# US 12,178,490 B2 · Enhanced medical device for use in bodily cavities, for example an atrium

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- Number: US 12,178,490 B2
- Document ID: US12178490B2
- Status: Granted
- Kind: B2
- Application number: 17/182,732
- Filed: 2021-02-23
- Published: 2021-06-10
- Granted: 2024-12-31
- Earliest claimed: 2011-01-21
- Assignees: Kardium Inc.
- Applicants: Kardium Inc.
- Inventors: Fernando Lopes; Saar Moisa; Jorge Jaramillo; Douglas Goertzen; Peter Hawes; Ashkan Sardari; Aldo Antonio Salvestro
- Web page: https://patentgrep.com/patent/US12178490B2

## CPC

- A61B 18/00: Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body (eye surgery A61F9/007; ear surgery A61F11/00)
- A61B 5/065: {Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe}
- 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 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61M 25/0074: {Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable}
- A61B 5/026: Measuring blood flow {(A61B3/1233, A61B3/1241 take precedence)}
- A61B 5/0538: invasively, e.g. using a catheter
- A61B 5/06: Devices, other than using radiation, for detecting or locating foreign bodies {; Determining position of diagnostic devices within or on the body of the patient}
- A61B 5/6843: {Monitoring or controlling sensor contact pressure}
- A61B 2018/0016: {Energy applicators arranged in a two- or three dimensional array}
- A61B 2018/00267: {having a basket shaped structure}
- A61B 2018/00351: {Heart}
- A61B 2018/00357: {Endocardium}
- A61B 2018/00577: {Ablation}
- A61B 2018/00791: {Temperature}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/00863: {Fluid flow}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2090/065: {for measuring contact or contact pressure}
- A61M 25/0082: {Catheter tip comprising a tool}
- 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

Systems, methods, and devices allow intravascular or percutaneous mapping, orientation and/or ablation, in bodily cavities or lumens. A device includes elongate members, moveable between an unexpanded configuration and an expanded or fanned configuration. The elongate members form a stack in the unexpanded configuration to fit through a catheter sheath. The elongate members follow respective arcuate or curvilinear paths as advanced from the sheath into the bent or coiled stack configuration, adopting volute, scroll or rho shapes, and may be nested. The elongated members are fanned or radially spaced circumferentially with respect to one another into the expanded or fanned configuration. Transducer elements carried by elongate members sense various physiological characteristics of or proximate tissue, and/or may apply energy to or proximate tissue. The elongate members are rotatable in groups or as a group in the expanded configuration. The device is retractable.

## Claims

### Claim 1

A method of operating a medical device, the method comprising:
positioning at least a portion of the medical device within a heart, the medical device including a catheter shaft member and a plurality of elongate members, each elongate member of the plurality of elongate members including a first surface that includes or supports, directly or indirectly, one or more transducers, such that the at least the portion of the medical device collectively includes a plurality of transducers, the plurality of transducers configured to ablate tissue;
moving the at least the portion of the medical device between a delivery configuration, in which the plurality of elongate members are arranged and sized to be percutaneously deliverable to the heart, and an expanded configuration, in which the plurality of elongate members are expanded to be arranged and sized too large to be percutaneously deliverable to the heart;
positioning various transducers of the plurality of transducers proximate tissue within the heart with the at least the portion of the medical device in the expanded configuration;
causing first tissue ablation with at least some of the various transducers positioned proximate tissue within the heart with the at least the portion of the medical device in the expanded configuration;
changing, after causing the first tissue ablation, the expanded configuration of the at least the portion of the medical device; and
causing second tissue ablation with at least some transducers of the plurality of transducers with the at least the portion of the medical device in the changed expanded configuration.

### Claim 2 (depends on 1)

The method of claim 1, comprising reducing stored potential energy in each of at least one elongate member of the plurality of elongate members during a movement of the at least portion of the medical device from the expanded configuration to the changed expanded configuration.

### Claim 3 (depends on 1)

The method of claim 1, wherein the causing the first tissue ablation with at least some of the various transducers positioned proximate tissue within the heart with the at least the portion of the medical device in the expanded configuration creates a first ablated tissue region, and the causing the second tissue ablation with at least some transducers of the plurality of transducers with the at least the portion of the medical device in the changed expanded configuration creates a second ablated tissue region, the first ablated tissue region and the second ablated tissue region stitched together to form a continuous ablation lesion.

### Claim 4 (depends on 1)

The method of claim 1, wherein the causing the first tissue ablation with at least some of the various transducers positioned proximate tissue within the heart with the at least the portion of the medical device in the expanded configuration comprises a positioning a first set of the plurality of transducers proximate a first tissue region while the at least the portion of the medical device is in the expanded configuration, and the causing the second tissue ablation with at least some transducers of the plurality of transducers with the at least the portion of the medical device in the changed expanded configuration comprises positioning a second set of the plurality of transducers proximate a second tissue region while the at least the portion of the medical device is in the changed expanded configuration, and wherein the method comprises forming an ablation region extending continuously between the first tissue region and the second tissue region.

### Claim 5 (depends on 1)

The method of claim 1, wherein each elongate member of the plurality of elongate members comprises a respective proximal end, a respective distal end, and a respective intermediate portion located between the respective proximal end and the respective distal end, each intermediate portion comprising a thickness, a front surface, and a back surface opposite across the thickness from the front surface, and wherein at least the respective intermediate portions of at least three elongate members of the plurality of elongate members are arrayed along a first direction front surface-toward-back surface in a stacked array when the at least the portion of the medical device is in the delivery configuration.

### Claim 6 (depends on 1)

The method of claim 1, wherein each elongate member of the plurality of elongate members comprises a respective proximal end, a respective distal end, and a respective intermediate portion located between the respective proximal end and the respective distal end, and wherein the intermediate portions of the plurality of elongate members are angularly arranged about an axis when the at least the portion of the medical device is in the expanded configuration.

### Claim 7 (depends on 6)

The method of claim 6, wherein the intermediate portions of the plurality of elongate members are angularly arranged about a tubular member when the at least the portion of the medical device is in the expanded configuration.

### Claim 8 (depends on 6)

The method of claim 6, wherein the intermediate portions of the plurality of elongate members are angularly arranged about a tubular member when the at least the portion of the medical device is in the changed expanded configuration.

### Claim 9 (depends on 6)

The method of claim 6, wherein the intermediate portions of the plurality of elongate members are angularly arranged about the axis when the at least the portion of the medical device is in the changed expanded configuration.

### Claim 10 (depends on 9)

The method of claim 9, wherein the respective intermediate portion of each elongate member of at least some of the plurality of elongate members forms a ring-like profile in the expanded configuration.

### Claim 11 (depends on 9)

The method of claim 9, wherein, when the at least the portion of the medical device is in the expanded configuration, a first portion of the respective intermediate portion of each elongate member of at least some of the elongate members of the plurality of elongate members is diametrically opposite from a second portion of the respective intermediate portion of the elongate member of the at least some of the elongate members of the plurality of elongate members.

### Claim 12 (depends on 9)

The method of claim 9, wherein the plurality of elongate members comprises a first elongate member and a second elongate member, and wherein a particular angular orientation of the respective intermediate portion of the first elongate member relative to the second elongate member when the at least the portion of the medical device is in the expanded configuration is different from a particular angular orientation of the respective intermediate portion of the first elongate member relative to the second elongate member when the at least the portion of the medical device is in the changed expanded configuration.

### Claim 13 (depends on 9)

The method of claim 9, wherein the plurality of elongate members is physically coupled to a distal end portion of the catheter shaft member, and wherein a particular angular orientation of the respective intermediate portion of a first elongate member of the plurality of elongate members relative to the distal end portion of the catheter shaft member when the at least the portion of the medical device is in the expanded configuration is different from a particular angular orientation of the respective intermediate portion of the first elongate member of the plurality of elongate members relative to the distal end portion of the catheter shaft member when the at least the portion of the medical device is in the changed expanded configuration.

### Claim 14 (depends on 9)

The method of claim 9, wherein the respective intermediate portion of each elongate member of at least some of the plurality of elongate members has a ring-like profile when the at least the portion of the medical device is in the changed expanded configuration.

### Claim 15 (depends on 14)

The method of claim 14, wherein the plurality of elongate members is physically coupled to a distal end portion of the catheter shaft member, and wherein a particular angular orientation of the respective intermediate portion of a first elongate member of the plurality of elongate members relative to the distal end portion of the catheter shaft member when the at least the portion of the medical device is in the expanded configuration is different from a particular angular orientation of the respective intermediate portion of the first elongate member of the plurality of elongate members relative to the distal end portion of the catheter shaft member when the at least the portion of the medical device is in the changed expanded configuration.

### Claim 16 (depends on 9)

The method of claim 9, wherein, when the at least the portion of the medical device is in the changed expanded configuration, a first portion of the respective intermediate portion of each elongate member of at least some of the elongate members of the plurality of elongate members is diametrically opposite from a second portion of the respective intermediate portion of the elongate member of the at least some of the elongate members of the plurality of elongate members.

### Claim 17 (depends on 16)

The method of claim 16, wherein the plurality of elongate members is physically coupled to a distal end portion of the catheter shaft member, and wherein a particular angular orientation of the respective intermediate portion of a first elongate member of the plurality of elongate members relative to the distal end portion of the catheter shaft member when the at least the portion of the medical device is in the expanded configuration is different from a particular angular orientation of the respective intermediate portion of the first elongate member of the plurality of elongate members relative to the distal end portion of the catheter shaft member when the at least the portion of the medical device is in the changed expanded configuration.

### Claim 18 (depends on 9)

The method of claim 9, wherein rotation of at least some of the respective intermediate portions about the axis accompanies a movement of the at least the portion of the medical device from the expanded configuration to the changed expanded configuration.

### Claim 19 (depends on 18)

The method of claim 18, wherein each respective intermediate portion of the at least some of the respective intermediate portions rotates in a same first rotational direction about the axis during the movement of the at least the portion of the medical device from the expanded configuration to the changed expanded configuration.

### Claim 20 (depends on 18)

The method of claim 18, wherein each elongate member of the plurality of elongate members is configured to be delivered with the respective distal end of the elongate member ahead of the respective proximal end of the elongate member to the heart when the at least the portion of the medical device is in the delivery configuration, wherein each elongate member of the plurality of elongate members has a respective end-to-end dimension between the respective proximal end of the elongate member and the respective distal end of the elongate member, and wherein each of at least some of the elongate members of the plurality of elongate members has a smaller end-to-end dimension when the at least the portion of the medical device is in the expanded configuration than when the at least the portion of the medical device is in the delivery configuration.

### Claim 21 (depends on 20)

The method of claim 20, wherein each of at least some of the elongate members of the plurality of elongate members has a smaller end-to-end dimension when the at least the portion of the medical device is in the changed expanded configuration than when the at least the portion of the medical device is in the delivery configuration.