Colonoscope control system

Abstract

A control system for a colonoscope having a shaft deflectable via two rotatable knobs is provided. The system includes a first drive unit external to the housing of the colonoscope. The first drive unit includes a first drive mechanism for engaging with the two rotatable knobs or gears in place of the two rotatable knobs. The system further includes a second drive unit attachable to the shaft of the endoscope. The second drive unit can linearly translate the shaft back and forth. A palm-engageable user interface controls the first drive mechanism.

Description

[Technical Field]

[0001] Related Applications This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 981,569, filed February 26, 2020, the contents of which are incorporated herein by reference in their entirety. [Background technology]

[0002] The present invention relates to a system for motorized control of a standard colonoscope. An embodiment of the present invention relates to a control system that includes a control interface, a coupled motorized drive unit, and an adapter for retrofitting a standard colonoscope.

[0003] Colonoscopy is a medical procedure in which a flexible endoscope, or colonoscope, is advanced into a patient's lower gastrointestinal tract to perform diagnostic examination and / or surgical treatment of the colon. A standard colonoscope is generally 135–185 cm long and 12–19 mm in diameter, and includes a control head and a flexible shaft with a steerable tip containing a camera or fiber optic bundle. The head is connected to a light source via an "umbilical" cord, which carries other tubes for conveying air, water, and suction. A working channel is used to pass diagnostic or therapeutic tools.

[0004] Two rotatable knobs, one above the other, are attached to the side of the control head and are used to move the tip of the shaft up and down and left and right. The colonoscope is manually advanced through the lower gastrointestinal tract by pushing and pulling the control head and shaft.

[0005] The lower colon is tortuous, and as the colonoscope is advanced through the colon, it rubs against the mucosal surface of the colon along the outside of each bend. Friction and sagging of the colonoscope increase with each turn, making advancing and retracting the colonoscope increasingly difficult.

[0006] Although colonoscopes can be maneuvered through tortuous anatomical structures, such maneuvering requires experience and the use of both hands, making simultaneous control of other instruments (e.g., diagnostic or therapeutic tools placed through the working channel) impossible.

[0007] To address this limitation of standard flexible colonoscopes, the inventors have devised a control unit that allows the operator to remotely control the tip of the flexible endoscope and advance the colonoscope shaft. Summary of the Invention

[0008] The present invention provides a control system for a colonoscope having a shaft that is deflectable via two rotatable knobs, the control system comprising: a first drive unit mounted on the exterior of a housing of the colonoscope, the first drive unit including a first drive mechanism for engaging with the two rotatable knobs or gears in place of the two rotatable knobs; a second drive unit attachable to a shaft of the endoscope, the second drive unit being capable of linearly translating the shaft back and forth; and a user interface including a first interface attached to a pivotal support, the first interface engageable by the palm of a hand, the user interface for controlling the first drive unit and, optionally, the second drive unit.

[0009] The control system may also include a third drive unit attachable to the shaft of the "baby tool," the third drive unit being capable of linearly translating the shaft of the "baby tool" back and forth and actuating an end effector at the distal end of the shaft of the "baby tool."

[0010] 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 belongs. Although methods and materials similar or equivalent to those described herein can be used to practice or test the present invention, the preferred methods and materials are described below. In case of conflict, the present patent specification, including definitions, will control. Furthermore, the materials, methods, and examples are illustrative only and are not intended to be limiting.

[0011] The present invention will now be described, by way of example only, with reference to the accompanying drawings. While specific reference will be made in detail to the drawings, it is emphasized that the particulars shown are by way of example and merely for the purpose of illustrative description of preferred embodiments of the invention, presented to provide what is believed to be the most useful and understandable explanation of the principles and conceptual aspects of the invention. In this regard, no attempt has been made to show structural details of the invention beyond those necessary for a fundamental understanding of the invention, and the description chosen in conjunction with the drawings will make clear to those skilled in the art how several forms of the invention may be embodied in practice. [Brief explanation of the drawings]

[0012] [Figure 1] The system is shown in an operating room environment. [Figure 2] This system is shown mounted on a cart. [Figure 3a] A standard colonoscope (FIG. 3a) is shown fitted with standard control knobs (FIGS. 3d-3f) or adaptor gears (FIGS. 3g-3i). [Figure 3b] A standard colonoscope (Figure 3a) is shown attached with a standard adjustment knob (Figures 3d-3f) or adapter gear (Figures 3g-3i). [Figure 3c] A standard colonoscope (Figure 3a) is shown attached with a standard adjustment knob (Figures 3d-3f) or adapter gear (Figures 3g-3i). [Figure 3d] A standard colonoscope (Figure 3a) is shown attached with a standard adjustment knob (Figures 3d-3f) or adapter gear (Figures 3g-3i). [Figure 3e] A standard colonoscope (Figure 3a) is shown attached with a standard adjustment knob (Figures 3d-3f) or adapter gear (Figures 3g-3i). [Figure 3f] A standard colonoscope (Figure 3a) is shown attached with a standard adjustment knob (Figures 3d-3f) or adapter gear (Figures 3g-3i). [Figure 3g] A standard colonoscope (Figure 3a) is shown attached with a standard adjustment knob (Figures 3d-3f) or adapter gear (Figures 3g-3i). [Figure 3h] A standard colonoscope (Figure 3a) is shown attached with a standard adjustment knob (Figures 3d-3f) or adapter gear (Figures 3g-3i). [Figure 3i] A standard colonoscope (Figure 3a) is shown attached with a standard adjustment knob (Figures 3d-3f) or adapter gear (Figures 3g-3i). [Figure 4-1] 4A-4I illustrate the shaft deflection drive unit of the present invention and its components, with the "mini-tool" shown in FIG. 4e and the mini-tool drive module shown in FIGS. 4f-4l. [Figure 4c] 4A-4I illustrate the shaft deflection drive unit of the present invention and its components, with the "mini-tool" shown in FIG. 4e and the mini-tool drive module shown in FIGS. 4f-4l. [Figure 4d] 4A-4I illustrate the shaft deflection drive unit of the present invention and its components, with the "mini-tool" shown in FIG. 4e and the mini-tool drive module shown in FIGS. 4f-4l. [Figure 4e]4A-4I illustrate the shaft deflection drive unit of the present invention and its components, with the "mini-tool" shown in FIG. 4e and the mini-tool drive module shown in FIGS. 4f-4l. [Figure 4-2] 4A-4I illustrate the shaft deflection drive unit of the present invention and its components, with the "mini-tool" shown in FIG. 4e and the mini-tool drive module shown in FIGS. 4f-4l. [Figure 4h] 4A-4I illustrate the shaft deflection drive unit of the present invention and its components, with the "mini-tool" shown in FIG. 4e and the mini-tool drive module shown in FIGS. 4f-4l. [Figure 4i] 4A-4I illustrate the shaft deflection drive unit of the present invention and its components, with the "mini-tool" shown in FIG. 4e and the mini-tool drive module shown in FIGS. 4f-4l. [Figure 4j] 4A-4I illustrate the shaft deflection drive unit of the present invention and its components, with the "mini-tool" shown in FIG. 4e and the mini-tool drive module shown in FIGS. 4f-4l. [Figure 4k] 4A-4I illustrate the shaft deflection drive unit of the present invention and its components, with the "mini-tool" shown in FIG. 4e and the mini-tool drive module shown in FIGS. 4f-4l. [Figure 4l] 4A-4I illustrate the shaft deflection drive unit of the present invention and its components, with the "mini-tool" shown in FIG. 4e and the mini-tool drive module shown in FIGS. 4f-4l. [Figure 5a] 1 shows a shaft push-pull drive unit of the present invention. [Figure 5b] 1 shows a shaft push-pull drive unit of the present invention. [Figure 5c] 1 shows a shaft push-pull drive unit of the present invention. [Figure 6] 6a-c show the finger interface (FIG. 6a) and its various control states (FIGS. 6b-6c). [Figure 7a] 1 shows an endoscope shaft and a "mini-tool" interface of the present invention. [Figure 7b] 1 shows an endoscope shaft and a "mini-tool" interface of the present invention. [Figure 7c]1 shows an endoscope shaft and a "mini-tool" interface of the present invention. [Figure 8a] 1 shows an expansion module and an expansion interface that allow for rolling movement of the endoscope shaft. [Figure 8b] 1 shows an expansion module and expansion interface that allows roll movement of the endoscope shaft. [Figure 8c] 1 shows an expansion module and an expansion interface that allow for rolling movement of the endoscope shaft. [Figure 8d] 1 shows an expansion module and an expansion interface that allow for rolling movement of the endoscope shaft. [Figure 8e] 1 shows an expansion module and an expansion interface that allow for rolling movement of the endoscope shaft. [Figure 8f] 1 shows an expansion module and an expansion interface that allow for rolling movement of the endoscope shaft. [Figure 8g] 1 shows an expansion module and an expansion interface that allow for rolling movement of the endoscope shaft. [Figure 8h] 1 shows an expansion module and an expansion interface that allow for rolling movement of the endoscope shaft. [Figure 9a] 10A-10C show a schematic representation of the sequence of interface entry and corresponding shaft advancement within the colon. [Figure 9b] 10A-10C show a schematic representation of the sequence of interface entry and corresponding shaft advancement within the colon. [Figure 9c] 10A-10C show a schematic representation of the sequence of interface entry and corresponding shaft advancement within the colon. [Figure 9d] 10A-10C show a schematic representation of the sequence of interface entry and corresponding shaft advancement within the colon. [Figure 9e] 10A-10C show a schematic representation of the sequence of interface entry and corresponding shaft advancement within the colon. [Figure 9f]10A-10C show a schematic representation of the sequence of interface entry and corresponding shaft advancement within the colon. [Figure 9g] 10A-10C show a schematic representation of the sequence of interface entry and corresponding shaft advancement within the colon. [Figure 10] 1 shows one of many possible setup configurations for the system. [Figure 11] 1 is a flowchart outlining the workflow that allows the colonoscope control system to be set up and switched between powered and manual modes. [Figure 12a] 1 illustrates bench testing of a prototype constructed in accordance with the teachings of the present invention. [Figure 12b] 1 illustrates bench testing of a prototype constructed in accordance with the teachings of the present invention. [Figure 12c] 1 illustrates bench testing of a prototype constructed in accordance with the teachings of the present invention. [Figure 12d] 1 illustrates bench testing of a prototype constructed in accordance with the teachings of the present invention. [Figure 12e] 1 illustrates bench testing of a prototype constructed in accordance with the teachings of the present invention. [Figure 12f] 1 illustrates bench testing of a prototype constructed in accordance with the teachings of the present invention. [Figure 12g] 1 illustrates bench testing of a prototype constructed in accordance with the teachings of the present invention. [Figure 12h] 1 illustrates bench testing of a prototype constructed in accordance with the teachings of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0013] The present invention provides a colonoscope control system that can be used to control a standard colonoscope. Specifically, the present invention can be used to remotely operate a standard colonoscope, allowing a surgeon to precisely navigate the colonoscope through the lower gastrointestinal tract and to manipulate "mini-tools" placed through the working channel of the endoscope.

[0014] The principles and operation of the present invention may be better understood with reference to the drawings and accompanying descriptions.

[0015] Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details set forth in the following description or illustrated by way of example. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.

[0016] Navigating a standard colonoscope through the tortuous anatomy of the lower gastrointestinal tract requires skill and experience. One of the most serious complications of colonoscopy is endoscopic perforation of the colon, which has a reported incidence of 0.03% to 0.7%. Colonoscopic perforation (CP) is a rare complication but can be associated with high mortality and morbidity.

[0017] In practicing the present invention, the inventors have devised a colonoscope control system that allows for precise and intuitive control of the operation of a colonoscope within the lower gastrointestinal tract. As further described herein, the control system can be retrofitted to existing standard colonoscopes and can allow for switching between motorized and manual control of shaft advancement and / or deflection.

[0018] Thus, in accordance with one aspect of the present invention, there is provided a control system for a colonoscope having a shaft that is deflectable via two rotatable knobs.

[0019] The control system of the present invention includes a first drive unit external to the housing of the colonoscope, and a first drive mechanism for engaging two rotatable knobs of the colonoscope or an adapter including gears that replace the two rotatable knobs, the gears being attached to the shafts of the two rotatable knobs.

[0020] The control system also includes a second drive unit that can be attached to the shaft of the endoscope, for example, via rollers, and that can linearly translate the shaft back and forth to move the shaft through the lower gastrointestinal tract.

[0021] The control system also includes a user interface that includes a first interface mounted on the pivotal support (e.g., gimbaled) and engageable by the palm of a user's hand, such interface being usable to control a first drive mechanism that manipulates the up / down and left / right deflection of the shaft.

[0022] The user interface can also include a second interface for controlling the second drive mechanism. The second interface can include a sliding interface for linearly translating the shaft back and forth.

[0023] The user interface can also include a third interface pivotally mounted to the first interface that can be operated by one or more digits of a hand (e.g., pads operable simultaneously by the thumb and index finger of the hand) and that is used to control the endoscope shaft gripping mechanism for back and forth linear shaft movement.

[0024] The user interface can also include a fourth interface including a sliding button for linearly translating the "mini tool" shaft back and forth, and a fifth interface operable with one or more fingers of a hand (e.g., pads operable simultaneously by the thumb and index finger of that hand) to actuate a tool (e.g., a grasper, a lasso) placed through the working channel of the colonoscope.

[0025] A typical layout of the control system of the present invention includes a first drive unit attached to the colonoscope adjustment knob (or shaft via a geared adapter), a second drive unit attached to the shaft (e.g., via rollers), and a user interface located remotely from the colonoscope and connected to the drive unit via a wired or wireless connection. The user interface can be located in the operating room in close proximity to the colonoscope and patient, or outside the operating room (e.g., telemedicine), where the patient and colonoscope can be visualized via a remote camera feed.

[0026] Referring now to the drawings, FIGS. 1 and 2 show a typical operating room setup (FIG. 1) and cart layout (FIG. 2) of the system, herein referred to as system 10. A monitor 12 can be used by a surgeon 14 to monitor the procedure. As shown in FIG. 1, system 10 is positioned near a patient 700 using a cart 20. Modules of system 10 are arranged on different articulated shelves 22 in an optimal layout (further described below with reference to FIGS. 10-11). The surgeon operates a colonoscope 24 via user interfaces 400 and 401.

[0027] 3a-3c show a prefabricated colonoscope 24 (Pentax EC-3831L Flexible Video Colonoscope Endoscope) having a body 26 attached with manual knobs 28 and 30. The surgeon 14 can deflect the distal tip 32 of the shaft 33 by rotating the knobs 28 and 30 to a desired orientation. Also connected to the body 26 of the colonoscope 24 is a camera cable with an attached adapter 36 and a light source 34.

[0028] FIG. 3b shows adapters 40 and 42 that replace manual knobs 28 and 30. Adapters 40 and 42 have keyhole patterns designed to engage the ends of shafts 44 and 46, which mechanically transmit knob input to the articulation mechanism of colonoscope 24. Adapter 40 has a circular base 48, and adapter 42 has a circular base 50. Circular bases 48 and 50 function as stops for manual knobs 28 and 30 or for mechanical gears retrofitted in their place. FIG. 3b also shows valve buttons 52 and 54 on colonoscope 24, which provide the interface for suction and air / water through tunnels 51 and 53 (respectively).

[0029] FIG. 3c shows adapters 40 and 42 attached to shafts 44 and 46 (keyholes prevent adapters 40 and 42 from slipping).

[0030] 3d-3f illustrate an embodiment of the present invention in which manual knob 28 is coupled to adapter 42 and manual knob 30 is coupled to adapter 40. Such coupling allows for continued manual operation of colonoscope 24 via the knobs and facilitates rapid switching between manual and powered operation of colonoscope 24.

[0031] 3g-3i show the coupling where gear 60 is coupled to adapter 40 and gear 62 is coupled to adapter 42. Following such coupling, colonoscope 24 may be fitted with a drive unit 66 for actuating the articulation via gears 60 and 62. Additional functions of colonoscope 24 (various valves and buttons) may also be coupled to other drive / control mechanisms, thereby converting colonoscope 24 from manual operation to fully motorized operation.

[0032] 4a-4k show the components of drive unit 66. Drive unit 66 is mounted to the exterior of body 26 of colonoscope 24. The motor of drive unit 66 is coupled to knobs 40 and 42 (or their shafts via gears) of colonoscope 24, allowing any standard manual colonoscope to be converted into a powered (e.g., robotic) colonoscope.

[0033] 4a shows the coupling of motors 68 and 69 to gears 60 and 62 attached to colonoscope 24. Housing 70 of drive unit 66 is secured to colonoscope body 26 via bracket 72. Motors 68 and 69 are mounted along vertical plate 78 of chassis 70 and are coupled to gears 60 and 62 via worm gears 74 and 76. Potentiometers 80 and 82 are also attached to vertical plate 78 and are coupled to worm gears 74 and 76 via gears 61 and 63. Motor controller 75 is secured to colonoscope body 26 via bracket 72.

[0034] 4c-4e illustrate a drive unit, referred to herein as drive unit 132, that may be used to control the advancement and actuation of a "mini-tool" through the working channel of colonoscope 24. FIG.

[0035] Colonoscopy often requires tissue sampling or processing during the procedure. Such sampling or processing can be performed using a "mini-tool" that is inserted through the working channel of the colonoscope 24 and positioned out the distal end of the colonoscope shaft 33 so that its end effector is in proximity 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.

[0036] A typical miniature tool (referred to herein as tool 110) is shown in Figure 4e. 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 at the distal end of shaft 112. End effector 114 is typically manually operated using a fixed handle 118 and a sliding button 127. Pressing sliding button 127 on handle 118 toward the distal end of shaft 112 opens the jaws of tool 110, and vice versa.

[0037] 4c shows the adapter 130 connected to the housing 70. The adapter 130 connects the push / pull drive unit 132 of the tool 110 to the housing 70 using screws (not shown) through holes 134. A port 136 in the body 26 provides access to the working channel of the colonoscope 24.

[0038] 4d shows the basic components of the drive unit 132 of the tool 110. To translate the shaft 112 out of the working channel and precisely position the end effector 114 at a desired anatomical landmark, the shaft 112 is inserted into a groove 142 in the adapter 130 and secured via a knob 144.

[0039] The adapter 130 is connected to a slider 148 that has a typical range of travel of 50 mm. The slider 148 is driven via a screw mechanism that includes a screw 156, a motor (not shown), and a gear 158 that is coupled to a gear 160.

[0040] To use the tool 110, the surgeon slides the shaft 112 through the working channel of the colonoscope 24 until the end effector 114 is visible on the monitor 12. The surgeon then secures the shaft 112 to the adapter 130, as described above.

[0041] FIG. 4 f shows the drive unit 132 connected to the housing 70 via the adapter 130 with the groove 142 aligned with the center of the port 136 .

[0042] FIG. 4g shows an electric mechanism 170 for electrically activating the suction valve 52 and the air / water valve 54.

[0043] Housing 70 includes protrusions 180 that act as enclosures for solenoids 182 and 184, which actuate valves 52 and 54 (respectively). The surgeon controls the state of each valve via switches, as further described below with reference to FIG. 7b.

[0044] FIG. 4h shows a configuration in which drive unit 132 and drive unit 66 share a common enclosure 192. Rail 194 forms part of enclosure 192 and serves as a connector for opening / closing module 198 of tool 110 (FIG. 4i). Module 198 can be releasably connected to drive unit 132 via connector 200. Connector 137 is part of chassis 210. To activate the opening or closing operation of tool 110, handle 118 is inserted into module 198 with shaft 112 facing toward drive unit 132. Button 127 of tool 110 clamps to the opening / closing mechanism of module 198, and cover 206 slides onto chassis 210 to close module 198.

[0045] 4j shows the opening and closing mechanism of module 198. Handle body 118 is clamped to housing 218 and housing 222, and slide button 127 is clamped to the arm of rotating lever 224. Lever 224 is connected to servo motor 226, which is connected to chassis 210 via slider 228. Slider 228 of servo motor 226 is used to optimize the point of rotation of lever 224, allowing for the use of different miniature tools of various types, lengths, and shapes.

[0046] When the lever 224 rotates forward, the handle 127 is pushed forward. The handle 127 is connected to the end effector 114 via a push-pull wire. By pushing the push-pull wire of the small tool 110, the jaw mechanism of the end effector 114 opens the jaws. By retracting the slide button 127, the jaws of the end effector 114 close.

[0047] 4k shows a typical configuration of drive units 66, 132 and module 198. Drive unit 132 is connected to drive unit 66. Module 198, which actuates the opening and closing of the mini-tool distal end effector 114, is connected to drive unit 132.

[0048] Figure 4l shows drive units 66 and 132 and module 198 assembled in housing 217. Vacuum pads 237 are used to secure housing 217 to any flat surface, as described further below.

[0049] 5a to 5c show a drive unit 300 for advancing / retracting the flexible shaft 33 of the endoscope 24. FIG.

[0050] 5a is a perspective view of the drive unit 300. The drive unit 300 includes a motorized linear mechanism 302 that linearly drives a slider 304 having a linear travel range of 100 mm, and two gripping actuators 308 and 310.

[0051] Rollers 312 and 314 are adjacent to arm 315 with groove 316 disposed therebetween. The roller and groove setup guides flexible shaft 33 to gripping actuator 310. Cover 344 is connected to plate 22, typically via vacuum pad 330. Plate 22 is connected to cart 20 via arm 402.

[0052] A button 340 on cover 344 controls both grasping actuators (308 and 310). To attach the flexible shaft 33 to the drive unit 300, the surgeon presses button 340 to open the grasping actuators 308 and 310, then the flexible shaft 33 can be placed between the jaws of the grasping actuators 308 and 310, and by pressing button 340 again, the flexible shaft 33 will be locked into the grasping actuators 308 and 310.

[0053] FIG. 5b shows the components of the drive unit 300. The body 350 includes a screw-based linear drive mechanism that drives the slider 304 on the body 350 (from point P, which indicates a proximal position, to point D, which indicates a distal position). The gripping actuator 308 is attached to the slider 304. The gripping actuator 308 moves linearly with the slider 304 and is hereinafter referred to as the "moving gripping actuator." The 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 covers 368 designed to optimize contact with the flexible shaft 33, allowing for the use of different endoscope types of various types, lengths, coating materials, and diameters.

[0054] 5c shows gripping actuators 308 and 310. Body 360 contains motor 361 and a screw-based linear mechanism that drives arms 362 and 364 along rail 366.

[0055] 6a to 6c and 7a to 7b show the user interface of the drive unit 300 (hereinafter referred to as interface 400).

[0056] To control the pushing and pulling of shaft 33 via drive unit 300, the surgeon grasps palm rest 402 of body 404 (FIG. 7a) of interface 400 with his index finger and thumb engaging finger pads 406 and 408 of finger interface 405 (FIGS. 6a-6c). Finger pads 406 and 408 can be actuated between an open position, shown in FIG. 6b, and a closed position, shown in FIG. 6c.

[0057] Finger pads 406 and 408 control gripping actuators 308 and 310. When finger pads 406 and 408 are open (FIG. 6b), the jaws of gripping actuator 308 are open. When finger pads 406 and 408 are closed (FIG. 6c), the jaws of gripping actuator 308 are closed and apply a frictional force to flexible shaft 33. This frictional force allows the surgeon to control the pushing and pulling of flexible shaft 33.

[0058] The control interface 400 also controls the distal articulation 32 of the flexible shaft 33, as well as the suction and air / water valves. To understand the mechanism and structure of the control of the distal articulation 32 by the interface 400, reference is now made to Figure 7b.

[0059] FIG. 7b shows the structure and components that allow the surgeon to simultaneously control the articulation of the flexible shaft 33 and the suction and air / water function valves 52, 54 via buttons 154 and 156 (respectively).

[0060] The surgeon rotates the interface body 404 to the desired side and height to control left-right and up-down movement of the articulation. Potentiometers 170, 172 measure the orientation of the body 404 (as shown in FIG. 7b), and the resulting electrical signal is converted by an electrical controller 75 into rotation commands for the motors 68 and 69. As the motors 68 and 69 rotate, the worm gears 74 and 76 rotate, which in turn rotates the shaft of the distal articulation mechanism. As the worm gears 74 and 76 rotate, they also rotate gears 61 and 63. The gears 61 and 63 are coupled to rotary potentiometers 80, 81.

[0061] The signals from the potentiometers 80, 81 are sent to the controller 75 and compared with the signals from the azimuth potentiometers 170, 172 of the body 404, causing the controller 75 to send the next rotation command to the motor until the measured values ​​of the processed signals from the potentiometers 80, 81 of the motor and the potentiometers 170, 172 of the control interface body 404 are equal or within tolerance.

[0062] The above measurement and movement cycles can be sampled at a frequency of 100 Hz or higher to ensure fast response of the articulation mechanism without slowing it down.

[0063] The body 404 is connected to a housing 412, as shown in FIG. 7a. The housing 412 is linearly slidable between a proximal end 414(p) and a distal end 416(d) of a housing 418. A linear potentiometer is disposed on the housing 418, and as the surgeon slides the housing 412 along the sliding housing 420, the slider of the linear potentiometer 415 measures the position and orientation of the interface body 404. The combined measurement of the body 404 of the interface 400 and the state of the finger pads 406 and 408 allows the surgeon to control the drive unit 300, as will be described in more detail in FIGS. 9a-9g.

[0064] To control the "mini-tool" shaft with the push / pull module 132, the surgeon grasps the palm of the body 407 of the interface 401 ( FIG. 7c ) and slides the housing 419 along the slide-type housing 429, with the potentiometer slider measuring the position of the interface body 407. A position signal from the potentiometer is sent to the controller 75, which converts the signal into a motion command for the module 132 that drives the "mini-tool" shaft 112. While controlling the linear motion of the shaft 112, the surgeon can simultaneously control the actuation of the end effector 114 by controlling the open / closed state of the pads 406 and 408 of the finger interface 405. The controller 75 measures the state of the finger pads 406 and 408 and activates the open / close module 198 accordingly, allowing the surgeon to control the position of the distal end of the "mini-tool" shaft 112 and simultaneously control the actuation of the end effector 114.

[0065] Figures 8a-8h show a motorized expansion module that allows longitudinal rolling motion of the flexible shaft, which the surgeon can use to better position the distal end of the flexible shaft as it is advanced within the GI tract.

[0066] To rotate the endoscope flexible shaft 33, module 500 is connected to the push-pull module 300 via connector 510 to position point C, the center of the flexible shaft, at the center of arc 508. Arc 508 is hingedly connected to frame 502. Arc 508 includes gear 507 at its distal end, which meshes with worm gear 506. Motor 504 rotates the worm gear. When motor 504 is activated by interface 400 (as described with reference to FIGS. 8e-8h), push-pull module 300 rotates about point C, as shown in FIGS. 8c-8d.

[0067] Figures 8e-8h show the extended rotating frame module 600. The module 600 consists of a fixed base 606 with vacuum legs 604. A frame 608 is hingedly connected to the fixed frame 606 via hinges 603 and 605. A rotation sensor 602 is connected to the hinge 605 and continuously measures the angle α. To control rotation about the center of the colonoscope shaft, the interface 400 is attached to a surface 607 of the rotating frame 608 via a vacuum pad 150. To rotate the colonoscope shaft, the surgeon tilts the interface, thereby rotating the frame 608 as well. The rotation sensor measurement serves as input for a motor 504 that rotates the module 300 about a center point C. Figures 8g-8h illustrate tilted positions of the frame 608. Such an interface configuration allows the surgeon to simultaneously and intuitively control the push-pull motion of the flexible shaft 33, the articulation of the distal end 32 (up, down, left, right), and the roll angle of the flexible shaft 33.

[0068] There are several operating states for the gripping actuator 308: (i) Closed and stationary state, (ii) open and stationary; (iii) closed and moving distally (towards the patient's body); (iv) closed and moving proximally (away from the patient's body); (v) Open and move distally; and (vi) open and proximally mobile; is.

[0069] 9a to 9g show a schematic sequence of inputs of the interface 400 and the corresponding mechanical outputs of the drive unit 300. FIG.

[0070] 9a schematically illustrates flexible shaft 33 with its distal end located at point A within a patient's lower gastrointestinal tract. Finger pads 406 and 408 are in an open position, as is gripping actuator 308. Grip actuator 310 is closed to prevent unwanted movement of colonoscope shaft 33.

[0071] 9b shows finger pads 406 and 408 in a closed state, with gripping actuator 308 similarly closed to grip flexible shaft 33. Grip actuator 310 is open, but shaft 33 does not move because the surgeon has not moved palm rest 404.

[0072] When the surgeon moves interface body 404 distally toward point D with finger pads 406 and 408 closed, gripping actuator 308 moves toward point D. With gripping actuator 310 open, flexible shaft 33 is translated from point A to point B within the patient's gastrointestinal tract.

[0073] To advance the shaft 33 from point B to point C, the surgeon opens the finger pads 406 and 408, thus closing the gripping actuator 310 and opening the gripping actuator 308 ( FIG. 9d ). Next, the surgeon slides the interface body 404 to point P, and the surgeon closes the finger pads 406 and 408, thus closing the gripping actuator 308 and opening the gripping actuator 310. Moving the interface body 404 distally with the finger pads 406 and 408 closed ( FIG. 9g ) moves the flexible shaft 33 to point C. This sequence of events is similar to manually pinching and pulling the shaft of a colonoscope, allowing the surgeon to pull the flexible shaft 33 back and forth in an intuitive manner that mimics manual manipulation without having to learn new skills or surgical techniques. Note that the surgeon can always choose to manually control the movement of the flexible shaft 33 if, for example, tactile feedback is desired.

[0074] The scale between the linear movement of the palm rest body 404 and the movement of the distal end of the flexible shaft 33 can be selected by the surgeon at any time during the procedure according to his or her needs. Typical scales range from 1:0.5 to 1:4.

[0075] The system 10 of the present invention can be used for lower gastrointestinal procedures (eg, colonoscopy) as follows.

[0076] FIG. 10 shows a typical setup of the system 10 that can be used for lower gastrointestinal procedures. The patient 700 lies on their side with their back facing the system 10. The distal end of the flexible shaft 33 is inserted into the patient's lower gastrointestinal tract through the anal orifice. The drive unit 300 is moved to the desired position, and the flexible shaft 33 is attached to the drive unit 300 and gripped by both gripping actuators (308 and 310). The drive units 66, 132, and 198, each with a common cover 192 assembled on a platform 217 located on the shelf 22, are moved to an optimal position relative to the drive unit 300 by the arms 422 and 423. Slack in the flexible shaft 33 is handled by the leading wheels 312 and 314. The colonoscope control interface 400 and the miniature tool control interface 401 are located on different plates for the surgeon's convenience.

[0077] To perform a procedure, the surgeon grasps both interfaces 400 and 401 and moves the flexible shaft 33 through the lower gastrointestinal tract. The surgeon can use interface 400 to optimally position and articulate the distal end of the flexible shaft relative to the patient's anatomy, while simultaneously using interface 401 to control the position and actuation of the mini-tool end effector. At any time, the surgeon can operate the suction / irrigation system and the air system by pressing buttons 154 and 156 (shown in FIG. 7b) located on the front of interface body 404. The surgeon can also choose to disconnect the endoscope and mini-tool from the powered module at any time to manually control the movement of the flexible shaft 33 and / or mini-tool, for example, if tactile feedback is desired.

[0078] FIG. 11 is a block diagram illustrating working mode selection by a colonoscope attached to and optionally controlled by the present system.

[0079] When preparing the colonoscope for a procedure, the surgeon can choose the preferred working mode to start with. If the surgeon wants to start in manual mode (the left branch of the diagram), he attaches the manual knob to the adapter. If the surgeon wants to start in powered mode (the right branch of the diagram), he attaches the gear to the adapter and then attaches the powered drive unit described above.

[0080] At any stage of the procedure, the surgeon can switch back and forth between powered and manual modes. For example, if the surgeon is working in manual mode and wants to switch to powered mode, the surgeon simply removes the manual knob and installs the gear, adapter, and drive unit. This procedure can be reversed if the surgeon wants to switch back to manual mode.

[0081] As used herein, the term "about" means ±10%.

[0082] Additional objects, advantages, and novel features of the present invention will become apparent to those skilled in the art upon examination of the following examples thereof, which are not intended to be limiting. [Example]

[0083] In addition to the above description, reference is now made to the following examples, which illustrate the invention in a non-limiting manner.

[0084] Bench testing of prototype systems A prototype of this system was created and its functionality was bench tested.

[0085] 12a-12b show the flexible shaft interface 400 with an operator's hand grasping the body 404 of the interface 400. The distal portion 32 of the flexible shaft 33 articulates according to the orientation of the body 404 (to the right in FIG. 12a and up in FIG. 12b).

[0086] The push / pull module 300 is also shown in these figures, with the finger interface pads 406, 408 in the open position (with the gripper 308 open and the stationary gripper 310 closed).

[0087] A GI simulator (designated 499) was used to conduct steering tests of the flexible shaft (FIGS. 12c-12g). FIG. 12c shows the movement of the flexible shaft 33 with the distal portion 32 in the GI simulator. FIG. 12d shows the distal end of the "mini-tool" shaft 112 and gripper 114 of the mini-tool 110 delivered from the distal end of the shaft 33 distal portion 32. FIG. 12e shows the articulation control capabilities of the system, showing the distal portion 32 articulating and advancing out of the GI simulator. FIG. 12f shows the ability to control the mini-tool 110 (shaft 112 and end effector 114) while advancing the flexible shaft 33 out of the GI simulator. FIG. 12g shows control of the distal articulation 32 of the flexible shaft 33 with concomitant control of the mini-tool 110. FIG. 12h shows manual control of the flexible shaft 33 with the grippers 308 and 310 in the open position.

[0088] It will be appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.

[0089] While the present invention has been described in connection with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims. All publications, patents, and patent applications mentioned herein are incorporated by reference in their entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. Furthermore, citation or identification of a reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. Section headings, if used, should not be construed as necessarily limiting. Additionally, any priority document(s) to this application are incorporated herein in their entirety.

Claims

1. 1. A control system for a colonoscope having a shaft deflectable via two rotatable knobs, the control system comprising: (a) a first drive unit mounted on the exterior of a housing of a colonoscope, the first drive unit including a first drive mechanism for engaging the two rotatable knobs or gears in place of the two rotatable knobs; (b) a second drive unit attachable to the shaft of the colonoscope, the second drive unit capable of linearly translating the shaft back and forth; and (c) a user interface including a first interface mounted on a pivotal support, the first interface engageable by a palm of a hand, the user interface for controlling the first drive unit, the user interface further including a second interface for controlling the second drive unit, the user interface enabling advancement of the shaft of the colonoscope and steering of its tip to enable continuous advancement of the shaft of the colonoscope through curved anatomical structures.

2. The control system of claim 1 , wherein the second interface is capable of sliding back and forth to linearly translate the shaft back and forth.

3. The control system of claim 1 , wherein the gear on a portion of an adapter is attached to the exterior surface of the colonoscope housing.

4. The control system of claim 1 , wherein the first drive unit controls up / down and left / right deflection of the shaft.

5. 10. The control system of claim 1, further comprising a third interface pivotally attached to the first interface and engageable by one or more fingers of a hand, the third interface for manipulating an end effector.

6. The control system of claim 5 , wherein the third interface includes a pad operable simultaneously with the thumb and index finger of the hand.

7. The control system of claim 1 , wherein the pivotal support is gimbaled.

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