MOTORIZED ACTUATION MODULE FOR ACTUATING AN ENDOSCOPIC INSTRUMENT
20230018532 · 2023-01-19
Assignee
Inventors
- Albert SERRA-TORRENT (BARCELONA, ES)
- Andras LEGNER (Wien, AT)
- Eugene SKELTON (Dublin, IE)
- Anthony WRIGHT (Dunqarvan, IE)
Cpc classification
A61B1/00133
HUMAN NECESSITIES
A61B1/0052
HUMAN NECESSITIES
A61B1/00124
HUMAN NECESSITIES
International classification
A61B1/00
HUMAN NECESSITIES
Abstract
A motorized actuation module actuates an endoscopic instrument. It is made up of a mounting plate able to be attached to the ulnar-palmar grasping zone of a handgrip of an endoscope, the mounting plate having an ulnar-palmar bearing surface extended by a heel extending in a direction that makes an angle of 90°±25° with respect to the perpendicular to the plane of the ulnar-palmar bearing surface. The heel includes an electromechanical sensor that delivers a control signal controlling the movement of an endoscopy instrument.
Claims
1. A motorized actuation module for an endoscopic instrument, comprising a mounting plate configured to be attached to an ulnar-palmar grasping zone of a handgrip of an endoscope, said mounting plate having an ulnar-palmar bearing surface extended by a heel extending in a direction forming an angle of 90°±25° relative to a perpendicular to a plane of said ulnar-palmar bearing surface, said heel comprising an electromechanical sensor delivering a control signal operable to control movement of said endoscopic instrument.
2. The motorized actuation module according to claim 1, wherein said median of said ulnar-palmar bearing surface is extended on an opposite side by a motorized drive block, comprising a motorized mechanism of a filiform element for connection with said instrument, a lower end of which opens into a flexible rod of said endoscope to ensure connection with said instrument, said mounting plate further being connected with said handgrip of said endoscope which is flexible.
3. The motorized actuation module according to claim 2, comprising a connection of said handgrip of said endoscope comprises an endpiece configured to be inserted into a working channel of said flexible rod of said endoscope.
4. The motorized actuation module according to claim 2, wherein said motorized drive block comprises a motor placed below said endpiece.
5. The motorized actuation module according to claim 1, wherein said heel is formed by a protrusion having thickness of less than 3 millimeters having, at its end, and a sensor whose actuating surface is defined by a generatrix forming an angle of 90°±20° with the longitudinal axis of said handgrip.
6. The motorized actuation module according to claim 1, wherein it further comprises, in a lower part of said ulnar-palmar grasping zone, a drive block comprising a motorized mechanism of a filiform element for connection with said instrument, a lower end of which opens into a flexible rod of said endoscope to provide a connection with said instrument
7. The motorized actuation module according to claim 6, wherein said drive block has a side actuating button controlling an emergency stop of movement of said instrument.
8. A flexible endoscope comprising a handgrip having suction and wash control buttons located above an ulnar-palmar grasping zone of a user's fingers, said handgrip being extended by a flexible rod having a working channel configured to allow passage of an instrument, movement of which is controlled by an electrical interface, said interface including an ulnar-palmar bearing surface extended by a heel extending in a direction forming an angle of 90°±25° relative to a perpendicular to a plane of said ulnar-palmar bearing surface, said heel comprising an electromechanical sensor delivering a control signal controlling the movement of an endoscopic instrument, another end of said interface (100) being formed by a drive block.
9. The flexible endoscope according to claim 8, wherein said heel is formed by a protrusion having thickness of less than 3 millimeters having, at its end, and a sensor whose actuating surface is defined by a generatrix forming an angle of 90°±20° with a longitudinal axis of said handgrip.
10. The flexible endoscope according to claim 9, wherein said sensor is a rotary sensor actuated by a wheel whose axis forms an angle between 0° and ±70° with respect to a longitudinal axis parallel to said longitudinal axis of said handgrip.
11. The flexible endoscope according to claim 8, wherein it further comprises, in a lower part of said ulnar-palmar grasping zone, a drive block comprising a motorized mechanism of a filiform element connected with said instrument, a lower end of which opens into said flexible rod of said endoscope to provide a connection with said instrument.
12. The flexible endoscope according to claim 8, wherein said drive block forms a protrusion relative to a surface of a lower part of said ulnar-palmar grasping zone, on an opposite side, relative to said ulnar-palmar grasping zone, at said extension constituting an actuation control of said movement of said instrument.
13. The flexible endoscope according to t claim 12, wherein said drive block has a side actuating button controlling an emergency stop of said movement of said instrument.
14. The flexible endoscope according to claim 8, wherein said control interface further comprises a length selector for moving said instrument by a predetermined length.
15. The flexible endoscope according to claim 8, wherein said control interface further comprises a coupling configured to connect to a peripheral of said instrument.
16. The flexible endoscope according to claim 8, wherein it comprises a motorized actuation module grouping together said interface and said drive block in a detachable subassembly of said handgrip.
17. The flexible endoscope according to claim 8, that wherein said sensor has an interaction surface opposite said ulnar-palmar grasping zone of less than 50 mm.sup.2.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] The invention is described below, by way of non-limiting example, with reference to the appended drawings, in which:
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DETAILED DESCRIPTION
[0051]
[0052] 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).
[0053] A pneumatic connector (12) is intended to be connected to a vacuum pump or a reversible air pump to control insufflation or aspiration 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).
[0054] The handgrip (1) is connected to the tube (2) by a sheath (16) extended by a sleeve (17). The handgrip has a working channel opening (18) fitted with a disposable valve (19).
[0055] The handgrip comprises a piston (20) controlling the wash channel and a piston (30) controlling the aspiration or insufflation via two tubes extending between the handgrip (1) and the distal end (3), one to bring air and water to said distal end, the other to perform a biopsy or an aspiration. The application of suction is regulated by means of a piston (30) provided on the handgrip. The piston is joined to a neighboring duct by welded connections. The pistons (20, 30) are coupled to the body of the handgrip by annular bases (32).
[0056] The piston (30) connects the suction channel to the working channel in the insertion tube. By pressing the piston button (31), aspiration of the working channel can be performed. The air/water piston (20) is similar to the piston and to the 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 blowing air to improve vision. The two pistons (20, 30) can be detached for replacement, when in use, or otherwise for cleaning.
DETAILED DESCRIPTION OF THE CONTROL INTERFACE
[0057] The handgrip according to the invention shown in
[0058] The aim is to allow the operator holding the handgrip (1) with one hand to continue to apply the usual controls, but also to control the movement of the endoscopic instrument to its working position without manual intervention, without requiring the use of the other hand, which is generally used to guide the endoscopic tube (2) in the introduction area, and without relying on the assistance of a second operator, which requires complex coordination. The movement of the instrument consists in progressing in the endoscopic tube along a trajectory corresponding to the median of the tube, forwards and backwards, to allow the active part of the instrument to reach the intervention zone. This is a movement relative to the endoscopic tube (2).
[0059] To do this, the handgrip (1) is equipped with a control interface (100) that is positioned on the handgrip (2) at the ulnar-palmar grasping zone (101) just below the piston (20) controlling the wash channel and the aspiration or insufflation control piston (30). This zone (101) is generally flat to allow support for the pads of at least two or three fingers, the index, middle, ring and little fingers.
[0060] The module illustrated in
[0061] This extension (112) has a decreasing width, from an initial width corresponding to the width of the median zone (111), to an end of lesser width bearing the sensor provided with an actuating surface (114). In the above example, the sensor is a rotary electromechanical sensor with an actuating surface (114) formed by a toothed wheel in the form of a spherical zone allowing actuation with the pad of a finger, for example the middle finger or the ring finger, leaving the index finger available for the other usual handgrip commands. The other end of the mounting plate (100) is formed by a motorized block (120) whose longitudinal axis (122) is inclined with respect to the longitudinal axis (200) of the handgrip (2), with an angle comprised between ±30°(tilted up or down) and 90°(orientation perpendicular to the longitudinal axis (200) of the handgrip (2)).
[0062] This motorized block (120) has a median channel opening on each side of the block (120) through a port (121) for the passage of the translation element of the endoscopic instrument, to ensure its movement inside of the endoscopic tube (1) and its distal positioning for a procedure with this instrument. To this end, 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 side connector. On the opposite wall, the block (120) has an emergency stop button (124).
[0063] In the embodiment illustrated by
Embodiment in the Form of an Accessory Module
[0064] The interface can be integrated into a handgrip (2) or be produced in the form of an accessory that can be mounted and attached on a pre-existing handgrip (2).
Alternative Embodiment of an Accessory Module
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[0066] The drive roller (180) is actuated by a motor (190) via a bevel gear (185). This motor (180) is controlled via the user control (114). The motor (190) is arranged in a substantially longitudinal direction, relative to the scrolling axis of the filiform element (160), with an angle of between 0° and ±30° relative to this axis to optimize the space requirement and weight distribution.
[0067] The motor (190) is positioned in the motorized block (120) below the interface (195), coming to be placed on the inlet of the working channel of the endoscope, in order to favor good balancing of the handgrip and to avoid raising the center of gravity of the handgrip fitted with this module. The axis (186) is guided by two arcuate slots (188, 189) formed on a frame (187) secured to the actuating button (124). In the intermediate position of the actuating button (124), the drive roller (180) ensures the movement of the filiform element (160), which is pressed against it by the free roller (181) with a controlled force.
[0068] When the actuating button (124) is pushed in the direction of the scrolling axis of the filiform element (160), in the direction of the handgrip when the module is mounted on the handgrip, it causes the uncoupling of the gears of the angle lever (185) together with the pressing of the drive roller (180) against the free roller (181), which blocks the scrolling of the filiform element (160). 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 handgrip and the inner surface of the actuating button (124), the drive roller (180) is moved away from the free roller (181), and the filiform element (160) is thus released and can then be moved manually.
[0069] The operation of this actuating button (124) is very intuitive. It controls the instantaneous opening or closing of the tool engagement mechanism: [0070] instantaneous engagement/disengagement of the tool moved by the filiform element (160); [0071] safety by immediate stopping for advance/withdrawal of the tool moved by the filiform element (160); [0072] instant switching between manual and automatic operation.
[0073] Manual operation of the tool allows a return to normal use of the endoscope without having to remove the motorized module.
[0074] Attaching the instrument to the working channel of the endoscope (
[0075] Attaching the module on the handgrip does not require an attachment element such as a collar or a clip, but is achieved by a frustoconical part shown in FIG. (13), having a flange (270) ensuring the seal between the working channel and the motorized module, extended by a tapered endpiece (271). Introducing into the working channel a “standard” endoscope of the longitudinal endpiece (271) that extends 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 handgrip. The generally tubular or tapered ring (271) has a seal (272) that seals the sheath (170) relative to the endoscopic guide. This seal (272) comprises a bead that engages by deformation and wedging around the end of the working channel (also comprising a bead).
[0076] The frustoconical endpiece (271) has, at its proximal end, a disc expansion (270) that engages in a complementary receiving zone provided on the front face of the motorized unit (120). The proximal end of the endpiece (271) has a circular space in which a seal (195) engages. This solution makes it possible to physically separate the working channel from the guide (1), from the motor and from the drive mechanism constituting the upper part of the motorized block (120). One or more fluid seals seal the fluid in the rod (1) passage.
[0077] Applications
[0078] The invention has multiple applications, which relate in particular to echo-endoscopically guided sampling with a fine needle (EUS-FNA), with cytological and histological study. Endoscopic ultrasound (EUS) has become an essential protocol for determining the stage of cancer in the gastrointestinal system, especially when combined with fine needle aspiration (FNA) or a fine needle biopsy (FNB) of body tissues. The FNA biopsy is performed using a dedicated needle called the FNA needle. During the procedure, an EUS imager is brought into contact with a body wall behind which the biopsy site is located, and then an FNA needle is advanced through the working channel of the EUS endoscope. The needle is advanced through the body wall to the site to be biopsied, usually a suspicious lesion, and negative pressure is applied to the inner end of the needle to retrieve tissue samples. The needle is then removed from the EUS field and the tissue sample is retrieved and analyzed.
[0079] The FNA needles available on the market 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 FNA needle proximal end handle comprises: [0080] 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 to the handgrip body; [0081] a needle slider for sliding and exposing the needle past the distal end of the sheath to reach the biopsy site; [0082] a safety ring that can be attached to the body of the handgrip to limit the longitudinal travel of the needle slider so that multiple needle insertions can be easily performed by the user; [0083] a port at the proximal end of the handle for applying negative pressure to the hollow inner bore of the needle.
[0084] 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 the passage speed are controlled by doctors. Usually, a long pass generally receives more sample than shorter passes, and a slow pass generally 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 can lead to undersampling 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 has been mentioned in patent DE10128336, a method has been proposed. This method of collecting cell samples by fine needle aspiration (FNA) biopsy consists in introducing a fine needle of a sampling device into the tissue, this fine needle being subjected to a vacuum; it is set in motion relative to the tissue, then the vacuum is released and the fine needle is withdrawn from the tissue.
[0085] The present invention provides a device with a tool control interface that improves control of biopsy needle sampling, standardizing tissue sampling that allows better reproducibility, planning and estimation of tissue samples. With prior art handgrips, actuation of the needle slider requires the endoscopist to leave his right hand on the axis of the endoscopic sight, which results in a loss of control of the endoscope and decreased accuracy. This is an important limitation because reaching different locations in the lesion is critical for diagnostic yield. A system that allows the user to operate an FNA needle while keeping one hand on the handgrip and the other on the rod of the endoscope is therefore desirable.
[0086] The control interface according to the invention can advantageously be used to control an FNA needle, the user keeping his right hand on the rod of the endoscope. The movement of the shaft and the needle can be controlled by operating the control interface.
[0087] Clean Specification
[0088] In a preferred embodiment, needle insertion is controlled by the right hand using the control interface, and a one-dimensional drive control allows for slow and precise needle operation. Once the needle is inserted to the desired depth, a second Boolean sampling control (on/off) can be used to repeat the motion: once the sampling control is pressed, the needle is retracted and reinserted at the same distance. This feature allows the user to make multiple passes with a similar depth while varying the position of the scope (ventilation technique) to reach multiple sites within the lesion. The needle can then be withdrawn using the drive controller and it can be withdrawn from the endoscope.
[0089] 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 sample control, the needle is inserted to the depth set by the length selector and returned to a default position.
[0090] In one embodiment, the control interface (100) is used in conjunction with an FNA needle integrating 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 integrating a battery. 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.
[0091] Summary of the “biopsy” application [0092] 1) An endoscope according to the invention, or a standard endoscope supplemented by a module according to the invention, comprises two parts intended for the operation of the endoscopic instrument: a user control interface and a drive unit. [0093] 2) The user control interface is mounted on the handgrip (2) of the endoscope and just below the suction and irrigation buttons (20, 30). The user control (114) comprises a first control button for applying a relatively slow movement command, and optionally a sampling button that continuously advances and retracts the biopsy needle for a fixed number of passes at the predefined length, set by the length selector. [0094] 3) Before attaching the drive unit to the sight, the needle safety ring should be tightened securely, ideally to the maximum length. This allows the needle to travel the maximum distance and to have the center weight point closer to the scope handgrip. [0095] 4) The drive unit consists of a linear actuator consisting of two parts, a non-sliding part and a sliding part. Each part containing an attachment means that is mounted on the biopsy needle device. The attachment means on the non-sliding part is attached to the safety ring of the needle device. The attachment means on the sliding part is attached to the sliding handgrip of the biopsy device. [0096] 5) The drive also comprises a lever-operated safety mechanism. When it is disabled, manual control of the needle device is possible. [0097] 6) To take a biopsy sample, the endoscopist advances the needle near the desired location using the drive controller or manually. A desired length is set on the length selector on the sliding part of the drive unit. A needle is advanced into the lesion via the drive control button. The desired needle penetration length can be adjusted, if necessary, until the needle arrives at the desired location in the target. [0098] 7) Once the needle is in the target and the desired penetration length is selected, multiple passes of the needle 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 to each other for a preset time. This movement of the linear actuator causes the needle to advance and retract to the preset distance based on the length selector. [0099] 8) When a set of passes is complete, the user can manually reposition the needle and readjust the desired penetration length, if necessary. Steps 8 and 9 are repeated until enough samples are collected. [0100] 9) Documentation of the sampling procedure—the user records each preselected length and the corresponding number of passes made by pressing the sampling button.
[0101] “Forceps” Application
[0102] Common endoscopic tools, such as forceps and collets (for example), require manual opening or closing of the tool handgrip (see
[0108] Modulation of the Movement Speed of the Endoscopic Instrument
[0109] Some endoscopic procedures require different speed controls, including slow speed for precise motion control and rapid advancement that allows perforation through the membrane of a structure. According to a variant, the invention makes it possible to provide two different speed control buttons on the user control interface, which allow more valuable control of the speed of the device, or even an indexed sensor making it possible to select the appropriate speed using the control button (114).
[0110] Module Setup
[0111] The configuration of the heel (112) of the actuation module can assume different forms, depending on the nature of the sensor that it bears. By way of non-limiting examples, six particular configurations are presented below.
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