Vessel sealing forceps with disposable electrodes

(Cross-reference of related applications) This application is US application number 09 / 425,696 filed by Tetzlaff et al. On October 22, 1999 (which is US application number 09 / 178,027 filed on October 23, 1998 by Tetzlaff et al., And October 1998 by Frazier et al. It is a partial continuation of US application number 09 / 177,950 filed on the 23rd (claiming priority in US application number 09 / 177,950) (the entire contents of all these applications are incorporated herein by reference in their entirety).

(background) The present disclosure relates to electrosurgical forceps used for open surgical procedures and / or laparoscopic surgical procedures. More specifically, the present disclosure relates to bipolar forceps having disposable electrode assemblies for sealing, cauterizing, coagulating / drying, and / or cutting blood vessel and vascular tissue.

(Technical field) Hemostat forceps or forceps are simple pliers-like tools that use mechanical movements between their jaws to tighten tissue and generally to grip, dissect, and / or clamp tissue. , Used in open surgical procedures. Electrosurgical forceps utilize both mechanical clamping and electrical energy to provide hemostasis by heating tissue and blood vessels to coagulate, cauterize and / or seal the tissue.

Using electrosurgical forceps, the surgeon can cauterize, coagulate / dry, and / or cut the tissue by controlling the intensity, frequency, and duration of the electrosurgical energy applied to the tissue, and / Alternatively, bleeding can simply be reduced or delayed. In general, the electrical composition of electrosurgical forceps can be divided into two categories: 1) unipolar electrosurgical forceps; and 2) bipolar electrosurgical forceps.

Unipolar forceps utilize one active electrode with a clamping end effector and a remote patient return electrode or pad that is externally attached to the patient. When electrosurgical energy is applied, this energy is transmitted from the active electrode to the surgical site and through the patient to the return electrode.

Bipolar electrosurgical forceps utilize two generally opposed electrodes, which are generally located on the internally opposed surfaces of the end effector, and both of these electrodes are electrically connected to the electrosurgical generator. Will be done. Each electrode is charged to a different potential. Since the tissue is a conductor of electrical energy, this electrical energy can be selectively transmitted through the tissue when the end effector is used to clamp or grip the tissue in between.

The process of coagulating small blood vessels is in principle different from vascular sealing. For the purposes herein, the term coagulation is defined as the process by which the histiocytes rupture and dry the dry tissue. Vascular seal is defined as the process of liquefying collagen in tissue so that the tissue crosslinks and reshapes into a fused mass. Therefore, coagulation of small vessels is sufficient to close them, but larger vessels need to be sealed to ensure permanent closure.

Two main mechanical parameters (pressure applied to the vessel and gap distance between the electrodes (both of which affect the thickness of the sealed vessel)) are used to provide proper sealing of the large vessel. It must be controlled accurately. More specifically, accurate application of pressure reduces tissue impedance to a value low enough to allow sufficient electrosurgical energy to pass through the tissue, thus facing the walls of the vessel, and thus during tissue heating. It is important to overcome the expansion force and to contribute to the final tissue thickness, which is an indicator of good sealing. In some examples, the fused vessel wall is optimally between 0.001 and 0.006 inches. Below this range, the seal can be torn or torn, and above this range, the lumen may not be sealed properly or effectively.

Numerous bipolar electrosurgical forceps have been proposed in the past for various open surgical procedures. However, some of these designs may not provide uniform and reproducible pressure on the blood vessels, and may result in ineffective or non-uniform seals. For example, Willis US Pat. Nos. 2,176,479, Hiltebrandt US Pat. Nos. 4,005,714 and 4,031,898, Boebel et al., US Pat. Nos. 5,827,274, 5,290,287 and 5,312,433, Lottick US Pat. , 5,026,370 and 5,116,332, Stern et al., US Pat. No. 5,443,463, Eggers et al., US Pat. No. 5,484,436, and Richardson et al., US Pat. Regarding electrosurgical instruments for sealing. However, some of these designs may not provide uniformly reproducible pressure on the blood vessels and may result in ineffective or non-uniform seals.

Many of these instruments include blade or shear members, which simply cut tissue in a mechanical and / or electromechanical manner and are relatively ineffective for the purpose of vascular sealing. Other instruments rely solely on clamping pressure to obtain the proper seal thickness, and gap tolerance and / or parallelism and flatness requirements (these are consistently effective when properly controlled). It is not designed in consideration of (a parameter that can guarantee a good tissue seal). For example, it is known that it is difficult to adequately control the thickness of the resulting sealed tissue by controlling only the clamping pressure for one of two reasons: 1) application If too much force is applied, the two poles may touch and energy is not transferred through the tissue, resulting in an invalid seal; or 2) if too little force is applied, it is thicker and more reliable. A low-quality seal is produced.

It has also been found that cleaning and sterilizing a large number of prior art bipolar instruments is often impractical because the electrodes and / or insulators can be damaged. More specifically, it is known that electrically insulating materials (eg, plastics) can be damaged or damaged by repeated sterilization cycles.

Therefore, there is a need to develop bipolar forceps that can seal blood vessels and tissues consistently and effectively and are not damaged by subsequent use and irrigation.

<p> (Summary) The present disclosure relates to a removable electrode assembly for use with forceps having opposing end effectors and handles for moving the end effectors relative to each other. The electrode assembly comprises a cover plate having at least a detachably engageable portion of at least a portion of the forceps and an electrode housing having at least a detachably engageable portion of at least a portion of the forceps. The pair of electrodes is attached to the distal end of this housing. Preferably, the electrodes are removably engaged with the end effectors of the forceps such that the electrodes are arranged so as to face each other. The device also comprises at least one stop member that controls the distance between the opposing electrodes. Preferably, the stopper is selectively engageable with the electrode. This electrode assembly can be used with both open and laparoscopic surgical procedures.</p><p> In one embodiment, the electrode comprises a conductive sealing surface and an insulating substrate, the retaining member being detachably attached to the insulating substrate. Preferably, the insulating substrate of each electrode is at least one mechanical interface such that it engages a complementary mechanical interface (eg, a notch) located on the corresponding end effector of this forceps. (For example, movement stop) is provided.</p><p> In another embodiment, the substrate comprises at least one anti-movement, and the mechanical interface of this corresponding end effector is like at least one complementary key for slidably and safely accommodating the immobility. Equipped with a socket.</p><p> In yet another embodiment, the stop member is attached to at least one electrode by thermal spraying and extruded from the inward surface of the jaw member by about 0.001 inch to about 0.005 inch. Preferably, the retaining member is extruded from the inward surface of the jaw member by about 0.002 inch to about 0.003 inch.</p><p> Another embodiment of the present disclosure relates to a bipolar electrosurgical instrument. The instrument comprises opposing end effectors and forceps with handles for moving the end effectors relative to each other, as well as an electrode assembly detachably attached to the forceps. The electrode assembly comprises a pair of opposing electrodes mounted at its distal end, which are detachably engaged with one of the end effectors so that the electrodes are present in opposition to each other. .. At least one stop member selectively engaged with this electrode controls the distance between opposing electrodes.</p><p> (Detailed explanation) With reference to FIGS. 1-3, the bipolar forceps 10 for use in combination with open and laparoscopic procedures include mechanical forceps 20 and electrode assembly 21. In the drawings and in the description below, the term "proximal" traditionally means the end of forceps 10 that is closer to the user, whereas the term "distal" is the end farther from the user. Means.</p><p> The mechanical forceps 20 comprises a first member 9 and a second member 11, each of which has an elongated shaft 12 and 14, respectively. Each of the shafts 12 and 14 comprises proximal ends 13 and 15, and distal ends 17 and 19, respectively. Proximal ends 13, 15 of each shaft portion 12, 14 include handle members 16 and 18 mounted therein, which allow the user to have at least one of the shaft portions 12 and 14 relative to the other. Can be moved. End effectors 22 and 24 extend from the distal ends 17 and 19 of the shaft portions 12 and 14, respectively. The end effectors 22 and 24 are movable relative to each other with respect to the movement of the handle members 16 and 18.</p><p> Preferably, the shaft portions 12 and 14 are fixed to each other at points proximal to the end effectors 22 and 24 around the swivel shaft 25 so that the movement of the handles 16 and 18 is from the open position to the end effector 22 And move 24. Here, the end effectors 22 and 24 are arranged in a spaced relationship with each other with respect to the clamping position or the closed position, where the end effectors 22 and 24 have a tubular blood vessel 150 between them. Work together to grab (see Figure 8). The swivel shaft 25 has a large surface area and is expected to suppress twisting and movement of the forceps 10 during operation. The forceps 10 can only be designed so that the movement of one or both of the handles 16 and 18 moves one (eg, 22) of the end effectors relative to the other end effector (eg, 24).</p><p> With reference to FIG. 3, the end effector 24 comprises an upper jaw member or first jaw member 44, which jaw member has an introverted surface 45 and a plurality of mechanical interfaces disposed therein. The interface is sized to detachably engage a portion of the disposable electrode assembly 21 described in more detail below. Preferably, the mechanical interface comprises a socket 41, which is disposed at least partially through the introverted surface 45 of the jaw member 44 and mounted on the top electrode 120 of the disposable electrode assembly 21. Designed to accommodate complementary movement stops. Although the term socket is used herein, either a female or male mechanical interface may be used for the jaw member 44, and the fitted mechanical interface is on the disposable electrode assembly 21. It is intended to be placed in.</p><p> In some cases, a mechanical interface 41 along another surface of the jaw member 44 is manufactured and the complementary mechanical interface of the disposable electrode assembly 21 is engaged in a different manner (eg, from its side). Can be preferable. The jaw member 44 also comprises an opening 67 that is disposed at least partially through the inward surface 45 of the end effector 24, which complement is located on the electrode 120 of the disposable electrode assembly 21. It is sized to accommodate the guide pin 124.</p><p> The end effector 22 comprises a second jaw member, i.e. the lower jaw member 42, which has an inward surface 47 facing the inward surface 45. Preferably, the jaw members 45 and 47 are dimensioned approximately symmetrically, but in some cases it is preferable to produce two asymmetric jaw members 42 and 44 that depend on a particular purpose. possible. In exactly the same manner as above for the jaw member 44, the jaw member 42 also comprises a plurality of mechanical interfaces or sockets 43 located on them, which are disposable electrode assemblies 21 as described below. It is sized to removably engage with a complementary portion located on the electrode 110 of the. Similarly, the jaw member 42 also comprises an opening 65 that is located at least partially through the introverted surface 47, which is a complementary guide pin 126 that is located on the electrode 110 of the disposable electrode assembly 21. Dimensioned to accommodate (see Figure 4).</p><p> Preferably, the shaft members 12 and 14 of the mechanical forceps 20 are designed to transmit a particular desired force to the opposing inward surfaces 47 and 45 of the jaw members 22 and 24, respectively, when clamped. .. In particular, the shaft members 12 and 14 work together effectively in a spring-like fashion (ie, a bend that behaves like a spring), so that the length, width, height and deflection of the shaft members 12 and 14 It directly affects the total transmission force applied to the opposing jaw members 42 and 44. Preferably, the jaw members 22 and 24 are stiffer than the shaft members 12 and 14, and the strain energy stored in the shaft members 12 and 14 provides a constant closing force between the jaw members 42 and 44. provide.</p><p> Each shaft member 12 and 14 also comprises ratchet portions 32 and 34. Preferably, each ratchet (eg, 32) extends from the proximal end 13 of its respective shaft member 12 towards the other ratchet 34 in a nearly vertically aligned manner, resulting in the respective ratchets 32 and 34. The introverted surfaces of the end effectors 22 and 24 come into contact with each other as they move from the open position to the closed position. Each ratchet 32 and 34 comprises a plurality of flanges 31 and 33, respectively, which project from the introverted surface of each ratchet 32 and 34 so that the ratchets 32 and 34 can be interlocked in at least one position. .. In the embodiment shown in FIG. 1, the ratchets 32 and 34 are interlocked at several different positions. Preferably, each ratchet position holds a particular (ie, constant) strain energy within the shaft members 12 and 14, which in turn applies a particular force to the end effectors 22 and 24, and thus to the electrodes 120 and 110. introduce. Designs without a ratchet system or similar system require the user to hold the jaw members 42 and 44 together by applying a constant force to the handles 16 and 18, which results in inconsistent results. obtain.</p><p> In some cases, it may be preferable to provide other mechanisms for controlling and / or limiting the movement of the jaw members 42 and 44 relative to each other. For example, a ratchet and claw system can be used to align the movement of two handles to separate units, which in turn move jaw members 42 and 44 separately with respect to each other.</p><p> Preferably, at least one of the shaft members (eg, 14) comprises a protrusion 99, which facilitates the operation of forceps 20 during the surgical condition and is a machine as described in more detail below. Facilitates the attachment of the electrode assembly 21 to the target forceps 20.</p><p> As best shown in FIGS. 2, 3 and 5, the disposable electrode assembly 21 is designed to work in combination with mechanical forceps 20. Preferably, the electrode assembly 21 comprises a housing 71 having a proximal end 77, a distal end 76 and an elongated shaft plate 78 disposed between them. The handle plate 72 is located near the proximal end 77 of the housing 71 and is sized enough to detachably engage and / or surround the handle 18 of the mechanical forceps 20. Similarly, the shaft plate 78 is sized to surround and / or detachably engage the shaft 14, and the swivel plate 74 located near the distal end 76 of the housing 71, and the swivel shaft 25, And sized to surround at least a portion of the distal end 19 of the mechanical forceps 20. The electrode assembly 21 may be manufactured to engage with any of the first member 9 or second member 11 of the mechanical forceps 20, and any of its respective component portions 12, 16 or 14, 18. ..</p><p> In the embodiment shown in FIG. 2, the handle 18, shaft 14, swivel shaft 25, and portion of the distal end 19 are all sized to fit within the corresponding channel located within the housing 71. For example, channel 139 is sized to accept the handle 18, channel 137 is sized to receive the shaft 14, and channel 133 is sized to receive the swivel shaft 25 and part of the distal end 19. It is such a dimension.</p><p> The electrode assembly 21 also comprises a cover plate 80, which is also designed to surround and / or engage the mechanical forceps 20 in a manner similar to that described for the housing 71. More specifically, the cover plate 80 comprises a proximal end 85, a distal end 86 and an elongated shaft plate 88 disposed between them. The handle plate 82 is located near the proximal end 85 and is preferably sized to detachably engage and / or surround the handle 18 of the mechanical forceps 20. Similarly, the shaft plate 88 is dimensioned to surround and / or detachably engage the shaft 14, and the swivel plate 94 located near the distal end 86 is the swivel shaft 25, and mechanically. Designed to surround the distal end 19 of forceps 20. Preferably, the handle 18, shaft 14, swivel shaft 25 and distal end 19 are all corresponding channels (not shown) arranged within the cover plate 80 in a manner similar to that described above for housing 71. It is a size that fits inside.</p><p> As best shown with respect to FIGS. 3 and 4, the housing 71 and cover plate 80 are designed to engage with each other on the first member 11 (eg, first member) of the mechanical forceps 20. Its respective component parts (eg, handle 18, shaft 14, distal end 19 and swivel shaft 25) are located between them. Preferably, the housing 71 and the cover plate 80 are arranged in various positions along the interior of the housing 71 and the cover plate 80 to provide a plurality of mechanical interfaces that result in mechanical engagement with each other. More specifically, multiple sockets 73 are located near the handle plate 72, shaft plate 78 and swivel plate 74 of the housing 71, and extend from the cover plate 80, making it possible to remove the corresponding multiple locks 83. It is a size that engages. Either a male mechanical interface or a female mechanical interface, or a combination of mechanical interfaces, may be placed in the housing 71, along with a mating mechanical interface placed on or in the cover plate 80. Is assumed.</p><p> As best shown with respect to FIGS. 5-7, the distal end 76 of the electrode assembly 21 has two prong-like members 103 and 105 extending outward from the distal end 76, electrodes 110 and 120. It branches to support each of them. More specifically, the electrode 120 is attached to the end 90 of the prong 105, and the electrode 110 is attached to the end 91 of the prong 103. Electrodes 110 and 120 can be attached to the ends 91 and 90 in any known fashion (eg, friction fit, or snap fit engagement).</p><p> The pair of wires 60 and 62 are connected to electrodes 120 and 110, respectively, as best shown in FIGS. 4 and 5. Preferably, the wires 60 and 62 are bundled together to form a wire bundle 28, which wire bundle is from the terminal connector 30 (see Figure 3) to the proximal end 77 of the housing 71. Along the interior of the housing 71, it extends to the distal end 76. The wire bundle 28 splits into wires 60 and 62 near the distal end 76, and the wires 60 and 62 are connected to the electrodes 120 and 110, respectively. In some cases, the wires 60 and 62 or the wire bundle 28 are captured at various pinch points along the inner cavity of the electrode assembly 21 and the wires 60 and 62 within the electrode assembly 21 by mounting the cover plate 80. It may be preferable to surround the.</p><p> This arrangement of wires 60 and 62 is designed to be convenient for the user so as not to interfere with the operation of the bipolar forceps 10. As mentioned above, the proximal end of the wire bundle 28 is connected to the terminal connector 30, but in some cases it is preferable to extend the wires 60 and 62 to the electrosurgical generator (not shown). obtain. Alternatively, the wires 60 and 62 can remain separate and extend along the first member 9 and the second member 11.</p><p> As best shown in FIG. 6, the electrode 120 comprises a conductive seal surface 126 and an electrically insulating substrate 121, which are attached to each other by snap-fit engagement or some other assembly method. (For example, the substrate 121 is overmolded to capture the conductive seal surface 126). Preferably, the substrate 121 is made from a molded plastic material and is molded to mechanically engage the corresponding socket 41 located within the jaw member 44 of the end effector 24. The substrate 121 not only insulates the current, but also aligns the electrodes 120, both of which contribute to seal quality and consistency. For example, the placement and thickness of the electrodes 120 can be controlled by overmolding the conductive surface 126 onto the substrate 121.</p><p> Preferably, the substrate 121 comprises a plurality of branched anti-movement locks 122 which compress and expand after insertion during insertion into the socket 41 to detachably engage the socket 41. Is formed as follows. It is envisioned that the snap-fit engagement of the electrode 120 and the jaw member 44 will accommodate a wider range of manufacturing tolerances. The substrate 121 also comprises an alignment or guide pin 124 that is sized to engage the opening 67 of the jaw member 44.</p><p> The conductive seal surface 126 comprises a wire crimp 145 designed to engage the distal end 90 of the prong 105 of the electrode assembly 21, and a corresponding wire connector attached to the wire 60 located within the electrode assembly. Electrically engages with. The sealing surface 126 also comprises an opposing surface 125, which is designed to transmit an electrosurgical current to the tubular vessel or tissue when held against the tubular vessel or tissue 150. Will be done.</p><p> Electrode 110 comprises similar elements and materials to insulate the electrosurgical current and to transfer the electrosurgical current to the tissue 150. More specifically, the electrode 110 comprises a conductive seal surface 116 and an electrically insulating substrate 111, which are attached to each other by snap-fit engagement or some other assembly method. The substrate 111 comprises a plurality of bifurcated anti-movement 112s and alignment pins 126 (see FIG. 4), which engage with a plurality of corresponding sockets 43 and openings 65 located in the jaw member 42. The dimensions are such that they fit. The conductive seal surface 116 comprises an extension 155 having a wire crimp 119, the wire crimp engaging the distal end 91 of the prong 103 and the corresponding wire attached to the wire 62 located within the housing 71. Electrically engages with the connector. The sealing surface 116 also comprises an opposing surface 115 that, when held against the tubular vessel or tissue 150, transmits an electrosurgical current to the tubular vessel or tissue.</p><p> Alternatively, the electrodes 110 and / or 120 may be formed as a piece and may include similar components for insulating and conducting electrical energy.</p><p> As best shown in FIG. 7, the substrate 111 also comprises an extension member 108 and a stop member 106, which stop member 106 has a corresponding extension member 155 and an interface 107 disposed on the conductive seal 116. Designed to engage with. To construct the electrode 110, the stop member 106 and the extension member 108 are formed on the interface 107 and the extension member 116 of the conductive seal 116. After construction, the wire crimp 119 is inserted into the end 91 of the prong member 103 and connected to the wire 62.</p><p> It is known that when this tissue is compressed and electrosurgical energy is applied to the tissue, the impedance of this tissue decreases as the humidity level decreases. As a result, the two mechanical factors (ie, the pressure applied between the opposing surfaces 47 and 45, and the gap distance between the opposing electrodes 110 and 120 (see Figure 5)) are: It plays an important role in determining the thickness and effectiveness of the seal. Jaw members 42 and 44 are constructed and provided at the end of the tissue sealing process so that the opposing electrodes 110 and 120 have the desired gap range (eg 0.001 and 0.006 inches) (see Figure 8). The material conditions and components associated with the electrode assembly 21 and mechanical forceps 20 assembly are configured to have specific manufacturing resistance, ensuring that the gap between the electrodes does not change outside the desired range. ..</p><p> It is also known that the thickness of the tissue is very difficult to control by force alone, that is, if the force is too great and the two electrodes come into contact, a poor seal will occur and energy will not pass through the tissue. Or, if the force is too low, the seal will be too thick. Applying the proper force is important for the following other reasons: to block the vascular lumen; reduce the impedance of the tissue to a sufficiently low value and allow the tissue to carry sufficient current. To enable; in addition to contributing to creating the required end tissue thickness, which is a good seal indication, to overcome the expanding force during tissue heating.</p><p> It is also known that the size of the gap provides a seal of tissue. For example, if the gap is too large (ie, the jaw member does not compress the tissue sufficiently), the tissue will not dissolve collagen properly for efficient sealing. On the other hand, if this gap is too small (ie, the jaw member compresses the tissue too much), electrosurgical energy does not cut the tissue efficiently, which is also not desired. To effectively seal the tissue and overcome the above drawbacks, the gap distance (range) 151 between the aperture electrodes 110 and 120 (see Figure 8) is preferably about 0.001 inch. It is found to be between about 0.006 inches, and more preferably between about 0.002 inches and about 0.005 inches.</p><p> To ensure that the desired gap range is achieved after construction and that the correct force is applied to seal the tissue, the substrate 111 comprises at least one type of stop member 106, which Designed to limit and / or regulate the movement of the two electrodes 110 and 120 relative to each other. Preferably, the forceps 20 also limit and / or control the distance between the end effectors 22 and 24 and / or the closing force applied between the opposing inner surfaces 47 and 45 of the end effectors 22 and 24. Then, at least one stop member (eg, 101) (see FIG. 3) is provided to control the distance between the electrodes 110 and 120. Since the stop member 106 is part of the disposable electrode assembly 21, this stop has the additional advantage of relying on the material of the disposable electrode assembly 21. Preferably, the "step" stop member is utilized due to its ease of manufacture and simplification.</p><p> Stop members are placed at various points along the disposable electrode assembly to achieve the desired gap range described above, and / or stop members are other parts of the device (eg, handles 16, 18). , Jaw members 42, 44, and / or shafts 12, 14).</p><p> Preferably, the seal surfaces 115 and 125 are relatively flat to avoid current densities at sharp edges and to avoid arcing between vertices. When engaged, in addition to and due to the reactive force of the structure 150, the jaw members 42 and 44 are preferably manufactured to withstand bending. For example, the jaw members 42 and 44 and the corresponding electrodes 110 and 120 are preferably tapered along the width "W", as initially shown in FIG. 3, for two reasons: 1) This taper applies a constant pressure in parallel to a constant tissue thickness; 2) The thick proximal portion of the electrode (eg 110) is the reaction of the tissue 150 Withstands bending due to force. The tapered shape of the electrode (eg, 110) can be obtained by calculating a mechanically favorable variation of the electrode 110 from the distal end to the proximal end, and thereby adjusting the width of the electrode 110. It is determined.</p><p> Preferably, at least one of the prong members (eg, 105) is elastic or has a contraction-relaxing portion 53, which the contraction-relaxing portion 53 is two prong members 105 and 103 (and thus two relative to each other). Allows the movement of electrodes 120 and 110). As best shown in FIG. 3, the electrode assembly 21 is removable to the mechanical forceps 20 by first moving the prong 105 towards the prong 103 by bending the prong 105 at the contraction relaxation portion 53. It is installed. Electrodes 110 and 120 are then slid between opposing jaw members 42 and 44 at their openings, resulting in anti-movement 112 and 122 and guide pins 126 and 124, respectively, corresponding sockets 43 and 41, respectively. Alternatively, they are aligned with the openings 65 and 67, respectively. Therefore, the housing 71 is also arranged such that the shaft 14, the handle 18, and the pivot 25 are all located proximal to their corresponding channels 137, 139, and 133, which are located within the housing 71.</p><p> When the contraction relief portion 53 is disengaged, the respective electrodes 110 and 120 are engaged with the jaw members 42 and 44, respectively, i.e. the anti-movement 112, 122, engagement sockets 43, 41, and housing 71. Engage with mechanical forceps 20. The cover plate 80 is then mounted on the housing 71 in the manner described above. Here, the bipolar forceps 10 are prepared for operation.</p><p> In one embodiment, the electrode assembly 21 is attached to the mechanical forceps 20 in a different manner. For example, as best shown in FIG. 3, the electrode assembly 21 is engaged with the mechanical forceps 120 in a four-step manner: 1) The electrode assembly 21 and the cover plate 80 are swiveled rearward. As a result, the tongue 99 engages slot 100 at the electrode assembly 21, step; 2) forward so that the electrode assembly 21 and cover plate 80 engage the shaft 14 of the mechanical forceps 20 between them. Swing, step; 3) Then engage the electrode 110 movement stop 112 with the socket 43 of the jaw member 22, step; and 4) engage the electrode 120 movement stop 122 with the jaw member 24 socket 41. The process.</p><p> In another embodiment, the electrode assembly 21 engages the forceps 20 by slide-on assembly techniques. More specifically, the slide-on version includes a series of keyhole-like devices 541 located on the end effectors 22 and 24, which extend from the insulators 111 and 121, respectively, and the corresponding mechanical boundaries. Engage with surfaces 112, 122 and 124. The slide-on mounting feature is expected to facilitate the removal and replacement of the electrode assembly 21 and reduce manufacturing costs by minimizing the critical resistance of the anti-movement 112, 122 and alignment pins 126.</p><p> Furthermore, it is considered that the slide-on assembly method compared to the snap-on assembly method can improve the reliability of the forceps 20 due to the low plastic deformation in the assembly. For example, snap-on technology requires deformation of fork-like anti-movement devices 112, 122 to facilitate secure engagement of the electrode assembly 21 with end effectors 22 and 24. As will be appreciated, low active slide-on technology can reduce material deformation during construction, then extend the life of the device, prevent slipping of electrode assembly 21, and electrode assembly during actuation. Prevent the separation of 21.</p><p> In addition, if this slide-on assembly technique can engage the electrode assembly 21 in a low active manner during construction, once engaged, a uniquely designed key-like interface 541 within the end effectors 22 and 24. It is considered to provide a more active connection that contributes to the good "seating" of the electrode assembly 21 of the. In addition, the more active seating of the electrode assembly 21 prevents slippage of the electrode assembly 21 and prevents separation of the electrode assembly 21 during operation.</p><p> FIG. 8 shows bipolar forceps 10 during use, where handle members 16 and 18 are moved closer to each other to apply a force that holds them to the tubular tissue 150, as shown in FIGS. 9 and 10. Brings a seal 152 that is as good as possible. Once sealed, the tubular vessel 150 is cut along the seal 152, separating the tissue 150 and forming a gap 154 between them, as shown in FIG.</p><p> After the bipolar forceps 10 are used or the electrode assembly 21 is damaged, the electrode assembly 21 can be easily removed and / or replaced by reversing the above procedure, and the new electrode assembly 21 is similar. Can be engaged with mechanical forceps 20 in any manner. For example, the electrode assembly 21 can be released from the mechanical forceps 20 in the following four steps: 1) the step of releasing the anti-movement 122 of the electrode 120 from the socket 41 of the jaw member 24; 2) the movement of the electrode 110. The step of releasing the stopper 112 from the socket 43 of the jaw member 22; 3) the step of releasing the electrode assembly 21 and the cover plate 80 from the shaft 14 of the mechanical forceps 20; and 4) turning the electrode assembly 21 and the cover plate 80. The process of releasing the tongue 99 from slot 100 in the electrode assembly 21 as a result.</p><p> By making the electrode assembly 21 disposable, it is assumed that the electrode assembly 21 is not likely to be damaged as it is intended for single use only and therefore does not require cleaning or sterilization. As a result, the functionality and consistency of key sealing components (eg, conductive surfaces 126, 116 and insulating surfaces 121, 111) ensure a uniform, good quality seal.</p><p> FIGS. 12-14 show another embodiment of the disclosure of the present invention for use with endoscopic surgical procedures, and include bipolar forceps 210 having a drive rod assembly 211 connected to a handle assembly 218. The drive rod assembly 211 comprises an elongated hollow shaft portion 212 having a proximal end 216 and a distal end 214. The end effector assembly 222 is mounted on the distal end 214 of the shaft 212 and comprises a pair of opposing jaw members 280 and 282. Preferably, the handle assembly 218 is mounted to the proximal end 216 of the shaft 212 and from the open position (where the jaw members 280 and 282 are spaced apart from each other) from the clamping position or An activator 220 is provided to provide movement of the jaw members 280 and 282 to a closed position, where the jaw members 280 and 282 cooperate to grip the tissue 150 between them.</p><p> As best shown in FIG. 13, the activator 220 comprises a movable handle 226 and a fixed handle 228, which movable handle 226 is at least one of the operator's fingers defined within the movable handle. The fixed handle 228 has an opening 232 for receiving the operator's thumb, which is defined in the fixed handle. The movable handle 226 is selectively movable from a first position relative to the fixed handle 228 to a second position closer to the fixed handle 228 in order to close the jaw members 280 and 282. Preferably, the fixed handle 228 comprises a channel 227 extending proximally to receive the ratchet 230 connected to the movable handle 226. This structure allows the gradual closure of the end effector assembly 222 and the locking engagement of the opposing jaw members 280 and 282. In some cases, it may be preferable to include other mechanisms for controlling and / or limiting the movement of the handle 226 with respect to the handle 228 (eg, hydraulic system, semi-hydraulic system and / or gearing system). ..</p><p> The fixed handle 228 comprises a rotating assembly 223 to control the rotational movement of the end effector assembly 222 around the longitudinal axis "A" of the elongated shaft 212. Preferably, the rotary assembly 223 comprises an upper knob portion 224a and a lower knob portion 224b, respectively, which are detachably engaged with each other around a gear 252 mounted on the shaft 212. The pair of handle sections 228a and 228b engage with each other by a plurality of mechanical interfaces to form a fixed handle 228. As best shown in FIG. 13, each handle section 228a and 228b is generally hollow, resulting in a cavity 250 inside to accommodate the various internal components that make up the forceps 210. ,It is formed. For example, the cavity 250 houses a PC substrate 258, which controls the electrosurgical energy transmitted from the electrosurgical generator (not shown) to the jaw members 280 and 282. More specifically, electrosurgical energy is generated from the electrosurgical generator and transmitted to the PC substrate by a cable 260 mounted through a wire port 229 located at the proximal end of the handle assembly 218. The PC board 258 converts electrosurgical energy from the generator into two different electrical potentials, which are transmitted to the jaw members 280 and 282 by separate terminal clips 264b and 264a, respectively. , FIG. 14 will be described in more detail below.</p><p> With reference to FIG. 14, rod assembly 211 comprises a drive rod 270 having a proximal end 271 and a distal end 272. The piston 238 is mounted on the proximal end 271 of the drive rod 270 and comprises a substantially round head portion 239 and a notch 241 located between the head portion 239 and the proximal end of the piston 238. Preferably, the U-link flanges 249a and 249b of the arm 240 are sized to accept the head 239 between the handle sections 228a and 228b when the arm 240 is assembled (see FIG. 6). That). The movement of the handle 226 towards the fixed handle 228 gives the turning motion of the upper end 245 of the arm 240 at the turning point 255, which is then from the first position (the piston 238 is located far from the end effector assembly 222). , Gives the movement of the piston 238 to the second position (the piston 238 is closer to the end effector assembly 222). As described in more detail below, the movement of the piston 238 between the first and second positions gives a linear movement of the drive rod 270, which is then towards and from each other. Move the jaw members 280 and 282 apart.</p><p> By placing a nearly round head 239 between the U-link flanges 249a and 249b, the user can effectively use the rotating assembly 223 without interfering with the linear movement of the piston 238.</p><p> The end effector assembly 222 includes a first jaw 280, a second jaw 282, and an electrically insulating yoke 284 located between them. Preferably, the jaw member 280 and the jaw member 282 are movable from the open position to the closed position by the movement of the handle assembly 218 as described above. It is contemplated that either or both of the jaw members 280 and 282 may be movable relative to each other. The first jaw member 280 has a first flange 281 (extending from the first jaw member) and a cam slot 286 (positioned through the first jaw member). Similarly, the second jaw 282 has a second flange 283 (extending from the second jaw member) and a cam slot 288 (positioned through the second jaw member).</p><p> The end effector assembly 222 also comprises an outer nose portion 294 and an inner nose portion 296, which engage jaw members 282 and 280, respectively. The first swivel shaft 305 is sized to engage the corresponding swivel hole 289, located on the outer nose portion 294 and located on the flange 283. The second swivel shaft 303 is sized to engage the corresponding swivel hole 287 located on the inner nose portion 296 and located on the flange 281. The center of rotation for the first jaw member 280 is the first swivel hole 287, and the center of rotation for the second jaw member 282 is the second swivel hole 289. Preferably, the nose portions 294 and 296 are made from a conductive material and transfer electrosurgical energy to the jaw members 282 and 280, respectively, as described in more detail below.</p><p> As described above with respect to FIG. 13, electrosurgical energy is transferred from the electrosurgical generator to the connector assembly 315, which converts this energy to the first and second poles of the PC substrate 258. To be equipped. A pair of terminal clips 264a and 264b are connected to the PC board 258 and transmit alternating potentials of the first and second poles to the drive rod assembly 211, respectively. Clip 264a connects to shaft 212 and leads the first pole to jaw member 282, and clip 264b connects to piston 238, which in turn connects to drive rod 270. The second pole is guided to the jaw member 280 along the drive rod 270. Both the drive rod 270 and the shaft 212 are made of conductive material, and preferably the insulating sleeve 275 is positioned between the drive rod 270 and the shaft 212 to prevent forceps 210 from shorting the circuit. ..</p><p> As best shown in FIG. 14, the inner nose portion 296 is electrically connected to the drive rod 270 and the outer nose portion 294 is electrically connected to the shaft 212. The inner nose portion 296 and the outer nose portion 294 capture the yoke 284 along the flanges 283 and 281. The yoke 284 moves axially along the axis "A" in the space between the inner and outer portions 296, and the spacer stake 319 at their distal ends has the nose portions 296 and 294. Maintain separation. The stake 319 is sized to engage and lock the inner nose portion 296 and the outer nose portion 294 together, which in turn locks the jaw members 280 and 282 at the top of the yoke 284. In some cases, it may be preferable to dimension the stake 319 so that the stake 319 acts as a stop member and controls the clearance distance between the opposing jaw members 280 and 282 with respect to each other. .. In this case, the stake 319 is formed from an electrically insulating material such as plastic. The nose portions 294 and 296 provide lateral support for the flanges 281 and 283 and help ensure that the locks 290 and 292 remain within cam slots 286 and 288, respectively.</p><p> The end effector assembly 222 also includes an inner insulator 302 and an outer insulator 300 for maintaining electrical insulation between the poles. The outer insulator 300 insulates the outer nose portion 294 from the inner nose portion 296 and the drive rod 270, which lead the electrosurgical energy of the second pole. The inner insulator 302 insulates the inner nose portion 296 from the outer nose portion 294 and the shaft 212, which lead the electrosurgical energy of the first pole. Thus, the outer nose portion 294 may provide electrical continuity between the shaft 212 and the jaw member 282, while the inner nose portion 296 may provide electrical continuity between the drive rod 270 and the jaw member 280. Can provide continuity.</p><p> Preferably, the spring contact 298 is used to maintain an electrical connection between the drive rod 270 and the inner nose portion 296 during the axial movement of the drive rod. A donut-shaped spacer 308 can also be used to ensure linear movement of the drive rod 270 within the sleeve 275 and to prevent accidental short circuits of forceps 210.</p><p> Looking back at FIG. 14, the yoke 284 is preferably formed from an electrically insulating material such as plastic. The first side surface 291 of the yoke 284 faces the first flange 281 and the second side surface 293 of the yoke 284 faces the second flange 283. When the yoke 84 is placed between the flanges 281 and 283, the yoke 284 electrically insulates the first jaw member 80 from the second jaw member 282. Thus, the dipole electrosurgical current can be conducted through the tissue 350 sandwiched between the jaws 280 and 282 without shorting of the flanges 281 and 283.</p><p> At least one jaw member 280 and to achieve the desired gap range (eg, about 0.001 to about 0.006 inches, preferably about 0.002 inches to about 0.003 inches) and apply the desired force to seal the tissue. / Or 282 comprises a stop member 339, which limits the movement of the two opposing jaw members 280 and 282 relative to each other. As explained above, in some cases this stake 319 is dimensioned so that the stake 319 acts like a stop member and limits the movement of the two opposing jaw members 280 and 282 relative to each other. It may be preferable to decide. Preferably, the retaining members 339 and / or stake 319 are made from insulating material and sized to limit the opposite movement of the jaw members 280 and 282 within the above gap range.</p><p> In another embodiment, the retaining member may be sized for selective and replaceable mounting on the jaw member, depending on the particular purpose. For example, as best shown in FIGS. 15A-15C, this stop member is made of jaw members through a series of openings 441 and 443 defined via inner surfaces 115, 125 and insulators 116, 126, respectively. It can be sized as a plug 439 that is selectively attached to the inward facing surfaces 115 and 125. The gap plug 439 is preferably designed for snap-fit engagement through openings 441 and 443 of at least one of the jaw members (eg, 120), and a distance "R" protrusion from its inner surface 125. It is sized to do (Fig. 15C). As can be understood, this gap plug 439 has a minimum gap distance "G" between the opposing inward facing surfaces 115 and 125 when the jaw members 110 and 120 work together to grip the tissue between them. (Fig. 8) occurs.</p><p> During operation and / sealing, the user may selectively engage one or more gap plugs 439 as needed to produce the desired gap distance between jaw members 110 and 120. is assumed. As can be understood, the total gap distance "G" can be easily and selectively changed by replacing / replacing gap plugs of a particular size.</p><p> Preferably, the retaining members 139, 239, 339 and / or 439 are made of insulating material (eg, parylene, nylon and / or ceramic) and have specific opposite movements of jaw members 110 and 120 in a specific gap range. The dimensions are limited to. It is envisioned that the stop members 139, 239, 339 and / or 439 may be placed on one or both of the jaw members 110 and 120 depending on a particular purpose or to achieve a particular result. Preferably, these retaining members 139, 239, 339 and / or 439 have any known geometric or multinomial configuration (eg, triangular, linear, circular, elliptical, etc., depending on the particular purpose. It can be composed of scallops (such as scallops). Furthermore, it is intended that any combination of different retaining members 139, 239, 339 and / or 439 can be constructed along the sealing surfaces 115 and 125 to achieve the desired gap distance. Preferably, non-conductive stoppers 139, 239, 339 and / or 439 are molded onto jaw members 110 and 120 (eg, overmolded, injection molded, etc.) or stamped onto jaw members 110 and 120. Or deposited on jaw members 110 and 120 (eg, vapor deposition). These retaining members 139, 239, 339 and / or 439 can also be slidably attached to the jaw member and / or attached to the conductive surfaces 115 and 125 in a snap-fit fashion.</p><p> Other techniques for attaching stop members 139, 239, 339 and / or 439 are also intended. For example, one technique involves hot spraying a ceramic material onto the surfaces of jaw members 110 and 120 to form stop members 139, 239, 339 and / or 439. Several heat spraying techniques are intended, which include the process of depositing a wide range of heat resistant insulating materials on conductive surfaces 115 and 125 to produce stop members 139, 239, 339 and / or 439. (For example, light-speed oxy-fuel deposition, plasma deposition, etc.).</p><p> From the above, and with reference to the various drawings, one of ordinary skill in the art will appreciate that certain modifications may also be made to the present disclosure without departing from the scope of the present disclosure. For example, it is preferred that the electrodes 110 and 120 face each other in parallel and thus face each other in the same plane, but in some cases the electrodes 110 and 120 face each other at their distal ends, resulting in It may be preferable that additional closing forces on the handles 16 and 18 are required to slightly deflect the electrodes in the same plane.</p><p> It is preferable to place the electrodes 110 and 120 vertically, but in some cases it is preferable to place the electrodes 110 and 120 facing each other either vertically or transversely in order to fit a particular purpose. ..</p><p> It is preferred that the electrode assembly 21 comprises a housing 71 and a cover plate 80 to engage the mechanical forceps 20 between them, but in some cases the disposable electrode assembly 21 will provide the mechanical forceps 20. It may preferably be manufactured such that only one component (eg, housing 71) is required to engage.</p><p> Although only one embodiment of the present disclosure has been described, the present disclosure is limited thereto as the present disclosure is as broad as the art allows and is construed to be read herein as well. Not interpreted to do. Therefore, the above description should be construed as merely an example of a preferred embodiment, not as a limitation. Those skilled in the art envision other changes within the spirit and scope of the claims attached herein.</p><p> Various embodiments of the device of interest are described herein with reference to the accompanying drawings.</p>

<figref num="1">FIG. 1 is a perspective view of bipolar forceps according to the present disclosure.</figref><figref num="2">FIG. 2 is an enlarged perspective view of the distal end of the bipolar forceps shown in FIG.</figref><figref num="3">FIG. 3 is a perspective view of a disassembled part of the forceps shown in FIG.</figref><figref num="4">FIG. 4 is an enlarged side view of the disposable electrode assembly of FIG. 1 shown without a cover plate.</figref><figref num="5">FIG. 5 is an enlarged perspective view of the distal end of the disposable electrode assembly of FIG.</figref><figref num="6">FIG. 6 is a perspective view of a disassembled part of the upper electrode of the disposable electrode assembly of FIG.</figref><figref num="7">FIG. 7 is a perspective view of a disassembled part of the lower electrode of the disposable electrode assembly of FIG.</figref><figref num="8">FIG. 8 is a perspective view of the forceps of the present disclosure showing the operating motion of the forceps for sealing a tubular blood vessel.</figref><figref num="9">FIG. 9 is an enlarged partial perspective view of the sealing site of the tubular blood vessel.</figref><figref num="10">FIG. 10 is a longitudinal sectional view of the sealing portion taken along line 10-10 of FIG.</figref><figref num="11">FIG. 11 is a longitudinal sectional view of the sealing site of FIG. 9 after separation of the tubular blood vessel.</figref><figref num="12">FIG. 12 is a perspective view of another embodiment of the present disclosure.</figref><figref num="13">FIG. 13 is an exploded assembly view of the embodiment of FIG.</figref><figref num="14">FIG. 14 is an enlarged perspective view of the operating end of the embodiments of FIGS. 12 and 13.</figref>