# US 2025/0128031 A1 · Intravascular devices, systems, and methods to address eye disorders

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- Number: US 2025/0128031 A1
- Document ID: US20250128031A1
- Status: Published application
- Kind: A1
- Application number: 18/937,157
- Filed: 2024-11-05
- Published: 2025-04-24
- Earliest claimed: 2018-12-31
- Assignees: J.D. Franco & Co., LLC
- Applicants: J.D. Franco & Co., LLC
- Inventors: Michael CALHOUN; Stephen MICHAEL; Zachary TEGELS
- Web page: https://patentgrep.com/patent/US20250128031A1

## CPC

- A61M 25/104: {used for angioplasty}
- A61B 3/102: {for optical coherence tomography [OCT]}
- A61B 5/0066: {Optical coherence imaging}
- A61B 17/12109: {in a blood vessel}
- A61B 17/12136: {Balloons}
- A61M 25/0021: {characterised by the form of the tubing (A61M25/0054 takes precedence)}
- A61M 25/0045: {multi-layered, e.g. coated (coating materials A61L29/08)}
- A61M 25/005: {with embedded materials for reinforcement, e.g. wires, coils, braids}
- A61M 25/0052: {Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port}
- A61M 25/0053: {having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid}
- A61M 25/0054: {with regions for increasing flexibility}
- A61M 25/0068: {Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure}
- A61M 25/0102: {Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod}
- A61M 25/0105: {Steering means as part of the catheter or advancing means; Markers for positioning (systems for detection of markers A61B)}
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- A61M 25/09: Guide wires
- A61M 25/1006: {Balloons formed between concentric tubes}
- A61M 25/1034: {Joining of shaft and balloon}
- A61M 25/1036: {Making parts for balloon catheter systems, e.g. shafts or distal ends (A61M25/1029 takes precedence)}
- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- G06T 7/0012: {Biomedical image inspection}
- A61B 2017/22067: {Blocking; Occlusion (A61B2017/22054 takes precedence)}
- A61F 9/007: Methods or devices for eye surgery
- A61M 25/0041: {pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04)}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/0136: {Handles therefor}
- A61M 25/0152: {with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes}
- A61M 25/0662: {Guide tubes}
- 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 2025/0024: {Expandable catheters or sheaths}
- A61M 2025/0042: {Microcatheters, cannula or the like having outside diameters around 1 mm or less}
- A61M 2025/0058: {having an electroactive polymer material, e.g. for steering purposes, for control of flexibility, for locking, for opening or closing}
- A61M 2025/0183: {Rapid exchange or monorail catheters}
- A61M 2025/0186: {Catheters with fixed wires, i.e. so called "non-over-the-wire catheters"}
- A61M 2025/09008: {having a balloon}
- A61M 2025/09166: {having radio-opaque features}
- A61M 2025/1061: {having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube}
- A61M 2025/1079: {having radio-opaque markers in the region of the balloon}
- 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 2210/0612: Eyes
- A61M 2210/12: Blood circulatory system
- G06T 2207/30041: Eye; Retina; Ophthalmic
- G06T 2207/30101: Blood vessel; Artery; Vein; Vascular
- 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)
- G06T: IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

A method may include accessing an artery in communication with an ophthalmic artery of a subject, and advancing a microcatheter along the accessed artery so as to align a distal end of the microcatheter with an ostium of the ophthalmic artery, wherein the microcatheter includes a lumen having a guidewire positioned therein. In addition, the method includes proximally withdrawing the guidewire relative to the microcatheter so as to enable a distal portion of the microcatheter to assume a curved relaxed configuration, and cannulating the ostium with the distal portion of the microcatheter when the distal portion is in the curved relaxed configuration.

## Claims

### Claim 1

A balloon catheter, comprising:
a shaft extending between a proximal end and a distal end, the shaft including:
an inner shaft portion extending from the proximal end, through a balloon, to a distal tip, the inner shaft portion having:
an inner liner;
a metallic support middle layer; and
an outer layer; and
an outer shaft extending from the proximal end to the balloon.

### Claim 2 (depends on 1)

The balloon catheter of claim 1, wherein the outer shaft portion has a first flexibility at the proximal end and a second flexibility at the distal end, wherein the second flexibility is greater than the first flexibility.

### Claim 3 (depends on 1)

The balloon catheter of claim 1, wherein the inner liner comprises a polymer, the metallic support middle layer is a coil, and the outer layer comprises a thermoplastic elastomer.

### Claim 4 (depends on 3)

The balloon catheter of claim 3, wherein the inner liner includes etched polytetrafluoroethylene (PTFE), the coil includes spring temper 304v stainless steel, and the thermoplastic elastomer includes PEBAX® 3533.

### Claim 5 (depends on 1)

The balloon catheter of claim 1, wherein a portion of the inner shaft portion extends distally beyond a distal waist of the balloon to form the distal tip.

### Claim 6 (depends on 3)

The balloon catheter of claim 3, further comprising at least one marker band provided radially between the inner shaft portion and the balloon at one or more positions.

### Claim 7 (depends on 6)

The balloon catheter of claim 6, wherein the at least one marker band is a radiopaque marker band.

### Claim 8 (depends on 6)

The balloon catheter of claim 6, wherein the at least one marker band abuts a distal terminus of the coil of the middle layer.

### Claim 9

A balloon catheter, comprising:
a balloon; and
a shaft, including:
an outer shaft portion, wherein a proximal neck of the balloon is coupled to a distal end of the outer portion; and
a multilayered inner shaft portion extending through the balloon to a distal tip, wherein a distal neck of the balloon is coupled to the multilayered inner shaft portion, the multilayered inner shaft portion having:
an inner liner;
a metallic support middle layer; and
an outer layer;
wherein each of the outer shaft portion and the inner shaft portion extend between a proximal end of the shaft and a distal end of the shaft.

### Claim 10 (depends on 9)

The balloon catheter of claim 9, wherein the inner liner comprises a polymer, the metallic support middle layer is a coil, and the outer layer comprises a thermoplastic elastomer.

### Claim 11 (depends on 10)

The balloon catheter of claim 10, wherein the inner liner includes etched polytetrafluoroethylene (PTFE), the coil includes spring temper 304v stainless steel, and the thermoplastic elastomer includes PEBAX® 3533.

### Claim 12 (depends on 9)

The balloon catheter of claim 9, wherein a portion of the inner shaft portion extends distally beyond the distal neck of the balloon to form the distal tip.

### Claim 13 (depends on 10)

The balloon catheter of claim 10, further comprising at least one marker band provided radially between the inner shaft portion and the balloon at one or more positions.

### Claim 14 (depends on 13)

The balloon catheter of claim 13, wherein the at least one marker band is a radiopaque marker band.

### Claim 15 (depends on 13)

The balloon catheter of claim 13, wherein the at least one marker band abuts a distal terminus of the coil of the middle layer.

### Claim 16

A balloon catheter, comprising:
a catheter shaft outer portion;
a catheter shaft inner portion disposed radially within the outer portion and defining a guidewire lumen extending therethrough, an annular space between the outer portion and the inner portion defining an inflation lumen;
a distal tip section, wherein, in a curved configuration, the distal tip section includes at least a first curve in a first direction and a second curve in a second direction different than the first direction; and
a balloon in fluid communication with the inflation lumen, wherein a proximal neck of the balloon is coupled to the outer portion and a distal neck of the balloon is coupled to the inner portion.

### Claim 17 (depends on 16)

The balloon catheter of claim 16, wherein the outer portion includes a series of increasing flexible polymer tubes from a proximal end of the outer portion to a distal end of the outer portion.

### Claim 18 (depends on 16)

The balloon catheter of claim 16, further comprising at least one radiopaque marker provided on the inner portion adjacent to at least one of a proximal end and a distal end of the balloon.

### Claim 19 (depends on 16)

The balloon catheter of claim 16, wherein the first curve has a radius of approximately 7.5 mm to 15 mm and an arc length of approximately 35° to 55°, wherein the second curve has a radius of approximately 2 mm to 3 mm and an arc length of approximately 170° to 190°.

### Claim 20 (depends on 16)

The balloon catheter of claim 16, wherein, in the curved configuration, the distal tip section includes a third curve extending from a distal end of the second curve.
