Electric operating module for operating an endoscopic instrument

Abstract

The present invention discloses an electric actuation module for actuating an endoscopic instrument, the electric actuation module comprising a mounting plate attachable to an ulnar-palmar grasping zone of a handgrip of an endoscope, the mounting plate having an ulnar-palmar bearing surface extending to a heel that extends in a direction forming an angle of 90°±25° with respect to a direction perpendicular to the plane of the ulnar-palmar bearing surface, the heel including an electromechanical sensor that sends a control signal for controlling the movement of the endoscopic instrument.

Description

Detailed Description of the Invention

[0001] [Field of the Invention] The present invention relates to the field of flexible (soft) endoscopes. More particularly, the present invention relates to a system for controlling the translational movement of a flexible endoscope tool within an outgoing flexible endoscope. The flexible endoscope comprises a handgrip having control buttons. By means of the control buttons, the flexible end of the endoscope rod can be moved in various directions. The user can hold the handgrip with the left hand and guide the insertion area of the flexible rod with the right hand while operating various adjustment buttons with the fingers of the left hand.

[0002] Initially, flexible endoscopes were mainly used for diagnosis, particularly for in vivo imaging of cavities. However, the use of flexible endoscopes in therapy has been evolving for decades and additional microsurgical instruments are implemented. The additional microsurgical instruments are inserted through a working channel that is present on the endoscope or attached outside the endoscope. These accessory instruments generally have at least one mechanism for actuating and / or moving the active (moving) tip to position it.

[0003] During the use of a flexible endoscope in therapy, the user generally needs to actuate and control the insertion, i.e., the forward and backward movement, of the distal instrument with the right hand. As the movement is transmitted along the endoscope rod, the insertion area of the endoscope rod is no longer guided by the user's hand, the position of the camera changes, and as a result, the target disappears from the field of view.

[0004] The combination of these events often hinders the continuity of the workflow and as a result, the treatment time is often lengthened. To solve this problem, a second operator / assistant is often required to hold the endoscope rod while the main operator uses the unused hand to manually control the flexible tool on the flexible endoscope handgrip.

[0005] This requires a learning cycle to achieve good communication and cooperation between the operator and the assistant without completely avoiding work interruptions. This is because it is often difficult to specify the angles, positions, timings, and procedures of the desired movements. Therefore, various automatic tool control devices for flexible endoscopes have been proposed to overcome these difficulties.

[0006] [Prior Art] To facilitate the control of the movement of the instrument without using an assistant, a solution has been proposed in the prior art where the movement is motorized and the handgrip has a motion control unit.

[0007] In the prior art, international patent application WO2015 / 029041 is known. The application describes a palm interface engageable with the palm of the hand, a restraint elastically deformable to apply a restraint force to the back of the hand, and a finger interface engageable with one or more fingers of the hand.

[0008] The solution proposed in the above document is a) a first interface mounted on a pivotal support (shaft support) attached to the housing of the control unit and engageable with the palm of the hand; b) a restraint having an element elastically deformable to apply a restraint force to the back of the hand when the palm of the hand engages with the first interface, pivotally attached to the first interface; and c) a second interface pivotally attached to the first interface and engageable with one or more fingers of the hand, comprising.

[0009] Also, European patent EP2106735 is known. The patent describes an endoscope configured to be carried by one hand, and the endoscope · An insertion portion that extends in the major axis direction, includes a tip portion and a proximal end portion, and is configured to be inserted into the body; and, · An operation portion that is coaxially connected to the proximal end portion of the insertion portion, extends in the major axis direction, and is configured to be held and operated by an operator, comprising: · The insertion portion includes a bent portion configured to bend.

[0010] The operation portion is as follows: · A first gripping portion that extends in the major axis direction and is configured to be gripped by an operator; · A bent operation portion main body that is disposed on the proximal end portion side with respect to the first gripping portion in the major axis direction and includes a proximal end portion; · Extending in the width direction and configured to move along the major axis direction by rotation of a support portion, and at least one of the operator's thumb and fingers other than the thumb can be disposed on an operating finger placement portion; and, · A wireless unit that is connected to the proximal end portion of the bent operation portion main body and is configured to perform wireless communication. comprising:

[0011] [Disadvantages of the Prior Art] The first disadvantage of the prior art solutions relates to the ergonomics of the control members and their configurations. Such ergonomics do not conform to the handgrip of a standard flexible endoscope. Therefore, they involve a significant learning time for clinicians. In some solutions, the user has to operate their knobs by combining the thumb with the middle finger or the ring finger. This prevents the simultaneous actuation of the suction valve or the cleaning valve.

[0012] The second disadvantage lies in the fact that these solutions require a complete redesign of the handgrip and the replacement of existing endoscopes with new ones.

[0013] International Patent Application WO2017025969 describes a control unit attachable to a flexible endoscope having a deformable rod via two rotary knobs. The control unit includes a user interface including a first interface attached to a swivel support attached to the housing of the control unit. The first interface is engageable with the palm of the hand. The control unit further includes a drive unit operable via the user interface. The drive unit includes a first drive mechanism for engaging the two rotary knobs. Thereby, the user can control the bend of the endoscope shaft via the first interface.

[0014] [Solutions provided by the present invention] In two embodiments, the present invention aims to avoid the drawbacks of the prior art. The two embodiments are in the form of a separate module forming an accessory that enables the upgrade of a commercially available endoscope handgrip, and in the form of an endoscope handgrip that inherently has such a control module. In both embodiments, the present invention is composed of a mounting plate that can be attached to the ulna-palmar gripping zone of the endoscope handgrip. The mounting plate has an ulna-palmar support surface that extends to a heel that forms an angle of 90° ± 25° with respect to a direction perpendicular to the plane of the ulna-palmar support surface. The heel is provided with an electromechanical sensor that sends a control signal for controlling the movement of the endoscope instrument.

[0015] Within the scope of the gist of the present application, the term "mounting plate" means a thin blade (flat part) with a thickness of less than 2 millimeters that is flat or deformed so that the rear surface can conform to the surface of the ulna-palmar gripping zone of the endoscope handgrip.

[0016] The term "ulnar - palmar gripping zone of the endoscope handgrip" is understood to mean the semi - tubular side surface of the handgrip that extends between two laterally - facing front ends of the handgrip. The palm surrounds the handgrip which is of a generally tubular shape. The thumb extends on one side and the fingers (index finger, middle finger, ring finger, and optionally the little finger) fit on the other side of the ulnar - palmar gripping zone.

[0017] More particularly, the present invention relates to an electric operating module for an endoscope instrument, the electric operating module for the endoscope instrument being composed of a mounting plate that can be attached to the ulnar - palmar gripping zone of the endoscope handgrip, the mounting plate having an ulnar - palmar supporting surface that extends to a heel that forms an angle of 90° ± 25° with respect to a direction perpendicular to the plane of the ulnar - palmar supporting surface, the heel being provided with an electromechanical sensor that sends a control signal for controlling the movement of the endoscope instrument.

[0018] Advantageously, the central ulnar - palmar gripping surface extends to the opposite side up to an electric drive block having an electric mechanism for a filamentary element for connection to the instrument, the lower end of which opens into the flexible rod so as to ensure connection with the distal end of the instrument, and the mounting plate further has means for connection with the handgrip of the flexible endoscope.

[0019] Advantageously, the means for connection with the handgrip of the flexible endoscope consists of an end - piece that can be inserted into the working channel of the endoscope rod.

[0020] According to a preferred variant, the mounting plate comprises an electric drive block provided with a motor arranged below the end - piece and having an inlet for the working channel of the endoscope to be joined.

[0021] Advantageously, the heel is formed by a protrusion less than 3 millimeters thick, and the protrusion has a sensor at its end, and the operating surface of the sensor is defined by a generatrix forming an angle of 90° ± 20° with the longitudinal axis of the handgrip.

[0022] According to a particular embodiment, the drive block comprises an electric mechanism for a filamentary element for connection to the instrument, and its lower end opens into the flexible rod of the endoscope so that connection with the distal instrument is provided.

[0023] According to a variant, the drive unit has a side operating button for controlling an emergency stop of the movement of the instrument.

[0024] The present invention also relates to a flexible endoscope comprising a handgrip having a suction and washing control button located above the ulnar-palmar gripping zone of the user's finger, the handgrip extending to a flexible rod having a working channel for passage of the instrument, the movement of which is controlled by an electrical interface. The flexible endoscope is characterized in that the interface has an ulnar-palmar support surface which extends to a heel forming an angle of 90° ± 25° with respect to a direction perpendicular to the plane of the ulnar-palmar support surface, the heel comprising an electromechanical sensor for sending a control signal for controlling the movement of the endoscope instrument.

[0025] Advantageously, the heel is formed by a protrusion less than 3 millimeters thick, and the protrusion has a sensor at its end, and the operating surface of the sensor is defined by a generatrix forming an angle of 90° ± 20° with the longitudinal axis of the handgrip.

[0026] Advantageously, the sensor is a rotary sensor actuated by a wheel, and the axis of the wheel forms an angle of 0° to ±70° with respect to a longitudinal axis parallel to the longitudinal axis of the handgrip.

[0027] Advantageously, the attachment plate further comprises a drive block with an electric mechanism for a filamentary element for connection to the instrument at the lower part of the ulna-palmar grip zone, the lower end of which opens into the flexible rod of the endoscope so that connection to the distal instrument is provided.

[0028] Preferably, the drive block forms a protrusion with respect to the lower surface of the ulna-palmar grip zone, the protrusion being on the opposite side to the ulna-palmar grip zone where the extending part constituting the actuation control part is located.

[0029] Advantageously, the control interface further comprises a length selector for moving the instrument by a predetermined length.

[0030] Preferably, the control interface further comprises means for coupling the distal part of the instrument.

[0031] According to one variant, the endoscope comprises an electro-operating module in the form of a removable sub-assembly of the handgrip that combines the interface and the drive block.

[0032] According to another variant, the sensor has an interaction surface of less than 50 mm facing the ulna-palmar grip zone 2 and less.

[0033] [Detailed Description of Non-Limiting Embodiments] The present invention will be described below by way of non-limiting examples with reference to the accompanying drawings.

[0034] [Figure 1] Figure 1 is an exploded partial perspective view showing an endoscope handgrip according to the prior art; [Figure 2] Figure 2 is a 3 / 4 front view of an endoscope handgrip according to the present invention; [Figure 3] Figure 3 shows a 3 / 4 front view of an endoscope handgrip according to the present invention; [Figure 4] Figure 4 is a 3 / 4 front view of the second endoscopic handgrip deformation mode according to the present invention; [Figure 5] Figure 5 shows a 3 / 4 front view of the first deformation mode of the control module according to the present invention; [Figure 6] Figure 6 shows a 3 / 4 front view of the second deformation mode of the control module according to the present invention; [Figure 7] Figure 7 is a 3 / 4 front view of the third endoscopic handgrip deformation mode according to the present invention; [Figure 8] Figure 8 is a 3 / 4 front view of the third endoscopic handgrip deformation mode according to the present invention; [Figure 9] Figure 9 is a 3 / 4 front view of the second deformation mode of the module according to the present invention; [Figure 10] Figure 10 is a diagram of the internal mechanism of this second deformation mode of the module according to the present invention; [Figure 11] Figure 11 is a longitudinal sectional view of this second deformation mode of the module according to the present invention; [Figure 12] Figure 12 is a bottom view of this second deformation mode of the module according to the present invention; [Figure 13] Figure 13 is a perspective view of the end piece connected to the working channel of the endoscope; [Figure 14] Figure 14 is a perspective view of the first configuration of the mounting plate according to the present invention; [Figure 15] Figure 15 is a perspective view of the second configuration of the mounting plate according to the present invention; [Figure 16] Figure 16 is a perspective view of the third configuration of the mounting plate according to the present invention; [Figure 17] Figure 17 is a perspective view of the fourth configuration of the mounting plate according to the present invention; [Figure 18] Figure 18 is a perspective view of the fifth configuration of the mounting plate according to the present invention; [Figure 19] Figure 19 is a perspective view of the sixth configuration of the mounting plate according to the present invention.

[0035] [General context of the present invention: "Standard" endoscopic handgrip according to the prior art] Figure 1 shows an example of a known endoscope. This endoscope includes a handgrip (1). Extending from this handgrip is a flexible tube (2) having at one end a tip or operating end (3) that is introduced into the cavity to be explored. The orientation of the tip or operating end (3) can be controlled by a bendable sleeve (4). This sleeve is controlled by a wire that is pulled in a controlled state in accordance with the manual operation of knobs or buttons (5, 6, 7) provided on the handgrip (1) of the endoscope. By this lever control portion, a doctor can control all functions of the endoscope. The bending (spatial orientation) levers (5, 6, 7) direct the bending cable and control the bent portion at the tip of the insertion tube, enabling two-dimensional orientation. A locking mechanism (brake) can fix the bendable portion at a desired position.

[0036] Light is transmitted by an optical fiber (8) having a base end portion (9) coupled to an optical connector. The connection block (11) further includes an air inlet (10).

[0037] The air connector (12) is intended to be connected to a vacuum pump or a reversible air pump so as to control blowing or suction at the tip portion (3). Further, the technical block (11) includes an electrical connector (13), a connection support (14) for a safety cord, and a water supply portion (15).

[0038] The handgrip (1) is connected to the tube (2) by a sheath (16) that extends to the sleeve (17). The handgrip has a working channel opening (18) to which a disposable valve (19) is attached.

[0039] The handgrip comprises a piston (20) for controlling the cleaning channel and a piston (30) for controlling suction or blowing through two tubes extending between the handgrip (1) and the tip (3). One transports air and water to the tip, and the other performs biopsy or suction. The application of suction is regulated by a piston (30) provided on the handgrip. This piston is joined to the adjacent duct by a welded joint. The pistons (20, 30) are coupled to the body of the handgrip by an annular base (32).

[0040] The piston (30) connects the suction channel to the working channel within the insertion tube. By pressing the piston button (31), suction of the working channel can be performed. The air / water piston (20) is similar to the piston and the suction piston (30), except that a piston with a two-way button is used in the dual-channel device. This dual-channel device can transport air or water to the lens at the tip and perform cleaning or air supply to improve vision. The two pistons (20, 30) can be removed for replacement during use or for cleaning.

[0041] [Detailed Description of the Control Interface] The handgrip according to the present invention shown after FIG. 2 is different from a "standard" handgrip by virtue of an additional function of electric control of an endoscope instrument that is introduced into the endoscope tube (2) to perform procedures at the tip, such as, for example, specimen, electrocoagulation, suturing, incision, etc. This electric control is intended to move the endoscope instrument forward or backward within the endoscope tube (2) without the operator having to push or pull the endoscope instrument. This electric control does not relate to possible operations at the end of the endoscope instrument, for example, the opening and closing of a clamp provided at the tip of the endoscope instrument.

[0042] The aim is to (i) enable an operator holding the handgrip (1) with one hand to continue applying normal control, and (ii) enable the movement of the endoscopic instrument to the working position to be controlled without manual intervention and without the assistance of a second operator (who is generally required to guide the endoscopic tube (2) in the introduction area) and without the need for complex coordination. The movement of the endoscopic instrument means that it moves back and forth within the endoscopic tube along a trajectory corresponding to the center of the tube so that the active (moving) part of the endoscopic instrument can reach the zone to be intervened. This is a movement with respect to the endoscopic tube (2).

[0043] To achieve this, the handgrip (1) is provided with a control interface (100). The control interface (100) is arranged on the handgrip (2) in the ulna - palm gripping zone (101). The ulna - palm gripping zone (101) is located directly below the piston (20) for controlling the cleaning channel and the piston (30) for controlling suction or blowing. This zone (101) is substantially flat so as to support the palmar parts (pads) of at least two or three fingers among the index finger, middle finger, ring finger and little finger.

[0044] The modules shown in FIGS. 2 and 3 are composed of a thin mounting plate (110) about 1 mm thick having a central ulna - palm support part (111). The central ulna - palm support part (111) is superimposed on the ulna - palm gripping zone (101) of the handgrip (2) and extends across the side surface of the handgrip. This central part (111) extends to one side up to the extension part (112). The extension part (112) extends in a plane (113) that is substantially transverse. Within the scope of the present application, the "substantially transverse plane" means a surface that extends in a direction of +45° to -45° with respect to the longitudinal axis (200) of the handgrip (2).

[0045] The width of this extension (112) decreases from an initial width corresponding to the width of the central zone (111) to a smaller width at the end that supports the sensor (114) with the operating surface. In the above embodiment, the sensor is a rotary electric machine sensor (114) having an operating surface formed by a toothed wheel in the form of a spherical zone. Therefore, the sensor can be actuated by the palmar part (pad) of a finger (for example, the middle finger or the ring finger) while keeping the index finger available for other normal hand grip commands.

[0046] The other end of the mounting plate (100) is formed by an electric block (120). The longitudinal axis (122) of the electric block (120) is inclined at an angle of ±30° (up and down inclination) to 90° (orientation perpendicular to the longitudinal axis (200) of the hand grip (2)) with respect to the longitudinal axis (200) of the hand grip (2).

[0047] This electric block (120) has central channel openings on both sides of the block (120) through a port (121) for the passage of the translation element of the endoscope instrument. This ensures the movement of the translation element within the endoscope tube (1) and the positioning at the tip of the translation element for the treatment by the endoscope instrument. For this purpose, the block (120) comprises an electric motor or an electromagnetic actuator, and the electric motor or the electromagnetic actuator is controlled by the sensor (114) via an electronic control circuit. This is powered by a rechargeable electric battery (123) engaged in a side connector. On the opposite wall, the block (120) has an emergency stop button (124).

[0048] In the embodiment shown in FIG. 2, the extension (112) is curved upward at its end (116), and the end (116) supports the sensor (114). Further, the mounting plate is provided with a collar (117) for attachment around a standard hand grip (2).

[0049] In the modified form shown in FIG. 3, the emergency stop button (124) is arranged on the front surface of the electric unit (120). The mounting plate (110) has a laterally extending extension (111), and one end (116) is angled upward so as to support a sensor (114) operable by a hemispherical button.

[0050] [Embodiment in the form of an accessory module] The interface may be incorporated within the handgrip (2) or may be manufactured in the form of an accessory attachable onto the existing handgrip (2). FIGS. 5 and 6 show diagrams of such an accessory having the same technical characteristics as those described above.

[0051] The electric block (120) extends laterally up to an adapter for receiving a peripheral part (peripheral edge part) of an endoscopic instrument such as an automatic puncture device (140) as shown in FIG. 7, or a mechanism (150) for controlling forceps or a biopsy needle as shown in FIG. 8.

[0052] This adapter is constituted by an articulated arm (130) provided with an accessory support (131) or by a mechanical connector (135).

[0053] [Alternative embodiment of the accessory module] FIGS. 9 and 10 show alternative embodiments of the autonomous module constituting an accessory intended to be provided on an existing endoscopic handgrip. The above-described technical characteristics are present within this modified form.

[0054] The electric block (120) incorporates a mechanism that drives the filamentary element (160) by a drive roller (180) that contacts the surface of the filamentary element (160), and ensures good adhesion by a pressure roller (181) that contacts a position on the opposite side in the diameter direction. This pressure roller (181) rotates freely around a shaft supported by a movable carriage (182). The movable carriage (182) is pushed back in the direction of the drive roller (180) by a spring (183) having a direction perpendicular to the introduction axis of the filamentary element (160). This is powered by an electric wire (170) protected by a sleeve (171).

[0055] The drive roller (180) is operated by a motor (190) via a bevel gear (185). This motor (180) is controlled via a user control unit (114).

[0056] The motor (190) is arranged substantially longitudinally with respect to the scroll axis of the filamentary element (160) and has an angle of 0° to ±30° with respect to this axis so as to optimize the space requirements and weight distribution.

[0057] The motor (190) is arranged below the interface (195) within the electric block (120) and is positioned at the entrance of the working channel of the endoscope. This is to improve the balance adjustment of the hand grip and to prevent the center of gravity of the hand grip equipped with this module from becoming high.

[0058] The shaft (186) is guided by two arcuate slots (188, 189) formed on a frame (187) fixed to the operating button (124).

[0059] At the middle position of the operating button (124), the movement of the filamentary element (160) is ensured by the drive roller (180). The filamentary element (160) is pressed against the drive roller (180) by a controlled force by a free roller (181).

[0060] When the actuating button (124) is pushed in the scroll axis direction of the filamentary element (160), the pressing of the drive roller (180) against the free roller (181) and the separation of the gear (185) of the angular lever occur in the direction of the handgrip when the module is mounted on the handgrip. Thereby, the scrolling of the filamentary element (160) is obstructed.

[0061] Conversely, when the actuating button (124) is moved in the opposite direction by acting on the curved portion of the actuating button (124) with a finger sliding between the handgrip and the inner surface of the actuating button (124), the drive roller (180) moves away from the free roller (181), and as a result, the filamentary element (160) is released and can be moved manually.

[0062] The operation of this actuating button (124) is very intuitive. It controls the immediate opening and closing of the tool engagement mechanism: - Immediate engagement / disengagement of the tool moved by the filamentary element (160); - Safety by immediate stop regarding the forward / backward movement of the tool moved by the filamentary element (160); - Immediate switching between manual operation and automatic operation. By manually operating the tool, it is possible to return to the normal usage method of the endoscope without the need to remove the electric module.

[0063] [Attachment of the instrument to the working channel of the endoscope (Figs. 11 - 13)] The attachment of the module onto the handgrip does not require attachment elements such as a collar or clip, and is achieved by the frustoconical part shown in Fig. 13. This frustoconical part has a flange (270) that ensures the seal between the working channel and the electric module. The flange (270) extends to the tapered end piece (tip) (271). By introducing the longitudinal end piece (271) that extends the tip of the electric block (120) into the working channel of a "standard" endoscope, both the guiding of the filamentary element (160) and the wedging (engagement) of the module with respect to the endoscope handgrip are ensured. The generally tubular ring (271) or tapered ring (271) has a seal (272) that seals the sheath (170) with respect to the endoscope guide. This seal (272) has beads that engage by deformation and wedge (engage) around the end of the working channel (the end of the working channel also has beads).

[0064] The frustoconical end piece (271) has, at its proximal end, a disk extension (270). The disk extension (270) engages within a complementary receiving zone provided on the front face of the electric unit (120). The proximal end of the end piece (271) has a circular space in which the seal (195) engages. This solution makes it possible to physically separate the working channel from the guide (1), the motor, and the drive mechanism that constitutes the upper part of the electric block (120). One or more fluid seals seal the passage of the fluid within the rod (1).

[0065] [Application] The present invention has multiple applications. The multiple applications relate in particular to endoscopic ultrasound-guided sampling (EUS-FNA) with a thin needle in cytological and histological research. Endoscopic ultrasound (EUS) has become an essential protocol for determining the stage of cancer in the digestive system, especially when combined with fine needle aspiration (FNA) or fine needle biopsy (FNB) of body tissue. FNA biopsy is performed using a dedicated needle called an FNA needle. In this procedure, the body wall where the biopsy site is located behind the body wall is brought into contact with the EUS imaging device, and then the FNA needle is advanced through the working channel of the EUS endoscope. Through the body wall, the needle is advanced to the site to be biopsied (usually a suspected lesion), and a negative pressure is applied to the inner end of the needle to collect tissue specimens. Then, the needle is removed from the EUS target area (field), and the tissue specimen is collected and analyzed.

[0066] Commercially available FNA needles are very similar to each other: they are intended to be engaged via a standard luer lock at the proximal end of the working channel (1) and include a hollow needle housed within a sheath. The handle at the proximal end of the FNA needle comprises: - A sheath adjuster used to bring the end of the sheath into contact with the body wall to be penetrated (with the needle not exposed). Once the correct sheath position is achieved, the sheath adjuster can be fixed to the handgrip body;

[0067] - A needle slider for sliding and exposing the needle beyond the tip of the sheath to reach the biopsy site; - A safety ring for restricting the longitudinal movement of the needle slider, which can be attached to the body of the handgrip. As a result, the user can easily perform multiple needle insertions;

[0068] - A port at the proximal end of the handle for applying negative pressure to the hollow inner bore of the needle.

[0069] In FNA biopsy, the physician usually needs to manually pass the biopsy needle back and forth multiple times at various locations within the target lesion. The operation of passing the biopsy needle is not standardized, and the penetration depth and passing speed are controlled by the physician. Generally, if the passing distance is longer, more specimens (samples) can generally be obtained than when the passing distance is shorter, and if the passing speed is slower, more specimens can generally be obtained than when the passing speed is faster. Non-standardized sampling may result in yields that are less than optimal or biopsy sampling that lacks reproducibility. Also, conventional methods are inferior in estimating specimen yields, which can lead to undersampling and diagnostic failures. This can waste time, delay the treatment of patients, and also involve additional medical costs. Such additional medical costs can be avoided by a more standardized sampling method. Similar technical problems are mentioned in Patent DE10128336, and a method has been proposed. This method of collecting cell specimens by fine needle aspiration (FNA) biopsy involves introducing the fine needle of a sampling device into the tissue. The fine needle is exposed to a vacuum and is set to move relative to the tissue. Next, the vacuum is released and the fine needle is withdrawn from the tissue.

[0070] The present invention provides an apparatus having a tool control interface for improving the control of biopsy needle sampling, as well as a standardization of tissue sampling that enables better reproducibility, planning, and estimation of tissue specimens.

[0071] In a prior art handgrip, for the operation of the needle slider, the endoscopist needs to keep the right hand on the axis of the endoscopic field of view. Therefore, the control of the endoscope is lost and the accuracy decreases. Since reaching various locations within the lesion is extremely important for the diagnostic yield, this is a significant limitation. Therefore, a system that allows the user to operate the FNA needle while keeping one hand on the handgrip and the other hand on the rod of the endoscope is desirable.

[0072] The control interface according to the present invention can advantageously be used for a user to control an FNA needle while keeping the right hand on the rod of the endoscope. By operating the control interface, the movement of the shaft and the needle can be controlled.

[0073] In a preferred embodiment, the insertion of the needle is controlled by the right hand using the control interface, and by one-dimensional drive control, the needle can be operated at a low speed and accurately. Once the needle is inserted to the desired depth, the second Boolean sampling control unit (on / off) can be used to repeat the movement: when the sampling control unit is pressed once, the needle is retracted and re-inserted at the same distance. With this feature, the user can perform multiple passes at a similar depth while changing the position of the scope (ventilation technique) and reach multiple sites within the lesion. And the drive controller can be used to withdraw the needle and remove the needle from the endoscope.

[0074] According to a variant form, the control interface (100) further comprises a length selector by which the user can directly determine the penetration depth of the needle. When the user presses the sampling control unit, the needle is inserted to the depth set by the length selector and returned to the default position.

[0075] In one embodiment, the control interface (100) is used together with an FNA needle integrated with at least one linear actuator adapted to translate the needle. The actuator is connected to the control interface physically or wirelessly. Also, the FNA needle is connected to a power source either through a physical connection with the control interface or by being integrated with a battery.

[0076] In another embodiment, the control interface is attached to an available FNA needle and connected to an "EUS device" adapted to connect to the control interface.

[0077] [Overview of Application to "Biopsy"] 1) The endoscope according to the present invention, or a standard endoscope to which the module according to the present invention is added, comprises two parts intended for the operation of the endoscope instrument. That is: a user control interface and a drive unit.

[0078] 2) The user control interface is mounted on the handgrip (2) of the endoscope, directly below the suction and washing buttons (20, 30). The user control unit (114) comprises a first control button for applying commands for relatively slow movement and, optionally, a sampling button. The sampling button continuously advances and retracts the biopsy needle during a certain number of passes at a predetermined length set by the length selector.

[0079] 3) Before attaching the drive unit to the site (sight), the needle safety ring should ideally be tightened firmly up to the maximum length. This allows the needle to move the maximum distance and bring the central weight point closer to the scope handgrip.

[0080] 4) The drive unit consists of a linear actuator comprising two parts, a non-slide part and a slide part. Each part includes attachment means mounted on the biopsy needle device. The attachment means on the non-slide part is attached to the safety ring of the needle device. The attachment means on the slide part is attached to the slide handgrip of the biopsy device.

[0081] 5) Also, the drive unit is provided with a lever-operated safety mechanism. When it is disabled, manual control of the needle device becomes possible.

[0082] 6) The length selector is located on the slide part of the drive unit. The length selector determines the passing distance of the biopsy needle. The desired length needs to be determined before the needle passes.

[0083] 7) To obtain a biopsy specimen, the endoscopist advances the needle near the desired location using a drive controller or manually. A length selector on the slide portion of the drive unit is set to the desired length. The needle is advanced into the lesion via a drive control button. If necessary, the desired needle penetration length can be adjusted until the needle reaches the desired location within the target.

[0084] 8) Once the needle is within the target and the desired penetration length is selected, the needle can be passed multiple times. When the user presses the specimen button, a linear actuator housed within the drive unit is activated. The linear actuator brings a plurality of connectors closer to each other for a preset time. Due to the movement of this linear actuator, the needle advances and retracts to a preset distance based on the length selector.

[0085] 9) When a series of passes is completed, if necessary, the user can manually reposition the needle and readjust the desired penetration length. Steps 8 and 9 are repeated until sufficient specimen is collected.

[0086] 10) Documentation of the sampling procedure - The user records each preselected length and the corresponding number of passes made by pressing the sampling button.

[0087] [Application to "Forceps"] (For example), general endoscope tools such as forceps and collets require manual opening and closing of the tool handgrip (see Fig. 8).

[0088] The tool handgrip is usually controlled by an assistant under the supervision of the endoscopist and is not directly controlled by the endoscopist. However, communication can be difficult because the exact degree of opening and closing and the movements to be performed can be difficult to express in words. To achieve more effective communication, this usually requires an experienced assistant or a long learning process between the assistant and the endoscopist. Even when communication is good, it is still difficult to avoid transmission errors. Such transmission errors can lead to operation errors, extra operation time, and safety problems. One solution is to provide automatic control during tool opening and closing via a user control interface so that the endoscopist can control their own tools.

[0089] 1) The solution proposed by the present invention is fully applicable to the control of endoscopic instruments that require opening and closing control and are attached to a tool holder near the handgrip of the endoscope.

[0090] 2) It consists of a connector extending from the bottom of the drive unit and a tool holder connected to the connector.

[0091] 3) The tool holder consists of a linear actuator having two parts, namely a slide part and a non-slide part. At least a part of the endoscopic tool is attached onto the tool holder.

[0092] 4) The opening and closing endoscopic tool usually consists of a slide part and a non-slide (non-moving) part. The slide part of the device is attached onto the slide part of the tool. On the other hand, the non-slide part of the device is attached onto the non-slide part of the tool.

[0093] 5) The opening and closing of the tool is controlled by the position / movement of the slide part. The slide part can be controlled by the user via a user control interface (similar to the original control) or via a foot pedal.

[0094] [Adjustment of the moving speed of the endoscopic instrument] For some endoscopic procedures, various speed controls are required. Such various speed controls include a gentle speed for accurate motion control and a rapid forward movement that enables penetration of the membrane of the structure. According to one variant form, according to the present invention, two different speed control buttons can be provided on the user control interface, or even an indexed sensor can be provided. With the two different speed control buttons, more valuable control of the speed of the device can be achieved. Also, with the indexed sensor, an appropriate speed can be selected using the control button (114).

[0095] [Configuration of the module] The configuration of the heel (112) of the operating module can take various forms depending on the nature of the sensor it supports. As non-limiting examples, six specific configurations are presented below.

[0096] FIG. 14 is a perspective view of a first configuration of the mounting plate according to the present invention. The heel (112) extends in a direction substantially perpendicular to the support surface (111). And the heel (112) has a curved region in the direction of the electric drive block (120) so as to form a surface (212) that supports the sensor and is substantially parallel (or slightly inclined at an angle of about 30°). The sensor includes a button that can be actuated and pushed laterally from right to left to control, for example, the forward or backward movement of the tool and its blockage.

[0097] FIG. 15 is a perspective view of a second configuration of the mounting plate according to the present invention. The second configuration is the same as the previous configuration except that it has a bend in the direction opposite to the electric block.

[0098] Figure 16 is a perspective view of a third configuration of the mounting plate according to the present invention. In the third configuration, there is a bend in the same direction as the first configuration, and the surface (212) supports a wheel that can be operated in various directions. The wheel is of the "joystick" type and can be actuated by being pushed in.

[0099] Figure 17 is a perspective view of a fourth configuration of the mounting plate according to the present invention. In the fourth configuration, a second actuator (214) is mounted on a curved plate (212) connected to the engine block (120).

[0100] Figure 18 is a perspective view of a fifth configuration of the mounting plate according to the present invention. The mounting plate according to the fifth configuration has a second curved plate (212) that supports a plurality of sensors or a plurality of buttons (214) superimposed on the first sensor (114). These two sensors (114) and (214) are in a misaligned plane.

[0101] Figure 19 is a perspective view of a sixth configuration of the mounting plate according to the present invention. The mounting plate according to the sixth configuration has a second curved plate (212) that supports a plurality of sensors or a plurality of buttons (214) arranged longitudinally offset with respect to the first sensor (114). These two sensors (114) and (214) are in a misaligned plane.

Brief Description of the Drawings

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Claims

1. In an electric operating module for an endoscopic instrument, it is composed of a mounting plate (100) that can be attached to the ulna-palmar gripping zone of the handgrip of the endoscope, the mounting plate (100) has an ulna-palmar support surface (111), the ulna-palmar support surface (111) extends to a heel (112) that extends in a direction forming an angle of 90° ± 25° with respect to the plane of the ulna-palmar support surface (111), the heel (112) is provided with an electromechanical sensor (114) that sends a control signal for controlling the movement of the endoscopic instrument, and is characterized by an electric operating module.

2. the ulna-palmar support surface (111) extends to the opposite side up to an electric drive block (120) having an electric mechanism for a filamentous element for connection to the instrument, its lower end opens into the flexible rod (1) of the endoscope so as to ensure connection to the instrument, the mounting plate further has connection means with the handgrip of the flexible endoscope, and is characterized by the electric operating module for an endoscopic instrument according to claim 1.

3. the connection means with the handgrip of the flexible endoscope consists of an end piece (271) that can be inserted into the working channel of the flexible rod (1) of the endoscope, and is characterized by the electric operating module for an endoscopic instrument according to claim 2.

4. the electric drive block (120) is provided with a motor (190) disposed below the end piece (271), and is characterized by the electric operating module for an endoscopic instrument according to claim 3.

5. the heel (112) is formed by a protrusion (112) with a thickness of less than 3 millimeters, the protrusion (112) has a sensor (114) at its end, the operating surface of the sensor (114) is defined by a generatrix forming an angle of 90° ± 20° with respect to the longitudinal axis of the handgrip, and is characterized by the electric operating module for an endoscopic instrument according to claim 1.

6. the lower part of the ulna-palmar gripping zone further includes a drive block (120) having an electric mechanism for a filamentous element (160) for connection to the instrument, its lower end opens into the flexible rod (1) of the endoscope so as to provide connection to the instrument, and is characterized by the electric operating module for an endoscopic instrument according to claim 2.

7. The electric operating module for an endoscope instrument according to claim 6, wherein the drive block has a side operating button (124) for controlling an emergency stop of the movement of the instrument.

8. A hand grip (1) having suction and cleaning control buttons (20, 30) located above the ulna-palmar gripping zone of a user's finger, The hand grip (1) extends to a flexible rod (2) having a working channel for the passage of the instrument, In a flexible endoscope, its movement is controlled by an electrical interface, The interface (100) has an ulna-palmar support surface (111), The ulna-palmar support surface (111) extends to a heel (112) extending in a direction forming an angle of 90° ± 25° with respect to the plane of the ulna-palmar support surface (111), The heel is provided with an electromechanical sensor (114) for sending a control signal for controlling the movement of the endoscope instrument, A flexible endoscope, wherein the other end of the interface (100) is formed by a drive block (120).

9. The heel (112) is formed by a protrusion (112) with a thickness of less than 3 millimeters, The protrusion (112) has a sensor (114) at its end, The flexible endoscope according to claim 8, wherein the operating surface of the sensor (114) is defined by a generatrix forming an angle of 90° ± 20° with respect to the longitudinal axis of the hand grip.

10. The sensor (114) is a rotational sensor actuated by a wheel, The flexible endoscope according to claim 9, wherein the axis of the wheel forms an angle of 0° to ± 70° with respect to a longitudinal axis parallel to the longitudinal axis of the hand grip.

11. The drive block (120) further includes an electric mechanism of a filamentous element (160) for connection with the instrument at the lower part of the ulna-palmar gripping zone, The flexible endoscope according to claim 8, wherein its lower end opens into the flexible rod (1) of the endoscope so that connection with the instrument is provided.

12. The drive block (120) forms a protrusion with respect to the surface at the lower part of the ulna-palmar gripping zone. The flexible endoscope according to claim 8, characterized in that the protrusion is on the side opposite to the ulna-palm gripping zone where there is an extending part constituting the operation control part of the movement of the instrument.

13. The flexible endoscope according to claim 12, characterized in that the drive block has a side operation button (124) for controlling an emergency stop of the movement of the instrument.

14. The flexible endoscope according to claim 8, characterized in that the control interface (100) further comprises a length selector for moving the instrument by a predetermined length.

15. The flexible endoscope according to claim 8, characterized in that the control interface further comprises means (131) for coupling the distal part of the instrument.

16. The flexible endoscope according to claim 8, characterized by comprising an electric operation module (100) in the form of a detachable sub-assembly of the handgrip, which combines the interface and the drive block.

17. The flexible endoscope according to claim 8, characterized in that the sensor (114) has an interaction surface of less than 50 mm2 facing the ulna-palm gripping zone.

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