# US 12,678,591 B2 · Catheters and methods for making them

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- Number: US 12,678,591 B2
- Document ID: US12678591B2
- Status: Granted
- Kind: B2
- Application number: 17/473,875
- Filed: 2021-09-13
- Published: 2022-03-10
- Granted: 2026-07-14
- Earliest claimed: 2013-03-16
- Assignees: Clph, LLC
- Applicants: Clph, LLC
- Inventors: Stephen A. Leeflang; Christian S. Eversull
- Web page: https://patentgrep.com/patent/US12678591B2

## CPC

- A61M 25/005: {with embedded materials for reinforcement, e.g. wires, coils, braids}
- A61B 5/24: Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B 5/6852: {Catheters}
- A61B 5/6855: {with a distal curved tip}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61M 25/0012: {with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils}
- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- A61M 39/08: Tubes; Storage means specially adapted therefor
- A61B 5/0538: invasively, e.g. using a catheter
- A61B 5/068: {using impedance sensors}
- A61B 5/367: Electrophysiological study [EPS], e.g. electrical activation mapping or electro-anatomical mapping
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 2018/00166: {Multiple lumina}
- A61B 2018/0022: {Balloons}
- A61B 2018/00345: {Vascular system}
- A61B 2018/00482: {Digestive system}
- A61B 2018/00505: {Urinary tract}
- A61B 2018/00541: {Lung or bronchi}
- A61B 2018/00577: {Ablation}
- A61B 2018/00821: {measured by a thermocouple}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2018/1467: {using more than two electrodes on a single probe}
- A61B 2018/1497: {Electrodes covering only part of the probe circumference}
- A61B 2218/001: having means for irrigation and/or aspiration of substances to and/or from the surgical site (A61B2018/00029 and A61B2018/1472 take precedence)
- A61B 2560/0468: Built-in electrodes
- A61M 25/0032: {characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts}
- A61M 2025/0047: {the inner layer having a higher lubricity}
- A61M 2025/0059: {having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking}
- A61M 2025/0062: {having features to improve the sliding of one part within another by using lubricants or surfaces with low friction}
- A61M 2207/10: Device therefor
- Y10T 29/49117: Conductor or circuit manufacturing
- Y10T 29/49826: Assembling or joining
- 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)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

Catheters, sheaths, or other tubular devices are provided that include a proximal end, a distal end sized for introduction into a patient's body, and a steerable distal portion carrying a plurality of electrodes. The tubular device includes a primary lumen extending between the proximal and distal ends; a steering element lumen adjacent the primary lumen; a plurality of wires extending proximally from the electrodes, and reinforcement members including windings extending helically along at least the distal portion, at least some of the windings passing between the primary and steering element lumens and wires, and at least some of the windings surrounding the primary lumen and one or both of the steering element lumen and the wires. In one embodiment, a steering element is slidably disposed within the auxiliary lumen. Apparatus and methods for making such tubular devices are also provided.

## Claims

### Claim 1

A tubular device for a catheter or sheath, the tubular device comprising:
a proximal end and a distal end sized for introduction into a patient's body;
a primary lumen extending between the proximal and distal ends;
one or more elongate conducting elements extending at least partially between the proximal and distal ends within an auxiliary lumen extending adjacent the primary lumen;
a plurality of reinforcement members braided together around the primary lumen such that the reinforcement members pass over and under one another according to a predetermined arrangement, the reinforcement members comprising windings extending helically around the primary lumen between the proximal and distal ends, at least some of the windings passing between the primary lumen and the auxiliary lumen and at least some of the windings surrounding both the primary lumen and the auxiliary lumen;
one or more layers of material providing an outer jacket surrounding the one or more reinforcement members; and
one or more sensing elements on a distal portion of the tubular device electrically coupled to the one or more conducting elements.

### Claim 2 (depends on 1)

The tubular device of claim 1, wherein the one or more conducting elements comprise a plurality of wires.

### Claim 3 (depends on 2)

The tubular device of claim 2, wherein the plurality of wires are electrically insulated.

### Claim 4 (depends on 2)

The tubular device of claim 2, wherein the one or more sensing elements comprise a plurality of electrodes spaced apart from one another on the distal portion, wherein a first electrode of the plurality of electrodes is coupled to a first wire of the plurality of wires, and wherein a second electrode of the plurality of electrodes is coupled to a second wire of the plurality of wires.

### Claim 5 (depends on 1)

The tubular device of claim 1, wherein the one or more conducting elements extend substantially parallel to a longitudinal axis of the tubular device at least partially between the proximal and distal ends.

### Claim 6 (depends on 1)

The tubular device of claim 1, wherein the one or more conducting elements extend along a curvilinear path at least partially between the proximal and distal ends.

### Claim 7 (depends on 6)

The tubular device of claim 6, wherein the curvilinear path is generally sinusoidal.

### Claim 8 (depends on 1)

The tubular device of claim 1, wherein the one or more conducting elements extend helically around the primary lumen at least partially between the proximal and distal ends.

### Claim 9 (depends on 1)

The tubular device of claim 1, wherein the one or more sensing elements comprise one or more electrodes mounted on the distal portion.

### Claim 10

A tubular device for a catheter or sheath, the tubular device comprising:
a proximal end and a distal end sized for introduction into a patient's body;
a primary lumen extending between the proximal end and the distal end;
an auxiliary lumen extending at least partially between the proximal end and the distal end adjacent the primary lumen;
a plurality of reinforcement members braided together around the primary lumen such that the reinforcement members pass over and under one another according to a predetermined arrangement, the reinforcement members comprising windings extending helically around the primary lumen between the proximal end and the distal end; and
one or more layers of material providing an outer jacket surrounding the plurality of reinforcement members,
wherein the tubular device comprises a first portion where at least some of the windings pass between the primary lumen and the auxiliary lumen and at least some of the windings surround both the primary lumen and the auxiliary lumen and a second portion where the auxiliary lumen exits the reinforcement members.

### Claim 11 (depends on 10)

The tubular device of claim 10, wherein the first portion comprises a steerable portion of the tubular device.

### Claim 12 (depends on 10)

The tubular device of claim 10, wherein the auxiliary lumen exits from the outer jacket at one end of the tubular device.

### Claim 13 (depends on 12)

The tubular device of claim 12, wherein the tubular device comprises a side port at the one end of the tubular device that communicates with the auxiliary lumen.

### Claim 14 (depends on 12)

The tubular device of claim 12, further comprising a handle mounted to the one end and an elongate member extending from the handle into the auxiliary lumen to the first portion.

### Claim 15 (depends on 14)

The tubular device of claim 14, wherein the elongate member comprises a first end coupled to an actuator on the handle and a second end fixed within the tubular device adjacent the first portion.

### Claim 16 (depends on 15)

The tubular device of claim 15, wherein the first portion comprises a distal portion of the tubular member adjacent the distal end, the tubular device further comprising a distal tip on the distal end, the second end fixed adjacent the distal tip such that distal portion is steerable when the actuator is actuated to pull on the elongate member.

### Claim 17 (depends on 10)

The tubular device of claim 10, wherein a first set of the windings of the reinforcement members pass between the primary lumen and the auxiliary lumen and a second set of the windings surround both the primary lumen and the auxiliary lumen.

### Claim 18 (depends on 17)

The tubular device of claim 17, wherein all of the windings in the first set extend in a first helical direction and all of the windings in the second set extend in a second helical direction.

### Claim 19 (depends on 10)

The tubular device of claim 10, wherein the auxiliary lumen extends substantially parallel to the primary lumen along the first portion.

### Claim 20 (depends on 10)

The tubular device of claim 10, wherein the auxiliary lumen extends helically around the primary lumen along the first portion.