# US 11,305,096 B2 · Catheter system

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- Number: US 11,305,096 B2
- Document ID: US11305096B2
- Status: Granted
- Kind: B2
- Application number: 15/498,951
- Filed: 2017-04-27
- Published: 2017-08-10
- Granted: 2022-04-19
- Earliest claimed: 2014-10-30
- Assignees: Kardium Inc.
- Applicants: Kardium Inc.
- Inventors: Calvin Dane Cummings; Peter Josiah Hawes
- Web page: https://patentgrep.com/patent/US11305096B2

## CPC

- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
- A61B 5/6858: {with a distal basket, e.g. expandable basket}
- A61B 5/6869: {Heart}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61M 25/0009: {Making of catheters or other medical or surgical tubes}
- A61N 1/056: {Transvascular endocardial electrode systems}
- A61N 1/362: Heart stimulators (heart defibrillators A61N1/39)
- A61B 2018/0016: {Energy applicators arranged in a two- or three dimensional array}
- A61B 2018/0022: {Balloons}
- A61B 2018/00267: {having a basket shaped structure}
- A61B 2018/00357: {Endocardium}
- A61B 2018/00577: {Ablation}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/00702: {Power or energy}
- A61B 2018/00791: {Temperature}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2018/00988: {Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter}
- A61B 2560/066: catheters therefor
- A61M 25/0136: {Handles therefor}
- A61M 2025/0163: {Looped catheters}
- 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)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

A medical device system may include a structure including a first elongate member, a line including a plurality of flexible members, and an actuator coupled to the line to selectively transmit force to at least the first elongate member. The structure may include a delivery configuration in which at least a portion of the structure is arranged to be percutaneously delivered to a bodily cavity. Respective portions of the flexible members may be intertwined together to form a braided portion of the line, and the line may include an unbraided portion secured at least to the first elongate member. The braided portion of the line may be located between the actuator and the first elongate member.

## Claims

### Claim 1

A medical device system comprising:
a structure comprising a plurality of elongate members including a first elongate member;
a line comprising a plurality of flexible members; and
an actuator coupled to the line to selectively transmit force to at least the first elongate member,
wherein the structure includes a delivery configuration in which at least a portion of the structure is arranged to be operably percutaneously delivered to a bodily cavity, the actuator configured to vary tension in the line as the structure is moved between the delivery configuration and a deployed configuration, wherein respective portions of the flexible members are intertwined together to form a braided portion of the line, the line comprising an unbraided portion at an end of the line, the unbraided portion of the line overlapping at least part of the first elongate member, the unbraided portion of the line secured to at least the first elongate member at least at a location of the overlapping, and the braided portion of the line located between the actuator and the first elongate member, and
wherein the structure is selectively moveable between:
the delivery configuration in which the elongate members are arranged to be percutaneously deliverable to the bodily cavity, and
the deployed configuration in which respective portions of the elongate members are further separated from each other as compared to the delivery configuration, and in which the structure is arranged to have a size too large to be percutaneously deliverable to the bodily cavity.

### Claim 2 (depends on 1)

The medical device system of claim 1 wherein the first elongate member comprises a first hole, and wherein a first part of the line is located in the first hole.

### Claim 3 (depends on 2)

The medical device system of claim 2 wherein the first part of the line located in the first hole is a part of the unbraided portion of the line.

### Claim 4 (depends on 2)

The medical device system of claim 2 wherein the first part of the line located in the first hole is a part of the braided portion of the line.

### Claim 5 (depends on 2)

The medical device system of claim 2 wherein the first elongate member comprises a second hole, and wherein a second part of the line is located in the second hole.

### Claim 6 (depends on 5)

The medical device system of claim 5 wherein the second part of the line located in the second hole is a part of the unbraided portion of the line.

### Claim 7 (depends on 5)

The medical device system of claim 5 wherein the second part of the line located in the second hole is a part of the braided portion of the line.

### Claim 8 (depends on 1)

The medical device system of claim 1 wherein the first elongate member comprises a first layer and a second layer, and wherein the unbraided portion is secured to the first elongate member between the first layer and the second layer.

### Claim 9 (depends on 8)

The medical device system of claim 8 wherein respective portions of the flexible members in the unbraided portion are arranged in a planar configuration between the first layer and the second layer.

### Claim 10 (depends on 8)

The medical device system of claim 8 wherein the unbraided portion of the line is secured between the first layer and the second layer and has a thickness between the first layer and the second layer in a range of 20 to 100 microns.

### Claim 11 (depends on 8)

The medical device system of claim 8 wherein the unbraided portion is secured to the first elongate member between the first layer and the second layer at least by adhesive.

### Claim 12 (depends on 8)

The medical device system of claim 8 wherein the second layer is provided by a flexible printed circuit board, and the first layer is provided by a metallic backing that backs the flexible printed circuit board.

### Claim 13 (depends on 8)

The medical device system of claim 8, comprising at least a first electrode, the first electrode located on the second layer opposite across a thickness of the second layer from at least part of the unbraided portion of the line secured between the first and the second layers.

### Claim 14 (depends on 8)

The medical device system of claim 8 wherein the first layer comprises an electrically conductive layer and the second layer comprises an electrically insulative layer.

### Claim 15 (depends on 14)

The medical device system of claim 14
wherein the electrically conductive layer comprises an electrically conductive surface positioned to be operably exposed to bodily fluid flow within the bodily cavity at least when the structure is positioned in the deployed configuration in the bodily cavity.

### Claim 16 (depends on 8)

The medical device system of claim 8 wherein the first elongate member comprises a first hole in the first layer, and wherein a first part of the line is located in the first hole.

### Claim 17 (depends on 16)

The medical device system of claim 16 wherein the first part of the line located in the first hole is a part of the unbraided portion of the line.

### Claim 18 (depends on 16)

The medical device system of claim 16 wherein the second layer does not include any hole in which any portion of the line is located.

### Claim 19 (depends on 16)

The medical device system of claim 16 wherein the second layer occludes the first hole when viewed in a first direction through the first hole from the first layer toward the second layer.

### Claim 20 (depends on 16)

The medical device system of claim 16, comprising at least a particular electrode located on the second layer opposite across a thickness of the second layer from the first hole in the first layer.

### Claim 21 (depends on 16)

The medical device system of claim 16 wherein the flexible members in the unbraided portion of the line are arranged in a fanned shape, the fanned shape tapering toward the first hole.

### Claim 22 (depends on 21)

The medical device system of claim 21 wherein the flexible members in the unbraided portion of the line are arranged to a same side of the first hole.

### Claim 23 (depends on 21)

The medical device system of claim 21 wherein all of the flexible members in the unbraided portion of the line are arranged over a first portion of a surface of the first layer, the first portion of the surface of the first layer opposite across the first hole from a second portion of the surface of the first layer.

### Claim 24 (depends on 21)

The medical device system of claim 21 wherein the flexible members in the unbraided portion of the line are not circumferentially arranged about the first hole.

### Claim 25 (depends on 8)

The medical device system of claim 8 wherein the structure comprises a second elongate member, and wherein the line couples the first elongate member to at least the second elongate member.

### Claim 26 (depends on 25)

The medical device system of claim 25 wherein the braided portion of the line extends through a lumen provided by the second elongate member.

### Claim 27 (depends on 1)

The medical device system of claim 1 wherein the first elongate member comprises a proximal end, a distal end, and an intermediate portion extending between the proximal end and the distal end, wherein the first elongate member is arranged to be deliverable distal-end-first when the structure is in the delivery configuration, and wherein the braided portion of the line extends along a first direction away from the intermediate portion, and the unbraided portion of the line extends along the intermediate portion along a second direction different than the first direction at least when the structure is in the deployed configuration.

### Claim 28 (depends on 27)

The medical device system of claim 27 wherein the intermediate portion extends along an arcuate path between the proximal end and the distal end when the structure is in the deployed configuration, and wherein the second direction is an arcuate direction along the arcuate path.

### Claim 29 (depends on 27)

The medical device system of claim 27 wherein the intermediate portion comprises a front surface and a back surface opposite across a thickness of the intermediate portion from the front surface, wherein the front surface is arranged to operably contact a tissue wall of the bodily cavity when the structure is positioned in the bodily cavity in the deployed configuration, and wherein the first direction extends away from the intermediate portion along an axis that passes through a portion of the back surface.

### Claim 30 (depends on 27)

The medical device system of claim 27 wherein the intermediate portion comprises a front surface and a back surface opposite across a thickness of the intermediate portion from the front surface, wherein the front surface is arranged to operably contact a tissue wall of the bodily cavity when the structure is positioned in the bodily cavity in the deployed configuration, and wherein the first direction extends away from the intermediate portion along an axis that tangentially intersects a portion of the back surface.

### Claim 31 (depends on 1)

The medical device system of claim 1 wherein the first elongate member comprises a first layer and a second layer, and wherein the unbraided portion is secured to the first elongate member between the first layer and the second layer, wherein the first elongate member comprises a first hole in the first layer, a first part of the line located in the first hole, and wherein the braided portion of the line extends along a first direction away from the first hole, and the unbraided portion of the line extends between the first layer and the second layer along a second direction different than the first direction at least when the structure is in the deployed configuration.

### Claim 32 (depends on 31)

The medical device system of claim 31 wherein the first direction extends away from the first hole along an axis that passes through both the first layer and the second layer.

### Claim 33 (depends on 31)

The medical device system of claim 31 wherein the first direction extends away from the first hole along an axis that tangentially intersects a surface of the first layer.

### Claim 34 (depends on 1)

The medical device system of claim 1 wherein the unbraided portion of the line is a de-braided portion of the line.

### Claim 35 (depends on 1)

The medical device system of claim 1 wherein the unbraided portion is secured to the first elongate member at least by adhesive.

### Claim 36

A method of manufacturing at least a portion of a medical device system, the medical device system comprising a structure including a plurality of elongate members that include at least a first elongate member positionable in a delivery configuration in which the first elongate member is percutaneously deliverable to a bodily cavity, and the medical device system comprising a line including a plurality of flexible members, respective portions thereof intertwined together to form a braided portion of the line, the structure selectively moveable between the delivery configuration in which the elongate members are arranged to be percutaneously deliverable to the bodily cavity, and a deployed configuration in which respective portions of the elongate members are further separated from each other as compared to the delivery configuration and in which the structure is arranged to have a size too large to be percutaneously deliverable to the bodily cavity, the method comprising:
de-braiding a portion of the braided portion of the line to provide a de-braided portion of the line, the de-braided portion of the line located at an end of the line; and
adhering the de-braided portion of the line to the first elongate member at least with an adhesive.

### Claim 37 (depends on 36)

The method of claim 36 wherein the first elongate member comprises a first layer and a second layer, and wherein the adhering the de-braided portion of the line to the first elongate member at least with the adhesive comprises adhering the de-braided portion at least with the adhesive to the first elongate member between the first layer and the second layer.

### Claim 38 (depends on 37)

The method of claim 37 wherein the second layer comprises an electrically insulative layer and the first layer comprises an electrically conductive layer.

### Claim 39 (depends on 37)

The method of claim 37, comprising winding each of the first layer and the second layer around a mandrel and adhering the de-braided portion at least by the adhesive to the first elongate member between the wound first layer and the wound second layer.

### Claim 40 (depends on 37)

The method of claim 37 comprising causing an electrode to be located as part of a portion of the second layer opposite across a thickness of the second layer from the de-braided portion of the line adhered between the first and the second layers.

### Claim 41 (depends on 37)

The method of claim 37 wherein the first elongate member comprises a first hole in the first layer, and the method comprises locating a first part of the line in the first hole and positioning the second layer relative to the first layer to occlude the first hole when viewed in a first direction through the first hole from the first layer toward the second layer.

### Claim 42 (depends on 41)

The method of claim 41 comprising causing an electrode to be located as part of a portion of the second layer opposite across a thickness of the second layer from the first hole in the first layer.

### Claim 43 (depends on 41)

The method of claim 41 comprising arranging the de-braided portion of the line in a fanned shape tapering toward the first hole.

### Claim 44 (depends on 43)

The method of claim 43 comprising arranging the de-braided portion of the line over one, but not both, of a first portion of a surface of the first layer and a second portion of the surface of the first layer, the first portion of the surface of the first layer positioned opposite across the first hole from the second portion of the surface of the first layer.

### Claim 45 (depends on 36)

The method of claim 36 wherein the method comprises coupling each of the first elongate member and a second elongate member of the plurality of elongate members together with at least part of the line.
