Apparatus for tissue type recognition

• US 5,800,350 A
• Filed: 02/14/1997
• Issued: 09/01/1998
• Est. Priority Date: 11/01/1993
• Status: Expired due to Fees

• Current Assignee: Polartechnics Ltd.
• Original Assignee: Polartechnics Ltd.
• Inventors: Reid, Bevan Leslie, Coppleson, John Victor Malcom, Skladnev, Victor Nickaelovich
• Primary Examiner(s): Smith, Ruth S.
• Application Number:
  US08/799,970
• Time in Patent Office: 564 Days
• Field of Search: 600/547, 600/437, 600/407, 600/372-374, 600/382, 600/386, 600/389, 600/473, 600/475, 600/476, 600/477, 600/310, 600/342
• US Class Current: 600/372
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 2562/0217 Electrolyte containing
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take 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 5/0093 Detecting, measuring or recording by applying one single type of energy and measuring its conversion into another type of energy
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/4331 of the cervix A61B5/435 takes precedence
• CPC Class Codes: A61B 5/444 Evaluating skin marks, e.g. mole, nevi, tumour, scar
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4416 related to combined acquisition of different diagnostic modalities, e.g. combination of ultrasound and X-ray acquisitions

Abstract

A method and apparatus (21, 150) is disclosed for identifying tissue which is suspected of being physiologically changed as a result of pre-cancerous or cancerous activity. The apparatus (21, 150) includes a probe (1, 10; 151) configured to contact the tissue and which includes an arrangement (3-7, 17-47; 158-163) to subject the tissue to a plurality of different stimuli such as electrical, light, heat, sound, magnetic and to detect plural physical responses to the stimuli. The probe (1, 10; 151) connects to an analogue section (23; 152) which buffers signals between the probe (1, 10; 151) and a processor (22; 153). The processor (22; 153) processes the responses in combination in order to categorise the tissue, and then compares the categorisation with a catalogue of expected tissue to identify the tissue, the processing occurring in real-time with an indication of the tissue type (eg. normal, pre-cancerous/cancerous, or unknown) being provided to an operator of the apparatus.

Claims

1. An apparatus for categorization of a tissue type, comprising

(1) a probe comprising a probe tip, said probe tip configured to contact a tissue surface area selected by contacting said area with said probe tip, said probe tip comprising

a source of electrical current,

a source of electromagnetic radiation,

a sensor sensing from a tissue volume proximate said tissue surface a response to an electrical current from said current source, and

a sensor sensing from said tissue volume proximate said tissue surface a response to electromagnetic radiation from said source of electromagnetic radiation,

both of said sensors sensing responses from the same tissue volume before the probe is moved to contact another surface area,

(2) a controller coupled to each of said sensors to receive each corresponding tissue response, said controller including a memory storing a known catalogue of expected tissue types and associated paired electrical current/electromagnetic radiation responses, and

(3) a processor for processing paired responses from said tissue selected by contact with said probe tip and for analyzing said processed paired tissue responses, said processor processing the responses of said selected tissue to both of said sources to provide a categorization of the tissue type in accordance with a comparison of the tissue responses with said known catalogue of expected tissue types and associated paired responses.

2. The apparatus for categorization of a tissue type of claim 1, further comprising a calibration instrument comprising a synthetic tissue wherein said probe tip is contacted with said synthetic tissue, and said responses from said tissue are compared to predetermined limits.

3. The apparatus for categorization of a tissue type of claim 1, further comprising a calibration instrument having a complementary array in contact with said probe tip and comprising means to stimulate said probe sensors, wherein said responses from said tissue are compared to predetermined limits.

4. The apparatus for categorization of a tissue type of claim 1, wherein said probe comprises multiple arrays of electromagnetic and electric current sources and sensor elements configured to sample physical properties of selected tissue along the contour of a body organ.

5. The apparatus for categorization of a tissue type of claim 4, wherein said apparatus is configured to bring said probe tip in contact with a portion of a cervix.

6. The apparatus for categorization of a tissue type of claim 4, wherein said probe comprises flexible and conformable means to hold said sources and sensor elements along the contours of a body organ.

7. The apparatus for categorization of a tissue type of claim 4, wherein

said probe tip has a distal end to contact said tissue surface area,

said sensor sensing a response to said electrical current comprises at least three electrodes terminating at the distal end of said probe tip,

said controller comprises circuitry to measure the potential differences between different pairs of said electrodes and to provide signals representative of said potential differences to said processor, and

said processor comprises means to compare said measured potential differences between pairs of electrodes to determine that the probe is correctly oriented relative to said tissue surface, whereupon the processing of the paired responses of said selected tissue is enabled.

8. The apparatus for categorization of a tissue type of claim 7, further comprising means to signal an operator of said apparatus that the processing of paired responses has occurred.

9. The apparatus for categorization of a tissue type of claim 1, wherein said response to an electric current is a voltage decay after removal of an applied voltage to the tissue and said processor determines a value for the voltage decay.

10. The apparatus for categorization of a tissue type of claim 1, wherein said tissue type has a complex impedance in response to said source of electrical current and said processor determines a value for the complex impedance of the tissue over a range of frequencies.

11. The apparatus for categorization of a tissue type of claim 1, wherein said sensor sensing a response to an electrical current comprises electrodes, and said processor determines the current flow into the electrodes as a voltage is applied.

12. The apparatus for categorization of a tissue type of claim 11, wherein said apparatus comprises means to determine the current flow into one of the electrodes as a function of time.

13. The apparatus for categorization of a tissue type of claim 11, wherein said apparatus comprises means to determine the current flow into one of the electrodes as a function of frequency.

14. The apparatus for categorization of a tissue type of claim 1, wherein said sensor sensing a response to an electrical current comprises electrodes, and said processor determines a value for the current flow out of the tissue after the cessation of a voltage pulse applied to the electrodes.

15. The apparatus for categorization of a tissue type of claim 14, wherein said apparatus comprises means to determine the current flow into one of the electrodes as a function of time.

16. The apparatus for categorization of a tissue type of claim 14, wherein said apparatus comprises means to determine the current flow into one of the electrodes as a function of frequency.

17. The apparatus for categorization of a tissue type of claim 1, wherein said processor comprises means to determine a value for the conductivity of the selected tissue.

18. The apparatus for categorization of a tissue type of claim 17, wherein said sensor sensing a response to an electrical current comprises electrodes, said source of electric current comprises a sine wave voltage generator and said processor comprises means to determine from a value of the in-phase current flowing when said sine wave voltage generator applies a sine wave voltage to the electrodes.

19. The apparatus for categorization of a tissue type of claim 18, wherein said sine wave voltage generator comprises means to apply a sine wave voltage over a range of frequencies.

20. The apparatus for categorization of a tissue type of claim 1, wherein said sensor sensing a response to an electrical current comprises electrodes, and at least some of said electrodes are metal.

21. The apparatus for categorization of a tissue type of claim 20, wherein said probe tip has a face and said metal electrodes are formed from wires truncated at the probe tip face.

22. The apparatus for categorization of a tissue type of claim 20, wherein each of at least some of said electrodes has a shape chosen from the group consisting of circles, ellipses, squares, rectangles, triangles, segments of circles, and segments of annuli.

23. The apparatus for categorization of a tissue type of claim 20, wherein at least one electrode comprises an electrolytic cell coupled to the tissue by a salt bridge.

24. The apparatus for categorization of a tissue type of claim 20, wherein said metal electrodes are arranged symmetrically around the centroid of the probe tip.

25. The apparatus for categorization of a tissue type of claim 24, wherein said sensor sensing a response to electromagnetic radiation comprises a bundle of optical fibers and said apparatus further comprises an external tube having an internal surface, said metal electrodes comprise at least one electrode positioned in the center of said bundle of optical fibers and a plurality of cylindrical metal tube segments positioned adjacent and abutting against the internal surface of said external tube.

26. The apparatus for categorization of a tissue type of claim 20, wherein at least one of said electrodes is non-metallic.

27. The apparatus for categorization of a tissue type of claim 26, wherein said at least one non-metallic electrode is selected from the group consisting of a non-metallic semiconductor, silicon, carbon or titanium oxide bonded upon titanium.

28. An apparatus for categorization of a tissue type, comprising

(1) a probe comprising a probe tip, said probe tip configured to contact at its distal end a tissue surface area selected by contacting said area with said probe tip, said probe tip comprising

a source of electrical current,

a sensor comprising at least three electrodes terminating at the distal end of said probe tip sensing from a tissue volume proximate said tissue surface a response to an electrical current from said current source,

(2) a controller coupled to said sensor electrodes comprising circuitry to sequentially measure the potential difference between different pairs of said electrodes and to provide signals representative of said potential differences,

said controller including a memory storing a known catalogue of expected tissue types and potential responses, and

(3) a processor for processing responses from said tissue selected by contact with said probe tip and for analyzing said processed tissue responses, said processor processing the responses of said selected tissue to said source to provide a categorization of the tissue type in accordance with a comparison of the tissue responses with said known catalogue of expected tissue types and associated responses,

said processor comprising means to compare said measured potential differences between pairs of electrodes for determining whether the probe is correctly oriented to said tissue surface.

29. An apparatus for categorization of a tissue type, comprising

(1) a probe comprising a probe tip, said probe tip configured to contact a tissue surface area selected by contacting said area with said probe tip, said probe tip comprising

a source of a first energy type,

a source of a second energy type,

a sensor sensing from a tissue volume proximate said tissue surface a response to energy from said source of a first energy type, and

a sensor sensing from said tissue volume proximate said tissue surface a response to energy from said source of a second energy type,

both of said sensors sensing responses from the same tissue volume before the probe is moved to contact another surface area,

(2) a controller coupled to each of said sensors to receive each corresponding tissue response, said controller including a memory storing a known catalogue of expected tissue types and associated paired first energy type/second energy type responses, and

(3) a processor for processing paired responses from said tissue selected by contact with said probe tip and for analyzing said processed paired tissue responses, said processor processing the paired responses of said selected tissue to both of said sources to provide a categorization of the tissue type in accordance with a comparison of the paired tissue responses with said known catalogue of expected tissue types and associated paired responses.

30. The apparatus for categorization of a tissue type of claim 29, further comprising a calibration instrument comprising a synthetic tissue wherein said probe tip is contacted with said synthetic tissue, and said apparatus response is compared to predetermined limits.

31. The apparatus for categorization of a tissue type of claim 29, further comprising a calibration instrument having a complementary array in contact with said probe tip and comprising means to stimulate probe sensors, wherein said apparatus response is compared to predetermined limits.

32. The apparatus for categorization of a tissue type of claim 29, wherein said probe comprises multiple arrays of electromagnetic and electric current sources and sensor elements configured to sample physical properties of selected tissue along the contour of a body organ.

33. The apparatus for categorization of a tissue type of claim 32, wherein said apparatus is configured to bring said probe tip in contact with a portion of a cervix.

34. The apparatus for categorization of a tissue type of claim 32, wherein said probe comprises flexible and conformable means to hold said sources and sensor elements along the contours of a body organ.

35. The apparatus for categorization of a tissue type of claim 29, wherein

said probe tip has a distal end to contact said tissue surface area,

said sensor sensing a response to said first or second energy types comprises at least three sensor elements receiving signals from the distal end of said probe tip,

said controller comprises circuitry to measure the differences in response between different pairs of said sensor elements and to provide signals representative of said differences in response to said processor, and

said processor comprises means to compare said measured differences in response between pairs of sensor elements to determine that the probe is correctly oriented relative to said tissue surface, whereupon the processing of the paired responses of said selected tissue is enabled.

36. The apparatus for categorization of a tissue type of claim 35, further comprising means to signal an operator of said apparatus that the processing of paired responses has occurred.

39. The apparatus of one of claims 29-38 wherein said first energy type is ultrasonic energy.

37. An apparatus for categorization of a tissue type, comprising

(1) a probe comprising a probe tip, said probe tip configured to contact at its distal end a tissue surface area selected by contacting said area with said probe tip, said probe tip comprising

a source of a first energy type,

a sensor comprising at least three first sensor elements terminating at the distal end of said probe tip sensing from a tissue volume proximate said tissue surface a response to first energy type from said source of a first energy type,

(2) a controller coupled to said sensor elements comprising circuitry to sequentially measure the difference in response between different pairs of said sensor elements and to provide signals representative of said differences,

said controller including a memory storing a known catalogue of expected tissue types and potential responses, and

(3) a processor for processing responses from said tissue selected by contact with said probe tip and for analyzing said processed tissue responses, said processor processing the responses of said selected tissue to said source to provide a categorization of the tissue type in accordance with a comparison of the tissue responses with said known catalogue of expected tissue types and associated responses,

said processor comprising means to compare said measured differences in response between pairs of sensor elements for determining whether the probe is correctly oriented to said tissue surface.

38. The apparatus for categorization of a tissue type of claim 37, further comprising a source of a second energy type and a sensor comprising second sensor elements terminating at the distal end of said probe tip sensing from a said tissue volume proximate said tissue surface a response to a second energy type from said source of a second energy type.