System and method for control of tissue welding

• US 6,733,498 B2
• Filed: 02/19/2002
• Issued: 05/11/2004
• Est. Priority Date: 02/19/2002
• Status: Active Grant

• Current Assignee: BioFuse Medical Technologies, Inc.
• Original Assignee: Live Tissue Connect, Inc. (CSMG Technologies, Inc.)
• Inventors: Lebedev, Alexei V., Masalov, Yurii A., Zakharash, Mykhailo P., Lebedev, Vladimir K., Ivanova, Olga N., Furmanov, Yuri A., Paton, Boris E.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): ROANE, AARON F
• Application Number:
  US10/078,828
• Publication Number:
  US 20030158551A1
• Time in Patent Office: 812 Days
• Field of Search: 606/32, 606/41, 606/45, 606/49
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1442 Probes having pivoting end effectors, e.g. forceps
• CPC Class Codes: A61B 2018/00619 Welding
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00761 Duration
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00886 Duration

Abstract

A system and method for welding of biological tissue by applying an RF voltage during a first stage to electrodes of a tissue welding tool; monitoring tissue impedance, and determining a minimum tissue impedance value during the first stage; determining relative tissue impedance; detecting when the relative tissue impedance reaches a predetermined relative tissue impedance value and starting a second stage; calculating the duration of the second stage as a function of the duration of the first stage; and applying the RF voltage during the second stage to the electrodes of the tissue welding tool.

Claims

1. A method for welding of biological tissue comprising:

(a) applying an RF voltage during a first stage to electrodes of a tissue welding tool;

(b) monitoring tissue impedance, and determining a minimum tissue impedance value during the first stage;

(c) determining relative tissue impedance, the relative tissue impedance being equal to the ratio of tissue impedance to the minimum tissue impedance value;

(d) detecting when the relative tissue impedance reaches a predetermined relative tissue impedance value;

(e) starting a second stage when the relative tissue impedance reaches the predetermined relative tissue impedance value;

(f) calculating the duration of the second stage as a function of the duration of the first stage; and

(g) applying the RF voltage during the second stage to the electrodes of the tissue welding tool.

2. The method of claim 1 wherein the amplitude of the RF voltage applied during the first stage increases according to the following equation:

3. The method of claim 1 wherein monitoring tissue impedance of step (b) comprises measuring the RF voltage and electric current between the electrodes of the tissue welding tool and calculating tissue impedance by dividing the voltage by the electric current.

4. The method of claim 1 wherein the predetermined relative tissue impedance value is calculated as a function of the RF voltage during the first stage.

5. The method of claim 1 wherein the predetermined relative tissue impedance value is within the range of about 1-1.5.

6. The method of claim 1 wherein the RF voltage applied during the second stage is calculated as a function of the value of the RF voltage applied during the first stage when the relative tissue impedance reaches the predetermined relative tissue impedance value.

7. The method of claim 1 wherein the RF voltage applied during the second stage is between about 50-100% of the value of the RF voltage applied at the end of the first stage.

8. The method of claim 1 wherein applying the RF voltage during the second stage comprises substantially stabilizing the RF voltage applied during the second stage.

9. The method of claim 1 further comprising modulating the RF voltages applied during the first and second stages by pulses.

10. The method of claim 9 wherein the pulses have a frequency of between about 100 Hz-60 kHz and a duty cycle of between about 10-90%.

11. The method of claim 9 wherein the frequency of the pulses is varied during the first and second stages.

12. The method of claim 1 further comprising modulating the RF voltages applied during the first and second stages with pulses having a frequency of between about 100 Hz-60 kHz, and further modulating the RF voltage applied during the second stage with low frequency pulses.

13. The method of claim 12 further comprising substantially stabilizing the amplitude of the RF voltage applied during the second stage, wherein the amplitude of the RF voltage is calculated as a function of the value of the RF voltage at the end of the first stage.

14. The method of claim 12 wherein the frequency of the low frequency pulses is defined as a function of the duration of the first stage.

15. The method of claim 12 wherein the frequency of the low frequency pulses is defined such that there are between about 5-10 pulses during the second stage.

16. The method of claim 1 wherein applying the RF voltage during the second stage comprises varying the RF voltage as a function of the relative tissue impedance.

17. The method of claim 16 further comprising substantially stabilizing the relative tissue impedance at a relative tissue impedance level reached at the end of the first stage.

18. The method of claim 16 wherein the RF voltage applied during the second stage is varied as a function of the relative tissue impedance by reducing the RF voltage when the relative tissue impedance is greater than the predetermined relative tissue impedance value and increasing the RF voltage when the relative tissue impedance is less than the predetermined relative tissue impedance value.

19. The method of claim 1 wherein applying the RF voltage during the second stage comprises varying the RF voltage to vary the relative tissue impedance according to a preset program.

20. The method of claim 1 further comprising modulating the RF voltages applied during the first and second stages with pulses having a frequency of between about 100 Hz-60 kHz, and further modulating the RF voltage applied during the second stage with low frequency pulses, and further comprising substantially stabilizing the relative tissue impedance at a relative tissue impedance level reached at the end of the first stage.

21. The method of claim 20 wherein the frequency of the low frequency pulses is defined as a function of the duration of the first stage.

22. The method of claim 20 wherein the frequency of the low frequency pulses is defined such that there are between about 5-10 pulses during the second stage.

23. The method of claim 20 wherein stabilizing the relative tissue impedance is performed by a regulatory system.

24. The method of claim 23 wherein the regulatory system stabilizes the relative tissue impedance by varying the RF voltage by a predetermined amount, the RF voltage being varied based on the direction of change of the relative tissue impedance.

25. The method of claim 1 further comprising modulating the RF voltages applied during the first and second stages with pulses having a frequency of between about 100 Hz-60 kHz, and further modulating the RF voltage applied during the second stage with low frequency pulses, and further comprising varying the RE voltage to vary the relative tissue impedance according to a preset program.

26. The method according to claim 25 wherein varying the relative tissue impedance is performed by a regulatory system.

27. The method of claim 1 further comprising monitoring tissue welding, and stopping tissue welding and providing a signal to a user if the RF voltage applied during the first stage reaches a preset RF voltage level and/or if the relative tissue impedance fails to reach the predetermined relative tissue impedance value.

28. The method of claim 1 further comprising monitoring tissue welding and stopping tissue welding and providing a signal to a user when the tissue impedance reaches a short circuit impedance of the electrodes of the tissue welding tool.

29. The method of claim 1 further comprising monitoring tissue welding and providing a signal to a user after tissue welding is completed at the end of the second stage and the welded tissue has sufficiently cooled.

30. A control method for welding of biological tissue comprising:

(a) applying an increasing RF voltage to the electrodes of a tissue welding tool during a first stage;

(b) measuring the values of the RF voltage and electric current passing through the tissue, and the duration of the first stage;

(c) calculating tissue impedance values by dividing the RF voltage values by the electric current values;

(d) determining a minimum tissue impedance value;

(e) storing the minimum tissue impedance value;

(f) calculating relative tissue impedance values by dividing of the tissue impedance values by the minimum tissue impedance value;

(g) stopping the first stage when the relative tissue impedance reaches an endpoint relative tissue impedance value calculated as a function of the relative tissue impedance;

(h) storing the duration of the first stage and a value of the RF voltage at the end of the first stage;

(i) calculating an RF voltage level for a second stage as a function of the value of the RF voltage at the end of the first stage;

(j) calculating the duration of the second stage as a function of the duration of the first stage; and

(k) applying an RF voltage during the second stage at the RF voltage level calculated in step (i).

31. A control method for welding of biological tissue comprising:

(a) applying an increasing RF voltage to the electrodes of a tissue welding tool during a first stage;

(b) measuring the values of the RF voltage and electric current passing through the tissue, and the duration of the first stage;

(c) calculating tissue impedance values by dividing the RF voltage values by the electric current values;

(d) determining a minimum tissue impedance value;

(e) storing the minimum tissue impedance value;

(f) calculating relative tissue impedance values by dividing the tissue impedance values by the minimum tissue impedance value;

(g) stopping the RF voltage increase when the relative tissue impedance reaches an endpoint relative tissue impedance value calculated as a function of the relative tissue impedance;

(h) storing the duration of the first stage and the RF voltage at the end of the first stage;

(i) calculating an RF voltage level for a second stage as a function of the value of the RF voltage at the end of the first stage;

(j) calculating the duration of the second stage as a function of the duration of the first stage;

(k) calculating a modulation frequency as a function of the duration of the first stage; and

(l) applying an RF voltage at the RF voltage level calculated in step (i) for the duration of the second stage calculated in step (j), and modulating the RF voltage by pulses at the modulation frequency calculated in step (k).

32. A control method for welding of biological tissue comprising:

(a) applying an increasing RF voltage to the electrodes of a tissue welding tool during a first stage;

(b) measuring the values of the RF voltage and electric current passing through the tissue, and the duration of the first stage;

(c) calculating tissue impedance values by dividing the RF voltage values by the electric current values;

(d) determining a minimum tissue impedance value;

(e) storing the minimum tissue impedance value;

(f) calculating relative tissue impedance values by dividing the tissue impedance values by the minimum tissue impedance value;

(g) stopping the first stage when the relative tissue impedance reaches an endpoint relative tissue impedance value calculated as a function of the relative tissue impedance;

(h) storing the duration of the first stage and value of the RF voltage at the end of the first stage;

(i) calculating the duration of the second stage as a function of the duration of the first stage; and

(j) applying the RF voltage during the second stage, wherein the RF voltage is varied as a function of the relative tissue impedance during the second stage.

33. A control method for welding of biological tissue comprising:

(a) applying an increasing RF voltage to the electrodes of a tissue welding tool during a first stage;

(b) measuring the values of the RF voltage and electric current passing through the tissue, and the duration of the first stage;

(c) calculating tissue impedance values by dividing the RF voltage values by the electric current values;

(d) determining a minimum tissue impedance value;

(e) storing the minimum tissue impedance value;

(f) calculating relative tissue impedance values by dividing the tissue impedance values by the minimum tissue impedance value;

(g) stopping the first stage when the relative tissue impedance reaches an endpoint relative tissue impedance value calculated as a function of the relative tissue impedance;

(h) storing the duration of the first stage and a value of the RF voltage at the end of the first stage;

(i) calculating an initial RF voltage level for a second stage as a function of the value of the RF voltage at the end of the first stage;

(j) calculating the duration of the second stage as a function of the duration of the first stage;

(k) calculating a modulation frequency as a function of the duration of the first stage; and

(l) applying an RF voltage for the duration of the second stage calculated in step (j), initially setting the amplitude of the RF voltage to the initial RF voltage level calculated in step (i), modulating the RF voltage by pulses at the modulation frequency calculated in step (k), and varying the amplitude of the RF voltage as a function of the relative tissue impedance.

34. The method of claim 33 further comprising stabilizing the relative tissue impedance at the endpoint relative tissue impedance value.

35. The method of claim 34 wherein stabilizing the relative tissue impedance is performed by a regulatory system which stabilizes the relative tissue impedance by varying the amplitude of the RF voltage by a predetermined amount, the RF voltage being varied based on the direction of change of the relative tissue impedance.

36. The method of claim 33 wherein varying the RF voltage of step (I) comprises varying the RF voltage to vary the relative tissue impedance according to a preset program.