specially adapted therefor (combined with means for introducing catheters, e.g. dispensers, A61M25/0113); catheter kit packages (for surgical articles A61B50/30)}
- A61M 25/1006: {Balloons formed between concentric tubes}
- A61M 2025/1072: {having balloons with two or more compartments}
- A61M 2025/1084: {having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands}
- A61M 2210/105: Oesophagus
- 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

A method of using a balloon catheter is disclosed. One embodiment of this method may include coaxially disposing an inner catheter through an outer catheter and through a distal balloon, operably coupling a proximal hub with a distal balloon through the outer catheter and the inner catheter, maintaining an inner lumen in the inner catheter to pass over a guidewire, maintaining the outer catheter with a fluid pathway channel by which the distal balloon is inflated from a contracted state, including a distal end on the inner catheter in which a distal tip is operably disposed, and inflating the distal balloon into a unique shape using the fluid pathway channel of the outer catheter.

## Claims

### Claim 1

A method of manufacturing a balloon dilation catheter assembly, comprising:
coaxially disposing an inner catheter through an outer catheter and to a distal balloon;
operably coupling a proximal hub to the distal balloon through the outer catheter and the inner catheter;
maintaining an inner lumen in the inner catheter configured to pass over a guidewire; and
defining a fluid pathway channel between the inner catheter and the outer catheter by which fluid is selectively directed from the proximal hub to a lumen in the distal balloon;
wherein, the distal balloon is selectively inflatable to an inflated state having an at least partially oblong cross section using the fluid pathway channel.

### Claim 2 (depends on 1)

The method of claim 1, further comprising positioning a radiopaque marker on the outer catheter configured for visualization of the balloon catheter when operably disposed in a patient.

### Claim 3 (depends on 1)

The method of claim 1, wherein the oblong cross section of the balloon further comprises:
a first balloon profile on a first side; and
a second balloon profile along a second side;
wherein the first balloon profile and second balloon profile are fluidly coupled to one another to form the oblong cross-section of the balloon when in the inflated state.

### Claim 4

A method of using a catheter for dilating an area of the esophagus, comprising:
providing a substantially deflated balloon having an inflated cross-section that is at least partially oblong;
positioning the balloon in an upper esophagus area of a patient;
inflating the balloon to an inflated state wherein the cross-section is at least partially oblong;
deflating the balloon; and
removing the balloon from the upper esophagus area of the patient.

### Claim 5 (depends on 4)

The method of claim 4, wherein the balloon is positioned at least partially within an upper esophageal sphincter of the patient before being inflated.

### Claim 6 (depends on 5)

The method of claim 5, wherein the balloon at least partially dilates the upper esophageal sphincter when the balloon is inflated.

### Claim 7 (depends on 4)

The method of claim 4, wherein the balloon is comprised of a semi-compliant material selected from the group of polyamides, and engineered nylons such as Pebax®, Grilamid®, and Vestamid®, PET, and high durometer polyurethane.

### Claim 8 (depends on 4)

The method of claim 4, wherein the burst pressure of the balloon is between about 15 psi to about 265 psi.

### Claim 9 (depends on 4)

The method of claim 4, wherein inflating the balloon further comprises a first stage of expansion and a second stage of expansion.

### Claim 10 (depends on 9)

The method of claim 9, wherein the circumference of the balloon in the second stage of expansion is larger than the circumference of the balloon in the first stage of expansion.

### Claim 11 (depends on 10)

The method of claim 10, further wherein the width of the balloon in the first stage is not less than 16 mm and not greater than 38 mm.

### Claim 12

A balloon catheter kit comprising:
a first balloon assembly comprising:
a first balloon having a first lumen fluidly coupled to a first hub to selectively transition the first balloon between a deflated state and an inflated state;
wherein, in the inflated state, the first balloon has an oblong cross-section with a first circumference;
a second balloon assembly comprising:
a second balloon having a second lumen fluidly coupled to a second hub to selectively transition the second balloon between a deflated state and an inflated state;
wherein, in the inflated state, the second balloon has an oblong cross-section with a second circumference;
a container configured to removably contain both the first balloon assembly and the second balloon assembly;
further wherein both the first balloon assembly and the second balloon assembly are sized to pass over a guidewire.

### Claim 13 (depends on 12)

The balloon catheter kit of claim 12:
wherein, the first balloon assembly further comprises a first balloon profile on a first side and a second balloon profile along a second side that are fluidly coupled to one another to form the oblong cross-section of the first balloon; and
wherein, the second balloon assembly further comprises a first balloon profile on a first side and a second balloon profile along a second side that are fluidly coupled to one another to form the oblong cross-section of the second balloon.

### Claim 14 (depends on 12)

The balloon catheter kit of claim 12, further comprising a third balloon assembly comprising a third balloon having a third lumen fluidly coupled to a third hub to selectively transition the third balloon between a deflated state and an inflated state;
wherein, in the inflated state, the third balloon has an oblong cross-section with a third circumference.

### Claim 15 (depends on 12)

The balloon catheter kit of claim 12, wherein the second circumference is greater than the first circumference.

### Claim 16 (depends on 14)

The balloon catheter kit of claim 14, wherein the second circumference is greater than the first circumference and the third circumference is greater than the second circumference.

### Claim 17 (depends on 12)

The balloon catheter kit of claim 12, further comprising providing indicators on the container providing dimension information for the first balloon assembly and the second balloon assembly.

### Claim 18 (depends on 12)

The balloon catheter kit of claim 12, further comprising providing indicators on the first balloon assembly and the second balloon assembly distinguishing the first balloon assembly from the second balloon assembly.

### Claim 19 (depends on 12)

The balloon catheter kit of claim 12, further comprising providing instructions in or on the container instructing sequential use of the first balloon assembly before the use of the second balloon assembly.

### Claim 20 (depends on 12)

The balloon catheter kit of claim 12, further comprising a guidewire.
