Apparatus and method for rapid reliable electrothermal tissue fusion and simultaneous cutting

• US 9,498,277 B2
• Filed: 02/01/2007
• Issued: 11/22/2016
• Est. Priority Date: 02/01/2007
• Status: Expired due to Fees

• Current Assignee: Conmed Corporation (Jefferies Financial Group, Inc.)
• Original Assignee: Conmed Corporation (Jefferies Financial Group, Inc.)
• Inventors: McGreevy, Francis T., Pavlovsky, Katherine R.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): GOOD, SAMANTHA M
• Application Number:
  US11/701,884
• Publication Number:
  US 20080188844A1
• Time in Patent Office: 3,582 Days
• Field of Search: 606/45, 606/48, 606 51- 52
• US Class Current: 1/1
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/085 Forceps, scissors
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1442 Probes having pivoting end effectors, e.g. forceps
• CPC Class Codes: A61B 2018/00601 Cutting
• CPC Class Codes: A61B 2018/0063 Sealing
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00714 Temperature
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/00922 by switching or controlling the treatment energy directly within the hand-piece
• CPC Class Codes: A61B 2018/1415 multiple blades
• CPC Class Codes: A61B 2018/1455 having a moving blade for cutting tissue grasped by the jaws

Abstract

Pieces of tissue are fused together and simultaneously cut by compressing the pieces together at an interface, delivering an impulse of electrical power which is converted into sufficient thermal energy to fuse the pieces together at the interface and simultaneously cut the fused tissue pieces along a well-defined linear path. The impulse, and the fusion and the simultaneous cutting, occur within a preferable time of 1.5-2.0 seconds but no greater than 4.0 seconds. The temperature of the thermal energy is regulated between 220° C.-320° C. The force applied on the tissue pieces is sufficient to fuse the tissue at the interface followed by further compression to cut the fused tissue along the linear path as a result of the thermal energy and a zero distance gap between jaws which compress the tissue pieces. The jaws have smooth working surfaces with an Ra of 0.15 or less microns up to 0.40 microns.

Claims

1. Apparatus adapted to fuse together two pieces of biological tissue at a tissue fusion interface of a sealed area and adapted to simultaneously cut the fused tissue along a predetermined defined path through the sealed area in a fusion and simultaneous cutting procedure, comprising:

an instrument including an upper jaw and a lower jaw each of the jaws comprising

a heating element that develops a thermal energy in response to an electrical power impulse supplied thereto,

a working surface which is adapted to contact one of the two pieces of biological tissue and transfer the thermal energy from the working surface to the contacted piece of tissue, the working surface having a longitudinal dimension,

a temperature sensor which supplies a sensed temperature signal related to a temperature of the working surface;

a movement mechanism operative to move the upper and the lower jaws toward one another and adapted to compress the two pieces of tissue together between the working surface of the upper jaw and the working surface of the lower jaw to a fusion thickness sufficient to fuse the two pieces of tissue together at the tissue fusion interface of the sealed area from a combination of a compression and the thermal energy followed by an additional compression of the two pieces of tissue to a zero thickness to cut the previously fused two pieces of tissue along the predetermined defined path through the sealed area from a combination of the additional compression and the thermal energy, and the movement mechanism is adapted to move the working surface of the upper jaw and the working surface of the

lower jaw toward one another with the longitudinal dimension of the working surface of the upper jaw parallel to the longitudinal dimension of the working surface of the lower jaw during the compression and the additional compression of the two pieces of tissue for fusion and cutting, respectively, the longitudinal dimension of each of the working surface of the upper jaw and the working surface of the lower jaw aligning with the predetermined defined path of cutting through the sealed area, wherein the movement mechanism is operative to transfer a force from the working surfaces during compression of the two pieces of tissue, the force being measurable to create a force signal that is compared to determine when the compression has been applied to the two pieces of tissue; and

a power control device connected to the instrument, the power control device being responsive to the force signal and to each of the sensed temperature signals to regulate a duration and an amount of electrical energy provided in each of the electrical power impulse supplied to the upper jaw and the electrical power impulse being supplied to the lower jaw to create the thermal energy transferred from the respective working surfaces to fuse and simultaneously cut the two pieces of tissue at the sealed area, the power control device limiting the duration for each of the electrical power impulse supplied to the upper jaw and the electrical power impulse supplied to the lower jaw to no greater than 4.0 seconds, the power control device controlling the amount of electrical energy provided in each of the electrical power impulse supplied to the upper jaw and the electrical power impulse supplied to the lower jaw to first attain and then maintain a predetermined temperature in the range of 220°

C. to 320°

C. at each of the upper jaw and the lower jaw, respectively, during the duration.

2. Apparatus as defined in claim 1, wherein the duration of each of the electrical power impulse supplied to the upper jaw and the electrical power impulse supplied to the lower jaw is no greater than 2.0 seconds.

3. Apparatus as defined in claim 2, wherein the two pieces of tissue are apposite walls of a blood vessel.

4. Apparatus as defined in claim 3, wherein:

each of the electrical power impulses produces an energy density at the respective working surface of at least 388 W/cm² of an effective area of the respective working surface;

each of the upper jaw and the lower jaw and their respective working surfaces are formed of ceramic material having a thermal conductivity of at least 140 W/m°

K;

each of the working surfaces has a smoothness defined by an Ra of 0.40 microns or less; and

the movement mechanism is adapted to produce pressure on the two pieces of tissue at the tissue fusion interface of at least 0.88 N/mm² of the effective area of one of the working surfaces.

5. Apparatus as defined in claim 1, wherein the duration of each of the electrical power impulse supplied to the upper jaw and the electrical power impulse supplied to the lower jaw is approximately 1.5 seconds.

6. Apparatus as defined in claim 5, wherein the two pieces of tissue are apposite walls of a blood vessel.

7. Apparatus as defined in claim 6, wherein:

each of the electrical power impulses produces an energy density at the respective working surface of at least 388 W/cm² of an effective area of the respective working surface;

each of the upper jaw and the lower jaw and their respective working surfaces are formed of ceramic material having a thermal conductivity of at least 140 W/m°

K;

each of the working surfaces has a smoothness defined by an Ra of 0.40 microns or less; and

the movement mechanism is adapted to produce pressure on the two pieces of tissue at the tissue fusion interface of at least 0.88 N/mm² of the effective area of one of the working surfaces.

8. Apparatus as defined in claim 1, wherein the duration of each of the electrical power impulse supplied to the upper jaw and the electrical power impulse supplied to the lower jaw is in the range of 1.5 seconds to 2.0 seconds.

9. Apparatus as defined in claim 8, wherein the two pieces of tissue are apposite walls of a blood vessel.

10. Apparatus as defined in claim 9, wherein:

each of the electrical power impulses produces an energy density at the respective working surface of at least 388 W/cm² of an effective area of the respective working surface;

each of the upper jaw and the lower jaw and their respective working surfaces are formed of ceramic material having a thermal conductivity of at least 140 W/m°

K;

each of the working surfaces has a smoothness defined by an Ra of 0.40 microns or less; and

the movement mechanism is adapted to produce pressure on the two pieces of tissue at the tissue fusion interface of at least 0.88 N/mm² of the effective area of one of the working surfaces.

11. Apparatus as defined in claim 1, wherein the amount of electrical energy provided in each of the electrical power impulse supplied to the upper jaw and the electrical power impulse supplied to the lower jaw attains the temperature of each of the working surface of the upper jaw and working surface of the lower jaw at a rate of between 150°

C. per second to 500°

C. per second.

12. Apparatus as defined in claim 1, wherein the amount of electrical energy provided in each of the electrical power impulse supplied to the upper jaw and the electrical power impulse supplied to the lower jaw produces an energy density at the working surfaces of at least 233 W/cm² of an effective area of the respective working surface.

13. Apparatus as defined in claim 12, wherein the two pieces of tissue are apposite walls of a blood vessel.

14. Apparatus as defined in claim 1, wherein the amount of electrical energy provided in each of the electrical power impulse supplied to the upper jaw and the electrical power impulse supplied to the lower jaw produces an energy density at the working surfaces of at least 388 W/cm² of an effective area of the respective working surface.

15. Apparatus as defined in claim 14, wherein the two pieces of tissue are apposite walls of a blood vessel.

16. Apparatus as defined in claim 1, wherein the amount of electrical energy provided in each of the electrical power impulse supplied to the upper jaw and the electrical power impulse supplied to the lower jaw produces an energy density at the working surfaces of 388 W/cm² to 465 W/cm² of an effective area of the respective working surface.

17. Apparatus as defined in claim 1, wherein the movement mechanism is adapted to compress the two pieces of tissue with a force of at least 150 N to establish the zero thickness of the two pieces of tissue along the predetermined defined path.

18. Apparatus as defined in claim 1, wherein each of the working surfaces are formed of ceramic material having a thermal conductivity of at least 140 W/m°

K.

19. Apparatus as defined in claim 1, wherein each of the electrical power impulses is formed by direct current conducted to the respective heating element by the power control device.

20. Apparatus as defined in claim 1, wherein each of the working surfaces is a ceramic material having a smoothness defined by an Ra of no greater than 0.25 microns.

21. Apparatus as defined in claim 1, wherein each of the working surfaces is a ceramic material having a smoothness defined by an Ra of approximately 0.15 microns or less.

22. Apparatus as defined in claim 21, wherein the two pieces of tissue are apposite walls of a blood vessel.

23. Apparatus as defined in claim 1, wherein the movement mechanism is adapted to compress the two pieces of tissue to a pressure of at least 0.88 N/mm² of an effective area of each working surface.

24. Apparatus as defined in claim 1, wherein a fusion strength between the two pieces of tissue at the tissue fusion interface after fusion and cutting through the sealed area is less than the inherent strength of each of the two pieces of tissue adjoining the sealed area to allow separation of the two pieces of tissue at the tissue fusion interface at the sealed area before breaching either of the tissue pieces adjoining the sealed area.

25. Apparatus as defined in claim 1, wherein the two pieces of tissue are apposite walls of a vessel, and the fusion thickness of the apposite walls of the blood vessel is 0.05 mm to 0.10 mm.

26. Apparatus as defined in claim 1, wherein the working surface of one of the upper jaw and the lower jaw curves convexly toward the working surface of the other one of the upper jaw and the lower jaw in a direction transverse to the respective longitudinal dimension.

27. Apparatus as defined in claim 26, wherein each of the working surfaces curves laterally in a parallel relationship with one another transversely to the to the respective longitudinal dimension, and the predetermined defined path along which the sealed area is cut curves in a general parallel relationship to the curved relationship of the working surfaces.

28. Apparatus as defined in claim 1, wherein each of the working surfaces is a ceramic material having a smoothness defined by an Ra of 0.40 microns or less.

29. Apparatus as defined in claim 1, wherein the two pieces of tissue are apposite walls of a blood vessel.

30. Apparatus as defined in claim 1, wherein:

the force signal is supplied by a sensor mounted on a handle.

31. Apparatus as defined in claim 1, wherein:

the power control device responds to the force signal to initiate delivery of the electrical power impulses when the force signal indicates compression of the two pieces of tissue.

32. Apparatus as defined in claim 1, wherein the predetermined defined path is substantially linear.

33. Apparatus as defined in claim 1, wherein each of the working surfaces has a smoothness defined by an Ra of 0.40 microns or less.

34. Apparatus as defined in claim 1, wherein each of the working surfaces has a smoothness defined by an Ra of no greater than 0.25 microns.

35. Apparatus as defined in claim 1, wherein each of the working surfaces has a smoothness defined by an Ra of approximately 0.15 microns or less.

36. apparatus as defined in claim 1, wherein the two pieces of tissue are apposite walls of a vessel, and the fusion thickness sufficient to fuse the apposite walls of the vessel at the tissue fusion interface is in the range of 0.05 mm to 0.10 mm.