# US 11,305,092 B2 · Catheter devices and methods for making them

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- Number: US 11,305,092 B2
- Document ID: US11305092B2
- Status: Granted
- Kind: B2
- Application number: 16/011,398
- Filed: 2018-06-18
- Published: 2018-12-20
- Granted: 2022-04-19
- Earliest claimed: 2014-11-05
- Assignees: Clph, LLC
- Applicants: Clph, LLC
- Inventors: Stephen A. Leeflang; Christian S. Eversull
- Web page: https://patentgrep.com/patent/US11305092B2

## CPC

- A61M 25/0012: {with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils}
- A61M 25/005: {with embedded materials for reinforcement, e.g. wires, coils, braids}
- A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
- A61B 5/6852: {Catheters}
- A61B 2562/0215: Silver or silver chloride containing
- D04C 3/48: Auxiliary devices
- 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)
- D04C: BRAIDING OR MANUFACTURE OF LACE, INCLUDING BOBBIN-NET OR CARBONISED LACE; BRAIDING MACHINES; BRAID; LACE (machines for making soles from strips of material A43D29/00; cane working B27J1/00)

## Abstract

Tubular devices are provided that include a proximal end, a distal end sized for introduction into a patient's body, a central lumen, a conductor extending between the proximal and distal ends adjacent the central lumen, reinforcement members including windings extending helically around the central lumen, and an outer jacket. The tubular device includes a first portion in which the conductor extends helically around the central lumen, and a second portion in which the conductor extends longitudinally and either a) all of the windings surround the central lumen and the conductor remains outside the windings, b) at least some of the windings pass between the central lumen and the conductor and at least some of the windings surround both the central lumen and the conductor, and c) all of the windings surround both the central lumen and the conductor. Methods for making such tubular devices are also provided.

## Claims

### Claim 1

A tubular device for a catheter or sheath comprising a proximal end and a distal end sized for introduction into a patient's body, the tubular device comprising:
a central lumen extending between the proximal and distal ends, thereby defining a longitudinal axis;
an elongate conductor extending at least partially between the proximal and distal ends adjacent the central lumen;
one or more reinforcement members comprising windings extending helically around the central lumen between the proximal and distal ends; and
an outer jacket surrounding the one or more reinforcement members,
wherein the tubular device comprises a first portion in which the conductor and the reinforcement members extend helically around the central lumen, and a second portion in which the reinforcement members extend helically around the central lumen and the conductor extends substantially parallel to the longitudinal axis and either a) all of the windings surround the central lumen and the conductor remains outside the windings, b) at least some of the windings pass between the central lumen and the conductor and at least some of the windings surround both the central lumen and the conductor, and c) all of the windings surround both the central lumen and the conductor.

### Claim 2 (depends on 1)

The tubular device of claim 1, wherein the second portion is a distal portion adjacent the distal end, and the first portion is an intermediate portion between the proximal end and the distal portion.

### Claim 3 (depends on 2)

The tubular device of claim 2, further comprising one or more sensing elements carried on the distal portion and coupled to the conductor.

### Claim 4 (depends on 2)

The tubular device of claim 2, wherein the conductor comprises a plurality of wires, the tubular device further comprising a plurality of sensing elements carried on the distal portion and coupled to respective wires of the plurality of wires.

### Claim 5 (depends on 2)

The tubular device of claim 2, wherein the plurality of wires are braided around the central lumen in the same direction immediately adjacent one another along the first portion.

### Claim 6 (depends on 2)

The tubular device of claim 2, further comprising a steering element extending between the proximal and distal ends, the steering element extending along the distal portion within an auxiliary lumen, the auxiliary lumen extending substantially parallel to the longitudinal axis along the distal portion offset about ninety degrees around a circumference of the distal portion relative to the conductor.

### Claim 7 (depends on 1)

The tubular device of claim 1, wherein the conductor exits through the outer jacket at a location adjacent the second portion.

### Claim 8 (depends on 7)

The tubular device of claim 7, wherein the second portion comprises a proximal portion adjacent the proximal end, the tubular device further comprising a handle on the proximal end including a connector, wherein the conductor is coupled to the connector.

### Claim 9 (depends on 1)

The tubular device of claim 1, wherein the tubular device further comprises a third portion adjacent the second portion in which the conductor extends helically around the central lumen.

### Claim 10 (depends on 1)

The tubular device of claim 1, wherein the tubular device further comprises a third portion adjacent the first portion opposite the second portion in which the conductor extends substantially parallel to the longitudinal axis and either a) all of the windings surround the central lumen and the conductor remains outside the windings, b) at least some of the windings pass between the central lumen and the conductor and at least some of the windings surround both the central lumen and the conductor, and c) all of the windings surround both the central lumen and the conductor.

### Claim 11 (depends on 1)

The tubular device of claim 1, wherein the conductor comprises a plurality of wires that are braided around the central lumen in the same direction immediately adjacent one another along the first portion.

### Claim 12 (depends on 1)

The tubular device of claim 1, wherein the wires exit through the outer jacket adjacent the second portion.

### Claim 13 (depends on 12)

The tubular device of claim 12, wherein the wires exit through the outer jacket at different axial locations along the second portion.

### Claim 14 (depends on 1)

The tubular device of claim 1, wherein, along the second portion, all of the windings surround the central lumen and the conductor is disposed outside the windings.

### Claim 15 (depends on 1)

The tubular device of claim 1, wherein, along the second portion, at least some of the windings pass between the central lumen and the conductor and at least some of the windings surround both the central lumen and the conductor.

### Claim 16 (depends on 1)

The tubular device of claim 1, wherein, along the second portion, all of the windings surround both the central lumen and the conductor.

### Claim 17 (depends on 1)

The tubular device of claim 1, wherein, along the first portion, the conductor is braided with the reinforcement members.

### Claim 18 (depends on 17)

The tubular device of claim 17, wherein the conductor is braided with the reinforcement members such that the conductor extends helically around the central lumen in the same direction immediately adjacent one of the reinforcement members.

### Claim 19

A tubular device for a catheter or sheath comprising a proximal end and a distal end sized for introduction into a patient's body, the tubular device comprising:
a central lumen extending between the proximal and distal ends, thereby defining a longitudinal axis;
one or more reinforcement members comprising windings extending helically around the central lumen between the proximal and distal ends;
an outer jacket surrounding the one or more reinforcement members;
a conductor extending at least partially between the proximal and distal ends adjacent the central lumen; and
a steering element extending between the proximal and distal ends within an auxiliary lumen,
wherein the tubular device comprises a steerable distal portion adjacent the distal end in which the conductor and steering element extend substantially parallel to the longitudinal axis with the auxiliary lumen offset about ninety degrees around a circumference of the distal portion relative to the conductor, and
wherein the tubular device comprises an intermediate portion proximal to the distal portion in which the conductor extends helically around the central lumen and is braided with the reinforcement members.

### Claim 20 (depends on 19)

The tubular device of claim 19, wherein the one or more reinforcement members comprise windings extending helically along the distal portion.

### Claim 21

A tubular device for a catheter or sheath comprising a proximal end and a distal end sized for introduction into a patient's body, the tubular device comprising:
a central lumen extending between the proximal and distal ends, thereby defining a longitudinal axis;
one or more reinforcement members comprising windings extending helically around the central lumen between the proximal and distal ends;
an outer jacket surrounding the one or more reinforcement members; and
a plurality of conductors extending at least partially between the proximal and distal ends adjacent the central lumen;
wherein the tubular device comprises a distal portion adjacent the distal end in which the reinforcement members extend helically around the central lumen and the plurality of conductors extend substantially parallel to the longitudinal axis, the distal portion comprising a plurality of sensing elements spaced apart from one another along a length of the distal portion, each sensing element coupled to at least one of the conductors, and
wherein the tubular device comprises an intermediate portion proximal to the distal portion in which the conductors extend helically around the central lumen and are braided with the reinforcement members.
