(12) United States Patent Bambot et a].

Transcription

1 US B2 (12) United States Patent Bambot et a]. (10) Patent N0.: (45) Date of Patent: US 8,644,912 B2 Feb. 4, 2014 (54) (75) (73) (*) (21) (22) (65) (60) SYSTEM AND METHOD FOR DETERMINING TISSUE CHARACTERISTICS Inventors: Shabbir Bambot, Suwanee, GA (US); Mark L. Faupel, Alpharetta, GA (US); Anant AgraWal, Atlanta, GA (US); Keith D. Ignotz, Duluth, GA (US); Andrew Fordham, Sugar Hill, GA (US) Assignee: SpectRx, Inc., Norcross, GA (US) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 USC 154(b) by 0 days. Appl. No.: 13/214,638 Filed: Aug. 22, 2011 Prior Publication Data US 2011/ A1 Dec. 15,2011 Related US. Application Data Continuation of application No. 12/099,876,?led on Apr. 9, 2008, now abandoned, and a continuation of application No. 10/647,222,?led on Aug. 26, 2003, now abandoned, and a continuation-in-part of application No. 10/611,917,?led on Jul. 3, 2003, now Pat. No. 7,006,220, and a continuation-in-part of application No. 10/603,597,?led on Jun. 26, 2003, now Pat. No. 6,975,899, and a continuation-in-part of application No. 10/446,857,?led on May 29, 2003, now Pat. No. 6,870,620, and a continuation-in-part of application No. 10/337,687,?led on Jan. 8, 2003, now abandoned, and a continuation-in-part of application No. PCT/US02/06350,?led on Mar. 1, 2002, and a continuation of application No. 09/786,781,?led on Mar. 9, 2001, now abandoned, application No. 13/214,638, Which is a continuation of application No. 09/700,538,?led on Nov. 16, 2000, now Pat. No. 6,590,651, and a division of application No. 09/533,817,?led on Mar. 24, 2000, now Pat. No. 6,577,391, and a continuation of application No. 09/434,518,?led on Nov. 5, 1999, now abandoned, Which is a continuation-in-part of application No. PCT/US99/20646,?led on Sep. 10, 1999, and a continuation-in-part of application No. PCT/US99/10947,?led on May 19, (60) Provisional application No. 60/272,458,?led on Mar. 2, 2001, provisional application No. 60/126,056,?led on Mar. 23, (51) (52) (58) Int. Cl. A61B 6/00 ( ) US. Cl. USPC /476; 600/407; 600/473; 600/478 Field of Classi?cation Search USPC /407, 473, 476, 478 See application?le for complete search history. (56) References Cited 4,534,360 A * 6,364,829 B1 6,571,118 B1 U.S. PATENT DOCUMENTS 8/1985 Williams /473 4/2002 Fulghum 5/2003 UtZinger et al. FOREIGN PATENT DOCUMENTS W0 WO 00/ /2000 OTHER PUBLICATIONS Shabbir B. Bambot et al., Sensing oxygen through skin using a red diode laser and?uorescence liftetimes, Biosens and Bioelectronics, vol. 10, Nov. 6/7, pp , Kevin T. Shoemacher et al., Ultraviolet Laser-Induced Fluorescence of Colonic Tissues: Basic Biology and Diagnostic Potential, Laser in Surgery Medicine, vol. 12, pp , (Continued) Primary Examiner * Peter Luong (74) Attorney, Agent, or Firm * Altera LaW Group, LLC (57) ABSTRACT An apparatus to interrogate, receive, and analyze full emis sion spectra for at least one?uorescence excitation Wave length and for at least one re?ectance measurement to deter mine tissue characteristics. The apparatus includes a base unit having illumination, detection and control sub-units, the illu mination sub-unit providing illumination optical energy for illuminating a target tissue and the detection sub-unit detect ing tissue characteristics of a target tissue, a separate tissue interface unit, and a pathway coupling the base unit and the tissue interface unit. The system and apparatus may also include a tube for maintaining the distance between the tissue and units and for surrounding the tissue to prevent patient movement from being transmitted to the tissue. 25 Claims, 24 Drawing Sheets 80a

2 US 8,644,912 B2 Page 2 (56) References Cited OTHER PUBLICATIONS Charles E. Alpers et al., The Prevalance of Carcinoma in Situ in Normal and Cancer Associated Breasts, Human Pathology, vol. 16, No. 8, pp , Aug Danely Slaughter et al., Field CanceriZation in Oral Strati?ed Squamour Epithelium: Clinical Implication of Multicentric Origin Cancer, vol. 6, No. 4, pp , Cancer Diagnostics: The World Markets, Clinical Reports, PJB Pub lications, p. 72, * cited by examiner

3 US. Patent Feb. 4, 2014 Sheet 1 m4 US 8,644,912 B2 78a // : '74 FIG. 1A 80a FIG. 2

4 US. Patent Feb. 4, 2014 Sheet 2 m4 US 8,644,912 B2 L- f 2O ILLUMINATION SOURCE ILLUMINATION SUB-UNIT ELECTRO OPTIC DETECTION SUB-UNIT FIG. 1B

5 US. Patent Feb. 4, 2014 Sheet 3 m4 US 8,644,912 B2 72b FIG. 1C

6 US. Patent Feb. 4, 2014 Sheet 4 m4 US 8,644,912 B2 # Measurement Excitation Collection SpeC UO Meas. graph time center A secs Flourescence 350 nm (10 nm BP) 385 nm LP (66 385) 450nm 2 Flourescence 400 nm (10 nm BF ) 420 nm LP (GG 485) 500nrn 2 Flourescenee 460 nm (10 nm BP) 495 nm LP ((56 495) 560nm 4 Reflectance OD1.5 ND filter nm DD (56 26) 500nm 0.2 BPzbandpass LP=Long-pass FIG. 6

7 US. Patent Feb. 4, 2014 Sheet 5 m4 US 8,644,912 B2 23 a FIG FIG. 5

8 US. Patent Feb. 4, 2014 Sheet 6 m4 US 8,644,912 B2 K &12O i182 FIG. 7A

9 US. Patent Feb. 4, 2014 Sheet 7 m4 US 8,644,912 B \ l w SYSTEM ' POWER INTERFACE I MONITOR AND I re?ected/ 1 78b CONTROLLER emitted ' 1I78 178a 1I87 I light T F FVIDEO % fig) VIDEO CONTROLLER 1% ' I 173a I57 j I58 1I58a W T m _ r 4 CAMERA I ',lj 41w CAMERA CONTROLLER I 100 I (130 I Z ' m- LIGHT GUIDE 4 I light M - ~ b,173d I k M7721 IMAGE LITTb 183 K1770 J r L1 DOCKING I I STATION I I REDCEORDING I MONITOR I a VICE I I 120) FIG. 7B (1823 I

10 US. Patent Feb. 4, 2014 Sheet 8 m4 US 8,644,912 B [120 PROCESSOR POWER SUPPLY \ L ILLUMINATION ILLUMINATION VID EO SOURCE SOURCE CONTROLLER OUT DOCKINC UNIT \I 32 \132A FIG. 8A

11 US. Patent Feb. 4, 2014 Sheet 9 m4 US 8,644,912 B TRANSMITTER j DATA NTERFACE ) / APERTURE/ FILTER MOTOR CONTROLLER UNIT 504 SHUTTER 502 ) llgll'seiiigee / CONTROLLER UNIT 505 ANALOG ) INTERFACE /' UNIT FIG. 8B

12

13 US. Patent Feb Sheet 11 0f 24 FIG. 10

14 US. Patent Feb. 4, 2014 Sheet 12 0f 24 US 8,644,912 B2 [186 \ (172 ( 130 u g D O i FIG. 11

15 US. Patent Feb. 4, 2014 Sheet 13 m4 US 8,644,912 B2 199 K / r174 FIG. 12

16 US. Patent Feb. 4, 2014 Sheet 14 0f 24 US 8,644,912 B < FIG. 13

17 US. Patent Feb. 4, 2014 Sheet 15 m4 US 8,644,912 B FIG.14

18 US. Patent Feb. 4, 2014 Sheet 16 m4 US 8,644,912 B2-1 Order Spectra 0th?irx<+1 Order Spectra CCD Camera > + / 0c COG) (DOC) CDOCD CDOQ (:06 CO6 Virtual Area of 0C Cervix as projected on CCD FIG. 15

19 US. Patent Feb. 4, 2014 Sheet 17 m4 US 8,644,912 B2 CCEQWay [ Virtual Area of Cervix 210\ /21O Cb <50 <30 06 C00 (I) <:> CID 0CD CD Cl) CD06 O0 O0 - > COG O CID (Dd O (:3 CD (DOC; 0CD 0O FIG. 16

20 US. Patent Feb. 4, 2014 Sheet 18 m4 US 8,644,912 B2 CCD Array Virtual Area of Cervix 210\ FIG. 17

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37