# US 11,298,173 B2 · Enhanced medical device for use in bodily cavities, for example an atrium

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- Number: US 11,298,173 B2
- Document ID: US11298173B2
- Status: Granted
- Kind: B2
- Application number: 16/521,712
- Filed: 2019-07-25
- Published: 2019-11-14
- Granted: 2022-04-12
- 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/US11298173B2

## 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 medical device system comprising:
a shaft member comprising a first end portion and a second end portion; and
a structure comprising a plurality of elongate members and a plurality of transducer elements, each elongate member of the plurality of elongate members comprising a proximal end portion, a distal end portion, and an intermediate portion between the proximal end portion and the distal end portion along a length of the elongate member, the proximal end portion of each elongate member of the plurality of elongate members fixedly coupled to the second end portion of the shaft member, the intermediate portion of each elongate member of the plurality of elongate members comprising a respective group of transducer elements of the plurality of transducer elements, and the structure selectively moveable between:
(a) a delivery configuration in which the structure is sized for delivery through a bodily opening leading to a bodily cavity, and
(b) each of a plurality of expanded configurations, wherein, in each of the plurality of expanded configurations, the structure has an enlarged size as compared to a corresponding size of the structure in a state in which the structure is in the delivery configuration,
wherein the medical device system is configured to circumferentially arrange at least the intermediate portion of each elongate member of the plurality of elongate members about a first axis at least in a state in which the structure is in a first particular expanded configuration of the plurality of expanded configurations, the intermediate portions of the elongate members configured to extend like lines of longitude about the first axis at least in the state in which the structure is in the first particular expanded configuration of the plurality of expanded configurations, and
wherein the medical device system is configured, during a movement between the delivery configuration and a second particular expanded configuration of the plurality of expanded configurations, to cause a region of the distal end portion of each elongate member of the plurality of elongate members to be positioned adjacent a region of the proximal end portion of the elongate member to cause the intermediate portion of the elongate member to form a loop, the loop formed by the intermediate portion of each elongate member of at least some elongate members of the plurality of elongate members residing in a respective first spatial plane that assumes a skewed orientation relative to the proximal end portion of the elongate member due at least in part to the region of the distal end portion of each elongate member of the plurality of elongate members being positioned adjacent the region of the proximal end portion of the elongate member.

### Claim 2 (depends on 1)

The medical device system of claim 1, wherein the medical device system is configured, during at least part of the movement between the delivery configuration and the second particular expanded configuration, to cause the regions of the distal end portions of the plurality of elongate members to move along parallel paths.

### Claim 3 (depends on 2)

The medical device system of claim 2, wherein each of the parallel paths comprises an arcuate path.

### Claim 4 (depends on 1)

The medical device system of claim 1, wherein, in a state in which the structure is in the second particular expanded configuration, at least the intermediate portions of the plurality of elongate members are angularly arranged about a second axis.

### Claim 5 (depends on 4)

The medical device system of claim 4, wherein the medical device system is configured, during the movement between the delivery configuration and the second particular expanded configuration, to cause the region of the distal end portion of at least a first elongate member of the plurality of elongate members to move along a path on a second spatial plane coincident with the first axis to cause the region of the distal end portion of the first elongate member to be positioned adjacent the region of the proximal end portion of the first elongate member.

### Claim 6 (depends on 1)

The medical device system of claim 1, wherein the medical device system is configured, during the movement between the delivery configuration and the second particular expanded configuration, to cause the region of the distal end portion of at least a first elongate member of the plurality of elongate members to move along a path on a second spatial plane coincident with a longitudinal axis of the shaft member to cause the region of the distal end portion of the first elongate member to be positioned adjacent the region of the proximal end portion of the first elongate member.

### Claim 7 (depends on 1)

The medical device system of claim 1, wherein, in a state in which the structure is in the second particular expanded configuration, each loop surrounds a volume of space exclusive of any part of the shaft member.

### Claim 8 (depends on 1)

The medical device system of claim 1, wherein each loop formed by the intermediate portion of each elongate member during the movement between the delivery configuration and the second particular expanded configuration is open in a space between the region of the distal end portion of the elongate member and the adjacent region of the proximal end portion of the elongate member.

### Claim 9 (depends on 1)

The medical device system of claim 1, wherein the loop formed by the intermediate portion of each elongate member of at least some elongate members of the plurality of elongate members residing in the respective first spatial plane that assumes the skewed orientation relative to the proximal end portion of the elongate member is due at least in part to a twisted portion in the elongate member.

### Claim 10 (depends on 9)

The medical device system of claim 9, wherein, for each elongate member of the at least some elongate members of the plurality of elongate members, the twisted portion is sufficient to rotationally offset the loop formed by the intermediate portion of the elongate member from the proximal end portion by a same angular amount for each of the at least some elongate members of the plurality of elongate members.

### Claim 11 (depends on 1)

The medical device system of claim 1, wherein a side-to-side distance between two particular adjacent elongate members of the plurality of elongate members is relatively greater during the state in which the structure is in the first particular expanded configuration than in a state in which the structure is in the second particular expanded configuration.

### Claim 12 (depends on 1)

The medical device system of claim 1, wherein the intermediate portion of a first elongate member of the plurality of elongate members crosses the intermediate portion of a second elongate member of the plurality of elongate members at least in a state in which the structure is in the second particular expanded configuration.

### Claim 13 (depends on 1)

The medical device system of claim 1, wherein the loop formed by the intermediate portion of a first elongate member of the at least some elongate members of the plurality of elongate members crosses the loop formed by the intermediate portion of a second elongate member of the at least some elongate members of the plurality of elongate members at least in a state in which the structure is in the second particular expanded configuration.

### Claim 14 (depends on 13)

The medical device system of claim 13, wherein the loop formed by the intermediate portion of the first elongate member of the at least some elongate members of the plurality of elongate members is crossed by the loop formed by the intermediate portion of a third elongate member of the at least some elongate members of the plurality of elongate members at least in the state in which the structure is in the second particular expanded configuration.

### Claim 15 (depends on 1)

The medical device system of claim 1, wherein at least the intermediate portions of at least three elongate members of the plurality of elongate members extend in a direction along a longitudinal axis of the shaft member in the state in which the structure is in the delivery configuration.

### Claim 16 (depends on 1)

The medical device system of claim 1, wherein each elongate member of the plurality of elongate members comprises a front surface and a back surface opposite across a thickness of the elongate member from the front surface of the elongate member, and wherein at least three elongate members of the plurality of elongate members are arranged front surface-toward-back surface in a stacked array in the state in which the structure is in the delivery configuration.

### Claim 17 (depends on 1)

The medical device system of claim 1, wherein the transducer elements in at least one group of the respective groups of transducer elements are individually activatable.

### Claim 18 (depends on 1)

The medical device system of claim 1, wherein at least one transducer element in at least one group of the respective groups of transducer elements is activatable to transmit energy sufficient to form a lesion in tissue.

### Claim 19 (depends on 1)

The medical device system of claim 1, wherein each loop formed by the intermediate portion of each elongate member of at least one elongate member of the plurality of elongate members comprises a substantially elliptical shape in at least one particular expanded configuration of the plurality of expanded configurations.