IP Library Granted Patent US 12,161,505
Granted Patent B2
US 12,161,505 · App. 16/212,760 · Granted Dec 10, 2024

Patient interface system

Inventors: Carri K. Glide-Hurst (Novi, MI); Nebojsa Duric (Novi, MI); Peter J. Littrup (Novi, MI)
Assignee: Delphinus Medical Technologies, Inc.
A61B8/0825A61B8/085A61B8/0858A61B8/15A61B8/406A61B8/4494A61B8/5223A61B5/4312A61B8/4281
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Quick Facts
Patent No.
US 12,161,505
App. No.
16/212,760
Granted
Dec 10, 2024
Kind
B2
Abstract

A method for categorizing whole-breast density is disclosed. The method includes the steps of exposing breast tissue to an acoustic signal; measuring a distribution of an acoustic parameter by analyzing the acoustic signal; and obtaining a measure of whole-breast density from said measuring step. An apparatus is also disclosed.

Claims (24)

1. A system for determining present or future cancer risk from a volume of breast tissue, comprising:

(a) a non-ionizing apparatus comprising a transducer configured to transmit an acoustic signal through the volume of breast tissue;

(b) a tissue volume separator coupled to the non-ionizing apparatus, wherein the tissue volume separator is configured to facilitate measurement of a distribution of sound speed for the volume of breast tissue based upon an analysis of the acoustic signal; and

(c) a processor operatively connected to a non-transitory computer-readable storage medium with instructions stored thereon which when executed by the processor are configured to:

(i) obtain an average whole breast sound speed based on the distribution of sound speed over a volume of the breast,

(ii) generate a comparison between the average whole breast sound speed and at least one threshold condition associated with breast density of the volume of the breast, wherein the comparison comprises classifying the volume of breast tissue as Breast Imaging Reporting and Data System (BI-RADS) category 4 dense tissue if the average whole breast sound speed is greater than 1476 m/s, and

(iii) quantify present or future cancer risk based upon the comparison.

2. The system of claim 1 , wherein the non-ionizing apparatus comprises a platform disposed substantially adjacent a tank including a coupling fluid, wherein the platform is configured to facilitate insertion of the volume of breast tissue into the tank and proximate to the transducer, and wherein the transducer is configured to transmit the acoustic signal through the breast tissue for receipt at the tissue volume separator.

3. The system of claim 1 , wherein the non-ionizing apparatus comprises an ultrasound caliper disposed upon the coupling fluid and proximate to the breast tissue, wherein the ultrasound caliper comprises a transmitting end and a receiving end for transmitting the acoustic signal through the volume of breast tissue for receipt at the tissue volume separator.

4. The system of claim 1 , wherein the tissue volume separator comprises an imaging device, a waveform generator, a digital-to-analog converter coupled to the waveform generator, an acoustic transmit amplifier coupled to the digital-to-analog converter, wherein the acoustic transmit amplifier is connected to a transmitter end of the imaging device, a receive amplifier, wherein the receive amplifier is connected to a receiver end of the imaging device, an analog-to-digital converter coupled to the receive amplifier, and a value generator connected to the analog-to-digital converter.

5. The system of claim 4 , wherein the imaging device is an ultrasound tomography device defined, at least in part, by a transducer ring configured to scan the volume of breast tissue.

6. The system of claim 1 , wherein the at least one threshold condition associated with breast density of the volume of the breast is based at least in part on a threshold value of average whole breast sound speed.

7. A system for determining present or future cancer risk from a volume of breast tissue, comprising:

(a) a non-ionizing apparatus comprising a transducer configured to transmit an acoustic signal through the volume of breast tissue;

(b) a tissue volume separator coupled to the non-ionizing apparatus, wherein the tissue volume separator is configured to facilitate measurement of a distribution of sound speed for the volume of breast tissue based upon an analysis of the acoustic signal; and

(c) a processor operatively connected to a non-transitory computer-readable storage medium with instructions stored thereon which when executed by the processor are configured to:

(i) obtain an average whole breast sound speed based on the distribution of sound speed over the volume of the breast,

(ii) generate a comparison between the average whole breast sound speed and at least one threshold condition associated with breast density of the volume of the breast, wherein the comparison comprises classifying the volume of breast tissue as Breast Imaging Reporting and Data System (BI-RADS) category 3 heterogeneous tissue if the average whole breast sound speed has a value from 1463-1476 m/s, and

(iii) quantify present or future cancer risk based upon the comparison.

8. The system of claim 7 , wherein the non-ionizing apparatus comprises a platform disposed substantially adjacent a tank including a coupling fluid, wherein the platform is configured to facilitate insertion of the volume of breast tissue into the tank and proximate to the transducer, and wherein the transducer is configured to transmit the acoustic signal through the breast tissue for receipt at the tissue volume separator.

9. The system of claim 7 , wherein the non-ionizing apparatus comprises an ultrasound caliper disposed upon the coupling fluid and proximate to the breast tissue, wherein the ultrasound caliper comprises a transmitting end and a receiving end for transmitting the acoustic signal through the volume of breast tissue for receipt at the tissue volume separator.

10. The system of claim 7 , wherein the tissue volume separator comprises an imaging device, a waveform generator, a digital-to-analog converter coupled to the waveform generator, an acoustic transmit amplifier coupled to the digital-to-analog converter, wherein the acoustic transmit amplifier is connected to a transmitter end of the imaging device, a receive amplifier, wherein the receive amplifier is connected to a receiver end of the imaging device, an analog-to-digital converter coupled to the receive amplifier, and a value generator connected to the analog-to-digital converter.

11. The system of claim 10 , wherein the imaging device is an ultrasound tomography device defined, at least in part, by a transducer ring configured to scan the volume of breast tissue.

12. The system of claim 7 , wherein the at least one threshold condition associated with breast density of the volume of the breast is based at least in part on a threshold value of average whole breast sound speed.

Assignments (7)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 7, 2025
From: DELPHINUS MEDICAL TECHNOLOGIES, INC.
To: APERIA MEDICAL, LLC
Reel/Frame 072495/0454 →
CORRECTIVE ASSIGNMENT TO CORRECT THE SPELLING OF ASSIGNEE'S NAME PREVIOUSLY RECORDED ON REEL 67483 FRAME 574. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Oct 16, 2024
From: GLIDE-HURST, CARRI K.; DURIC, NEBOJSA; LITTRUP, PETER J.
To: BARBARA ANN KARMANOS CANCER INSTITUTE
Reel/Frame 069178/0332 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 21, 2024
From: BARBARA ANN KARMANOS CANCER INSTITUTE
To: DELPHINUS MEDICAL TECHNOLOGIES, INC.
Reel/Frame 067483/0631 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 21, 2024
From: DURIC, NEBOJSA; LITTRUP, PETER J.
To: DELPHINUS MEDICAL TECHNOLOGIES, INC.
Reel/Frame 067487/0526 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 21, 2024
From: GLIDE-HURST, CARRI K.; DURIC, NEBOJSA; LITTRUP, PETER J.
To: BARBARA ANN KARMOANOS CANCER INSTITUTE
Reel/Frame 067483/0574 →
RELEASE OF SECURITY INTEREST Recorded Mar 11, 2024
From: TRINITY CAPITAL INC.
To: DELPHINUS MEDICAL TECHNOLOGIES, INC.
Reel/Frame 066782/0168 →
SECURITY INTEREST Recorded Jun 26, 2023
From: DELPHINUS MEDICAL TECHNOLOGIES, INC.
To: TRINITY CAPITAL INC.
Reel/Frame 064093/0550 →
Continuity (4)
Continuation 14486551 · Sep 15, 2014
Continuation In Part 12115174 · May 5, 2008
Provisional Application 60915946 · May 4, 2007
Related Publication 20190142367A1 · May 16, 2019