Control system for colonoscopy

Abstract

A control system for a colonoscope having a shaft that can be deflected by two rotatable knobs is provided. The system includes a first drive unit mounted outside a colonoscope housing. The first drive unit includes a first drive mechanism for engaging the two rotatable knobs or gears in place of the two rotatable knobs. The system also includes a second drive unit attachable to the shaft of the endoscope. The second drive unit is capable of linearly translating the shaft back and forth. A user interface engageable by a palm controls the first drive mechanism.

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 981,569, filed February 26, 2020, the entire contents of which are incorporated herein by reference.

[0003] Technical Field and Background Technology

[0004] This invention relates to a system for electrically controlled standard colonoscopes. Embodiments of the invention relate to a control system including a control interface, a connected electric drive unit, and an adapter for retrofitting a standard colonoscope.

[0005] A colonoscopy is a medical procedure that involves inserting a flexible endoscope or colonoscope into a patient's lower gastrointestinal tract to perform diagnostic examinations and / or surgical procedures on the colon. A standard colonoscope is typically 135-185 cm long and 12-19 mm in diameter, and includes a control head and a flexible shaft with operable tips, including a camera or a fiber optic cable. The control head is connected to a light source via an umbilical cord, through which other tubes supply air, water, and suction. A working channel allows for the passage of diagnostic or therapeutic instruments.

[0006] Two rotatable knobs, one mounted on top of the other, are installed on the side of the control head and are used for up / down and right / left movement of the shaft tip. The colonoscope is manually advanced into the lower digestive tract by pushing and pulling the control head and shaft.

[0007] The lower colon is highly tortuous, and as the colonoscope is advanced inside, it rubs against the colonic mucosa along the outer edge of each rotation. The friction and relaxation of the colonoscope increase with each rotation, making it increasingly difficult to advance and withdraw.

[0008] Colonoscopy can be performed through complex anatomical structures; however, this procedure requires experience and the use of both hands, making it impossible to simultaneously control any other instruments (such as diagnostic or therapeutic tools positioned through the working channel).

[0009] To address this limitation of standard flexible colonoscopes, the inventors designed a control unit that allows the operator to remotely control the tip of the flexible endoscope and the advance of the colonoscope axis. Summary of the Invention

[0010] The present invention provides a control system for a colonoscope having an axis deflectable by two rotatable knobs, the control system comprising: a first drive unit mounted outside a housing of the colonoscope, the first drive unit including a first drive mechanism for engaging the two rotatable knobs or gears replacing the two rotatable knobs; a second drive unit attachable to the axis of the endoscope, the second drive unit being capable of linearly translating the axis back and forth; and a user interface including a first interface mounted on a pivot support, the first interface being ergonomically oriented to a palm, the user interface being used to control the first drive unit and optionally control the second drive unit.

[0011] The control system may further include a third drive unit that can be connected to the axis of the "small tool" and is capable of linearly translating the axis of the "small tool" forward and backward; and activating the end effector at the distal end of the axis of the "small tool".

[0012] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While similar or equivalent methods and materials may be used in the practice or testing of this invention, suitable methods and materials are described below. In case of conflict, the patent specification (including definitions) shall prevail. Furthermore, materials, methods, and examples are illustrative rather than restrictive. Attached Figure Description

[0013] The invention has been described herein by way of example only with reference to the accompanying drawings. A detailed description is now given with reference to the drawings, emphasizing that the details shown are merely illustrative and intended only to illustrate preferred embodiments of the invention and to provide the reasons for the invention being described in the most useful and readily understood manner in terms of principles and concepts. In this regard, no attempt is made to show the structural details of the invention in more detail than necessary for a basic understanding of the invention; the description, taken in conjunction with the drawings, makes it clear to those skilled in the art how various forms of the invention can be embodied in practice.

[0014] In the attached diagram:

[0015] Figure 1 The system is illustrated in an operating room environment.

[0016] Figure 2 The diagram illustrates the system mounted on a trolley.

[0017] Figure 3a -i indicates the configuration with standard control knobs ( Figure 3d -f) or adapter gear ( Figure 3g Standard colonoscopy (i) Figure 3a ).

[0018] Figure 4a -l shows the shaft deflection drive unit of the present invention and its components, with the "baby tool" shown in Figure 4e and the baby tool drive module shown in Figure 4f -l.

[0019] Figure 5a -c shows the shaft push / pull drive unit of the present invention.

[0020] Figure 6a -c shows the finger interface ( Figure 6a ) and its various control states ( Figure 6b -c).

[0021] [[ID==2]] Figure 7a -c shows the endoscope shaft and "baby tool" interface of the present invention.

[0022] Figure 8a -h shows the addition module and interface that allow control of the rolling motion of the endoscope shaft.

[0023] Figure 9a -g schematically shows a series of interface inputs and the advancement of the corresponding shaft within the colon.

[0024] Figure 10 shows one of the many possible setting configurations of the system.

[0025] Figure 11 is a flowchart outlining the settings of the colonoscopy control system and the workflow capable of switching between electric and manual modes.

[0026] Figure 12a y]] -h shows the bench-testing of a prototype constructed according to the teachings of the present invention. Detailed Description

[0027] The present invention is a colonoscopy control system that can be used to control a standard colonoscope. Specifically, the present invention can be used to remotely control a standard colonoscope, enabling a surgeon to accurately manipulate the colonoscope through the lower digestive tract and operate a "baby tool" positioned through the working channel of the endoscope.

[0028] The principles and operations of the present invention can be better understood by referring to the accompanying drawings and the attached description.

[0029] Before explaining at least one embodiment of the present invention in detail, it should be understood that the application of the present invention is not limited to the details set forth in the following description or illustrated by the examples. The present invention is capable of having other embodiments or of being practiced or carried out in various ways. In addition, it should be understood that the terminology used herein is for the purpose of description and should not be regarded as restrictive.

[0030] Performing a standard colonoscopy through the tortuous anatomy of the lower digestive tract requires skill and experience. One of the most serious complications of colonoscopy is colonoscopic perforation, reportedly occurring in 0.03% to 0.7% of cases. Although colonoscopic perforation (CP) is a rare complication, it is associated with high mortality and morbidity.

[0031] While putting this invention into practice, the inventors designed a colonoscopy control system that can accurately and intuitively control the operation of the colonoscope in the lower digestive tract. As further described herein, this control system can be retrofitted to existing standard colonoscopes and can switch between electric and manual control of axis advance and / or deflection.

[0032] Therefore, according to one aspect of the invention, a control system is provided for a colonoscope having an axis that can be deflected by two rotatable knobs.

[0033] The control system of the present invention includes a first drive unit mounted outside a housing of a colonoscope. The first drive unit includes a first drive mechanism for engaging two rotatable knobs of the colonoscope, or an adapter including gears replacing the two rotatable knobs. The gears are mounted on the shafts of the two rotatable knobs.

[0034] The control system also includes a second drive unit that can be attached to the axis of the endoscope via (e.g., a roller). The second drive unit is capable of linearly translating the axis forward and backward and maneuvering the axis forward through the lower digestive tract.

[0035] The control system also includes a user interface comprising a first interface mounted on a pivot support (e.g., a gimbaled universal joint) and engageable with the user's palm. Such an interface can be used to control the first drive mechanism to operate the up / down and left / right deflection of the shaft.

[0036] The user interface may further include a second interface for controlling the second drive mechanism. The second interface may include a slider interface for linearly translating the axis forward and backward.

[0037] The user interface may further include a third interface pivotally attached to the first interface. This interface may be operated by one or more fingers of one hand (e.g., a pad operated simultaneously by the thumb and forefinger of the hand) and used to control the linear axis forward and backward movement of the endoscope axis clamping mechanism.

[0038] The user interface may further include a fourth interface, which includes a slider button for linearly translating the "small tool" axis forward and backward. The user interface may also include a fifth interface, which can be operated by one or more fingers of one hand (e.g., a pad that can be operated simultaneously by the thumb and forefinger), for actuating tools (e.g., grippers, lassos) positioned through the working channel of a colonoscope.

[0039] A typical layout of the control system of the present invention includes a first drive unit connected to the colonoscope control knob (or connected to the shaft via a gear adapter), a second drive unit connected to the shaft (e.g., via a roller), and a user interface located away from the colonoscope and connected to the drive units via a wired or wireless connection. The user interface can be placed near the colonoscope and the patient in or outside the operating room (e.g., in telemedicine), in which case the patient and colonoscope can be visualized via a remote camera.

[0040] Please refer to the attached diagram. Figure 1 and Figure 2 This describes the typical operating room setup of this system. Figure 1 ) and stroller layout ( Figure 2 This is referred to herein as System 10. The surgeon 14 can use monitor 12 to monitor the procedure. For example... Figure 1 As shown, the system 10 is positioned near the patient 700 using a trolley 20. The modules of the system 10 are optimally arranged on different articulated shelves 22 (see below). Figure 10-11 (Further description). The surgeon operates the colonoscope 24 through user interfaces 400 and 401.

[0041] Figure 3a -c shows an off-the-shelf colonoscope 24 (Pentax EC-3831L flexible video colonoscope endoscope), whose body 26 is equipped with manual knobs 28 and 30. The surgeon 14 can deflect the distal end 32 of the shaft 33 by rotating the knobs 28 and 30 to the desired direction. A camera cable and a light source 34 with an attachment adapter 36 are also connected to the body 26 of the colonoscope 24.

[0042] Figure 3b Adapters 40 and 42 are shown as replacements for the manual knobs 28 and 30. Adapters 40 and 42 have keyhole patterns designed to engage with the ends of shafts 44 and 46, which serve to mechanically transmit the knob input to the articulated mechanism of the colonoscope 24. Adapter 40 has a circular base 48, and adapter 42 has a circular base 50. Circular bases 48 and 50 serve as stoppers for the manual knobs 28 and 30, or for mechanical gears modified in their location. Figure 3bValve buttons 52 and 54 of colonoscope 24 are also shown, which provide interfaces for (respectively) suction and air / water (respectively) passage through channels 51 and 53.

[0043] Figure 3c Adapters 40 and 42 are shown connected to shafts 44 and 46 (lock holes prevent adapters 40 and 42 from sliding).

[0044] Figure 3d -f illustrates one embodiment of the invention, wherein manual knob 28 is connected to adapter 42 and manual knob 30 is connected to adapter 40. This coupling still allows colonoscope 24 to be manually operated via knobs and facilitates quick switching between manual and electric operation of colonoscope 24.

[0045] Figure 3g -i illustrates the connection between gear 60 and adapter 40, and gear 62 and adapter 42. Following this connection, colonoscope 24 can be assembled with drive unit 66 for actuating the articulated mechanism via gears 60 and 62. Additional functions of colonoscope 24 (various valves and buttons) can also be connected to other drive / control mechanisms, thereby switching colonoscope 24 from manual operation to fully electric operation.

[0046] Figure 4a -k illustrates the components of the drive unit 66. The drive unit 66 is attached to the outer surface of the body 26 of the colonoscope 24. The motor of the drive unit 66 is connected to the knobs 40 and 42 of the colonoscope 24 (or connected to the shaft via gears), enabling any standard manual colonoscope to be converted into an electric (e.g., robotic) colonoscope.

[0047] Figure 4a The coupling of motors 68 and 69 to gears 60 and 62 mounted on colonoscope 24 is shown. The housing 70 of drive unit 66 is secured to colonoscope body 26 via bracket 72. Motors 68 and 69, attached along vertical plate 78 of chassis 70, are connected to gears 60 and 62 via worm gears 74 and 76. Potentiometers 80 and 82 are also connected to vertical plate 78 and to worm gears 74 and 76 via gears 61 and 63. Motor controller 75 is secured to colonoscope body 26 via bracket 72.

[0048] Figure 4c -e shows the drive unit, referred to herein as drive unit 132, which can be used to control the advance and actuation of the "small tool" through the working channel of colonoscope 24.

[0049] Colonoscopy often requires sampling or processing of tissue during the procedure. This sampling or processing can be performed using a "small instrument" inserted through the working channel of colonoscope 24 and positioned distal to the colonoscope axis 33 so that its end effector is close to the desired tissue. The surgeon can then use the end effector (e.g., a grasper or lasso or any other tool) to process or retrieve the tissue sample.

[0050] Figure 4e A typical small tool (referred to herein as tool 110) is shown. Tool 110 includes a thin, flexible shaft 112 (typically 1.2-3.1 mm in diameter and 60-210 cm in length). Tool 110 includes an end effector 114 located at the distal end of shaft 112. End effector 114 is typically manually operated using a fixed handle 118 and a sliding button 127. Pushing the sliding button 127 past handle 118 toward the distal end of shaft 112 opens the jaws of tool 110, and vice versa.

[0051] Figure 4c An adapter 130 connected to the housing 70 is shown. The adapter 130 connects the tool 110 push / pull drive unit 132 to the housing 70 using a screw (not shown) passing through a hole 134. A port 136 in the body 26 provides access to the working channel of the colonoscope 24.

[0052] Figure 4d The basic components of the drive unit 132 of tool 110 are shown. In order to translate the shaft 112 out of the working channel and accurately position the end effector 114 at the desired anatomical landmark, the shaft 112 is inserted into the groove 142 of adapter 130 and secured by knob 144.

[0053] The adapter 130 is connected to a slider 148 with a typical range of motion of 50 mm. The slider 148 is driven by a screw mechanism, which includes a screw 156, a motor (not shown), and a gear 158 coupled to a gear 160.

[0054] To use tool 110, the surgeon slides shaft 112 through the working channel of colonoscope 24 until end effector 114 is visible in monitor 12. The surgeon then secures shaft 112 to adapter 130 as described above.

[0055] Figure 4f A drive unit 132 is shown connected to the housing 70 via an adapter 130, with the recess 142 aligned with the center of the port 136.

[0056] Figure 4g An electric mechanism 170 is shown for electrically actuating the intake valve 52 and the air / water valve 54.

[0057] The housing 70 includes a protrusion 180 serving as the housing for solenoids 182 and 184, which (respectively) activate valves 52 and 54. The surgeon controls the state of each valve via a switch, as shown below. Figure 7b Further description.

[0058] Figure 4h A configuration is shown in which drive unit 132 and drive unit 66 share a common housing 192. Rail 194 forms part of housing 192 and serves as a connector for the opening / closing module 198 of tool 110. Figure 4i Module 198 can be releasably connected to drive unit 132 via connector 200. Connector 137 is part of chassis 210. To initiate the opening / closing action of tool 110, handle 118 is inserted into module 198, with shaft 112 pointing towards drive unit 132. Button 127 of tool 110 is engaged with the opening / closing mechanism of module 198, and cover 206 slides on chassis 210 to close module 198.

[0059] Figure 4j The opening / closing mechanism of module 198 is shown. The handle body 118 is clamped into housings 218 and 222, and the sliding button 127 is clamped into the arm of the rotating rod 224. The rod 224 is connected to a servo motor 226, which in turn is connected to the chassis 210 via a slider 228. The slider 228 of the servo motor 226 is used to optimize the rotation point of the rod 224, thereby enabling the use of different types, lengths, and shapes of small tools.

[0060] When lever 224 is turned forward, handle 127 is pushed forward. Handle 127 is connected to end effector 114 via a push / pull cable. By pushing the push / pull cable of miniature tool 110, the jaw mechanism of end effector 114 opens the jaws. Moving slide button 127 backward will cause the jaws of end effector 114 to close.

[0061] Figure 4k A typical configuration of drive units 66, 132, and module 198 is shown. Drive unit 132 is connected to drive unit 66. Module 198, which initiates the opening and closing of the small tool remote actuator 114, is connected to drive unit 132.

[0062] Figure 4l The drive units 66 and 132, as well as module 198, are shown assembled in housing 217. As further described below, vacuum pad 237 is used to secure housing 217 to any flat surface.

[0063] Figure 5a -c shows a drive unit 300 for advancing / retracting the flexible shaft 33 of the endoscope 24.

[0064] Figure 5a This is a perspective view of the drive unit 300. The drive unit 300 includes an electric linear mechanism 302 and two gripping actuators 308 and 310, wherein the electric linear mechanism 302 linearly drives a linear slider 304 having a linear stroke range of 100 mm.

[0065] Rollers 312 and 314 are located on the sides of arm 315, with groove 316 located between them. The roller and groove arrangement guides flexible shaft 33 into gripper actuator 310. Cover 344 is typically connected to plate 22 via vacuum pad 330. Plate 22 is connected to trolley 20 via arm 402.

[0066] Button 340 on cover 344 controls two gripping actuators (308 and 310). To mount the flexible shaft 33 in the drive unit 300, the surgeon clicks button 340 to open gripping actuators 308 and 310, then the flexible shaft 33 can be placed between the grippers of gripping actuators 308 and 310, and the flexible shaft 33 is locked inside gripping actuators 308 and 310 by clicking button 340 again.

[0067] Figure 5b The components of the drive unit 300 are shown. The body 350 includes a screw-based linear drive mechanism that drives a slider 304 on the body 350 (from point P indicating proximal position to point D indicating distal position). A gripping actuator 308 is attached to the slider 304. The gripping actuator 308 travels linearly with the slider 304 and is hereinafter referred to as the "moving gripping actuator". A gripping actuator 310 is attached to the proximal end P of the body 350 and is hereinafter referred to as the "fixed gripping actuator". Both gripping actuators 308 and 310 have caps 368 designed for optimal contact with the flexible shaft 33, thereby enabling the use of different types of endoscopes with different coating materials and diameters.

[0068] Figure 5c Grip actuators 308 and 310 are shown. Body 360 includes motor 361 and a screw-based linear mechanism. The linear mechanism drives arms 362 and 364 along track 366.

[0069] Figure 6a -c and 7a-b show the user interface of the drive unit 300 (interface 400 below).

[0070] In order to push / pull the axis 33 via the drive unit 300, the surgeon grasps the palm rest 402 of the body 404 of the interface 400. Figure 7a ), the finger pads 406 and 408 of the index finger and thumb joint finger interface 405 ( Figure 6b -c). Finger pads 406 and 408 are available Figure 6b The open state shown and Figure 6c The closed states shown are actuated.

[0071] Finger pads 406 and 408 control gripping actuators 308 and 310. When finger pads 406 and 408 are open, as... Figure 6b As shown, the jaws of the gripper 308 are open. When the finger pads 406 and 408 are closed, in Figure 6c In the process, the jaws of the clamping actuator 308 close and apply frictional force to the flexible shaft 33. This frictional force allows the surgeon to control the push / pull of the flexible shaft 33.

[0072] The control interface 400 also controls the distal joint 32 of the flexible shaft 33, as well as the suction valve and air / water valve. To understand the mechanism and structure of the distal joint 32 controlled by the interface 400, refer now to... Figure 7b .

[0073] Figure 7b The structure and components of valves 52 and 54, which allow surgeons to simultaneously control the joint of flexible shaft 33, the suction valve, and the air / water function via buttons 154 and 156, are shown.

[0074] To control the left / right upward / downward movement of the joint, the surgeon rotates the interface body 404 to the desired side and height. Potentiometers 170 and 172 measure the orientation of the body 404 (e.g., ...). Figure 7b (As shown), and their electrical signals are converted by the electrical controller 75 into rotation commands for motors 68 and 70. When motors 68 and 69 rotate, worm gears 74 and 76 rotate, causing the shaft of the distal joint motion mechanism to rotate. Simultaneously, worm gears 74 and 76 also cause gears 61 and 63 to rotate. Gears 61 and 63 are connected to rotary potentiometers 80 and 81.

[0075] Signals from potentiometers 80 and 81 are sent to controller 75 and compared with signals from directional potentiometers 170 and 172 from body 404, so that controller 75 will send the next rotation command to motor until the potentiometers 80 and 81 from motor and potentiometers 170 and 172 from control interface body 404 are equal or within the allowable difference range.

[0076] The above measurements and motion cycles can be sampled at frequencies of 100Hz or higher to ensure a rapid response of the joint mechanism without any delay.

[0077] like Figure 7aAs shown, the body 404 is connected to the housing 412. The housing 412 can slide linearly between the proximal end 414(p) and the distal end 416(d) of the housing 418. A linear potentiometer 415 is positioned within the housing 418, and as the surgeon slides the housing 412 along the slider housing 420, the linear potentiometer 415 measures the position and orientation of the interface body 404. The combined measurements of the body 404 of the interface 400 and the states of the finger pads 406 and 408 enable the surgeon to control the drive unit 300, which will... Figure 9a The -g option is described in detail.

[0078] In order to control the "miniature tool" axis via the push / pull module 132, the surgeon holds the flat portion of the body 407 of the interface 401. Figure 7c The potentiometer slider measures the position of the interface body 407 along the slider housing 429 and the sliding housing 419. The position signal from the potentiometer is sent to the controller 75, which converts the signal into a motion command to the module 132, which drives the "mini-tool" axis 112. While controlling the linear movement of the axis 112, the surgeon can simultaneously control the activation of the end effector 114 by controlling the open-close state of the pads 406 and 408 of the finger interface 405. The controller 75 measures the state of the pads 406 and 408 and activates the open-close module 198 accordingly, enabling the surgeon to control the position of the distal end of the "mini-tool" axis 112 while simultaneously controlling the activation of the end effector 114.

[0079] Figure 8a The -h option indicates an additional electric module that enables the flexible shaft to roll along its long axis. Surgeons can use this rolling motion to better position the distal end of the flexible shaft as it advances through the digestive tract.

[0080] To rotate the endoscope's flexible shaft 33, module 500 is connected to push / pull module 300 via connector 510. The center of the flexible shaft is at the center of arc 508 (positioning point C). Arc 508 is hinged to frame 502. Arc 508 includes a gear 507 at its distal end that meshes with worm gear 506. Motor 504 rotates the worm gear. When motor 504 is driven by interface 400 (refer to...) Figure 8e When activated (-h description), the push / pull module 300 rotates around point C, as follows: Figure 8c -d is shown.

[0081] Figure 8e-h illustrates the additional rotating frame module 600. Module 600 is contained within a fixed base 606 with vacuum feet 604. Frame 608 is hinged to the fixed frame 606 via hinges 603 and 605. Rotation sensor 602 is connected to hinge 605 and continuously measures angle α. To control the rotation of the colonoscope axis about its center, interface 400 is attached to surface 607 of rotating frame 608 via vacuum pad 150. To rotate the colonoscope axis, the surgeon tilts the interface, thereby similarly rotating frame 608. The rotation sensor measurements are used as input to motor 504, which rotates module 600 about center point C. Figure 8g -h illustrates the tilt position of frame 608. This interface configuration allows surgeons to simultaneously and intuitively control the push / pull movements of the flexible shaft 33, the joints (left / right, up / down) of the distal end 32, and the roll angle of the flexible shaft 33.

[0082] The gripper actuator 308 has several operating states:

[0083] (i) Closed and static;

[0084] (ii) Open and static;

[0085] (iii) Closure via distal movement (towards the patient's body);

[0086] (iv) Closure via proximal movement (away from the patient's body);

[0087] (v) Enable distal movement; and

[0088] (vi) Opening and proximal movement.

[0089] Figure 9a -g schematically illustrates a series of interface 400 inputs and corresponding mechanical outputs of drive unit 300.

[0090] Figure 9a The flexible shaft 33 is schematically shown, with its distal end located at point A in the patient's lower digestive tract. Finger pads 406 and 408 are in the open position, and the gripping actuator 308 is also open. The gripping actuator 310 is closed to eliminate any unwanted movement of the colonoscope shaft 33.

[0091] Figure 9b The finger pads 406 and 408 are shown in a closed state, with the gripping actuator 308 also closed and gripping the flexible shaft 33. However, the gripping actuator 310 is open, and the shaft 33 does not move because the surgeon has not moved the palm rest 404.

[0092] When the surgeon moves the interface body 404 distally toward point D with finger pads 406 and 408 in the closed position, the gripping actuator 308 moves toward point D. Since the gripping actuator 310 is open, the flexible shaft 33 translates from point A to point B within the patient's digestive tract.

[0093] To advance axis 33 from point B to point C, the surgeon opens finger pads 406 and 408, thereby closing gripper 310 and opening gripper 308. Figure 9d The surgeon then slides the interface body 404 to point P, and then closes the finger pads 406 and 408, thereby closing the gripping actuator 308 and opening the gripping actuator 310. With the finger pads 406 and 408 closed, the interface body 404 is moved distally. Figure 12g This causes the flexible axis 33 to move to point C. This sequence of events is similar to the manual squeezing and dragging of the colonoscope axis, allowing the surgeon to drag the flexible axis 33 forward and backward in an intuitive manner that mimics a manual procedure, without needing to acquire new skills or surgical techniques. It should be noted that, for example, in situations requiring haptic feedback, the surgeon can choose to manually control the movement of the flexible axis 33 at any time.

[0094] The ratio between the linear motion of the palm support body 404 and the travel of the distal end of the flexible shaft 33 can be selected by the surgeon at any time during the procedure, according to their needs. A typical ratio can be between 1:0.5 and 1:4.

[0095] The system 10 of the present invention can be used for the following lower gastrointestinal procedures (e.g., colonoscopy).

[0096] Figure 10 This describes the typical settings of System 10, which can be used for lower gastrointestinal procedures.

[0097] The patient 700 lies on their side, facing away from system 10. The distal end of the flexible shaft 33 is inserted into the patient's lower digestive tract through the anus. The drive unit 300 is moved to the desired position, and the flexible shaft 33 is mounted in the drive unit 300 and grasped by two gripping actuators (308 and 310). Drive units 66, 132, and 198, sharing a common cover 192, are assembled into a base 217 located on shelf 22 and moved by arms 422 and 423 to the optimal position relative to drive unit 300. Relaxation of the flexible shaft 33 is handled by front wheels 312 and 314. The colonoscope control interface 400 and the miniature tool control interface 401 are located on separate plates for the surgeon's convenience.

[0098] To perform the procedure, the surgeon holds interfaces 400 and 401 and moves the flexible shaft 33 through the lower digestive tract. The surgeon can use interface 400 to position the distal end of the flexible shaft in the optimal location relative to the patient's anatomy and joint orientation, while using interface 401 to control the position and activation of the small tool end effector. At any time, the surgeon can access the device by pressing buttons 154 and 156 located on the front of interface body 404 (e.g., ...). Figure 7b (As shown) to operate the suction / flushing system and air system. Furthermore, at any time (e.g., when tactile feedback is required), the surgeon can choose to disconnect the endoscope and small instruments from the power module to manually control the movement of the flexible shaft 33 and / or the small instruments.

[0099] Figure 11 This is a block diagram describing the selection of working modes for a colonoscope equipped with and optionally controlled by this system.

[0100] When a surgeon prepares for a colonoscopy, he / she can select the preferred operating mode at the start. If the surgeon prefers to start in manual mode (left branch of the diagram), he / she installs the manual knob on the adapter. If the surgeon prefers to start in electric mode (right branch of the diagram), he / she installs the gear on the adapter and then installs the electric drive unit described above.

[0101] At any stage of the surgery, the surgeon can switch between electric and manual modes. For example, if the surgeon wishes to switch to electric mode while working in manual mode, he / she simply removes the manual knob and installs the gears, adapter, and drive unit. This process can be reversed if the surgeon wishes to switch back to manual mode.

[0102] As used in this article, the term "about" refers to 10%.

[0103] Further objects, advantages and novel features of the present invention will become apparent to those skilled in the art upon examination of the following embodiments, which are not intended to be limiting.

[0104] Example

[0105] The invention is now illustrated in a non-limiting manner with reference to the following examples, which, together with the above description, illustrate the invention.

[0106] Benchmarking the prototype system

[0107] A prototype of the system was built, and its functionality was benchmarked.

[0108] Figure 12a-b illustrates a flexible axis interface 400, with the operator's hand gripping the main body 404 of the interface 400. The distal portion 32 of the flexible axis 33 is hinged according to the orientation of the main body 404—in Figure 12a Right side and in Figure 12b Above.

[0109] These figures also show the push-pull module 300. The finger pads 406 and 408 are in the open position (and the gripper 308 is open and the retaining gripper 310 is closed).

[0110] A digestive tract simulator (labeled 499) is used to test flexible shafts. Figure 12c Manipulation using -g). Figure 12c The movement of the flexible shaft 33 and the distal portion 32 in a digestive tract simulator is demonstrated. Figure 12d The distal end of the "small tool" axis 112 and the gripper 114 of the small tool 110 conveyed from the distal end of the distal portion 32 of the axis 33 are shown. Figure 12e The joint control capability of the system is demonstrated, showing the distal portion 32 articulated and guided out of the digestive tract simulator. Figure 12f The ability to control a small tool 110 (axis 112 and end effector 114) is demonstrated when the flexible axis 33 guides the digestive tract simulator. Figure 12g The control of the distal joint 32 of the flexible shaft 33 and the accompanying control of the small tool 110 are demonstrated. Figure 12h The manual control of the flexible shaft 33 is demonstrated when the grippers 308 and 310 are in the open position.

[0111] It should be understood that, for clarity, certain features of the invention described in the context of a single embodiment may also be provided in combination in a single embodiment. Conversely, for brevity, various features of the invention described in the context of a single embodiment may also be provided individually or in any suitable sub-combination.

[0112] Although the invention has been described in conjunction with specific embodiments thereof, it will be apparent to those skilled in the art that many alternatives, modifications, and variations will be readily apparent. Therefore, it is intended to cover all such alternatives, modifications, and variations falling within the spirit and broad scope of the appended claims. All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety, as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated herein by reference. Furthermore, any reference or designation of any reference in this application should not be construed as an admission that such reference is prior art to the invention. Within the scope of the use of section headings, they should not be construed as necessarily limiting. Furthermore, any priority documents of this application are incorporated herein in their entirety.

Claims

1. A control system for a colonoscope having an axis deflectable by two rotatable knobs, characterized in that: The control system includes: (a) A first drive unit, mounted outside a housing of the colonoscope, the first drive unit including a first drive mechanism for engaging two rotatable knobs or gears that replace the two rotatable knobs; (b) A second drive unit, attachable to the outer surface of the colonoscope's axis, the second drive unit being capable of linearly translating the colonoscope's axis forward and backward; and (c) A user interface, including; A first interface mounted on a pivot support, the first interface being accessible to the palm of the hand, the user interface being used to control the first drive mechanism; and A second interface for controlling the second drive unit, the second interface being able to slide back and forth to linearly translate the axis forward and backward.

2. The control system as described in claim 1, characterized in that: The gear is part of an adapter that connects to the outer surface of the colonoscope's housing.

3. The control system as described in claim 1, characterized in that: The first drive unit controls the up / down and left / right deflection of the shaft.

4. The control system as described in claim 1, characterized in that: The control system further includes a third interface pivotally attached to the first interface and engageable with one or more fingers of the hand, the third interface being used to operate an end effector.

5. The control system as described in claim 4, characterized in that: The third interface includes a pad that can be operated simultaneously by the thumb and forefinger of the hand.

6. The control system as described in claim 1, characterized in that: The pivot support is a universal joint.

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