# US 10,499,986 B2 · Medical device for use in bodily lumens, for example an atrium

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- Number: US 10,499,986 B2
- Document ID: US10499986B2
- Status: Granted
- Kind: B2
- Application number: 15/663,077
- Filed: 2017-07-28
- Published: 2017-11-23
- Granted: 2019-12-10
- Earliest claimed: 2007-11-16
- Assignees: Kardium Inc.
- Applicants: Kardium Inc.
- Inventors: Daniel Gelbart; Douglas Wayne Goertzen; Fernando Luis de Souza Lopes
- Web page: https://patentgrep.com/patent/US10499986B2

## CPC

- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes 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 5/065: {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 5/068: {using impedance sensors}
- A61B 5/4875: {Hydration status, fluid retention of the body}
- A61B 18/18: by applying electromagnetic radiation, e.g. microwaves
- A61B 18/20: using laser
- A61B 2018/00214: {Expandable means emitting energy, e.g. by elements carried thereon}
- A61B 2018/00351: {Heart}
- A61B 2018/00577: {Ablation}
- A61B 2018/00702: {Power or energy}
- A61B 2018/00791: {Temperature}
- A61B 2018/00863: {Fluid flow}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2018/025: {by circulating liquid}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/065: {for measuring contact or contact pressure}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A device positionable in a cavity of a bodily organ (e.g., a heart) may discriminate between fluid (e.g., blood) and non-fluid tissue (e.g., wall of heart) to provide information or a mapping indicative of a position and/or orientation of the device in the cavity. Discrimination may be based on flow, or some other characteristic, for example electrical permittivity or force. The device may selectively ablate portions of the non-fluid tissue based on the information or mapping. The device may detect characteristics (e.g., electrical potentials) indicative of whether ablation was successful. The device may include a plurality of transducers, intravascularly guided in an unexpanded configuration and positioned proximate the non-fluid tissue in an expanded configuration. Expansion mechanism may include helical member(s) or inflatable member(s).

## Claims

### Claim 1

A medical system, comprising:
a medical device including a frame positionable in at least a portion of a bodily organ, the frame including a plurality of transducers; and
electronic circuitry and a computing system coupled to the medical device and configured to:
apply a signal including a first frequency to a first transducer of the plurality of transducers;
measure a phase shift associated with the signal caused by contact between the first transducer and bodily material within the at least the portion of the bodily organ;
generate a map of at least some of a physical interior surface of a tissue wall of the bodily organ based at least on an analysis of the phase shift; and
cause at least one display device coupled to the computing system to display output representing at least part of the map.

### Claim 2 (depends on 1)

The medical system of claim 1, wherein:
the electronic circuitry and the computing system coupled to the medical device are configured to computationally discriminate between fluid and non-fluid tissue in the bodily organ based at least on the analysis of the phase shift; and
the generating of the map of the at least some of the physical interior surface of the tissue wall is based at least on the computationally discriminating between the fluid and the non-fluid tissue in the bodily organ.

### Claim 3 (depends on 2)

The medical system of claim 2, wherein the analysis of the phase shift includes determining a permittivity of the fluid or non-fluid tissue based at least on the phase shift.

### Claim 4 (depends on 1)

The medical system of claim 1, wherein the electrical circuitry includes a phase meter configured to measure the phase shift associated with the signal caused by the contact between the first transducer and the bodily material within the at least the portion of the bodily organ.

### Claim 5 (depends on 1)

The medical system of claim 1, wherein the electrical circuitry includes a selector configured to select the first frequency as opposed to a second frequency applicable to the first transducer of the plurality of transducers.

### Claim 6 (depends on 1)

The medical system of claim 1, wherein the electrical circuitry includes a resistor configured to receive and output the signal including the first frequency.

### Claim 7 (depends on 1)

The medical system of claim 1, wherein the bodily organ is a heart, and the bodily material within the at least the portion of the bodily organ is blood or tissue forming the physical interior surface of the tissue wall of the bodily organ.

### Claim 8 (depends on 1)

The medical system of claim 1, wherein:
the electronic circuitry and the computing system coupled to the medical device are configured to apply a respective signal including the first frequency to each transducer of the plurality of transducers, and, for each transducer of the plurality of transducers, measure a respective phase shift associated with the respective signal caused by contact between the transducer and bodily material within the at least the portion of the bodily organ; and
the generating of the map of the at least some of the physical interior surface of the tissue wall of the bodily organ is based at least on an analysis of the respective phase shifts.

### Claim 9 (depends on 8)

The medical system of claim 8, wherein:
the physical interior surface of the tissue wall of the bodily organ is interrupted by one or more ports in fluid communication with the bodily organ; and
the map indicates positions of the one or more ports.

### Claim 10 (depends on 1)

The medical system of claim 1, further comprising an ablation source, wherein each transducer of at least some of the plurality of transducers is coupled to the ablation source and is selectively operable to ablate a portion of non-fluid tissue in the bodily organ.

### Claim 11 (depends on 1)

The medical system of claim 1, further comprising an ablation source, wherein each transducer of at least the first transducer of the plurality of transducers is coupled to the ablation source and is selectively operable to ablate a portion of non-fluid tissue in the bodily organ.

### Claim 12 (depends on 10)

The medical system of claim 10, wherein the bodily organ is a heart, the non-fluid tissue is non-blood tissue forming a wall of the heart, and wherein each transducer of the plurality of transducers is responsive to electrical potential of the non-blood tissue.

### Claim 13 (depends on 10)

The medical system of claim 10, wherein each transducer of the plurality of transducers is responsive to electrical potential of the non-fluid tissue, and wherein the computing system is configured to produce an indication of whether the ablation was successful based on at least one sensed electrical potential of the non-fluid tissue.

### Claim 14 (depends on 10)

The medical system of claim 10, wherein each transducer of the plurality of transducers comprises a temperature sensor element.

### Claim 15 (depends on 1)

The medical system of claim 1, wherein each transducer of at least the first transducer of the plurality of transducers comprises a temperature sensor element.

### Claim 16 (depends on 1)

The medical system of claim 1, wherein each transducer of at least the first transducer of the plurality of transducers comprises a permittivity sensor element.

### Claim 17 (depends on 1)

The medical system of claim 1, wherein each transducer of at least the first transducer of the plurality of transducers comprises a flow sensor element.

### Claim 18 (depends on 1)

The medical system of claim 1, wherein the frame of the medical device is selectively moveable between an unexpanded configuration and an expanded configuration, the medical device sized to be delivered intravascularly in a case where at least the frame of the medical device is in the unexpanded configuration, and wherein each transducer of the plurality of transducers is configured to sense, in a case where at least the frame of the medical device is in the expanded configuration, at least one characteristic indicative of whether blood or non-blood tissue is present.

### Claim 19 (depends on 1)

The medical system of claim 1, wherein the medical system further comprises at least one communications path communicatively coupling the plurality of transducers and the computing system, the communications path including a multiplexer and a demultiplexer, the multiplexer located along the communications path at a first distance from the computing system, and the demultiplexer located along the communications path at a second distance from the computing system, the second distance greater than the first distance.

### Claim 20 (depends on 1)

The medical system of claim 1, further comprising a switch operable to selectively switch at least one transducer of the plurality of transducers between an ablation mode and a sense mode, wherein the at least one transducer of the plurality of transducers is configured to ablate non-blood tissue in the ablation mode and to sense, in the sense mode, at least one characteristic indicative of whether blood or non-blood tissue is present.

### Claim 21 (depends on 1)

The medical system of claim 1, wherein each transducer of at least some transducers of the plurality of transducers includes a temperature sensor element.

### Claim 22 (depends on 1)

The medical system of claim 1, wherein each transducer of at least some transducers of the plurality of transducers includes an ablation element.

### Claim 23 (depends on 1)

The medical system of claim 1, wherein each transducer of at least some transducers of the plurality of transducers includes a permittivity sensor element.

### Claim 24 (depends on 1)

The medical system of claim 1, wherein each transducer of at least some transducers of the plurality of transducers includes a flow sensor element.

### Claim 25

A method of operating a medical system, the method executed by electronic circuitry and a computing system of the medical system, the electronic circuitry and the computing system coupled to a medical device of the medical system, the medical device including a frame positionable in at least a portion of a bodily organ, the frame including a plurality of transducers, and the method comprising:
applying a signal including a first frequency to a first transducer of the plurality of transducers;
measuring a phase shift associated with the signal caused by contact between the first transducer and bodily material within the at least the portion of the bodily organ;
generating a map of at least some of a physical interior surface of a tissue wall of the bodily organ based at least on an analysis of the phase shift; and
causing at least one display device coupled to the computing system to display output representing at least part of the map.

### Claim 26 (depends on 25)

The method of claim 25, wherein the analysis of the phase shift includes determining a permittivity of fluid or non-fluid tissue based at least on the phase shift.

### Claim 27 (depends on 25)

The method of claim 25, wherein:
the physical interior surface of the tissue wall of the bodily organ is interrupted by one or more ports in fluid communication with the bodily organ; and
the map indicates positions of the one or more ports.

### Claim 28 (depends on 25)

The method of claim 25, wherein the bodily organ is a heart, and the bodily material within the at least the portion of the bodily organ is blood or tissue forming the physical interior surface of the tissue wall of the bodily organ.
