Motorized actuation module for an endoscopic instrument

The motorized actuation module addresses ergonomic issues in flexible endoscope systems by enabling single-handed control of endoscopic instruments, improving efficiency and reducing the need for additional operators.

FR3103696B1Active Publication Date: 2024-12-20INST HOSPITALO UNIV DE CHIRURGIE MINI INVASIVE GUIDEE PAR LIMAGE
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Patent Information

Application Number
FR2019013678
Authority / Receiving Office
FR · FR
Patent Type
Patents
Current Assignee / Owner
Filing Date
2019-12-03
Publication Date
2024-12-20
Estimated Expiration
2039-12-03

AI Technical Summary

Technical Problem

Existing flexible endoscope systems require significant learning time due to ergonomic issues with control elements that are not compatible with standard handles, often necessitating the redesign of endoscopes and requiring a second operator for precise instrument control during therapeutic procedures, disrupting workflow continuity.

Method used

A motorized actuation module that can be integrated as an accessory or native to the endoscope handle, featuring an electro-mechanical sensor and motorized drive block to control endoscopic instrument movement, allowing single-handed operation without the need for an assistant.

Benefits of technology

Enables precise and efficient control of endoscopic instruments, reducing procedure time and improving ergonomics by allowing single-handed operation, thus enhancing workflow continuity and reducing the need for additional personnel.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention presents a motorized actuation module for an endoscopic instrument. It consists of a plate adapted to be fixed to the cubito-palmar gripping area of ​​an endoscope handle, said plate having a cubito-palmar support surface extended by a heel extending in a direction forming an angle of 90° ± 25° with respect to the perpendicular to the plane of said cubito-palmar support surface, said heel comprising an electromechanical sensor delivering a control signal for the movement of an endoscopic instrument. Abbreviated figure: 1
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Description

Title of the invention: Motorized actuation module for an endoscopic instrument Field of invention

[0001] The present invention relates to the field of flexible endoscopy, more particularly to a system for controlling the translational movement of flexible endoscopic tools in an outgoing flexible endoscope. A flexible endoscope comprises a handle with control buttons that allow the flexible end of the endoscope shaft to be moved in different directions. The user holds the handle with his left hand, whose fingers can operate the various adjustment buttons, while the right hand guides the insertion area of ​​the flexible shaft.

[0002] Initially, flexible endoscopes were mainly used for diagnosis and in particular for in vivo imaging of hollow bodies. But the therapeutic uses of flexible endoscopes have developed over the last decades, implementing additional microsurgical instruments inserted via a working channel present on the endoscope or fixed to the outside of the endoscope. These accessory instruments generally have at least one mechanism for actuating and / or moving and positioning the active distal head.

[0003] During therapeutic use of a flexible endoscope, the user must operate and control the insertion, i.e. the advancement and retraction, of the distal instrument generally with the right hand. As the movement is transmitted along the endoscopic rod, the insertion zone of which is no longer guided by the user's hand, the position of the camera changes and leads to a loss of vision of the target.

[0004] Coordinating these actions often disrupts workflow continuity and results in longer procedure times. To address this issue, a second operator / assistant is often required to hold the endoscope shaft, while the primary operator uses the free hand to manually control the flexible tool on the flexible endoscope handle.

[0005] This requires learning cycles to achieve good communication and coordination between the operator and the assistant, without completely avoiding work disruptions, because it is often difficult to specify the desired angle, location, timing and sequence of movements. Therefore, various automated tool control devices for flexible endoscopes have been proposed to solve these difficulties. State of the art

[0006] To facilitate the control of the movement of the instrument without the use of an assistant, solutions have been proposed in the state of the art where the movement is motorized and where the handle has a movement control.

[0007] Patent EP1568305 describes an endoscopic system comprising: • a body comprising a treatment part for performing treatment in response to a reciprocating driving force, a transmission member connected to the treatment part for transmitting the reciprocating driving force to the treatment part, and a sheath member in which the transmission member is fitted to move reciprocally; and • an endoscope body comprising a channel through which the instrument body can be inserted, wherein the endoscopic treatment system further comprises: • a reciprocating mechanism for causing the transmission element to move back and forth in an axial direction relative to the sheath element; • a drive power source coupled with the endoscope body to drive the reciprocating mechanism, wherein the drive power source is a rotational drive source; and • a control element coupled to the endoscope body for delivering drive instructions to the power source

[0008] The instrument body further comprises: • a drive member connected to the transmission member and operable to cause the transmission member to move reciprocally in response to the reciprocating drive force from the reciprocating mechanism; • a base element including the drive element and connected to the sheath element; and • a conversion mechanism for converting a rotational movement of the drive source into a reciprocating drive force,

[0009] The drive member is a thin plate and the distal end of the drive member is connected to the proximal side of the transmission member.

[0010] The conversion mechanism comprises a rotating roller engaged with a rotating shaft connected to the drive source, and wherein a proximal end of the drive member is connected to an outer peripheral surface of the roller so as to be wound therearound.

[0011] The movement control is carried out using a large rotary knob with a thumbwheel protruding from either side of the handle.

[0012] Japanese patents JP5670002B1 and JP4914891 propose similar solutions where the insertion / removal assistance tool which comprises a base unit, a fixing unit for fixing the base unit to an instrument insertion part, in such a way that the base unit is capable of pivoting about the central axis of an instrument insertion opening; a first tubular member; and a fixing part. The insertion / removal assistance tool also comprises: a rotating part adjacent to the first tubular member and positioned so as to be attachable to and detachable from the base unit; and a removal mechanism.

[0013] US patent US7789822 discloses another example of an endoscope system comprising an endoscopic therapeutic instrument and an endoscope. The endoscopic therapeutic instrument comprises a treatment mechanism, a flexible transmission member which transmits an actuation drive force to the therapeutic section by moving forward and backward; and a flexible sheath section defining an interior space in which the flexible transmission member can be moved forward and backward and a flexible actuation tube section provided separately from the sheath section in an axial direction of the sheath section and connected to a proximal portion of the transmission member which projects from the sheath section.

[0014] The endoscope comprises a channel formed inside the endoscope and through which the endoscopic therapeutic instrument can be inserted, a first advance / recoil mechanism operable to cause the sheath section to move forward and backward inside the channel in an axial direction of the channel and a second advance / recoil mechanism configured to cause the flexible actuating tube section to move forward and backward inside the channel in the axial direction of the channel (20), separately from the first advance / recoil mechanism. A control section is operable to control a forward / reverse drive of each of the first and second advance / recoil mechanisms. The control section has: • a first mode configured to move the endoscopic therapeutic instrument forward / backward in the channel by driving both the first and second advance / recoil mechanisms to cause both the sheath section and the flexible actuating tube section to move forward and backward in the channel and • a second mode configured to actuate the therapeutic section by stopping the first advance / recoil mechanism and driving the second advance / recoil mechanism to bring the actuating tube section flexible to move forward and backward relative to the duct section.

[0015] Japanese patent JP2003265406 describes another known example of an endoscopic treatment instrument advancement and withdrawal device. A therapeutic device insertion conduit is provided in the vicinity of the treatment device insertion port; it comprises an actuating element manipulated by the fingers to control the advancement and withdrawal of the treatment instrument. Disadvantages of the prior art

[0016] A first drawback of the prior art solutions concerns the ergonomics of the control members, and their configuration which is not compatible with standard flexible endoscope handles. They therefore involve a significant learning time for the practitioner. Some solutions require users to combine the thumb and middle or ring finger to manipulate the knobs which prevents simultaneous actuation of the suction or washing valves. The position of the buttons located in the invention US7789822 would prevent the use of the middle and ring fingers to operate the knobs.

[0017] A second disadvantage is that these solutions require the complete redesign of a handle, and the replacement of existing endoscopes with new endoscopes. Solution provided by the invention

[0018] The present invention aims to avoid the drawbacks of the prior art in two embodiments, either in the form of a separate module forming an accessory for upgrading a commercial endoscope handle, or in the form of an endoscope handle natively having such a control module. In both embodiments, the invention consists of a plate capable of being fixed to the ulnar-palmar gripping area of ​​an endoscope handle, said plate having an ulnar-palmar support surface extended by a heel extending in a direction forming an angle of 90° ±25° relative to the perpendicular to the plane of said ulnar-palmar support surface, said heel comprising an electromechanical sensor delivering a signal for controlling the movement of an endoscopic instrument.

[0019] The invention relates more particularly to a motorized actuation module for an endoscopic instrument, characterized in that it is constituted by a plate capable of being fixed to the ulnar-palmar gripping zone of a handle of an endoscope, said plate having an ulnar-palmar bearing surface extended by a heel extending in a direction forming an angle of 90° ±25° relative to the perpendicular to the plane of said ulnar-palmar bearing surface, said heel comprising an electromechanical sensor delivering a signal to control the movement of an endoscopic instrument.

[0020] Advantageously, said medial ulnar-palmar gripping surface is extended on the opposite side by a motorized drive block, comprising a motorized mechanism of a filiform element for connection with said instrument, the lower end of which opens into said flexible rod to ensure a connection with said distal instrument, said plate further having means of connection with the handle of a flexible endoscope.

[0021] Advantageously, said means of connection with the handle of a flexible endoscope consist of a tip capable of being inserted into the operating channel of an endoscopic rod.

[0022] According to a preferred variant, the plate comprises a motorized drive block comprising a motor placed below the tip with the inlet of the operating channel of an associated endoscope.

[0023] Advantageously, said heel is formed by a protuberance with a thickness of less than 3 millimeters having at its end a sensor whose actuation surface is defined by a generator forming an angle of 90° ± 20° with the longitudinal axis of said handle.

[0024] According to a particular embodiment, the drive unit, comprising a motorized mechanism of a filiform element for connection with said instrument, the lower end of which opens into said flexible rod of the endoscope to ensure a connection with said distal instrument.

[0025] According to a variant, said drive block has a lateral actuation button controlling the emergency stop of the movement of said instrument.

[0026] The invention also relates to a flexible endoscope comprising a handle having suction and washing control buttons located above an ulnar-palmar gripping area of ​​the user's fingers, said handle being extended by a flexible rod having an operating channel for the passage of an instrument whose movement is controlled by an electrical interface, characterized in that said interface has an ulnar-palmar support surface extended by a heel extending in a direction forming an angle of 90° ±25° relative to the perpendicular to the plane of said ulnar-palmar support surface, said heel comprising an electromechanical sensor delivering a signal for controlling the movement of an endoscopic instrument.

[0027] Advantageously, said heel is formed by a protuberance with a thickness of less than 3 millimeters having at its end a sensor whose actuation surface is defined by a generator forming an angle of 90° ± 20° with the longitudinal axis of said handle.

[0028] Advantageously, said sensor is a rotary sensor actuated by a wheel whose axis forms an angle between 0° and ±70° relative to the longitudinal axis parallel to the longitudinal axis of said handle.

[0029] Advantageously, the plate further comprises in the lower part of said ulnar-palmar gripping zone, a drive block comprising a motorized mechanism of a filiform element for connection with said instrument, the lower end of which opens into said flexible rod of the endoscope to ensure a connection with said distal instrument.

[0030] Preferably, said drive block forms a protrusion relative to the surface of the lower part of the ulnar-palmar gripping zone, opposite, relative to said ulnar-palmar gripping zone, said extension constituting the actuation control.

[0031] Advantageously, said control interface (100) further comprises a length selector for moving the instrument by a predetermined length.

[0032] Preferably, said control interface further comprises means for coupling a peripheral to said instrument.

[0033] According to a variant, the endoscope comprises a motorized actuation module grouping together, in the form of a subassembly detachable from the handle, said interface and said drive unit.

[0034] According to another variant, said sensor has an interaction surface opposite said ulnar-palmar gripping zone of less than 50 mm2.

[0035] Detailed description of a non-limiting example of embodiment

[0036] The invention is described below, by way of non-limiting example, with reference to the appended drawings in which:

[0037] [Fig-1] [Fig. 1] is a partial exploded perspective view showing an endoscope handle according to the state of the art

[0038] [Fig.2] [Fig.2] is a 3 / 4 front view of an endoscope handle according to the invention

[0039] [Fig.3] [Fig.3] represents a 3 / 4 front view of an endoscope handle according to the invention

[0040] [Fig.4] [Fig.4] is a 3 / 4 front view of a second variant of endoscope handle according to the invention

[0041] [Fig.5] [Fig.5] represents a 3 / 4 front view of a first variant of a control module according to the invention

[0042] [Fig.6] [Fig.6] represents a 3 / 4 front view of a second variant of a control module according to the invention

[0043] [Fig.7] [Fig.7] is a 3 / 4 front view of a third handle variant endoscope according to the invention

[0044] [Fig.8] [Fig.8] is a 3 / 4 front view of a third handle variant endoscope according to the invention

[0045] [Fig.9] [Fig.9] is a 3 / 4 front view of a second variant of a module according to the invention

[0046] [Fig. 10] [Fig. 10] is a view of the internal mechanism of this second variant of a module according to the invention

[0047] [Fig. 11] [Fig. 11] is a longitudinal sectional view of this second variant of a module according to the invention

[0048] [Fig. 12] [Fig. 12] is a bottom view of this second variant of a module according to the invention

[0049] [Fig. 13] [Fig. 13] is a perspective view of the connecting end piece with the channel endoscope operation

[0050] [Fig. 14] [Fig. 14] is a perspective view of a first configuration of a platinum according to the invention

[0051] [Fig. 15] [Fig. 15] is a perspective view of a second configuration of a platinum according to the invention

[0052] [Fig. 16] [Fig. 16] is a perspective view of a third configuration of a platinum according to the invention

[0053] [Fig. 17] [Fig. 17] is a perspective view of a fourth configuration of a platinum according to the invention

[0054] [Fig. 18] [Fig. 18] is a perspective view of a fifth configuration of a platinum according to the invention

[0055] [Fig. 19] [Fig. 19] is a perspective view of a sixth configuration of a platinum according to the invention.

[0056] General context of the invention: the “standard” endoscope handles of the state of the art.

[0057] [Fig.l] shows an example of a known endoscope. It comprises a handle (1) from which extends a flexible tube (2) terminating in a distal or operational end (3) which is introduced into the cavity to be explored and whose orientation can be controlled by a deflectable sleeve (4). This sleeve is controlled by wires which are pulled in a controlled manner as a result of the manual actuation of knobs or buttons (5, 6, 7) provided on the endoscope handle (1). The control section of the movable joysticks allows the doctor to control all functions of the endoscope. The deflecting (orientation in space) joysticks (5, 6, 7) direct the deflecting cables and control the deflectable section at the distal end of the tube insertion, thus allowing two-dimensional orientation. Locking mechanisms (brakes) allow the bendable section to be fixed in the desired position.

[0058] The light is transmitted by an optical fiber (8) whose proximal end (9) is coupled to an optical connector. The connection block (11) further comprises an air intake (10).

[0059] A pneumatic connector (12) is intended to be connected to a vacuum pump or a reversible air pump to control insufflation or suction at the distal end (3). The technical block (11) also comprises an electrical connector (13) and a connection support (14) for a safety cord and a water supply (15).

[0060] The handle (1) is connected to the tube (2) by a sheath (16) extended by a sleeve (17). The handle has an opening of the operating channel (18) equipped with a disposable valve (19).

[0061] The handle comprises a piston (20) controlling the washing channel and a piston (30) for controlling suction or insufflation via two tubes extending between the handle (1) and the distal end (3), one for supplying air and water to said distal end, the other for performing a biopsy or suction. The application of suction is regulated by means of a piston (30) provided on the handle. The piston is connected to a neighboring conduit by welded connections. The pistons (20, 30) are coupled to the body of the handle by annular bases (32).

[0062] The piston (30) connects the suction channel to the working channel in the insertion tube. By pressing the button (31) on the piston, suction of the working channel can be performed. The air / water piston (20) is similar to the piston and suction piston (30), except that a piston with a two-way button is used in a dual channel device that allows air or water to be conveyed to the lens at the distal end, for washing or air insufflation to improve vision. Both pistons (20, 30) can be detached for replacement, when in use, or otherwise for cleaning. Detailed description of the command interface

[0063] The handle according to the invention represented by [Fig.2] and following, is distinguished from the “standard” handles by an additional function of motorized control of an endoscopic instrument introduced into the endoscopic tube (2) to carry out at the distal end an intervention such as a sample, electrocoagulation, suture, incision, etc.

[0064] The aim is to allow the operator holding the handle (1) with one hand to continue to exercise the usual controls, but also to control without manual intervention the movement of the endoscopic instrument to its working position, without requiring the use of the other hand, generally used to guide the tube endoscopic (2) in the introduction area, and without resorting to the assistance of a second operator, requiring complex coordination.

[0065] For this, the handle (1) is equipped with a control interface (100) which is positioned on the handle (2) at the level of the ulnar-palmar gripping zone (101) just below the piston (20) controlling the washing channel and the piston (30) controlling the suction or insufflation. This zone (101) is generally flat to allow the support of the palm of the middle finger, the ring finger and the little finger.

[0066] The module illustrated by figures 2 and 3 is constituted by a plate (110) of small thickness, approximately 1 millimeter, having a middle part (111) for ulnar-palmar support which is superimposed on the ulnar-palmar gripping zone (101) of the handle (2). This middle part (111) is extended on one side by an extension (112) extending in a substantially transverse plane (113). For the purposes of this patent, the term "substantially transverse plane" means a surface extending in a direction between +45° and -45° relative to the longitudinal axis (200) of the handle (2).

[0067] This extension (112) has a decreasing width, from an initial width corresponding to the width of the middle zone (111), to an end of lesser width supporting the sensor provided with an actuation surface (114). In the example described, the sensor is a rotary electromechanical sensor with an actuation surface (114) formed by a notched wheel in the form of a spherical zone allowing actuation with the palm of a finger, for example the middle or ring finger, leaving the index finger available for the other usual controls of the handle.

[0068] The other end of the plate (100) is formed by a motorized block (120) whose longitudinal axis (122) is inclined relative to the longitudinal axis (200) of the handle (2), with an angle between ±30° (inclined upwards or downwards) and 90° (orientation perpendicular to the longitudinal axis (200) of the handle (2)).

[0069] This motorized block (120) has a median channel opening on each side of the block (120) by an orifice (121) for the passage of the translation element of the endoscopic instrument, to ensure its movement inside the endoscopic tube (1) and its distal positioning for an intervention with this instrument. For this purpose, the block (120) comprises an electric motor or an electromagnetic actuator controlled by the sensor (114) via an electronic control circuit. It is powered by a rechargeable electric battery (123) engaged in a lateral connector. On the opposite wall, the block (120) has an emergency stop button (124).

[0070] In the embodiment illustrated by [Fig.2], the extension (112) is curved upwards at its end (116), which carries the sensor (114). Furthermore, the plate is provided with a collar (117) for fixing around a standard handle (2).

[0071] In the variant illustrated by [Fig. 3], the emergency stop button (124) is arranged on the front face of the motorized block (120), and the plate (110) has an extension (111) extending transversely, with one end (116) inclined upwards to support a sensor (114) actuable by a hemispherical button. Production in the form of an accessory module

[0072] The interface can be integrated into a handle (2) or be produced in the form of an accessory which can be mounted and fixed on a pre-existing handle (2). Figures 5 and 6 illustrate views of such an accessory, having the same technical characteristics as those previously described.

[0073] The motorized block (120) is extended laterally by an adapter to receive a peripheral to the endoscopic instrument, for example an automated puncture equipment (140) as shown in [Fig.7] or a mechanism (150) for controlling scissors or a biopsy needle as shown in [Fig.8].

[0074] This adapter consists of an articulated arm (130) equipped with an accessory support (131) or by a mechanical connector (135). Variant of the production of an accessory module

[0075] Figures 9 and 10 represent an alternative embodiment of a stand-alone module, constituting an accessory intended to equip a pre-existing endoscopic handle. The technical characteristics previously described are present in this alternative.

[0076] The motorized block (120) incorporates a mechanism for driving the filiform element (160) by a drive roller (180) coming into contact with the surface of this filiform element (160), a pressure roller (181) coming into diametrically opposite contact to ensure good adhesion. This pressure roller (181) rotates freely around an axis supported by a movable carriage (182) pushed towards the roller (180) by a spring (183) oriented perpendicular to the axis of introduction of the filiform element (160). It is powered by an electric wire (170) protected by a sleeve (171).

[0077] The drive roller (180) is actuated by a motor (190) via an angle gear (185). This motor (180) is controlled via the user control (114).

[0078] The motor (190) is arranged in a substantially longitudinal direction, relative to the axis of movement of the filiform element (160), with an angle between 0° and ± 30° relative to this axis to optimize the size and the distribution of the masses.

[0079] The motor (190) is positioned in the motorized block (120) below the interface (195) placed on the entrance to the operating channel of the endoscope, in order to promote good balancing of the handle and avoid raising the center of gravity of the handle equipped with this module.

[0080] The axis (186) is guided by two arcuate slots (188, 189) formed on a rod (187) integral with the actuating button (124).

[0081] In the intermediate position of the actuating button (124), the drive roller (180) ensures the movement of the filiform element (160) which is pressed with a controlled force against it by the free roller (181).

[0082] When the actuating button (124) is pushed towards the scrolling axis of the filiform element (160), towards the handle when the module is mounted on the handle, the gears of the angle lever (185) are uncoupled together with the pressing of the drive roller (180) against the free roller (181), which blocks the scrolling of the filiform element (160).

[0083] When, on the contrary, the actuating button (124) is moved in the opposite direction, by acting on its curved part with a finger slipped between the handle and the inner surface of the actuating button (124), the drive roller (180) is moved away from the free roller (181) and thus the filiform element (160) is released, which can then be moved manually.

[0084] The operation of this actuation button (124) is very intuitive. It controls the instantaneous opening or closing of the tool engagement mechanism:

[0085] - instantaneous engagement / disengagement of the tool moved by the filiform element (160)

[0086] - safety by immediate stop for advancement / withdrawal of the tool moved by the element filiform (160)

[0087] - instant switching between manual and automation operation

[0088] Manual operation of the tool allows you to return to normal use of the endoscope, without having to remove the motorized module.

[0089] Fixing the instrument on the working channel of the endoscope ([Fig. 11 ] to 13)

[0090] Fixing the module to the handle does not require a fixing element such as a collar or clip, but is made by a truncated part shown in figure (13), having a collar (270) ensuring the seal between the operating channel and the motorized module, extended by a truncated tip (271). The introduction into the operating channel of a “standard” endoscope of the longitudinal tip (271) extending the distal end of the motorized block (120) ensures both the guidance of the filiform element (160) and the wedging of the module relative to the endoscopic handle. The crown (271) of generally tubular or truncated shape has a seal (272) which ensures the seal of the sheath (170) relative to the endoscopic guide. This seal (272) comprises a bead which engages by deformation and wedging around the end of the operating channel (also comprising a bead).

[0091] The truncated cone-shaped tip (271) has at its proximal end a disc expansion (270) which engages in a complementary receiving zone provided on the front face of the motorized block (120). The proximal end of the tip (271) has a circular space in which a seal (195) engages. This solution makes it possible to physically separate the operating channel from the guide (1), the motor and the drive mechanism constituting the upper part of the motorized block (120). One or more fluid seals seal the fluid in the passage of the rod (1). Applications

[0092] The applications of the invention are multiple, they concern in particular the echo-endoscopically guided fine needle aspiration (EUS-FNA), with cytological and histological study. Endoscopic ultrasound (EUS) has become an essential protocol for determining the stage of cancer advancement in the gastrointestinal system, in particular when combined with fine needle aspiration (FNA) or fine needle biopsy (FNB) of body tissues. FNA biopsy is performed using a dedicated needle called an FNA needle. During the procedure, an EUS imager is brought into contact with a body wall behind which the biopsy site is located, then an FNA needle is advanced into the working channel of the EUS endoscope.The needle is advanced through the body wall to the site to be biopsyed, usually a suspicious lesion, and negative pressure is applied to the inner tip of the needle to retrieve tissue samples. The needle is then withdrawn from the EUS field and the tissue sample is retrieved and analyzed.

[0093] Commercially available FNA needles are quite similar: they are intended to be engaged at the proximal end of the working channel (1), usually via the Luer lock and comprise a hollow needle housed in a sheath. The handle of 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 unexposed). Once the correct sheath position is achieved, the sheath adjuster can be secured relative to the handle body. - a needle slider to slide and expose the needle beyond the distal end of the sheath to reach the biopsy site - a safety ring that can be attached to the handle body to limit the longitudinal travel of the needle slider so that multiple needle insertions can be easily performed by the user. - an orifice at the proximal end of the handle for applying negative pressure to the hollow inner bore of the needle.

[0094] An FNA biopsy typically requires the physician to manually pass the biopsy needle multiple times, back and forth, at different locations within the target lesion. The action of passing the biopsy needle is not standardized, as the penetration depth and speed of passage are controlled by physicians. Typically, a long pass typically receives more sample than shorter passes; and a slow pass typically receives more sample than faster passes. Non-standardized sampling could result in suboptimal yield or non-reproducible biopsy sampling. The conventional method also produces a poor estimate of sample yield, which may result in insufficient sampling and diagnostic failure.This wastes time, likely delays patient treatment, and is associated with additional medical costs that could be avoided with a more standardized sampling method. A similar technical problem was mentioned in patent DE10128336, a method was proposed. This method of collecting cell samples by fine needle aspiration (FNA) biopsy involves introducing a fine needle of a sampling device into the tissue, this fine needle is subjected to a vacuum and is set in motion relative to the tissue, then the vacuum is stopped and the fine needle is withdrawn from the tissue.

[0095] The present invention provides a device with a tool control interface that improves control of biopsy needle sampling, standardizing tissue sampling that allows for better reproducibility, planning and estimation of tissue samples.

[0096] With prior art handles, actuation of the needle slider requires the endoscopist to keep his or her right hand on the axis of the endoscopic viewing scope, resulting in a loss of control of the endoscope and decreased accuracy. This is a significant limitation because reaching different locations within the lesion is critical to diagnostic efficiency. A system that allows the user to operate an FNA needle while maintaining one hand on the handle and the other on the shaft of the endoscope is therefore desirable.

[0097] The control interface according to the invention can advantageously be used to control an FNA needle, the user keeping his right hand on the shaft of the endoscope. The movement of the shaft and the needle can be controlled by actuating the control interface.

[0098] In a preferred embodiment, needle insertion is controlled by the right hand using the control interface, a one-dimensional drive control allows for slow and precise operation of the needle. Once the needle Once inserted to the desired depth, a second Boolean sampling control (on / off) can be used to repeat the movement: once the sampling control is pressed, the needle is retracted and reinserted to the same distance. This feature allows the user to make multiple passes with similar depth while varying the scope position (fanning technique) to reach multiple sites within the lesion. The needle can then be withdrawn using the drive controller and it can be removed from the endoscope.

[0099] According to a variant, the control interface (100) further comprises a length selector to allow the user to directly define the penetration depth of the needle. When the user presses the sampling control, the needle is inserted to the depth defined by the length selector and returned to a default position.

[0100] In one embodiment, the control interface (100) is used in conjunction with an FNA needle incorporating at least one linear actuator adapted to translate the needle. The actuator is connected to the control interface physically or wirelessly. The FNA needle is also connected to a power source, either via a physical connection with the control interface or by incorporating a battery.

[0101] In another embodiment, the control interface is connected to an "EUS device" adapted to be mounted on an available FNA needle and connected to the control interface. Summary of the application "#biopsy#"

[0102] 1) An endoscope according to the invention, or a standard endoscope supplemented by a The module according to the invention comprises two parts intended for the operation of the endoscopic instrument: a user control interface and a drive unit.

[0103] 2) the user control interface is mounted on the handle (2) of the endoscope and just below the aspiration and irrigation buttons (20, 30). The user control (114) includes a first control button for applying a relatively slow movement command; and optionally a sampling button which continuously advances and retracts the biopsy needle for a fixed number of passes at the predefined length, defined by the length selector.

[0104] 3) Before fixing the drive unit on the viewfinder, the safety ring of The needle should be tightened tightly, ideally at the maximum length. This allows the needle to travel the maximum distance and has the central weight point closer to the scope handle.

[0105] 4) The drive unit consists of a linear actuator composed of 2 parts, a non-sliding part and a sliding part. Each part containing a means fixing means which is mounted on the biopsy needle device. The fixing means on the non-sliding part is fixed on the safety ring of the needle device. The fixing means on the sliding part is fixed on the sliding handle of the biopsy device.

[0106] 5) The drive also includes a safety mechanism operated by a lever. When deactivated, manual control of the needle device is possible.

[0107] 6) A length selector is located on the sliding part of the unit drive. The length selector determines the distance the biopsy needle is passed. The desired length must be set before passing the needle.

[0108] 7) To take a biopsy sample, the endoscopist advances the needle close from the desired location using the drive controller or manually. A desired length is set on the length selector on the sliding portion of the drive unit. A needle is advanced into the lesion via the drive control knob. The desired needle penetration length can be adjusted, if necessary, until the needle arrives at the desired location in the target.

[0109] 8) Once the needle is in the target and the desired penetration length is selected, multiple needle passes can be made. When the user presses the sample button, the linear actuator housed in the drive unit is activated. The linear actuator brings the connectors closer together for a preset time. This movement of the linear actuator causes the needle to advance and retract to the preset distance according to the length selector.

[0110] 9) When a passing play is completed, the user can manually reposition the needle and readjust the desired penetration length, if necessary. Steps 8 and 9 are repeated until sufficient samples are collected.

[0111] 10) Documentation of the sampling procedure - the user records each preselected length and the corresponding number of passes made by pressing the sample button. “#pliers#” application

[0112] Common endoscopic tools, such as forceps and snares (for example), require manual opening or closing of the tool handle (see [Fig.8]).

[0113] Control of the tool handle is usually performed by an assistant under the supervision of an endoscopist and not directly by an endoscopist. Communication, however, could be difficult because the exact degree of closure / opening and the movement to be performed could be difficult to verbalize. This usually requires an experienced assistant or a long learning curve between an assistant and the endoscopist to achieve more effective communication. With good communication, it is still difficult to avoid miscommunication that could lead to operating errors, additional operating time, and safety issues. One solution is to provide automatic control when closing and opening the tool via a user control interface, so that endoscopists can control their own tool.

[0114] 1) The solution proposed by the present invention applies perfectly to the control of an endoscopic instrument requiring an opening or closing command and which is attached to a tool holder adjacent to the handle of the endoscope.

[0115] 2) It consists of a connector that extends from the lower part of the unit drive and a tool holder that connects to the connector.

[0116] 3) The tool holder consists of a two-part linear actuator: one part sliding and a non-sliding portion. At least a portion of the endoscopic tool is mounted on the tool holder.

[0117] 4) Open and closed endoscopic tools generally consist of a part sliding and non-sliding (non-moving). A sliding part of the device is mounted on the sliding part of the tool; while the non-sliding part of the device is mounted on the non-sliding part of the tool.

[0118] 5) The opening or closing of the tool is controlled by the position / movement of the sliding part, which can be controlled by the user via a user control interface (similar to the original control) or foot pedals.

[0119] Modulation of the movement speed of the endoscopic instrument

[0120] Some endoscopic procedures require different speed controls, including a slow speed for precise movement control; and a fast advancement that allows perforation through the membrane of a structure. The invention alternatively provides two different speed control knobs on the user control interface, which allow more valuable control of the speed of the apparatus, or an indexed sensor for selecting the appropriate speed using the control knob (114). Module configuration

[0121] The configuration of the heel (112) of the actuation module can take different forms, depending on the nature of the sensor that it supports. As non-limiting examples, six particular configurations are presented below.

[0122] [Fig. 14] is a perspective view of a first configuration of a plate according to the invention. The heel (112) extends in a direction substantially perpendicular to the bearing surface (111), then has a curved zone, in the direction of the motorized drive block (120) to form a surface (212) substantially parallel (or slightly inclined with an angle of the order of 30°) supporting a sensor provided with a button which can be actuated laterally, from right to left. left, and pressed, for example to control the advancement or retraction of a tool and its blocking.

[0123] [Fig. 15] is a perspective view of a second configuration of a plate according to the invention similar to the previous configuration, except that the bending is in the opposite direction to the motorized block.

[0124] [Fig. 16] is a perspective view of a third configuration of a plate according to the invention where the curvature is in the same direction as in the first configuration, the surface (212) supporting a wheel actuable in different directions, of the “joystick” type, with possible actuation by pushing.

[0125] [Fig. 17] is a perspective view of a fourth configuration of a plate according to the invention where a second actuator (214) is mounted on a curved plate (212) connected to the engine block (120).

[0126] [Fig. 18] is a perspective view of a fifth configuration of a plate according to the invention with a second curved plate (212) supporting several sensors or buttons (214) superimposed on the first sensor (114), the two sensors (114) and (214) being in offset planes.

[0127] [Fig. 19] is a perspective view of a sixth configuration of a plate according to the invention with a second curved plate (212) supporting several sensors or buttons (214) offset longitudinally relative to the first sensor (114), the two sensors (114) and (214) being in offset planes.

Claims

Claims

1. - Motorized actuation module for an endoscopic instrument characterized in that it is constituted by a plate (100) capable of being fixed on the ulnar-palmar gripping zone of a handle of an endoscope, said plate (100) having an ulnar-palmar bearing surface (111) extended by a heel (112) extending in a direction forming an angle of 90° ± 25° relative to the plane of said ulnar-palmar bearing surface. said heel (112) comprising an electromechanical sensor (114) delivering a signal for controlling the movement of an endoscopic instrument.

2. - Motorized actuation module for an endoscopic instrument according to claim 1 characterized in that said median cubito-palmar support surface (111) is extended on the opposite side by a motorized drive block (120), comprising a motorized mechanism of a filiform element for connection with said instrument, the lower end of which opens into the flexible rod (1) of an endoscope to ensure a connection with said instrument, said plate further having means of connection with the handle of a flexible endoscope.

3. - Motorized actuation module of an endoscopic instrument according to the preceding claim, characterized in that said means of connection with the handle of a flexible endoscope are constituted by a tip (271) capable of being inserted into the operating channel of said flexible rod (1) of the endoscope.

4. - Motorized actuation module of an endoscopic instrument according to claim 2 characterized in that said motorized drive unit (120) comprises a motor (190) placed below the tip (271).

5. - Motorized actuation module of an endoscopic instrument according to claim 1 characterized in that said heel (112) is formed by a protuberance (112) of thickness less than 3 millimeters having at its end a sensor (114) whose actuation surface is defined by a generator forming an angle of 90° ± 20° with the longitudinal axis of said handle.

6. - Motorized actuation module of an endoscopic instrument according to claim 1 characterized in that it further comprises in the lower part of said cubito-gripping zone palmar, a drive block (120), comprising a motorized mechanism of a filiform element (160) for connection with said instrument, the lower end of which opens into said flexible rod (1) of the endoscope to ensure a connection with said instrument

7. - Motorized actuation module for an endoscopic instrument according to the preceding claim, characterized in that said drive unit has a lateral actuation button (124) controlling the emergency stop of the movement of said instrument.

8. - Flexible endoscope comprising a handle (1) having control buttons (20, 30) for suction and washing located above an ulnar-palmar gripping area of ​​the user's fingers, said handle (1) being extended by a flexible rod (2) having an operating channel for the passage of an instrument whose movement is controlled by an electrical interface characterized in that said interface (100) has an ulnar-palmar support surface (111) extended by a heel (112) extending in a direction forming an angle of 90° ±25° relative to the perpendicular to the plane of said ulnar-palmar support surface (111), said heel comprising an electromechanical sensor (114) delivering a signal for controlling the movement of an endoscopy instrument, the other end of the interface (100) being formed by a drive block (120).

9. - Flexible endoscope according to claim 8 characterized in that said heel (112) is formed by a protuberance (112) of thickness less than 3 millimeters having at its end a sensor (114) whose actuating surface is defined by a generator forming an angle of 90° ± 20° with the longitudinal axis of said handle.

10. - Flexible endoscope according to the preceding claim, characterized in that said sensor (114) is a rotary sensor actuated by a wheel whose axis forms an angle between 0° and ±70° relative to the longitudinal axis parallel to the longitudinal axis of said handle.

11. - Flexible endoscope according to claim 8 characterized in that it further comprises in the lower part of said cubito-palmar gripping zone, a drive block (120), comprising a motorized mechanism of a filiform element (160) of connection with said instrument, the lower end of which opens into said flexible rod (1) of the endoscope to ensure a connection with said instrument.

12. - Flexible endoscope according to claim 8 characterized in that said drive block (120) forms a protuberance relative to the surface of the lower part of the ulnar-palmar gripping zone, opposite, relative to said ulnar-palmar gripping zone, said extension constituting the control of the movement of said instrument.

13. - Flexible endoscope according to the preceding claim, characterized in that said drive block has a lateral actuation button (124) controlling the emergency stop of the movement of said instrument.

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

15. - Flexible endoscope according to claim 8 characterized in that said control interface further comprises a coupling means (131) of a peripheral of said instrument.

16. - Flexible endoscope according to claim 8 characterized in that it comprises a motorized actuation module (100) grouping together in the form of a detachable subassembly of the handle said interface and said drive unit.

17. - Flexible endoscope according to claim 8 characterized in that said sensor (114) has an interaction surface opposite said ulnar-palmar gripping zone of less than 50 mm2.