# US 10,117,710 B2 · Endometrial lining tissue treatment device

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- Number: US 10,117,710 B2
- Document ID: US10117710B2
- Status: Granted
- Kind: B2
- Application number: 14/876,515
- Filed: 2015-10-06
- Published: 2016-04-07
- Granted: 2018-11-06
- Earliest claimed: 2014-10-07
- Assignees: Hologic, Inc.
- Applicants: Hologic, Inc.
- Inventors: William Lucas Churchill; Catherine Withers; Matthew LaPlaca; Victor M. Solano Umaña
- Web page: https://patentgrep.com/patent/US10117710B2

## CPC

- A61B 18/1485: {having a short rigid shaft for accessing the inner body through natural openings}
- A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- A61B 2017/4225: {Cervix uteri}
- A61B 2018/0022: {Balloons}
- A61B 2018/00559: {Female reproductive organs}
- A61B 2018/1475: {Electrodes retractable in or deployable from a housing}
- A61B 2218/007: Aspiration
- 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

An endometrial tissue treatment device includes an elongate positioning member and an energy applicator coupled to a distal end of the positioning member, the energy applicator including a tissue contacting member and an expandable-collapsible support structure underlying the tissue contacting member, the expandable-collapsible support structure comprising a substantially non-compliant elongate balloon disposed within the tissue contacting member that, when inflated, has a length oriented substantially transverse to the positioning member, including a first closed end that positions a corresponding first corner portion of the tissue contacting member in a first cornu of a uterine cavity, and a second closed end that positions a corresponding second corner portion of the tissue contacting member in a second cornu of a uterine cavity, with a lengthwise portion of the balloon positioning a distal facing portion of the tissue contacting member for contacting a fundal wall of a uterus.

## Claims

### Claim 1

An endometrial tissue treatment device, comprising:
an elongate positioning member; and
an energy applicator coupled to a distal end of the positioning member,
the energy applicator comprising a tissue contacting member and an expandable-collapsible support structure underlying the tissue contacting member,
the expandable-collapsible support structure comprising a substantially non-compliant elongate balloon disposed within a distal portion of the tissue contacting member that, when inflated within a uterus, has a lengthwise dimension oriented substantially transverse to the positioning member that spans a fundal wall of the uterus extending between a first corner portion of the tissue contacting member positioned in a first cornu of the uterus and a second corner portion of the tissue contacting member positioned in a second cornu of the uterus, such that the tissue contacting member is disposed between a distal facing surface of the inflated balloon and the fundal wall of the uterus, the inflated balloon having a widthwise dimension transverse to the lengthwise dimension, wherein the widthwise dimension of the inflated balloon is less than half the lengthwise dimension.

### Claim 2 (depends on 1)

The endometrial tissue treatment device of claim 1, further comprising an elongate hollow delivery sheath having a distal portion configured for transcervical placement into the uterus, the delivery sheath having a lumen and an open distal end in communication with the delivery sheath lumen,
wherein the respective positioning member and energy applicator are slidably disposed in the delivery sheath lumen so that the energy applicator slidably moves between
a collapsed configuration in which the energy applicator is at least partially withdrawn through the open distal end of the delivery sheath and into the delivery sheath lumen, and
an extended configuration in which the energy applicator is extended out the open distal end of the delivery sheath and at least partially self-expanded to conform to the uterus.

### Claim 3 (depends on 2)

The endometrial tissue treatment device of claim 2, wherein the delivery sheath and positioning member are operatively coupled to an actuator that moves the positioning member relative to the delivery sheath to thereby move the energy applicator between the collapsed configuration and the extended configuration.

### Claim 4 (depends on 1)

The endometrial tissue treatment device of claim 1, further comprising at least one inflation member having an inflation lumen fluidly coupled to an interior of the balloon, with a proximal end of the respective inflation member configured for fluidly coupling the respective inflation lumen with a source of inflation media.

### Claim 5 (depends on 1)

The endometrial tissue treatment device of claim 1, further comprising an elongate tensioning member that is movable relative to the positioning member, the tensioning member having a distal end fixed to the balloon at an approximate lengthwise midpoint of the balloon.

### Claim 6 (depends on 5)

The endometrial tissue treatment device of claim 5, wherein the distal end of the tensioning member comprises, or is otherwise connected to, a ring member that at least partially circumferentially surrounds the balloon at the approximate lengthwise midpoint of the balloon.

### Claim 7 (depends on 1)

The endometrial tissue treatment device of claim 1, the support structure further comprising opposing first and second flexures disposed within the tissue contacting member, the flexures having a delivery configuration in which the flexures are in a side-by-side configuration aligned with the positioning member, and a deployed configuration in which a distal end of the first flexure is positioned in the first corner portion of the tissue contacting member, and a distal end of the second flexure is positioned in the second corner portion of the tissue contacting member, the first and second flexures having arcuate outer surfaces.

### Claim 8 (depends on 7)

The endometrial tissue treatment device of claim 7, wherein in the side-by-side delivery configuration, the arcuate outer surfaces of the first and second flexures together define a cylindrical outer surface.

### Claim 9 (depends on 7)

The endometrial tissue treatment device of claim 7, wherein in the side-by-side delivery configuration, the distal ends of the first and second flexures together define a tapered or rounded tip.

### Claim 10 (depends on 7)

The endometrial tissue treatment device of claim 7, the first and second flexures each comprising one or more embedded conductors, each conductor electrically connected to a respective portion of the tissue contacting member.

### Claim 11 (depends on 7)

The endometrial tissue treatment device of claim 7, wherein at least one of the first and second flexures comprises an embedded inflation lumen fluidly coupled to an interior of the balloon.

### Claim 12 (depends on 1)

The endometrial tissue treatment device of claim 1, wherein the tissue contacting member is moisture permeable.

### Claim 13 (depends on 1)

The endometrial tissue treatment device of claim 1, further comprising an actuator including a grip-style handle that is actuated by squeezing together a pair of pivotably connected grip members.

### Claim 14 (depends on 1)

The endometrial tissue treatment device of claim 1, further comprising an aspiration lumen extending through the positioning member and having an open distal end located within the support structure.
