# US 11,298,205 B2 · Devices for guiding tissue treatment and/or tissue removal procedures

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- Number: US 11,298,205 B2
- Document ID: US11298205B2
- Status: Granted
- Kind: B2
- Application number: 16/721,493
- Filed: 2019-12-19
- Published: 2020-05-07
- Granted: 2022-04-12
- Earliest claimed: 2018-05-15
- Assignees: CairnSurgical, Inc.
- Applicants: CairnSurgical, Inc.
- Inventors: Venkataramanan Krishnaswamy; Robert F. Rioux; David Danielsen; George Bourne
- Web page: https://patentgrep.com/patent/US11298205B2

## CPC

- A61B 90/17: for soft tissue, e.g. breast-holding devices
- A61B 10/0041: {Detection of breast cancer (mammography by transillumination A61B5/0091, by X-rays A61B6/502, by ultrasonic means A61B8/0825)}
- A61B 10/0233: {Pointed or sharp biopsy instruments}
- A61B 17/3403: {Needle locating or guiding means}
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 90/11: with guides for needles or instruments, e.g. arcuate slides or ball joints
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2017/00796: {Breast surgery}
- A61B 2017/3405: {using mechanical guide means}
- A61B 2017/3411: {with a plurality of holes, e.g. holes in matrix arrangement}
- A61B 2017/3413: {guided by ultrasound}
- A61B 2018/00023: {closed, i.e. without wound contact by the fluid}
- A61B 2018/00291: {using suction}
- A61B 2034/107: {Visualisation of planned trajectories or target regions}
- A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides}
- A61B 2090/3908: {Soft tissue, e.g. breast tissue}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

The present disclosure includes customized guidance devices in the form of guidance templates configured to fit over a given area of a patient's body and provide guidance during a tissue treatment or tissue removal procedure of that given area, which may include administration of an agent to a target tissue, target tissue biopsy, target tissue resection, or target tissue ablation. The customized guidance templates are generally constructed via an additive manufacturing process (i.e., three-dimensional (3D) printing) or subtractive manufacturing process (i.e., milling) based on a fabrication instruction file, which may include imaging data of the given area of the patient's body in which targeted tissue treatment is to be performed. The fabrication instruction file may further include additional data, such as the type of procedure to be performed (i.e., biopsy of the tissue abnormality, destruction or resection of the tissue abnormality, etc.).

## Claims

### Claim 1

A method of creating a fabrication instruction file for use in constructing a customized guidance template device wherein the customized guidance template device is for providing guidance during a targeted tissue treatment procedure or a targeted tissue removal procedure, the method comprising:
obtaining imaging data based on one or more diagnostic imaging procedures performed on at least one part of a body of a patient, the obtained imaging data representing at least the at least one part of the body of the patient and also representing a surface contour of the at least one part of the body of the patient;
adding the obtained imaging data to the fabrication instruction file; and
adding additional data to the fabrication instruction file, the additional data representing the targeted tissue treatment procedure or the targeted tissue removal procedure to be performed on the at least one part of the body of the patient;
wherein the customized guidance template device when constructed from the fabrication instruction file will include a cover portion, an access site integrally formed with the cover portion, and an imaging jig integrally formed with the cover portion, the cover portion configured to fit over the surface contour of the at least one part of the body of the patient, the access site configured to direct a working end of a first medical device, and the imaging jig configured to retain an imaging device.

### Claim 2 (depends on 1)

The method of claim 1 wherein the step of obtaining imaging data includes obtaining imaging data while the patient is in a supine position.

### Claim 3 (depends on 1)

The method of claim 1 wherein the step of obtaining imaging data includes obtaining imaging data based on magnetic resonance imaging (MRI).