IP Library Granted Patent US 9,295,392
Granted Patent B2
US 9,295,392 · App. 13/625,867 · Granted Mar 29, 2016

Method for identifying malignancies in barrett's esophagus using white light endoscopy

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Quick Facts
Patent No.
US 9,295,392
App. No.
13/625,867
Filed
Sep 24, 2012
Granted
Mar 29, 2016
Kind
B2
Art Unit
3737
USPC
600/476
Abstract

A method is described for computing a statistically significant difference between dysplasia and Barrett's esophagus (both with and without inflammatory component) using a discriminate function with diffuse reflectance measurements performed at a minimum of four different wavelengths of 485, 513, 598, and 629 nm. The discriminate function found depends both on local blood fraction volume T HB and oxygenation SO 2 . A pull-back approach of spectral data acquisition is disclosed which takes into account tissue motility in esophagus and measurement geometry peculiarities. The pull-back approach provides a significant improvement of measurement reproducibility and reduction of data deviation by 75-100%, resulting in a better discrimination between different histological groups.

Claims (42)

1. A method for assessing cancer risk by diffuse reflectance spectroscopy, comprising:

directing light from a source to an area of esophageal tissue with an endoscope to provide wide field illumination of a surface of the tissue, the light having a wavelength range that includes at least a portion of the visible spectrum;

measuring, with a reflectance probe, intensity of diffusely reflected light in at least four distinct narrow wavelength bands at different tissue sampling sites, said at least four bands being in the wavelength range of the illumination light, two of said bands being in the blue light range, and two of said bands being in the red light range;

computing a parameter value for each of the different tissue sampling sites, the parameter being a predetermined linear discriminate function based on said intensity measurements; and

assessing malignancy of the tissue based on the computed parameter values from the different tissue sampling sites.

2. The method of claim 1 , wherein the at least four distinct narrow wavelength bands include the wavelengths 485±5 nm, 513±5 nm, 598±5 nm, and 629±5 nm.

3. The method of claim 2 , wherein the discriminate function is

B 4=−14.32+626.88* Rd 485 −721.31* Rd 513 +253.76* Rd 598 +75.16* Rd 629 ,

wherein Rd 485 is diffuse reflectance measured at 485±5 nm, Rd 513 is diffuse reflectance measured at 513±5 nm, Rd 598 is diffuse reflectance measured at 598±5 nm, Rd 629 is diffuse reflectance measured at 629±5 nm, and the computed parameter value is represented by B4.

4. The method of claim 3 , wherein the diffuse reflectance measured at 485±5 nm, 513±5 nm, 598±5 nm, and 629±5 nm is normalized with respect to reflectance in the infrared wavelength range (650-750 nm) where absorption of blood is negligible.

5. The method of claim 1 , further comprising

placing the reflectance probe in close proximity to the tissue surface at one of said sampling sites and then carrying out said measuring; and

lifting the reflectance probe (pull-back) from said close proximity to the tissue surface to a distance where the reflectance probe no longer shadows the tissue and then repeating said measuring.

6. The method of claim 5 , wherein the lifting is repeated at least once for a tissue spot, said measuring being repeated after each lifting.

7. The method of claim 1 , wherein the blue light range is 470-520 nm, and the red light range is 590-650 nm.

8. The method of claim 1 , wherein said directing light from the source to the area of esophageal tissue comprises directing light through a light guide of the endoscope.

9. A real-time method for assessing cancer risk by diffuse reflectance spectroscopy, comprising:

directing light from a source to an area of esophageal tissue with an endoscope to provide wide field illumination of a surface of the tissue, the light having a wavelength range that includes at least a portion of the visible spectrum;

measuring, with a reflectance probe, intensity of a diffusely reflected light in at least four distinct narrow wavelength bands at different tissue sampling sites, said at least four bands being in the wavelength range of the illumination light, two of said bands being the blue light range, and two of said bands being in the red light range;

computing, via a processor, a parameter value for each of the different tissue sampling sites, the parameter being a predetermined linear discriminate function based on said intensity measurements; and

assessing malignancy of the tissue based on the computed parameter values from the different tissue sampling sites.

10. The method of claim 9 , wherein the at least four distinct narrow wavelength bands include the wavelengths 485±5 nm, 513±5 nm, 598±5 nm, and 629±5 nm.

11. The method of claim 10 , wherein the discriminate function is

B 4=−14.32+626.88* Rd 485 −721.31* Rd 533 +253.76* Rd 598 +75.16* Rd 629 ,

wherein Rd 485 is diffuse reflectance measured at 485±5 nm, Rd 513 is diffuse reflectance measured at 513±5 nm, Rd 598 is diffuse reflectance measured at 598±5 nm, Rd 629 is diffuse reflectance measured at 629±5 nm, and the computed parameter value is represented by B4.

12. The method of claim 11 , wherein the diffuse reflectance measured at 485±5 nm, 513±5 nm, 598±5 nm, and 629±5 nm is normalized with respect to reflectance in the infrared wavelength range (650-750 nm) where absorption of blood is negligible.

13. The method of claim 9 , further comprising:

placing the reflectance probe in close proximity to the tissue surface at one of said sampling sites and then carrying out said measuring; and

lifting the reflectance probe (pull-back) from said close proximity to the tissue surface to a distance where the reflectance probe no longer shadows the tissue and then repeating said measuring.

14. The method of claim 13 , wherein the lifting is repeated at least once for a tissue spot, said measuring being repeated after each lifting.

15. The method of claim 9 , wherein the blue light range is 470-520 nm, and the red light range is 590-650 nm.

16. The method of claim 9 , wherein said directing light from the source to the area of esophageal tissue comprises directing light through a light guide of the endoscope.

17. A method for identifying malignancies in Barrett's Esophagus using white light endoscopy, comprising:

directing light from a source to a tissue with an endoscope to provide wide field illumination of a surface of the tissue, the light having a wavelength range that includes at least a portion of the visible spectrum;

measuring, with a reflectance probe, intensity of diffusely reflected light in at least four distinct narrow wavelength bands at different tissue sampling sites, said at least four bands being in the wavelength range of the illumination light, two of said bands being in the blue light range, and two of said bands being in the red light range;

determining a parameter value for each of the different tissue sampling sites, the parameter being a predetermined linear discriminate function based on said intensity measurements; and

discriminating between Barrett's Esophagus and dysplasia at the different tissue sampling sites based on the parameter values.

18. The method of claim 17 , wherein the at least four distinct narrow wavelength bands include the wavelengths 485±5 nm, 513±5 nm, 598±5 nm, and 629±5 nm.

19. The method of claim 18 , wherein the discriminate function is

B 4=−14.32+626.88* Rd 485 −721.31* Rd 513 +253.76* Rd 598 +75.16* Rd 629 ,

wherein Rd 485 is diffuse reflectance measured at 485±5 nm, Rd 513 is diffuse reflectance measured at 513±5 nm, Rd 598 is diffuse reflectance measured at 598±5 nm, Rd 629 is diffuse reflectance measured at 629±5 urn, and the computed parameter value is represented by B4.

20. The method of claim 19 , wherein the diffuse reflectance measured at 485±5 nm, 513±5 nm, 598±5 nm, and 629±5 nm is normalized with respect to reflectance in the infrared wavelength range (650-750 nm) where absorption of blood is negligible.

Assignments (18)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 26, 2023
From: STRYKER EUROPEAN OPERATIONS LIMITED
To: STRYKER CORPORATION
Reel/Frame 066140/0647 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ERRONEOUSLY FILED AGAINST APPLICATION NO. 15/570,072 PREVIOUSLY RECORDED AT REEL: 053823 FRAME: 0445. ASSIGNOR(S) HEREBY CONFIRMS THE NUNC PRO TUNC ASSIGNMENT EFFECTIVE 11/29/2018. Recorded May 3, 2021
From: STRYKER EUROPEAN HOLDINGS III, LLC
To: STRYKER EUROPEAN HOLDINGS LLC
Reel/Frame 056426/0496 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ERRONEOUSLY FILED AGAINST APPLICATION NO. 15/570,072 PREVIOUSLY RECORDED AT REEL: 052873 FRAME: 0548. ASSIGNOR(S) HEREBY CONFIRMS THE NUNC PRO TUNC ASSIGNMENT EFFECTIVE 11/30/2017. Recorded May 3, 2021
From: NOVADAQ TECHNOLOGIES ULC
To: STRYKER EUROPEAN HOLDINGS I, LLC
Reel/Frame 056425/0616 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ERRONEOUSLY FILED AGAINST APPLICATION NO. 15/570,072 PREVIOUSLY RECORDED AT REEL: 052860 FRAME: 0900. ASSIGNOR(S) HEREBY CONFIRMS THE NUNC PRO TUNC ASSIGNMENT EFFECTIVE 12/31/2018. Recorded May 3, 2021
From: STRYKER EUROPEAN HOLDINGS LLC
To: STRYKER EUROPEAN OPERATIONS LIMITED
Reel/Frame 056426/0585 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ERRONEOUSLY FILED AGAINST APPLICATION NO. 15/570,072 PREVIOUSLY RECORDED AT REEL: 044910 FRAME: 0507. ASSIGNOR(S) HEREBY CONFIRMS THE MERGER AND CHANGE OF NAME. Recorded May 3, 2021
From: NOVADAQ TECHNOLOGIES INC.
To: NOVADAQ TECHNOLOGIES ULC
Reel/Frame 056425/0530 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ERRONEOUSLY FILED AGAINST APPLICAITON NO. 15/570,072 PREVIOUSLY RECORDED AT REEL: 053318 FRAME: 0612. ASSIGNOR(S) HEREBY CONFIRMS THE NUNC PRO TUNC ASSIGNMENT EFFECTIVE 09/05/2018. Recorded May 3, 2021
From: STRYKER EUROPEAN HOLDINGS I, LLC
To: STRYKER EUROPEAN HOLDINGS IV, LLC
Reel/Frame 056425/0731 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ERRONEOUSLY FILED AGAINST APPLICATION NO. 15/570,072 PREVIOUSLY RECORDED AT REEL: 052873 FRAME: 0597. ASSIGNOR(S) HEREBY CONFIRMS THE NUNC PRO TUNC ASSIGNMENT EFFECTIVE 09/05/2018. Recorded May 3, 2021
From: STRYKER EUROPEAN HOLDINGS IV, LLC
To: STRYKER EUROPEAN HOLDINGS III, LLC
Reel/Frame 056426/0352 →
NUNC PRO TUNC ASSIGNMENT Recorded Jun 7, 2020
From: STRYKER EUROPEAN HOLDINGS I, LLC
To: STRYKER EUROPEAN HOLDINGS IV, LLC
Reel/Frame 053318/0612 →
NUNC PRO TUNC ASSIGNMENT Recorded Jun 7, 2020
From: STRYKER EUROPEAN HOLDINGS LLC
To: STRYKER EUROPEAN OPERATIONS LIMITED
Reel/Frame 052860/0900 →
NUNC PRO TUNC ASSIGNMENT Recorded Jun 7, 2020
From: NOVADAQ TECHNOLOGIES ULC
To: STRYKER EUROPEAN HOLDINGS I, LLC
Reel/Frame 052873/0548 →
NUNC PRO TUNC ASSIGNMENT Recorded Jun 7, 2020
From: STRYKER EUROPEAN HOLDINGS IV, LLC
To: STRYKER EUROPEAN HOLDINGS III, LLC
Reel/Frame 052873/0597 →
NUNC PRO TUNC ASSIGNMENT Recorded Jun 7, 2020
From: STRYKER EUROPEAN HOLDINGS III, LLC
To: STRYKER EUROPEAN HOLDINGS LLC
Reel/Frame 053823/0445 →
MERGER AND CHANGE OF NAME Recorded Dec 19, 2017
From: NOVADAQ TECHNOLOGIES INC.; STRYKER CANADA OPERATIONS ULC
To: NOVADAQ TECHNOLOGIES ULC
Reel/Frame 044910/0507 →
RELEASE OF SECURITY INTEREST Recorded Sep 8, 2017
From: MIDCAP FINANCIAL TRUST
To: NOVADAQ TECHNOLOGIES INC.; NOVADAQ CORP.
Reel/Frame 043788/0799 →
RELEASE OF SECURITY INTEREST Recorded Sep 8, 2017
From: MIDCAP FUNDING IV TRUST (AS SUCCESSOR AGENT TO MIDCAP FINANCIAL TRUST)
To: NOVADAQ TECHNOLOGIES INC.; NOVADAQ CORP.
Reel/Frame 043786/0344 →
SECURITY AGREEMENT (TERM) Recorded Jan 9, 2017
From: NOVADAQ TECHNOLOGIES; NOVADAQ CORP.
To: MIDCAP FINANCIAL TRUST, AS AGENT
Reel/Frame 041306/0189 →
SECURITY AGREEMENT (REVOLVING) Recorded Jan 9, 2017
From: NOVADAQ TECHNOLOGIES; NOVADAQ CORP.
To: MIDCAP FINANCIAL TRUST, AS AGENT
Reel/Frame 041306/0172 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 4, 2014
From: DOUPLIK, ALEXANDRE; ADLER, DESMOND C; WILSON, BRIAN; MARCON, NORMAN
To: NOVADAQ TECHNOLOGIES INC.
Reel/Frame 034380/0763 →