IP Library Granted Patent US 10,500,014
Granted Patent B2
US 10,500,014 · App. 15/920,126 · Granted Dec 10, 2019

Surgical implant for marking soft tissue

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Quick Facts
Patent No.
US 10,500,014
App. No.
15/920,126
Granted
Dec 10, 2019
Kind
B2
Abstract

An implantable tissue marker device is provided to be placed in a soft tissue site through a surgical incision. The device can include a bioabsorbable body in the form of a spiral and defining a spheroid shape for the device, the spiral having a longitudinal axis, and turns of the spiral being spaced apart from each other in a direction along the longitudinal axis. A plurality of markers can be disposed on the body, the markers being visualizable by a radiographic imaging device. The turns of the spiral are sufficiently spared apart to form gaps that allow soft tissue to infiltrate between the turns and to allow flexibility in the device along the longitudinal axis in the manner of a spring.

Claims (13)

1. A method of delivering radiation therapy to a target tissue comprising:

placing a marker device into a cavity during an open surgical procedure, the cavity having a cavity border, and the marker device comprising a bioabsorbable spiral shaped body sufficiently rigid to support the cavity border, the spiral shaped body comprising a first end, a second end, an equatorial diameter ranging from about 2 cm to about 6 cm, and a plurality of radiopaque markers including at least three radio-opaque markers secured to the marker device in a spaced configuration, wherein the spaced configuration comprises at least one radiopaque marker of the plurality of radiopaque markers at the first end and the second end, and the remaining radiopaque markers of the plurality of radiopaque markers spaced about the equatorial diameter, the first end including a first extension and the second end including a second extension, the first extension extending towards the second extension and the second extension extending towards the first extension so that the first extension and the second extension extend toward a center of the body; and

delivering radiation to the target tissue.

2. The method of claim 1 , further comprising imaging the cavity border using CT, MRI, mammography, ultrasound, or a combination thereof.

3. The method of claim 1 , further comprising using a sizing tool to measure one or more dimensions of the cavity and selecting a marker device for placement into the cavity based upon the measured dimensions.

4. The method of claim 1 , wherein the cavity is a lumpectomy cavity.

5. The method of claim 1 , further comprising suturing the marker device to the cavity border.

6. The method of claim 1 , wherein the delivered radiation is used to treat breast cancer.

7. The method of claim 1 , wherein the spiral shaped body comprises one radiopaque marker disposed within the first extension at the first end and one radiopaque marker disposed within the second extension at the second end, and four radiopaque markers spaced about the equatorial diameter.

8. The method of claim 1 , wherein the spiral shaped body consists of a continuous filament heat-formed in the spiral shape.

9. The method of claim 1 , wherein the spiral shaped body has a length along a longitudinal axis between about 2 cm and about 8 cm.

10. The method of claim 1 , wherein the target tissue is breast tissue.

11. The method of claim 1 , wherein the delivered radiation is external beam radiation.

Assignments (7)
RELEASE OF SECURITY INTEREST RECORDED AT REEL/FRAME 054089/0804 Recorded Apr 28, 2026
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: HOLOGIC, INC., ON ITS OWN BEHALF AND AS SUCCESSOR-BY-MERGER TO FOCAL THERAPEUTICS, INC.; GEN-PROBE INCORPORATED; FAXITRON BIOPTICS, LLC; GEN-PROBE PRODESSE, INC.
Reel/Frame 075504/0575 →
SECURITY INTEREST Recorded Apr 8, 2026
From: BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.; CYTYC CORPORATION; SUROS SURGICAL SYSTEMS, INC.; GYNESONICS, INC.; BOLDER SURGICAL, LLC; FAXITRON BIOPTICS, LLC; HEALTH BEACONS, INC.; HOLOGIC, INC.
To: ROYAL BANK OF CANADA, AS COLLATERAL AGENT
Reel/Frame 075462/0440 →
MERGER AND CHANGE OF NAME Recorded Jul 13, 2021
From: FOCAL THERAPEUTICS, INC.; HOLOGIC, INC.
To: HOLOGIC, INC.
Reel/Frame 056835/0532 →
SECURITY INTEREST Recorded Oct 15, 2020
From: HOLOGIC, INC.; FAXITRON BIOPTICS, LLC; FOCAL THERAPEUTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 054089/0804 →
SECURITY INTEREST Recorded Oct 14, 2019
From: HOLOGIC, INC.; CYNOSURE, LLC; CYTYC CORPORATION; FAXITRON BIOPTICS, LLC; FOCAL THERAPEUTICS, INC.; GEN-PROBE INCORPORATED
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 050719/0701 →
SECURITY INTEREST Recorded Nov 26, 2018
From: FOCAL THERAPEUTICS, INC.
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 047582/0020 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 13, 2018
From: HERMANN, GEORGE D.; WILLIS, DAVID B.; DREWS, MICHAEL J.; LEBOVIC, GAIL S.; STUBBS, JAMES B.
To: FOCAL THERAPEUTICS, INC.
Reel/Frame 045582/0604 →