# US 11,896,265 B2 · Systems and methods for endometrial ablation

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- Number: US 11,896,265 B2
- Document ID: US11896265B2
- Status: Granted
- Kind: B2
- Application number: 16/783,987
- Filed: 2020-02-06
- Published: 2021-01-14
- Granted: 2024-02-13
- Earliest claimed: 2010-10-15
- Assignees: Minerva Surgical, Inc.
- Applicants: Minerva Surgical, Inc.
- Inventors: Csaba Truckai
- Web page: https://patentgrep.com/patent/US11896265B2

## CPC

- A61B 17/42: Gynaecological or obstetrical instruments or methods {(ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708)}
- A61B 18/042: {using additional gas becoming plasma}
- A61B 18/1206: {Generators therefor}
- A61B 18/14: Probes or electrodes therefor
- A61B 18/1485: {having a short rigid shaft for accessing the inner body through natural openings}
- A61B 2017/00017: {Electrical control of surgical instruments}
- A61B 2017/00132: {Setting operation time of a device (A61B2017/00123 takes precedence)}
- A61B 2017/00137: {Details of operation mode}
- A61B 2017/00199: {with a console, e.g. a control panel with a display}
- A61B 2017/4225: {Cervix uteri}
- A61B 2018/0022: {Balloons}
- A61B 2018/00232: {having an irregular shape}
- A61B 2018/00285: {Balloons}
- A61B 2018/00559: {Female reproductive organs}
- A61B 2018/00577: {Ablation}
- A61B 2018/0063: {Sealing}
- A61B 2018/00791: {Temperature}
- A61B 2018/00863: {Fluid flow}
- A61B 2018/122: {ionizing, with corona}
- A61B 2018/147: {Electrodes transferring energy by capacitive coupling, i.e. with a dielectricum between electrode and target tissue}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2218/007: Aspiration
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A system for treating uterine tissue having a seal assembly configured for positioning in a patient's cervical canal and uterine cavity; an expandable distal balloon portion; an expandable elongate medial balloon portion configured for movement between a first transversely expanded shape for engaging a cervical canal and a second transversely non-expanded shape for trans-cervical insertion; and a fluid source in communication with distal balloon portion and medial balloon portion for expansion of said balloon portions.

## Claims

### Claim 1

A system for transcervical introduction to a patient's uterus, said system comprising:
a radially expandable sleeve having a proximal end, a distal end, and a central passage therebetween, said sleeve being adapted to be introduced into a patient's cervix in a reduced width configuration and to be immobilized in the patient's cervix in an expanded width configuration;
wherein the sleeve includes a distal balloon and a ridge region extending proximal of the distal balloon, the ridge region including a plurality of ridges and valleys alternatingly disposed along a length thereof;
an inflation port in fluid communication with both an interior of the distal balloon and an interior of the ridge region; and
a probe shaft slidably received in the central passage of the sleeve, wherein the probe shaft may be advanced and retracted within the central passage while the sleeve remains immobilized in the patient's cervix.

### Claim 2 (depends on 1)

The system of claim 1, wherein the sleeve includes a proximal collar with a lock that selectively locks the sleeve to the probe shaft.

### Claim 3 (depends on 2)

The system of claim 2, wherein the lock includes a button on the proximal collar which can be pushed inwardly to engage and lock the probe shaft.

### Claim 4 (depends on 1)

The system of claim 1, wherein the distal balloon is configured to be inflated to engage an interior surface of a cervical os while the ridge region extends through a cervical canal, and wherein the distal balloon has a greater diameter than the ridge region.

### Claim 5 (depends on 4)

The system of claim 4, wherein the distal balloon has an annular shape in the expanded width configuration.

### Claim 6 (depends on 1)

The system of claim 1, wherein the plurality of ridges and valleys are configured to differentially expand when the sleeve is radially expanded to the expanded width configuration.

### Claim 7 (depends on 5)

The system of claim 5, wherein the plurality of valleys have a higher durometer than the plurality of ridges.

### Claim 8 (depends on 6)

The system of claim 6, wherein a pressurized fluid source is connected to the inflation port to selectively inflate the distal balloon and the ridge region.

### Claim 9 (depends on 8)

The system of claim 8, wherein the pressurized fluid source is configured to apply pressurized fluid to the sleeve to expand the plurality of ridges, but not the plurality of valleys, in accordance with the respective durometers.

### Claim 10 (depends on 1)

The system of claim 1, wherein the plurality of ridges and valleys are configured for folding and unfolding upon expansion.

### Claim 11

A system for transcervical introduction to a patient's uterus, said system comprising:
a radially expandable sleeve having a proximal end, a distal end, and a central passage therebetween, said sleeve being adapted to be introduced into a patient's cervix in a reduced width configuration and to be immobilized in the patient's cervix in an expanded width configuration;
wherein the sleeve includes a distal balloon and a plurality of ridges and valleys alternatingly disposed along a length of the sleeve proximal of the distal balloon;
a pressurized fluid source fluidly connected to an interior of the sleeve to inflate the plurality of ridges and the distal balloon; and
a probe shaft slidably received in the central passage of the sleeve, wherein the probe shaft may be advanced and retracted within the central passage while the sleeve remains immobilized in the patient's cervix.

### Claim 12 (depends on 11)

The system of claim 11, wherein the plurality of valleys have a higher durometer than the plurality of ridges.

### Claim 13 (depends on 11)

The system of claim 11, wherein the plurality of ridges and valleys are annular.

### Claim 14 (depends on 11)

The system of claim 11, wherein the plurality of ridges and valleys are helical.

### Claim 15 (depends on 11)

The system of claim 11, wherein the sleeve comprises a proximal collar with a lock that selectively locks the sleeve to the probe shaft.

### Claim 16 (depends on 11)

The system of claim 11, wherein the distal balloon is configured to engage an interior surface of a cervical os in the expanded width configuration.

### Claim 17 (depends on 16)

The system of claim 16, wherein the distal balloon has a radial extent larger than the plurality of ridges in the expanded width configuration.

### Claim 18

A system for transcervical introduction to a patient's uterus, said system comprising:
a radially expandable sleeve having a proximal end, a distal end, and a central passage therebetween, said sleeve being adapted to be introduced into a patient's cervix in a reduced width configuration and to be immobilized in the patient's cervix in an expanded width configuration;
wherein the sleeve includes a distal balloon and a ridge region extending proximal of the distal balloon, the ridge region including a plurality of ridges and valleys alternatingly disposed along a length of the sleeve;
a pressurized fluid source fluidly connected to an interior of the sleeve to inflate the ridge region and the distal balloon to transition the sleeve from the reduced width configuration to the expanded width configuration; and
a probe shaft slidably received in the central passage of the sleeve, wherein the probe shaft may be advanced and retracted within the central passage while the sleeve remains immobilized in the patient's cervix;
wherein a length of the ridge region decreases when the sleeve transitions from the reduced width configuration to the expanded width configuration.

### Claim 19 (depends on 18)

The system of claim 18, wherein the distal balloon has a radial extent larger than the ridge region in the expanded width configuration.

### Claim 20 (depends on 18)

The system of claim 18, wherein the plurality of valleys have a higher durometer and/or greater wall thickness than the plurality of ridges.
