# US 12,589,261 B2 · Histotripsy systems and methods

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- Number: US 12,589,261 B2
- Document ID: US12589261B2
- Status: Granted
- Kind: B2
- Application number: 18/464,721
- Filed: 2023-09-11
- Published: 2024-01-04
- Granted: 2026-03-31
- Earliest claimed: 2018-11-28
- Assignees: HistoSonics, Inc.
- Applicants: HistoSonics, Inc.
- Inventors: Ryan M. Miller; Alexander P. Duryea; Jonathan M. Cannata; Joshua Stopek; Dejan Teofilovic; Zeljko Mladenovic; Aleksandra Rakic
- Web page: https://patentgrep.com/patent/US12589261B2

## CPC

- A61N 7/00: Ultrasound therapy (lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 {; using ultrasound for introducing media into the body A61M37/0092})
- A61B 34/30: Surgical robots
- A61B 8/085: {for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules}
- A61B 8/5261: {combining images from different diagnostic modalities, e.g. ultrasound and X-ray}
- A61B 2017/22008: {used or promoted}
- A61N 2007/0039: {using microbubbles}
- A61N 2007/0052: {using the same transducer for therapy and imaging}
- A61N 2007/0091: {with moving parts, e.g. transducers, lenses, reflectors}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A histotripsy therapy system configured for the treatment of tissue is provided, which may include any number of features. Provided herein are systems and methods that provide efficacious non-invasive and minimally invasive therapeutic, diagnostic and research procedures. In particular, provided herein are optimized systems and methods that provide targeted, efficacious histotripsy in a variety of different regions and under a variety of different conditions without causing undesired tissue damage to intervening/non-target tissues or structures.

## Claims

### Claim 1

A histotripsy treatment method, comprising the steps of:
receiving a digital treatment plan that includes a target tissue volume of a subject divided into a plurality of treatment volumes arranged within a plurality of radial layers;
controlling a robotic positioning system coupled to an ultrasound therapy transducer with a processor to implement the digital treatment plan by:
mechanically moving a focus of the ultrasound therapy transducer array with the robotic positioning to a first of the plurality of treatment volumes within a first radial layer of the plurality of radial layers;
forming a cavitation bubble cloud in the first of the plurality of treatment volumes with the ultrasound therapy transducer array;
mechanically moving the focus with the robotic positioning system in a spiraling fashion and forming a cavitation bubble cloud through the remaining plurality of treatment volumes in the first radial layer;
transitioning the focus from the first radial layer to a second radial layer of the plurality of radial layers with the robotic positioning system;
mechanically moving the focus with the robotic positioning system in a spiraling fashion and forming a cavitation bubble cloud through the remaining plurality of treatment volumes in the second radial layer; and
repeating the moving, forming, and transitioning steps for each of a remaining plurality of radial layers.

### Claim 2 (depends on 1)

The method of claim 1, wherein the target tissue volume is generally spherical.

### Claim 3 (depends on 1)

The method of claim 1, wherein the target tissue volume is contoured to a tumor.

### Claim 4 (depends on 1)

The method of claim 1, wherein the target tissue volume includes a margin.

### Claim 5 (depends on 1)

The method of claim 1, wherein the target tissue volume is an ellipsoid.

### Claim 6 (depends on 1)

The method of claim 1, further comprising electronically steering the focus within at least one of the plurality of treatment volumes with the ultrasound therapy transducer.

### Claim 7 (depends on 1)

The method of claim 1, wherein the plurality of treatment volumes are column-shaped.

### Claim 8 (depends on 1)

The method of claim 1, further comprising electronically steering the focus at each of the plurality of treatment volumes before moving the focus to subsequent treatment volumes.

### Claim 9 (depends on 8)

The method of claim 8, wherein electronically steering the cavitation bubble cloud further comprises electronically steering the cavitation bubble cloud in a z-direction through each of the plurality of treatment volumes.

### Claim 10 (depends on 1)

The method of claim 1, wherein the first radial layer is centrally located within the target tissue volume.

### Claim 11 (depends on 1)

The method of claim 1, wherein the the processor controls the robotic positioning system to progress through the plurality of radial layers from a central-most radial layer to an outer-most radial layer according to the digital treatment plan.

### Claim 12 (depends on 1)

The method of claim 1, wherein moving the focus in a spiraling fashion comprises moving the focus outward in a spiraling fashion.

### Claim 13 (depends on 1)

The method of claim 1, wherein transitioning from the first radial layer to the second radial layer comprises moving the focus to a closest untreated treatment volume of the plurality of treatment volumes of the second radial layer.

### Claim 14 (depends on 1)

The method of claim 1, wherein the plurality of treatment volumes cover at least 90% of the target tissue volume.

### Claim 15

An ultrasound therapy system, comprising;
a robotic positioning system;
an ultrasound therapy transducer array connected to the robotic positioning system;
a generator operatively coupled to the ultrasound therapy transducer array, the generator and ultrasound therapy transducer array being configured to deliver histotripsy pulses into a subject to generate a cavitation bubble cloud in the subject;
at least one processor operatively coupled to the robotic positioning system and the generator, the at least one processor being configured to control the robotic positioning system and the generator to provide histotripsy therapy to the subject according to a treatment plan that includes a target tissue volume divided into a plurality of treatment volumes arranged within a plurality of radial layers by:
controlling the robotic positioning system to move a focus of an ultrasound therapy transducer array to a first of the plurality of treatment volumes within a first radial layer of the plurality of radial layers;
controlling the generator to deliver histotripsy pulses with the ultrasound therapy transducer array to form a cavitation bubble cloud in the first of the plurality of treatment volumes with the ultrasound therapy transducer array;
controlling the robotic positioning system and the generator to move the focus in a spiraling fashion and form cavitation bubble clouds through the remaining plurality of treatment volumes in the first radial layer;
controlling the robotic positioning system to transition from the first radial layer to a second radial layer of the plurality of radial layers;
moving the focus in a spiraling fashion and forming a cavitation bubble cloud through the remaining plurality of treatment volumes in the second radial layer; and
repeating controlling the robotic positioning system and the generator to move the focus and deliver histotripsy pulses for each of a remaining plurality of radial layers.

### Claim 16 (depends on 15)

The ultrasound therapy system of claim 15, further comprising an imaging system configured to image the cavitation bubble cloud in real-time.

### Claim 17 (depends on 15)

The ultrasound therapy system of claim 15, wherein the ultrasound therapy system is configured to communicate with an imaging system selected from the group consisting of MRI, CT, cone beam CT (CBCT), PET-CT, and/or an ultrasound imaging system.

### Claim 18 (depends on 17)

The ultrasound therapy system of claim 17, wherein the treatment plan is based on pre-treatment images.

### Claim 19 (depends on 16)

The ultrasound therapy system of claim 16, wherein the imaging system comprises an ultrasound imaging probe configured within a bore of the ultrasound therapy transducer array.

### Claim 20 (depends on 15)

The ultrasound therapy system of claim 15, wherein the at least one processor receives the treatment plan.

### Claim 21 (depends on 15)

The ultrasound therapy system of claim 15, wherein the at least one processor is configured to generate the treatment plan.

### Claim 22 (depends on 15)

The ultrasound therapy system of claim 15, wherein the target tissue volume of the treatment plan has a shape selected from the group consisting of generally spherical, an ellipsoid, and an arbitrary shape.

### Claim 23 (depends on 15)

The ultrasound therapy system of claim 15, wherein the at least one processor is configured to control the robotic positioning system to progress through the plurality of radial layers from a distal-most radial layer to a proximal-most radial layer.

### Claim 24 (depends on 15)

The ultrasound therapy system of claim 15, wherein the plurality of treatment volumes are column-shaped.

### Claim 25 (depends on 15)

The ultrasound therapy system of claim 15, wherein moving the focus in a spiraling fashion comprises moving the focus outward in a spiraling fashion.

### Claim 26 (depends on 15)

The ultrasound therapy system of claim 15, wherein controlling the robotic positioning system to transition from the first radial layer to the second radial layer comprises moving the focus to a closest untreated treatment volume of the plurality of treatment volumes of the second radial layer.