IP Library Granted Patent US 12,226,222
Granted Patent B2
US 12,226,222 · App. 18/464,441 · Granted Feb 18, 2025

Wireless active monitoring implant system

Inventor: Estefania Alvarez (West Newton, MA)
Assignee: Hologic, Inc.
A61B5/4312A61B5/0022A61B5/1468A61B5/4842A61B5/4848A61B5/6867A61B5/74G16H20/10G16H50/20A61B2560/0219
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Quick Facts
Patent No.
US 12,226,222
App. No.
18/464,441
Granted
Feb 18, 2025
Kind
B2
Abstract

Examples of the present disclosure describe systems and methods for the long-term, real-time active monitoring of a wireless implant. In aspects, a wireless biosensor may be implanted in a breast biopsy cavity. The biosensor may detect biochemical parameter data of the breast biopsy cavity and the human body. The biosensor may transmit the detected biochemical parameter data in real-time to a surveillance system wirelessly coupled to the biosensor. The surveillance system may then facilitate the evaluation of the biochemical parameter data. In examples, the evaluation may comprise detecting trends in a tumor's microenvironment, monitoring the progress of a treatment, or adjusting a treatment to tailor a personalized treatment.

Claims (47)

1. A method of detecting data related to a human body, the method comprising:

detecting data related to the human body at a biosensor disposed in a breast cavity in real-time, wherein the data comprises one or more biochemical parameters;

transmitting the data to an external monitoring device located outside of the breast;

receiving feedback from the external monitoring device, wherein the feedback relates to the transmitted data and anatomical measurements related to a portion of the breast adjacent the breast cavity, the anatomical measurements comprising at least one of diameter, length, phenotype, and lesion distribution;

based on the feedback, adjusting a set of biochemical parameters to be monitored; and

monitoring the adjusted set of biochemical parameters to modify a cancer treatment.

2. The method of claim 1 , wherein detecting the data comprises receiving an activation signal from the external monitoring device.

3. The method of claim 2 , wherein the activation signal is used to specify a set of biochemical parameters to monitor.

4. The method of claim 1 , wherein detecting the data comprises recording the biochemical parameters, timestamping the biochemical parameters, and organizing the timestamped biochemical parameters according to one or more criteria.

5. The method of claim 1 , wherein the breast cavity comprises a breast biopsy cavity.

6. The method of claim 1 , wherein the biosensor is not bioabsorbable.

7. The method of claim 1 , wherein the biosensor is visible under at least one imaging modality.

8. A method of detecting data related to a human body, the method comprising:

receiving data collected in real-time from a biosensor implanted in a breast cavity of the human body, wherein the data comprises one or more biochemical parameters and respective values;

transmitting the data to an external monitoring device located outside of the breast;

receiving one or more anatomical measurements of a portion of the breast adjacent the biopsy cavity, the anatomical measurements comprising at least one of diameter, length, phenotype, and lesion distribution;

evaluating the one or more anatomical measurements against detected changes to the one or more biochemical parameters; and

implementing one or more actions based on the evaluation as a closed feedback loop to enhance the efficacy of a treatment.

9. The method of claim 8 , wherein the monitoring system is wirelessly coupled to the biosensor.

10. The method of claim 8 , wherein the breast cavity comprises a breast biopsy cavity.

11. The method of claim 8 , further comprising:

applying the data to one or more statistical processing models, wherein the one or more statistical processing models are operable to:

compare the data to a set of baseline measurements acquired after implanting the biosensor; and

identify one or more trends in the human body.

12. The method of claim 11 , wherein identifying the one or more trends comprises determining an effectiveness of a treatment, wherein the effectiveness of the treatment corresponds to a modification of a neoplastic microenvironment.

13. The method of claim 12 , wherein identifying the one or more trends comprises determining a set of biochemical parameters to monitor, and transmitting the determined set of biochemical parameters to the biosensor for monitoring.

14. The method of claim 11 , wherein identifying the one or more trends comprises:

applying trend data to an assessment component, wherein the assessment component is operable to perform at least one function selected from the group consisting of:

determining one or more treatments to be applied to a neoplastic microenvironment;

modifying the treatment being applied to the neoplastic microenvironment;

providing at least one of: a notification and a warning; and

generating a report related to the treatment.

15. A method of detecting data related to a human body, the method comprising:

detecting data in real-time with a biosensor implanted in a breast cavity, wherein the data comprises one or more biochemical parameters related to the human body;

collecting the data from the implanted biosensor at a monitoring device discrete from the implanted biosensor;

receiving, at the monitoring device, a user input comprising at least one anatomical measurement of a portion of the breast adjacent the breast cavity, the anatomical measurements comprising at least one of diameter, length, phenotype, and lesion distribution;

evaluating the at least one anatomical measurement against the data; and

implementing at least one action based on the evaluation.

16. The method of claim 15 , wherein the implanted biosensor is externally powered.

17. The method of claim 15 , wherein the implanted biosensor begins detecting data in response to an activation signal from the monitoring device.

18. The method of claim 17 , wherein the activation signal comprises a set of biochemical parameters to be monitored by the implanted biosensor.

19. The method of claim 15 , further comprising:

receiving, at a data analysis device, the data;

processing, by the data analysis device, the data to obtain processed data;

using the processed data to determine one or more trends; and

evaluating the one or more trends to assess the breast biopsy cavity.

20. The method of claim 19 , wherein identifying the one or more trends comprises generating at least one of: a warning, a notification, a report, and an action item.

Assignments (4)
RELEASE OF SECURITY INTEREST RECORDED AT REEL/FRAME 065286/0407 Recorded Apr 24, 2026
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: HOLOGIC, INC.; GEN-PROBE INCORPORATED; FAXITRON BIOPTICS, LLC; BIOTHERANOSTICS, INC.; GEN-PROBE PRODESSE, INC.
Reel/Frame 075457/0767 →
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 →
SECURITY INTEREST Recorded Oct 19, 2023
From: HOLOGIC, INC.; FAXITRON BIOPTICS, LLC; BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 065286/0407 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 11, 2023
From: ALVAREZ, ESTEFANIA
To: HOLOGIC, INC.
Reel/Frame 064858/0158 →