Method and apparatus for ultrasonic surgical cutting and hemostatis

• US 5,026,387 A
• Filed: 03/12/1990
• Issued: 06/25/1991
• Est. Priority Date: 03/12/1990
• Status: Expired due to Term

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ultracision, Inc. (Giga-tronics, Inc.)
• Inventors: Thomas, Alan E.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): Shumaker, Steven J.
• Application Number:
  US07/492,491
• Time in Patent Office: 470 Days
• Field of Search: 604/22, 606/167-171, 310/316, 128/24 A, 433/86
• US Class Current: 606/169
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 2017/00115 with audible or visual output with imaging means A61B90/37, A61B34/20
• CPC Class Codes: A61B 2017/00973 pedal-operated
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2017/320082 for incising tissue
• CPC Class Codes: A61B 2017/320089 node location
• CPC Class Codes: B06B 1/0253 taken directly from the generator circuit
• CPC Class Codes: B06B 2201/40 with testing, calibrating, safety devices, built-in protection, construction details
• CPC Class Codes: B06B 2201/76 Medical, dental

Abstract

A power control arrangement for an ultrasonic surgical device such as a scalpel which provides power on demand in response to the continuous or periodic sensing of the loading condition (tissue contact or withdrawal) of the blade such that the device goes from a low power, idle state to a selectable high power, cutting state automatically depending on whether the scalpel is or is not in contact with tissue. A third, high power coagulation mode is manually selectable with automatic return to an idle power level when the blade is not in contact with tissue.

Claims

1. An ultrasonic surgical apparatus having at least two operating modes, said apparatus comprising:

an instrument for performing a surgical function including cutting and cauterization;

means for transmitting power at an ultrasonic frequency to the instrument at a relatively high level when in a first operating mode wherein the surgical function is to be effected and the load on said instrument is relatively high;

said means also transmitting power to the instrument at a relatively low level in a second operating mode wherein the surgical function is not be effected;

means responsive to said power transmitting means for sensing an electrical parameter with an instantaneous value indicative of a loaded or an unloaded condition wherein, respectively, the instrument is or is not in contact with a medium on which the surgical function is to be performed;

means responsive to said sensing means for operating the means for transmitting in said first operating mode when the instrument is in contact with said medium and for operating the transmitting means in said second mode when the instrument is not in contact with said medium.

2. The apparatus in claim 1 wherein the instrument includes a cutting means.

3. The apparatus of claim 1 wherein the means for transmitting includes means for selecting one of a plurality of high level power settings when in said first operating mode and wherein each setting is a percentage of maximum cutting power.

4. The apparatus of claims 2 or 3 wherein the power applied to the cutting instrument is sufficiently high in said first operating mode as to cause relatively high ultrasonic vibratory movement of said instrument, which results in increased cutting efficiency and a zone of thermal coagulation at the incision.

5. The apparatus as in claim 4 wherein said parameter is driving current.

6. The apparatus of claim 1 further including:

manual switch means;

means responsive to said switch means for causing said means for transmitting to operate in a third mode so as to substantially produce its maximum power output and approximate maximum ultrasonic vibratory movement and maximum heating of said cutting instrument.

7. The apparatus as specified in claim 6 including further means for causing the transmitting means to switch from said third operating mode to said second operating mode when the sensing means indicates that the cutting instrument is not in contact with said medium.

8. The apparatus as in claim 7 wherein said parameter is driving current.

9. The apparatus of claim 8 wherein about a 3% or greater current decrease in the unloaded condition is required to cause said means for transmitting to shift from aid second operating mode to said first operating mode.

10. In an ultrasonic cutting instrument having at least two operating modes, the method of supplying power to said instrument comprising:

transmitting power at an ultrasonic frequency to the cutting instrument at a relatively high level when in a first operating mode wherein cutting is to be effected and the load on said cutting instrument is relatively high;

transmitting power at an ultrasonic frequency to the cutting instrument at a relatively low level in a second operating mode wherein cutting is not to be effected;

sensing an electrical parameter with an instantaneous value which is indicative of a loaded or unloaded condition where, respectively, the cutting instrument is or is not in contact with a medium to be cut;

operating in said first mode when contact with the medium is sensed; and

operating in said second mode when contact with the medium is not sensed.

11. The method of claim 10 wherein said first operating mode includes a plurality of selectable high level power settings each representative of a percentage of maximum cutting power and the method further includes the step of selecting one of said plurality of settings.

12. The method of claims 10 or 11 wherein the power transmitted to the cutting instrument in said first operating mode is sufficiently high as to cause sufficient ultrasonic vibratory movement of said instrument as to result in increased cutting efficiency and increased thermal energy in a localized area of the cutting instrument.

13. The method as specified in claim 10 further including the step of causing power to be transmitted at an ultrasonic frequency to the cutting instrument in a third operating mode so as to substantially produce its maximum ultrasonic vibratory movement and maximum heating of the cutting instrument.

14. The method as specified in claim 13 further including the step of causing the cutting instrument to switch from said third operating mode to said second operating mode when non-contact with said medium is sensed.

15. The method of claim 10 wherein the cutting instrument is a scalpel and the sensed parameter is drive current.

16. The method of claim 15 further including the step of causing the instrument to cease operating in said second mode when about a 3% or greater current decrease is sensed when in the unloaded condition.

17. The method as specified in claim 16 further including the step of causing operation of the instrument in said first mode to cease when the sensed current is approximately 95% or more of a stored maximum threshold value.

18. A process of operating an ultrasonic instrument, said instrument having at least two operating modes, the process comprising the steps of:

operating the instrument in a first power mode wherein the power applied is sufficiently high as to cause the instrument to exhibit ultrasonic vibratory movement;

operating the instrument in a second power mode wherein power is applied at a level sufficient to monitor electrical operating parameters but is sufficiently reduced as to substantially eliminate any ultrasonic vibratory movement;

monitoring an operating parameter which is indicative of whether or not the instrument is in contact with a medium on which the instrument is to operate;

causing the instrument to operate in said first power mode when it is in contact with said medium; and

causing the instrument to operate in said second power mode when it is not in contact with said medium.

19. The method of claim 18 wherein said medium is physiological tissue, said instrument is for use in incising and cauterizing said tissue and wherein the power applied in said first mode is sufficiently high as to produce sufficient vibratory movement to cause an increase in cutting efficiency of the instrument as well as causing a zone of thermal coagulation of the incision which reduces or eliminate bleeding.

20. The method of claim 19 wherein operating the surgical instrument in said first power mode includes the step of selecting one of a plurality of high level power settings wherein each setting is equal to a percentage of maximum cutting power.

21. The process of claim 19 or 20 further including the steps of operating the surgical instrument in a third power mode so as to substantially produce its maximum ultrasonic vibratory movement and maximum heating of said cutting instrument.

22. The process of claim 21 including the further step of causing the operation of the surgical instrument to shift from operating in said third mode to operating in said second mode when loss of contact between the cutting instrument and tissue is detected.

23. The process of claim 20 wherein the operating parameter to be monitored is driving current and a 5% or greater decrease in the non-contact current is required to cause the instrument to begin operating in said first power mode.

24. An ultrasonic apparatus for use in surgical incising and cauterizing of tissue, the apparatus comprising:

a surgical instrument;

a power element operative in a first mode of operation to supply driving power to said instrument that is of a sufficient level to cause ultrasonic vibratory movement of the instrument, and operative in a second mode to supply sufficient power to said instrument to monitor electrical operating parameters but insufficient to cause substantial ultrasonic movement of the instrument;

a feedback network responsive to said power element for detecting said operating parameters;

a processing circuit responsive to said feedback network for monitoring at least one of said parameters for detecting whether or not said instrument is in contact with tissue,

said processing circuit causing said power element to operate in said first mode when said tissue contact is detected and in said second mode when no contact is detected.

25. The ultrasonic apparatus of claim 24 wherein said surgical instrument is a scalpel.

26. The ultrasonic apparatus as in claim 25 further comprising an input means connected to said processing circuit for selecting one of a plurality of driving power levels for use in said first mode of operation wherein each of said plurality of levels represents a percentage of maximum cutting power,

said processing circuit causing said power element to operate at the selected power level when said tissue contact is detected.

27. An ultrasonic apparatus as specified in claim 26 wherein said power element is operative in a third mode of operation to supply substantially maximum driving power so as to substantially produce maximum ultrasonic vibratory movement and maximum heating of said cutting instrument,

said apparatus further including a manual selection means connected to said processing circuit for causing said power element to operate in said third mode.

28. An ultrasonic apparatus as specified in claim 27 wherein the processing circuit upon detecting no tissue contact will cause said power element to switch from either said first or said third modes to said second mode of operation.

29. An ultrasonic apparatus as specified in claim 28 wherein said parameter for determining whether or not said instrument is in contact with tissue is driving current.

30. The ultrasonic apparatus as specified in claim 29 wherein the processing circuit will cause the power element to shift from said second mode to said first mode of operation only if a 5% of greater decrease in current is sensed.

31. The ultrasonic apparatus as in claim 30 wherein the frequency of the ultrasonic vibratory movement is approximately 55 kilohertz.

32. The ultrasonic apparatus as in claim 31 wherein the ultrasonic driving power delivered in said first mode is sufficiently high at each of the selectable levels as to cause sufficient ultrasonic vibratory movement of the scalpel blade so as to result in increased cutting efficiency as well as producing a narrow zone of white thermal coagulation.

33. The ultrasonic apparatus of claim wherein the power delivered in said third mode of operation causes sufficient heating of the scalpel blade as to obtain white thermal and coaptive coagulation of vessels up to 4 mm in diameter.

34. The ultrasonic apparatus as in claim 33 wherein the processing circuit includes a storage device storing an upper current threshold value and said processor causes the power element to switch to said second mode of operation from said first or third modes of operation when said driving current equals or exceeds said threshold value.