Apparatus and method for characterization and treatment of tumors

• US 5,630,426 A
• Filed: 03/03/1995
• Issued: 05/20/1997
• Est. Priority Date: 03/03/1995
• Status: Expired due to Fees

• Current Assignee: Intact Medical Corporation (Medtronic Plc)
• Original Assignee: Neovision LLC (Medtronic Plc)
• Inventors: Eggers, Philip E., Shmulewitz, Ascher
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US08/398,644
• Time in Patent Office: 809 Days
• Field of Search: 128/734, 128/642, 607/98, 607/99, 607/113, 606/21, 606/27, 606/28, 606/30, 606/41, 606/49, 606/50, 606/34
• US Class Current: 600/547
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/1487 Trocar-like, i.e. devices producing an enlarged transcutaneous opening
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00708 switching the power on or off
• CPC Class Codes: A61B 2018/00761 Duration
• CPC Class Codes: A61B 2018/00827 Current
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00886 Duration
• CPC Class Codes: A61B 2018/0091 Handpieces of the surgical instrument or device
• CPC Class Codes: A61B 2018/00916 with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/1273 including multiple generators in one device
• CPC Class Codes: A61B 2018/128 : generating two or more frequencies
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/162 : located on the probe body
• CPC Class Codes: A61B 5/0531 : Measuring skin impedance

Abstract

Apparatus and methods are provided for performing an in situ characterization of a tissue mass which may be normal, malignant, or benign, and, based on the measured characteristics of the tissue mass, therapeutically treating the tissue mass to cause necrosis of the tissue. In an illustrative preferred embodiment, the characterization of the tissue is accomplished by measuring an electrical property of the tissue, such as electrical impedance, while treatment is accomplished by supplying heat to the tissue to induce cauterization.

Claims

1. Apparatus for in situ diagnosis and treatment of biological tissue comprising:

a probe comprising an elongate member including first and second electrodes, the probe having a first mode of operation in which a parameter indicative of a property of a biological tissue is sensed to enable differentiation among normal biological tissue, malignant tumorous biological tissue, and nonmalignant tumorous biological tissue, and a second mode of operation causing in situ necrosis of the biological tissue;

first circuitry coupled to the first electrode for sensing the parameter during the first mode of operation;

second circuitry coupled to the second electrode for inducing necrosis of the biological tissue during the second mode of operation; and

means for coupling the probe to the first and second circuitries.

2. Apparatus as defined in claim 1 wherein the elongate member has a distal end and a proximal end and the first and second electrodes are disposed axially at intervals between the distal end and the proximal end.

3. Apparatus as defined in claim 2 wherein the second circuitry induces necrosis of the biological tissue by supplying a voltage to the second electrode.

4. Apparatus as defined in claim 2, wherein the first and second electrodes comprise a material selected from the group consisting of platinum, silver, gold, stainless steel, and other biocompatible electrically conductive materials.

5. Apparatus as defined in claim 1 wherein the probe further comprises a switch for selectively activating either the first or second modes of operation.

6. Apparatus as defined in claim 1 further comprising:

a user interface for providing a sensory indication of the sensed parameter.

7. Apparatus as defined in claim 6 wherein the user interface provides a sensory indication, during the first mode of operation, corresponding to a degree of vascularity of the biological tissue to enable characterization of the degree of malignancy.

8. Apparatus as defined in claim 6, wherein the user interface comprises a visual display or an auditory device.

9. Apparatus as defined in claim 1, wherein the parameter indicative of a property of the biological tissue is selected from the group consisting of electrical impedance and dielectric constant.

10. Apparatus as defined in claim 1 wherein the probe includes a third electrode coupled to the first circuitry and a fourth electrode coupled to the second circuitry.

11. A probe for use in situ diagnosis and treatment of biological tissue comprising:

a handle;

a support member removably connected to the handle;

a plurality of electrodes, disposed on the support member, for sensing a parameter indicative of a property of a biological tissue to enable differentiation among normal biological tissue, benign tumorous biological tissue, and malignant tumorous biological tissue; and

disposed from the support member, means for causing in situ necrosis of the biological tissue.

12. Apparatus as defined in claim 11 further comprising a user interface to provide a sensory indication corresponding to a degree of vascularity of the biological tissue to enable characterization of the degree of malignancy.

13. A probe as defined in claim 11 further comprising a switch, operatively coupled to the plurality of electrodes and the means for causing in situ necrosis, for selectively activating either the plurality of electrodes for sensing or the means for causing in situ necrosis.

14. A probe as defined in claim 13 wherein the means for causing in situ necrosis comprises a subset of the plurality of electrodes.

15. A probe as defined in claim 13, wherein the electrodes comprise a material selected from the group consisting of platinum, silver, gold, stainless steel, and other biocompatible electrically conductive materials.

16. A method for in situ diagnosis and treatment of biological tissue comprising a series of steps of:

positioning a probe relative to a biological tissue in situ;

actuating the probe to sense a parameter indicative of a property of the biological tissue to enable differentiation among normal biological tissue, malignant tumorous biological tissue, and nonmalignant tumorous biological tissue;

characterizing a region of the biological tissue based upon the sensed parameter; and

selectively actuating the probe to cause necrosis of the region of biological tissue.

17. The method of claim 16 wherein the step of characterizing comprises assessing the degree of malignancy of the region.

18. The method of claim 16, wherein the parameter is selected from a group consisting of electrical impedance and dielectric constant.

19. The method of claim 16, wherein the step of sensing measures the electrical impedance of the biological tissue at one or more frequencies in the range of 20 kHz to 20 MHz.

20. The method of claim 16, wherein the step of selectively actuating the probe to cause necrosis induces elevated temperatures in the region of biological tissue.

21. The method of claim 20, wherein the elevated temperatures are in a range of 60°

C. to 100°

C.

22. The method of claim 20, wherein elevated temperatures are induced by passing a radio-frequency electric current through the biological tissue, the electric current having a frequency in a range 100 KHz to 1 MHz.

23. A probe for use in situ diagnosis and treatment of biological tissue comprising:

a handle;

a support member removably connected to the handle;

at least one electrode, disposed on the support member, for sensing a parameter indicative of a property of a biological tissue to enable differentiation among normal biological tissue, benign tumorous biological tissue, and malignant tumorous biological tissue; and

disposed from the support member, means for causing in situ necrosis of the biological tissue.

24. Apparatus as defined in claim 23 further comprising a user interface to provide a sensory indication corresponding to a degree of vascularity of the biological tissue to enable characterization of the degree of malignancy.

25. A probe as defined in claim 23 further comprising a switch, operatively coupled to the at least one electrode and the means for causing in situ necrosis, for selectively activating either the at least one electrode for sensing or the means for causing in situ necrosis.

26. A probe as defined in claim 23, wherein the at least one electrode comprises a material selected from the group consisting of platinum, silver, gold, stainless steel, and other biocompatible electrically conductive materials.

27. Apparatus for in situ diagnosis and treatment of biological tissue comprising:

a first probe comprising an elongate member including a first electrode and a second probe comprising an elongate member including a second electrode, the first and second probes having a first mode of concurrent operation in which a parameter indicative of a property of a biological tissue is sensed to enable differentiation among normal biological tissue, malignant tumorous biological tissue, and nonmalignant tumorous biological tissue, and a second mode of concurrent operation causing in situ necrosis of the biological tissue;

first circuitry coupled to the first and second electrodes for sensing the parameter during the first mode of concurrent operation;

second circuitry coupled to the first and second electrodes for inducing necrosis of the biological tissue during the second mode of concurrent operation; and

means for coupling the first and second probes to the first and second circuitries.

28. Apparatus as defined in claim 27 wherein the first probe includes a third electrode coupled to the first circuitry and the second probe includes a fourth electrode coupled to the first circuitry.

29. Apparatus as defined in claim 27 further comprising a switch operatively coupled to the first and second circuitries for selectively activating either the first or second modes of concurrent operation.

30. Apparatus as defined in claim 27 further comprising a user interface for providing a sensory indication of the sensed parameter.

31. Apparatus as defined in claim 30 wherein the user interface provides a sensory indication, during the first mode of concurrent operation, corresponding to a degree of vascularity of the biological tissue to enable characterization of the degree of malignancy.

32. Apparatus as defined in claim 30, wherein the user interface comprises a visual display or an auditory device.

33. Apparatus as defined in claim 27, wherein the parameter indicative of a property of the biological tissue is selected from the group consisting of electrical impedance and dielectric constant.

34. Apparatus as defined in claim 27 wherein the second circuitry induces necrosis of the biological tissue by supplying a voltage to the first and second electrodes.

35. Apparatus as defined in claim 27, wherein the first and second electrodes comprise a material selected from the group consisting of platinum, silver, gold, stainless steel, and other biocompatible electrically conductive materials.