In vivo tissue analysis methods and apparatus

• US 5,785,658 A
• Filed: 06/07/1995
• Issued: 07/28/1998
• Est. Priority Date: 09/14/1992
• Status: Expired due to Term

• Current Assignee: JB IP Acquisitions LLC
• Original Assignee: Sextant Medical Corporation
• Inventors: Goldberger, Daniel S., Benaron, David A.
• Primary Examiner(s): Casler, Brian L.
• Application Number:
  US08/473,004
• Time in Patent Office: 1,147 Days
• Field of Search: 128/664, 128/665, 128/633, 128/634, 128/754, 606/2, 606/14, 606/15, 606/16, 606/167, 606/172, 606/173, 606/170, 606/205, 606/207, 606/211, 606/139, 606/140, 607/88, 607/89, 356/432, 356/433, 356/435, 433/29, 433/31, 600/473, 600/476, 600/310, 600/342, 600/567
• US Class Current: 600/473
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3474 Insufflating needles, e.g. Veress needles
• CPC Class Codes: A61B 17/3494 with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors for the peridural space A61B17/3401
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61B 2017/00061 spectrum
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2017/00508 using laser
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2562/0242 for varying or adjusting the optical path length in the tissue
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/0086 : using infrared radiation
• CPC Class Codes: A61B 5/6848 : Needles
• CPC Class Codes: G01N 21/4795 : spatially resolved investigating of object in scattering medium in vivo A61B

Abstract

A tool for nondestructive interrogation of the tissue including a light source emitter and detector which may be mounted directly on the surgical tool in a tissue contacting surface for interrogation or mounted remotely and guided to the surgical field with fiber optic cables. The light source may be broadband and wavelength differentiation can be accomplished at the detector via filters or gratings, or using time, frequency, or space resolved methods. Alternatively, n discrete monochromatic light sources may be provided which are subsequently multiplexed into a single detector by time or by frequency multiplexing. The optical sensing elements can be built into a surgical tool end effector tip such as a tissue grasping tool which has cooperating jaws (bivalve or multi-element). In the preferred embodiment the light source (or the fiber optic guide) is mounted on one jaw and the detector (or fiber optic guide) is mounted in the opposing jaw so that the light emitter and detector are facing one another either directly (i.e., on the same optical axis when the tool is closed) or acutely (i.e., with intersecting optical axes so that the light emitted is detected). In this case, the sensor is working in a transmission modality. Arrangements with the optical components mounted on the same member of a single member or a multi member structure, operating in a reflective modality, are disclosed.

Claims

1. An analyzer for characterizing tissue in vivo comprising:

a source of electromagnetic radiation to emit electromagnetic radiation into a tissue to be characterized;

a spectrometer adapted to be optically coupled to said tissue to detect electromagnetic radiation, having a detection spectra output corresponding to at least one preselected wavelength of the detected radiation in response to at least a portion of said electromagnetic radiation having passed through the tissue to be characterized; and

a signal processor connected to the spectrometer output, having a library of known spectra records corresponding to a plurality of known tissue types, wherein said processor is operable to relate said detection spectra to said library to identify the detection spectra as corresponding to one of one of said plurality of known tissue types in said library and none of said plurality of known tissue types, and generate a first output signal characterizing the identified tissue type.

2. The analyzer of claim 1 wherein said library of spectra records includes a set of spectra records corresponding to distinct types of tissue classes, including ureter, liver, and kidney.

3. The analyzer system of claim 1 wherein said library of spectra records includes a set of spectra records corresponding to different pathological states of a selected tissue class including normal and cancerous.

4. The analyzer of claim 1 further comprising a light source controller operatively connected to said source of electromagnetic radiation to control an amount of electromagnetic radiation emitted, wherein the signal processor further comprises a second output signal in response to an identification of said detection spectra that is a control signal, wherein said light source controller is responsive to said control signal to cause the source of electromagnetic radiation to emit said controlled amount of electromagnetic radiation.

5. The analyzer of claim 1 wherein the spectrometer further comprises an optical demultiplexor separating the detected radiation into at least two distinct wavelengths corresponding to the detection spectra.

6. The analyzer of claim 5 wherein the optical demultiplexor is one of a synchronous demultiplexor and a frequency demultiplexor.

7. The analyzer of claim 1 wherein the signal processor further comprises an interlock output signal in response to the identified tissue type being one of a subset of the plurality of known tissue types in said library.

8. The analyzer of claim 1 wherein said library comprises a plurality of predetermined spectra records corresponding to a plurality of known tissue types.

9. The analyzer of claim 8 wherein said signal processor further comprises a memory device containing said library and is operable to modify said library by data input from at least one of a CD-ROM, a magnetic tape, an IC ROM, a modem, a PCMCIA disk, a PCMCIA memory, a direct user input, and a previously detected detection spectra.

10. The analyzer of claim 8 wherein said signal processor further comprises means for improving an accuracy level of the signal processor in response to an operation of said signal processor and a previously detected detection spectra.

11. The analyzer of claim 1 further comprising a determination memory wherein at least some data is stored in response to each tissue characterization.

12. The analyzer of claim 1 wherein said signal processor further comprises means for providing said first output signal as output signals corresponding to multiple tissue types identified.

13. The analyzer of claim 1 wherein said spectrometer further comprises means for detecting a feature of said electromagnetic radiation having passed through the tissue selected from at least one of absorbance, scattering, fluorescence, optical rotation, elastic scattering, temperature, time resolved optical data, frequency-resolved optical data, reflectance, opacity and turbidity.

14. The analyzer of claim 1 wherein said spectrometer further comprises means for separating an absorbance effect and a scattering effect of said electromagnetic radiation.

15. The spectrometer of claim 14 wherein said separating means is operable to perform a time-resolved analysis.

16. The spectrometer of claim 14 wherein said separating means is operable to perform a frequency-resolved analysis.

17. The spectrometer of claim 14 wherein said separating means is operable to perform multifiber spatial-analysis.

18. A method for characterizing tissue in vivo comprising:

launching electromagnetic radiation into a tissue to be characterized;

detecting electromagnetic radiation that has been modified by passage through said tissue as a detection spectra corresponding to at least one preselected wavelength of the detected electromagnetic radiation;

providing a library of spectra records corresponding to a plurality of known tissue types;

processing the detection spectra and relating said detection spectra to said library; and

identifying the detection spectra as corresponding to one of one of said plurality of known tissue types in said library and none of said plurality of known tissue types, thereby to characterize the identified tissue.

19. The method of claim 18 wherein said providing the library further comprises providing a set of spectra records corresponding to distinct types of tissue classes, including ureter, liver, and kidney.

20. The method of claim 18 wherein providing the library further comprises providing a set of spectral records corresponding to different pathological states of a selected tissue class including normal and cancerous.

21. The method of claim 18 wherein detecting the detected radiation further comprises providing an optical demultiplexor and separating the detected radiation into at least two distinct wavelengths corresponding to the detection spectra.

22. The method of claim 18 further comprising generating an interlock output signal in response to the identified tissue type being one of a predetermined subset of the plurality of known tissue types in said library.

23. The method of claim 18 further comprising updating said library with a set from at least one of a CD-ROM, a magnetic tape, an IC ROM, a modem, a PCMCIA disk, a PCMCIA memory, a direct user input, and a previously detected detection spectra.

24. The method of claim 18 further comprising improving an accuracy level of the identifying step in response to a prior processing and relating of a detection spectra and said library.

25. The method of claim 18 wherein detecting the electromagnetic radiation further comprises detecting a feature of said electromagnetic radiation selected from at least one of absorbance, scattering, fluorescence, optical rotation, elastic scattering, temperature, time resolved optical data, frequency resolved optical data, reflectance, opacity and turbidity.

26. The method of claim 18 wherein detecting the electromagnetic radiation further comprises separating an absorbance effect and a scattering effect of said electromagnetic radiation and performing one of a time-resolved analysis, a frequency-resolved analysis, and a spatial-resolved analysis.

27. The method of claim 18 further comprising performing a surgical intervention wherein said intervention further comprises coupling an optical fiber to a surgical tool end effector for performing said intervention, and detecting the detection spectra using said optical fiber at said end effector, determining whether the characterized tissue at said end effector is one of a subset of the plurality of known tissue types, and indicating whether or not to perform the surgical intervention on said characterized tissue in response to said determination.

28. The method of claim 27 wherein performing the surgical intervention further comprises not severing the characterized tissue in response to the characterized tissue being one of tissue containing a flow of blood, a nerve, a bile duct, a lymph duct, and a ureter, wherein the indicating step further comprises generating an alarm indicative of not severing the characterized tissue.

29. The method of claim 28 wherein generating the alarm further comprises inhibiting the end effector from severing said tissue.

30. An analyzer for characterizing tissue in vivo comprising:

a source of electromagnetic radiation to emit electromagnetic radiation into a tissue to be characterized;

a spectrometer adapted to be optically coupled to said tissue to detect electromagnetic radiation, having a detection spectra output corresponding to at least one preselected wavelength of the detected radiation in response to at least a portion of said electromagnetic radiation having passed through the tissue to be characterized; and

a signal processor connected to the spectrometer output, having a library of known spectra records corresponding to a plurality of known tissue types, wherein said library includes a set of spectra records corresponding to a sequence of effects of a surgical intervention on a blood carrying tissue including normal blood flow, coagulated blood and over-coagulated blood in said tissue, wherein the blood carrying tissue contains at least one of an artery, a vein, and a capillary bed, wherein said processor is operable to relate said detection spectra to said library to identify the detection spectra as corresponding to one of one of said plurality of known tissue types in said library and none of said plurality of known tissue types, and generate a first output signal characterizing the identified tissue type.

31. The analyzer of claim 30 wherein said signal processor further comprises means for averaging multiple ones of said detection spectra over time and improving an accuracy level of the first output signal.

32. The analyzer of claim 30 wherein said signal processor further comprises means for providing a second output signal corresponding to a probabilistic strength of the first output signal.

33. The analyzer of claim 32 wherein said signal processor further comprises means for averaging multiple ones of said detection spectra over time and improving an accuracy level of the first output signal.

34. An analyzer for characterizing tissue in vivo comprising:

a source of electromagnetic radiation to emit electromagnetic radiation into a tissue to be characterized;

a spectrometer adapted to be optically coupled to said tissue to detect electromagnetic radiation, having a detection spectra output corresponding to at least one preselected wavelength of the detected radiation in response to at least a portion of said electromagnetic radiation having passed through the tissue to be characterized; and

a signal processor connected to the spectrometer output, having a library of known spectra records corresponding to a plurality of known tissue types, wherein said processor is operable to relate said detection spectra to said library to identify the detection spectra as corresponding to one of one of said plurality of known tissue types in said library and none of said plurality of known tissue types, and generate a first output signal characterizing the identified tissue type, wherein said signal processor further comprises means for averaging multiple ones of said detection spectra over time and improving an accuracy level of the first output signal.

35. The analyzer of claim 34 wherein said signal processor further comprises means for providing a second output signal corresponding to a probabilistic strength of the first output signal.

36. An analyzer for characterizing tissue in vivo comprising:

a source of electromagnetic radiation to emit electromagnetic radiation into a tissue to be characterized;

a spectrometer adapted to be optically coupled to said tissue to detect electromagnetic radiation, having a detection spectra output corresponding to at least one preselected wavelength of the detected radiation in response to at least a portion of said amount of said electromagnetic radiation having passed through the tissue to be characterized; and

a signal processor connected to the spectrometer output, having a library of known spectra records corresponding to a plurality of known tissue types, wherein said processor is operable to relate said detection spectra to said library to identify the detection spectra as corresponding to one of one of said plurality of known tissue types in said library and none of said plurality of known tissue types, and generate a first output signal characterizing the identified tissue type, wherein said signal processor further comprises means for providing a second output signal corresponding to a probabilistic strength of the first output signal.

37. A method for characterizing tissue in vivo comprising:

launching electromagnetic radiation into a tissue to be characterized;

detecting electromagnetic radiation that has been modified by passage through said tissue as a detection spectra corresponding to at least one preselected wavelength of the detected electromagnetic radiation;

providing a library of spectra records corresponding to a plurality of known tissue types including a set of spectra records corresponding to a sequence of effects of a surgical intervention on a blood carrying tissue including normal blood flow, coagulated blood and over-coagulated blood in said tissue, wherein the blood carrying tissue contains at least one of an artery, a vein, and a capillary bed;

processing the detection spectra and relating said detection spectra to said library; and

identifying the detection spectra as corresponding to one of one of said plurality of known tissue types in said library and none of said plurality of known tissue types, thereby to characterize the identified tissue.

38. The method of claim 37 wherein processing the detection spectrum further comprises averaging multiple ones of said detection spectra over time, thereby to improve an accuracy level of tissue characterization.

39. The method of claim 37 wherein processing said detection spectra further comprises providing a signal corresponding to a probabilistic strength of the tissue characterization.

40. The method of claim 39 wherein performing the processing the detection spectrum further comprises averaging multiple ones of said detection spectra over time, thereby to improve an accuracy level of tissue characterization.

41. A method for characterizing tissue in vivo comprising:

launching electromagnetic radiation into a tissue to be characterized;

detecting electromagnetic radiation that has been modified by passage through said tissue as a detection spectra corresponding to at least one preselected wavelength of the detected electromagnetic radiation;

providing a library of spectra records corresponding to a plurality of known tissue types;

processing the detection spectra and relating said detection spectra to said library; and

identifying the detection spectra as corresponding to one of one of said plurality of known tissue types in said library and none of said plurality of known tissue types, thereby to characterize the identified tissue;

wherein processing the detection spectrum further comprises averaging multiple ones of said detection spectra over time, thereby to improve an accuracy level of tissue characterization.

42. The method of claim 41 wherein processing said detection spectra further comprises providing a signal corresponding to a probabilistic strength of the tissue characterization.

43. A method for characterizing tissue in vivo comprising:

launching electromagnetic radiation into a tissue to be characterized;

detecting electromagnetic radiation that has been modified by passage through said tissue as a detection spectra corresponding to at least one preselected wavelength of the detected electromagnetic radiation;

providing a library of spectra records corresponding to a plurality of known tissue types;

processing the detection spectra by and relating said detection spectra to said library;

identifying the detection spectra as corresponding to one of one of said plurality of known tissue types in said library and none of said plurality of known tissue types, thereby to characterize the identified tissue; and

providing a signal corresponding to a probabilistic strength of the tissue characterization.