# US 12,161,825 B2 · Intravascular devices, systems, and methods to address eye disorders

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- Number: US 12,161,825 B2
- Document ID: US12161825B2
- Status: Granted
- Kind: B2
- Application number: 17/168,028
- Filed: 2021-02-04
- Published: 2021-05-27
- Granted: 2024-12-10
- 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/US12161825B2

## 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 including:
a proximal shaft section;
a mid-shaft section extending distally of the proximal shaft section;
a multi-lumen distal shaft section extending from the mid-shaft section, the distal shaft section including a balloon positioned thereon; and
a junction, including a seal, between a proximal end of the multi-lumen distal shaft section and a distal end of the mid-shaft section, wherein the junction is configured to burst at a pressure that is lower than a burst pressure of the balloon.

### Claim 2 (depends on 1)

The balloon catheter of claim 1, wherein the seal includes a thermal bond.

### Claim 3 (depends on 1)

The balloon catheter of claim 1, wherein the balloon has a nominally rated inflation pressure and the junction is configured to burst between 1 ATM and 4 ATM above the nominally rated inflation pressure.

### Claim 4 (depends on 1)

The balloon catheter of claim 1, wherein the distal shaft section includes an inner portion and an outer portion.

### Claim 5 (depends on 4)

The balloon catheter of claim 4, wherein the outer portion includes a first polymer, and the inner portion includes an inner polymeric liner, a metallic middle layer, and an outer polymeric layer.

### Claim 6 (depends on 5)

The balloon catheter of claim 5, wherein the distal shaft section further includes a tack bond provided between the outer portion and the inner portion to thereby limit longitudinal movement between the outer portion and the inner portion.

### Claim 7 (depends on 6)

The balloon catheter of claim 6, wherein the tack bond is configured to transmit longitudinal push forces between the outer portion and the inner portion.

### Claim 8 (depends on 4)

The balloon catheter of claim 4, wherein the inner portion includes an inner liner that extends from the proximal end of the distal shaft section to a proximal end of the balloon.

### Claim 9 (depends on 8)

The balloon catheter of claim 8, wherein the junction includes a guidewire port, and the inner liner extends from the guidewire port to the proximal end of the balloon.

### Claim 10 (depends on 9)

The balloon catheter of claim 9, wherein a distal waist of the balloon is thermally bonded to a distal portion of the inner liner to form a distal tip section.

### Claim 11 (depends on 9)

The balloon catheter of claim 9, wherein a distal waist of the balloon is thermally bonded to a distal portion of the inner liner to form a distal tip section.

### Claim 12 (depends on 1)

The balloon catheter of claim 1, further comprising a core wire extending within the proximal shaft section and extending into the mid-shaft section.

### Claim 13

A balloon catheter comprising:
a shaft including:
a proximal shaft section;
a mid-shaft section extending distally of the proximal shaft section; and
a distal shaft section extending from the mid-shaft section, a junction between the distal shaft section and the mid-shaft section including a seal, the distal shaft section including:
a distal outer portion extending distally to a balloon, wherein a proximal neck of the balloon is coupled to a distal end of the distal outer portion; and
a multilayered inner portion extending through the balloon, to a distal tip, wherein a distal neck of the balloon is coupled to the inner portion, and the multilayered inner portion having:
an inner liner;
a metallic support middle layer; and
an outer layer,
wherein a junction between the mid-shaft section and the distal shaft section, as a portion of the shaft proximal of the balloon, is configured to burst at a pressure that is lower than a burst pressure of the balloon, and
wherein the balloon has a nominally rated inflation pressure and the junction is configured to burst between 1 ATM and 4 ATM above the nominally rated inflation pressure.

### Claim 14 (depends on 13)

The balloon catheter of claim 13, wherein the distal outer portion includes a first polymer, the inner liner includes PTFE, the metallic support layer includes a stainless steel coil, and the outer layer includes a second polymer.

### Claim 15 (depends on 13)

The balloon catheter of claim 13, wherein the distal shaft section further includes a tack bond provided between the distal outer portion and the multilayered inner portion, the tack bond being thermally formed to thereby limit longitudinal movement between the distal outer portion and the multilayered inner portion.

### Claim 16 (depends on 15)

The balloon catheter of claim 15, wherein the tack bond is configured to transmit longitudinal push forces between the outer portion and the inner portion.

### Claim 17 (depends on 13)

The balloon catheter of claim 13, wherein the seal includes a thermal bond.

### Claim 18 (depends on 13)

The balloon catheter of claim 13, further comprising a core wire extending within the proximal shaft section and extending into the mid-shaft section.

### Claim 19 (depends on 13)

The balloon catheter of claim 13, wherein the inner liner extends from the proximal end of the distal shaft section to a proximal end of the balloon.

### Claim 20 (depends on 19)

The balloon catheter of claim 19, wherein the junction includes a guidewire port, and the inner liner extends from the guidewire port to the proximal end of the balloon.