Source: https://patents.com/us-6932810.html
Timestamp: 2019-10-18 23:35:02
Document Index: 67724195

Matched Legal Cases: ['art 25', 'art 25', 'art 49', 'art 50', 'art 35', 'art 36', 'art 48', 'art 25']

US Patent # 6,932,810. Apparatus and method for sealing and cutting tissue - Patents.com
United States Patent 6,932,810
Inventors: Ryan; Thomas Patrick (Fort Collins, CO)
Appl. No.: 09/992,301
591328 Jun., 2000
925805 Sep., 1997 6267761
Current U.S. Class: 606/38 ; 606/34; 606/37; 606/45; 606/46; 606/50
Field of Search: 606/8,32-52,129,167,120,135-137,151-158,201,205-211
6022347 February 2000 Lindenmeier et al.
6613045 September 2003 Laufer et al.
2001/0020126 September 2001 Swanson et al.
US 6,090,109, 07/2000, Lands et al. (withdrawn) .
Heniford et al. "Initial Research and Clinical Results with an Electrothermal Bipolar Vessel Sealer" Oct. 1999. .
"Innovations in Electrosurgery" Sales/Product Literature. .
LigaSure Vessel Sealing System, the Seal of Confidence in General, Gynecologic, Urologic, and Laparaoscopic Surgery Sales/Product Literature. .
Carbonell et al., "Comparison of theGyrus PlasmaKinetic Sealer and the Valleylab LIgaSure Device in the Hemostasis of Small, Medium, and Large-Sized Arteries". .
Carolinas Laparoscopic and Advanced Surgery Program, Carolinas Medical Center, Charlotte, NC. .
Strasberg et al., "Use of a Bipolar Vessel-Sealing Device for Parenchymal Transection During Liver Surgery" Journal of Gastrointestinal Surgery, vol. 6, No. 4, Jul./Aug. 2002 pp. 569-574. .
Muller et al., "Extended Left Hemicolectomy Using the LigaSure Vessel Sealing System" Innovations That Work, Sep. 1999. .
McLellan et al. "Vessel Sealing For Hemostasis During Gynecologic Surgery" Sales Product Literature. .
Jarrett et al., "Use of the LigaSure Vessel Sealing System for Peri-Hilar Vessels in Laparoscopic Nephrectomy" Sales Product Literature. .
E. David Crawford "Evaluation of a New Vessel Sealing Device in Urologic Cancer Surgery" Sales Product Literature. .
Joseph Ortenberg "LigaSure System Used in Laparoscopic 1st and 2nd Stage Orchiopexy" Innovations That Work, Nov. 2002. .
Koyle et al., "Laparoscopic Palomo Varicocele Ligation in Children and Adolescents" Pediatric Endosurgery & Innovative Techniques, vol. 6, No. 1, 2002. .
Dulemba et al. "Use of a Bipolar Electrothermal Vessel Sealer in Laparoscopically Assisted Vaginal Hysterectomy" Sales Product Literature. .
Johnson et al. "Evaluation of a Bipolar electrothermal Vessel Sealing Device in Hemorrhoidectomy" Sales Product Literature. .
Sigel et al., "The Mechanism of Blood Vessel Closure by High Frequency Electrocoagulation", Surgery Gynecology & Obstetrics, Oct. 1965 pp. 823-831. .
Bergdahl et al. "Studies on Coagulation and the Development of an Automatic Computerized Bipolar Coagulator", J. Neurosurg, vol. 75, Jul. 1991, pp. 148-151..
1. A bipolar electrosurgical instrument for sealing and cutting tissue, comprising: a chassis having a longitudinal axis defined therethrough and first and second end effectors attached thereto, one of said first and second end effectors being movable along said longitudinal axis relative to the other of said first and second end effectors from a first position for positioning tissue therebetween to a second position for grasping tissue between said first and second end effectors, wherein said first and second end effectors include complimenting vessel sealing electrodes which partially matingly engage one another, said electrodes adapted to be connected to a source of electrosurgical energy such that the electrodes are capable of sealing and cutting tissue disposed therebetween upon activation of said electrodes; an activator for moving said end effectors from the first to second positions; a sensor for measuring the impedance across the tissue held between said end effectors; and means for selectively applying electrosurgical energy from an electrosurgical energy source to said end effectors in response to the impedance measurement across the tissue from said sensor.
10. A method of applying electrosurgical energy to tissue comprising the steps of: providing a chassis having a longitudinal axis therethrough and first and second end effectors attached thereto, one of said end effectors being movable along said longitudinal axis relative to the other of said first and second end effectors from a first position for positioning tissue therebetween to a second position for grasping tissue between said first and second end effectors, wherein said first and second end effectors include complimenting vessel sealing electrodes which partially matingly engage one another, said electrodes adapted to be connected to a source of electrosurgical energy such that the electrodes are capable of sealing and cutting tissue disposed therebetween upon activation of said electrodes; moving said end effectors from the first to second positions to engage tissue therebetween; measuring the impedance across the tissue held between said end effectors; and selectively applying electrosurgical energy from an electrosurgical energy source to said end effectors in response to the impedance measurement across the tissue.
FIG. 1 is a perspective view of an elongate tubular bipolar tissue sealer or cutter 10 for application by a surgeon of electrosurgical energy to tissue. A handle 11, for holding and manipulation by the surgeon, is on a proximal end 12 of the elongate bipolar tissue sealer or cutter 10. The handle 11 has both first and second handle grips 13 and 14, respectively. A chassis 15, carried on the handle 11 by mechanical connection with the first handle grip 13, extends axially along axis "A" relative to the handle 11 and away from the surgeon a distance adequate to reach the patient's operative site. The chassis 15 is comprised of at least two parts. The first is an outer tube 16 which extends from the handle 11 along the axis "A." The outer tube 16 is fixed on the chassis 15. The second part is a member or chassis extension 17 extending from a patient end 18 of the outer tube 16, also along the axis "A." An inner tube 19 is moveable to and from the handle 11 in the preferred embodiment. The inner tube 19 is guided along the axis "A." The inner tube 19 connects to the second handle grip 14 for surgeon access. A distal end 20 is on the inner tube 19 and faces the operative site. The elongate tubular sealer or cutter 10 thus in part slides along its axis "A" with inner tube 19 which is an internal, concentric slider to axially bring together end effectors 21 and 22. Inner tube 19 is telescopically carried, in the preferred embodiment, on the chassis 15 for axial movement relative to and therealong. The inner tube 19 moves relative to the chassis 15, a surgeon end 23 and the distal end 20 which are disposed along the axis "A" thereof as shown in FIGS. 1 and 3. FIG. 2 is a view of the inner and outer tubes 19 and 16 in cross section as would be seen along lines 2--2 in FIG. 1. The preferred outer and inner tubes 16 and 19 are metallic and thus should be insulated from each other and from the user by a coating 19' as seen in FIG. 2.
End effector 21 on the distal end 20 is in position to contact tissue upon movement axially away from the handle 11 by the surgeon's manipulation of second handle grip 14. FIG. 3 is a side view of the reusable elongate tubular structure of FIG. 1 with both of the various end effectors 21 and 22 shown from the side. The effector 21 and 22 are made of materials for conducting electrosurgical energy such as metal, conductive polymer or ceramic. The end effector 22 has member jaw member 24 supported by the chassis extension 17 normal thereto in position opposite the patient end 20 of the inner tube 19. A part 25 on the member 24 thereof is transversely located relative to the axis "A" in FIG. 1. The end effectors 21 and 22 are thus opposed for engagement upon relative axial displacement of the inner tube 19 and/or chassis 15. FIG. 4 is a side view of a disposable elongate tubular structure of FIG. 1 with one of the various end effectors 21 and 22 shown from the side in FIG. 3. As shown in FIG. 3 the chassis extension 17, member 24, and part 25 are made for conducting electrosurgical energy. Of course, insulation can be added as needed to direct the bipolar electrosurgery to the space between the end effectors 21 and 22.
The end effectors 21 and 22 include complimentary sealing or cutting surfaces 33 and 34 for partial mating engagement upon their axial movement toward one another along the axis "A." FIG. 13 illustrates end effectors 21 and 22 or the conjugating jaws of FIG. 5 with a vessel therebetween prior to sealing. Similarly, FIG. 14 illustrates end effectors 21 and 22 or the conjugating jaws of FIG. 5 with a vessel therebetween during sealing. The end effectors 21 and 22 could be removably attached to the member 24 and/or the inner tube 19, respectively. FIG. 15 is a partial enlarged view of the end effectors 21 and 22 of FIG. 1 viewed from the side with an open vessel clamped therebetween during the method or process of sealing. The partial mating complimentary surfaces 33 and 34 in FIG. 8 are curvelinear for providing more tissue contacting area than flat surfaces of the same width would. In FIG. 8 the end effectors 21 and 22 have conjugating complimentary surface 33 and 34 that nest configured with a pedistaled male part 49 and a mating U shaped female part 50 for the jaws. FIG. 9 is an enlarged top view of end effectors 21 and 22 showing conjugating surfaces that nest with a male part 35 terraced and a female part 36 shaped to fit as jaws. FIG. 10 is an enlarged top view of end effectors 21 and 22 showing conjugating surfaces that nest with a pair of upstanding nibs 38 and a complimentary pair of ker 37 as the jaws. FIG. 11 is an enlarged top view of the end effectors 21 and 22 showing conjugating surfaces that nest with a single upstanding rib 39 and a complimentary kerf 40 as the jaws. FIG. 12 is an enlarged top view of end effectors 21 and 22 showing conjugating surfaces that nest with a pair of upstanding opposite nibs 41 and complimentary opposed kerfs 42 wherein therein one rib 41 is on each of the end effectors 21 and 22 across from its complimentary kerf 42 on the opposite end effectors either 21 or 22.
Any complimentary mating curvelinear jaws even "S" shaped or those shown in FIG. 1 could be arranged to provide more surface area for contact than the flat surfaces defined by the cords thereacross. FIG. 5 is an enlarged top view end effectors 21 and 22 showing conjugating surfaces 33 and 34 that nest with V shaped complimentary jaws 43 and 44. FIG. 6 is an enlarged top view of end effectors 21 and 22 showing conjugating surfaces 33 and 34 that nest with a rib 45 and a channel 46 as complimentary jaws. FIG. 7 is an enlarged top view of end effectors 22 and 23 showing conjugating surfaces 33 and 34 that nest with a male part pedistaled 47 and V shaped female part 48 as complimentary jaws.
The partial mating complimentary surfaces 33 and 34 might be parallel but skewed to axis "A" as in FIG. 15 to provide elongate contact with axial movement between the inner tube 19 and chassis 15 thus keeping the size of the laparoscopic portal through which the end effectors 21 and 22 must pass to a minimum transverse dimension. The partial mating complimentary surfaces 33 and 34 could be substantially flat as in FIGS. 3 and 4. The partial mating complimentary surfaces 33 and 34 may be circular sections such as appear in FIGS. 1 and 8. The partial mating complimentary surfaces 33 and 34 might be elliptical and thus similar to FIGS. 1 and 8 with the curvatures being a part of an ellipse instead of a circle. Because of the perspective showing in FIG. 1, the observable differences in such an illustration between a circle and an ellipse can not be perceived. The partial mating complimentary surfaces 33 and 34 could also be triangular as in FIGS. 5, 7, 13 and 14. The partial mating complimentary surfaces 33 and 34 may include at least one conjugating rib and slot as in FIGS. 6 and 11. The partial mating complimentary surfaces 33 and 34 could include several nibs as in FIGS. 10 and 12.
A method of applying the elongate tubular bipolar tissue sealer or cutter 10 along an axis "A" includes use by a surgeon to deliver bipolar electrosurgical energy to the tissue and bodily fluids of a patient. The method has the steps of holding and manipulating the handle 11 by the surgeon. Extending axially inner tube 19 and/or the chassis 15 carried on the handle 11 away from the surgeon is a step. The method can have the step moving the inner tube 19 relative to the chassis 15 along the axis "A." Carrying inner tube 19 for axial movement relative to and along the chassis 15 is a step of the preferred method. The method step includes positioning end effector 22 on the patient end 18 to first contact tissue upon movement axially of the inner tube 19 by the surgeon. Using a supported member 24 the chassis 15 is a step of the method. The method may have the step of using a part 25 located transversely relative to the axis "A" and on the member 24.
The method may have the steps of applying the provided end effectors with partially complimentary sealing or cutting surfaces 33 and 34, and partially mating engagement of the complimentary sealing or cutting surfaces 33 and 34 upon axial movement toward one another along the axis "A." FIG. 16 is a perspective illustration of a sealed vessel 51 as a consequence of performing the method to form seal 52. The method might use the step of choosing to removably attach the end effectors 26 and 27, inner tube 19 and the chassis 15, respectively. The method has the step of using partially mating the complimentary surfaces 33 and 34 engagable along curvelinear paths for providing more tissue contacting area than between flat surfaces. The method has the step of using the partially mating the complimentary surfaces 33 and 34 preferably parallel along a plane skewed to the axis "A" to provide elongate contact with axial movement between the inner tube 19 and chassis 15.
As a result of laboratory testing of a model of the bipolar tissue sealer or cutter results have shown excellent performance in sealing a range of vessels of various sizes. The bipolar tissue sealer or cutter with linear travel was tested on freshly excised porcine splenic arteries ranging from 1.8 to 3.3 mm. A single activation of power (14 W, 500 kHz) was used on each vessel firmly clamped between the end effector bipolar electrodes. FIG. 17 shows the voltage, current, impedance, power, and energy during activation on a 2.6 mm porcine splenic artery with the bipolar device shown in FIG. 15. The voltage ranges from 18-23 volts until the impedance rises at about 14 sec. At this point, the vessel is sealed and the power is manually switched off. The impedance curve shows an initial decrease as the vessel is heated with radiofrequency energy, down to about 20 ohms. The rapid increase to about 200 ohms signals that the vessel is desiccated and sealing process is over.
The preferred elongate tubular bipolar tissue sealer or cutter 10 for application of electrosurgical energy to tissue by a surgeon as covered in the claims that follow has structure that slides along its axis "A" with an internal, concentric sliding portion. The inner or inside sliding tube 19 is attached to the proximal end effector 21 and the external fixed tube or chassis 15 connects to the distal end effector 22 in the preferred embodiment. The two end effectors 21 and 22 are matched so that the distal end effector 22 fits snugly against the proximal end effector 21. These end effectors 21 and 22 can be any of a number of conjugating shaped pairs including triangular, spherical, rectangular, with or without a notch. The notch is not just for alignment but also may define a sharp edge to sever the tissue or vessel by application of a pulse of high-power RF to the clamped site of tissue in between the end effectors 21 and 22. In the preferred embodiment, the handle 11 is squeezed so the inner tube 19 slides away the user and the chassis 15 is fix in relation to the inner tube 19 as the end effectors 21 and 22 act on the tissue therebetween. Of course it can be reversed so the chassis 15 moves and the inner tube 19 is fixed.
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