# US 12,611,247 B2 · Steerable sheath and catheter with circular deflection

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- Number: US 12,611,247 B2
- Document ID: US12611247B2
- Status: Granted
- Kind: B2
- Application number: 17/866,740
- Filed: 2022-07-18
- Published: 2023-02-09
- Granted: 2026-04-28
- Earliest claimed: 2021-08-06
- Assignees: Biosense Webster (Israel) Ltd.
- Applicants: Biosense Webster (Israel) Ltd.
- Inventors: Raymond Yue-Sing Tang; Matthew W. Hitzeroth; Daniele Ghidoli
- Web page: https://patentgrep.com/patent/US12611247B2

## CPC

- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61M 25/0029: {characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports (catheter shaft surface irregularities A61M2025/006)}
- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- A61B 2017/00327: {with actuating members moving in opposite directions}
- A61B 2018/00577: {Ablation}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/1435: {Spiral}
- A61M 2025/0161: {wherein the distal tips have two or more deflection regions}
- 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 catheter including: an elongated body sized to traverse vasculature; a lumen formed in the elongated body; and a pull-wire. The elongated body has a transition zone disposed between proximal and distal ends of the elongated body, a first shaft extending from the proximal end of the elongated body to the transition zone and defining a longitudinal axis, and a second shaft extending proximally from the distal end to the transition zone. The lumen defines a curved path curved about the longitudinal axis and extending from the distal end to the transition zone, and a straight path extending from the transition zone to the proximal end. The pull wire extends within the curved and straight paths, and is anchored to the second shaft such that translation of the pull-wire near the proximal end deflects the second shaft substantially along the curved path.

## Claims

### Claim 1

A catheter comprising:
an elongated body sized to traverse vasculature and comprising:
an outer surface, a proximal end and a distal end disposed on opposite sides thereof with a transition zone disposed therebetween,
a first shaft extending distally from the proximal end of the elongated body to the transition zone and defining a longitudinal axis,
a second shaft extending proximally from the distal end to the transition zone, the second shaft extending axially relative to the longitudinal axis in a delivery configuration, the second shaft bending relative to the longitudinal axis in a deployed configuration;
a first lumen formed in the elongated body and defining:
a first curved lumen path curved about the longitudinal axis and extending fully from the distal end to the transition zone, the first curved lumen path being curved in the delivery configuration, and
a first straight lumen path substantially parallel to the longitudinal axis and extending from the transition zone to the proximal end; and
a first pull-wire extending within the first curved and straight lumen paths, the first pull-wire being anchored to the second shaft such that translation of the first pull-wire near the proximal end deflects the second shaft substantially along the first curved lumen path.

### Claim 2 (depends on 1)

The catheter of claim 1, a proximal end of the first curved lumen path being connected to the transition zone offset approximately 90 degrees about the longitudinal axis from a distal end of the first curved lumen path connected to the distal end of the elongated body.

### Claim 3 (depends on 1)

The catheter of claim 1, a proximal end of the first curved lumen path being connected to the transition zone offset approximately 180 degrees about the longitudinal axis from a distal end of the first curved lumen path connected to the distal end of the elongated body.

### Claim 4 (depends on 1)

The catheter of claim 1, the elongated body comprising a substantially circular cross section comprising a diameter, a length of the second shaft being at least about two times the diameter.

### Claim 5 (depends on 1)

The catheter of claim 1 further comprising:
a second lumen formed in the elongated body, the second lumen defining a second straight lumen path substantially parallel to the longitudinal axis and extending from the distal end to the proximal end; and
a second pull-wire extending within the second lumen and anchored to the distal end such that translation of the second pull-wire near the proximal end deflects the second shaft substantially along the second straight lumen path.

### Claim 6 (depends on 1)

The catheter of claim 1 further comprising:
a second lumen formed in the elongated body, the second lumen defining a second straight lumen path substantially parallel to the longitudinal axis and extending from the proximal end to the transition zone; and
a second pull-wire extending within the second lumen and anchored to the transition zone such that translation of the second pull-wire near the proximal end deflects the transition zone substantially along the second straight lumen path.

### Claim 7 (depends on 6)

The catheter of claim 6, an anchor point of the second pull-wire being located proximally along the elongated body relative to a proximal end of the first curved lumen path.

### Claim 8 (depends on 7)

The catheter of claim 7, wherein simultaneous translation of the first pull-wire and the second pull-wire near the proximal end deflects the second shaft substantially along the first curved lumen path and deflects the transition zone substantially along the second straight lumen path.

### Claim 9 (depends on 1)

The catheter of claim 1 further comprising:
a second lumen formed in the elongated body and defining:
a second curved lumen path curved about the longitudinal axis and extending from the distal end to the transition zone, and
a second straight lumen path substantially parallel to the longitudinal axis and extending from the proximal end to the transition zone; and
a second pull-wire extending within the second lumen and anchored to the second shaft such that translation of the second pull-wire near the proximal end deflects the second shaft substantially along the second curved lumen path.

### Claim 10 (depends on 9)

The catheter of claim 9, the first curved lumen path having a clockwise rotational direction about the longitudinal axis as referenced from the distal end and the second curved lumen path has a counterclockwise rotational direction about the longitudinal axis as referenced from the distal end.

### Claim 11 (depends on 10)

The catheter of claim 10, the distal end of the first curved lumen path being offset from the distal end of the second curved lumen path.

### Claim 12 (depends on 1)

The catheter of claim 1, further comprising a control handle at the proximal end of the elongated body, a proximal end of the first pull-wire being attached to the control handle such that manipulating the control handle tightens the first pull-wire.

### Claim 13 (depends on 1)

The catheter of claim 1 further comprising a tip electrode disposed on the second shaft approximate to a distal tip of the second shaft.

### Claim 14 (depends on 1)

The catheter of claim 1 further comprising one or more sensing electrodes disposed on the second shaft.

### Claim 15 (depends on 1)

The catheter of claim 1 further comprising:
a second lumen formed in the elongated body, the second lumen defining a second lumen path;
a second pull-wire extending within the second lumen and anchored to the elongated body such that translation of the second pull-wire near the proximal end deflects the elongated body substantially along the second lumen path;
a third lumen formed in the elongated body, the third lumen defining a third lumen path; and
a third pull-wire extending within the third lumen and anchored to the elongated body such that translation of the third pull-wire near the proximal end deflects the elongated body substantially along the third lumen path.

### Claim 16 (depends on 15)

The catheter of claim 15, wherein
the second lumen path comprises:
a second curved lumen path curved about the longitudinal axis and extending from the distal end to the transition zone, and
a second straight lumen path substantially parallel to the longitudinal axis and extending from the proximal end to the transition zone; and
translation of the second pull-wire near the proximal end deflects the second shaft substantially along the second curved lumen path.

### Claim 17 (depends on 15)

The catheter of claim 15, wherein
the third lumen path is substantially parallel to the longitudinal axis and extends from the distal end to the proximal end; and
the third pull-wire is anchored to the distal end such that translation of the third pull-wire near the proximal end deflects the second shaft substantially along the third lumen path.

### Claim 18 (depends on 15)

The catheter of claim 15, wherein
the third lumen path is substantially parallel to the longitudinal axis and extends from the transition zone to the proximal end; and
the third pull-wire is anchored to the transition zone such that translation of the third pull-wire near the proximal end deflects the transition zone substantially along the third lumen path.

### Claim 19 (depends on 1)

The catheter of claim 1, wherein translation of the first pull-wire near the proximal end deflects the second shaft substantially along the first curved lumen path forming a generally circular shape, and further comprising:
a second lumen formed in the elongated body, the second lumen defining a second straight lumen path substantially parallel to the longitudinal axis and extending from the proximal end to the transition zone; and
a second pull-wire extending within the second lumen and anchored to the transition zone such that translation of the second pull-wire near the proximal end deflects the transition zone substantially along the second straight lumen path.

### Claim 20

A navigable sheath comprising:
an elongated body having a distal end, a proximal end, and a transition zone therebetween, the elongated body being sized to traverse vasculature and comprising:
a first shaft extending distally from the proximal end of the elongated body and defining a longitudinal axis, and
a second shaft extending proximally from the distal end of the elongated body, the second shaft being deflectable, the second shaft extending axially relative to the longitudinal axis in a delivery configuration, the second shaft bending relative to the longitudinal axis in a deployed configuration;
a first lumen formed in the elongated body and comprising a first curved lumen path curved about the longitudinal axis and extending fully proximally from the distal end to the transition zone, the first curved lumen path being curved in the delivery configuration; and
a first pull-wire extending through the first lumen and anchored to the second shaft such that translating the first pull-wire near the proximal end deflects the second shaft substantially along the first curved lumen path.