Ultrasonic surgical instrument

The present invention generally relates to a tissue pad intended for use in an ultrasonic clamp coagulator and a method for mounting washers on a clamping arm of an ultrasonic clamp coagulator.

Field of the invention [0002] Ultrasound surgical instruments are more and more commonly used in surgical procedures due to the unique characteristics of operation. Depending on the particular device configuration and operating parameters, ultrasonic surgical instruments can substantially provide simultaneous tissue cutting and homeostasis provided by coagulation, it being desirable to minimize the injuries experienced by the patient's body. The cutting action is generally carried out by the end effector at the distal end of the device, transmitting ultrasound energy to the tissue in contact with the end effector. Ultrasound devices of this type can be used in open surgery, laparoscopy or endoscopic surgical procedures,

[0003] Ultrasonic surgical instruments equipped with a clamp mechanism to press the tissue into the tip of the end effector have been developed to ensure the coupling of ultrasound energy with the tissue of the patient's body. Such a configuration (sometimes referred to as a clamp coagulator shears or an ultrasound scalpel) has been disclosed in U.S. Patent Nos. 5,322,055, 5,873,873, and 6,325,811. The surgeon activates the clamping arm to press the clamp washer against the blade by squeezing the handle or handle. Some of the currently used ultrasonic scissors, however, have a tendency to form tissue papilla. Tissue warts are tissue that remains clenched in the jaw and intact after cutting and most of the tissue clenched in the jaw. The cause of tissue papillary formation may be insufficient proximal load on the end effector and / or reduced proximal blade activity. Surgeons may restrict the occurrence of tissue papillae either by increasing the vertical stress (i.e., by stressing the tissue with the blade) or by traction directed backward to move the uncut tissue to the more active part of the blade to complete the incision. Some currently used ultrasonic shears use tissue washers that close parallel to the surface of the blade. Such solutions pose some problems from the point of view of the pressure profile exerted on the tissue. When you compress tissue between the jaw and the blade, the proximal part of the blade deflects under pressure more strongly than the proximal part of the clamping arm moving to apply a load to the blade. This deflection is partly due to the part of the blade distal to the most distal node of the device. It is also partly caused by the deflection of the load carrying rod, proximal to the most distal node. In addition, the fact that the amplitude of the blade decreases as it approaches the tip of the blade further aggravates the situation, because the amount of energy transferred to the tissue is reduced, even when applying constant pressure. It is also partly caused by the deflection of the load carrying rod, proximal to the most distal node. In addition, the fact that the amplitude of the blade decreases as it approaches the tip of the blade further aggravates the situation, because the amount of energy transferred to the tissue is reduced, even when applying constant pressure. It is also partly caused by the deflection of the load carrying rod, proximal to the most distal node. In addition, the fact that the amplitude of the blade decreases as it approaches the tip of the blade further aggravates the situation, because the amount of energy transferred to the tissue is reduced, even when applying constant pressure.

[0004] Current designs of tissue pads utilize PTFE as a material in contact with the tissue and the blade. Although such structures are suitable and sufficient, they are characterized by an unfavorable short lifespan because the inserts are subject to wear during long surgical procedures. In newer constructions of the clamp coagulator shear the blade amplitude and / or the load of the pad against the tissue and the blade is increased and the pad material is crushed, which shortens the life of the pad under the tissue. The pad material limits the amount of force that can be applied to the tissue and the blade, which in turn limits the thickness of the tissue or the size of the vessel that can efficiently intersect and coagulate some of the currently used shear clamp coagulator.

[0005] Some of the currently used scissors of the zccsso coagulator use the concept of an internal pipe placed in the outer pipe to open and close Γ'3πίθηί3. During surgical sutures, the clamping arm may be subjected to axially acting clamping forces exceeding 11.1 N and / or torsional overloads, which may cause the clamping arm to disengage from the inner tube or complete disengagement from the shear.

[0006] Some of the currently used shear designs of the clamping coagulum utilize a spring mechanism applying a constant force to prevent applying excessive force to the clamping arm and blade. Although such a mechanism transmits a relatively constant force to the system, the spring causes a certain decrease in the applied force curve. For applications using a small clamping force, the drop is not significant. In the case of applications using a greater clamping force, the difference in the magnitude of the forces resulting from the fall in the range of compressible compressions is, however, very significant and may exceed the maximum value that the blade, pipe sets or other elements of the system can accept. A large drop may lead to exceeding the maximum permissible force value in case of abuse of the device or due to normal changes in the manufacturing tolerances of the devices. In this situation, the blade may bend, the blade actuating mechanism may be damaged or undesirable effects may occur in the tissues (i.e., a quick cut, which is accompanied by minimal tissue coagulation). This situation is additionally strengthened by the fact that the jaw (clamping arm and washer) of the device may encounter sufficient resistance, causing the mechanism to limit the working force when the jaw almost touches the blade (during cutting the thin tissue or at the end of the operation, or during crimping hard objects, such as other devices), or when the jaw is still open (when cutting thick tissue).

[0007] Some of the currently used shear designs of the clamping coagulum use springs limiting the amount of acting force to ensure that the acting clamping forces assume values ​​from a particular range. The construction of the spring limiting the acting force should also allow the surgeon to "feather"

(applying a force less than the maximum force and gradually increasing the force until the maximum value is reached). In the case of these mechanisms, the jaws close so as to reach a force of a certain value, and then an additional stroke causes the mechanism to move to a range in which the force is limited. In some cases, however, the surgeon may unconsciously not apply full force to the jaw placed on the tissue, resulting in incomplete tissue cutting or insufficient coagulation. The surgeon may also unknowingly reduce the full force acting on the jaw placed on the tissue during the operation, which leads to incomplete tissue cutting or insufficient coagulation.

[0008] Some of the currently used clip clamping shears use a pedal-operated pedal supplying the surgical instrument. The surgeon presses the pedal with the foot while pressing the handle to clamp the tissue between the jaw and the blade to engage the generator that delivers the energy transmitted to the cutting blade that performs tissue cutting and coagulation. The most important disadvantages of this type of device incorporation include the loss of focus on the surface where the surgery is performed when the surgeon searches the pedal with a leg, when the pedal interferes with the body movements performed by the surgeon during surgery and fatigue of the surgeon's leg during long surgeries.

[0009] Some of the currently used shear coil squeeze designs have eliminated the pedal leg and provide manual activation of the stationary trigger.

This solution can be embarrassing, especially for surgeons who have large hands.

[0010] Some of the currently used clamp coagulum designs utilize grips in the form of a pistol grip or scissors handle. Constructions in the form of a scissors holder may have one thumb or finger grip, immovable and fixed on the casing, and one movable thumb or finger grip. This type of handle may be unknown to surgeons using other surgical instruments for open surgery, such as hemostats, during which the thumb and finger operated handles move in opposite directions.

[0011] It would be desirable to provide an ultrasound surgical instrument that lacks some of the shortcomings of the devices currently in use. The ultrasonic surgical instrument described in the text does not have these shortcomings.

Summary of the Invention [0012] The present invention relates to a tissue pad intended for use in an ultrasonic clamp coagulator, and a method of mounting tissue pads on a clamping arm of an ultrasonic clamp coagulator. The ultrasound clamping coagulator assembly is adapted to perform selective lancing, coagulation and tissue clamping during surgical procedures. The elongated part of the device can be adapted for endoscopic applications and has an external diameter of less than 6 mm. The design includes a clamping mechanism, consisting of a clamping arm rotatably mounted on the distal portion of the device, specifically adapted to produce the desired, large enough clamping forces, large forces exceeding 17.8 N after the trigger is fully closed,

[0013] The clamping mechanism also includes a washer construction and a pad material that allows the production of larger clamping forces for the tissue.

[0014] The clamping coagulator also has a force limiting mechanism that effectively reduces excessive force on the tissue.

[0015] The clamp coagulator also has a manual activation solution adapted to provide the surgeon with a pleasant, ergonomic grip and handling. Manually operated switches are within the natural range of the surgeon's thumb, regardless of whether the surgical instrument is caught with the right or left hand. Brief description of the figures [0016] The novel features of the invention are described in particular in the claims. The invention itself, both in terms of structure and modes of operation, can best be understood from the following description, contemplated along with the included drawings, in which: Fig. 1 is a perspective view showing an embodiment of the ultrasonic surgical instrument according to the present invention;

Fig. 2 is a perspective assembly view of an embodiment of the ultrasonic surgical instrument according to the present invention,

Fig. 3a is a perspective assembly view of the clamping arm and tissue pads;

Fig. 3b is a sectional view showing the clamp arm and the T-shaped groove;

Fig. 3c is a sectional view showing a clamp arm and a dovetail groove;

Fig. 3d is a perspective view of the tissue pads fitted and placed on supports in the clamping arm;

Fig. 3e is a side view of the clamping arm showing a conical profile;

Fig. 3f is a plan view of a clamp arm;

Fig. 4a is a perspective view of the blade unit, the clamp arm, the tissue pad and the actuator tube with the clamp arm in the closed position;

Fig. 4b is a perspective view of the blade unit, clamp arm, tissue pad and actuator tube with the clamp arm in the open position;

Fig. 4c is a schematic diagram of a clamp arm according to the present invention, showing force calculation;

Fig. 5 is a cutaway side view of a portion of the housing of the ultrasonic surgical instrument according to an embodiment of the present invention showing the force limiting springs and latch closure ratchet mechanism, and a partial cut off viewed top view of the transmission rod and end effector;

Fig. 6a is an enlarged view of the housing, showing thumb-activated buttons and a switch and actuator assembly of a clamp actuator connected by a finger grip;

Fig. 6b is an enlarged view of the housing with the switch assembly removed for clarity of illustration;

Fig. 7 is a perspective assembly view of the switch assembly and ring electrical contactors;

Fig. 8a is a perspective assembly view of the switch assembly and ring electrical contactors;

Fig. 8b is a perspective view of the proximal end of the relay showing the guide rings;

Fig. 8c is an electrical diagram of a button circuit;

Fig. 9 is a perspective view of an ultrasonic surgical instrument with a sealed housing connected to a relay; Fig. 10 is a perspective view of an ultrasound surgical instrument with a distal protrusion and a clamp arm in the open position;

Fig. 11 is a perspective view of an ultrasound surgical device with the trigger retracted proximally and the clamp arm in the closed position;

Fig. 12 is a side view of a left-handed handle of an embodiment of the ultrasonic surgical instrument of the present invention;

Fig. 13 is a side view of the left hand operated handle of the ultrasound surgical instrument in accordance with an embodiment of the present invention with an index finger accessing the rotatable target;

Fig. 14 is a side view of the left hand operated handle of the ultrasound surgical instrument of the present invention with the thumb having access to the first switch;

Fig. 15 is a side view of the left hand operated handle of the ultrasound surgical instrument of the present invention with the thumb having access to a second switch;

Figs. 16a-c are force curves representing different forces as a function of the position of the tumbler and the state of the tissue;

Fig. 17 is a side view of a surgical instrument with a graphic representation of the surgeon's finger position;

Fig. 18 is a perspective assembly view illustrating a second embodiment of the ultrasonic surgical instrument of the present invention;

Figure 19 is an enlarged view of the handle connector;

Figures 20a-b are enlarged views of a large slip ring and a small slip ring, respectively;

Figure 21 is an enlarged view of the elastic circuit;

Figure 22 is an electrical diagram of the flexible circuit according to figure 21;

Figure 23 is a side view of a surgical instrument according to one aspect of the invention; and

Figure 24 is a perspective view of a surgical instrument in accordance with an alternative aspect of the invention;

DETAILED DESCRIPTION OF THE INVENTION Before describing the invention in detail, it should be noted that the invention is not limited in its application or use to the constructional details and arrangement of parts shown in the incorporated drawings and description. The scope of the invention is defined by the claims set out below.

[0018] It should also be understood that any, one or more of the embodiments described below, embodiments, examples, etc. may be combined with any one or more embodiments described herein below, embodiments of examples, examples , etc.

[0019] The present invention in particular relates to an improved tissue pad intended for use with an ultrasound, surgical clamping coagulator adapted to perform incision, coagulation and / or tissue clamping during surgical procedures, and a method of mounting a tissue pad on a clamping arm of an ultrasonic clamp coagulator. The present invention can be easily adapted for use in open surgical procedures, as well as laparoscopic and endoscopic procedures as well as surgical procedures supported by robots. Versatile applications of the invention facilitate the selective use of ultrasound energy. When the ultrasonic components of the device are inactive, the tissue can be easily grasped and manipulated as needed without cutting or damaging the tissue. After switching on the ultrasound elements, the device enables gripping the tissue to be combined with the ultrasound energy performing tissue coagulation, with the use of increased pressure thanks to which it is possible to efficiently incision and coagulate the tissue. If desired, the ultrasound energy can be transmitted to the tissue without using the device clamping mechanism by properly manipulating the ultrasonic blade.

[0020] The presented clamping coagulator is particularly suitable for single use due to its simple construction, which will become more apparent from the further part of the description. It is contemplated to use the device as such together with a generator set of the ultrasound surgical system, wherein the ultrasound energy from the generator assembly provides the desired ultrasound action transmitted by the presented clamp coagulator. It should be appreciated that the clamping coagulator can be adapted for repeated use and permanently connected to a suitable assembly of an ultrasonic generator. The disconnection of the clamping coagulum described in the text with a suitable ultrasound generator assembly is, however, currently beneficial from the point of view of the use of the device during the single patient procedure.

[0021] The present invention will be described as being used together with the ultrasound device described in the text. Such a description is only an example, and its intention is not to limit the scope and applications of the invention. For example, the invention is useful in connection with a series of ultrasound devices, including devices described e.g. in^patentac^h America^ñskica^h No. 5^.938^.633; 5^.935¹44; 5^.944^.737;

5,322,055, 5,630,420 and 5,449,370.

[0022] Figures 1-3 illustrate an embodiment of a surgical system 19, including an ultrasonic surgical instrument 100 according to the present invention. The surgical system 19 includes an ultrasound generator 30 connected to an ultrasonic relay 50 with a cable 22, and an ultrasonic surgical instrument 100. It should be noted that for some applications, the ultrasound relay 50 is called the "handle assembly" because the surgical device 19 is adapted to allow the surgeon to capture and manipulate the course of various ultrasound transducers 50 of the procedures and operations performed. A suitable generator is the GEN 300 generator sold by Ethicon EndoSurgery, Inc. based in Cincinnati, Ohio, USA.

[0023] The ultrasonic surgical instrument 100 has a multi-element handle assembly 68 adapted to isolate the vibration of the audio assembly mounted inside the relay 50 from the operator's body. The handle assembly 68 may be in a shape that allows the user to hold it in a conventional manner, but it is believed that the described ultrasonic surgical instrument 100 may be substantially grasped and manipulated by a trigger type system provided by the device handle assembly, as further described herein. Although the figures show a multi-element handle assembly 68, the handle assembly 68 may, however, be one or a combined element. The proximal end of the ultrasound surgical device 100 is intended for mounting and mounting the distal end of the ultrasonic relay 50 therein by sliding the relay into the holder assembly 68. The ultrasonic surgical instrument 100 can be mounted on and removed from the ultrasonic relay 50 as a unit. The ultrasonic surgical instrument 100 may have a housing assembly 68 comprising a matching housing portion, a housing portion 70, and a transfer assembly 71. Although the instrument shown in the text is adapted for endoscopic applications, its design may, however, be dimensioned such that the outer diameter assembly is in an elongated transfer unit. 71 of the ultrasonic surgical instrument 100 extends in a perpendicular direction from the device holder assembly 68.

handle assembly 68 as described later in the text. The handle assembly 68 may be formed in a durable plastic, such as a polycarbonate or a liquid crystal polymer. An alternative is also contemplated to make the handle assembly 68 from a range of materials including other plastics, ceramics or metals.

The conveyor assembly 71 may include an outer tubular member or outer sheath 72, a tube-shaped inner actuator 76, a guide 80, and an end effector 81 (blade 79, clamp arm 56 and one or more clamp washers 58). According to a further part of the description, the outer cover 72, the actuator 76 and the guide or transfer rod 80 can be connected to realize a rotational movement as one unit (together with an ultrasonic relay 50) relative to the handle assembly 68. The guide 80, adapted to transmit ultrasonic energy from the relay 50 to the blade 79, can be flexible, semi-flexible or rigid. The guide 80 may also be adapted to enhance the mechanical vibrations transmitted by the guide 80 to the blade 79, which is a solution well known in the art. The guide 80 may also have characteristic elements to provide control of the amplification of longitudinal vibrations along the guide 80 and characteristic elements to ensure tuning of the guide 80 to the resonance frequency of the system. The guide 80 may in particular have any suitable section. For example, the guide 80 may have a substantially constant cross-section or the guide 80 may be tapered in different parts or along its entire length. In one embodiment of the present invention, the nominal guide diameter is about 2.87 mm to minimize deflection at the blade 79, so that the gap in the proximal end effector 81 is also minimized.

The ultrasound guide 80 can also have at least one radial hole or slit 66 passing therethrough, in a direction substantially perpendicular to the longitudinal axis of the guide 80. The slot 66 that can be in the node is adapted to receive a connector pin 27 connecting the guide 80 to the tube-shaped actuating member 76, and the tube-shaped outer cover 72, the rotary knob 29 for co-rotating the elements, including the end effector 81, relative to the handle assembly of the device.

[0026] In the case of at least one embodiment of the present invention, the ultrasonic guide 80 may have a series of grooves or notches (not shown) formed on its outer circumference. The grooves may be located in the guide nodes 80 and serve as adjustment indicators for the assembly of the damping cover, stabilizing silicon rings or appropriate brackets during the production process. In the extreme distal node nearest to the end effector 81, there may be a gasket 67 restricting the passage of tissue, blood and other material through the area between the guide 80 and the actuator 76.

[0027] The blade 79 may be an integral element of the guide 80 and may form a common assembly. In the case of an alternative embodiment of the illustrated embodiment, the blade 79 can be connected to a thread guide, a weld, or other connecting mechanisms. The distal end of the blade 79 is located near the wave arrow to tune the acoustic unit to a preferred resonant frequency fo when the acoustic unit is not loaded with tissue. After switching on the power supply of the ultrasonic relay 50, the distal end of the blade 79 can move in the longitudinal direction in a range of, for example, about 10 to 500 micrometers between the wave crests, and preferably in the range from about 20 to about 200 micrometres at a predetermined frequency vibration, for example, 55 500 Hz.

[0028] According to the illustrated embodiment, the blade 79 is curved together with a respective clamp arm 56. This solution is only demonstrative, and the blade 79 and the corresponding clamping arm 56 can have any shape known to a person skilled in the art.

[0029] The ultrasonic 50 and ultrasound relay 80 together form the zest of the illustrated surgical system 19, the acoustic unit providing ultrasound energy for surgical operations after switching on the power supply of the generator 30. The acoustic unit of the surgical device 100 generally has a first acoustic part and a second acoustic part. In the case of the illustrated embodiment, the first acoustic part has ultrasound-active elements of the ultrasonic transducer 50 and the second acoustic part has ultrasound-active elements of the transmission unit 71. Furthermore, in the case of the illustrated embodiment, the distal end of the first acoustic part is operably connected to the proximal end of the second part acoustic, for example using a threaded connection.

[0030] Referring in particular to Figs. 2 and 9-11, the reciprocating movement of the actuating member 76 causes the clamping arm to open and close. The force limiting mechanism 91 is operably connected to the actuating member 76 and consists of a cap 98 of the safety tube fastening and fixing the distal washer 97, the distal wound spring 96, the proximal washer 95 and the proximal corrugated spring 94 on the cap of the collar 93. The collar 93 has an extending span. in the axial direction of the mesh 92 connected to the respective openings 75 in the proximal part in the form of an actuator tube 76. In the circumferential groove 74 of the actuating member 76 an O-ring 73 is contacted, in contact with the inner surface of the outer skirt 72.

[0031] The rotation of the actuator 76 together with the tube-shaped outer cover 72 and the inner guide 80 is provided by a cotter 27 passing through these elements and by a rotary knob 29. The tube-shaped actuator 76 has an elongated seat 31 through which the cotter passes connecting 27 to adjust the reciprocating movement of the actuator 76 with respect to the outer cover 72 and the inner guide 80.

[0032] The force limiting mechanism 91 is part of the mechanism of the tool clamp 100 that performs the rotary motion of the clamping arm 56 by reciprocating the actuator 76. The drive mechanism of the clamp also has a drive yoke 33 operatively connected to the trigger serving 34 of the device, the operating trigger 34 is thus connected to the reciprocating actuator 76 via the drive carrier 33 and the mechanism 91 limiting the operating force. The trigger 34 is pivotally connected to the drive link 33 via tabs 35 and 36 and the link 37 and is pivotally connected to the drive carrier 33 and the housing 68 via the post 38.

[0033] The movement of the trigger 34 towards the handle 68 causes the actuator 76 to move in the proximal direction, thereby rotating the clamp arm 56 towards the blade 79. The operation of the trigger 34 and the handle 68 cooperating with it facilitates comfortable and efficient manipulation and setting of the device, and operation of the clamping mechanism in the distal part of the device, whereby the tissue is effectively directed towards the blade 79. The movement of the trigger 34 away from the handle 68 causes the actuator 76 to move in the distal direction, thereby rotating the clamp arm 56 away from the blade 79.

[0034] Referring specifically to Figs. 1-4, one of the embodiments of a clamp 60 intended for use with the illustrated ultrasonic surgical instrument 100 and adapted to cooperate with the blade 79 is shown thereon. The clamp 60 together with the blade 79 is commonly referred to as end effector 81, and clamp 60 is also commonly referred to as a jaw. The clamp 60 has a rotatable clamp arm 56 connected to the distal end of the outer cover 72 and the actuator 76 in connection with the tissue-engaging washer or clamp washer 58. In one embodiment of the embodiment, the clamp washer 58 is made from a trademark available under the trade name TEFLON® polymer from EI Du Pont de Nemours and Company, a polymer with a low friction coefficient, or from any other material with a low coefficient of friction. The clamping washer 58 is mounted on the clamping arm 56 as an element cooperating with the blade 79, wherein the rotation of the clamping arm 56 positions the clamping pad substantially parallel to and in the position in which the pad contacts the blade 79, thus defining the tissue treatment zone. Due to this construction, the tissue is caught between the clamping pad 58 and the blade 79. According to the illustration, the clamp pad 58 may have a rough surface reminiscent of the saw teeth, providing better tissue grip in cooperation with the blade 79. The teeth-like structure, or teeth, provide traction for blade movement. Teeth also provide anti-traction for the movement of the blade and the movement that causes the tissue to be clamped.

With reference to Fig. 3a, the first embodiment of the present embodiment has a clamping washer 58 having a proximal portion 58b slightly smoother than the distal portion 58a such that the proximal portion 58b can be devoid of a surface resembling a sawtooth or other contemplated contacting surface. with tissue. The use of the smooth proximal portion 58b of the clamping pad 58 allows the tissue to move in the proximal region distally, according to the blade oscillating motion, towards the more active blade zone 79, to avoid the formation of tissue nodules. This concept uses the natural blade motion profile 79. Because of the sinusoidal movement, the largest displacement or amplitude of motion occurs in the most distal part of the blade 79, whereas the proximal part of the tissue treatment zone shows an amplitude of 50% of the amplitude observed in the distal tip. During the procedure, the tissue located in the proximal zone of the end effector (zone 58b) will dry out, and the thin and distal portion of the end effector 81 will cut the tissue in this distal zone, thereby allowing the dried and thin tissue in the proximal zone to shift in the distal direction , to the more active zone of the end effector 81 to complete the tissue cutting operation.

In a second embodiment of the embodiment shown, the clamp washer 58 consists of a single washer having a smooth proximal end 58b and a distal portion 58a having a saw tooth-like structure. In the third embodiment of the illustrated embodiment, the clamping washer 58 may consist of two separate elements, a distal portion 58a 'resembling the teeth of the saw, and a proximal portion 58b' smoother than the distal portion 58a '. The advantage of using two separate elements 58a 'and 58b' is that each washer can be constructed of different materials. The present invention, having a two-part tissue pad, uses a material having a very good lubricating properties at the distal end, which is not particularly resistant to high temperatures compared to a very heat-resistant material and a proximal end that does not have particular lubricating properties, because the proximal end is a zone of smaller amplitude. This configuration ensures compatibility of the tissue pad material with the blade amplitude

79.

[0037] In the fourth embodiment of the described embodiment of the present invention, the clamp washer 58a 'is made of a TEFLON® polymer or any other material that provides a correspondingly low frictional force. Clamping washer 58b 'is made of a base material and at least one filler material that is a different material than the base material. The surface of the proximal clamping washer 58b 'may be smoother: the outer surface of the clamp washer 58a', or the proximal clamping washer 58b 'may also have a similar surface configuration resembling the shape of the saw teeth.

[0038] One or more embodiments of the invention provide several advantages and benefits. A tissue pad made of a base material and at least one filler material allows selection of the base material and at least one filler material with different hardness, stiffness, lubricity, dynamic coefficient of friction, thermal conductivity coefficient, abrasion resistance, thermal radiation reflective temperature , a glass transition temperature and / or a melting point to achieve increased strength of the tissue pad, which is important when clamping forces are used, because the tissue pads wear faster with larger clamping forces than with smaller clamping forces. Applicants found in the course of the experiment that the graphite-filled graphetium made of polytetrafluoroethylene, the tissue pad showed substantially the same wear when using a 31.1 N clamping force, as made of 100% polytetrafluoroethylene tissue washer subjected to clamping force of 6.67 N. Having a flexible clamping arm and / or an elastic tissue pad should also improve the strength of the tissue pad for wear due to the ability of the elastic element to distribute the load more evenly over the entire surface of the tissue pad. Further advantages and methods for carrying out this embodiment are described in US provisional application number 60 / 548,301,

In a fifth embodiment of the illustrated embodiment, a tissue pad made of a base material and at least two filler materials allows selection of the base material and at least two filler materials as materials with different hardness, stiffness, lubricity, dynamic coefficient of friction. , thermal conductivity, abrasion resistance, thermal radiation reflection temperature, glass transition temperature and / or melting point to achieve increased strength under tissue, which is important when clamping forces are used, because tissue pads wear out faster when using larger clamping forces than when using smaller clamping forces.Applicants found in the experiment that graphite-filled and 30% PTFE-filled polyamide tissue pads showed essentially the same or less wear when using a 20 N clamping force compared to 100% polytetrafluoroethylene tissue pad subjected to a clamping force of 6.7 N.

[0040] The advantage of a 15% filled graphite filled with 30% PTFE polyimide tissue pad is increased thermal resistance, improving the overall strength of the tissue pad for wear. This polyimide-composite crimping pad exhibits a useful thermal resistance to a temperature of about 427 ° C to about 649 ° C, compared to a useful thermal strength in the range of up to about 349 ° C, exhibited by a PTFE-based clamping pad. Alternatively, other materials used as fragments of the tissue pad (i.e. as element 58b ') such as ceramics, metals, glasses and graphite are also useful. [0041] Referring to Figs. 3a-e, one of the deployed clamping arms 56 has nests having different shapes, allowing two or more pads to be placed under tissue. This solution prevents improper loading of the tissue pads and provides the confidence to load the corresponding pad in the appropriate location of the clamp arm 56. For example, the clamp arm 56 may have a T-shaped distal seat 53a for receiving a distal pitch-shaped flange 53b 'of the washer clamping 58a ', and a wedge-shaped or dovetail proximal socket 55a for receiving a wedge-shaped collar 55b' of the proximal clamp washer 58b '. The latch lock 51 contacts the proximal end of the proximal clamp pad 58b 'to secure the clamp washers on the clamp arm 56. Those skilled in the art would appreciate the fact that the flanges 53b' and 55b ' and the corresponding seats 53a and 55a may have other shapes and sizes to ensure the attachment of the clamp washers on the clamping arm. The flange configurations shown in the illustrations are for illustrative purposes only and allow the assembly of a specific clamping pad material according to one embodiment, but the size and shape of the collar may be different, including but not limited to flanges of the same size and shape. In the case of individual tissue pads, the collar may have one configuration. It is also possible to provide other latch locks and they may use any of a number of methods for mechanically securing clamping washers on a clamping arm, such as rivets, glue, press studs or other fastening solutions known to a person skilled in the art.

[0042] In the case of the second embodiment of the illustrated embodiment, the clamping washers 58a and 58b are cut diagonally, whereby the connection between the two tabs forms a material overlay, reducing the gap to a minimum (Figures 4a, 4b). For example, an oblique cut at 45 degrees allows a small gap to be maintained, but the gap width available to the tissue is minimized.

[0043] In the third embodiment of the embodiment shown, the height of the clamping arm 56 increases in a direction from the distal end to the proximal end (D1 <D2). The value of D2 is preferably from about 105% to about 120% greater than the value of D1 and more preferably, the value of D2 is from about 108% to about 113% greater than the value of D1, and most preferably, the value of D2 is about 110% greater than the value D1. The flanges 153 can receive flanges of one clamping washer 58 or two clamp washers 58a and 58b. The tapered clamping arm 56 allows the use of flat washers and increases the pressure in the proximal part of the end effector 81 and disturbances in the operation of the blade 79. If the clamping arm 56 evades to a greater extent than the blade 79, on the tissue pad and the connection with the blade there is still pressure, there are disruptions in the blade, which prevents the formation of a gap. The increased pressure also helps to compensate for the reduced blade amplitude at the proximal end of the blade 79 and provides a relatively constant pressure acting between the clamp washer 58 and the blade 79.

The first embodiment of the method of inserting clamping washers, which is not a method according to the invention, comprises: a) inserting first and second clamping washers having a first shape collar into a clamping arm 56 having a first shape receiving collar; and b) activating the lock of the washer to secure the clamp washers in the clamping arm. In the case of a second embodiment of this method, one clamping pad can be made of a polymeric material such as TEFLON, and the second clamping pad can be made of a base material and at least one filler material other than the base material, and the clamping arm is made of metal, such as stainless steel or titanium.

[0045] A third embodiment of the method of inserting clamping washers according to the invention comprises a) inserting a first clamping pad having a first-form collar into a clamping arm having a seat adapted to receive a first-shaped collar therein; b) inserting a second clamping pad having a second-shaped flange into the clamping arm having a seat adapted to receive a second-shaped flange therein; and c) activating the lock of the washer in order to clamp the washers on the clamping arm. In the fourth embodiment of this method, one clamping pad can be made of a polymeric material such as TEFLON, and the second clamping pad can be made of a base material and at least one filler material, other than the basic material, and the clamping arm is made of metal, such as stainless steel or titanium. The tissue-contact surfaces of the clip pads may be smooth or may have characteristics to capture tissue, such as saw tooth-like structures.

[0046] A first embodiment of the method of replacing the clamp washers 58 would include the steps of: a) disengaging the lock of the washer; b) removing the first clamp pad from the clamp arm; c) removing the second clamp pad from the clamp arm; d) inserting the third and fourth washers into the clamping arm; and e) activating the lock of the washer to secure the third and fourth clamp washers in the clamping arm. In the case of a second embodiment of the method, one of the third and fourth clamping pads may be made of a polymeric material such as TEFLON, and the other of the clamping washers may be made of a base material and at least one filler material other than the base material, and the clamp arm is made of metal, such as stainless steel or titanium. The tissue-contact surfaces of the clip pads may be smooth or may have characteristics to capture tissue, such as saw tooth-like structures.

Referring now to Fig. 4, the rotation of the clamping member 60 relative to the blade 79 is affected by a pair of pivot points on the clamping arm 56 connected to the outer tube 72 and the inner tube 76, respectively. The outer tube 72 is fixed on the handle 68 by means of a rotary knob 29. The clamping arm 56 is pivotally connected to the outer tube 72 via respective openings 52a and 52b formed in the clamping arm 56 and 52c and 52d made in the outer tube 72. The locking pin or rivet 57 moves through the openings 52a-dw for attaching the clamping arm 56 to the outer tube 72. In one embodiment, the pin 57 is laser welded to the clamp arm 56 so thatthat the pin 57 is fixed on the clamping arm 56 and rotates relative to the outer skirt 72.

[0048] The inner tube 76 moves along the longitudinal axis of the outer tube 72 and is fixed on the holder 68 by a rotary knob 29. The pivot pins 54a, b (pin 54a is not shown) on the clamping arm 56 slide into the pivot holes 54c, d ( hole 54d is not shown) at the distal end of the inner tube 76. The swivel connection of the clamp arm 56 with the inner and outer tubes 76, 72 increases the end effector 81 strength and minimizes breakdowns due to axial or torsional overload. The embodiment described in the text also increases the efficiency of the end effector 81, providing clamping forces exceeding 6.67 N._AND (provided by actuator 76) and shear force F_T (measured at the midpoint of the optimum tissue treatment zone).

[⁰⁰⁹⁴] ^FT = F- (X²/^X1) Pbwnarns [] _] [0050] In case the force F_AND has a value equal to the preload of the proximal spring 94 (less losses due to friction forces), which in one of the embodiments is 55, 6 N, the force value F_T is about 20 N, as shown in Figure 16c. Fig. 16c graphically shows the values ​​of F_T and F_AND in the function of the trigger movement 34 and the input forces acting on the trigger 34.

[0051] The value of F_T is measured in the connection and transition areas of the clamping arm / blade, where optimal tissue treatment is carried out, as determined by tissue indicia 61a and 61b. Tissues 61 a, b are etched onto or protruding from the clamp arm 56, providing the surgeon with a clear indication of the optimal surface of the tissue being treated. Tissues 61 a, b are located at a distance of 7 mm from each other, more preferably at a distance of 5 mm from each other.

[0052] The rotation of the transmission unit 71 of the ultrasonic surgical instrument 100 can be performed together with the relative rotational movement of the ultrasonic relay 50 relative to the device holder assembly 68. In order to connect the transmission unit 71 to the ultrasonic relay 50 in the form of a ultrasonic transfer connection, the proximal part of the outer casing 72 can be made with corresponding turn key surfaces 46. Plane 46 for inserting a flat wrench allows the torque to be applied using a suitable torque wrench or similar device, allowing the guide 80 to be connected to an ultrasonic relay 50. The ultrasonic relay 50 and the transmission assembly 71 can therefore be rotated as a unit,

The interior of the handle assembly 68 has dimensions adapted to realize such relative movement of the ultrasonic relay 50. The spring 28 is tensioned between the rotary knob 29 and the inner housing surface 65. The spring 28 provides the pressure or force opposing the rotary knob 29, preventing the end effector from rotating accidentally 81.

Referring now to Figs. 2, 5, 6 and 16, the size-limiting mechanism 91 provides first and second compression springs, a distal spring 96 and a proximal spring 94. The distal spring 96 is operably connected to the yoke 33, driven by by means of a trigger 34. Proximal and distal springs 96 are functionally dependent. The distal spring 96 creates a load on the end effector, and the proximal spring 94 maintains a constant load on the end effector. Thanks to such a solution, the load on the end effector is significantly and also weakens more precisely controlled factors that cause overloading of the elements. they protect the distal spring

Washers 97 and 95 prior to compression (Figure 5), thereby preventing the spring 96 from being exceeded and unusable during subsequent clamping operations. A person skilled in the art would appreciate the fact that the use of a double spring force limiting system can be used in other surgical devices using radiation energy (such as radio, microwave and laser devices) encountering clamping forces during operation as well as in mechanical devices such as terminal applicators, grippers and staplers.

[0054] In one embodiment of the embodiment shown, distal spring 96 has a constant value of 17.5 N / mm, preferably over 21.9 N / mm, and most preferably about 23.6 N / mm. The pre-tensioning of the spring 96 is not necessary but may be tensioned by a force of less than 44.5 N, preferably less than 22.2 N, and most preferably a force of about 4.45 N. The proximal spring 94 has a constant value of 4 , 38 N / mm, and preferably more than 8.76 N / mm, and most preferably about 12.3 N / mm. The proximal spring 94 is pre-tensioned with the necessary force to obtain the required shear force indicated in equation 1 above, and this force is a function of the mechanical joint of the clamping arm 56 and losses on the frictional force within the device.

Referring now to Fig. 16a, the curve 82 represents the force of the actuating member 76 and the curve 83 shows the force of the trigger 34 as a function of the rotational trigger angle 34 (on the x-axis, position -18.0 means the clamp arm 56 in the fully open position, and 0.0 is a clamping arm completely closed and in contact with the blade 79) under conditions of lack or minimal tissue load. Point 82a indicates the point where the yoke 33 begins to deflect or compress the distal spring 96, and the force of the actuating member 76 increases while the trigger 34 is further pressed until the force reaches the pre-tensioning force of the proximal spring 94 at the inflection point 82b, and the value of the coefficient the slope of the force curve decreases.

[0056] In Fig. 16b, the curve 84 represents the force of the actuator 76 and the curve 85 represents the force of the trigger 34 as a function of angular rotation of the trigger 34 under conditions of excessive tissue loading when the tissue completely fills the end effector in the open position. Point 84a indicates the point where the yoke 33 begins to deflect or compress the distal spring 96, and the force of the actuator 76 increases while the trigger 34 is pressed until the force reaches the value of the pre-tensioning force of the proximal spring 94 at the point of inflection 84b, at which point the value of the slope coefficient of the force decreases.

[0057] Referring now to Figs. 2 and 5, the surgical instrument 100 also provides a solution to the surgeon that the trigger has already completed a full stroke, and the clamp arm 56 applies the correct force to the tissue. Such a solution is useful during long surgical procedures or tissue cutting operations, when the surgeon's grip can involuntarily and slightly relax, thus reducing pressure on the tissue from the clamping arm 56.

[0058] In the case of one of the methods of implementing the example shown, the pawl spring 110 is mounted in the pawl bracket 112 located in the housing portion 69. The catch tab 114 on the trigger 34 contacts and quickly retracts the pawl spring 110 when the trigger 34 is completely closed or when the actuator 76 reaches the extreme proximal position of the stroke. The ratchet spring 110 is generally flat and made of a flexible plastic that deflects sufficiently when it contacts the tab 114, thus providing an audible and / or palpable signal to the surgeon, indicating a complete closure of the end effector 81. The tab 114 preferably impacts the wand. deflects the latch spring 110 when the trigger 34 is rotated from a fully closed position in the opposite direction, thus providing the surgeon with an audible and / or perceptible signal indication, that the end effector 81 is no longer fully closed. A person skilled in the art would appreciate the fact that the indicator may be perceptible, audible, visual or a combination thereof. It is possible to use various types of indicators, including dome switches, hard blocks, springs mounted on brackets, and any number of mechanical or electrical switches known to those with skill in the field. Various other solutions may be used to provide the surgeon with a feedback signal, including, but not limited to, lights, audible signals and vibrating elements. It is possible to use various types of indicators, including dome switches, hard blocks, springs mounted on brackets, and any number of mechanical or electrical switches known to those with skill in the field. Various other solutions may be used to provide the surgeon with a feedback signal, including, but not limited to, lights, audible signals and vibrating elements. It is possible to use various types of indicators, including dome switches, hard blocks, springs mounted on brackets, and any number of mechanical or electrical switches known to those with skill in the field. Various other solutions may be used to provide the surgeon with a feedback signal, including, but not limited to, lights, audible signals and vibrating elements.

[0059] Referring now to Figs. 1, 2 and 6-8, housing 68 has a proximal end, a distal end, and an empty space 59 extending longitudinally within the housing. The cavity 59 is adapted to accommodate the switch assembly 300 and the relay assembly 50 connected to the housing 68 by means of the switch assembly 300.

[0060] The relay 50 has a first conductive ring 400 and a second conductive ring 410 mounted securely within the relay body 50. In one embodiment of the embodiment shown, the first conductive ring 400 has a ring member seated between the relay 50 and the tube 130. The first conductive ring 400 is preferably formed near or as part of the collar 160 within the cavity 162 and is electrically insulated from the other. electrical components. The first conductive ring 400 is anchored to and extends upwardly from a non-conducting platform or similar element (not shown) formed in the relay body 50. The first conductive ring 400 is electrically connected to the conductor 22 (FIG.

[0061] The second conductive ring 410 of the relay 50 likewise has an annular element between the relay body 150 and the tube 130. The second conductive ring 410 is located between the first conductive ring 400 and the tube 130, and thus the first and second conductive rings 400, 410 are concentric elements . The second conductive ring 410 is likewise electrically isolated from the first conductive ring 400 and from other electrical elements in the relay 50. Similar to the first conductive ring 400, the second conductive ring 410 is preferably fixed to and extends upward from the non-conductive platform. It should be understood that the first and second conductive rings 400, 410 are at a sufficient distance from each other, ensuring their mutual electrical isolation. This can be achieved by using one or more spacers 413 arranged between the first and second conductive rings 400, 410 or between the rings 400, 410 and other elements in the relay 50. The second conductive ring 410 is also electrically connected to the cable 22 (figure 1 ) using one or more electrical wires (not shown) extending along the relay 50 and extending to the second conductive ring 410. The second conductive ring 410 thus serves to partially determine the second electrical path from the cable 22 to the switch mechanism 300. A suitable ultrasonic relay 50 is the relay Model No. HP054 marketed by Ethicon Endo-Surgery, Inc. based in Cincinnati, Ohio, USA.

[0062] In one of the embodiments of the illustrated embodiment, the distal end of the relay 50 is connected by a threaded connection to the proximal end of the transfer rod 80. The distal end of the relay 50 is also connected to the relay assembly 300 to provide the surgeon with finger-actuated control devices 100 .

The switch assembly 300 consists of a button assembly 310, a flexible circuit assembly 330, a switch housing 350, a first guide 360 ​​in the form of a resilient slip ring, and a second guide 370 in the form of a resilient slip ring. The switch housing 350 has a substantially cylindrical shape and is mounted in the holder assembly 68 using suitable mounting brackets on the switch assembly 350 and housing parts 69 and 70. The housing 350 defines the first hollow space 353, the mounting pivot 352, and the second hollow space 351. The hollow space 353 allows the proximal end of the relay 50 to be accommodated therein, the tube 130 passing through the hollow space 351 to connect it to the transfer rod 80.

Referring now in particular to Fig. 8a, the slip rings 360 and 370 are essentially open O-shaped springs slid onto the mounting pin 352. Each slip ring spring has two pressure contacts (361a-bi). 371a-b) in contact with the respective ring conductors 400 and 410 of relay 50. The bias of the springs 360 and 370 provides contact between the contacts 361a-b, 371a-b and conductors 400 and 410. It is evident that the slide ring design provides an electrical contact even when rotating the relay 50 by the surgeon while using the instrument.The posts 364 and 374 of the respective slip rings are electrically contacted with a respective conductor within the elastic circuit 330 to close the electric circuit as shown in FIG.

8c.

The flexible circuit 330 provides an electromechanical connection between the buttons 311 a, b, 312 a, b by a generator 30 via a relay 50. The elastic circuit has four dome switches 332 a, b and 334 a, b mechanically activated by pressing the keys 311 a, b or 312 a, respectively b, a corresponding button assembly 310. Dome switches 332 and 334 are electrical contact switches that, when pressed, provide an electrical signal to the generator 30 as shown in the wiring diagram of Figure 8c. The elastic circuit 330 also has two diodes in the diode package 336, also shown in Fig. 8c. The elastic circuits 330 and 337 in a manner known to those of skill in the art, connected to the slip-ring conductors 360 and 370 through electrical tabs 364 and 374, respectively,

[0066] The elastic circuit 330 is generally wrapped around the switch housing 350 so that the dome switches 334a, bi 332a, b are connected to the respective supporting surfaces 356a, bi 358a, b on the switch housing 350. The bearing surfaces provide for secure embedding of the dome switches in work, in a manner discussed later in the text. The dome switches 334a, b and 332a, b can be fixed permanently on the supporting surfaces 356a, b and 358a, b in any convenient way, e.g. using glue. The elastic circuit is mounted on the switch housing 350 using a matching tab 354 and a snap-in pin 355 on the switch assembly 350, and a corresponding matching hole 338 and a latching hole 339 on the flexible perimeter 330.

[0067] A flexible circuit includes a switch assembly 310 having a corresponding saddle shape corresponding to elastic circuit 330, and substantially wrapped around the switch housing 350. The button assembly 310 has four buttons, distal buttons 312a, and bi proximal buttons 311a, b, having appropriate pressure pins 315a, b and 314a, b. The buttons are connected to brackets 313a, b and 316a, b, ensuring elastic return of buttons after release. It is clear that by pressing buttons 311 and 312, respective pressure pins 314 and 315 are pressed against respective dome switches 334 and 332 to enable the circuit shown in Fig. 8c. Switches 312a and b are connected in parallel, so that the surgeon can operate the buttons using the left hand or right hand. Similarly, switches 311a and b are connected in parallel, so that the surgeon can operate the buttons using the left hand or right hand. When the surgeon presses button 312a or 312b, the generator will respond with energy of a certain potential, such as obtained for the maximum ("max") power setting; when the surgeon presses the button 311a or 311b, the generator will respond with energy of a certain potential, such as obtained for the minimum ("min") power setting, which is a solution consistent with the industry practice of button placement and appropriate power settings. such as obtained for the maximum ("max") power setting; when the surgeon presses the button 311a or 311b, the generator will respond with energy of a certain potential, such as obtained for the minimum ("min") power setting, which is a solution consistent with the industry practice of button placement and appropriate power settings. such as obtained for the maximum ("max") power setting; when the surgeon presses the button 311a or 311b, the generator will respond with energy of a certain potential, such as obtained for the minimum ("min") power setting, which is a solution consistent with the industry practice of button placement and appropriate power settings.

[0068] Alternatively, the keys may be formed in the button housing 350 or in the holder assembly 68 to reduce the number of components and increase the reliability of the entire device. The buttons can be attached by means of small brackets, enabling a reliable mounting of buttons on other elements, ensuring at the same time that the buttons are turned on using a small amount of force.

[0069] Referring now to Figs. 12-15, one embodiment of the embodiment shown makes it possible to arrange the keys 311a, bi 312a, b in a manner that provides an ergonomic grip and operation of the device by the surgeon. The switches may be within the natural range of the surgeon's thumb, irrespective of whether the surgical instrument 100 is gripped by the right or left hand. In the case of the second embodiment of the embodiment shown, the switches are placed on the housing 68 to prevent the device from accidentally turning on the side opposite the thumb when the surgeon presses the trigger 34 or rotates the rotary knob 29. In the third embodiment, the series of embodiments baffles, such as ridges and / or depressions, or "peaks and valleys" they are made in a housing 68. In the case of at least one embodiment, the housing defines a first surface and a series of baffles defines at least one second surface such that the second surface is higher than the surface of the housing. The partition can also define a third surface lower than the housing surface. As can be seen in Figures 1, 2, the switches 312a, b are surrounded by the upper ridge 320 and the lower ridge 324. The ridges 320 and 324 may be discontinuous physical features separated from each other, or the ridges 320 and 324 may be continuous elements without deviating from the scope of the invention. The spines 320 and 324 may further extend through the entire upper housing part 68 as shown in Fig. 1215, or the edges 320 and 324 may be more discontinuous as shown in Figures 1 and 2. This design and position of the switches 312a, b prevent the risk of accidentally pressing the button even when the finger moves over the button due to the fact that the ridges cause the finger to move above the plane of the button. The spines also provide the surgeon with a tactile response that determines the position of the buttons, and whether the button corresponds to enabling the minimum or maximum power of the device. It is evident that the buttons 312a, b are surrounded by ridges 320 and 324, and the buttons 311a, b are above and proximally to the spine 320. Such a tactile response is very important for the surgeon, hence he can carry out a continuous assessment of the place where he is guided treatment, with certainty about which device buttons are actually pressed. In another embodiment of the embodiment shown, switches 312a, b are embedded in recess 322 and further surrounded by ridges 320 and 324. Referring again to Figure 12, the surgeon operates the apparatus 100 with the left hand. The index and middle fingers are set to trigger the trigger 34, and the ring finger and small grip the grip 39. The thumb is positioned in a convenient place from which moving up will activate button 312a or 311a. The ridges 320 and 324 extend along the upper housing part 69. and the ring finger and the small catch grip the handle 39. The thumb is positioned in a comfortable place, from which moving up will activate button 312a or 311a. The ridges 320 and 324 extend along the upper housing part 69. and the ring finger and the small catch grip the handle 39. The thumb is positioned in a comfortable place, from which moving up will activate button 312a or 311a. The ridges 320 and 324 extend along the upper housing part 69.

[0071] Fig. 13 shows a side of the apparatus 100 opposite to the side shown in Fig. 12, and buttons 311b and 312b. In this case, the surgeon's forefinger finger has access to the rotary knob 29, which rotates the end effector 81. As can be seen, the button 312b is accidentally switched on with the index finger. The ridge 324, however, raises the index finger above the plane of the button 312b, which reduces the risk of accidentally pressing the button.

[0072] In Figure 14, the surgeon pressed the button 34 to close the arm 56 on the blade 79, and the left thumb gained easy access to the button 312b switching on the maximum power of the device.

[0073] In Fig. 15, the surgeon pressed the button 34 to close the arm 56 on the blade 79, and the left thumb gained easy access to the button 311b activating the minimum power of the device.

A base element 45 is connected to a finger-contacting element 43 having a generally T-shape which, together with the base element 45, defines two openings typically having a U-shape, a groove for index finger 42 and a groove for a middle finger 44. Extreme, distal the T-shaped finger joint surface 43 defines a launch surface 41 that also allows fingers 382 and 384 to be placed thereon. The grooves 42 and 44 have sizes adapted to accommodate fingers of different sizes, commonly variable, which is obvious in view of the different sex and size of surgeons' hands. In the case of the first embodiment of the illustrated embodiment, the sizes of the grooves 42 and 44 are based on the results of personal data regarding the size of the fingers, for people from the fifth centile of women to the ninety-fifth centile of men. In the case of a second embodiment of the illustrated embodiment, the grooves 42 and 44 narrow, the size of each groove opening being greater than the base dimensions of each groove 42 and 44. Such a configuration advantageously allows close fitting of fingers of different sizes to each of the grooves, and minimizing clearance between the finger and the walls of the grooves.

[0075] Referring now to Figs. 10 and 11, the clamp arm 56 is completely open relative to the blade 79 when the trigger 34 is in the extreme distal position (Figure 10). The fingers 382 and 384 can be placed in the respective grooves 42 and 44, or alternatively, on the surface 41 to press the trigger 34 due to the movement of the fingers on the arc described by the arrow 47. When the trigger reaches the extreme proximal position of the stroke (when the latch tab 114 is in contact with the pawl spring 110), the clamp arm 56 is in a fully closed position with respect to the blade 79 (figure 11). In order to reverse the movement of the trigger along the stroke path 47, the fingers 382 and 384 contact the grooves 42 and 44 and press the trigger 34 in the distal direction to open the end effector. The clamp arm 56 is not directed to the open position,

[0076] Referring now to Fig. 18, the elements indicated by reference numerals as illustrated in Fig. 2 perform a function analogous to the function discussed above. Particular attention is directed to the alternative handle assembly 168 that allows the end effector to be activated 81. The handle assembly 168 has two swivel parts 420 and 422 of the handle, connected to the right guard 169 and the left guard.

170.

[0077] The right sheath 169 is adapted to snap into the left sheath 170 through a series of inwardly directed pins formed on the left side of the sheath 170 to form a housing 171. When the left sheath 170 is connected to the right guard 169 between the covers, there is an empty space in which to place different elements forming the handle assembly 168 in a manner discussed later in the text. Also formed are gaps 172 and 174 for receiving a thumb ring or part 420 of the handle and finger ring or handle part 422 that are outside the left and right guards, allowing the cords in the left and right guards to move. At the proximal end of the shields, a gap 173 is formed, in which a relay 50 is placed (see Figure 8b).

[0078] The handle assembly 168 has a U-shaped shackle 424 slidable inside the housings 169 and 170 through the slots 421a and 421b and using the cotter 423a and 423b, respectively. The distal end of the handle 420 is connected to the right guard 169 and the yoke through the opening 402 and the pin 423a, and the proximal end of the handle 420 connects to the yoke 424 through the link 428 connected to the hole 404 using a tab 426, and with the hole 410 using a pin 430. The distal end of the handle 422 is connected to the right guard 169 through the opening 406 and the pin 423b, and the proximal end of the handle 422 connects to the yoke 424 through the link 432 connected to the hole 408 using a tab 434, and with the hole 412 using a tab 430. In practice , while pushing the handles 420 and 4222 away from the housing 171 (for example,

[0079] In one of the embodiments of the embodiment shown, the pawl spring 482 is mounted in a housing portion 171. The catch cam 480 rotates on the yoke 168 and engages and returns with the latch spring 482 latched when the handles 420 and 422 are in place. in a completely closed position. The pawl spring 482 is generally made of flexible plastic sufficiently flexing when in contact with the cam 480, thus providing an audible signal to the surgeon indicating a complete closure of the end effector 81. The cam 480 preferably impacts and deflects the ratchet spring 482 at the moment. rotating the handles 420 and 422 from a fully closed position in the opposite direction, thus providing the surgeon with an audible signal,

[0080] Referring now to Fig. 24, it shows a second embodiment of the illustrated embodiment having a pistol rod 433 connected to the handle 422 and activating a dome switch 435 coated with a silicone rubber provided on the housing assembly 171. After the handle 422 has been fully closed, the post 433 is pressed against the silicone which in turn transfers the force exerted on it to the dome switch 435, which allows the switch to provide audible and tactile feedback to the surgeon. In one embodiment, the post 433 is a cylinder having a diameter of 4.32 mm, in the middle of which a 1.78 mm socket is located. The preferred hardness of a silicone rubber is²⁰ ws^kand^{li Sh}ore A.

[0081] Referring now to Fig. 23, a connector 450, slip rings 452, 454, a flexible circuit 456 and a pivot switch 462 are also arranged inside the housing 171. The pivot switch 462 is pivotally connected to the right cover 169 through the slit 469, and switches 462 and 464 are located outside the housing 171 in a place accessible to the surgeon. The switches 462 and 464 are mechanically connected by a swivel arm 466 having a pivot post 468 connected to the slit 469. In this configuration, the keys 462 and 464 can not be pressed simultaneously, this would lead to an error message being sent by the generator 30. Flexible circuit 456 provides an electromechanical connection between the switches 464 and 466 and the generator 30 via a relay 50 (see Fig. 8b). With reference to Fig. 21,

[0083] Referring now in particular to Figures 19 and 20a-b, the sliding guides 452 and 454 are generally O-shaped open springs, slid onto the mounting surfaces 453 and 455 of the connector 450, respectively. Each spring in the form of a slip ring, it has two pressure contacts (510a-b and 522a-b) in contact with the respective ring conductors 400 and 410 of the holder 50. The tension of the slip rings 452 and 454 provides contact between the contacts 510a-b, 522a-b and 400 and 410 It is evident that the slide ring design provides an electrical contact even when the surgeon 50 rotates the handle while using the device.Posts 512 and 524 of the respective slip rings are electrically contacted with a corresponding conductor within the elastic circuit 456 to close the electric circuit as shown in Figure 22.

The plastic cladding 550 also provides a more adhesive surface between the grips and thumb of the surgeon and opposes a smooth, plastic connection surface known in the art. Such a solution is particularly advantageous from the point of view of accepting fingers of various sizes of male and female surgeons, yet providing a comfortable and well-gripping surface. The plastic cladding 550 may be smooth or may have contours formed on the surface of cladding 550, such as the ribs depicted in FIGS. 23 and 24. Other contours may be bumps and peaks and valleys. Various other shapes and combinations are within the scope of the invention, which would be apparent to those skilled in the art.

[0086] In one embodiment of the present invention, the soft-touch cladding 550 has a hardness measured by a durometer of about 35 Shore A to about 75 Shore A, and more specifically from about 50 on the Shore A scale to about 60 on a scale

Shore A. Such appropriate materials can be purchased at LNP company from^ande^dwith^IBA in ^Exton, PA (nr ^kand^tand^labout^gthat^{y 8211-55} B¹⁰⁰ Gyo-8²⁶-³) and at Advanced Elastomer Systems based in Akron, ^ABOUTH (nr ^kand^tand^labout^gthat^s 8^211-55B100)^{, US}AND.

[0087] The soft-touch material can also be useful and help the surgeon to identify a particular characteristic of the device, while the surgeon is at the same time focused on the surgery being performed. For example, a "soft to the touch" cladding with one shape can be placed on the button for the "maximum" value, and a "soft-touch cladding" with a second shape can be placed on the "min" button, so that the surgeon can it is easy to determine the presence of any of the buttons without having to distract from the place of the procedure. The "soft-touch" cladding can also be placed on the knobs 29 and 129 with contours allowing identification of the different positions of the end effector 81 when rotated.

[0088] Although the present invention has been described based on the description of several embodiments, the applicant's intention is not to limit the scope of the claims to such specific characteristics. People with skills in the field will be aware of possible, numerous variants, changes and substitutions that do not deviate from the scope of the claims.

26663 / PE / 16 EP 1 802 245