# US 12,758,134 B2 · Medical dilator, and systems, methods, and kits for medical dilation

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- Number: US 12,758,134 B2
- Document ID: US12758134B2
- Status: Granted
- Kind: B2
- Application number: 18/351,704
- Filed: 2023-07-13
- Published: 2023-11-09
- Granted: 2026-10-13
- Earliest claimed: 2021-01-14
- Assignees: Boston Scientific Medical Device Limited
- Applicants: Boston Scientific Medical Device Limited
- Inventors: Gareth Davies; Lauren Koon; John Paul Urbanski; Eduardo Moriyama
- Web page: https://patentgrep.com/patent/US12758134B2

## CPC

- A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
- A61M 29/00: Dilators with or without means for introducing media, e.g. remedies
- 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

A medical dilator includes an elongate member having a proximal end portion, an opposed distal end portion, and a lumen extending through the elongate member from the proximal end portion to the distal end portion. A dilating tip is at the distal end portion. The dilating tip has a first end of enlarged cross-sectional area and tapers going in the distal direction to a second end of reduced cross-sectional area. At least a first electrode is associated with the dilating tip. An electrical conductor is electrically connected to the first electrode and extends proximally from the first electrode towards the proximal end portion for electrical connection with an electroanatomical mapping system.

## Claims

### Claim 1

A medical dilator, comprising:
an elongate member having a proximal end portion, an opposed distal end portion, and a lumen extending through the elongate member from the proximal end portion to the distal end portion;
a dilating tip at the distal end portion, the dilating tip having a first end of enlarged cross-sectional area and tapering going in the distal direction to a second end of reduced cross-sectional area, the dilating tip comprising a proximal piece having a distal-facing shoulder surface and a neck extending distally from the shoulder surface;
at least a first electrode associated with the dilating tip; and
an electrical conductor electrically connected to the first electrode and extending proximally from the first electrode towards the proximal end portion for electrical connection with an electroanatomical mapping system;
wherein the first electrode is annular and is received on the neck and abuts the shoulder surface; and
wherein the dilating tip further comprises a distal piece received on the neck distally of and abutting the first electrode.

### Claim 2 (depends on 1)

The medical dilator of claim 1, wherein the first electrode is positioned between the first end of the dilating tip and the second end of the dilating tip.

### Claim 3 (depends on 1)

The medical dilator of claim 1, wherein the first electrode is positioned proximal of the first end of the dilating tip.

### Claim 4 (depends on 1)

The medical dilator of claim 1, wherein the first electrode has an electrode outer surface, and the electrode outer surface is flush with a tip circumferential outer surface of the dilating tip.

### Claim 5 (depends on 1)

The medical dilator of claim 1, wherein the dilating tip has a tip circumferential outer surface, a tip circumferential inner surface, and a tip sidewall extending between the tip circumferential inner surface and the tip circumferential outer surface, and the electrical conductor extends from the first electrode through the tip sidewall and into the lumen.

### Claim 6 (depends on 1)

The medical dilator of claim 1, wherein the elongate member has a circumferential outer surface, a circumferential inner surface, and a sidewall extending along the length of the elongate member between the circumferential inner surface and the circumferential outer surface, and the electrical conductor is embedded in the sidewall and extends from the first electrode to the proximal end portion.

### Claim 7 (depends on 6)

The medical dilator of claim 6, wherein the circumferential outer surface has a longitudinal groove defined therein and extending from the first electrode to the proximal end portion, and wherein the electrical conductor is seated in the longitudinal groove.

### Claim 8 (depends on 6)

The medical dilator of claim 6, wherein the elongate member comprises an outer tube defining the circumferential outer surface, and an inner liner within the outer tube and defining the circumferential inner surface, and wherein the electrical conductor is a tubular braid and is positioned between the outer tube and the inner liner.

### Claim 9 (depends on 1)

The medical dilator of claim 1, wherein the first electrode is radiopaque or has an echogenic profile.

### Claim 10

A medical dilation system, comprising:
a medical dilator comprising an elongate member having a proximal end portion, an opposed distal end portion, and a lumen extending through the elongate member from the proximal end portion to the distal end portion; a dilating tip at the distal end portion, the dilating tip having a first end of enlarged cross-sectional area and tapering going in the distal direction to a second end of reduced cross-sectional area, the dilating tip comprising a proximal piece having a distal-facing shoulder surface and a neck extending distally from the shoulder surface; at least a first electrode associated with the dilating tip; and an electrical conductor electrically connected to the first electrode and extending proximally from the first electrode to the proximal end portion; and
an electroanatomical mapping system electrically connectable to the electrical conductor and configured to receive an electroanatomical mapping signal from the electrode and determine a location of the dilating tip based on the electroanatomical mapping signal;
wherein the first electrode is annular and is received on the neck and abuts the shoulder surface; and
wherein the dilating tip further comprises a distal piece received on the neck distally of and abutting the first electrode.

### Claim 11 (depends on 10)

The medical dilation system of claim 10, wherein the electroanatomical mapping system is a dielectric open source system.
