US20160074104A1 - Single action tissue sealer - Google Patents

Abstract

An endoscopic bipolar forceps includes a housing and a shaft, the shaft having an end effector assembly at its distal end. The end effector assembly includes two jaw members for grasping tissue therebetween. The jaw members are adapted to connect to an electrosurgical energy source which enable them to conduct energy through the tissue to create a tissue seal. A drive assembly is disposed within the housing which moves the jaw members. A switch is disposed within the housing which activates the electrosurgical energy. A knife assembly is included which is advanceable to cut tissue held between the jaw members. A movable handle is connected to the housing. Continual actuation of the movable handle engages the drive assembly to move the jaw members, engages the switch to activate the electrosurgical energy source to seal the tissue, and advances the knife assembly the cut the tissue disposed between the jaw members.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• The present application is a continuation of U.S. patent application Ser. No. 14/611,845 filed on Feb. 2, 2015, which is a continuation of U.S. patent application Ser. No. 14/162,192 filed Jan. 23, 2014, now U.S. Pat. No. 8,945,127, which is a continuation of U.S. patent application Ser. No. 14/091,505 filed Nov. 27, 2013, now abandoned, which is a continuation of U.S. patent application Ser. No. 13/633,554 filed Oct. 2, 2012, now abandoned, which is a continuation of U.S. application Ser. No. 12/621,056 filed Nov. 18, 2009, now U.S. Pat. No. 8,277,447, which is a continuation of U.S. application Ser. No. 11/207,956 filed Aug. 19, 2005, now U.S. Pat. No. 7,628,791, the entire contents of each of which are incorporated herein by reference.
BACKGROUND
• The present disclosure relates to an electrosurgical forceps and more particularly, the present disclosure relates to an endoscopic bipolar electrosurgical forceps for manipulating, clamping, sealing and cutting tissue in a single action.
TECHNICAL FIELD
• Electrosurgical forceps utilize both mechanical clamping action and electrical energy to affect hemostasis by heating the tissue and blood vessels to coagulate, cauterize and/or seal tissue. As an alternative to open forceps for use with open surgical procedures, many modern surgeons use endoscopes and endoscopic instruments for remotely accessing organs through smaller, puncture-like incisions. As a direct result thereof, patients tend to benefit from less scarring and reduced healing time.
• Endoscopic instruments are inserted into the patient through a cannula, or port, which has been made with a trocar. Typical sizes for cannulas range from about three millimeters to about 12 millimeters. Smaller cannulas are usually preferred, which, as can be appreciated, ultimately presents a design challenge to instrument manufacturers who look for ways to make endoscopic instruments that fit through the smaller cannulas.
• Many endoscopic surgical procedures require cutting or ligating blood vessels or vascular tissue. Due to the inherent spatial considerations of the surgical cavity, surgeons often have difficulty suturing vessels or performing other traditional methods of controlling bleeding, e.g., clamping and/or tying-off transected blood vessels. By utilizing an endoscopic electrosurgical forceps, a surgeon can either cauterize, coagulate/desiccate and/or simply reduce or slow bleeding simply by controlling the intensity, frequency and duration of the electrosurgical energy applied through the jaw members to the tissue. Most small blood vessels, i.e., in the range below two millimeters in diameter, can often be closed using standard electrosurgical instruments and techniques. However, if a larger vessel is ligated, it may be necessary for the surgeon to convert the endoscopic procedure into an open-surgical procedure and thereby abandon the benefits of endoscopic surgery. Alternatively, the surgeon can seal the larger vessel or tissue.
• It is thought that the process of coagulating vessels is fundamentally different from electrosurgical vessel sealing. For the purposes herein, “coagulation” is defined as a process of desiccating tissue wherein the tissue cells are ruptured and dried. “Vessel sealing” or “tissue sealing” is defined as the process of liquefying the collagen in the tissue so that it reforms into a fused mass. Coagulation of small vessels is sufficient to permanently close them, while larger vessels need to be sealed to assure permanent closure.
• In order to effectively seal larger vessels (or tissue) two predominant mechanical parameters should be accurately controlled—the pressure applied to the vessel (tissue) and the gap distance between the electrodes—both of which are affected by the thickness of the sealed vessel. More particularly, accurate application of pressure is important to oppose the walls of the vessel; to reduce the tissue impedance to a low enough value that allows enough electrosurgical energy through the tissue; to overcome the forces of expansion during tissue heating; and to contribute to the end tissue thickness which is an indication of a good seal. It has been determined that a typical fused vessel wall is optimum between about 0.001 and about 0.006 inches. Below this range, the seal may shred or tear and above this range the lumens may not be properly or effectively sealed.
• With respect to smaller vessels, the pressure applied to the tissue tends to become less relevant whereas the gap distance between the electrically conductive surfaces becomes more significant for effective sealing. In other words, the chances of the two electrically conductive surfaces touching during activation increases as vessels become smaller.
• As mentioned above, in order to properly and effectively seal larger vessels or tissue, a greater closure force between opposing jaw members is required. It is known that a large closure force between the jaws typically requires a large moment about the pivot for each jaw. This presents a design challenge because the jaw members are typically affixed with pins which are positioned to have small moment arms with respect to the pivot of each jaw member. A large force, coupled with a small moment arm, is undesirable because the large forces may shear the pins. As a result, designers compensate for these large closure forces by either designing instruments with metal pins and/or by designing instruments which at least partially offload these closure forces to reduce the chances of mechanical failure. As can be appreciated, if metal pivot pins are employed, the metal pins should be insulated to avoid the pin acting as an alternate current path between the jaw members which may prove detrimental to effective sealing.
• Increasing the closure forces between electrodes may have other undesirable effects, e.g., it may cause the opposing electrodes to come into close contact with one another which may result in a short circuit and a small closure force may cause pre-mature movement of the tissue during compression and prior to activation. As a result thereof, providing an instrument which consistently provides the appropriate closure force between opposing electrodes within a preferred pressure range will enhance the chances of a successful seal. As can be appreciated, relying on a surgeon to manually provide the appropriate closure force within the appropriate range on a consistent basis would be difficult and the resultant effectiveness and quality of the seal may vary. Moreover, the overall success of creating an effective tissue seal is greatly reliant upon the user's expertise, vision, dexterity, and experience in judging the appropriate closure force to uniformly, consistently and effectively seal the vessel. In other words, the success of the seal would greatly depend upon the ultimate skill of the surgeon rather than the efficiency of the instrument.
• It has been found that the pressure range for assuring a consistent and effective seal is between about 3 kg/cm²to about 16 kg/cm²and, desirably, within a working range of about 7 kg/cm²to about 13 kg/cm². Manufacturing an instrument which is capable of providing a closure pressure within this working range has been shown to be effective for sealing arteries, tissues and other vascular bundles.
• Various force-actuating assemblies have been developed in the past for providing the appropriate closure forces to affect vessel sealing. For example, one such actuating assembly has been developed by Valleylab, Inc., of Boulder Colo., a division of Tyco Healthcare LP, for use with Valleylab's vessel sealing and dividing instrument commonly sold under the trademark LIGASURE ATLAS®. This assembly includes a four-bar mechanical linkage, a spring and a drive assembly which cooperate to consistently provide and maintain tissue pressures within the above working ranges. The LIGASURE ATLAS® is presently designed to fit through a 10 mm cannula and includes a bi-lateral jaw closure mechanism which is activated by a foot switch. A trigger assembly extends a knife distally to separate the tissue along the tissue seal. A rotating mechanism is associated with distal end of the handle to allow a surgeon to selectively rotate the jaw members to facilitate grasping tissue. Co-pending U.S. application Ser. Nos. 10/179,863 and 10/116,944 and PCT Application Serial Nos. PCT/US01/01890 and PCT/7201/11340 describe in detail the operating features of the LIGASURE ATLAS® and various methods relating thereto. The contents of all of these applications are hereby incorporated by reference herein.
• It would be desirous to develop an instrument that reduces the number of steps it takes to perform the tissue seal and cut. Preferably, the instrument would be able to manipulate, clamp, seal and cut tissue in a single action (e.g., by squeezing a handle).
SUMMARY
• The present disclosure relates to an endoscopic bipolar forceps which includes a housing and a shaft affixed to the distal end of the housing. Preferably, the shaft includes a diameter such that the shaft is freely insertable through a trocar. The shaft also includes a longitudinal axis defined therethrough and a pair of first and second jaw members attached to a distal end thereof. The forceps includes a drive assembly for moving the first jaw member relative to the second member from a first position wherein the jaw members are disposed in spaced relation relative to each other to a second position wherein the jaw members cooperate to grasp tissue therebetween. A movable handle is included which is rotatable about a pivot located above the longitudinal axis of the shaft. Movement of the movable handle mechanically cooperates with internal components to move the jaw members from the open and closed positions, to clamp tissue, to seal tissue and to cut tissue. Advantageously, the pivot is located a fixed distance above the longitudinal axis to provide lever-like mechanical advantage to a drive flange of the drive assembly. The drive flange is located generally along the longitudinal axis. The forceps is connected to a source of electrosurgical energy which carries electrical potentials to each respective jaw member such that the jaw members are capable of conducting bipolar energy through tissue held therebetween to affect a tissue seal.
• The forceps includes a switch disposed within the housing which is electromechanically connected to the energy source. Advantageously, the switch allows a user to supply bipolar energy to the jaw members to affect a tissue seal. The switch is activated by contact from a cutter lever or the movable handle itself when a user continues to compress the movable handle after the tissue has been clamped.
• The forceps includes an advanceable knife assembly for cutting tissue in a forward direction along the tissue seal. The knife assembly is advanced when a user continues to compress the movable handle after the tissue has been sealed, forcing the cutter lever forward. A rotating assembly may also be included for rotating the jaw members about the longitudinal axis defined through the shaft.
• In one embodiment, the movable jaw member includes a first electrical potential and the fixed jaw member includes a second electrical potential. A lead connects the movable jaw member to the first potential and a conductive tube (which is disposed through the shaft) conducts a second electrical potential to the fixed jaw member. Advantageously, the conductive tube is connected to the rotating assembly to permit selective rotation of the jaw members.
• In one embodiment, the drive assembly includes a reciprocating sleeve which upon activation of the movable handle, translates atop the rotating conductive tube to move the movable jaw member relative to the fixed jaw member. In one embodiment, the movable jaw member includes a detent which extends beyond the fixed jaw member which is designed for engagement with the reciprocating sleeve such that, upon translation thereof, the movable jaw member moves relative to the fixed jaw member. Advantageously, a spring is included with the drive assembly to facilitate actuation of the movable handle and to ensure the closure force is maintained within the working range of about 3 kg/cm²to about 16 kg/cm²and, preferably, about 7 kg/cm²to about 13 kg/cm²
• In one embodiment, at least one of the jaw members includes a series of stop members disposed thereon for regulating the distance between the jaw members (i.e., creating a gap between the two opposing jaw members) during the sealing process. As can be appreciated, regulating the gap distance between opposing jaw members along with maintaining the closing pressure to within the above-described ranges will produce a reliable and consistent tissue seal.
• The present disclosure also relates to an endoscopic bipolar forceps which includes a shaft having a movable jaw member and a fixed jaw member at a distal end thereof. The forceps also includes a drive assembly for moving the movable jaw member relative to the fixed jaw member from a first position wherein the movable jaw member is disposed in spaced relation relative to the fixed jaw member to a second position wherein the movable jaw member is closer to the fixed jaw member for manipulating tissue. A movable handle is included which actuates the drive assembly to move the movable jaw member.
• The forceps connects to a source of electrosurgical energy which is conducted to each jaw member such that the jaw members are capable of conducting bipolar energy through tissue held therebetween to affect a tissue seal. Advantageously, the forceps also includes a selectively advanceable knife assembly for cutting tissue in a distal direction along the tissue seal and a stop member disposed on at least one of the jaw members for regulating the distance between jaw members during sealing.
BRIEF DESCRIPTION OF THE DRAWINGS
• Various embodiments of the subject instrument are described herein with reference to the drawings wherein:
• FIG. 1 is a partial schematic view of one embodiment of an endoscopic bipolar forceps having a movable thumb handle in an unactuated position according to one aspect of the present disclosure;
• FIG. 2 is a partial schematic view of the forceps ofFIG. 1 illustrated in a partially actuated position;
• FIG. 3 is a partial schematic view of another embodiment of an endoscopic bipolar forceps having a movable finger handle illustrated in a partially actuated position;
• FIG. 4 is an enlarged, perspective view of an end effector assembly with jaw members shown in an open configuration;
• FIG. 5 is an enlarged, side view of the end effector assembly ofFIG. 4;
• FIG. 6 is an enlarged, perspective view of the tissue contacting side of an upper jaw member of the end effector assembly;
• FIG. 7 is an enlarged, broken perspective view showing the end effector assembly and highlighting a cam-like closing mechanism which cooperates with a reciprocating pull sleeve to move the jaw members relative to one another;
• FIG. 8 is a full perspective view of the end effector assembly ofFIG. 7;
• FIG. 9 is a left, perspective view of a rotating assembly, drive assembly, knife assembly and lower jaw member according to the present disclosure;
• FIG. 10 is a rear, perspective view of the rotating assembly, drive assembly and knife assembly;
• FIG. 11 is an enlarged, top, perspective view of the end effector assembly with parts separated;
• FIG. 12 is an enlarged, perspective view of the knife assembly;
• FIG. 13 is an enlarged, perspective view of the rotating assembly;
• FIG. 14 is an enlarged, perspective view of the drive assembly;
• FIG. 15 is an enlarged, perspective view of the knife assembly with parts separated;
• FIG. 16 is an enlarged view of the indicated area of detail ofFIG. 15;
• FIG. 17 is a greatly-enlarged, perspective view of a distal end of the knife assembly;
• FIG. 18 is a greatly-enlarged, perspective view of a knife drive of the knife assembly;
• FIG. 19 is an enlarged, perspective view of the rotating assembly and lower jaw member with parts separated;
• FIG. 20 is a cross section along line20-20 ofFIG. 19;
• FIG. 21 is a greatly-enlarged, perspective view of the lower jaw member;
• FIG. 22 is an enlarged, perspective view of the drive assembly;
• FIG. 23 is an enlarged perspective view of the drive assembly ofFIG. 22 with parts separated;
• FIG. 24 is a greatly-enlarged, cross section of the shaft taken along line24-24 ofFIG. 25;
• FIG. 25 is a side, cross section of the shaft and end effector assembly;
• FIG. 26 is a greatly-enlarged, perspective view of a handle assembly and latch mechanism for use with the forceps;
• FIG. 27 is a greatly-enlarged view of an end effector;
• FIG. 28 is a greatly-enlarged view of the drive assembly;
• FIG. 29 is an enlarged, rear, perspective view of the end effector shown grasping tissue;
• FIG. 30 is an enlarged view of a tissue seal;
• FIG. 31 is a side, cross section of a tissue seal taken along line31-31 ofFIG. 30;
• FIG. 32 is an enlarged view of the end effector showing distal translation of the knife; and
• FIG. 33 is a side, cross section of a tissue seal after separation by the knife assembly.
DETAILED DESCRIPTION
• Turning now toFIGS. 1-3, one embodiment of an endoscopicbipolar forceps10 is shown for use with various surgical procedures and generally includes ahousing20, ahandle assembly30, a rotatingassembly80, anend effector assembly100, a knife assembly140 (seeFIGS. 10,12,15-18), adrive assembly150, aswitch500 and alatch assembly600 which all mutually cooperate to grasp, seal and divide tubular vessels and vascular tissue420 (FIG. 29). Although the majority of the figure drawings depict abipolar forceps10 for use in connection with endoscopic surgical procedures, the present disclosure may be used for more traditional open surgical procedures. For the purposes herein, theforceps10 is described in terms of an endoscopic instrument, however, it is contemplated that an open version of the forceps may also include the same or similar operating components and features as described below.
• Forceps10 includes ashaft12 which has adistal end16 dimensioned to mechanically engage theend effector assembly100 and aproximal end14 which mechanically engages thehousing20. In the drawings and in the descriptions which follow, the term “proximal,” as is traditional, will refer to the end of theforceps10 which is closer to the user, while the term “distal” will refer to the end which is farther from the user.
• Forceps10 also includes anelectrosurgical cable310 which connects theforceps10 to a source of electrosurgical energy, e.g., a generator (not shown). Generators such as those sold by Valleylab—a division of Tyco Healthcare LP, located in Boulder, Colo. are contemplated for use as a source of electrosurgical energy, e.g., FORCE EZ™ Electrosurgical Generator, FORCE FX™ Electrosurgical Generator, FORCE 1C™, FORCE 2™ Generator, SurgiStat™ II. One such system is described in commonly-owned U.S. Pat. No. 6,033,399 entitled “ELECTROSURGICAL GENERATOR WITH ADAPTIVE POWER CONTROL,” the entire contents of which are hereby incorporated by reference herein. Other systems have been described in commonly-owned U.S. Pat. No. 6,187,003 entitled “BIPOLAR ELECTROSURGICAL INSTRUMENT FOR SEALING VESSELS,” the entire contents of which are also incorporated by reference herein.
• In one embodiment, the generator includes various safety and performance features including isolated output, independent activation of accessories. In one embodiment, the electrosurgical generator includes Valleylab's Instant Response™ technology features which provide an advanced feedback system to sense changes in tissue 200 times per second and adjust voltage and current to maintain appropriate power. The Instant Response™ technology is believed to provide one or more of the following benefits to surgical procedure:
• Consistent clinical effect through all tissue types;
• Reduced thermal spread and risk of collateral tissue damage;
• Less need to “turn up the generator”; and
• Designed for the minimally invasive environment.
• Cable310 is internally divided into cable leads (not shown) which each transmit electrosurgical energy through their respective feed paths through theforceps10 to theend effector assembly100. A detailed discussion of the cable leads and their connections through theforceps10 is described in commonly-assigned, co-pending U.S. application Ser. No. 10/460,926 entitled “VESSEL SEALER AND DIVIDER FOR USE WITH SMALL TROCARS AND CANNULAS” by Dycus et al., which is hereby incorporated by reference in its entirety herein.
• Handleassembly30 includes a fixedhandle50, amovable handle40, acutter lever700 and ahandle detent710. Fixedhandle50 is integrally associated withhousing20 andmovable handle40 is movable relative to fixedhandle50 as explained in more detail below with respect to the operation of theforceps10.
• In one embodiment, rotatingassembly80 is integrally associated with thehousing20 and is rotatable approximately 180 degrees in either direction about a longitudinal axis “A” (FIGS. 1 and 3). Details of the rotatingassembly80 are described in more detail with respect toFIGS. 9 and 10.
• Housing20 may be formed from two housing halves (not shown) which each include a plurality of interfaces which are dimensioned to mechanically align and engage one another to formhousing20 and enclose the internal working components offorceps10. A detailed discussion of the housing halves and how they mechanically engage with one another is described in commonly-assigned, co-pending U.S. application Ser. No. 10/460,926 entitled “VESSEL SEALER AND DIVIDER FOR USE WITH SMALL TROCARS AND CANNULAS” by Dycus et al., which is hereby incorporated by reference in its entirety herein.
• It is envisioned that a plurality of additional interfaces (not shown) may be disposed at various points around the periphery of housing halves for ultrasonic welding purposes, e.g., energy direction/deflection points. It is also contemplated that housing halves (as well as the other components described below) may be assembled together in any fashion known in the art. For example, alignment pins, snap-like interfaces, tongue and groove interfaces, locking tabs, adhesive ports, etc. may all be utilized either alone or in combination for assembly purposes.
• Rotatingassembly80 includes twohalves82aand82b(seeFIGS. 13 and 19) which, when assembled, form the rotatingassembly80 which, in turn, houses thedrive assembly150 and theknife assembly140.Half82bincludes a series of detents/flanges375a,375b,375cand375dwhich are dimensioned to engage a pair of corresponding sockets or other mechanical interfaces (not shown) disposed within rotating half82a. In one embodiment,movable handle40 is of unitary construction and is operatively connected to thehousing20 and the fixedhandle50 during the assembly process.
• As mentioned above,end effector assembly100 is attached at thedistal end14 ofshaft12 and includes a pair of opposingjaw members110 and120.Movable handle40 ofhandle assembly30 is in mechanical cooperation withdrive assembly150 which, together, mechanically cooperate to impart movement of thejaw members110 and120 from an open position wherein thejaw members110 and120 are disposed in spaced relation relative to one another, to a clamping or closed position wherein thejaw members110 and120 cooperate to grasp tissue420 (FIG. 29) therebetween.
• It is envisioned thatjaw members110 and120 ofend effector assembly100 may be curved (as illustrated inFIG. 3) in order to reach specific anatomical structures and promote more consistent seals for certain procedures. For example, it is contemplated that dimensioning thejaw members110 and120 at an angle of about 45 degrees to about 70 degrees is preferred for accessing and sealing specific anatomical structures relevant to prostatectomies and cystectomies, e.g., the dorsal vein complex and the lateral pedicles. Other angles may be preferred for different surgical procedures. Such an end effector assembly with curved jaw members is described in commonly-assigned, co-pending U.S. application Ser. No. 10/834,764 entitled “ELECTROSURGICAL INSTRUMENT WHICH REDUCES DAMAGE TO ADJACENT TISSUE,” by Dycus et al., which is hereby incorporated by reference in its entirety herein.
• It is envisioned that theforceps10 may be designed such that it is fully or partially disposable depending upon a particular purpose or to achieve a particular result. For example,end effector assembly100 may be selectively and releasably engageable with thedistal end16 of theshaft12 and/or theproximal end14 ofshaft12 may be selectively and releasably engageable with thehousing20 and thehandle assembly30. In either of these two instances, theforceps10 would be considered “partially disposable” or “reposable,” i.e., a new or different end effector assembly100 (or endeffector assembly100 and shaft12) selectively replaces the oldend effector assembly100 as needed. As can be appreciated, the presently disclosed electrical connections would have to be altered to modify the instrument to a reposable forceps.
• Turning now to the more detailed features of the present disclosure,movable handle40 includes afinger loop41 which has anaperture42 defined therethrough which enables a user to grasp and move themovable handle40 relative to the fixedhandle50.FIGS. 1 and 2 illustrate amovable handle40 withfinger loop41 designed to be grasped and moved by a thumb, whileFIG. 3 illustrates amovable handle40 withfinger loop41 designed to be grasped and moved by one or more fingers. Further, themovable handle40 ofFIGS. 1 and 2 is on the proximal side of fixedhandle50, while themovable handle40 ofFIG. 3 is on the distal side of fixedhandle50.Movable handle40 may also include one ore more ergonomically-enhanced gripping elements (not shown) disposed along the inner peripheral edge ofaperture42 or on fixedhandle50 which is designed to facilitate gripping of thehandles40 and50 during activation. It is envisioned that the gripping element may include one or more protuberances, scallops and/or ribs to enhance gripping.
• As best seen inFIGS. 1 and 2,movable handle40 is selectively moveable about apivot point29 from a first position (FIG. 1) relative to fixedhandle50 to a second position (FIG. 2) in closer proximity to the fixedhandle50 which, as explained below, imparts movement of thejaw members110 and120 relative to one another. It is contemplated that there may be intermediate positions between those shown inFIGS. 1 and 2, e.g., discrete closure points which correspond to ratchet positions as discussed in more detail below. Additionally, continued movement of themoveable handle40 towards the fixedhandle50 first engagesswitch500, which causes the tissue to be sealed, and then engagesknife assembly140, which cuts the tissue. Operation of the forceps is discussed further below.
• As best seen inFIGS. 1-3 and26, the lower end of themovable handle40 includes aflange90.Flange90 also includes anend95 which rides within a predefined channel52 (seeFIG. 26) and mechanically engages withramps57 disposed within fixedhandle50. Additional features with respect to theend95 are explained below in the detailed discussion of the operational features of theforceps10.
• Movable handle40 is designed to provide a distinct mechanical advantage over conventional handle assemblies due to the position of thepivot point29 relative to the longitudinal axis “A” of theshaft12 and the disposition of thedrive assembly150 along longitudinal axis “A.” In other words, it is envisioned that by positioning thepivot point29 above thedrive assembly150, the user gains lever-like mechanical advantage to actuate thejaw members110 and120 enabling the user to close thejaw members110 and120 with lesser force while still generating the required forces necessary to affect a proper and effective tissue seal and to cut thetissue420. It is also envisioned that the unilateral design of theend effector assembly100 will also increase mechanical advantage as explained in more detail below.
• As shown best inFIGS. 4-8, theend effector assembly100 includes opposingjaw members110 and120 which cooperate to effectively grasptissue420 for sealing purposes. Theend effector assembly100 is designed as a unilateral assembly in this particular embodiment, i.e.,jaw member120 is fixed relative to theshaft12 andjaw member110 pivots about apivot pin103 to grasptissue420. A bilateral jaw assembly is also envisioned wherein both jaw members are movable.
• More particularly, the unilateralend effector assembly100 includes one stationary or fixedjaw member120 mounted in fixed relation to theshaft12 and pivotingjaw member110 mounted about apivot pin103 attached to thestationary jaw member120. Areciprocating sleeve60 is slidingly disposed within theshaft12 and is remotely operable by thedrive assembly150. The pivotingjaw member110 includes a detent orprotrusion117 which extends fromjaw member110 through anaperture62 disposed within the reciprocating sleeve60 (FIG. 8). The pivotingjaw member110 is actuated by sliding thesleeve60 axially within theshaft12 such that adistal end63 of theaperture62 abuts against thedetent117 on the pivoting jaw member110 (seeFIGS. 7 and 8). Pulling thesleeve60 proximally closes thejaw members110 and120 abouttissue420 grasped therebetween and pushing thesleeve60 distally opens thejaw members110 and120 for grasping purposes.
• As best illustrated inFIGS. 4 and 6, aknife channel115aand115bruns through the center of thejaw members110 and120, respectively, such that aknife blade185 from theknife assembly140 can cut thetissue420 grasped between thejaw members110 and120 when thejaw members110 and120 are in a closed position. More particularly, theknife blade185 can only be advanced through thetissue420 when thejaw members110 and120 are closed thus preventing accidental or premature activation of theknife blade185 through thetissue420. Put simply, the knife channel115 (made up ofhalf channels115aand115b) is blocked when thejaws members110 and120 are opened and theknife channel115 is aligned for distal activation when thejaw members110 and120 are closed (seeFIGS. 25 and 27). It is also envisioned that the unilateralend effector assembly100 may be structured such that electrical energy can be routed through thesleeve60 at theprotrusion117 contact point with thesleeve60 or using a “brush” or lever (not shown) to contact the back of the movingjaw member110 when thejaw member110 closes. In this instance, the electrical energy would be routed through theprotrusion117 to thestationary jaw member120. Alternatively, acable lead311 may be routed to energize thestationary jaw member120 and the other electrical potential may be conducted through thesleeve60 and transferred to the pivotingjaw member110 which establishes electrical continuity upon retraction of thesleeve60. It is envisioned that this particular envisioned embodiment will provide at least two important safety features: 1) theknife blade185 cannot extend while thejaw members110 and120 are opened; and 2) electrical continuity to thejaw members110 and120 is made only when the jaw members are closed. The illustratedforceps10 only includes theknife channel115.
• As best shown inFIG. 4,jaw member110 also includes ajaw housing116 which has an insulative substrate orinsulator114 and an electricallyconducive surface112. In one embodiment,insulator114 is dimensioned to securely engage the electricallyconductive sealing surface112. This may be accomplished by stamping, by overmolding, by overmolding a stamped electrically conductive sealing plate and/or by overmolding a metal injection molded seal plate. For example and as shown inFIG. 11, the electricallyconductive sealing plate112 includes a series of upwardly extendingflanges111aand111bwhich are designed to matingly engage theinsulator114. Theinsulator114 includes a shoe-like interface107 disposed at a distal end thereof which is dimensioned to engage thejaw housing116 in a slip-fit manner. The shoe-like interface107 may also be overmolded about the outer periphery of thejaw110 during a manufacturing step. It is envisioned thatcable lead311 terminates within the shoe-like interface107 at the point wherecable lead311 electrically connects to the seal plate112 (not shown). Themovable jaw member110 also includes awire channel113 which is designed to guidecable lead311 into electrical continuity with sealingplate112.
• All of these manufacturing techniques producejaw member110 having an electricallyconductive surface112 which is substantially surrounded by an insulatingsubstrate114. In one embodiment, theinsulator114, electricallyconductive sealing surface112 and the outer,non-conductive jaw housing116 are dimensioned to limit and/or reduce many of the known undesirable effects related to tissue sealing, e.g., flashover, thermal spread and stray current dissipation. Alternatively, it is also envisioned that thejaw members110 and120 may be manufactured from a ceramic-like material and the electrically conductive surface(s)112 may be coated onto the ceramic-like jaw members110 and120.
• Jaw member110 includes a pivot flange118 (FIG. 6) which includes aprotrusion117.Protrusion117 extends frompivot flange118 and includes an arcuately-shapedinner surface111 dimensioned to matingly engage theaperture62 ofsleeve60 upon retraction thereof.Pivot flange118 also includes apin slot119 which is dimensioned to engagepivot pin103 to allowjaw member110 to rotate relative tojaw member120 upon retraction of thereciprocating sleeve60. As explained in more detail below,pivot pin103 also mounts to thestationary jaw member120 through a pair ofapertures101aand101bdisposed within a proximal portion of thejaw member120.
• It is envisioned that the electricallyconductive sealing surface112 may also include an outer peripheral edge which has a pre-defined radius and theinsulator114 meets the electricallyconductive sealing surface112 along an adjoining edge of the sealingsurface112 in a generally tangential position. In one embodiment, at the interface, the electricallyconductive surface112 is raised relative to theinsulator114. These and other envisioned embodiments are discussed in co-pending, commonly assigned Application Serial No. PCT/US01/11412 entitled “ELECTROSURGICAL INSTRUMENT WHICH REDUCES COLLATERAL DAMAGE TO ADJACENT TISSUE” by Johnson et al. and co-pending, commonly assigned Application Serial No. PCT/US01/11411 entitled “ELECTROSURGICAL INSTRUMENT WHICH IS DESIGNED TO REDUCE THE INCIDENCE OF FLASHOVER” by Johnson et al., both of which are hereby incorporated by reference in their entirety herein.
• The electrosurgical seal and/or cut can be made utilizing various electrode assemblies on the jaw members, such that energy is applied to the tissue through sealing plates. This and other envisioned electrosurgical sealing and cutting techniques are discussed in co-pending, commonly assigned application Ser. No. 10/932,612 entitled “VESSEL SEALING INSTRUMENT WITH ELECTRICAL CUTTING MECHANISM” by Johnson et al., which is hereby incorporated by reference in its entirety herein.
• In one embodiment, the electricallyconductive surface112 and theinsulator114, when assembled, form a longitudinally-orientedslot115adefined therethrough for reciprocation of theknife blade185. It is envisioned that theknife channel115acooperates with acorresponding knife channel115bdefined instationary jaw member120 to facilitate longitudinal extension of theknife blade185 along a preferred cutting plane to effectively and accurately separate thetissue420 along the formed tissue seal450 (seeFIGS. 30 and 33).
• Jaw member120 includes similar elements tojaw member110 such as jaw housing126 having aninsulator124 and an electricallyconductive sealing surface122 which is dimensioned to securely engage theinsulator124. Likewise, the electricallyconductive surface122 and theinsulator124, when assembled, include a longitudinally-orientedchannel115adefined therethrough for reciprocation of theknife blade185. As mentioned above, when thejaw members110 and120 are closed abouttissue420,knife channels115aand115bform acomplete knife channel115 to allow longitudinal extension of theknife blade185 in a distal fashion to severtissue420 along thetissue seal450. It is also envisioned that theknife channel115 may be completely disposed in one of the two jaw members, e.g.,jaw member120, depending upon a particular purpose. It is envisioned that the fixedjaw member120 may be assembled in a similar manner as described above with respect tojaw member110.
• As best seen inFIG. 4,jaw member120 includes a series ofstop members750 disposed on the inner facing surfaces of the electricallyconductive sealing surface122 to facilitate gripping and manipulation of tissue and to define a gap “G” (FIG. 29) between opposingjaw members110 and120 during sealing and cutting of tissue. It is envisioned that the series ofstop members750 may be employed on one or bothjaw members110 and120 depending upon a particular purpose or to achieve a desired result. A detailed discussion of these and other envisioned stopmembers750 as well as various manufacturing and assembling processes for attaching and/or affixing thestop members750 to the electrically conductive sealing surfaces112,122 are described in commonly-assigned, co-pending U.S. Application Serial No. PCT/US01/11413 entitled “VESSEL SEALER AND DIVIDER WITH NON-CONDUCTIVE STOP MEMBERS” by Dycus et al. which is hereby incorporated by reference in its entirety herein.
• Jaw member120 is designed to be fixed to the end of arotating tube160 which is part of the rotatingassembly80 such that rotation of thetube160 will impart rotation to the end effector assembly100 (seeFIGS. 13 and 19).Jaw member120 includes a rear C-shapedcuff170 having aslot177 defined therein which is dimensioned to receive aslide pin171. More particularly,slide pin171 includes aslide rail176 which extends substantially the length thereof which is dimensioned to slide into friction-fit engagement withinslot177. A pair ofchamfered plates172aand172bextend generally radially from theslide rail176 and include a radius which is substantially the same radius as the outer periphery of therotating tube160 such that theshaft12 can encompass each of the same upon assembly.
• As best shown inFIGS. 19 and 20, therotating tube160 includes anelongated guide slot167 disposed in an upper portion thereof which is dimensioned to carrycable lead311 therealong. Thechamfered plates172aand172balso form awire channel175 which is dimensioned to guide thecable lead311 from thetube160 and into the movable jaw member110 (seeFIG. 4). Cable lead311 carries a first electrical potential tomovable jaw110.
• As shown inFIG. 19, the distal end of thetube160 is generally C-shaped to include two upwardly extendingflanges162aand162bwhich define acavity165 for receiving the proximal end of the fixedjaw member120 inclusive of C-shapedcuff170 and slide pin171 (seeFIG. 21). In one embodiment, thetube cavity165 retains and secures thejaw member120 in a friction-fit manner, however, thejaw member120 may be welded to thetube160 depending upon a particular purpose.Tube160 also includes aninner cavity169 defined therethrough which reciprocates theknife assembly140 upon distal activation thereof and anelongated guide rail163 which guides theknife assembly140 during distal activation (seeFIG. 20). The details with respect to the knife assembly are explained in more detail with respect toFIGS. 15-18. The proximal end oftube160 includes a laterally orientedslot168 which is designed to interface with the rotatingassembly80 as described below.
• FIG. 19 also shows the rotatingassembly80 which includes C-shapedrotating halves82aand82bwhich, when assembled abouttube160, form a generally circular rotating member82. More particularly, each rotating half, e.g.,82b, includes a series ofmechanical interfaces375a,375b,375cand375dwhich matingly engage a corresponding series of mechanical interfaces in the other half, e.g.,82a, to form rotating member82.Half82balso includes atab89bwhich, together with a corresponding tab89adisposed on half82a(phantomly illustrated), cooperate to matingly engageslot168 disposed ontube160. As can be appreciated, this permits selective rotation of thetube160 about axis “A” by manipulating the rotating member82 in the direction of the arrow “B” (seeFIG. 2).
• As best shown in the exploded view ofFIG. 11,jaw members110 and120 are pivotably mounted with respect to one another such thatjaw member110 pivots in a unilateral fashion from a first open position to a second closed position for grasping and manipulatingtissue420. More particularly, fixedjaw member120 includes a pair of proximal, upwardly extendingflanges125aand125bwhich define acavity121 dimensioned to receiveflange118 ofmovable jaw member110 therein. As explained in detail below with respect to the operation of thejaw members110 and120, proximal movement of thetube60 engagesdetent117 to pivot thejaw member110 to a closed position.
• FIGS. 1-3 show thehousing20 and the component features thereof, namely, thehandle assembly30, the rotatingassembly80, theknife assembly140, thedrive assembly150, theswitch500, thelatch assembly600 and acutter lever700.
• The housing includes two halves (constructed similarly to the halves of rotatingassembly80, as discussed above with reference toFIG. 19) which, when mated, formhousing20. As can be appreciated,housing20, once formed, houses the various assemblies identified above which will enable a user to selectively manipulate, grasp, seal and severtissue420 in a single action. In one embodiment, each half of the housing includes a series of mechanical interfacing components (not shown) which align and/or mate with a corresponding series of mechanical interfaces to align the two housing halves about the inner components and assemblies. The housing halves can then be sonic welded to secure the housing halves once assembled.
• Themovable handle40 includesclevis45 which pivots aboutpivot point29 to pull thereciprocating sleeve60 along longitudinal axis “A” and force adrive flange47 against thedrive assembly150 which, in turn, closes thejaw members110 and120, as explained above. As mentioned above, the lower end of themovable handle40 includes aflange90 which has anend95 which rides within apredefined channel52 disposed within fixed handle50 (seeFIG. 26). The arrangement of theclevis45 and thepivot point29 of themovable handle40 provides a distinct mechanical advantage over conventional handle assemblies due to the position of thepivot point29 relative to the longitudinal axis “A” of thedrive flange47. In other words, by positioning thepivot point29 above thedrive flange47, the user gains lever-like mechanical advantage to actuate thejaw members110 and120. This reduces the overall amount of mechanical force necessary to close thejaw members110 and120 to affect a tissue seal.
• Movable handle40 also includes afinger loop41 which defines opening42 which is dimensioned to facilitate grasping themovable handle40. In one embodiment,finger loop41 includes rubber insert which enhances the overall ergonomic “feel” of themovable handle40.
• Handleassembly30 further includes acutter lever700 positioned withinhousing20. Whenmovable handle40 is actuated (squeezed) past a certain threshold, aswitch lever502 is depressed bymovable handle40 to initiate a tissue seal cycle. Aflexible detent602 provides tactile feedback that themovable handle40 is nearing an exit of the latch sealing zone and an end of theramps57. When themovable handle40 is pushed past theflexible detent602, end95 offlange90 drops down fromramps57 and the user is able to return themovable handle40 proximally to open thejaw members110,120 without cutting the seal. The user may also close themovable handle40 to cut the sealedtissue420 via actuation of thelever700. When closingmovable handle40 farther to cut tissue, end95 contacts alatch spring704, which provides resistance on themovable handle40. This provides an indication to the user that tissue cutting is about to begin.
• Themovable handle40 or ahandle detent710 contacts thecutter lever700, which activatesknife assembly140, which severs thetissue420. As can be appreciated, this prevents accidental or premature severing oftissue420 prior to completion of thetissue seal450. The generator may provide an audible signal or other type of feedback when the seal cycle is complete. The surgeon can then safely cut the seal or return themovable handle40 without cutting. In an alternative method, an electromechanical, mechanical or electrical feature could prevent cutting without initially sealing or without the surgeon activating a special over-ride feature.
• Fixedhandle50 includes a channel52 (FIG. 26) defined therein which is dimensioned to receiveend95 offlange90 whenmovable handle40 is actuated. Theend95 offlange90 is dimensioned forfacilereception withramps57 withinchannel52 of fixedhandle50. It is envisioned thatflange90 may be dimensioned to allow a user to selectively, progressively and/or incrementally movejaw members110 and120 relative to one another from the open to closed positions. For example, it is contemplated thatend95 and ramps57 may include a ratchet-like interface (FIGS. 1-3) which lockingly engages themovable handle40 and, therefore,jaw members110 and120 at selective, incremental positions relative to one another depending upon a particular purpose. Such a ratchet-like interface can also prevent themovable handle40 from becoming unactuated prior to the severing oftissue420.
• It is also contemplated that the ratchet-like interface between theend95 and ramps57 are configured such that a catch basin is disposed between each step of the ratchet. A catch basin is described in commonly-assigned, co-pending U.S. application Ser. No. 10/460,926 entitled “VESSEL SEALER AND DIVIDER FOR USE WITH SMALL TROCARS AND CANNULAS” by Dycus et al., which is hereby incorporated by reference in its entirety herein, and can be utilized to be a stopping point between each of the functions that themovable handle40 can control (i.e., manipulation, clamping, sealing and cutting). Employing such a catch basin will enable the user to selectively advance themovable handle40, while ensuring the functions are carried out in the proper order.
• Other mechanisms may also be employed to control and/or limit the movement ofmovable handle40 relative to fixed handle50 (andjaw members110 and120) such as, e.g., hydraulic, semi-hydraulic, linear actuator(s), gas-assisted mechanisms and/or gearing systems.
• In one embodiment,forceps10 includes at least one tactile element which provides tactile feedback to the user to signify when tissue is being grasped, when the tissue has been sealed and/or when the tissue has been cut. Such a tactile element may include the turning on/off of lights (not shown) onhousing20 or mechanical vibrations being created in the fixedhandle50 ormovable handle40. It is further envisioned for a sensor to be disposed on or withinforceps10 to alert to the user when one or more completion stages has occurred, i.e., at the completion of tissue grasping, tissue sealing and/or tissue cutting.
• As best illustrated inFIG. 26, housing halves form an internal cavity which predefines thechannel52 within fixedhandle50 such that an entrance pathway51 and anexit pathway58 are formed for reciprocation of theend95 offlange90 therein. When assembled, tworamps57 are positioned to define a rail or track192, such that theflange90 can fit between theramps57 and end95 moves along the track192. During movement ofend95 offlange90 along the entrance and exitpathways51 and58, respectively, theend95 rides along track192 according to the particular dimensions of theramps57, which, as can be appreciated, predetermines part of the overall pivoting motion ofmovable handle40 relative to fixedhandle50.
• As best illustrated inFIGS. 1 and 2, once actuated,movable handle40 moves in a generally arcuate fashion towards fixedhandle50 aboutpivot point29.End95 offlange90 moves along ramps57 (shown as a single ramp inFIGS. 1-3 for clarity) which forces driveflange47 against thedrive assembly150 which, in turn, pulls reciprocatingsleeve60 in a generally proximal direction to closejaw member110 relative tojaw member120. Continued actuation ofmovable handle40 forces end95 offlange90 farther alongramps57 and forces themovable handle40 orcutter lever700 into acontact502 ofswitch500, which causes the sealing oftissue420 to occur. Continued actuation ofmovable handle40 then forcesmovable handle detent710 intocutter lever700 to initiate engagement thereof. A detailed discussion of how the sealing occurs, including by electro-mechanical means, is described in commonly-assigned, co-pending U.S. application Ser. No. 10/932,612 entitled “VESSEL SEALING INSTRUMENT WITH ELECTRICAL CUTTING MECHANISM” by Johnson et al., which is hereby incorporated herein.
• Continued actuation ofmovable handle40 forces end95 offlange90 farther along theramps57 and into aflexible latch detent602. The user feels a resistance when theend95 contacts theflexible latch detent602, which signifies that the device is about to exit the sealing position and either cut or return to its original position without cutting. To cut thetissue seal450, the user continues to actuate themovable handle40, such that thecutter lever700 activatesknife assembly140, which in turn severs thetissue seal450. At this cutting stage, theend95 contacts adetent rib704 which provides increased resistance to the user indicating that cutting of the tissue is about to begin. Theend95 slides distally along detent rib704 (in the embodiment shown inFIG. 3, thedetent rib704 is contacted proximally). When the cut is complete, thedetent rib704 may stop the motion of theend95 and allowflange90 to follow its return path58 (FIG. 26), as discussed above. Therefore, a full actuation ofmovable handle40 grasps and clampstissue420, seals thetissue420, and cuts thetissue seal450, before returning themovable handle40 to its original, unactuated position.
• FIG. 3 illustrates theforceps10 with themovable handle40 located on the distal side of fixedhandle50. As can be appreciated, the internal dynamics of this embodiment are similar to those of the forceps illustrated inFIGS. 1 and 2, thus causing theforceps10 to function in a comparable way.
• It is envisioned that theflexible latch detent602 may include one or more electro-mechanical switches, similar to those ofswitch500, to seal thetissue420. In this embodiment,handswitch500 and contact502 are not necessary. Details relating to the handswitch are discussed below.
• It is also envisioned thatlatch spring704 may include one or more mechanical or electro-mechanical switches or activations to drive theknife assembly140 to cut thetissue seal450, such that when end95 contacts thelatch spring704, thetissue seal450 is automatically severed.
• The operating features and relative movements of the internal working components of theforceps10 are shown as phantom lines in the various figures.
• As themovable handle40 is actuated andflange90 is incorporated intochannel52 of fixedhandle50, thedrive flange47, through the mechanical advantage of the above-the-center pivot points, biases aring flange154 ofdrive ring159 which, in turn, compresses adrive spring67 against arear ring156 of the drive assembly150 (FIG. 28). As a result thereof, therear ring156 reciprocatessleeve60 proximally which, in turn, closesjaw member110 ontojaw member120. It is envisioned that the utilization of an over-the-center pivoting mechanism will enable the user to selectively compress the drive spring67 a specific distance which, in turn, imparts a specific pulling load on thereciprocating sleeve60 which is converted to a rotational torque about thejaw pivot pin103. As a result, a specific closure force can be transmitted to the opposingjaw members110 and120.
• FIG. 26 shows the initial actuation ofmovable handle40 towards fixedhandle50 which causes theend95 offlange90 to move generally proximally and upwardly along entrance pathway51 (this illustration is the embodiment of the forceps shown inFIG. 3; the internal environment of the forceps ofFIGS. 1 and 2 is similarly situated). During movement of theflange90 along the entrance and exitpathways51 and58, respectively, theend95 rides along track192 along theramps57. Once thetissue420 is clamped, sealed and cut, end95 clearsedge193 andmovable handle40 andflange90 are redirected to exitpathway58, where themovable handle40 returns to its unactuated position.
• As mentioned above, thejaw members110 and120 may be opened, closed and rotated to manipulatetissue420 until sealing is desired. This enables the user to position and re-position theforceps10 prior to activation and sealing. Theend effector assembly100 is rotatable about longitudinal axis “A” through rotation of the rotatingassembly80. It is envisioned that the feed path of thecable lead311 through the rotatingassembly80, alongshaft12 and, ultimately, to thejaw member110 enables the user to rotate theend effector assembly100 approximately 180 degrees in both the clockwise and counterclockwise directions without tangling or causing undue strain oncable lead311. As can be appreciated, this facilitates the grasping and manipulation oftissue420.
• Again as best shown inFIGS. 1 and 2,cutter lever700 mounts adjacentmovable handle40 and cooperates with theknife assembly140 to selectively translateknife blade185 through atissue seal450.
• Distal activation of the movable handle40 (in the embodiment shown inFIGS. 1 and 2) forces thecutter lever700 distally, which, as explained in more detail below, ultimately extends theknife blade185 through thetissue420. Aknife spring350 biases the knife assembly70 in a retracted position such that after severingtissue420 theknife blade185 and the knife assembly70 are automatically returned to a pre-firing position.
• Drive assembly150 includes reciprocatingsleeve60, drivehousing158,drive spring67,drive ring159,drive stop155 and guidesleeve157 which all cooperate to form thedrive assembly150. More particularly and as best shown inFIGS. 22 and 23, thereciprocating sleeve60 includes adistal end65 which as mentioned above has anaperture62 formed therein for actuating thedetent117 ofjaw member110. In one embodiment, thedistal end65 includes a scoop-like support member69 for supporting aproximal end61 of the fixedjaw member120 therein. Theproximal end61 of thereciprocating sleeve60 includes aslot68 defined therein which is dimensioned to slidingly support the knife assembly70 for longitudinal reciprocation thereof to severtissue420. Theslot68 also permits retraction of thereciprocating sleeve60 over theknife assembly140 during the closing ofjaw member110 relative tojaw member120.
• Theproximal end61 of thereciprocating sleeve60 is positioned within an aperture151 indrive housing158 to permit selective reciprocation thereof upon actuation of themovable handle40. Thedrive spring67 is assembled atop thedrive housing158 between arear stop156 of thedrive housing158 and aforward stop154 of thedrive ring159 such that movement of theforward stop154 compresses thedrive spring67 against therear stop156 which, in turn, reciprocates thedrive sleeve60. As a result thereof, thejaw members110 and120 and themovable handle40 are biased bydrive spring67 in an open configuration. Thedrive stop155 is fixedly positioned atop thedrive housing158 and biases themovable handle40 when actuated such that thedrive flange47 forces thestop154 of thedrive ring159 proximally against the force of thedrive spring67. Thedrive spring67, in turn, forces therear stop156 proximally to reciprocate thesleeve60. In one embodiment, the rotatingassembly80 is located proximal to thedrive flange47 to facilitate rotation of theend effector assembly100. Theguide sleeve157 mates with theproximal end61 of thereciprocating sleeve60 and affixes to thedrive housing158. The assembleddrive assembly150 is shown best inFIG. 14.
• As best shown in FIGS.12 and15-18, theknife assembly140 includes anelongated rod182 having a bifurcated distalend comprising prongs182aand182bwhich cooperate to receive aknife bar184 therein. Theknife assembly180 also includes aproximal end183 which is keyed to facilitate insertion intotube160 of the rotatingassembly80. Aknife wheel148 is secured to theknife bar182 by apin143. More particularly, theelongated knife rod182 includesapertures181aand181bwhich are dimensioned to receive and secure theknife wheel148 to theknife rod182 such that longitudinal reciprocation of theknife wheel148, in turn, moves theelongated knife rod182 to severtissue420.
• In one embodiment, theknife wheel148 is donut-like and includesrings141aand141bwhich define adrive slot147 designed to receive a drive bar (not shown) such that actuation of themovable handle40 forces the drive bar and theknife wheel148 distally. It is envisioned thatapertures181aand181bmay be used for different configurations. As such,pin143 is designed for attachment through eitheraperture181aor181bto mount the knife wheel148 (seeFIG. 18).Knife wheel148 also includes a series ofradial flanges142aand142bwhich are dimensioned to slide along bothchannel163 oftube160 andslot68 of the reciprocating sleeve60 (seeFIG. 9).
• As mentioned above, theknife rod182 is dimensioned to mount theknife bar184 betweenprongs182aand182b, which can be in a friction-fit engagement. Theknife bar184 includes a series ofsteps186a,186band186cwhich reduce the profile of theknife bar184 towards the distal end thereof. The distal end of theknife bar184 includes aknife support188 which is dimensioned to retainknife blade185. The end of theknife support188 can include a chamfered edge188a. It is envisioned that theknife blade185 may be welded to theknife support188 or secured in any manner known in the trade.
• As best shown inFIGS. 1 and 2, as the tissue is securely grasped and thecutter lever700 advances distally due to actuation ofmovable handle40,switch500 activates, by virtue ofmovable handle40engaging contact502. At this point, electrosurgical energy is transferred through cable leads tojaw members110 and120, as described in commonly-assigned, co-pending U.S. application Ser. No. 10/460,926 entitled “VESSEL SEALER AND DIVIDER FOR USE WITH SMALL TROCARS AND CANNULAS” by Dycus et al., which is hereby incorporated by reference in its entirety herein. As can be appreciated from the mechanics of theforceps10, theswitch500 cannot fire unless thejaw members110 and120 are closed. A sensor (not shown) may be included in the generator or the housing which prevents activation unless thejaw members110 and120 havetissue420 held therebetween. In addition, other sensor mechanisms may be employed which determine pre-surgical, concurrent surgical (i.e., during surgery) and/or post surgical conditions. The sensor mechanisms may also be utilized with a closed-loop feedback system coupled to the electrosurgical generator to regulate the electrosurgical energy based upon one or more pre-surgical, concurrent surgical or post surgical conditions. Various sensor mechanisms and feedback systems are described in commonly-owned, co-pending U.S. patent application Ser. No. 10/427,832 entitled “METHOD AND SYSTEM FOR CONTROLLING OUTPUT OF RF MEDICAL GENERATOR” filed on May 1, 2003 the entire contents of which are hereby incorporated by reference herein.
• In one embodiment, thejaw members110 and120 are electrically isolated from one another such that electrosurgical energy can be effectively transferred through thetissue420 to formseal450. For example and as best illustrated inFIGS. 24 and 25, each jaw member, e.g.,110, includes a uniquely-designed electrosurgical cable path disposed therethrough which transmits electrosurgical energy to the electricallyconductive sealing surface112. It is envisioned thatjaw member110 may include one or more cable guides or crimp-like electrical connectors to directcable lead311 towards electricallyconductive sealing surface112. In one embodiment,cable lead311 is held loosely but securely along the cable path to permit rotation of thejaw member110 aboutpivot103. As can be appreciated, this isolates electricallyconductive sealing surface112 from the remaining operative components of theend effector assembly100,jaw member120 andshaft12. The second electrical potential is conducted tojaw member120 throughtube160. The two potentials are isolated from one another by virtue of the insulative sheathing surroundingcable lead311.
• It is contemplated that utilizing a cable feed path forcable lead311 and by utilizing aconductive tube160 to carry the first and second electrical potentials not only electrically isolates eachjaw member110 and120 but also allows thejaw members110 and120 to pivot aboutpivot pin103 without unduly straining or possibly tanglingcable lead311. Moreover, it is envisioned that the simplicity of the electrical connections greatly facilitates the manufacturing and assembly process and assures a consistent and tight electrical connection for the transfer of energy through thetissue420.
• As discussed in commonly-assigned, co-pending U.S. application Ser. No. 10/460,926 entitled “VESSEL SEALER AND DIVIDER FOR USE WITH SMALL TROCARS AND CANNULAS” by Dycus et al., which is hereby incorporated by reference in its entirety herein, it is envisioned that select cable leads are fed throughhalves82aand82bof the rotatingassembly80 in such a manner to allow rotation of the shaft12 (via rotation of the rotating assembly80) in the clockwise or counter-clockwise direction without unduly tangling or twisting the cable leads. More particularly, select cable leads are fed through a series of conjoining slots84a,84b,84cand84dlocated in the twohalves82aand82bof the rotatingassembly80. In one embodiment, each conjoining pair of slots, e.g.,84a,84band84c,84d, is large enough to permit rotation of the rotatingassembly80 without unduly straining or tangling the cable leads. The presently disclosed cable lead feed path is envisioned to allow rotation of the rotation assembly approximately 180 degrees in either direction.
• Turning back toFIGS. 1-3 which show a view of thehousing20, rotatingassembly80,movable handle40, fixedhandle50,latch assembly600,switch500 andcutter lever700, it is envisioned that all of these various component parts along with theshaft12 and theend effector assembly100 are assembled during the manufacturing process to form a partially and/or fullydisposable forceps10. For example and as mentioned above, theshaft12 and/or endeffector assembly100 may be disposable and, therefore, selectively/releasably engagable with thehousing20 and rotatingassembly80 to form a partiallydisposable forceps10 and/or theentire forceps10 may be disposable after use.
• Once assembled,drive spring67 is poised for compression atopdrive housing158 upon actuation of themovable handle40. More particularly, movement of themovable handle40 aboutpivot point29 reciprocates theflange90 into fixedhandle50 and forces driveflange47 againstflange154 ofdrive ring159 to compressdrive spring67 against therear stop156 to reciprocate the sleeve60 (seeFIG. 28).
• Theswitch500 is prevented from firing before thetissue420 is clamped byjaw members110 and120. For the sealing to take place, themovable handle40 should be actuated far enough to contact (or, alternatively, for thecutter lever700 to contact) theswitch500, contact502 or a sensor (not shown). Before theswitch500 is contacted, themovable handle40 should travel sufficiently far enough to causejaw members110 and120 to be clamped. It is envisioned that the opposingjaw members110 and120 may be rotated and partially opened and closed before activation ofswitch500 which, as can be appreciated, allows the user to grip and manipulate thetissue420 before thetissue420 is sealed.
• It is envisioned that configuring thepivot29 above or relative to a longitudinal axis defined through the shaft provides an increased mechanical advantage, thus facilitating and easing selective compression of the drive spring67 a specific distance which, in turn, imparts a specific load on thereciprocating sleeve60. As best seen inFIG. 2, themoveable handle40 includes a drive cam surface49′ which is designed in-line with the longitudinal axis “A,” which together with the position of the pivot28 being disposed above axis “A,” increase the mechanical advantage of themovable handle40 and reduce the amount of force necessary to actuate thejaw members110,120 with the preferred closure force. The load of thereciprocating sleeve60 is converted to a torque about thejaw pivot103. As a result, a specific closure force can be transmitted to the opposingjaw members110 and120 between the range of about 3 kg/cm²to about 16 kg/cm². As mentioned above, thejaw members110 and120 may be opened, closed and rotated to manipulatetissue420 until sealing is desired. This enables the user to position and re-position theforceps10 prior to activation and sealing.
• Once the desired position for the sealing site is determined and thejaw members110 and120 are properly positioned,movable handle40 may be actuated farther such that theswitch500 is engaged to seal thetissue420 with electrosurgical energy. Continued actuation ofmovable handle40 engages knife assembly140 (as discussed above), which causes thetissue seal450 to be severed.
• It is envisioned that theend effector assembly100 and/or thejaw members110 and120 may be dimensioned to off-load some of the excessive clamping forces to prevent mechanical failure of certain internal operating elements of theend effector100.
• As can be appreciated, the combination of the increased mechanical advantage provided by the above-the-axis pivot29 along with the compressive force associated with thedrive spring67 facilitate and assure consistent, uniform and accurate closure pressure about thetissue420 within the desired working pressure range of about 3 kg/cm²to about 16 kg/cm²and, preferably, about 7 kg/cm²to about 13 kg/cm². By controlling the intensity, frequency and duration of the electrosurgical energy applied to thetissue420, the user can effectively seal tissue.
• In one embodiment, the electrically conductive sealing surfaces112 and122 of thejaw members110 and120, respectively, are relatively flat to avoid current concentrations at sharp edges and to avoid arcing between high points. In addition and due to the reaction force of thetissue420 when engaged,jaw members110 and120 can be manufactured to resist bending. For example, thejaw members110 and120 may be tapered along the width thereof which is advantageous for two reasons: 1) the taper will apply constant pressure for a constant tissue thickness at parallel; 2) the thicker proximal portion of thejaw members110 and120 will resist bending due to the reaction force of thetissue420.
• As mentioned above, at least one jaw member, e.g.,120, may include astop member750 which limits the movement of the two opposingjaw members110 and120 relative to one another. In one embodiment, thestop member750 extends a predetermined distance from the sealing surface122 (according to the specific material properties [e.g., compressive strength, thermal expansion, etc.]) to yield a consistent and accurate gap distance “G” during sealing (FIG. 29). The gap distance between opposing sealingsurfaces112 and122 during sealing ranges from about 0.001 inches to about 0.006 inches and, desirably, between about 0.002 and about 0.003 inches. It is envisioned that thenon-conductive stop members750 may be molded onto thejaw members110 and120 (e.g., overmolding, injection molding, etc.), stamped onto thejaw members110 and120 or deposited (e.g., deposition) onto thejaw members110 and120. For example, one technique involves thermally spraying a ceramic material onto the surface of thejaw member110 and120 to form thestop members750. Several thermal spraying techniques are contemplated which involve depositing a broad range of heat resistant and insulative materials on various surfaces to createstop members750 for controlling the gap distance between electricallyconductive surfaces112 and122.
• As energy is being selectively transferred to theend effector assembly100, across thejaw members110 and120 and through thetissue420, atissue seal450 forms isolating twotissue halves420aand420b. With other known vessel sealing instruments, the user then removes and replaces theforceps10 with a cutting instrument (not shown) or manually activates another switch to divide the tissue halves420aand420balong thetissue seal450. As can be appreciated, this is both time consuming and tedious and may result in inaccurate tissue division across thetissue seal450 due to misalignment or misplacement of the cutting instrument along the ideal tissue cutting plane.
• As explained in detail above, the present disclosure incorporates aknife assembly140 which, when activated via thehandle assembly30, progressively and selectively divides thetissue420 along an ideal tissue plane in precise manner to effectively and reliably divide thetissue420 into two sealedhalves420aand420bwith atissue gap475 therebetween (seeFIG. 33). Theknife assembly140 in conjunction with thehandle assembly30 allows the user to quickly separate thetissue420 immediately after sealing without substituting a cutting instrument through a cannula or trocar port and without having to perform a different action (e.g., manually activating a switch or pulling a trigger). As can be appreciated, accurate sealing and dividing oftissue420 is accomplished with a single, continuous motion using thesame forceps10.
• It is envisioned thatknife blade185 may also be coupled to the same or an alternative electrosurgical energy source to facilitate separation of thetissue420 along the tissue seal450 (not shown). Moreover, it is envisioned that the angle of the tip of theknife blade185 may be dimensioned to provide more or less aggressive cutting angles depending upon a particular purpose. For example, theknife blade185 may be positioned at an angle which reduces “tissue wisps” associated with cutting. Moreover, theknife blade185 may be designed having different blade geometries such as serrated, notched, perforated, hollow, concave, convex etc. depending upon a particular purpose or to achieve a particular result.
• From the foregoing and with reference to the various figure drawings, those skilled in the art will appreciate that certain modifications can also be made to the present disclosure without departing from the scope of the same. For example, it may be preferable to add other features to theforceps10, e.g., an articulating assembly to axially displace theend effector assembly100 relative to theelongated shaft12.
• It is also contemplated that the forceps10 (and/or the electrosurgical generator used in connection with the forceps10) may include a sensor or feedback mechanism (not shown) which automatically selects the appropriate amount of electrosurgical energy to effectively seal the particularly-sized tissue grasped between thejaw members110 and120. The sensor or feedback mechanism may also measure the impedance across the tissue during sealing and provide an indicator (visual and/or audible) that an effective seal has been created between thejaw members110 and120. Examples of such sensor systems are described in commonly-owned U.S. patent application Ser. No. 10/427,832 entitled “METHOD AND SYSTEM FOR CONTROLLING OUTPUT OF RF MEDICAL GENERATOR,” filed on May 1, 2003 the entire contents of which are hereby incorporated by reference herein.
• Although the figures depict theforceps10 manipulating anisolated vessel420, it is contemplated that theforceps10 may be used with non-isolated vessels as well. Other cutting mechanisms are also contemplated to cuttissue420 along the ideal tissue plane.
• It is envisioned that the outer surface of theend effector assembly100 may include a nickel-based material, coating, stamping, metal injection molding which is designed to reduce adhesion between thejaw members110 and120 with the surrounding tissue during activation and sealing. Moreover, it is also contemplated that theconductive surfaces112 and122 of thejaw members110 and120 may be manufactured from one (or a combination of one or more) of the following materials: nickel-chrome, chromium nitride, MedCoat 2000 manufactured by The Electrolizing Corporation of OHIO, inconel 600 and tin-nickel. The tissueconductive surfaces112 and122 may also be coated with one or more of the above materials to achieve the same result, i.e., a “non-stick surface.” As can be appreciated, reducing the amount that the tissue “sticks” during sealing improves the overall efficacy of the instrument.
• One particular class of materials disclosed herein has demonstrated superior non-stick properties and, in some instances, superior seal quality. For example, nitride coatings which include, but not are not limited to: TiN, ZrN, TiAlN, and CrN are preferred materials used for non-stick purposes. CrN has been found to be particularly useful for non-stick purposes due to its overall surface properties and optimal performance. Other classes of materials have also been found to reducing overall sticking. For example, high nickel/chrome alloys with a Ni/Cr ratio of approximately 5:1 have been found to significantly reduce sticking in bipolar instrumentation. One particularly useful non-stick material in this class isInconel 600. Bipolar instrumentation having sealingsurfaces112 and122 made from or coated with Ni200, Ni201 (˜100% Ni) also showed improved non-stick performance over typical bipolar stainless steel electrodes.
• While several embodiments of the disclosure have been shown in the figures, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Claims (16)

What is claimed is:

1. A bipolar forceps, comprising:

a housing;

an elongated member extending distally from the housing and defining a longitudinal axis;

an end effector assembly disposed adjacent a distal end of the elongated member, the end effector assembly including a first jaw member and a second jaw member, the first jaw member moveable relative to the second jaw member from a first position in spaced relation to the second jaw member to a second position closer to the second jaw member for grasping tissue therebetween, at least one of the jaw members adapted to connect to an electrosurgical energy source such that the jaw members are capable of conducting energy through tissue grasped therebetween to effect a tissue seal;

a drive assembly operably coupled to the housing for moving the first jaw member from the first position to the second position;

a knife assembly configured to cut tissue disposed between the jaw members; and

a movable handle connected to the housing and selectively rotatable about a pivot, wherein a single, continuous actuation of the movable handle is operable to engage the drive assembly to move the first jaw member and to advance the knife assembly to cut tissue disposed between the jaw members;

wherein the knife assembly is prevented from being advanced to cut tissue prior to the first jaw member being moved toward its second position.

2. A bipolar forceps according toclaim 1, wherein each of the jaw members includes a longitudinally-extending knife channel extending at least partially therethrough.

3. A bipolar forceps according toclaim 1, wherein at least one of the jaw members includes at least one stop member disposed thereon that regulates the distance between the jaw members.

4. A bipolar forceps according toclaim 3, wherein the distance between the jaw members is between 0.001 inches and 0.006 inches.

5. A bipolar forceps according toclaim 1, wherein a pressure range between the jaw members when disposed in the second position is between about 3 kg/cm²and about 16 kg/cm².

6. A bipolar forceps according toclaim 1, further including at least one tactile element that provides tactile feedback to a user relating to at least one of tissue sealing and tissue cutting.

7. A bipolar forceps according toclaim 1, further including a switch operably coupled to the housing and configured to activate the electrosurgical energy source.

8. A bipolar forceps, comprising:

a housing;

an elongated member extending distally from the housing and defining a longitudinal axis;

an end effector assembly disposed adjacent a distal end of the elongated member, the end effector assembly including a first jaw member and a second jaw member, the first jaw member being moveable relative to the second jaw member from a first position in spaced relation to the second jaw member to a second position closer to the second jaw member for grasping tissue therebetween;

a drive assembly operably coupled to the housing for moving the first jaw member from the first position to the second position;

a knife assembly configured to cut tissue disposed between the jaw members; and

a movable handle connected to the housing and selectively rotatable about a pivot, wherein a single actuation of the movable handle is operable to engage the drive assembly to move the first jaw member and to advance the knife assembly to cut tissue disposed between the jaw members;

wherein the knife assembly is prevented from being advanced to cut tissue prior to the first jaw member being moved toward its second position, and wherein the movable handle is the only user actuatable feature that effects the ability to advance the knife assembly.

9. A bipolar forceps according toclaim 8, wherein each of the jaw members includes a longitudinally-extending knife channel extending at least partially therethrough.

10. A bipolar forceps according toclaim 8, wherein at least one of the jaw members includes at least one stop member disposed thereon that regulates the distance between the jaw members.

11. A bipolar forceps according toclaim 10, wherein the distance between the jaw members is between 0.001 inches and 0.006 inches.

12. A bipolar forceps according toclaim 8, wherein a pressure range between the jaw members when disposed in the second position is between about 3 kg/cm²and about 16 kg/cm².

13. A bipolar forceps according toclaim 8, further including at least one tactile element that provides tactile feedback to a user relating to at least one of tissue sealing and tissue cutting.

14. A bipolar forceps according toclaim 8, wherein at least one of the jaw members is adapted to connect to an electrosurgical energy source such that the jaw members are capable of conducting energy through tissue grasped therebetween to effect a tissue seal.

15. A method for using a bipolar forceps to grasp and cut tissue, the method comprising:

providing a bipolar forceps, the forceps having a housing, a shaft extending from the housing, and an end effector assembly disposed adjacent a distal end thereof, the end effector assembly including a first jaw member and a second jaw member, a drive assembly operably coupled to the housing, a knife assembly, and a movable handle connected to the housing and selectively rotatable about a pivot;

with a single, continuous actuation of the movable handle, engaging the drive assembly to move the first jaw member toward the second jaw member such that the first and second jaw members grasp tissue therebetween, and advancing at least a portion of the knife assembly to cut tissue disposed between the jaw members; and

wherein the knife assembly is prevented from being advanced to cut tissue prior to the first jaw member being moved toward the second jaw member.

16. A method for using a bipolar forceps to grasp and cut tissue ofclaim 15 wherein the movable handle is the only user actuatable feature that effects the ability to advance the knife assembly.

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