# US 11,896,295 B2 · High-density electrode-based medical device system

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- Number: US 11,896,295 B2
- Document ID: US11896295B2
- Status: Granted
- Kind: B2
- Application number: 16/655,775
- Filed: 2019-10-17
- Published: 2020-02-13
- Granted: 2024-02-13
- Earliest claimed: 2011-01-21
- Assignees: Kardium Inc.
- Applicants: Kardium Inc.
- Inventors: Fernando Luis de Souza Lopes; Saar Moisa; Peter Josiah Hawes
- Web page: https://patentgrep.com/patent/US11896295B2

## CPC

- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- 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 5/0538: invasively, e.g. using a catheter
- A61B 5/6885: {Monitoring or controlling sensor contact pressure}
- A61B 2018/0016: {Energy applicators arranged in a two- or three dimensional array}
- A61B 2018/00208: {actively driven, e.g. by a motor}
- A61B 2018/00267: {having a basket shaped structure}
- A61B 2018/00357: {Endocardium}
- A61B 2018/00577: {Ablation}
- A61B 2018/1407: {Loop}
- A61B 2018/1417: {Ball}
- A61B 2018/1467: {using more than two electrodes on a single probe}
- A61B 2018/1475: {Electrodes retractable in or deployable from a housing}
- A61B 2562/0271: Thermal or temperature sensors
- A61B 2562/04: Arrangements of multiple sensors of the same type
- A61B 2562/046: in a matrix array
- A61N 1/056: {Transvascular endocardial electrode systems}
- 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 is disclosed including a high-density arrangement of transducers, which may be configured to ablate, stimulate, or sense characteristics of tissue inside a bodily cavity, such as an intra-cardiac cavity. High-density arrangements of transducers may be achieved, at least in part, by overlapping elongate members on which the transducers are located, and varying sizes, shapes, or both of the transducers, especially in view of the overlapping of the elongate members. Also, the high-density arrangements of transducers may be achieved, at least in part, by including one or more recessed portions in an elongate member in order to expose one or more transducers on an underlying elongate member in a region adjacent an elongate-member-overlap region.

## Claims

### Claim 1

A medical device system comprising:
a structure comprising a plurality of elongate members; and
a plurality of electrodes positionable in a bodily cavity and supported by the plurality of elongate members of the structure, the plurality of elongate members including a first elongate member and a second elongate member,
wherein the structure is selectively moveable between:
a delivery configuration in which the structure is sized to be percutaneously deliverable to the bodily cavity, and
a deployed configuration in which the structure is sized too large to be percutaneously deliverable to the bodily cavity, and in which a first portion of the first elongate member is in an at least partially overlapping relationship with a first portion of the second elongate member,
wherein a first group of electrodes of the plurality of electrodes is arranged in a first ringed arrangement about an axis of the structure in a state in which the structure is in the deployed configuration,
wherein the first group of electrodes comprises a first electrode supported by the first portion of the first elongate member and comprises a second electrode supported by the first portion of the second elongate member, the first electrode including an exterior surface having a different size, shape, or both size and shape than a corresponding exterior surface of the second electrode, such that the first ringed arrangement in which the first group of electrodes is arranged comprises electrodes including exterior surfaces having different sizes, shapes, or both sizes and shapes,
wherein the different size, shape, or both size and shape of the exterior surface of the first electrode compared to the corresponding exterior surface of the second electrode is or are configured to accommodate the at least partially overlapping relationship between the first portion of the first elongate member and the first portion of the second elongate member, and
wherein each electrode of at least one electrode in the first group of electrodes is configured to selectively transmit energy from the exterior surface of the electrode, the energy sufficient to ablate tissue.

### Claim 2 (depends on 1)

The medical device system of claim 1,
wherein an elongate member of the plurality of elongate members includes a proximal end portion and a distal end portion,
wherein, in a state in which the structure is in the delivery configuration, the elongate member is configured to cause the distal end portion of the elongate member to be deliverable ahead of the proximal end portion of the elongate member to the bodily cavity,
wherein, in the state in which the structure is in the deployed configuration, the distal end portion of the elongate member is positioned at least proximate the proximal end portion of the elongate member, and
wherein, at least one electrode in the first group of electrodes is or are supported by the elongate member.

### Claim 3 (depends on 2)

The medical device system of claim 2, wherein at least two electrodes of the plurality of electrodes including exterior surfaces having different sizes, shapes, or both sizes and shapes are supported on the elongate member.

### Claim 4 (depends on 1)

The medical device system of claim 1,
wherein an elongate member of the plurality of elongate members includes a proximal end portion and a distal end portion,
wherein, in a state in which the structure is in the delivery configuration, the elongate member is configured to cause the distal end portion of the elongate member to be deliverable ahead of the proximal end portion of the elongate member to the bodily cavity,
wherein, in the state in which the structure is in the deployed configuration, the distal end portion of the elongate member is positioned at least proximate the proximal end portion of the elongate member, and
wherein at least two electrodes of the plurality of electrodes including exterior surfaces having different sizes, shapes, or both sizes and shapes are supported by the elongate member.

### Claim 5 (depends on 1)

The medical device system of claim 1,
wherein at least a portion of an elongate member of the plurality of elongate members comprises a coiled profile in the state in which the structure is in the deployed configuration, and
wherein at least one electrode in the first group of electrodes is or are supported by the at least the portion of the elongate member.

### Claim 6 (depends on 1)

The medical device system of claim 1,
wherein at least a portion of an elongate member of the plurality of elongate members comprises a coiled profile in the state in which the structure is in the deployed configuration, and
wherein at least two electrodes of the plurality of electrodes including exterior surfaces having different sizes, shapes, or both sizes and shapes are supported by the at least the portion of the elongate member.

### Claim 7 (depends on 1)

The medical device system of claim 1,
wherein at least a portion of an elongate member of the plurality of elongate members comprises a volute-shaped profile in the state in which the structure is in the deployed configuration, and
wherein at least one electrode in the first group of electrodes is or are supported by the at least the portion of the elongate member.

### Claim 8 (depends on 1)

The medical device system of claim 1, further comprising an elongated shaft member configured to percutaneously deliver the structure to the bodily cavity in a state in which the structure is in the delivery configuration, the elongated shaft member comprising a proximal end portion, a distal end portion, and an elongated portion extending between the proximal end portion of the elongated shaft member and the distal end portion of the elongated shaft member,
wherein an elongate member of the plurality of elongate members includes a proximal end portion, a distal end portion comprising a distal end, and an intermediate portion between the distal end portion of the elongate member and the proximal end portion of the elongate member, the intermediate portion located along a length of the elongate member,
wherein, in the state in which the structure is in the delivery configuration, the elongate member is configured to cause the distal end portion of the elongate member to be deliverable ahead of the proximal end portion of the elongate member to the bodily cavity,
wherein in the state in which the structure is in the deployed configuration, the elongate member comprises (a) a first portion positioned proximately to the distal end portion of the elongated shaft member, the first portion of the elongate member bending away from the distal end portion of the elongated shaft member, and (b) a loop-shaped second portion positioned along the length of the elongate member closer toward the distal end of the elongate member than the first portion of the elongate member, and
wherein at least one electrode in the first group of electrodes is or are supported by the loop-shaped second portion of the elongate member.

### Claim 9 (depends on 8)

The medical device system of claim 8, wherein the loop-shaped second portion of the elongate member comprises a region skewed with respect to the distal end portion of the elongated shaft member in the state in which the structure is in the deployed configuration.

### Claim 10 (depends on 8)

The medical device system of claim 8, wherein the loop-shaped second portion of the elongate member comprises a region transverse with respect to the distal end portion of the elongated shaft member.

### Claim 11 (depends on 8)

The medical device system of claim 8, wherein the axis of the structure is configured to avoid intersecting the distal end portion of the elongated shaft member at least in the state in which the structure is in the deployed configuration.

### Claim 12 (depends on 1)

The medical device system of claim 1, further comprising an elongated shaft member configured to percutaneously deliver the structure to the bodily cavity in a state in which the structure is in the delivery configuration, the elongated shaft member comprising a proximal end portion, a distal end portion, and an elongated portion extending between the proximal end portion of the elongated shaft member and the distal end portion of the elongated shaft member,
wherein an elongate member of the plurality of elongate members includes a proximal end portion, a distal end portion comprising a distal end, and an intermediate portion between the distal end portion of the elongate member and the proximal end portion of the elongate member, the intermediate portion located along a length of the elongate member,
wherein, in the state in which the structure is in the delivery configuration, the elongate member is configured to cause the distal end portion of the elongate member to be deliverable ahead of the proximal end portion of the elongate member to the bodily cavity,
wherein in the state in which the structure is in the deployed configuration, the elongate member comprises (a) a first portion positioned proximately to the distal end portion of the elongated shaft member, the first portion of the elongate member bending away from the distal end portion of the elongated shaft member, and (b) a loop-shaped second portion positioned along the length of the elongate member closer toward the distal end of the elongate member than the first portion of the elongate member, and
wherein at least two electrodes of the plurality of electrodes including exterior surfaces having different sizes, shapes, or both sizes and shapes are supported by the at least the loop-shaped second portion of the elongate member.

### Claim 13 (depends on 1)

The medical device system of claim 1, wherein a second group of electrodes of the plurality of electrodes is arranged in a second ringed arrangement about the axis of the structure in the state in which the structure is in the deployed configuration.

### Claim 14 (depends on 13)

The medical device system of claim 13, wherein the second group of electrodes of the plurality of electrodes comprises a third electrode, the third electrode including an exterior surface having a different size, shape, or both size and shape than each of (i) a corresponding exterior surface of the first electrode, and (ii) the corresponding exterior surface of the second electrode.

### Claim 15 (depends on 13)

The medical device system of claim 13, wherein the second group of electrodes of the plurality of electrodes comprises a third electrode and a fourth electrode, the third electrode including an exterior surface having a different size, shape, or both size and shape than a corresponding exterior surface of the fourth electrode, such that the second ringed arrangement in which the second group of electrodes is arranged comprises electrodes including exterior surfaces having different sizes, shapes, or both sizes and shapes.

### Claim 16 (depends on 15)

The medical device system of claim 15, wherein the exterior surfaces of the first electrode, the second electrode, and the third electrode have different sizes, shapes, or both sizes and shapes from one another.

### Claim 17 (depends on 15)

The medical device system of claim 15, wherein the exterior surfaces of the first electrode, the second electrode, the third electrode, and the fourth electrode have different sizes, shapes, or both sizes and shapes from one another.

### Claim 18 (depends on 13)

The medical device system of claim 13, wherein each electrode in the second group of electrodes includes a respective exterior surface, and wherein the respective exterior surfaces of all the electrodes in the second group have a same shape.

### Claim 19 (depends on 13)

The medical device system of claim 13, wherein the first ringed arrangement and the second ringed arrangement are concentrically arranged about the axis of the structure in the state in which the structure is in the deployed configuration.

### Claim 20 (depends on 1)

The medical device system of claim 1, wherein the structure forms part of a basket catheter.

### Claim 21 (depends on 1)

The medical device system of claim 1, wherein the structure forms part of a balloon catheter.

### Claim 22 (depends on 1)

The medical device system of claim 1, wherein the energy is radio-frequency (RF) energy.

### Claim 23 (depends on 1)

The medical device system of claim 1, wherein the plurality of electrodes includes a plurality of electrode sets, each electrode set of the plurality of electrode sets supported by a respective elongate member of the plurality of elongate members.

### Claim 24 (depends on 1)

The medical device system of claim 1, wherein each electrode in the first group of electrodes is configured to selectively transmit energy from the exterior surface of the electrode, the energy sufficient to ablate tissue.

### Claim 25

A catheter device system comprising:
an elongated catheter member including a proximal end portion, a distal end portion comprising a distal end, and an elongated portion between the distal end portion of the elongated catheter member and the proximal end portion of the elongated catheter member, the elongated portion located along a length of the elongated catheter member, the elongated catheter member selectively moveable between:
a delivery configuration in which at least the distal end portion of the elongated catheter member is sized to be percutaneously deliverable to a bodily cavity, the elongated catheter member configured to cause the distal end portion of the elongated catheter member to be deliverable ahead of the elongated portion of the elongated catheter member to the bodily cavity in a state in which the elongated catheter member is in the delivery configuration, and
a deployed configuration in which at least the distal end portion of the elongated catheter member is sized too large to be percutaneously deliverable to the bodily cavity; and
a plurality of electrodes positionable in the bodily cavity, each electrode of the plurality of electrodes comprising a respective external energy transmission surface,
wherein each electrode of at least one electrode of the plurality of electrodes is configured to selectively transmit energy from the external energy transmission surface of the electrode, the energy sufficient to ablate tissue,
wherein, in a state in which the elongated catheter member is in the deployed configuration, the distal end portion of the elongated catheter member comprises (a) a first portion bending away from the elongated portion of the elongated catheter member, and (b) a loop-shaped second portion positioned along the length of the elongated catheter member closer toward the distal end of the distal end portion of the elongated catheter member than the first portion of the distal end portion of the elongated catheter member, the plurality of electrodes located on the loop-shaped second portion of the distal end portion of the elongated catheter member,
wherein, in the state in which the elongated catheter member is in the deployed configuration, a first portion of the loop-shaped second portion of the distal end portion of the elongated catheter member is in an at least partially overlapping relationship with a second portion of the loop-shaped second portion of the distal end portion of the elongated catheter member,
wherein the plurality of electrodes comprises a first electrode and a second electrode, the external energy transmission surface of the first electrode having a different size, shape, or both size and shape than the corresponding external energy transmission surface of the second electrode, such that the plurality of electrodes include external energy transmission surfaces having different sizes, shapes, or both sizes and shapes, and
wherein the different size, shape, or both size and shape of the external energy transmission surface of the first electrode compared to the corresponding external energy transmission surface of the second electrode is or are configured to accommodate the at least partially overlapping relationship between the first portion of the loop-shaped second portion of the distal end portion of the elongated catheter member and the second portion of the loop-shaped second portion of the distal end portion of the elongated catheter member.

### Claim 26 (depends on 25)

The catheter device system of claim 25, wherein the loop-shaped second portion comprises a coiled profile in the state in which the elongated catheter member is in the deployed configuration.

### Claim 27 (depends on 25)

The catheter device system of claim 25, wherein the loop-shaped second portion comprises a volute-shaped profile in the state in which the elongated catheter member is in the deployed configuration.

### Claim 28 (depends on 25)

The catheter device system of claim 25, wherein the first portion comprises a region skewed with respect to the elongated portion in the state in which the elongated catheter member is in the deployed configuration.

### Claim 29 (depends on 25)

The catheter device system of claim 25, wherein the first portion comprises a region transverse with respect to the elongated portion in the state in which the elongated catheter member is in the deployed configuration.

### Claim 30 (depends on 25)

The catheter device system of claim 25, wherein the plurality of electrodes is arranged in a first ringed arrangement in the state in which the elongated catheter member is in the deployed configuration.

### Claim 31 (depends on 30)

The catheter device system of claim 30, wherein the plurality of electrodes is a first plurality of electrodes, and wherein the catheter device system comprises a second plurality of electrodes other than the first plurality of electrodes, the second plurality of electrodes arranged in a second ringed arrangement in the state in which the elongated catheter member is in the deployed configuration.

### Claim 32 (depends on 31)

The catheter device system of claim 31, wherein each electrode of the second plurality of electrodes comprises a respective external energy transmission surface, and wherein each electrode of the second plurality of electrodes is configured to selectively transmit energy from the external energy transmission surface of the electrode, the energy sufficient to ablate tissue.

### Claim 33 (depends on 31)

The catheter device system of claim 31, wherein each electrode of the second plurality of electrodes comprises a respective external energy transmission surface, the second plurality of electrodes comprising a third electrode, the external energy transmission surface of the third electrode having a different size, shape, or both size and shape than the corresponding external energy transmission surface of (a) the first electrode of the first plurality of electrodes, (b) the second electrode of the first plurality of electrodes, or each of (a) and (b).

### Claim 34 (depends on 31)

The catheter device system of claim 31, wherein each electrode of the second plurality of electrodes comprises a respective external energy transmission surface, the second plurality of electrodes comprising a third electrode and a fourth electrode, the external energy transmission surface of the third electrode having a different size, shape, or both size and shape than the corresponding external energy transmission surface of the fourth electrode, such that the second plurality of electrodes include external energy transmission surfaces having different sizes, shapes, or both sizes and shapes.

### Claim 35 (depends on 34)

The catheter device system of claim 34, wherein the external energy transmission surfaces of the first electrode, the second electrode, the third electrode, and the fourth electrode have different sizes, shapes, or both sizes and shapes from one another.

### Claim 36 (depends on 31)

The catheter device system of claim 31, wherein the second plurality of electrodes are located on the distal end portion.

### Claim 37 (depends on 25)

The catheter device system of claim 25, wherein the distal end portion forms part of a basket catheter.

### Claim 38 (depends on 25)

The catheter device system of claim 25, wherein the distal end portion forms part of a balloon catheter.

### Claim 39 (depends on 25)

The catheter device system of claim 25, wherein the energy is radio-frequency (RF) energy.

### Claim 40 (depends on 25)

The catheter device system of claim 25, wherein each electrode of the plurality of electrodes is configured to selectively transmit energy from the external energy transmission surface of the electrode, the energy sufficient to ablate tissue.
