Low-power tissue sealing device and method

• US 10,166,064 B2
• Filed: 01/07/2016
• Issued: 01/01/2019
• Est. Priority Date: 06/07/2010
• Status: Active Grant

• Current Assignee: Bolder Surgical, LLC (Hologic Incorporated)
• Original Assignee: JustRight Surgical, LLC (Hologic Incorporated)
• Inventors: Kennedy, Jenifer, Schmaltz, Dale, Schechter, David, Helfer, Joel, Ross, David
• Primary Examiner(s): Kim, Eunhwa
• Application Number:
  US14/990,584
• Publication Number:
  US 20160192978A1
• Time in Patent Office: 1,090 Days
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1233 with circuits for assuring patient safety
• CPC Class Codes: A61B 18/1445 at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
• 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 2017/00141 continuous, e.g. wave
• CPC Class Codes: A61B 2018/00607 Coagulation and cutting with the same instrument
• CPC Class Codes: A61B 2018/00619 Welding
• CPC Class Codes: A61B 2018/0063 Sealing
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00708 switching the power on or off
• CPC Class Codes: A61B 2018/0072 Current
• CPC Class Codes: A61B 2018/00767 Voltage
• CPC Class Codes: A61B 2018/00875 Resistance or impedance

Abstract

A surgical system and method for fusing tissue are disclosed. The system has an electrosurgical generator capable of delivering electrosurgical power, a surgical instrument electrically connected to the electrosurgical generator and adapted to transfer the electrosurgical power from the electrosurgical generator to a distal end of the surgical instrument, and a power control circuit for controlling the delivery of radio frequency energy to the tissue in contact with the distal end of the surgical instrument. The surgical system is configured to: deliver the radio frequency energy at a non-pulsing power to the tissue for a period of time of 3 seconds or less, wherein the non-pulsing power is held constant, the output current is held under 2 Amperes RMS, and the output voltage is held under 100 Volts RMS, the non-pulsing power further causing the tissue to begin to desiccate and to fuse within the period of time.

Claims

1. A surgical system for fusing tissue, the surgical system comprising:

an electrosurgical generator capable of delivering electrosurgical power;

a surgical instrument electrically connected to the electrosurgical generator and adapted to transfer the electrosurgical power from the electrosurgical generator to a distal end of the surgical instrument, wherein the distal end of the surgical instrument has a pair of end effectors; and

a power control circuit configured to control the delivery of radio frequency energy to the tissue disposed between the pair of end effectors;

wherein the power control circuit is further configured to;

deliver the radio frequency energy at a non-pulsing power to the tissue for a period of time of 3 seconds or less, wherein the period of time is measured from the beginning of the application of the non-pulsing power and continues through fusing of the tissue, wherein the output current is held under 2 Amperes RMS, and the output voltage is held under 100 Volts RMS, the non-pulsing power further applying a current density of 0.1 Amperes per square millimeter or less to the tissue, the non-pulsing power further causing the tissue to begin to desiccate and to fuse within the period of time.

2. The surgical system of claim 1, wherein the radio frequency energy is delivered to the tissue with a current density of 0.04 Amperes per square millimeter or less.

3. The surgical system of claim 1, wherein the surgical system is configured to:

calculate an impedance of the tissue being fused; and

limit the flow of non-pulsing power when the impedance of the tissue being fused reaches a set impedance threshold within the period of time.

4. The surgical system of claim 1, wherein the surgical system is configured to:

calculate an impedance of the tissue being fused during the period of time; and

terminate the flow of the non-pulsing power when the impedance of the tissue being fused reaches a predetermined level.

5. The surgical system of claim 1, wherein each end effector of the pair of end effectors has a contacting surface area of less than 42 square millimeters.

6. The surgical system of claim 5, wherein the contacting surface area is between 8 and 22 square millimeters.

7. The surgical system of claim 1, wherein the non-pulsing power has an output current of between 0.2 and 1.75 Amperes RMS.

8. The surgical system of claim 1, wherein the non-pulsing power has an output current of between 0.75 and 1.00 Amperes RMS.

9. The surgical system of claim 1, wherein the non-pulsing power has a power output of 35 Watts or less.

10. The surgical system of claim 1, wherein the non-pulsing power has an output voltage of between 70and 90 Volts RMS.

11. The surgical system of claim 1, wherein the pair of end effectors are adapted to apply between 172 and 862 kPa of pressure to the tissue being fused.

12. The surgical system of claim 11, wherein the surgical system is configured to deliver the radio frequency energy at the non-pulsing power at a power of 35 Watts or less.

13. The surgical system of claim 1, wherein the pair of end effectors adapted to at least one of:

compress the tissue being fused between a gap of greater than 0.0 millimeters and 0.127 millimeters or less;

or apply between 448 and 758 kPa of pressure to the tissue being fused.

14. The surgical system of claim 1, wherein the pair of end effectors are adapted to:

compress the tissue to a gap of greater than 0.0 millimeters and less than or equal to 0.127 millimeters; and

apply pressure to the tissue therebetween 448 and 758 kPa.

41. The surgical system of claim 1, wherein the surgical system is configured to:

deliver the radio frequency energy to the tissue being fused with the current density of about 0.034 Amperes per square millimeter or more.

42. The surgical system of claim 1, wherein the surgical system is configured to:

deliver the radio frequency energy to the tissue being fused with the current density of about 0.04 Amperes per square millimeter.

15. A power control system for delivering radio frequency energy to a surgical instrument, the power control system comprising:

a power supply for delivering an output voltage and an output current to a distal end of the surgical instrument, wherein the distal end of the surgical instrument has a pair of end effectors;

a sensing circuit for detecting parameters indicative of an impedance of a tissue portion being fused; and

a power sequencing module for automatically sequencing an electrosurgical power delivered to the surgical instrument;

wherein the power sequencing module is adapted to;

apply non-pulsing power to the tissue portion disposed between the pair of end effectors for a period of time of 3 seconds or less, wherein the period of time is measured from beginning application of the application of the non-pulsing power through the beginning of a desiccation of the tissue portion and through a drying out and the fusing of the tissue portion, and wherein the output current is held under 2 Amperes RMS, and- the output voltage is held under 100 Volts RMS, and the output current applies a current density of 0.1 Amperes per square millimeter or less to the tissue portion being fused.

16. The power control system of claim 15, wherein the power sequencing module is adapted to terminate the flow of the non-pulsing power to the tissue portion being fused when the impedance of the tissue being fused reaches 150 ohms or more.

17. The power control system of claim 15, wherein the power sequencing module is further adapted to calculate an impedance of the tissue portion being fused through the sensing circuit during the period of time;

and limit the flow of the non-pulsing power to the tissue portion being fused by between 60 and 80% when the impedance of the tissue portion being fused reaches a set impedance threshold within the period of time.

18. The power control system of claim 15, wherein the power sequencing module is further adapted to reduce the non-pulsing power to the tissue portion being fused for a predetermined length of time prior to terminating the flow of the non-pulsing power to the tissue portion being fused.

19. The power control system of claim 15, wherein the power sequencing module is further adapted to calculate the impedance of the tissue portion being fused through the sensing circuit during the period of time;

and

terminating the flow of the non-pulsing power to the tissue portion being fused when the impedance of the tissue portion being fused reaches a predetermined level.

20. The power control system of claim 15, wherein the power sequencing module is further adapted to:

hold the non-pulsing power to 35 Watts or less.

21. The power control system of claim 15, wherein the power sequencing module is adapted to apply the-non-pulsing power to the tissue being fused with the current density of about 0.034 Amperes per square millimeter or more.

22. The power control system of claim 15, wherein the power sequencing module is adapted to apply the non-pulsing power to the tissue being fused with the current density of about 0.04 Amperes per square millimeter.

23. The power control system of claim 15, wherein the power sequencing module is adapted to apply the non-pulsing power at a power of 35 Watts or less.

24. A surgical system for fusing tissue, the surgical system comprising:

an electrosurgical generator capable of delivering electrosurgical power;

a surgical instrument electrically connected to the electrosurgical generator and adapted to transfer electrosurgical power from the electrosurgical generator to a distal end of the surgical instrument, wherein the distal end of the surgical instrument has a pair of end effectors; and

a power control circuit configured to control the delivery of radio frequency energy to the tissue disposed between the pair of end effectors;

wherein the power control circuit is further configured to

deliver a radio frequency energy to the tissue, the radio frequency energy having a non-pulsed power having an output current and an output voltage; and

apply the non-pulsed power to the tissue for a period of time while the output current is held under 2 Amperes RMS, and the output voltage is held under 100 Volts RMS, wherein the period of time is measured from beginning of the application of the non-pulsed power through fusing of the tissue, and the non-pulsed power applies a current density of 0.1 Amperes per square millimeter or less to the tissue, and the non-pulsed power further causes the tissue to begin to desiccate within the period of time, wherein the period of time is 3 seconds or less.

25. The surgical system of claim 24, wherein each end effector of the pair of end effectors has a contacting surface area of less than 42 square millimeters.

26. The surgical system of claim 24, wherein the power control circuit is further configured to:

calculate an impedance of the tissue being fused;

limit the flow of the non-pulsed power when the impedance of the tissue being fused reaches a set impedance threshold; and

terminate the flow of the non-pulsed power when the impedance of the tissue being fused reaches a predetermined level indicative that the tissue being fused is desiccated.

27. The surgical system of claim 24, wherein the power control circuit is further configured to:

limit the output voltage to a maximum of between 70 and 85 Volts.

28. A method of fusing tissue, the method comprising:

providing a surgical system having an electrosurgical generator and a surgical instrument electrically connected to the electrosurgical generator and adapted to transfer electrosurgical power from the electrosurgical generator to a distal end of the surgical instrument, wherein the distal end of the surgical instrument has a pair of end effectors;

positioning the tissue between the pair of end effectors;

delivering a radio frequency energy to the tissue, the radio frequency energy having a non-pulsed power having an output current and an output voltage; and

applying the non-pulsed power to the tissue for a period of time, the output current is held under 2 Amperes RMS, and the output voltage is held under 100 Volts RMS, wherein the period of time is measured from the beginning of the application of the non-pulsed power and continues through fusing of the tissue, and the non-pulsed power causes the tissue to begin to desiccate within the period of time, wherein the period of time is 3 seconds or less, and wherein the non-pulsed power applies a current density of 0.1 Amperes per square millimeter or less to the tissue.

29. The method of claim 28, further comprising:

limiting the output voltage to a maximum of between 70 and 85 Volts; and

limiting the non-pulsed power to a maximum of 35 Watts.

30. The method of claim 28, further comprising:

terminating the flow of the non-pulsed power to the tissue being fused when an impedance of the tissue being fused reaches 150 ohms or more.

31. The method of claim 28, further comprising:

terminating the flow of non-pulsed power when an impedance of the tissue being fused reaches a predetermined level indicative that the tissue being fused is desiccated.

32. The method of claim 28, further comprising at least one of:

compressing the tissue to a gap of greater than 0.0 millimeters and less than or equal to 0.127 millimeters;

or

applying pressure of between 448 and 758 kPa to compress the tissue between the pair of end effectors on the surgical instrument.

33. The method of claim 28, wherein the step of applying the non-pulsed power to the tissue applies the current density of between 0.034 and 0.1 Amperes per square millimeter.

34. The method of claim 28, wherein:

the tissue being fused comprises internal elastic laminae; and

the non-pulsed power causes the internal elastic laminae to fuse within the period of time.

35. The method of claim 28, wherein the step of applying the non-pulsed power to the tissue applies the current density of 0.034 Amperes per square millimeter or more.

36. The method of claim 28, wherein the step of applying the non-pulsed power to the tissue applies the current density of 0.04 Amperes per square millimeter.

37. The method of claim 28, further comprising delivering the non-pulsed power at a power of 35 Watts or less.

38. The method of claim 28, wherein the pair of end effectors are adapted to compress the tissue being fused between a gap of greater than 0.0 millimeters and 0.127 millimeters or less.

39. The method of claim 38, wherein the pair of end effectors are adapted to apply between 448 and 758 kPa of pressure to the tissue being fused.

40. The method of claim 28, further comprising:

compressing the tissue to a gap of greater than 0.0 millimeters and less than or equal to 0.127 millimeters; and

applying pressure of between 448 and 758 kPa to compress the tissue between the pair of end effectors on the surgical instrument.