# US 12,109,432 B2 · Fiducial marker for oncological and other procedures

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- Number: US 12,109,432 B2
- Document ID: US12109432B2
- Status: Granted
- Kind: B2
- Application number: 18/355,984
- Filed: 2023-07-20
- Published: 2023-11-16
- Granted: 2024-10-08
- Earliest claimed: 2019-02-14
- Assignees: Videra Surgical Inc.
- Applicants: Videra Surgical Inc.
- Inventors: Alex Vayser; Sunny Mitchell; Henry Jay Lee; Joseph Guido
- Web page: https://patentgrep.com/patent/US12109432B2

## CPC

- A61N 5/1007: {Arrangements or means for the introduction of sources into the body}
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61N 5/1049: {for verifying the position of the patient with respect to the radiation beam}
- G06T 7/0012: {Biomedical image inspection}
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2090/3908: {Soft tissue, e.g. breast tissue}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61B 2090/3991: {having specific anchoring means to fixate the marker to the tissue, e.g. hooks}
- A61N 2005/1008: {Apparatus for temporary insertion of sources, e.g. afterloaders}
- A61N 2005/1058: {using ultrasound imaging}
- A61N 2005/1062: {using virtual X-ray images, e.g. digitally reconstructed radiographs [DRR]}
- G06T 2207/10081: Computed x-ray tomography [CT]
- G06T 2207/30068: Mammography; Breast
- G06T 2207/30096: Tumor; Lesion
- G06T 2207/30204: Marker
- 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)
- G06T: IMAGE DATA PROCESSING OR GENERATION, IN GENERAL

## Abstract

A method and apparatus for marking a target with a radiopaque marker is disclosed. The method may include providing a radiopaque filament and inserting at least portion of the radiopaque filament into tissue. The filament may extend continuously and at last partially around a perimeter of the target so that the filament is disposed in a plurality of surgical planes to demarcate the target with the radiopaque maker.

## Claims

### Claim 1

A radiopaque marker device for marking a target tissue surrounding a surgical cavity formed during a surgical procedure, comprising:
a spring element disposed in a closed loop having a perimeter, the spring element comprising a first elongate flexible radiopaque filament disposed in a closed loop, wherein the spring element is observable under radiographic imaging,
wherein the spring element is configured to expand from a collapsed configuration to an expanded configuration,
wherein the radiopaque marker device is configured to be implanted into the surgical cavity during the surgical procedure,
wherein the perimeter of the closed loop is radiopaque and configured to engage the target tissue surrounding the cavity, and
wherein the radiopaque marker device is configured to move with the target tissue during movement thereof.

### Claim 2 (depends on 1)

The radiopaque marker device of claim 1, wherein the spring element in the expanded configuration is adapted to fill a void or the surgical cavity.

### Claim 3 (depends on 2)

The radiopaque marker device of claim 2, wherein the first elongate flexible radiopaque filament is configured to move with tissue as the tissue is moved to close the void or the surgical cavity.

### Claim 4 (depends on 2)

The radiopaque marker device of claim 2, wherein the first elongate flexible radiopaque filament is configured to continuously follow a contour of a wall of the void or the cavity.

### Claim 5 (depends on 1)

The radiopaque marker device of claim 1, wherein the first elongate flexible radiopaque filament comprises a coating.

### Claim 6 (depends on 5)

The radiopaque marker device of claim 5, wherein the coating comprises a hydrogel or wherein the coating increases friction on the first elongate filament and limits movement of the first elongate filament in tissue.

### Claim 7 (depends on 1)

The radiopaque marker device of claim 1, further comprising a hydrogel coupled to the first elongate flexible radiopaque filament.

### Claim 8 (depends on 1)

The radiopaque marker device of claim 1, further comprising an anchor, wherein the anchor is configured to be coupled to the first elongate radiopaque filament.

### Claim 9 (depends on 8)

The radiopaque marker device of claim 8, wherein the anchor comprises a clip and wherein the clip is absorbable, or wherein the clip is echogenic and visible under ultrasound.

### Claim 10 (depends on 8)

The radiopaque marker device of claim 8, wherein the anchor is configured to attach the first elongate radiopaque filament to tissue, the tissue disposed in one or more surgical planes.

### Claim 11 (depends on 1)

The radiopaque marker device of claim 1, wherein the first elongate radiopaque filament is configured to be threaded or clipped to tissue.

### Claim 12 (depends on 1)

The radiopaque marker device of claim 1, wherein the first elongate radiopaque filament is bioresorbable or non-absorbable.

### Claim 13 (depends on 1)

The radiopaque marker device of claim 1, wherein the first elongate radiopaque filament comprises a metal.

### Claim 14 (depends on 1)

The radiopaque marker device of claim 1, wherein the spring element further comprises a second elongate radiopaque filament.

### Claim 15 (depends on 14)

The radiopaque marker device of claim 14, wherein the first elongate radiopaque filament has a first radiopaque pattern and the second elongate radiopaque filament has a second radiopaque pattern different than the first radiopaque pattern, such that the first and second radiopaque patterns are distinguishable from one another under radiography.

### Claim 16 (depends on 1)

The radiopaque marker device of claim 1, wherein the first elongate radiopaque filament has two ends knotted together to form the closed loop.

### Claim 17 (depends on 1)

The radiopaque marker device of claim 1, wherein the spring element is free of material disposed inside the perimeter of the closed loop.

### Claim 18

A method for marking a target tissue surrounding a surgical cavity, the method comprising:
providing a spring element in a collapsed configuration, wherein the spring element is disposed in a closed loop having a perimeter and comprises a first elongate flexible radiopaque filament disposed in a closed loop;
performing a surgical procedure to form the surgical cavity:
disposing the spring element adjacent the target tissue during the surgical procedure; and
self-expanding the spring element from the collapsed configuration to an expanded configuration, wherein the perimeter of the closed loop is radiopaque and in the expanded configuration the perimeter of the spring element abuts the target tissue surrounding the cavity, and
wherein the spring element is configured to move with the target tissue during movement thereof.

### Claim 19 (depends on 18)

The method of claim 18, further comprising observing the spring element under radiographic imaging.

### Claim 20 (depends on 18)

The method of claim 18, wherein the target tissue defines a void or the surgical cavity, and wherein the spring element is disposed in the void or the surgical cavity to fill demarcate a boundary of the void or the surgical cavity.

### Claim 21 (depends on 20)

The method of claim 20, further comprising closing the void or the surgical cavity thereby causing the first elongate flexible radiopaque filament to move with tissue surrounding the void or the cavity.

### Claim 22 (depends on 20)

The method of claim 20, wherein disposing the spring element adjacent the target tissue comprises disposing the first elongate flexible radiopaque filament to continuously follow a contour of a wall of the void or the surgical cavity.

### Claim 23 (depends on 18)

The method of claim 18, further comprising contacting a hydrogel disposed on the first elongate flexible radiopaque filament with the target tissue.

### Claim 24 (depends on 18)

The method of claim 18, further comprising limiting movement of the first elongate filament in tissue with an anchor, a hydrogel or a coating disposed on the first elongate radiopaque filament.

### Claim 25 (depends on 24)

The method of claim 24, wherein the anchor comprises an echogenic clip, the method further comprising observing the clip with ultrasound.

### Claim 26 (depends on 18)

The method of claim 18, further comprising causing biodegradation of the first elongate radiopaque filament.

### Claim 27 (depends on 18)

The method of claim 18, wherein disposing the spring element adjacent the target tissue comprises threading the first elongate radiopaque filament into tissue, or clipping the first elongate radiopaque filament to tissue.

### Claim 28 (depends on 18)

The method of claim 18, wherein the spring element further comprises a second elongate radiopaque filament.

### Claim 29 (depends on 28)

The method of claim 28, wherein the first elongate radiopaque filament has a first radiopaque pattern and the second elongate radiopaque filament has a second radiopaque pattern different than the first radiopaque pattern, the method further comprising observing the first and second elongate radiopaque filaments under radiography and distinguishing the first and second elongate radiopaque filaments based on the first and second radiopaque patterns.

### Claim 30 (depends on 18)

The method of claim 18, wherein the first elongate flexible radiopaque filament has two ends knotted together to form the closed loop.

### Claim 31 (depends on 18)

The method of claim 18, wherein the spring element is free of material disposed inside the perimeter of the closed loop.