Bonding of soft biological tissues by passing high frequency electric current therethrough

• US 6,562,037 B2
• Filed: 02/12/1998
• Issued: 05/13/2003
• Est. Priority Date: 02/12/1998
• Status: Expired due to Term

• Current Assignee: BioFuse Medical Technologies, Inc.
• Original Assignee: Live Tissue Connect, Inc. (CSMG Technologies, Inc.)
• Inventors: Lebedev, Vladimir K., Zhyvodernikov, Yevgen V., Lebedev, Alexsey V., Furmanov, Alexandr Y., Lyashenko, Andrei A., Ivanova, Olga N., Vorona, David S., Sidorenko, Dmitry F., Iemchenko-Ribko, Vitaly P., Vasilchenko, Valery A., Karchemsky, Volodimir I., Furmanov, Yuri A., Savitskaya, Irina M., Paton, Boris E.
• Primary Examiner(s): Kearney, Rosiland S.
• Application Number:
  US09/022,869
• Publication Number:
  US 20020091385A1
• Time in Patent Office: 1,916 Days
• Field of Search: 606/32, 606/33, 606/34, 606/35, 606/41, 606/42, 606/45, 606/46, 606/50, 606/51, 606/52
• US Class Current: 606/51
• 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 2018/0063 Sealing
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00672 lower
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/1462 Tweezers
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself

Abstract

A technique for bonding soft biological tissue having an incision therein with forceps adapted to grip a portion of the tissue on both sides of the incision. Electrodes are secured to the forceps for contacting the tissue portion. An electrical power source provides a high frequency electrical signal to the electrodes to be passed through the tissue portion. The electrical power source is controlled to provide the electrodes with one voltage signal during a first of two stages, and another voltage signal during a second of the two stages. During the first stage the voltage rises linearly. During the second stage, the voltage is stabilized and is modulated with a low frequency rectangular signal. A clamping means applies force with the forceps to compress the tissue at one level or at different levels during two time periods while the high frequency voltage is passed through the electrodes. The tissue impedance is measured as a function of time, with its minimal value being determined and stored. At an instant when the impedance reaches its minimal value, the linear rise of the high frequency voltage is stopped, and the voltage is stabilized at the attained level. After that the ratio of the tissue impedance to its minimal value is determined as a function of time. The passing of the high frequency voltage to the electrodes is stopped as soon as such ratio reaches a preset value, which is specific for each tissue being bonded. The material for making electrodes is selected so that the electrode may serve as an effective heat sink for conducting heat away from the tissue surface. The electrodes are dimensioned relative to the thickness of tissue in a compressed state.

Claims

1. Apparatus for bonding an incision or split in soft biological tissue, the incision or split dividing the tissue into first and second portions, the apparatus comprising:

a first electrode to contact the first portion of the tissue;

a second electrode to contact the second portion of the tissue;

means to apply pressure to the first and second electrodes to grip the first and second portions of the tissue;

an electrical power source for providing a high frequency electrical signal to said electrodes to be passed through said first and second portions of said tissue; and

control means coupled to said electrical power source to provide said electrodes with one voltage signal during a first of two stages, and another voltage signal during a second of said two stages, wherein the voltage signal during the second stage is sustained at a constant level equivalent to a maximum voltage of the first stage voltage signal to provide tissue welding that forms a weld to reconnect the tissue.

2. The apparatus of claim 1, wherein said control means controls the voltage signal of said first stage to have a varying level.

3. The apparatus of claim 2, wherein said control means provides a constant rate of increase in the voltage of said voltage signal during said first stage.

4. The apparatus of claim 3, wherein said constant rate of increase begins at a voltage of zero.

5. The apparatus of claim 3, wherein said constant rate of increase reaches a maximum voltage during said first stage equal to said constant voltage level applied during said second stage.

6. The apparatus of claim 2, further comprising means for measuring impedance of said tissue, wherein said control means controls duration of said first stage in response to said measured impedance.

7. The apparatus of claim 6, wherein said control means controls said constant voltage level of said signal during said second stage based on said measured impedance.

8. The apparatus of claim 7, wherein said control means controls duration of said second stage based on a relative tissue impedance value derived from a ratio of said measured impedance value to a minimal impedance value thereof.

9. The apparatus of claim 2, further comprising means for measuring impedance of said tissue as a function of time, means for detecting an impedance minimum of said tissue after said first stage commences, wherein said control means controls duration of said first stage in response to occurrence of said impedance mimimum.

10. The apparatus of claim 9, wherein said control means controls said constant level of said signal based on occurrence of said impedance minimum.

11. The apparatus of claim 2, wherein said control means controls duration of said second stage by terminating said second stage when a current measured tissue impedance value rises to a level equal to a predetermined ratio of the current measured value tissue impedance value of a minimum measured tissue impedance value.

12. The apparatus of claim 1, wherein said electrodes are adapted to engage said tissue portions when said first and second tissue portions are joined together in the form of a flange which includes joined edges of tissue from both sides of said incision and said electrodes are further adapted to engage opposite sides of said flange.

13. The apparatus of claim 12, wherein the forceps includes clamping means for applying force to clamp the flange between said electrodes to thereby compress said tissue portion.

14. The apparatus of claim 13, wherein said clamping means compresses said flange during said first and second stages.

15. The apparatus, of claim 13, wherein the clamping means controls said force applied to said flange to a predetermined level.

16. The apparatus of claim 13, wherein said clamping means is mechanical.

17. The apparatus of claim 13, wherein said clamping means is electromagnetic.

18. The apparatus of claim 14, wherein said clamping means continues to compress said flange for a time period after said second stage is completed.

19. The apparatus of claim 18, wherein the clamping means increases said force during said second stage.

20. The apparatus of claim 1, wherein the power source provides a frequency between 50 kHz and 300 kHz.

21. Apparatus for bonding soft biological tissue having an incision therein, comprising:

forceps adapted to grip a portion of the tissue on both sides of the incision;

electrodes adapted to contact said tissue portion;

an electrical power source for providing a high frequency electrical signal to said electrodes to be passed through said tissue portion; and

control means coupled to said electrical power source to provide said electrodes with a first voltage signal during a first of two stages, and a second voltage signal during a second of said two stages, wherein said control means modulates said second voltage level during at least said second stage by a low frequency signal to provide tissue welding that forms a weld to reconnect the tissue.

22. The apparatus of claim 21, wherein said low frequency signal is in the range of 4 Hz and 6 kHz.

23. Apparatus for bonding soft biological tissue having an incision therein, comprising:

forceps adapted to grip a portion of the tissue on both sides of the incision;

electrodes adapted to contact said tissue portion;

an electrical power source for providing a high frequency electrical signal to said electrodes to be passed through said tissue portion; and

control means for providing a constant voltage level of said signal during at least a portion of a time period when said high frequency electrical energy is passed through said tissue portion, and for modulating said constant level by a low frequency signal to provide tissue welding that forms a weld to reconnect the tissue.

24. The apparatus of claim 23, wherein the frequency of said low frequency signal is in the range of 4 Hz to 6 kHz.

25. The apparatus of claim 24, wherein said low frequency signal is a substantially square pulse.

26. Apparatus for bonding soft biological tissue having an incision therein, comprising:

forceps adapted to grip a portion of the tissue on both sides of the incision;

electrodes adapted to contact said tissue portion;

an electrical power source for providing an electrical signal to said electrodes to be passed through said tissue portion;

means for providing a gradually increasing electrical signal to said tissue portion;

means for measuring an impedance of said tissue portion as a function of time while said electrical signal passes through said tissue portion;

means for determining and memorizing a minimum impedance while a gradually increasing electrical signal passes through said tissue portion;

means for stabilization of the electrical signal at a level correspoinding to said minimum value of tissue impedance at a time following said period of gradual increase of the electrical signal;

means for determining said tissue portion impedance relative to its said minimum value while said electrical signal passes through said tissue poirtion after the impedance has reached its minimum value; and

means for stopping said electrical signal from being passed through said tissue portion when said tissue portion impedance value relative to its minimum impedance value reaches a preset level, said preset level being specific in particular to the biological tissue being bonded.

27. The apparatus of claim 26, wherein said measuring means includes a voltage sensor, a current sensor and means to calculate a ratio therebetween.

28. Apparatus for bonding soft biological tissue having an incision therein, comprising:

forceps adapted to grip a portion of the tissue on both sides of the incision;

electrodes adapted to contact said tissue portion in an electrode/tissue contact area;

an electrical power source for providing a high frequency electrical signal to said electrodes to be passed through said tissue portion; and

wherein a dimension of said electrodes is selected relative to a thickness of said tissue portion in order to avoid overheating of the electrodes to provide tissue welding that forms a weld to reconnect the tissue.

29. The apparatus of claim 28, wherein said electrodes are dimensioned such that a linear dimension of said electrode/tissue contact area is at least as large as a thickness of said tissue portion.

30. Apparatus for bonding soft biological tissue having an incision therein, comprising:

forceps adapted to grip a portion of the tissue on both sides of the incision;

electrodes adapted to contact said tissue portion;

an electrical power source for providing an electrical signal to said electrodes to be passed through said tissue portion, wherein said signal includes a high frequency signal modulated by a low frequency signal;

means for measuring impedance of said tissue portion as a function of time while said electrical signal passes through said tissue portion;

means for determining and storing a minimal value of tissue impedance while said electrical signal passes through said tissue portion;

means for determining more than one ratio of said measured tissue portion impedance to said minimal value of tissue impedance while said electrical signal passes through said tissue portion after said impedance reaches its minimal value; and

means for stopping said electrical signal from being passed through said tissue portion when said impedance ratio reaches a preset value, said preset value being specific for each bonded biological tissue.

31. The apparatus of claim 30 wherein the high frequency signal is in the range of 50 Kilohertz to 1 Megahertz, and further wherein said high frequency signal is modulated by the low frequency signal, said low frequency signal being in the rane of 4 Hertz to 6 Kilohertz.