Vessel sealer and divider for large tissue structures

p00001Vessel sealer and divider for large tissue structures

p00002The present exhibition refers to electrosurgical forceps and, more particularly, to electrosurgical forceps for sealing and / or cutting large tissue structures.

p00003Technical Field

p00004In electrosurgical forceps both the mechanical pinching action and the electrical energy are used to perform hemostasis, heating the tissue and blood vessels to coagulate, cauterize and / or seal tissue. Many surgical procedures require cutting and / or linking large blood vessels and large tissue structures. Due to the spatial considerations inherent in the surgical cavity, surgeons often have difficulty suturing the vessels or putting into practice other traditional methods of bleeding control, for example, clamping and / or ligation of blood vessels or tissue. Using elongated electrosurgical forceps, a surgeon can cauterize, coagulate / desiccate and / or simply reduce or delay bleeding, simply by controlling the intensity, frequency and duration of electrosurgical energy applied to the tissue through the jaw means . Most small blood vessels, that is, those in the range below two millimeters in diameter, can often be closed using electrosurgical instruments and techniques. However, large vessels can be more difficult to close using these standard techniques.

p00005In order to solve many of the known problems described above, and other problems relevant to cauterization and coagulation, a technology has recently been developed by Valleylab, Inc. of Boulder, Colorado (USA). called glass or tissue sealing. The process of coagulating the vessels is fundamentally different from the sealing of electrosurgical vessels. For the purposes pursued here, "coagulation" is defined as a process to desiccate tissue in which tissue cells are broken and dried. The "sealing of the vessel" or "sealing of the tissue" is defined as the process of liquefying the collagen that contains the tissue, so that it is reformed, becoming a molten mass with a limited demarcation between the opposing tissue structures. Coagulation of the small vessels is sufficient to permanently close them, while the major vessels and tissues have to be sealed to ensure their permanent closure.

p00006In order to effectively seal the large vessels (or tissues), two predominant mechanical parameters are precisely controlled - the pressure applied to the vessel (tissue) and the separation distance between the electrodes - that both are affected by the thickness of the sealed glass More particularly, an accurate application of the pressure that opposes the vessel walls is important; to reduce the impedance of the tissue to a sufficiently low value to allow sufficient electrosurgical energy to circulate through the tissue to overcome the expansion forces during tissue heating, and to contribute to the final thickness of the tissue, which is an indication of a good seal.

p00007As mentioned above, in order to properly and effectively seal large vessels or tissue, a greater closing force is required between opposing jaw members. It is known that a large closing force between the jaws typically requires a great moment around the pivot for each jaw. This poses a challenge in terms of design, since the jaw members are typically fixed with pins that are positioned so that they have a small moment arm with respect to the pivot of each jaw member. A large force, coupled with a small moment arm, is not desirable, since large forces can shear the pins. As a result, designers compensate for these large closing forces by designing instruments with metal pins and / or designing instruments that compensate, at least partially, those closing forces to reduce the chances of mechanical failure. As can be seen, if metal pivot pins are used, the metal pins should be insulated to prevent the pin from acting as an alternative path for the current, between the jaw members, which can be detrimental to an effective seal.

p00008Increasing the closing forces between the electrodes may have other undesirable effects, for example, it may cause the opposite electrodes to come into close contact with each other, which may result in a short circuit and a small closing force may cause of premature tissue movement during compression and before activation.

p00009As a result, having an instrument that consistently provides the appropriate closing force between opposing electrodes, within a preferred range of pressures, will improve the chances of a satisfactory seal. As can be seen, relying on the surgeon to manually provide the appropriate closing force within the appropriate range, on a consistent basis, would be difficult, and the efficacy and quality of the resulting seal may vary. In addition, the total success of creating an effective seal in the fabric is based largely on the expert that the user is, on their vision, on their skill and on their experience to judge what the appropriate closing force is to seal. the glass in a uniform, consistent and effective way. In other words, the success of the seal would depend largely on the final skill of the surgeon, rather than on the efficiency of the instrument.

p00010It has been found that the pressure range to ensure a consistent and effective seal for large vessels and tissue structures is between approximately 3 kg / cm2 and approximately 16 kg / cm2 and, desirably, within a working range of 7 kg / cm2 + at 13 kg / cm2. As can be seen, the manufacture of an instrument that is capable of consistently providing a closing pressure between these working margins poses a design challenge to instrument manufacturers.

p00011Several force acting sets have been developed in the past to provide the appropriate closing forces to effect vessel sealing. For example, one such actuator assembly has been developed by the firm Valleylab, Inc. of Boulder, Colorado (USA). .UU.) For use with the Valleylab vessel sealing and division instrument for sealing large vessels and tissue structures, commonly marketed under the trademark LIGASURE ATLAS®. The LIGASURE ATLAS® is currently designed to fit through a 10 mm cannula, and includes a bilateral jaw closure mechanism and is activated by a foot switch.

p00012Other sets of performance have also been developed by force, by the firm Valleylab, Inc., of Boulder (Colorado) (USA) with the instrument to seal and divide vessels of the Valleylab to seal large vessels and tissue structures commonly marketed under the trademark LIGASURE 5mm. The LIGASURE 5 mm ™ is currently designed to fit through a 5 mm cannula and includes a unilateral jaw closure mechanism and is activated by a manual switch.

p00013In US 2004/0254573 A, WO 2005/004735 A1 and WO 2005/004734 A1 an endoscopic bipolar forceps for sealing and dividing tissue are described.

SUMMARY

p00015Forceps according to the present invention are defined in claim 1.

p00016The forceps include a housing, an axis that has a defined longitudinal geometric axis through it, a drive assembly and a movable handle. The shaft includes a final actuator assembly having a pair of jaw members attached to a distal end thereof. The jaw members are movable from a first position, in relation to spaced apart, to at least a second position in which they are closer to each other. The jaw members are for grabbing tissue between them. Each of the jaw members is adapted to connect with an electrosurgical energy source, thereby enabling the jaw members to conduct energy through the tissue held between the jaw members, to create a tissue seal.

p00017The drive assembly moves the jaw members relatively together from a first position, in which the jaw members are arranged in spaced relation to each other, to a second position in which the jaw members are closer to each other. To manipulate tissue. The movable handle is rotatable around a pivot to force a drive flange of the drive assembly to move the jaw members between the first and second positions. In one embodiment, the pivot is located at a fixed distance above the longitudinal geometric axis and the actuation flange is generally located along the longitudinal geometric axis. This mechanical arrangement creates a mechanical advantage similar to that of a level around the pivot to facilitate the closure of the jaw members around the tissue. The forceps also include a blade assembly having a generally movable blade bar of T, which is sized to be operatively applied in a corresponding groove defined within the housing. The groove guides the movement of the knife bar during its translation.

p00018In one embodiment, the blade bar is operatively coupled to a blade arranged for sliding within the shaft. The forceps further include a finger actuator operatively coupled to the blade assembly, in which the movement of the finger actuator moves to the blade bar which, in turn, moves the blade to cut tissue disposed between the jaw members. In another embodiment, the shaft includes a drive sleeve arranged for sliding therein, which operatively connects with the drive assembly to move the jaw members, and the blade assembly includes a fist at the distal end of the bar. knife. The cuff is sized to encapsulate and move over the drive sleeve when the movement of the knife bar takes place. The forceps may also include a finger actuator operatively connected to the blade assembly. The finger actuator includes two generally U-shaped tabs, which rotate around a pivot to fully abut and force the fist distally, which, in turn, results in the distal translation of the blade bar .

p00019In still another embodiment, a spring is included that loads the blade assembly in a more proximal direction. Also included is a rotating assembly that is configured to rotate the jaw members around the defined longitudinal geometric axis through the axis. A manual switch may also be included inside the housing, which is adapted to connect to the electrosurgical energy source. The manual switch allows a user to selectively supply bipolar energy to the jaw members to effect the sealing of a tissue. At least one of the jaw members includes a series of stop members disposed therein to regulate the distance between the jaw members during sealing.

p00020In one embodiment, the pivot is located at a fixed distance on the longitudinal axis and the drive unit. A trigger assembly is included which is operatively coupled to the housing and operatively coupled to the blade assembly. The blade assembly may include a drive rod which, upon actuation of the trigger assembly, selectively moves a blade through the tissue disposed between the jaw members. A blade guide may also be included that is sized to facilitate alignment and translation of the blade through and into a blade channel defined between the jaw members.

p00021In one embodiment, the blade guide includes two halves that can be applied to each other, which isolate the jaw members from each other. The blade guide may also include one or more openings defined therein, which allow the pivot to extend therethrough. The drive assembly may also include a cam pin at a distal end thereof, which is operatively applied to the jaw members, and the blade guide may be configured to include one or more grooves defined therein which allow the Cam pin extends through it.

p00022According to the present invention, the pivot includes a defined opening therein, which allows the blade to extend therethrough. The pivot may include a rod and a cap that are applied for matching coupling on opposite sides of the shaft, to secure the jaw members during assembly.

p00023In yet another embodiment, the trigger assembly selectively moves the blade through the tissue disposed between the jaw members, and the blade assembly includes a knife carriage having a distal end of a t-shape that is applied to the trigger assembly , and a proximal end that is applied to a knife bar mounted for sliding inside the housing. The blade bar may include a fist at a distal end thereof, which defines an opening located therethrough. The shaft is sized to rotate and slide through the fist opening.

p00024The drive assembly may further include a cam pin that operatively couples the distal end of the drive sleeve to the jaw members for actuation thereof. The blade may be sized to include a groove defined therein that allows the cam pin to extend therethrough.

BRIEF DESCRIPTION OF THE DRAWINGS

p00026Several embodiments of the instrument in question are described herein, with reference to the drawings, in which:

p00027Fig. 1A is a perspective view of bipolar forceps depicted in open configuration and including a housing, a shaft, a handle assembly, a trigger assembly, and a final actuator assembly in accordance with the present disclosure.

p00028Fig. 1B is a perspective view of the bipolar forceps of Fig. 1A depicted in closed configuration;

p00029Fig. 2 is a rear view of the forceps of Fig. 1A;

p00030Fig. 3A is an enlarged front perspective view of the final actuator assembly of Fig. 1A, shown in open configuration;

p00031Fig. 3B is an enlarged front perspective view of the final actuator assembly of Fig. 1A shown in closed configuration;

p00032Fig. 3C is an enlarged side view of the final actuator assembly of Fig. 1A, shown in open configuration;

p00033Fig. 3D is an enlarged front view of the final actuator assembly of Fig. 1A shown in open configuration;

p00034Fig. 3E is an exploded perspective view, very enlarged, of the upper jaw member;

p00035Fig. 3F is an exploded perspective view, very enlarged, of the lower jaw member;

p00036Fig. 4 is a perspective view of the endoscopic forceps of Fig. 1A, with the internal working components of the forceps exposed:

p00037Fig. 5A is a side view of the endoscopic forceps of Fig. 1A with the internal working components of the exposed forceps;

p00038Fig. 5B is a side view of the endoscopic forceps of Fig. 1B, with the internal work components of the exposed forceps;

p00039Fig. 5C is a very enlarged perspective view of the handle assembly in open configuration;

p00040Fig. 5D is a very enlarged perspective view of the handle assembly in closed configuration;

p00041Fig. 6A is an internal perspective view of the endoscopic forceps of Fig. 1B, with the internal working components of the exposed forceps and the trigger represented in the non-actuated position;

p00042Fig. 6B is an internal perspective view of the endoscopic forceps of Fig. 1B, with the internal working components of the exposed forceps and the trigger represented in the actuated position;

p00043Fig. 6C is a schematic representation of the electrical configuration for the trigger assembly;

p00044Fig. 7 is a side, internal view of the endoscopic forceps of Fig. 1B with the trigger represented in the actuated position;

p00045Fig. 8A is a side cross-sectional view showing the trigger5 in the actuated position;

p00046Fig. 8B is an enlarged side cross-sectional view, showing the jaw members in a spaced apart orientation;

p00047Fig. 8C is an enlarged side cross-sectional view showing the jaw members in a closed orientation;

p00048Fig. 9A is a cross-sectional view of the housing, in which both the trigger and the non-operated handle have been shown;

p00049Fig. 9B is a side cross-sectional view of the housing, in which both the trigger and the driven handle have been shown;

p00050Fig. 10A is an enlarged side cross-sectional view, in which the final actuator is shown in a closed position, and the blade in a non-driven position;

p00051Fig. 10B is an enlarged side cross-sectional view, in which the final actuator is shown in a closed position and the blade in an actuated position;

p00052Fig. 10C is an enlarged front perspective view of a lower jaw member5 of the final actuator assembly, in which the blade is shown in a non-driven position;

p00053Fig. 10D is an enlarged front perspective view of the lower jaw member, in which the blade is shown in an actuated position;

p00054Fig. 11 is an exploded perspective view of the forceps of Fig. 1A;

p00055Fig. 12 is an exploded perspective view, enlarged, of the housing;

p00056Fig. 13 is an exploded perspective view, enlarged, of the final actuator assembly and of the shaft; and

p00057Fig. 14 is an exploded perspective view, very enlarged, of the final actuator assembly.

DETAILED DESCRIPTION

p00059Turning now to Figs. 1A-2, an embodiment of bipolar forceps 10 for use in various surgical procedures and which generally include a housing 20, a handle assembly 30, a rotating assembly 80, a trigger assembly 70 and a assembly has been shown of final actuator 100, which cooperate mutually to grasp, seal and divide large tubular vessels and large vascular tissues. Although most of the drawings in the figures represent bipolar forceps 10 for use in relation to endoscopic surgical procedures, the present disclosure can be used for more traditional open surgical procedures. For the purposes pursued here, forceps 10 are 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 operant components and features as described in the following.

p00060The forceps 10 include an axis 12 having a distal end 16 sized to be mechanically applied to the final actuator assembly 100, and a proximal end 14 that is mechanically applied to the housing 20. Details of how the axis 12 is connected to the final actuator they are described in more detail in the following with respect to Figs. 13 and 14. The proximal end 14 of the axis 12 is received inside the housing 20 and the connections relating thereto are also described in detail in the following in relation to Figs. 11 and 12. In the drawings and in the descriptions that follow, the term "proximal", as is traditional, will refer to the end of the forceps 10 that is closest to the user, while the term "distal" will refer to the end which is further from the user.

p00061As will be best seen in Figs. 1A and 2, the forceps 10 also include an electrosurgical cable 310 that connects the forceps 10 with an electrosurgical energy source, for example, a generator 500 (schematically represented). Generators such as those marketed by the firm Valleylab, located in Boulder, Colorado (USA) can be used as a source of electrosurgical energy, for example the Ligature Generator, the FORCE EZ Electrosurgical Generator, the FORCE Electrosurgical Generator FXTM, the FORCE 1CTM Generator, the FORCE 2TM, the SurgiStatTM II, or other suitable generators that can perform different or enhanced functions.

p00062In one embodiment, the generator 500 includes several safety and performance features, including independent, isolated output activation of the accessories. The electrosurgical generator can include features of Valleylab's Instant ResponseTM technology, which provides an advanced feedback system to perceive changes in the tissue two hundred times per second and adjust the voltage and current to maintain an appropriate power supply . Instant ResponseTM technology is believed to provide one or more of the following benefits for the surgical procedure:

<dl><dt>* </dt><dd>Consistent clinical effect across all types of tissue; </dd></dl>

<dl><dt>* </dt><dd>Reduction of thermal expansion and the risk of collateral tissue damage; </dd></dl>

<dl><dt>* </dt><dd>Less need to "connect the generator"; and</dd></dl>

<dl><dt>* </dt><dd>Designed for a minimally invasive environment. </dd></dl>

p00063Cable 310 is internally divided into cable conductors 310a, 310b and 325b (Fig. 6C), which are designed to transmit electrical potentials through their respective supply paths through forceps 10 to the final actuator assembly 100 More particularly, the cable feed 325b connects through the housing 20 of the forceps and through the rotating assembly with the jaw member 120. The conductor 310a connects to one side of the switch 60 and the conductor 310c connects to the opposite side of the switch 60, such that, when the switch is activated, energy is transmitted from the conductor 310a to 310c. The conductor 310c is spliced ​​with the conductor 310b, which connects through the rotating assembly with the jaw member 110 (see Fig. 6C). The details regarding the electrical connections are explained in more detail in the following, in the study of the switch 60.

p00064The handle assembly 30 includes a handle rijo 50 and a movable handle 40. The fixed handle 50 is integrally associated with the housing 20, and the handle 40 is movable with respect to the fixed handle 50, as explained in more detail in what continues with respect to the operation of the forceps 10. The fixed handle 50 is oriented approximately thirty degrees relative to a longitudinal geometric axis "AA" defined through axis 12. The fixed handle 50 may include one or more ergonomic improvement elements, to facilitate handling, for example, shells, protuberances, elastomeric material.

p00065The rotary assembly 80 is associated with the housing 20 and is rotatable approximately 180 degrees around a longitudinal geometric axis "AA" (see Fig. 1A). The details of the rotating assembly 80 are described in more detail with respect to Fig. 11.

p00066As mentioned above, the final actuator assembly 100 is attached at the distal end 14 of the shaft 12 and includes a pair of opposing jaw members 110 and 120. The movable handle 40 of the handle assembly 30 is finally connected to a drive assembly 130 (Fig. 5A), which together cooperate mechanically to communicate movement of the jaw members 110 and 120 from an open position, in which the jaw members 110 and 120 are arranged relative to spaced relative to each other, to a position of pinched or closed, in which jaw members 110 and 120 cooperate to grab tissue between them.

p00067The forceps 10 may be designed such that they are totally or partially disposable, depending on the particular purpose or to achieve a particular result. For example, the final actuator assembly 100 may be susceptible of selective and releasable application with the distal end 16 of the axis 12 and / or the proximal end 14 of the axis 12 may be susceptible of selective and releasable application with the housing 20 and the assembly of handle 30. In either of these two cases, the forceps 10 would be considered as "partially disposable"

p00068or "replaceable," that is, a new or different end actuator assembly 100 (or end actuator assembly 100 and axle 12) selectively replaces final actuator assembly 100 where necessary. As I could see, the electrical connections described here would have to be altered to modify the instrument to convert it into replaceable forceps.

p00069Turning now in more detail to the characteristics of the present exhibition, as described with respect to Figs. 1A-14, the movable handle 40 includes a loop 43 for the finger, which has a defined opening 41 therethrough, which allows the user to grasp and move the handle 40 relative to the fixed handle 50. The finger loop 43 is typically ergonomically improved and may include one or more grip elements (not shown) disposed along the inner peripheral edge of the opening 41, which are designed to facilitate the grip of the movable handle 40 during activation , for example, with a so-called "soft touch" material. The grip elements may include one or more protuberances, shells and / or ribs to improve grip.

p00070As best seen in Figs. 5A and 5B, the movable handle 40 is selectively movable around a pivot pin 45 from a first position relative to the fixed handle 50 to a second position in closer proximity to the fixed handle 50, which, as explained in the following , communicates movement of jaw members 110 and 120, each in relation to the other. The movable handle includes a fork 46 forming a pair of upper flanges 46a and 46b, each having an opening at an upper end thereof to receive a pivot pin 45 (see Fig. 12) therethrough, and mount the upper end of the handle 40 in the housing 20. In turn, the pivot pin 45 mounts to the respective halves of the housing 20a and 20b. The pivot pin 45 is sized for mounting inside the receptacle 45a of the half of the housing 20b.

p00071Each upper flange 46a and 46b also includes a force-acting or actuating flange 47a and 47b (see Fig. 7), respectively, which are aligned along the geometric axis "a" and which abut against the drive assembly 130, such that the pivoting movement of the handle 40 forces the drive tabs 47a and 47b against the drive assembly 130 which, in turn, closes the jaw members 110 and 120 (see Figs 5A and 5B). For the purposes pursued herein, 47a and 47b acting simultaneously on the drive assembly 130, are designated as "drive flange 47". In the following a more detailed explanation of the cooperating components of the handle assembly 30 and the drive assembly 130 is set forth.

p00072As best seen in Fig. 5C, the lower end of the movable handle 40 includes a flange 42 that is typically integrally associated with, or operatively connected to, the movable handle 40. The flange 42 is typically T-shaped, and includes a element similar to a pin 44 that projects laterally or transversely from a distal end thereof and that is configured to be applied to a corresponding rail 55 disposed within the fixed handle 50. More particularly, the pin 44 is configured to move within a previously defined channel 53, disposed within the rail 55, to block the movable handle 40 relative to the fixed handle 50, as the alternative movement thereof takes place. Additional characteristics are explained in the following with respect to the T-shaped tab 42, in the detailed exposition of the operational characteristics of the forceps

p0007310.

p00074The movable handle 40 is designed to provide a clear mechanical advantage over conventional handle assemblies, due to the unique position of the pivot pin 45 (ie, the pivot point) relative to the longitudinal geometric axis "A" of the axis 12 and to the arrangement of the actuation flange 47 along the longitudinal geometric axis "A". In other words, by placing the pivot pin 45 above the actuation flange 47, the user obtains a mechanical advantage similar to that of a lever for operating the jaw members 110 and 120, enabling the user to close the jaw members 110 and 120 with less force, even while still generating the required forces, necessary to effect a correct and effective tissue sealing.

p00075As you can see better in Figs. 3A-3F, 13 and 14, the final actuator assembly 100 includes opposing jaw members 110 and 120 that cooperate to effectively grasp the tissue for sealing purposes. The final actuator assembly 100 is designed as a bilateral assembly, that is, both jaw members 110 and 120 pivot relative to each other around a pivot pin 95 disposed therethrough. Jaw members 110 and 120 are curved, to facilitate tissue manipulation and to provide a better "sight line" for access to organs and large tissue structures.

p00076An alternative movement drive sleeve 134 is arranged for sliding within the axis 12, and is operable remotely by the drive assembly 130, as explained in more detail below. The drive sleeve 134 includes a bifurcated distal end composed of halves 134a and 134b, respectively, which define a cavity 134 'between them to receive the jaw members 110 and 120. More in particular, and as best illustrated in Figs. 13 and 14, jaw members 110 and 120 include proximal tabs 113 and 123, respectively, each of which includes an elongated angle groove 117 and 127, respectively, defined therethrough. A drive pin 139 (see Fig. 13) mounts jaw members 110 and 120 at the end of a sleeve 134 and into the cavity 134 'disposed between flanges 134a and 134b. The cam pin or drive pin 139 mounts through openings 139a and 139b defined in the tabs 134a and 134b, respectively, and is movable with reciprocating movement within the grooves 16a 'and 16b' arranged at the distal ends 16a and 16b of axis 12 (see Fig. 14). Slots 16a 'and 16b' can extend into openings 95 'and 95' 'to facilitate mounting of pin 129. The pin 139 may be composed of two elements that are in mechanical interface, sized to frictionically receive each other to retain the pin 139 in its once mounted position. Alternatively, or in addition, the pin 139 can be held in place by one of several known manufacturing techniques, including: laser or heat welding, mechanical interaction by pressure adjustment (or by other interlocking geometry mechanically, with adhesive, by chemical bonding, etc.). A component arranged outside the axis 12 can also be used to hold the pin 139 in position, once mounted. For example, a heat shrinkage material, adhesive tape, rubber, or other insulating sheath or silicone can be used for this purpose. A version of pin 139 of varying diameter can be used to prevent the pin from being loose once mounted. Likewise, a cover or stem arrangement (not shown) can also be used for this purpose.

p00077The drive sleeve 134, which finally connects to the drive assembly 130, is sized to receive sliding blade drive rod 193, blade 190, and posts 171a and 171b of halves 170a and 170b of the guide of blade 170. Drive sleeve 134, in turn, is received within axis 12. By operating the drive assembly 130, the drive sleeve 134 travels with reciprocating motion which, in turn, causes the drive pin 139 to move within the grooves 117 and 127, to open and close the jaw members 110 and 120, as desired. The jaw members 110 and 120, in turn, pivot about the pivot pin 95 disposed through the respective pivot holes 113a and 123a, disposed within the tabs 113 and 123. As can be seen, pressing the handle 40 towards the handle 50 pulls the drive sleeve 134 and the drive pin 139 in the proximal direction, to close the jaw members 110 and 120 around the tissue gripped between them, and pushing the sleeve 134 in distal direction the jaw members 110 and 120 are opened, for gripping purposes.

p00078Going back to the details of jaw members 110 and 120, as best seen in Figs. 3A-3F, the jaw member 110 includes a support base 119 which extends in the distal direction from the flange 113 and which is sized to support an insulating plate 119 'thereon. The insulating plate 119 ', in turn, is configured to support an application surface to the electrical conductive fabric, or sealing plate 112, thereon. Sealing plate 112 may be fixed on top of insulating plate 119 'and support base 119, in any suitable manner, such as by pressure adjustment, overmolding, stamping, ultrasonic welding, etc. The support base 119 together with the insulating plate 119 'and the surface 112 for application to the electrical conductive fabric are encapsulated by an outer insulating housing 116. The outer housing 116 includes a cavity 116a that is sized to be safely applied to the electric conductive sealing surface 112, as well as the support base 119 and the insulating plate 119 '. This can be achieved by stamping, overmolding, overmolding a stamped electric conductive sealing plate and / or overmolding a metal injection molded seal plate, or by other suitable methods (for example, with a conductive surface attached to a structural support through an insulating material). All of these manufacturing techniques produce the jaw member 110 having an electric conductive surface 112 that is substantially surrounded by an insulating housing or substrate 116.

p00079For example, and as illustrated in Fig. 3E, the electric conductive sealing plate 112 includes a peripheral flange 112a that surrounds the periphery of the sealing plate 112. The flange 112a is designed to be applied in coincidence with a lip interior 116b of the exterior insulation 116. Again, this can be achieved by any of the aforementioned processes, for example, by overmolding. The conductor 310b, which extends from the switch 60 (see Fig. 6C) terminates inside the outer insulator 116 and is designed for electromechanical coupling with the sealing plate 112, by virtue of a connection 325a similar to an overhang. The insulator 119 ', the electric conductive sealing surface 112 and the outer non-conductive jaw housing 116, are preferably sized to limit and / or reduce many of the undesirable effects related to tissue sealing, for example, combustion sealing Sudden generalized, thermal expansion and dissipation of parasitic currents.

p00080The electric conductive sealing surface 112 may also include an outer peripheral edge having a predefined radius and the outer housing 116 meets the electric conductive sealing surface 112 along a contiguous edge of the sealing surface 112, in a position in general tangential. At the interface, the electrical conductive surface 112 is enhanced in relation to the outer housing 116.

p00081The electrical conductive surface or sealing plate 112 and the outer housing 116, when mounted, form a longitudinally oriented groove 115a therethrough, for reciprocating movement of the blade 190 (see Fig. 13). The knife groove 115a cooperates with a corresponding knife groove 115b defined in the jaw member 120 to facilitate the longitudinal extension of the blade 190 along a preferred cutting plane, to effectively and accurately separate the tissue a along the tissue seal formed. The blade slots 115a and 115b, together, form the blade channel 115 for alternative movement of the blade 190. As best illustrated in Figs. 3A-3F, the blade channel 115 runs through the center of the jaw members 110 and 120, respectively, such that a sheet 190 of the blade assembly 70 can quote the seized tissue between the jaw members 110 and 120 , when jaw members 110 and 120 are in a closed position. As described in more detail in the following, the handle 30a includes a passive locking flange 49 'that prevents the action of the blade assembly 70 when the handle 40 is open, thus preventing accidental or premature activation of the blade 190 a through the tissue. In addition, the passive locking flange 49 'is sized to force the trigger 70 to retract the blade 190 when the handle 40 is moved into an open position.

p00082As explained above and illustrated in Figs. 3F, 8B, 8C, 10C and 100, the knife channel 115 is formed when the jaw members 110 and 120 are closed. In other words, the knife channel 115 includes two knife channel halves - the knife slot 115a , disposed in the sealing plate 112 of the jaw member 110, and the knife groove 115b disposed in the sealing plate 122 of the jaw member 120. The blade channel 115 can be sized to include a certain degree of curvature, to cause the blade 190 to move through the tissue in a curved shape. Alternatively, the blade channel 115 may be configured as a straight groove, without any degree of curvature, which, in turn, causes the blade 190 to move through the tissue in a substantially straight manner. The insulating plate 119 'is also part of the blade channel 115 and includes the groove 115a' defined therein, which extends along the insulating plate 119 'and which is aligned vertically with the knife groove 115a for facilitate the translation of the distal end 192 of the blade 190 therethrough.

p00083As mentioned above, the final actuator assembly 100 also includes the blade guide 170 which is sized to facilitate the alignment and translation of the blade 190 through and into the blade channel 115. More in particular , the blade guide 170 includes the half 170a and the half 170b that make mechanical interface to encapsulate the blade 190 when assembling (see Fig. 13). The blade guide 170, once mounted, aligns the blade 190 for easy translation through the blade channel 115, when the alternative movement of a blade drive rod 193 takes place (Fig. 13). The operation of the drive rod 193 is described in the following with reference to the operational characteristics of the forceps 10. Each half 170a and 170b of the blade guide 170 includes several interfaces therein, and openings defined therein, which allow the unobstructed movement of the various operating characteristics of the final actuator assembly 100, for example, of the pivot 95, the drive pin 139 and blade 190. More particularly, halves 170a and 170b include openings 173a and 173b, respectively, defined therethrough, which allow the passage of pivot 95 during assembly. Halves 170a and 170b also include laterally aligned grooves 172a and 172b, defined therein, which allow alternative movement of drive pin 139 when opening and closing jaw members 110 and 120. One or more guides 327 may also be included. (Fig. 14) to guide the conductors, for example the conductor 325a, along the blade guide 170, and the electrical conductive plates, for example, to the plate 192. The blade guide halves 170a and 170b also include posts 171a and 171b that extend proximally into the groove 16 ', when assembling, for application to the blade 190.

p00084The blade channel 115 runs through the center of the jaw members 110 and 120, respectively, such that a distal end 192 of the blade 190 can cut the tissue that is gripped between the jaw members 110 and 120, when jaw members 110 and 120 are in the closed position. More in particular, and as described in more detail in the following with respect to the operation of the forceps 10, the blade 190 can only be advanced through the tissue when the jaw members 110 and 120 are arranged in a configuration open The blade 190 The blade 190 may be sized to allow other components to pass through, which also provides the benefit of improving the total flexibility of the blade to facilitate passage through the blade channel 115.

p00085Alternatively, one of the two jaw members may also include a safety lock to prevent the blade 190 from advancing while the jaw members are in the open configuration.

p00086The jaw member 120 includes elements similar to those of the jaw member 110, such as the jaw housing 126, which encapsulates a support plate 129, an insulating plate 129 'and an electrically conductive sealing surface 122. Similarly, the electrical conductive surface 122 and the insulating plate 129 ', when mounted, include respective longitudinally oriented blade grooves 115b and 115b' defined therethrough, for alternative movement of the blade blade 190. As mentioned above, when the jaw members 110 and 120 are closed around the fabric, the knife grooves 115a and 115b form a full blade channel 115, to allow longitudinal extension of the blade 190 distally. , to cut tissue along a tissue seal. The blade channel 115 may be arranged entirely in one of the two jaw members, for example, in the jaw member 120, depending on the particular purpose being pursued. The jaw member 120 may be mounted in a manner similar to that described above with respect to the jaw member 110. More particularly, the sealing plate 122 may be sized to include an outer peripheral flange 122a that is sized to make a mechanical interface with an inner lip 126b of the housing 126, to secure the sealing plate 122 to the housing 126 with the plates 129 and 129 'encapsulated therein.

p00087As best seen in Fig. 3F, the jaw member 120 includes a series of stop members 90 disposed on the inside facing surface of the electrically conductive sealing surface 122 to facilitate grip and tissue manipulation and to define a gap "G" (Fig. 10B) between the opposing jaw members 110 and 120 during sealing and tissue cutting. The series of stop members 90 can be used in one or both jaw members 110 and 120, depending on the particular purpose pursued, or to achieve a desired result.

p00088The jaw member 120 is connected to a second electrical conductor 325b extending from the switch 60 (see Fig. 6B) that terminates inside the jaw housing 126 and is designed for electromechanical coupling with the sealing plate 122, by virtue of connection 326b similar to an overhang. As explained in more detail below, conductors 310b and 325b allow the user to selectively supply bipolar electrosurgical energy to jaw members 110 and 120, as needed during surgery.

p00089The jaw members 110 and 120 are electrically isolated from each other, such that electrosurgical energy can be effectively transferred to form a seal in the tissue. For example, and as best illustrated in Figs. 3A-3F, Each jaw member 110 and 120 includes a path for the uniquely designed electrosurgical cable that transmits electrosurgical energy through cable conductors 310b and 325b, to electric conductive sealing surfaces 112 and 122, respectively. Cable conductors 310b and 325b are held loosely but firmly along the cable path to allow rotation of jaw members 110 120. As can be seen, this insulates the electrical conductive sealing surfaces 112 and 122 of the remaining operating components of the final actuator assembly 100 and axis 12. The two electrical potentials are isolated from each other by virtue of the insulating sheath surrounding 310b and 325b cable conductors.

p00090The jaw members 119 and 120 are applied to the end of the rotating shaft 12 by the pivot pin 95, such that the rotation of the rotating assembly 80 rotates correspondingly to the axis 12 (together with the sleeve 134 and the blade 190 ), which, in turn, rotates the final actuator assembly 100 (see Fig. 1A). More particularly, the distal end of the rotating shaft 12 is bifurcated to include the ends 16a and 16b defining a channel 16 'therein, to receive the jaw members 110 and 120. The pivot pin 95 includes a rod arrangement 95a and cover 95b which is sized for application through openings 95 'and 95' 'arranged at ends 16b and 16a, respectively. When mounting, and as best illustrated in Figs. 13 and 14, the rod 95a of the pivot pin 95 extends, in order, through the end 16a of the shaft 12, through the opening 123a of the jaw member 120, through the opening 173a of the half 170a of the blade guide 170 , by the opening 173b of the half 170b of the blade guide 170, by the opening 113a of the jaw member 110 and by the end 16b of the shaft 12 to fit the head 95b. The grooves 16a 'and 16b' are defined within the distal ends 16a and 16b and are sized to allow alternative movement of the drive pin 139 therein. The stem 95a includes a through hole 96 defined therein, which allows the passage of the knife 190 through it to cut tissue while still allowing a large surface area of ​​rotation for the jaw members during loading.

p00091Turning now to the cooperating components of the housing, in Figs. 5A, 5B, 6A, 6B, 11 and 12 show the details of the housing 20 and the characteristics of the components thereof, namely the drive assembly 130, the rotating assembly 80, the actuator assembly of the blade 160, of the trigger assembly 70, and handles 40 and 50. More particularly in Figs. 5A and 5B show the assemblies and components identified above, in the form of mounted in the housing 20, and in Figs. 11 and 12 shows an exploded view of each of the assemblies and components identified above.

p00092As mentioned above and as can be seen better in Figs. 11 and 12, the proximal end of the axis 12 is mechanically applied to the housing 20. The housing 20 is formed of two (2) housing halves 20a and 20b, each of which includes a plurality of interfaces that are sized to align and mechanically applied with each other to form the housing 20 and enclose the internal work components of the forceps 10. As can be seen, the fixed handle 50 which, as mentioned above, is integrally associated with the housing 20, includes halves 50a and 50b that take the shape of the handle 50 when assembling the housing halves 20a and 20b

p00093A plurality of additional interfaces (not shown) may be arranged at various points around the periphery of the housing halves 20a and 20b, for ultrasonic welding purposes, for example at energy direction / deflection points. It is contemplated that ultrasonic welding provides better dimensional stability, strength and reliability of the joint, than those obtained by other more traditional methods. For example, housing halves can be ultrasonically welded using a combination of a primary weld joint using traditional triangular energy directors (or the like) to form a bonded joint coupled with a secondary hardtop surface (separated from the surface of primary union) to avoid overcompression of the joint. Through the housing halves 20a and 20b a tertiary set of alignment pins can be used, which are configured to precisely align the halves 20a and 20b during assembly, and also to provide strength and stability during manufacturing, the handling and transportation.

p00094The housing halves 20a and 20b (as well as the other components described in the following) can be assembled together in any suitable way. For example, alignment pins, pressure-like interfaces, tongue and groove interfaces, locking fins, adhesive ports, etc., can be used either alone or in combination for the purpose of mounting.

p00095As best seen in Figs. 11 and 12, the rotating assembly 80 includes two halves 80a and 80b of C-shape which, when assembled, form the rotating assembly 80. Half 80a includes a series of fasteners / flanges (not shown) that are sized to be applied to a pair of corresponding receptacles or other mechanical interfaces (not shown) disposed within the rotating shaft 80b. Half 80a also includes a fin 84a (illustrated in dashed line) which, together with a corresponding fin 84b disposed in half 80b, cooperates for application by coupling in slot 80 'arranged on axis 12. As can be seen, this it allows the selective rotation of the axis 12 around the geometric axis "AA", by manipulating the rotating member 80 in the direction of the arrow "B", which, in turn, causes the final actuator assembly to rotate in the direction of arrow "C" (see Fig. 1A). The rotating assembly may include one or more mechanical interfaces that essentially block the rotating assembly in a fully left rotation position, or in a fully right rotation position. This may allow left or right orientations for the final actuator assembly, for particular users.

p00096As mentioned above, and as best illustrated in Figs. 5A, 5B, 6A and 6B, the movable handle 40 includes the fork 46 that forms the upper flanges 46a and 46b, which pivot around pins 45a and 45b to pull the sleeve 134 that travels with reciprocating movement along the axis geometrical longitudinal “AA” and force the drive tabs 47a and 47b against the drive assembly 130, which, in turn, closes the jaw members 110 and 120. The various movement ratios of the flanges 47a and 47b and the drive assembly 130 are explained in more detail in the following with respect to the operation of the forceps 10. The arrangement of the drive tabs 47a and 47b and the pivot point 45 of the movable handle 40, provides a clear mechanical advantage over conventional handle assemblies, due to the unique position of the pivot pins 45a and 45b (i.e., of the pivot points) in relation to the longitudinal geometric axis "AA" of the drive tabs 47a and 47b. In other words, by placing the pivot pins 45a and 45b above the actuation tabs 47a and 47b, the user gains mechanical advantage, similar to that of a lever, for actuating the jaw members 110 and 120. This reduces the amount Total mechanical force required to close jaw members 110 and 120 to produce a tissue seal.

p00097The handle 40 also includes a finger loop 43 defining the opening 41, which is sized to facilitate grip of the handle 40. In one embodiment, the finger loop 43 includes a rubber insert that improves the " Total ergonomic touch of the handle member 40. A locking flange 49 'is disposed on the outer periphery of the handle member 40 above the finger loop 43. The locking flange 49 'may be designed as a safety locking mechanism to prevent the trigger assembly 70 from firing when the handle member 40 is oriented in a non-actuated position, that is, the jaw members 110 and 120 are open. As can be seen, this would prevent an accidental cut

p00098or premature tissue, before the tissue seal has been completed.

p00099The fixed handle 50 includes the halves 50a and 50b which, when mounted, form the handle 50. The fixed handle 50 includes a channel 51 defined therein, which is sized to receive the flange 42 so that it moves proximally when the movable handle 40 is operated. The t-shaped pin 44 of the handle 40 is sized for easy reception within the channel 51 of the handle 50. The flange 42 may be sized to allow a user to selectively, gradually and / or incrementally move the jaw members 110 and 120 each relative to the other, from the open or closed positions. For example, it is also contemplated that the flange 42 may include an interface similar to a ratchet, which is applied to lock the movable handle 40 and, therefore, to the jaw members 110 and 120, in selective positions, by increments of each one in relation to the other, depending on the particular purpose pursued. Other suitable mechanisms can also be used to control and / or limit the movement of the handle 40 relative to the handle 50 (and the jaw members 110 and 120) such as, for example, actuator or hydraulic, semi-hydraulic, linear actuators, mechanisms with gas servo and / or gear systems.

p00100As best illustrated in Figs. 5D and 12, the housing halves 20a and 20b, when assembled, form an internal cavity 52 that predefines the channel 51 within the fixed handle 50 adjacent to the rail 55, in which the pin 44 is moved alternately t. Once mounted, the rail 55 is seated inside the cavity 52 in coincidence with the entrance path 51 for alternative movement of the flange 42. The flange 42 and the housing halves 20a and 20b are designed to facilitate accurate and consistent reception of the t-shaped pin 44 in the rail 55.

p00101During the movement of the flange 42 along the entrance to the channel 51, the t-shaped pin 44 travels through the passage 53 along the rail 55 and is forced to engage the cover or seat 55 to block the handle 40 relative to the handle 50. When the user releases the handle 40, the hitch cover 55 retains the t-shaped pin 44 in a secured position relative to the handle 50, as explained in more detail in the following . The rail 55 may be seated on one of the pivot elements 55a which allows the rail 55 to pivot upon receiving the t-shaped pin 44 therethrough. A spring element 57 loads the rail 55 to cause it to return to the original receiving position, once the t-shaped pin 44 is seated. The rail 55, again, can pivot in response to the release of the t-shaped pin 44 of the hitch cover 55. The operation of the handle 40 together with the elements of the actuating assembly 130 that cooperate with each other, closes the jaw members 110 and 120 around the fabric, with a predetermined and consistent closing pressure, to effect a tissue sealing. As mentioned above, the closing pressures for sealing large tissue structures are preferably within the range of about 3 kg / cm2 to about 16 kg / cm2.

p00102When the handle 40 is reattached, the t-shaped pin 44 is forced out of, or disengaged from, the hitch tray 55 'and moves along an exit path to release the handle 40 from the channel 51 A spring or other loading member 57 can be used to facilitate securing of the flange 42 inside the coupling tray 55 'and also configured to facilitate the release of the flange 42 of the coupling tray 55' when picking up again. the handle 40.

p00103As explained in more detail in the following, once operated, the handle 40 moves in a generally arcuate manner towards the fixed handle 50 around the pivot pins 45a and 45b, which forces the drive assembly 130 into proximal direction, which in turn pulls the reciprocating sleeve 134 in a generally proximal direction, to close the jaw members 110 and 120, each relative to the other.

p00104As can be seen better in Figs. 5A, 5B and 11, the drive assembly 130 mounts on top of the proximal part of the drive sleeve 134. A pair of retaining rings or clips 131 'and 131' '(see Fig. 11) cooperate with a corresponding pair of relieved parts 133a and 133b, arranged in the drive sleeve 134 to mount the drive assembly 130 on top of the drive sleeve 134, such that the relative movement of the drive assembly moves correspondingly to drive sleeve

p00105134 Since the handle 40 pivots around the pivot point 45 and moves relative to the handle 50, and the flange 42 is incorporated in the channel 51 of the fixed handle 50, the drive tabs 47a and 47b, through the mechanical advantage from the pivot point above the center, the drive assembly 130 is forced in the p5oximal direction against the spring 131.

p00106As a result, the drive sleeve 134 travels with reciprocating movement in the proximal direction, which in turn closes the jaw members 110 and 120. The use of an off-center pivot mechanism will allow the user to selectively compress the helical spring 131 at a specific distance which, in turn, communicates a specific load to the reciprocating sleeve 134, which becomes a torque around the pin of pivot 95 of the jaw. As a result, a specific closing force can be transmitted to the opposing jaw members 110 and 120.

p00107In Figs. 5A and 5B have shown the initial action of the handle 40 towards the handle 50, which causes the pin 44 of the flange 42 to move in general in the proximal and upward direction, along the inlet path 51. During the movement of the flange 42 along the inlet path 51, respectively, the t-shaped pin 44 travels through the passage 53 along the rail 55, as explained above. Once the desired position for the sealing location has been determined, and the jaw members 110 and 120 are correctly positioned, the handle 40 can be fully compressed, such that the pin 44 in the form of t of tab 42 seats inside the 55 'hitch tray. Once the pin 44 clears an edge or passes a predetermined point in step 53 at the edge of the hitch tray 55 ', the release movement of the handle 40 and the flange 42 is redirected towards a hitch tray 55 '.

p00108More particularly, when a slight reduction in the closing pressure of the handle 40 against the handle 50 takes place, the handle 40 returns slightly distally towards the inlet path 51, but is again directed to settle inside the bowl hitch 55 '. At this point, the release of the return pressure between the handles 40 and 50, which is attributable and directly proportional to the deliberative pressure associated with the compression of the drive assembly 130, causes the pin 44 of the flange 42 to seat or lock into the 55 'hitch tray. The handle 40 is then secured in position within the fixed handle 50, which, in turn, locks the jaw members 110 and 120 in a closed position against the fabric.

p00109As mentioned above, jaw members 110 and 120 can be opened, closed and rotated to manipulate the tissue until sealing is desired. This allows the user to position and modify the position of the forceps 10 before activation and sealing. As illustrated in Fig. 1A, the final actuator assembly 100 is rotatable about the longitudinal geometric axis "AA" through the rotation of the rotary assembly 80. As explained in more detail in the following, the single feeding path of the cable conductors 325a and 325b, through the rotating assembly 80, along the axis 12 and, finally, to the jaw members 110 and 120 , enables the user to rotate the final actuator assembly 100 approximately 180 degrees in both directions, right and left, without entangling or causing excessive stress on cable conductors 325a and 325b. As can be seen, this facilitates the grip and manipulation of the tissue.

p00110As can be seen better in Figs. 5A, 5B, 6A, 9A, 9B, 11 and 12, the trigger assembly 70 mounts on top of the movable handle 40 and cooperates with the blade assembly 160 to selectively move the blade 190 through a tissue seal. More particularly, the trigger assembly 70 includes a U-shaped finger actuator 71, which has a pair of upwardly extending flanges 71a and 71b. A pivot pin 179 extends through a pair of openings 162a and 162b in each of the tabs 71a and 71b, respectively, to mount the trigger assembly 70 in a knife carriage 165, as explained in more detail in What follows. The finger actuator 71 is selectively pivotable within a predefined slot 21 disposed within the housing 20 (see Fig. 6A). More particularly, a pair of pivots 77a and 77b are arranged on either side of the finger actuator 71 and are configured to mount between the housing halves 20a and 20b to pivot the finger actuator into the groove 21.

p00111The blade assembly 160 includes a blade bar 167 that travels with reciprocating movement that has the drive sleeve 134 mounted thereon and between the flanges 71a and 71b extending upwards. The blade bar 167 includes a proximal end 167 'in the form of t and a cuff 137 disposed at the distal end thereof. The cuff 137 is sized to encapsulate the drive sleeve 134 when the blade assembly 160 is mounted. A spring 76 loads the fist in a more proximal orientation. The proximal end 167 'is sized to mount and move with reciprocating movement within a slot 167' 'formed by the housings 20a and 20b in the assembly (see Fig. 12). A locking cap 137a and a mounting pin 179 secure the cuff 137 to the proximal end 193b of the blade rod 193 through the opening 197 disposed therein, such that the proximal movement for the finger actuator 71 gives as a result distal movement of the blade bar 193. The cuff 137 and the head 137a also allow 360 degrees of rotation of the drive sleeve 134 therethrough.

p00112As mentioned above, a knife carriage 165 mounts the upwardly extending flanges 71a and 71b of the finger actuator 71. More particularly, the distal end 162 of the knife carriage 165 is shaped as includes two pins 162c and 162d extending laterally, which fit into openings 162a and 162b, respectively, in tabs 71a and 71b. The proximal end 161 of the knife carriage 165 includes an opening 161a defined therein, which coincides with a latch 167a extending transversely through the knife carriage 165.

p00113As best illustrated in Figs. 5A-7, when the handle 40 is arranged in a spacing or open configuration with respect to the handle 50, the flange 49 ', which extends from the handle 40, prevents the actuation of the trigger assembly 70. More particularly, The finger actuator 71 is prevented from being operated proximally by the flange 49 'when the jaw members 110 and 120 are open. As can be seen, this prevents premature actuation of the blade 190 when the tissue is not caught between the jaw members 110 and 120. When the handle 40 is moved selectively with respect to the handle 50, a gap 21 is formed between the tab 49 'and finger actuator 71 (see Fig. 5B). Therefore, the user is free to selectively actuate the blade 190, by squeezing the finger actuator 71 in the proximal direction within the gap 21.

p00114As best illustrated in Figs. 6B, 7 and 8A, once the clearance has been obtained by movement of the handle 40, the movement in the proximal direction of the finger actuator 71 around the pivot 74 results in the distal direction of the knife bar 167, which, in turn, results in the distal direction translation of the blade rod 193 and the blade 190. More particularly, when the finger actuator 71 is pressed in the proximal direction, the U-shaped tabs 71a and 71b rotate around the pivot 74 to fully abut the fist 137 and essentially throw the knife carriage 165 forward, which, in turn, leads the blade bar 167 forward, to force the blade rod 193 distally. Slot 167 '' is configured to gently guide blade bar 167 distally through the forward and return stroke. As illustrated in Figs. 10A and 10B, the distal direction translation of the blade rod 193 moves the blade 190 through the channel 115 in the jaw members 110 and 120. As mentioned above, the blade rod 193 assembles the blade 190 by means of one or more mechanical interface elements, or it can be fixed in any of the ways known in the art. A groove 197 defined within the blade 190 provides clearance for the pin 139 of the drive sleeve 134 during the alternative movement of the blade 190. By releasing the finger actuator 71, the spring 76 charges the blade assembly back to a position more proximal The blade bar 167 provides a variable mechanical advantage and a linear advantage when the blade 190 is triggered. In addition, the incorporation of the blade bar 167 significantly reduces friction loss and provides a smoother mechanical cut than is obtained by the above known methods.

p00115Turning now in detail to the operation of the drive assembly, as best seen in Figs. 5A, 5B, 11 and 12, drive assembly 130 includes reciprocating sleeve 134, drive housing 135, spring 131, drive rings 135a and 135b, drive stops 135c and 135d, and rings holding 131 'and 131' ', which all cooperate to form drive assembly 130. The stop 135c can be removed, and the ring 131 '' would perform the function for which the 135c is intended. The proximal end 132 of the reciprocating sleeve 134 is located within an opening 135 'defined through the drive housing 135 to allow selective alternative movement of the drive sleeve 134 therethrough when the movable handle 40 acts. The spring 131 is mounted above the drive housing 135 between a rear stop 135d and the ring 135b, such that the movement of the handle 40 around the pivot 45 moves the entire drive assembly and the sleeve 134 proximally, which, in turn, pulls the cam pin 139 proximally to close the jaw members 110 and 120. Once the jaw members close around the tissue, the drive assembly 130 essentially stops (i.e., preventing the movement in the proximal direction of the reciprocating sleeve from continuing) and the additional movement of the handle 40 around the pivot 45 compresses the spring 131, resulting in a additional closing force on the fabric. In addition, the spring 131 also tends to load the jaw members 110 and 120 and the movable handle 40 in an open configuration.

p00116Returning to Fig. 12, in which the exploded view of the housing 20, the rotating assembly 80, the trigger assembly 70, the movable handle 40 and the fixed handle 50, all those component parts, together with the shaft 12 and with the final actuator assembly 100, are mounted during the manufacturing process to form partially and / or fully disposable forceps 10. For example, and as mentioned above, the axis 12 and / or the final actuator assembly 100 may be disposable and, therefore, susceptible of selective / releasable application with the housing 20 and with the rotating assembly 80 , to form partially disposable forceps 10 and / or whole forceps 10 may be disposable after use.

p00117As best seen in Figs. 5A, 5B and 13, once mounted, the spring 131 is loaded for compression over the drive housing 135 when the action of the movable handle 40 takes place. More particularly, the movement of the handle 40 around the pivot pins 45a and 45b, makes it move alternately to the flange 42 within the fixed handle 50, and forces the drive assembly 130 to compress the spring 131 against the rear stop 135d, to move the sleeve 134 with alternative movement.

p00118As mentioned above, the trigger assembly 70 is initially prevented from being able to shoot, by means of the locking flange 49 'arranged in the movable handle 40, which abuts against the trigger assembly 70, prior to actuation. . Opposite jaw members 110 and 120 can be rotated and partially open and closed without unlocking the trigger assembly 70 which, as can be seen, allows the user to grasp and manipulate the tissue without premature activation of the blade assembly 160. As mentioned in the following, only when the t-shaped pin 44 of the flange 42 is displaced with alternate movement completely within the channel 51 of the fixed handle 50 and seated within the coupling bucket 55 'defined above, will it allow the locking tab 49 'full activation of the trigger assembly 70. The operational characteristics and relative movements of these internal work components of the forceps 10 have been shown in dashed lines and direction arrows, and are best illustrated in the various figures.

p00119The mechanical advantage of the centering pivot may make it possible for the user to selectively compress the helical spring 131 at a specific distance, which, in turn, communicates a specific load to the reciprocating sleeve 134. The load of the reciprocating sleeve 134 becomes a torque around pivot 95 of the jaw. As a result, a specific closing force can be transmitted to opposing jaw members 110 and 120. As mentioned above, jaw members 110 and 120 can be opened, closed and rotated to handle tissue until sealing is desired, without unlocking trigger assembly 70. This allows the user to position and modify the position of the forceps 10 before activation and sealing. More particularly, as illustrated in Fig. 1A, the final actuator assembly 100 is rotatable about the longitudinal geometric axis "AA" through the rotation of the rotary assembly 80.

p00120Once the desired position for the sealing location has been determined and the jaw members 110 and 120 are positioned correctly, the handle 40 can be compressed completely, such that the t-shaped pin 44 of the flange 42 free a predefined rail edge located above the rail 55. Once the end 44 clears the edge of the rail, the end 44 is directed into the hitch tray 55 'to lock the handle 40 with respect to the handle 50. The deliberative or return pressure between the handles 40 and 50, which is attributable and directly proportional to the release pressure associated with the compression of the drive assembly 130, causes the end 44 of the flange 42 to seat or lock within the 55 'hitch bucket. The handle 40 is then secured in position within the fixed handle 50, which, in turn, locks the jaw members 110 and 120 in a closed position against the fabric.

p00121At this point, jaw members 110 and 120 are compressed completely around the tissue. In addition, the forceps 10 are now ready for selective application of electrosurgical energy and the subsequent separation of the tissue, that is, since as the t-shaped end 44 sits inside the hitch cuvette 55 ', the locking flange 49' is moves by going to a position to allow the trigger assembly 70 to be activated.

p00122By seating the t-shaped end 44 of the flange 42 into the hitching bowl 55 '. a proportional axial force is maintained on the reciprocating sleeve 134, which, in turn, maintains a compression force between opposing jaw members 110 and 120 against the tissue. The final actuator assembly 100 and / or jaw members 110 and 120 can be sized to discharge some of the excessive pinching forces to prevent mechanical failure of certain internal operating elements of the final actuator 100.

p00123As can be seen, the combination of the mechanical advantage of the centering pivot, together with the compression force associated with the compression spring 131, facilitates and ensures a consistent, uniform and precise closing pressure around the fabric, within the range of pressures. desired working from about 3 kg / cm2 to about 16 kg / cm2 and, desirably, from about 7 kg / cm2 to about 13 kg / cm2. By controlling the intensity, frequency and duration of the electrosurgical energy applied to the tissue, the user can treat tissue, that is, seal tissue.

p00124As mentioned above, two mechanical factors play an important role in determining the resulting thickness of the sealed tissue and in the effectiveness of the seal, that is, the pressure applied between the opposing jaw members and the separation distance " C "between opposite sealing surfaces 112, 122 of jaw members 110 and 120 during the sealing process. However, the thickness of the resulting tissue seal cannot be adequately controlled with just the force. In other words, too much force would cause the two jaw members 110 and 120 to touch each other and possibly a short circuit resulting in low energy travel through the tissue, thereby obtaining a poor seal 450 in the tissue. A force that is too small would make the seal too thick.

p00125The application of the correct force is also important for other reasons, to oppose the walls of the vessel, to reduce the impedance of the tissue to a sufficiently low value that allows sufficient current to pass through the tissue; and to overcome the forces of expansion during heating, in addition to contributing to the creation of the required thickness of the final tissue, which is an indication of a good seal.

p00126In one embodiment, the electrical conductive sealing surfaces 112 and 122 of the jaw members 110 and 120, respectively, are relatively flat to avoid current concentrations at the live edges and to prevent arc formation between the high points. In addition, and due to the reaction force of the tissue when fitted, the jaw members 110 and 120 can be manufactured to resist bending. For example, jaw members 110 and 120 may be wedging along the width thereof, which is advantageous for two reasons: 1) because the wedge will apply a constant pressure for a constant tissue thickness in parallel; 2) because the thickest proximal part of jaw members 110 and 120 will resist bending, due to the reaction force of the tissue.

p00127As mentioned above, at least one jaw member, for example 120, may include one or more butt members 90 that limit the movement of the two opposite jaw members 110 and 120, each relative to the other. In one embodiment, the stop members 90 extend from the sealing surface 122 over a predetermined distance, according to the specific properties of the material (for example, its compressive strength, thermal expansion, etc.), to obtain a consistent and precise separation distance "C" during sealing (Fig. 10B). Margins from about 0.025 mm to about 0.125 mm and, desirably, between about 0.050 mm and about 0.125 mm are contemplated for the separation distance between opposite sealing surfaces 112 and 122 during sealing. In one embodiment, the non-conductive stop members 90 are molded on the jaw members 110 and 120 (for example, by overmolding, injection molding, etc.), stamped on the jaw members 110 and 120, or deposited ( for example by deposition) on the jaw members 110 and 120. For example, one technique involves thermally spraying a ceramic material on the surface of the jaw members 110 and 120 to form the stop members 90. Various techniques for thermal spraying are contemplated, which improve the deposition of a wide range of heat-resistant materials and insulators, on various surfaces, to create stop members 90 to control the separation distance between electrical conductive surfaces 112 and

p00128122.

p00129When energy is selectively transferred to the final actuator assembly 100, through the jaw members 110 and 120 and through the tissue, a seal is formed in the tissue that isolates two halves of the tissue. At this point, and with other known vessel sealing instruments, the user can remove and replace the forceps 10 with a cutting instrument (not shown) to divide the tissue halves along the seal into the tissue. As can be seen, this while taking time, is a tedious task and can result in an inaccurate division of the tissue through the seal in the tissue, due to misalignment or a defective placement of the cutting instrument along the plane of ideal cut of the fabric.

p00130As explained in detail above, the present disclosure incorporates the blade assembly 160 which, when activated through the trigger assembly 70, gradually and selectively divides the tissue along an ideal plane of the tissue, from a precise way, to divide the tissue in an effective and reliable way into two sealed halves. The blade assembly 160 allows the user to quickly separate the tissue, immediately after sealing without replacing a cutting instrument through a cannula or trocar port. As can be seen, precise sealing and division of the tissue with the same forceps 10 is achieved.

p00131The blade 190 can also be coupled to the same source, or to an alternative source of electrosurgical energy, to facilitate tissue separation along the seal in the tissue. In addition, the angle of shot of the blade 190 can be sized to provide more or less aggressive cutting angles, depending on the particular purpose pursued. For example, the blade can be positioned at an angle that reduces the "tissue pitting" associated with the cut. In addition, the blade 190 can be designed with different blade geometries, such as toothed, notched, perforated, hollow, concave, convex, etc., depending on the particular purpose pursued, or to achieve a particular result The blade assembly 160 generally cuts a gradual, unidirectional shape (ie, in the distal direction).

p00132Once the tissue is divided into tissue halves, the jaw members 110 and 120 can be opened by re-grabbing the handle 40 as explained in the following. Restarting or re-grabbing the handle 40 again moves the t-shaped pin 44 of the tab 42 in general in the proximal direction.

p00133As best seen in Fig. 13, the proximal parts of the jaw members 110 and 120 and the distal end 16 of the axis 12, can be covered by a flexible elastic insulating material 185, to reduce the concentrations of stray currents during the electrosurgical activation. The tail or proximal end of the jaw members 110 and 120 can be removed and covered with an extended section of the guide element 170, creating a semi-insulating barrier to reduce the concentrations of stray currents during electrosurgical activation. An insulating sheath (not shown) can also be placed on top of the proximal parts of jaw members 110 and 120 to further reduce current concentrations and stray currents, preventing them from damaging adjacent tissue. Details relating to an insulating sheath contemplated are described with respect to that commonly belonging to Series No. 60 / 722,213 of US provisional application entitled "INSULATING FUNCTION FOR ELECTROCHIRURICAL FORCEPS", which is incorporated by reference here.

p00134The switch 60 is ergonomically sized and adapts to the outer shape of the housing 20 (once mounted). The switch 60 is designed to cooperate electromechanically with a flexible circuit 400 (see Fig. 6C) to allow a user to selectively activate the jaw members 110 and 120. It is contemplated that a flexible circuit design facilitates manufacturing, due to the unique capacity of the circuit to adapt as necessary to closely spaced areas. The switch 60 may also allow the user to selectively activate the forceps 10 in a variety of different orientations, that is, multi-oriented activation or activation as per "flip-flop". As can be seen, this simplifies activation. The switch 60 can also be designed as a so-called "dome switch", which also provides the user with tactile feedback when activated.

p00135When switch 60 is depressed, the trigger driver 310b carries the first electrical potential to the jaw member 110, thus completing a bipolar circuit. More particularly, when switch 60 is depressed and flexible circuit 400 is activated, the generator recognizes a voltage drop across conductors 310a and 310c, which initiates generator activation to supply a first electrical potential to the power member. jaw 110 and a second electrical potential to jaw member 120. The switch 60 acts as a control circuit and is protected or removed from the current current loop that supplies electrical power to the jaw members 110 and

p00136120. This reduces the chances of electrical failure of switch 60 due to high current loads during activation. A foot switch (not shown) that can also be used with forceps 10, also operates in a similar way, that is, when the foot switch is activated, the generator recognizes a voltage drop across the input conductors. and output of the foot switch, which, in turn, sends a signal to the generator to initiate electrosurgical activation of jaw members 110 and 120.

p00137A safety switch or circuit (not shown) may be used such that the switch cannot activate, unless jaw members 110 and 120 are closed and / or unless jaw members 110 and 120 have tissue retained between them. .

p00138In the latter case, a suitable sensor (not shown) can be used to determine if there is tissue retained between them. In addition, other sensor mechanisms can be used to determine pre-surgical conditions simultaneous to the surgical act (i.e., during surgery) and / or after the surgical act. The sensor mechanisms can also be used with a closed loop feedback system coupled to the electrosurgical generator to regulate electrosurgical energy based on one or more pre-surgical conditions, simultaneous to the surgical act, or post-surgical.

p00139The conductive surfaces 115a and 115b are electrically isolated from each other, and from the jaw members 110 and 120, such that electrosurgical energy can be effectively transferred through the tissue, to form the seal. Cable conductors 310b and 325b are held loosely but securely along the cable path, to allow rotation of jaw members 110 and 120 about the longitudinal geometric axis "A" (see Fig. 1A). More particularly, the cable conductors 310b and 325b are fed through the respective halves 80a and 80b of the rotating assembly 80, such that they allow the rotation of the axis 12 (by means of the rotation of the rotating assembly 80) in the direction to the right or to the left, without entanglement or undue twisting of the cable conductors 310b and 325b. The feeding path of the cable conductor currently described may allow rotation of approximately 180 degrees of the rotating assembly in one direction or another.

p00140In view of the foregoing, and with reference to the various drawings of the figures, those skilled in the art will appreciate that certain modifications can also be made to the present exhibition without exceeding the scope thereof. For example, it may be preferable to add other features to the forceps 0, for example, an articulated assembly for axially displacing the final actuator assembly 100 with respect to the elongated shaft 12.

p00141It is also contemplated that the forceps 10 (and / or the electrosurgical generator used in relation to the forceps 10) may include a sensor or feedback mechanism (not shown) that automatically selects the appropriate amount of electrosurgical energy to effectively seal the tissue of particular dimensions gripped between jaw members 110 and 120. The sensor or feedback mechanism can also measure the impedance through the tissue during sealing, and provide an indicator (visual and / or audible) that an effective seal has been created between jaw members 110 and 120.

p00142In addition, the trigger assembly 70 may include other types of recoil mechanism that are designed to fulfill the same purpose, for example, gas actuated recoil, electrically actuated recoil (ie, by a solenoid), etc. Forceps 10 can also be used to cut unsealed tissue. Alternatively, the blade assembly 70 may be coupled to the same source of electrosurgical energy, or an alternative, to facilitate tissue cutting.

p00143The outer surface of the final actuator assembly 100 may include a coating, stamping, metal injection molding of nickel-based material, which is designed to reduce the adhesion between jaw members 110 and 120 with the surrounding tissue during activation and the seal. In addition, the conductive surfaces 112 and 122 of the jaw members 110 and 120 can be manufactured from one (or a combination of one or more) of the following materials: chrome-nickel, chromium nitride, MedCoat 2000 manufactured by The Electrolizing Corporation of OHIO (USA), Inconel 600 and tin-nickel. The conductive surfaces 112 and 122 of the fabric can also be coated with one or more of the above materials to achieve the same result, that is, a "non-adherent surface". As can be seen, by reducing the amount of tissue that "adheres" during sealing, the overall efficiency of the instrument is improved.

p00144A particular class of materials described here has demonstrated superior properties when not being adherent and, in some cases, superior seal quality. For example, nitride coatings that include, but are not limited to, TiN, ZrN, TiAIN and CrN, are preferred materials used for non-adhesion purposes. CrN has been found to be particularly useful for non-adhesion purposes, due to its superior surface properties and optimum performance. It has also been found that materials of other classes reduce total adhesion. For example, alloys with a high nickel / chromium content, with a Ni / Cr ratio of approximately 5: 1, have been found to significantly reduce adhesion in bipolar instrumentation. A particularly useful non-stick material of this class is the Inconel 600. Bipolar instrumentation that has sealing surfaces 112 and 122 made of, or coated with, Ni200, Ni201 (100% Ni) also exhibited improved non-adhesion performances on typical bipolar stainless steel electrodes.

p00145As can be seen, the placement of the switch 60 in the forceps 10 has many advantages. For example, switch 60 reduces the amount of power cord in the operating room, and eliminates the possibility of activating the wrong instrument during a surgical procedure, due to a "line of sight" activation. In addition, the switch 60 may be configured such that it is deactivated mechanically, or electromechanically during trigger activation to eliminate unintentional activation of the device during the cutting process. The switch 60 may also be arranged on another part of the forceps 10, for example, in the fixed handle 50, in the rotating assembly 80, in the housing 20, etc.

p00146The forceps 10 may be equipped with an automatic, electromechanical release mechanism (not shown) that releases the tissue once a final seal has been determined (i.e. the final tone signal of the generator). For example, an electromechanical interface can be configured to automatically release the t-shaped pin 44 of the hitch cuvette 55 when a final tone condition occurs.

p00147It is also contemplated that the forceps 10 can be sized to include a trigger assembly 70 that operates in place of the switch assembly 60 to activate the forceps to seal tissue while also advancing the blade 190 to divide the tissue through the seal. For example, trigger assembly 70 could be configured to have two stages: a first or initial run stage that activates the generator to selectively seal tissue; and a second or subsequent stage in which the blade advances through the tissue. Alternatively, another embodiment may include a trigger assembly that simultaneously activates jaw members 110 and 120 to seal tissue and advance blade 190 through tissue during activation.

p00148The rotary assembly 80 may be equipped with one or more mechanical interfaces that are rotatable with, or within, the rotary assembly 80 and that are configured to produce tactile and / or audible feedback to the user during rotation. The tactile and / or audible feedback (ie, a "click") can be configured to correspond to a particular degree of rotation of the final actuator assembly 100 around the geometric axis "A". It is also contemplated that one or more types of visual indexes can also be used with the rotating assembly 80, so that they correspond to the amount or degree of rotation of the final actuator assembly 100 and that can be designed to correspond or refer to audible and / or tactile feedback, depending on the particular purpose pursued.

p00149Another version of the forceps 10 may include a telescopic shaft that allows the user to selectively regulate the length of the instrument for particular surgical purposes. For example, the shaft can include two movable elements with alternative sliding movement, and extendable, which, when actuated (ie pulled, twisted or by virtue of a mechanical lever on the handle), lengthen or shorten the size of the elongated shaft 12, depending on the particular surgical purpose pursued.

p00150In addition, it is also contemplated that the diameter of the shaft 12 can be selectively expandable, depending on a particular surgical purpose, or to provide rigidity for the forceps 10 within the surgical cavity, or to improve the sealing effect of the shaft a through a trocar. More particularly, it is contemplated that axis 12 can be configured to expand by acting (i.e., by twisting or rotating an element inside another (as does an iris), sliding a mechanical lever, an inflatable system, a system of mechanical expansion, or other types of known expansion systems). As a result, the surgeon can selectively expand the outer diameter of the shaft 12 to increase the stiffness of the shaft 12 within a trocar and / or improve the sealing effect of the shaft 12 within the trocar to reduce the chances of pressure leakage from the Surgical cavity during use. In addition, the same forceps can be selectively adaptable to work with trocars and / or cannulas of different sizes, which can be advantageous for operations and other particular surgical specifics.

p00151It is also contemplated that the forceps 10 can be configured such that the handle 50 is selectively replaceable or selectively positioned, depending on the user's preferences. For example, the handle 50 can be selectively extended and replaced by another handle 50 that is of different dimensions (ie, of different size, weight, angle, orientation for the user's hand, etc.), which facilitates handling during surgical procedures Alternatively, the handle 50 may be selectively positioned relative to the housing 20 (ie, that the angle of the handle with the housing is adjustable) to facilitate handling and use during particular surgical procedures or for the convenience of the user.

p00152The forceps may be configured to include a visual indicator (which cooperates with the "final tone" indicator on the generator) to provide visual confirmation of a satisfactory seal (for example, a green LED indicator). The visual indicator (not shown) can be used in, or in connection with, the final actuator assembly 100 or with axis 12 that is in the surgeon's line of action during use. The visual indicator can also be designed to warn the user of a condition of lack of seal or a condition of grabbing again (for example, a red LED indicator). Alternatively, the visual indicator can also be configured to provide feedback Progressive seal formation during the sealing process. For example, a series of LEDs can be used on the final actuator assembly 100 (or on axis 12) that are progressively illuminated through the sealing process, to provide visual feedback to the user in relation to the state of the seal. In addition, one or both jaw members may include visual marks indicating the end of the seal and / or the length of the seal cut.

p00153The guide element 170 (see Fig. 14) can be configured to not only guide the blade 190 into the blade channel 115 disposed between the jaw members 110 and 120, but can also be sized to precisely space the members jaw 110 and 120 each relative to the other, around pivot 95. In addition, the guide element 170 may be configured to include one or more grooves or tracks (not shown) to guide the electrical connections or the conductive wires 310b and 325b through the final actuator assembly 100. The guide element 170 may It is also configured to limit the distal movement of the drive rod 193 for the blade 190, which, in turn, limits the total travel of the blade 190 through the blade channel 115. The distal end of the guide element can be extended to work with the overmolded jaw elements 116 and 126, to create a set of tissue blocking features that inhibit the tissue from being left behind or moving proximally towards the surface of the active electrode

p00154The rod 95a of the pivot pin 95 may include a stepped diameter that securely compresses the jaw members 110 and 120 together when mechanically secured with the head 95b. In addition, the pivot may be sized to include a passage through or opening 96 allowing the translation of the blade therethrough. The two-piece pivot 95, which includes the rod 95a and the head 95b, can be mounted during the manufacturing process by any of the known manufacturing techniques, including: laser or heat-based welding, mechanical interaction of adjustment to pressure (or other mechanical interlocking geometry), with adhesive, chemical bonding, etc.

p00155The axis may be sized to improve visibility and / or asymmetric dependence with respect to a particular purpose. For example, it is contemplated that the axis can be generally oval in its dimensions, thereby providing unidirectional resistance in one dimension against another, and maximizing the visibility of the area of ​​operation in one direction, compared to the one in another direction. Alternatively, the axis may have other geometric configurations, depending on the particular purpose pursued, such as I-beam, square, polygonal, etc.

p00156The final actuator assembly 100 is optimized to be reapplied to long tissue sections and for visibility of the operation area. Jaw members 110 and 120 may also be sized to include distal ends configured for gross or blunt dissection.

p00157While some embodiments of the invention have been shown in the figures, it is not intended that the invention be limited thereto, since it is the intention that the invention be as wide-ranging as the technique allows and that the specification be equally read. Therefore, the above description should not be construed as limiting, but merely as examples of particular embodiments. Those skilled in the art will imagine other modifications within the scope of the appended claims.