Apparatus and method for rapid reliable electrothermal tissue fusion

• US 9,492,220 B2
• Filed: 02/01/2007
• Issued: 11/15/2016
• 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:
  US11/701,857
• Publication Number:
  US 20080187989A1
• Time in Patent Office: 3,575 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 18/085 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 2018/0063 Sealing
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00714 Temperature
• CPC Class Codes: A61B 2018/00791 Temperature

Abstract

Pieces of tissue are fused together 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. The impulse and the fusion occur within a preferable time of 0.5-2.0 seconds but no greater than 4.0 seconds. The temperature of the thermal energy is regulated between 150° C.-200° C. The tissue pieces are compressed to a thickness of 0.05-0.10 mm. Jaws which compress the tissue and transfer the energy have smooth working surfaces with an Ra of 0.15 or less microns to 0.40 microns.

Claims

1. Apparatus to fuse together two pieces of biological tissue at a tissue fusion interface in a tissue fusion procedure, comprising:

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

a heating element that develops a thermal energy from an electrical power impulse supplied thereto,

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

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 jaw and the lower jaw 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 predetermined thickness in the range of 0.05 mm to 0.10 mm to fuse the two pieces of tissue together at the tissue fusion interface from a combination of the compression and the thermal energy, wherein 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 compression of the two pieces of tissue to the predetermined thickness, and 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 two pieces of tissue have been compressed; and

a power control device connected to the tissue fusion instrument, the power control device being responsive to the force signal and to each of the sensed temperature signals to separately 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 supplied to the lower jaw, the power control device limiting the duration of each of the electrical power impulses to a predetermined time duration of no greater than 4.0 seconds, the power control device controlling the amount of electrical energy provided in each of the electrical power impulses to attain and maintain a predetermined temperature in the range of 150°

C. to 200°

C. at each of the upper jaw and the lower jaw during the respective predetermined time duration.

2. Apparatus as defined in claim 1, wherein said predetermined time duration 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 each of the working surfaces of at least 155 W/cm² of an effective area of the respective working surface;

each of the jaws 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 produces a pressure on the two pieces of tissue at the tissue fusion interface in the range of 0.88 N/mm² to 1.2 N/mm² of the effective area of the respective working surface.

5. Apparatus as defined in claim 1, wherein said predetermined time duration is approximately 0.5 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:

the amount of electrical energy provided in each of the electrical power impulses supplied to each of the heating elements produces an energy density at the respective working surface of at least 155 W/cm2 of an effective area of the respective working surface;

each of the jaws 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 each have a smoothness defined by an Ra of 0.40 microns or less; and

the movement mechanism produces a pressure on the two pieces of tissue at the tissue fusion interface in the range of 0.88 N/mm2 to 1.2 N/mm² of the effective area of the respective working surface.

8. Apparatus as defined in claim 1, wherein said predetermined time duration is in a range of 0.5 seconds to 2.0 seconds.

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

10. Apparatus as defined in claim 9, wherein:

the amount of electrical energy provided in each of the electrical power impulses supplied to each of the heating elements produces an energy density at the respective working surface of at least 155 W/cm2 of an effective area of the respective working;

each of the jaws and the working surfaces are formed of ceramic material having a thermal conductivity of at least 140 W/m°

K;

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

the movement mechanism produces a pressure on the two pieces of tissue at the tissue fusion interface in the range of 0.88 N/mm² to 1.2 N/mm² of the effective area of the respective working surface.

11. Apparatus as defined in claim 1, wherein the amount of electrical energy provided in each of the electrical power impulses elevates the temperature of the respective working surface at a rate in the range of between 150°

C. per second to 500°

C. or greater per second.

12. Apparatus as defined in claim 1, wherein the amount of electrical energy provided in each of the electrical power impulses produces an energy density at the respective working surface of at least 155 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 impulses produces an energy density at the respective working surface of at least 233 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 movement mechanism includes a lock to operatively hold the upper jaw and the lower jaw in a held position where the two pieces of tissue are compressed between the working surface of the upper jaw and the working surface of the lower jaw to the predetermined thickness, and the movement mechanism further includes a release to operatively release the upper jaw and the lower jaw from the held position, thus releasing each of the respective working surfaces from the two pieces of tissue.

17. Apparatus as defined in claim 1, wherein 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.

18. Apparatus as defined in claim 17, wherein each of the ceramic working surfaces has a smoothness defined by an Ra of 0.40 microns or less.

19. Apparatus as defined in claim 17, wherein each of the ceramic working surfaces has a smoothness defined by an Ra of no greater than 0.25 microns.

20. Apparatus as defined in claim 17, wherein each of the ceramic working surfaces has a smoothness defined by an Ra of approximately 0.15 microns or less.

21. 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.

22. 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.

23. 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.

24. Apparatus as defined in claim 1, wherein the compression of the two pieces of tissue at the tissue fusion interface is in the range of 0.88 N/mm² to 1.2 N/mm² of an effective area of the respective working surface.

25. Apparatus as defined in claim 24, wherein the two pieces of tissue are apposite walls of a blood vessel.

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

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

28. 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.

29. Apparatus as defined in claim 1, wherein the power control device separately regulates the duration and the amount of electrical energy provided in each of the electrical power impulses on a basis of a proportional, integral and derivative algorithm.

30. 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.

31. Apparatus as defined in claim 1, wherein:

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

32. Apparatus as defined in claim 1, wherein:

the power control device responds to the force signal to initiate delivery of each of the electrical power impulses when the force signal indicates compression of the two pieces of tissue to the predetermined thickness at the tissue fusion interface.