Endoscope system and assembly

Abstract

An endoscope assembly, system, and method of manufacture are disclosed. In particular, an endoscope is provided having controls and / or tool port openings at one end of an elongated handle, and an insertion tube assembly and umbilical extending to a console at the other end of the elongated handle. Also described are the arrangement of fluid controls and flow paths within the handle of the endoscope, as well as the configuration of the articulation link and the structure of the insertion tube.

Description

[Technical field]

[0001] The present disclosure relates generally to endoscopes, including small diameter endoscopes, including, but not limited to, cholangioscopes, ureteroscopes, cytoscopes, and / or hysteroscopes. [Background technology]

[0002] Endoscopes are used in a wide variety of medical procedures to visualize internal cavities or potential spaces within the human body, either for diagnostic or therapeutic procedures. In particular, medical endoscopes are widely used because they allow the insertion of a long, thin insertion portion into a body cavity to observe a target area within the body cavity without dissection, and, if necessary, to perform a therapeutic procedure using treatment tools. Summary of the Invention [Problem to be solved by the invention]

[0003] In many cases, body cavities are very small, requiring a small diameter endoscope to view and treat them. For example, ureteroscopy is the examination of a patient's ureters and kidneys using a ureteroscope. A ureteroscope typically includes a long, thin, flexible section that can be inserted through a patient's urethra, bladder, and ureteral opening that connects the bladder to the ureter. A ureteroscope typically also includes a camera and lighting system to adequately visualize the endoscope passage and the working area within the ureter or kidney. In many cases, ureteroscopy involves treating stones that are stuck in the patient's mid-to-upper ureter or within the calyx of the kidney. Due to the size of the working space, it is desirable to produce an endoscope that can be easily maneuvered within small body cavities and tracts.

[0004] Endoscopic procedures may involve the use of multiple scopes, which in turn necessitates overly complex systems requiring multiple tools and multiple assistants. Due to the size of the operating room, it is desirable to reduce the complexity of these procedures and develop less complex and more capable endoscopes. Thus, there is a need for improvement in this field. [Means for solving the problem]

[0005] This disclosure relates generally to endoscopy, although it will be appreciated that many of the features disclosed may be applicable in other technical fields, particularly in other medical devices.

[0006] The present disclosure provides improved endoscopes and associated console and cartridge assemblies. In some embodiments, the endoscope may be a small diameter endoscope, such as a ureteroscope, cholangioscope, cystoscope, hysteroscope, or bronchoscope. The endoscope may be a disposable (single-use) endoscope and / or a reusable endoscope. The endoscope assembly is connected by a tube, sometimes referred to as an "umbilical," to a cartridge that is connectable to a console suitable for use with the endoscope assembly.

[0007] The endoscope includes an insertion tube for insertion into the patient's body. The insertion tube may include a distal end for insertion into the patient's body and a proximal end. The insertion tube may include a main lumen extending through at least a portion of the insertion tube. The insertion tube may include a tool tube extending within at least a portion of the insertion tube. The tool tube preferably defines a tool channel that allows for the insertion and extension of various tools into the patient's body through the insertion tube.

[0008] The insertion tube may include an optical sensor module, such as a CCD and / or a complementary metal oxide semiconductor (CMOS) image sensor, to provide information to the console and / or to project an image onto a monitor, such as a video feed from the end of the insertion tube. The video feed may be infrared, thermal, or visible light. The insertion tube may include a light emitting diode (LED) wire to provide power to an LED at the end of the insertion tube.

[0009] The endoscope has a handle assembly having a handle body. The handle body may be comprised of a first housing member and a second housing member. The handle assembly may include an insertion tube strain relief and an umbilical strain relief. The strain relief may help stabilize and support the connections between the rigid components of the endoscope and the insertion tube and umbilical. The strain relief may be internal and / or external to the handle body.

[0010] The handle body may be non-cylindrical. For example, the handle body may have a pistol-shaped configuration. Advantageously, this shape may aid in improving the endoscopist's ability to apply torque to the insertion tube of the endoscope, which may aid in steering the endoscope while advancing it into and / or through the patient's body, and / or aid in changing the direction in which the camera of the endoscope is pointed. A non-cylindrical handle may also provide a reference for the rotational orientation of the insertion tube.

[0011] The umbilical can be an integrated umbilical that incorporates both fluid lumens and electrical signal conductors that extend between the cartridge and the handle assembly of the endoscope. The integrated umbilical can reduce the number of tubes and / or cables that a user must manage during a procedure. Furthermore, by consolidating the electrical signal conductors and fluid lumens in a single umbilical that is attached to the console at one point by the cartridge, the user is constrained to operate the machine / device at only one point, which allows for greater freedom of operation.

[0012] The top of the handle body can include an articulation control lever, a tool port, and / or a fluid control button / trigger with flow adjustment mechanism. The articulation control lever is located close to the center of the handle body to facilitate both left and right handed use.

[0013] The tool port is operably located at the top of the endoscope. The tool port may also be located in the center of the endoscope, similar to the articulation control lever, to facilitate use with both hands. The tool port is preferably an opening to a tool channel that extends through the endoscope to the distal end of the insertion tube, allowing a tool to pass through the endoscope and into the patient's body. By locating the tool port at the top of the endoscope handle body, the tool port and any excess portion of the tool that does not extend through the tool channel may be less likely to impede the movement of the endoscopist compared to an arrangement in which the tool port is located at the side of the handle body. If the tool port is located at the side of the handle body, it may be more difficult for the endoscopist to grip the handle body, and the endoscopist may accidentally bump the tool. The location of the tool port further allows the endoscopist to adjust the tool port using the thumb and index finger of the same hand that grasps the handle body. Such an arrangement may advantageously make use of the tool port less taxing and allow for one-handed operation of the handle assembly of the endoscope. The tool port preferably includes a lock adapted to lock in place a tool extending through the port.

[0014] The fluid control button preferably allows a user to control the flow or aspiration of irrigation fluid from the endoscope handle using the index finger of the same hand that grips the handle, thereby allowing for single-handed operation of the endoscope handle assembly. Repeatedly pressing and releasing the flow control button creates a pulsatile flow, which is beneficial in dislodging objects within a patient's body, such as urinary stones lodged in the patient's ureter.

[0015] The flow rate adjustment mechanism can be a lever or knob. In embodiments using a knob flow rate adjustment mechanism, the knob can be rotated. Such rotation of the knob can move the fluid control button to an at least partially depressed state. The flow rate adjustment mechanism can hold the fluid control button in an at least partially depressed state and provide a constant minimum irrigation or aspiration flow rate without requiring the user to continuously apply force to the fluid control button. If a higher flow rate is desired, the fluid control button can be further depressed until it is fully depressed to a maximum flow rate, whatever the desired constant flow rate is. Additionally, pulsating flow can be used as described above. For example, the flow rate adjustment mechanism can hold the fluid control button depressed to generate a constant flow rate of 20%. If a higher flow rate or pulsating flow rate is desired, the user can further press the fluid control button to provide a higher flow rate or pulsating flow, as described above. It will be appreciated that the flow rate adjustment mechanism can be utilized to achieve any desired constant flow rate.

[0016] The endoscope assembly may include one or more pulley assemblies. The pulley assembly may include at least one pulley operably arranged to rotate in response to movement of an articulation control lever. Associated with the at least one pulley is an articulation wire or a pair of articulation pull wires (e.g., two separate wires or a continuous wire with wire segments looped over the pulley and extending from opposite sides of the pulley) configured to bend a distal shaft portion of the endoscope assembly upon actuation. The articulation wires may be fixed to the pulley (e.g., tied or secured by an anchor) and / or extend around at least a portion of the pulley (e.g., form a loop around the pulley). The pulley may be a cam.

[0017] The articulation wires extend through the handle body to and through the proximal portion of the insertion tube. Within the handle body, the articulation wires may extend through an articulation wire management tube.

[0018] Additionally, the pulley assembly may include an articulation termination coil that receives one or more articulation coils that are wound around respective articulation wires connected to the pulley. The articulation termination coils may provide tension to the articulation wires. The articulation termination coils may be adjustable to remove slack in the articulation wires. For example, the articulation termination coils may be adjustable along the longitudinal axis of the endoscope assembly to control tension in the articulation pull wires. The interior of the handle assembly may include a number of locking slots for the proximal end of the insertion tube. Such an arrangement helps maintain tension in the articulation wires during assembly of the endoscope. The locking slots are useful when an insertion tube is utilized to counteract the pulling force of the articulation wires. In an embodiment, articulation coils and / or locking slots may be utilized.

[0019] The friction element can be used to hold the position of the articulation control lever when it is released by the user. The friction element can prevent the distal tip of the insertion tube from returning to a neutral configuration when the user releases the articulation control lever. Thus, for example, the user can maintain the optical sensor module over the target viewing area without having to maintain the position of the articulation control lever.

[0020] The second housing member can extend through one or more pulleys. The pulleys can rotate about the second housing member when rotated by the articulation control lever. A friction element can be disposed between a static friction surface of the second housing member and a rotating friction surface of the pulley. In some embodiments, friction grease can be used in place of the friction element. In some examples, the friction element can be an O-ring. When the pulley is not being rotated to articulate the distal end of the insertion tube, the friction element maintains the position of the pulley by opposing the rotation of the rotating friction surface relative to the static friction surface, preventing the pulley from rotating back to a neutral position.

[0021] The handle body can include a fluid passage assembly. The fluid passage assembly can be used for irrigation and / or aspiration. For illustrative purposes, the fluid passage is described in connection with irrigation.

[0022] The endoscope may include a first / main irrigation lumen from a first irrigation source extending through the handle body. A valve incorporated within the handle body of the endoscope may be positioned to restrict and / or direct the flow of fluid within the first irrigation lumen. For example, the valve may be a pinch valve. The valve is preferably a normally closed valve that allows fluid to flow through the first irrigation lumen upon actuation of a fluid control button during a procedure. However, the valve may also be a normally open valve. A user may be able to control the valve using the thumb and / or index finger of the same hand that grips the handle.

[0023] The first irrigation lumen is attached to a first T-piece. The first T-piece can connect a first flow path of the first irrigation lumen to the tool channel. A connecting lumen can extend from the first T-piece toward the insertion tube. A second T-piece can be included to integrate a second irrigation source and / or aspiration source. The second T-piece can be disposed along the flow path between the first T-piece and the insertion tube.

[0024] The endoscope may include a second / secondary irrigation lumen from a second irrigation source extending through the handle body. The second irrigation lumen is attached to a second T-fitting. The second T-fitting may be used to connect a second flow path of the second irrigation lumen to the tool channel. The second T-fitting, the first flow path, the second flow path, and the tool channel may all be in fluid communication. The location of the second irrigation lumen allows for the incorporation of a second irrigation / aspiration source without interfering with the user's access to the first fluid control button controlled irrigation source. In one example, the first irrigation source is a constant pressure bag, while the second irrigation source is a suction pump or a single acting (pulsatile) irrigation pump. The second fluid source may be controlled remotely from the handle assembly (e.g., by an assistant supporting the user during the procedure).

[0025] The second irrigation lumen preferably exits the handle through an umbilical strain relief and terminates in a connector, such as a female luer. The connector can be covered with a cap to prevent leakage when the first irrigation source is in use and / or the insertion tube is inserted into the fluid-filled cavity. During use, the cap is removed and a secondary fluid source, such as a fluid-filled syringe, is connected to the connector.

[0026] The second irrigation lumen preferably exits the handle through an umbilical strain relief and terminates in a connector, such as a female luer. A syringe-actuated valve can be integrated into the connector to prevent leakage when the first irrigation source is in use and / or the insertion tube is inserted into the fluid-filled cavity. During use, a syringe can be connected to the connector and valve to provide a secondary fluid source.

[0027] A one-way valve can be disposed between the tool port and the first Tee. The one-way valve can be incorporated into the first Tee. The one-way valve can be a duckbill valve. The one-way valve preferably resists unintended flow of fluid from the first irrigation source out of the tool port (e.g., an unfastened Tuohy borst adapter).

[0028] The insertion tube may have multiple sections including a proximal section, a transition section, and an articulation section located at a distal end of the insertion tube. The proximal section of the insertion tube may be made of a higher durometer polymer than the articulation section to resist bending of the proximal section during articulation movement of the articulation section. The articulation section may include an articulation link assembly (described in more detail below) for articulating the distal end of the insertion tube. The articulation section may be made of a lower durometer polymer than the proximal section such that the articulation section is bent by an articulation wire. The transition section is operably disposed between the articulation section and the proximal section. The transition section may be made of a polymer with a higher durometer value than the articulation section and a lower durometer measurement than the proximal section. This allows the transition section to passively bend during articulation movement of the articulation section of the insertion tube. Thus, there can be a smooth, fluid transition between the articulation portion and the proximal portion that has no or minimal movement as the articulation portion articulates.

[0029] The compression coil may extend to and terminate at the proximal end of the proximal link of the articulation link assembly. The insertion tube may include an outer polymer jacket and a braid inside the jacket. Thus, during assembly, a single insertion tube (which may include links, articulation wires, articulation coil, camera assembly, and electrical signal conductors) may be pulled through and attached to the handle assembly in a single motion. This allows for easier assembly and repair and reduced labor costs.

[0030] The distal end can include a termination band, the articulation wires can be attached to an inner wall of the termination band, for example, by welding and / or adhesive, and the diameter of the termination band can be larger than the diameter of the cap assembly, and the cap assembly can be inserted into and secured to an opening in the termination band.

[0031] The insertion tube extends over the articulation link assembly. Electrical signal conductors extend from the camera and / or LED from the cap assembly through the articulation link assembly.

[0032] The articulation link assembly may include a plurality of links and / or a support beam that extends at least partially along the length of the plurality of links. The support beam may include support struts attached to the plurality of links. The plurality of links may be manufactured via additive and / or subtractive manufacturing processes. The support beam and support struts may be used to support the links and keep them aligned during the manufacturing process. After assembly of the articulation link assembly, the support beam and support struts may be removed and discarded. The manufacturing process may allow for a series of unique links (described in more detail below). The manufacturing process does not require a separate mold for each articulation link of the articulation link assembly.

[0033] The articulation link can include two openings for the articulation wires to extend through the link. The lower portion of the link can include a concave / recessed articulation pivot and the upper portion of the link can include a convex / protruding articulation pivot. Each link can include a hollow interior or lumen that extends the length of the link.

[0034] A plurality of links is comprised of two or more links. In some embodiments, the links are designed and arranged such that the angle (i.e., angle X°) between the opposing faces of adjacent links gradually increases and / or the length (L1, L2) decreases along the length of the assembly (e.g., angle X° increases and / or length decreases along a direction from the proximal end to the distal end). Such an arrangement may allow the user to bend the distal end more than the proximal end and / or to bend the distal end before the proximal end begins to bend.

[0035] The links can be modified to allow greater articulation movement at the distal end of the articulation assembly. The links can be positioned to reduce the articulation wire force required to obtain a desired degree of articulation at the distal end of the insertion tube. For example, links closer to the distal end can have a shorter length than links closer to the proximal end. The links can also be positioned to increase the articulation angle at the distal end. The convex articulation pivots can have a smaller pivot radius for links closer to the distal end than for links closer to the proximal end, and / or the concave articulation pivots can have a larger pivot radius for links closer to the distal end than for links closer to the proximal end.

[0036] All of these features can be varied on individual links or in combination with multiple links to achieve a desired articulation response and shape. Such an arrangement can provide the ability to initiate distal articulation movement prior to or simultaneously with proximal articulation movement. Additionally, such an arrangement can provide the ability to mitigate increased pulling forces that build up at the proximal end of the articulation section. Additionally, such an arrangement can provide a uniform radius of curvature along the articulation section from the proximal end to the distal end.

[0037] The multiple links may be disposed throughout the articulation link assembly. The multiple links may include a proximal end link at a proximal end of the articulation link assembly and a distal end link at a distal end of the articulation link assembly. The proximal end link can be laterally held by a composite insertion tube. The distal end link can be secured to the camera assembly by a termination band. Articulation wires extending through the links can be laser welded to the termination band.

[0038] The distal end of the articulation wire can be attached to the distal end of the insertion tube. The distal end of the articulation wire can extend through the distal termination link or can be laser welded to the termination band. The articulation wire can be disposed in a groove, e.g., a U-shaped groove, in the step-down portion of the distal termination link. The articulation wire is secured, e.g., by adhesive, and locked into place by sliding the termination band over the step-down portion of the distal termination link. Preferably, the termination band provides a secure connection between the distal termination link and the cap assembly.

[0039] In some embodiments, no articulation link is utilized. As described above, the insertion tube includes a proximal section, a transition section, and an articulation section. The insertion tube may include an outer polymer jacket and / or a braid inside the jacket. Inside the braid, a polytetrafluoroethylene (PTFE) sleeve may extend from the proximal section to the articulation section. The articulation wire may extend through the sleeve. The articulation wire may be secured to the wall of the termination band behind the braid, for example by welding. The articulation wire may be a flat pull wire.

[0040] The PTFE liner of the main shaft is disposed opposite the braid of the PTFE sleeve. The liner defines the main lumen of the insertion tube. Advantageously, this arrangement eliminates the need for a link and increases the available cross-sectional area at the distal end of the insertion tube. The increased available cross-sectional area may facilitate free movement of tool channels, electrical signal conductors, and other elongated objects that may be disposed within the main lumen of the insertion tube. This arrangement allows the distal end of the insertion tube to bend more than 300 degrees, and in some cases as much as 310 degrees.

[0041] The umbilical assembly includes an umbilical and a first cartridge. The umbilical assembly can include a fluid lumen and an electrical signal conductor extending between the cartridge and the handle assembly of the endoscope. The umbilical is attached at one end to the cartridge at a location. The cartridge can include a housing. A second tube can extend from another location of the housing. The second tube is connected to the first irrigation source described above. The second tube can include a luer lock connector at one end of the tube for connecting the second tube to the first irrigation source. The second tube can extend through the housing of the cartridge and into the umbilical. Advantageously, in the case of a manual or mobile irrigation source, the second tube can reduce the possibility of the first irrigation source pulling the endoscope handle during a procedure.

[0042] The cartridge may include a printed circuit board (PCB). The PCB may include electrical signal spring tabs. The cartridge spring tabs may interface with the console to establish an electrical connection between the console and the cartridge and / or endoscope. The cartridge may include a combination of static and / or dynamic retention tabs. The retention tabs may operably connect the cartridge to a receptacle on the console by connecting to a corresponding retention slot. The retention tabs may provide a "snap-on" connection of the cartridge to the console. The ability to snap the cartridge onto the console may enable a quick and safe method for attaching or removing the cartridge from the console.

[0043] The console may be relatively small to conserve space in the operating room or on the cart during use. The console may not include a fluid control. The console may include a receptacle. The receptacle may include an electrical signal connector for connecting an electrical signal spring tab of the first cartridge to the console. The receptacle may further include a retention slot for receiving and connecting the dynamic retention tab of the cartridge and the retention slot for the static retention tab of the cartridge. This connection may form an electrical connection between the console and the cartridge. If excessive tension is placed on the umbilical, the dynamic retention tab may automatically release from the dynamic retention slot. Advantageously, this safety release may prevent unintentional damage to the console or cartridge. Only static retention tabs and static retention slots may be utilized. In some embodiments, only dynamic retention tabs and dynamic retention slots are utilized. In other embodiments, both static retention tabs and static retention slots and dynamic retention tabs and dynamic retention slots may be utilized.

[0044] The console may further include an illumination control. The illumination control may control power to an LED at the distal end of the insertion tube. The illumination control may control the wavelength of light emitted from the LED. The console may also include a power control for powering the console on or off. For example, the power control may be a switch, knob, or button.

[0045] The cartridge can include a bracket for mounting the console vertically on a column. The receptacle can be oriented so that the cartridge can be connected to the cartridge in the same manner whether the console is horizontal or vertical. The receptacle can be rotated to a desired orientation based on the orientation of the console. Advantageously, this allows a desired ergonomic tube placement to be maintained regardless of the orientation of the console in the operating room.

[0046] The present disclosure further provides a second cartridge and a second console. The second cartridge and the second console may be larger than the first console and the first cartridge due to the use of a fluid control mechanism in the second console and the second cartridge. The system may include a cartridge inserted into a control valve assembly of the console. The cartridge may be connected to the endoscope by an umbilical. For example, the cartridge may be connected to the single-use endoscope by one or more fluid tubes and / or electrical conductors.

[0047] The cartridge may be connected to a support. The support may include an irrigation pump, an insufflator, and / or a vacuum pump (e.g., stand-alone or central). The cartridge may be disposed between the endoscope and the support.

[0048] In some embodiments, the console may include a user interface (not shown) that allows a user to change various variables of the endoscopic system. In one embodiment, the user interface is a touch screen integrated with an electro-visual display. In another example, the user interface may include a keyboard, a mouse, a trackball, and / or a touch-sensitive pointing device, etc.

[0049] The console may include a control valve assembly for receiving and operating the cartridge. The console may provide power, fluid and / or fluid pressure, vacuum pressure, and / or transmission and / or reception of electrical signals to and from the endoscope assembly. The console may include a monitor (not shown) for visualizing signals received from the endoscope assembly, such as a video feed from a camera at the distal end of the disposable shaft assembly.

[0050] The control valve assembly can be used to selectively actuate an actuatable portion of the flow path of the cartridge. The control valve assembly can include an actuator and a support structure having a first surface and a second surface.

[0051] The actuators may be linear or rotary actuators. The actuators may be solenoids. Although there may be only one actuator, in a preferred embodiment the control valve assembly includes four actuators. The actuators are adapted to actuate valve portions of the flow paths within the cartridge to selectively open and / or close the flow paths.

[0052] The valve portion of the flow path can comprise any acceptable valve. For example, the valve portion can comprise a petcock. The valve portion can also comprise a portion of tubing (e.g., a pinch valve) disposed for compression between the anvil of the first side of the door and an actuator (e.g., a solenoid) of the control valve assembly. The valve portion can function as a valve for any number of fluid functions of the endoscope, such as a suction valve associated with the actuator, a camera irrigation flow valve associated with the actuator, an insufflation valve associated with the actuator, and / or an insufflation vent valve associated with the actuator.

[0053] The actuator of the control valve assembly can include an electrical connector for being received by the console to electrically connect the actuator to the console, such that when connected to the console, the console can provide power and user input commands to the actuator to open and / or close fluid passageways in the cartridge.

[0054] The cartridge may include an identifier that is readable and / or writable by the control valve assembly. The identifier may include information regarding the type of cartridge and / or usage information (e.g., whether the cartridge has been used before). Preferably, the control valve assembly is configured to read and process the identifier of the cartridge (e.g., to determine the type of cartridge and / or whether the cartridge has been used before). The identifier may be readable and / or writable via an electrical connector of the cartridge and / or via other means (e.g., RFID, optics, and / or mechanical contact).

[0055] The first surface of the support structure can include an electrical connector for forming an electrical connection with an electrical connector of the cartridge. The electrical connection between the control valve assembly of the console and the cartridge allows the console to receive image and control data (valve / actuator and / or image data) sent from the endoscope through the cartridge to the console. The electrical connection allows the console to provide power to light emitting diodes (LEDs) of the endoscope assembly.

[0056] The cartridge can be a disposable cartridge, which can eliminate the need for the use of a permanent valve body contained within a reusable endoscope and / or console, thereby eliminating the need to sterilize a reusable valve after each use.

[0057] The cartridge has a housing. The housing can include a first side and a second side. The housing further includes a first fluid side and a second fluid side that allow fluid to move into and out of the cartridge housing. The housing can define one or more fluid paths, fluid connectors, and / or electrical connectors. For example, the cartridge housing can include an electrical connector that electrically communicates with electrical conductors of the endoscope, and an optical sensor module that optionally includes optical sensor calibration data and / or a unique identifier of the endoscope. The housing can define windows. In one example, the housing includes four windows. The windows can be defined by an inner surface of the housing. The inner surface can form a generally circular opening in the housing. The circumference of some windows can be larger than other windows to accommodate a larger flow path cross-section.

[0058] The window can be configured to receive an actuator from the console into a chamber defined by the inner surface. As described above, the actuator can pass through the window and / or contact an anvil on a door of the control valve assembly of the console to form a pinch valve with the door. When the cartridge is placed on the control valve assembly and the door is closed, the window aligns with the anvil of the door and the actuator of the control valve assembly. The window can be arranged to define a geometric shape. For example, the window can define a diamond shape.

[0059] As described above, the actuator or actuators may be solenoids configured to extend into a window in the cartridge housing and / or contact an anvil on the door of the control valve assembly, forming a pinch valve when closed.

[0060] The housing may further include an electrical connector for connecting to the electrical connector of the control valve assembly. The cartridge electrical connector may be spring finger electrical contacts configured to contact a corresponding number of flat pad electrical contacts of the control valve assembly of the console, or vice versa. The cartridge housing electrical connector may transmit image data and control data provided by the endoscope to the console. The housing electrical connector may transmit power from the console to LEDs used by the endoscope within the patient's body.

[0061] The cartridge is inserted flush with a first surface of the support structure of the control valve assembly. A first fluid side of the cartridge can include loose tubing that leads into the umbilical and into a disposable shaft assembly (not shown) of the endoscope.

[0062] The second fluid side of the cartridge can be connected to a support. The support can include an irrigation pump, an insufflator, and / or a vacuum pump (standalone or central). The cartridge can provide fluid communication between the endoscope and the support.

[0063] The control valve assembly can include a ledge surface and a latch. The cartridge can include a ledge surface and a latch receiver. In another embodiment, the control valve assembly includes the latch receiver and the cartridge includes the latch. When the cartridge is received in the control valve assembly, the latch contacts the latch receiver to secure a first end of the cartridge to the control valve assembly. Alternatively, opposite the latch and the latch receiver, a ledge surface of the cartridge and a ledge surface of the control valve assembly can contact each other to secure a second end of the cartridge to the control valve assembly.

[0064] In some embodiments, the cartridge can include two or more magnets disposed on a first side of the cartridge. In some embodiments, one magnet is located at the bottom of the first face of the cartridge and a second magnet is located at the top of the first face of the cartridge. The first face of the control valve assembly can include two or more magnetic sensors (Hall or Reed) corresponding to the location of the magnets on the cartridge. For example, one is located at the bottom of the first face and another is located at the top of the first face. The bottom magnet on the cartridge interacts with the bottom magnetic sensor on the control valve assembly to retract the actuator (e.g., solenoid) valve and reduce the force required to tilt the cartridge into the control valve assembly. The top magnet interacts with the top magnetic sensor on the control valve assembly to confirm the presence of the cartridge on the console and operate the console to release the appropriate actuator and initiate the actuator operating mode for endoscopy.

[0065] The system can include a first cartridge and a second cartridge. The first cartridge is connected to a first endoscope (not shown) and the second cartridge is connected to a second endoscope (not shown). The first cartridge and the second cartridge are securely inserted into a first control valve assembly and a second control valve assembly, respectively, of the console. The console can have any number of control valve assemblies, each capable of receiving an independent cartridge. The first control valve assembly can be adapted to receive the first cartridge and the second control valve assembly can be adapted to receive the second cartridge. Not all control valve assemblies need to receive cartridges in all medical procedures.

[0066] Each cartridge may be connected to a separate support and independent medical device, such as an endoscope.

[0067] The first and second control valve assemblies are configured to operate independently and / or in a primary / secondary relationship. The first (aka "mother") endoscope can be the primary controller and the second (aka "daughter") endoscope can be the secondary controller. In this arrangement, the controls of the primary endoscope can control the functionality of one or more secondary endoscopes (e.g., image controls and / or LEDs). The primary endoscope can control the functionality of the flow paths of the secondary endoscope by providing electrical signals to the second control valve assembly (e.g., via one or more cartridges connected to the console) to selectively activate actuators described herein. The first endoscope can further control the functionality of the second endoscope (e.g., operation of the LEDs and / or camera) by providing electrical signals from the first endoscope to change the state of the second control valve assembly (e.g., to change the electrical signal provided by the second control valve assembly to the cartridge of the second endoscope). For example, the control valve assembly can provide electrical signals to the LEDs and / or camera of the second endoscope based on signals received from the first endoscope. This arrangement further allows multiple endoscopes to be set up and utilized for a procedure at once, eliminating or reducing much of the setup time typically used to exchange one endoscope for another, and / or eliminating or reducing the need for additional equipment such as multiple control consoles.

[0068] The console may include a user interface, which may be any suitable input / output device, and may include a touch screen.

[0069] The second control console may include a fluid control and be larger than a console without a fluid control. The second console may include one or more receptacle / control valve assemblies. The receptacle may include an electrical signal connector for connecting the electrical signal spring tabs of the cartridge to the console. The second console may allow a user to install a cartridge with or without a fluid control. In some examples, a larger cartridge may be connected to a receptacle of a larger second console. The larger second cartridge may cover a portion of the receptacle. In this example, the console includes a valve that operates to control the flow of fluid through the cartridge, as described above. In another example, the first cartridge described above may be installed to cover a smaller portion of the receptacle of the second console than the larger cartridge. In a third example, a larger cartridge may be used to cover the entire receptacle, but no fluid control is utilized.

[0070] Advantageously, for example, a cartridge without a fluid control can be flexible enough to connect to small pole-mounted consoles such as those found in doctor's offices, as well as larger consoles (e.g., dual consoles) such as those found in operating rooms for ureteroscopy. Additionally, a single-use cholangioscope can be used in combination with a hybrid duodenoscope during endoscopic retrograde cholangiopancreatography, such as by connecting both to a dual console. Additionally, a single-use cholangioscope can be used with a small console without a fluid control, in combination with a third-party reusable duodenoscope and associated video processing unit.

[0071] Additionally, an improved four-way steering flexible endoscope is disclosed. The endoscope assembly may include an umbilical and an insertion tube. The insertion tube may include an articulation section. The insertion tube may further include articulation wires. The articulation wires are used to articulate the articulation section of the insertion tube. In one embodiment, the insertion tube includes two articulation wires for either up-down or left-right articulation. In one exemplary embodiment, the insertion tube includes four articulation wires. This configuration allows for up-down and left-right articulation by the user.

[0072] Additionally, a mounting structure is disclosed for mounting one endoscope to the handle of another endoscope. The ability to mount and secure one endoscope to the other allows the endoscopist to easily handle both endoscopes and reduces the hassle of handling two endoscopes. Often, a small diameter endoscope is deployed through a tool channel of a larger diameter endoscope, e.g., a cholangioscope through a duodenoscope. The mounting structure is adapted to secure the small diameter endoscope to the handle and / or strain relief of the larger diameter endoscope.

[0073] The mounting structure can include an elastic strap having an alignment pad, such as an elastomeric pad. In some embodiments, the alignment pad is curved to match the typical shape of the body of the large bore endoscope. The alignment pad prevents movement of the small bore endoscope on the large bore endoscope. The mounting structure can further include a cam latch and a land for the cam latch. In the open position, the cam latch is released from the land for the cam latch. In the closed / locked position, the cam latch is locked to the land for the cam latch. In the closed position, the small bore endoscope is securely locked to the body of the large bore endoscope.

[0074] The handle of the endoscope has an integrated suction control that allows for variable manual suction and allows for variable suction strength selection. Valves may also control the flow of irrigation fluid.

[0075] The suction control may include an integrated variable suction valve and a suction tube. The integrated suction valve may include a valve variable screw, a valve sliding button, a valve spring, and a valve anvil. The screw may be rotatable or may be non-rotatable and compressed. When the screw is rotated, the suction tube is compressed against the valve anvil to reduce the strength of suction or released from the valve anvil to increase suction. The level of suction may range from the suction tube being completely closed against the valve anvil and providing no suction to the screw being completely open and not compressing the suction tube against the anvil. By adjusting the screw, the user can obtain a variable amount of suction.

[0076] The insertion tube may be a solid polytetrafluoroethylene (PTFE) extrusion with an integral lumen extending therethrough (as described below). The insertion tube may include a lumen defining a tool channel for deploying various medical instruments through the insertion tube and into the patient's body. The insertion tube may further include another lumen for one or more electrical conductors for transmitting electrical signals to a camera and / or photodiode at the distal end of the insertion tube, for example, a complementary metal oxide semiconductor (CMOS) sensor wire. The insertion tube may further include fluid conduits, such as irrigation and suction conduits. As described above, the insertion tube may further include articulation wires for articulating the insertion tube. Additionally, the insertion tube includes a core profile surrounded by a braid.

[0077] The core profile can be made of a lubricious polymer and includes a central lumen with four articulation wire lumens for passing articulation wires. In some embodiments, the central lumen is PTFE. In one exemplary embodiment, the articulation wire lumens are equally spaced around the central lumen. The four lumens (the tool channel lumen, the electrical conductor lumen, and the two fluid lumens) can be made of nylon, EVA, and / or PVC.

[0078] The braid surrounds at least a portion of the outside of the central lumen of the core profile. The braid is surrounded by a sheath / outer jacket. The outer jacket may be constructed from HDPE, EVA, PVC, and / or PBAX.

[0079] During manufacture of the insertion tube, the lumens that define the tool channel, the lumens that have electrical conductors extending therethrough, the various fluid tubes, and the articulation wire lumen are pulled through the central lumen of the central profile. In one embodiment, the lumens are all drawn and formed at once. This manufacturing method limits the number of leak points.

[0080] The articulation section may include two opposing series of articulating cuts in the core profile. The cuts are formed over at least a portion of the length of the articulation section. The cuts form a series of articulating living hinges that facilitate bending in a single plane, for example at 90 degree angles to one another. The articulation section may be made of a different material than the core profile, for example nylon. The articulation section may be detachably attached to the remainder of the insertion tube by adhesive, by mechanical connection, or by an articulation wire that extends through the articulation section and the remainder of the insertion tube.

[0081] The insertion tube may have multiple sections including a proximal section, a transition section, and an articulation section located at the distal end of the insertion tube. The proximal section of the insertion tube may be made of a higher durometer polymer than the articulation section to prevent bending of the proximal section during articulation of the articulation section. The articulation section may be made of a lower durometer polymer than the proximal section to allow the articulation section to bend by an articulation wire. The transition section is operatively disposed between the articulation section and the proximal section. The transition section may be made of a polymer having a higher durometer value than the articulation section and a lower durometer value than the proximal section. This allows the transition section to passively bend during articulation movement of the articulation section of the insertion tube. Thus, articulation of the articulation section creates a smooth, flowing transition between the proximal section, which is not moving or has minimal movement, and the articulation section.

[0082] The insertion tube may further include a camera cap assembly located at a distal end of the insertion tube. The insertion tube may further include a transition band between the articulation shaft portion and the transition band. The diameter of the transition band may be larger than the diameter of the cap assembly such that the cap assembly is inserted into and secured to the opening in the termination band.

[0083] The insertion tube end fitting can receive an articulation compression coil that receives one or more articulation coils wound around respective articulation wires. The articulation wires are configured to bend a distal shaft portion of the endoscope assembly upon actuation. The insertion tube end fitting further aids in securing the insertion tube to the endoscope handle body.

[0084] The camera cap assembly may include a camera cap, an optical sensor (camera) within the camera cap, and a tool channel that extends from the endoscope handle body through the insertion tube and through the camera cap.

[0085] The insertion tube includes an articulation section polymer jacket, a transition section polymer jacket, and a proximal section polymer jacket, which encompass an articulation section, a transition section, and a proximal section, respectively. The three jackets make up an outer composite tube. The outer composite tube can be assembled in one operation on a mandrel prior to inserting any of the internal components of the insertion tube.

[0086] The insertion tube may include multiple articulation links extending throughout the insertion tube. The multiple links are comprised of a series of two or more links. The links facilitate articulation movement of a distal portion (articulation shaft portion) of the insertion tube within the patient. The use of distal articulation links creates a greater degree of articulation based on a given input when a tool is in a given position within the tool channel compared to other methods.

[0087] The coil and heat stake attach the coil to the proximal shaft section. Following the initial shaft layup, the coil is inserted into the proximal shaft section and heat staked to secure it in place, simplifying manufacturing.

[0088] The proximal shaft portion (proximal portion) may include an outer proximal polymer jacket. The polymer jacket may extend circumferentially around the proximal shaft portion. A braided wire may extend within the polymer jacket. A coil may be within the braided wire.

[0089] The transition shaft section (transition section) may be identical to the proximal shaft section with a transition polymer jacket in place of the proximal polymer jacket.

[0090] The articulation shaft (articulation section) includes an outer articulation section polymer jacket. The polymer jacket may extend circumferentially around the articulation shaft section. A braided wire extends within the polymer jacket. The braided wire surrounds the assembly of articulation links.

[0091] During manufacture of the insertion tube, the articulation components (coils, articulation wires, links, inner tube) can be pulled into the composite insertion tube as a single unit. During manufacture, the proximal shaft section, including the compression coils and articulation wires, can be extended through the articulation shaft section and pulled through the composite insertion tube until the proximal shaft section reaches the insertion tube end fitting and the compression coils and pull wires extend beyond the insertion tube end fitting. Pulling all the internal articulation parts as a whole facilitates assembly. Advantageously, the articulation coils can prevent unintended movement of the proximal shaft section by isolating the articulation forces from the proximal shaft.

[0092] To attach the distal end of the articulation wire to the distal end of the insertion tube, the articulation wire can be placed in a groove, e.g., a U-shaped groove, in the stepped-down portion of the distal articulation link. The articulation wire is secured, e.g., by adhesive, and locked into place by positioning a transition band over the distal articulation link. This provides a simple method of fastening using a continuous wire and reduces the risk of the wire end coming loose.

[0093] In a second embodiment for attaching the distal end of the articulation wire to the distal end of the insertion tube, the distal end of the articulation wire extends through the distal articulation link and is secured (e.g., laser welded) to the transition band.

[0094] In both embodiments, the transition band provides a secure connection between the distal articulation link and the cap assembly. Advantageously, either embodiment allows for anchoring the distal end of the articulation link within the limited space of a small bore endoscope.

[0095] During manufacture, multiple links or printed links may be used with a support beam that extends at least partially the length of the multiple links. The support beam includes a removable support strut attached to the multiple links. The multiple links may be formed during manufacture of the multiple links. As discussed above, some of the multiple links may be different from each other. The manufacturing method may be injection molding, additive manufacturing, and / or subtractive manufacturing. The support beam and separate support struts may support the links and maintain alignment of the links during manufacture. In assembly of the articulation link assembly, the support beam and support struts are removed and discarded.

[0096] A runner with support struts may be attached to the multiple links. The runner includes the support struts and the links are formed by injection molding. The links may be connected by flexible link connectors. The flexible link connectors may be foldable to allow adjacent links of the articulation link to pivot toward each other after removal of the support struts and / or runners. The flexible link connectors may aid in proper ordering and orientation of the links during assembly.

[0097] The proximal (bottom) end of the articulation link may include two spaced apart concave / recessed articulation pivots and the distal (top) end of the link may include two corresponding convex / protruding articulation pivots, with each concave / recessed articulation pivot and corresponding convex / protruding articulation pivot forming a pair.

[0098] When articulating to one side, only one pair of convex / concave articulation pivots may contact one another. When articulating to a different side, a different pair of convex / concave articulation pivots may contact one another. Thus, when pivoted to one side, adjacent links articulate about a different pivot point than when the assembly is pivoted to a different side. In such an example, one articulation wire may be located at a first distance from the pivot point when the assembly articulates to a first side and at a second distance when the assembly articulates to a second side. Advantageously, such an arrangement may enable the articulation wire to generate a larger moment (i.e., rotational force) relative to a pulling force applied to the wire to pivot adjacent links relative to one another when the assembly articulates to one side and the other.

[0099] A plurality of links is comprised of two or more links. In one embodiment, the links are designed with varying distances between pairs of convex / concave articulation pivots to control where the articulation movement first occurs. By decreasing the distance between the pivots relative to the centerline of the links, a given force can generate a larger articulation torque, as described above. In a preferred embodiment, the distance between the convex / concave pivots decreases with each successive convex / concave pivot toward the distal tip of the insertion tube. During articulation movement, an articulation angle occurs between the links.

[0100] All of these features can be varied on individual links or in combination with multiple links to achieve a desired articulation response and shape. This arrangement provides the ability to initiate a distal articulation movement prior to or simultaneously with a proximal articulation movement. Additionally, this arrangement provides the ability to mitigate increased pulling forces that build up at the proximal end of the articulation section. This arrangement can provide a uniform radius of curvature along the articulation section from the proximal end to the distal end.

[0101] Another embodiment of the insertion tube is disclosed herein. All applicable disclosures including the above insertion tube are incorporated herein. The insertion tube may be composed of two continuous sections (proximal section and distal articulation section). The insertion tube may include a proximal multi-lumen shaft section with a multi-lumen proximal extrusion section and a flexible section as a steerable sheath. There is a flexible transition section between the two sections. The two sections are linearly connected by an outer braid and a multi-segment polymer jacket.

[0102] The use of a proximal multi-lumen (including a central lumen and four articulation wire lumens as described above) shaft section simplifies the construction of the proximal shaft. The use of a central lumen facilitates pulling the internal components including the fluid lumens, lumens defining the tool channels, articulation wire lumens, and electrical conductors as a single operation during assembly (as described above). The distal flexure section can be pre-assembled on a mandrel with the proximal multi-lumen extrusion section prior to over-braiding and reflow.

[0103] The insertion tube includes an outer proximal polymer jacket, an inner flexure transition liner, an outer flexure transition jacket, an inner flexure liner, and an outer flexure jacket.

[0104] One or more pairs of articulation wires may be attached to the distal transition band. The transition band serves as a fixation point for the articulation wires and as a transition connecting the distal tip of the flexure and the camera cap assembly. The transition band provides a low profile connection between the flexure and the camera cap assembly. The transition band and articulation wire assembly may be inserted into the combined proximal / articulation tube, facilitating assembly.

[0105] The flexure is configured as a steerable sheath. This steerable sheath configuration can provide a larger lumen size compared to alternative steerable configuration technologies.

[0106] The proximal shaft portion may include an articulation wire lumen through which the articulation wire extends. In some embodiments, there are four articulation wire lumens. The proximal shaft portion may further include a central lumen.

[0107] The flexure further includes an articulation wire jacket.

[0108] During manufacture of the insertion tube, the articulation components, including the articulation wires, can be pulled into the insertion tube as a single unit. Additionally, during manufacture, the proximal multi-lumen shaft section, including the articulation wires, can be extended through the flexure and pulled through the insertion tube until the articulation wires extend from the end of the insertion tube. Pulling all of the internal articulation parts together facilitates assembly.

[0109] Disclosed herein is a system for articulation wire tension adjustment with adjustable stops that moves either a compression coil or a catheter shaft distally relative to a proximal pull wire fixation point, thereby tensioning one or more articulation wires.

[0110] The use of various systems for adjusting the position of the articulation coil or the insertion tube relative to the articulation wire is disclosed. The required function of tensioning the articulation control assembly is achieved by moving the articulation coil or the insertion tube relative to the articulation wire. Moving the articulation coil or the insertion tube instead of adjusting the articulation wire has the following advantages: 1) the articulation wire is more fragile than the articulation coil and therefore may be at greater risk of damage during tension adjustment / repositioning than the articulation coil; 2) if crimping or adhesive is used to secure the articulation wire, it is more difficult to secure and repeat than a cut coil / insertion tube; and 3) since the articulation wire typically terminates in a pulley, it is easier to incorporate tension adjustment into the handle body where the articulation coil terminates.

[0111] The articulation compression coil may contact an adjustable stop that may be adapted to counteract the force of the articulation wire.

[0112] In another embodiment, the insertion tube may contact an adjustable insertion tube stop. To facilitate cooperation with the stop, the insertion tube may include an insertion tube collar.

[0113] In the first position, the adjustable coil spacer is positioned between the stop and the spacer retainer. The spacer retainer is used to hold the coil spacer in place relative to the stop. In the second position, the coil spacer is positioned such that the stop is between the coil spacer and the spacer retainer. In this configuration, the coil spacer prevents the compression coil from hitting the stop. This configuration allows the insertion tube to move relative to the articulation wire and handle body to tension the articulation control assembly.

[0114] A sliding coil retainer is used to secure the compression coil. The compression coil may be secured within the coil retainer by any known mechanism. The coil retainer may include a number of grooves extending along the length of the coil retainer.

[0115] The handle body allows the coil retainer to be selectively repositioned within the handle body to tension the articulation wire. The handle body may include a plurality of grooves along the length of the handle body. When the coil retainer is selectively repositioned within the handle body, the grooves of the coil retainer and the grooves of the handle body may be aligned. In the aligned state, a pin may be inserted into the aligned groove to lock the coil retainer, and thus the compression coil, in place. Other known locking mechanisms may be used to lock the coil retainer to the handle body, such as a set screw and / or adhesive, to name a few non-limiting examples.

[0116] Another embodiment for slidingly retaining a compression coil is disclosed herein. An articulation coil collar is disclosed having an upper portion that is wider than a lower portion. The collar receives and retains the compression coil. In some embodiments, the compression coil is inserted and / or rotated into the coil collar. The handle body includes a plurality of grooves along the length of the handle body. The grooves are shaped to receive and retain an upper portion of the collar.

[0117] Yet another embodiment for sliding and holding a compression coil is disclosed herein. The articulation wire can extend through an opening in a portion of the handle. A sliding stepped wedge can be positioned against the portion of the handle to cover the opening through which the wire extends through the portion of the handle. The sliding stepped wedge can include stepped surfaces of different heights. The compression coil can move between the steps to vary the tension on the articulation wire.

[0118] Yet another embodiment for sliding and holding the compression coil is disclosed herein. The rotating stepped wedge includes a stepped surface. In some embodiments, the rotating stepped wedge may include three steps of different heights. The compression coil may be secured against the stepped surface. Each stepped surface includes a groove for the articulation wire to extend through. As the rotating stepped wedge rotates, the compression coil may move between the steps to vary the tension on the articulation wire 1008.

[0119] Another embodiment is disclosed herein for varying the position of the compression coil to control tension in the articulation wire. This embodiment includes a cannulated set screw configured to the handle. In this embodiment, the compression coil is inserted into the set screw and can be rotated until it is securely held by the set screw. The compression coil can be rotated within the set screw so that more or less of the compression coil is within the set screw, depending on the tension required.

[0120] Yet another embodiment for varying the position of a compression coil to control tension in an articulation wire is disclosed herein. This embodiment includes a rotating threaded hub adapted to rotate within a number of grooves in a handle. The threaded hub can be rotated to move within the grooves. A compression coil can be inserted and held within the rotating threaded hub. To change tension in the articulation wire, the threaded hub is rotated clockwise or counterclockwise to change the position of the compression coil proximally or distally.

[0121] A series of hybrid handle (disposable / reusable) variations associated with small diameter bi-directional (single plane) flexible endoscopes are disclosed. These hybrid handle variations exhibit various degrees of functionality associated with the disposable portion of the handle. For example, one hybrid handle variant requires remote fluid control, while another variation only incorporates electronic switches for imaging, lighting, etc. into the reusable handle. The bi-directional hybrid handle variations disclosed herein support multiple clinical applications including cholangioscopy, ureteroscopy, cystoscopy, and bronchoscopy.

[0122] In addition to the hybrid handle variations disclosed, several bi-directional operating engagement mechanisms are disclosed, including both self-aligning shaft configurations and spring-loaded engagement configurations.

[0123] The endoscope assembly may include a separable reusable handle and a disposable endoscope handle. The reusable handle may include electronically controlled switches and electrical conductors. The electronically controlled switches are for image capture, lighting power, video capture, etc.

[0124] The single-use endoscope handle may include a tool port, an insertion tube, an umbilical, an articulation control lever, a fluid control button / trigger, and electrical conductors. The disclosures of the tool port, the various insertion tubes, the umbilicals, the articulation control levers, and the fluid control buttons described above are incorporated herein. The electrical conductors are connected to other electrical conductors to transmit electrical signals between the single-use endoscope handle and the reusable handle. The electrical signals from the reusable handle are sent to the cartridge described above and sent to the console when the cartridge is connected to the console. The electrical signals are also sent from the console to the distal end of the insertion tube.

[0125] The use of a reusable handle reduces waste by transferring some of the structure, mechanics, and electronics of the endoscope handle from the single-piece disposable endoscope to the reusable handle of the multi-piece endoscope. By transferring the electronic control from the single-piece disposable endoscope to the reusable handle of the multi-piece endoscope, additional functionality and higher quality components can be incorporated while not imposing additional costs on the disposable handle. In other words, more expensive, higher quality electronics can be used in the reusable handle, and the disposable endoscope handle can be cheaper to manufacture, as opposed to a single-piece disposable endoscope that must be discarded after each use. Thus, costs can be reduced by allowing the continuous use of the reusable handle with a series of disposable endoscope handles. The use of electrical conductors associated with the single-use endoscope handle to provide power and signal connections to the reusable handle eliminates the need for secondary cables or batteries that require replacement or charging. The use of a wired connection also eliminates latency and / or connectivity issues often associated with wireless connections.

[0126] Another embodiment of an endoscope assembly having a detachable reusable handle and a disposable endoscope handle is disclosed herein. Many of the components are similar to the embodiment described above. Therefore, only the differences in the endoscope assembly will be described.

[0127] The reusable handle includes electronic controls for image capture, light levels, video capture, etc., and an articulation lever with an optional brake. The reusable handle includes an articulation control lever with similar functionality to the articulation control lever described above, and an articulation drive shaft with an engagement feature. The single-use endoscope handle includes an articulation pulley with an engagement portion configured to mate with the articulation drive shaft. Movement of the lever drives the drive shaft to drive the pulley. The pulley controls the articulation of the articulation wire within the insertion tube.

[0128] The use of a self-aligning, detachable articulation drive (drive shaft and pulley) between the reusable handle and the disposable endoscope handle allows additional features such as brake levers / mechanisms and higher quality parts to be incorporated while not imposing additional cost on the disposable endoscope handle. In other words, more expensive, higher quality parts can be used in the reusable handle, making the disposable endoscope handle cheaper to manufacture, as opposed to a disposable, single-piece endoscope that must be discarded after each use. Thus, costs can be reduced by allowing the continuous use of a reusable handle with a series of disposable endoscope handles.

[0129] Another embodiment of an endoscope assembly having a detachable reusable handle and a disposable endoscope handle is disclosed herein. Many of the components are similar to the embodiment described above. Therefore, only the differences in the endoscope assembly are described herein.

[0130] The reusable handle includes electronic controls for image capture, light levels, video capture, etc., articulation levers with optional brakes, and fluid buttons to mechanically pinch (control) the fluid conduits contained within the disposable endoscope handle.

[0131] The single-use endoscope handle includes a slot and a fluid control tube. When the reusable handle and the single-use endoscope handle are connected, a pinch valve is formed between the fluid control button and the fluid control tube. The fluid control button can be pressed by a user to pinch the fluid control tube to limit the amount of fluid passing through the fluid control tube. By pressing the fluid control button with varying force, the user can control the amount of fluid passing through the fluid control tube. The fluid control button allows a maximum flow rate through the tube when the button is not pressed. The fluid passing through the tube is gradually reduced depending on how much the user presses the control button inward.

[0132] This embodiment also moves the mechanical pinch valve button and mechanism from the single-use endoscope handle to the reusable handle. This configuration allows for higher quality parts to be incorporated without the added cost of a disposable cartridge. In other words, more expensive, higher quality components can be used in the reusable handle, making the single-use endoscope handle less expensive to manufacture, as opposed to a single-use, one-piece endoscope that must be discarded after each use. Thus, costs can be reduced by allowing the use of a reusable handle in series with a series of single-use endoscope handles.

[0133] Another embodiment of an endoscope assembly having a detachable reusable handle and a disposable endoscope handle is disclosed. Many of the components are similar to the embodiment described above. Therefore, only the differences in the endoscope assembly are described herein.

[0134] The reusable handle includes electronic controls for image capture, light levels, video capture, etc., and an articulation lever with an optional brake. The reusable handle further includes an electrical switch for pinching (controlling) the fluid conduit using a remotely located electromechanical actuator.

[0135] The reusable handle includes an electrical switch that, when pressed by a user, sends a signal to an electromechanical actuator that operates on a fluid line (as described above) to restrict or prevent the flow of fluid through the fluid line.

[0136] In this embodiment, the mechanical pinch valve button and mechanism is replaced with an electrical switch associated with the reusable handle and an electromechanical pinch valve located remotely from the endoscope assembly. By eliminating the mechanical pinch valve from the single-use endoscope handle and / or the reusable handle, the cost of the disposable cartridge is reduced.

[0137] Disclosed herein is a self-centering articulation drive shaft and an articulation pulley having an associated engagement portion. As disclosed above, the reusable handle may include an articulation drive shaft. The drive shaft is driven by an articulation control lever as described above.

[0138] The housing of the reusable handle supports a drive shaft coupled to the articulation control lever. The drive shaft extends into a region of the reusable handle that receives the single-use endoscope handle. The drive shaft extends into a recess in the single-use endoscope handle such that the drive shaft engages a pulley disposed on the single-use endoscope handle when the reusable handle and the single-use endoscope handle are joined together.

[0139] The drive shaft may include a pulley engaging portion that may have a non-circular cross-sectional geometry capable of transmitting torque, including, but not limited to, an ellipse, a spline, a square, or a star, to name a few non-limiting examples.

[0140] The single use endoscope handle may include one or more pulleys. The pulley may be adapted to receive an end of a drive shaft. Preferably, actuation of an articulation control lever associated with the drive shaft rotates the pulley. Preferably, the pulley has an engagement portion that mates with an engagement portion of the drive shaft to rotationally couple the pulley and the drive shaft to one another. Preferably, the engagement portion does not rely solely on friction between the drive shaft and the pulley. Preferably, the engagement portion includes a geometric interference between the articulation shaft and the pulley.

[0141] Associated with at least one pulley is an articulation wire or a pair of articulation wires (e.g., two separate wires or one continuous wire looped over the pulley with wire segments extending from opposite sides of the pulley) configured to bend the distal end of the insertion tube. The articulation wires may be fixed to the pulley and / or may extend around at least a portion of the pulley (e.g., looped around the pulley). Preferably, the articulation wires are configured to bend the distal end of the insertion tube in mutually orthogonal planes.

[0142] An alternative embodiment is disclosed for engaging a drive shaft to a pulley having a spring biased engagement portion. All applicable descriptions above are incorporated herein. The drive shaft may include a spring loaded engagement tab. The spring loaded engagement tab may include one or more spring loaded retractable blades. The spring loaded engagement tab may mate with an engagement portion on the pulley to operably lock the drive shaft to the pulley. The engagement portion may include one or more slots for receiving the retractable blades of the spring loaded engagement tab.

[0143] The spring loaded (with guide ramp) retractable blade allows the user to simply press the two pieces together. As the control lever is articulated through its range of motion, the retractable blade reaches a slot on the bore of the articulation pulley and extends to engage the articulation pulley. This allows the user to attach the single-use endoscope handle without having to pre-align the reusable handle with the single-use endoscope handle.

[0144] Yet another embodiment is disclosed for mating a drive shaft with a pulley. The reusable handle may include a drive disk. The drive disk may include a center alignment pin (e.g., an alignment boss with a guide chamfer) and a spring loaded pull-in pin (e.g., a spring loaded torque pin with a guide chamfer) offset from the centerline of the disk to transmit torque. The articulation pulley may have a mating portion including a center alignment hole and an offset hole with a guide chamfer having a guide for the torque pin.

[0145] The spring-loaded retract pin (with guide chamfer) allows the user to simply press the two components together. Articulation of the control lever through its range of motion causes the retracted spring-loaded retract pin to extend and engage a mating portion on the face of the articulation pulley. This allows the user to attach the single-use endoscope handle without pre-aligning the reusable handle and the single-use endoscope handle.

[0146] Further disclosed herein is a novel braid pattern to achieve the mutual benefits of coils and braids on the insertion tube of an endoscope. A novel braid pattern is disclosed that incorporates a unique multi-filar aligned braid pattern in one or more of the helical paths to impart the kink resistance associated with coils while providing the torqueability associated with conventional braids. This new and improved braid pattern can be made using conventional braiding mechanisms with a modified carrier position to produce it. This novel braid pattern can improve the kink resistance of small bore endoscopes including, but not limited to, cholangioscopes, ureteroscopes, cystoscopes, and bronchoscopes.

[0147] One embodiment of the small bore endoscope insertion tube is a single helical thread over the multifilament group all oriented in the same direction. In some embodiments, the multifilament group can be from 2 to 10 or more. In one exemplary embodiment, the multifilament group is 3.

[0148] A single helical yarn combined with multiple opposing yarn groups provides the torque properties associated with typical one-to-one braid patterns or other variations.

[0149] The multiple filaments are all aligned in the same direction in a helical pattern. This configuration creates a simulated coil to provide kink resistance for the insertion tube. The ability to create a simulated coil during the braiding process reduces process steps, eliminates the need for additional equipment, and eliminates the cost of using coils in manufacturing endoscope insertion tubes.

[0150] Any of the aspects and embodiments of the invention described herein may be used independently or in combination with each other. A single medical device may include all aspects disclosed herein.

[0151] Other aspects, objects, and advantages of the present disclosure will become more apparent from the following detailed description taken in conjunction with the accompanying drawings. Further aspects, objects, features, forms, benefits, advantages, and embodiments of the present disclosure will become apparent from the detailed description and drawings provided herein. [Brief description of the drawings]

[0152] [Figure 1] FIG. 2 illustrates an endoscope assembly and cartridge. [Figure 2A] FIG. 2 is a right side view of the endoscope assembly of FIG. 1. [Figure 2B] FIG. 2 shows a rear view of the endoscope assembly of FIG. [Figure 2C] FIG. 2 is a left side view of the endoscope assembly of FIG. 1. [Figure 2D] FIG. 2 shows a front side view of the endoscope assembly of FIG. 1. [Diagram 3] FIG. 2 shows a perspective view of the endoscope assembly of FIG. 1. [Figure 4] FIG. 2 shows a top view of the endoscope assembly of FIG. 1. [Diagram 5] 2 illustrates the endoscope assembly of FIG. 1 with a housing piece removed. [Figure 6] 2 illustrates a cross-sectional view of a pulley assembly including a friction element of the endoscope assembly of FIG. 1. [Figure 7] 2 illustrates a cross-sectional view of another embodiment of a pulley assembly including a friction element of the endoscope assembly of FIG. 1. [Figure 8A] 2 shows a cross-sectional view of the endoscope assembly of FIG. 1. [Figure 8B] The second / secondary fluid lumen is shown. [Figure 8C] The second / secondary fluid lumen is shown. [Figure 8D] The second / secondary fluid lumen is shown. [Figure 8E] The second / secondary fluid lumen is shown. [Figure 8F] The second / secondary fluid lumen is shown. [Figure 8G] The second / secondary fluid lumen is shown. [Figure 8H] The second / secondary fluid lumen is shown. [Figure 9] FIG. 5 is a cross-sectional view of the top of the endoscope assembly of FIG. [Figure 10] FIG. 2 is a side view of the insertion tube of the endoscope assembly of FIG. 1 with the handle assembly removed. [Figure 11A] FIG. 11 is a cross-sectional view of the insertion tube of FIG. [Figure 11B] 11 is another cross-sectional view of the insertion tube of FIG. 10. [Figure 11C] FIG. 11 is a cross-sectional view of the articulation portion of the insertion tube of FIG. 10. [Figure 12] FIG. 11 is an exploded perspective view of the end band and cap assembly of the insertion tube of FIG. [Figure 13] FIG. 11 is a partially exploded perspective view of the insertion tube of FIG. 10. [Figure 14] 11 illustrates multiple links of the insertion tube of FIG. 10. [Figure 15A] FIG. 15 is a bottom view of a single link of the multiple links of FIG. [Figure 15B] FIG. 15 is a top view of a single link of the multiple links of FIG. [Figure 16]FIG. 15 is a side view of two of the links of FIG. 14. [Figure 17] FIG. 11 is a cross-sectional view of the articulation link assembly of the insertion tube of FIG. [Figure 18] FIG. 13 is an exploded perspective view of a distal link and an end cap. [Figure 19] FIG. 13 is an exploded perspective view of another embodiment of a distal link and end cap. [Figure 20] FIG. 11 is a cross-sectional view of the articulation portion of the insertion tube of FIG. 10. [Figure 21] FIG. 2 illustrates an endoscope assembly and cartridge. [Figure 22] FIG. 2 shows an endoscope and a cartridge. [Figure 23] FIG. 23 is a perspective view of the cartridge of FIG. 22. [Figure 24] FIG. 24 is an exploded view of the cartridge of FIG. 23. [Diagram 25] FIG. 2 is a perspective view showing the console and the cartridge. [Figure 26A] FIG. 26 is a perspective view of the console of FIG. 25. [Figure 26B] FIG. 26 is a perspective view of the console of FIG. 25 in a vertical orientation. [Figure 27] FIG. 13 is a perspective view of another embodiment of a cartridge and console including a control valve assembly. [Figure 28] FIG. 28 is a perspective view of the control valve assembly of FIG. 27. [Figure 29] FIG. 28 is a perspective view of the console of FIG. 27 and the cartridge of FIG. 23. [Diagram 30] FIG. 13 is a front perspective view of another endoscope assembly. [Diagram 31] FIG. 31 is a rear perspective view of the endoscope assembly of FIG. [Figure 32A] FIG. 31 is a rear perspective view of the top of the endoscope assembly of FIG. 30 with the mounting structure in an open position. [Figure 32B] FIG. 31 is a rear perspective view of the upper portion of the endoscope assembly of FIG. 30 with the mounting structure in a fixed position. [Diagram 33]FIG. 31 is a partially exploded perspective view of the endoscope assembly of FIG. 30 with the top cover and pulleys removed. [Diagram 34] FIG. 34 is a partially exploded perspective view of the endoscope assembly of FIG. 33. [Diagram 35] FIG. [Diagram 36] FIG. 2 is a side view of the articulation portion of the insertion tube. [Figure 37] FIG. 13 is a perspective view of the insertion tube with the handle assembly removed. [Figure 38] FIG. 38 is a side view of the insertion tube of FIG. 37. [Figure 39] FIG. 38 is a cross-sectional view of the insertion tube of FIG. 37. [Figure 40A] FIG. 38 is a cross-sectional view of the proximal shaft portion of the insertion tube of FIG. 37. [Figure 40B] FIG. 2 is a cross-sectional view of an articulation shaft portion of the insertion tube. [Diagram 41] FIG. 38 is a partially exploded perspective view of the insertion tube of FIG. 37. [Figure 42A] FIG. 38 is a cross-sectional view of the distal end of the insertion tube of FIG. 37. [Figure 42B] 38 is a cross-sectional view of another embodiment of the distal end of the insertion tube of FIG. 37. [Figure 43A] FIG. 13 illustrates a plurality of links having support beams and support struts during manufacturing of the plurality of links. [Figure 43B] FIG. 13 illustrates a plurality of links having support beams and support struts during manufacturing of the plurality of links. [Diagram 44] 1 illustrates a plurality of links having flexible link connectors during manufacturing of the plurality of links. [Diagram 45] 13A-13C show a plurality of links having a flexible link connector folded to attach a pair of articulation links together during manufacture of the plurality of links. [Diagram 46] FIG. 38 is a side view of a plurality of links including a compression coil and an articulation link of the insertion tube of FIG. 37. [Figure 47A]FIG. 1 illustrates two assembled proximal articulation links. [Figure 47B] FIG. 1 illustrates two assembled proximal articulation links. [Figure 48A] FIG. 1 illustrates two assembled distal articulation links. [Figure 48B] FIG. 1 illustrates two assembled distal articulation links. [Figure 49] 13 is a perspective view of another embodiment of the insertion tube with the handle assembly removed. FIG. [Figure 50] FIG. 50 is a side view of the insertion tube of FIG. 49. [Figure 51] FIG. 50 is a cross-sectional view of the insertion tube of FIG. 49. [Figure 52A] 50 is a cross-sectional view of the proximal shaft portion of the insertion tube of FIG. 49. [Figure 52B] 50 is a cross-sectional view of the flexible portion of the insertion tube of FIG. 49. [Figure 52C] FIG. 38 is a cross-sectional view of a flexure transition portion of the insertion tube of FIG. 37. [Figure 53] FIG. 50 is a partially exploded perspective view of the insertion tube of FIG. 49. [Figure 54A] FIG. 50 shows the distal end of the insertion tube of FIG. 49 in a straightened state. [Figure 54B] FIG. 50 shows the distal end of the insertion tube of FIG. 49 in an articulated state. [Figure 55A] FIG. 13 shows an insertion tube with a compression coil against an adjustable stop. [Figure 55B] FIG. 13 shows the insertion tube against the adjustable stop. [Figure 56A] FIG. 13 illustrates an embodiment of an adjustable stop in a first position. [Figure 56B] FIG. 13 illustrates an embodiment of an adjustable stop in a second position. [Figure 57A] FIG. 13 shows another embodiment of an adjustable stop in a first position. [Figure 57B] FIG. 13 illustrates another embodiment of an adjustable stop in a second position. [Figure 58A] FIG. 13 shows another embodiment of an adjustable stop in a first position. [Figure 58B] FIG. 13 illustrates another embodiment of an adjustable stop in a second position. [Figure 59A] FIG. 13 shows another embodiment of an adjustable stop in a first position. [Figure 59B] FIG. 13 illustrates another embodiment of an adjustable stop in a second position. [Figure 60A] FIG. 13 shows another embodiment of an adjustable stop in a first position. [Figure 60B] FIG. 13 illustrates another embodiment of an adjustable stop in a second position. [Figure 61A] FIG. 13 shows another embodiment of an adjustable stop in a first position. [Figure 61B] FIG. 13 illustrates another embodiment of an adjustable stop in a second position. [Figure 62A] FIG. 13 shows another embodiment of an adjustable stop in a first position. [Figure 62B] FIG. 13 illustrates another embodiment of an adjustable stop in a second position. [Figure 63A] FIG. 1 is a rear perspective exploded view of an endoscope having a reusable handle incorporating only the electronic controller. [Figure 63B] FIG. 63B is a front perspective exploded view of the endoscope of FIG. 63A. [Figure 63C] FIG. 63B is another front perspective exploded view of the endoscope of FIG. 63A. [Fig. 64A] FIG. 1 is a rear perspective exploded view of an endoscope having a reusable handle incorporating an electronic controller and an articulation control lever. [Fig. 64B] FIG. 64B is a front perspective exploded view of the endoscope of FIG. 64A. [Fig. 64C] FIG. 64B is another front transparent exploded perspective view of the endoscope of FIG. 64A. [Figure 65A]FIG. 1 illustrates a rear perspective exploded view of an endoscope having a reusable handle incorporating an electronic controller, articulation control levers, and mechanical push buttons for controlling fluid conduits within the disposable endoscope handle. [Figure 65B] FIG. 65B is a front perspective exploded view of the endoscope of FIG. 65A. [Figure 65C] FIG. 65B is another front perspective exploded view of the endoscope of FIG. 65A. [Figure 66A] FIG. 1 is a rear perspective exploded view of an endoscope having a reusable handle incorporating an electronic controller, articulation control levers, and electronic switches for controlling fluid conduits within a single-use endoscope handle using remotely located electromechanical actuators. [Figure 66B] FIG. 66B is a front perspective exploded view of the endoscope of FIG. 66A. [Figure 66C] FIG. 66B is another front perspective exploded view of the endoscope of FIG. 66A. [Figure 67] FIG. 1 illustrates an endoscope with a drive shaft and pulley having self-aligning engagement portions. [Figure 68A] FIG. 68 is a cross-sectional view of the drive shaft and pulley of FIG. [Figure 68B] FIG. 68 is a rear view of the drive shaft and pulley of FIG. [Figure 69] FIG. 1 illustrates an endoscope with a drive shaft and pulley having a spring biased engagement. [Figure 70A] FIG. 70 is a cross-sectional view of the drive shaft and pulley of FIG. [Figure 70B] FIG. 70 is a rear view of the drive shaft and pulley of FIG. [Figure 71] 13A-13C show another embodiment of an endoscope with a drive shaft and pulley. [Figure 72A] FIG. 72 is a cross-sectional view of the drive shaft and pulley of FIG. 71. [Fig. 72B] FIG. 72 is a rear view of the drive shaft and pulley of FIG. 71. [Figure 73] FIG. 2 is a perspective view showing the blade pattern of the insertion tube. [Figure 74] FIG. 74 is a side view of the pattern of FIG. 73. [Figure 75] FIG. 74 is an enlarged view of the pattern of FIG. 73. [Figure 76] FIG. 74 is another enlarged view of the pattern of FIG. 73. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0153] For the understanding of the principles of the present disclosure, reference will now be made to the embodiments shown in the drawings and specific terms will be used to describe them. However, this is not intended to limit the scope of the present disclosure. Any changes and further modifications in the described embodiments, and any further applications of the principles of the present disclosure described herein are contemplated as being normally made by those skilled in the art to which the present disclosure pertains. Although the exemplary embodiments of the present disclosure are shown in detail, it will be apparent to those skilled in the art that some features not related to the present disclosure may not be shown for clarity of description.

[0154] The present disclosure provides improved endoscopes and associated console and cartridge assemblies. In some embodiments, the endoscope may be a small diameter endoscope, such as a ureteroscope, cholangioscope, cystoscope, hysteroscope, or bronchoscope. The endoscope may be a single-use endoscope or a reusable endoscope. Figures 1-4 show various views of an endoscope assembly 1. Figure 1 shows an endoscope assembly connected to a cartridge 511 by a tube 501, sometimes referred to as an "umbilical," which is connectable to a console 600 or 700 suitable for use with the endoscope assembly.

[0155] 2A-2D and 3 show an endoscope including an insertion tube 201 for insertion into a patient's body. The insertion tube includes a distal end 214 for insertion into the patient's body and a proximal end 216. The insertion tube may include a main lumen 218 extending through at least a portion of the insertion tube. The insertion tube may include a tool tube 162 extending through at least a portion of the insertion tube. The tool tube defines a tool channel 161 through which various tools can be inserted and extended into the patient's body through the insertion tube.

[0156] The insertion tube can include an optical sensor module, such as a CCD and / or CMOS image sensor, to provide information readable by the console and to project an image, such as a video feed from the end of the insertion tube, onto a monitor. The video feed can be infrared, thermal, or visible light. The insertion tube can include a light emitting diode (LED) wire to provide power to an LED at the end of the insertion tube.

[0157] The endoscope has a handle assembly 100 having a handle body 101. The handle body may be comprised of a first housing member 139 and a second housing member 140. The handle assembly may include an insertion tube strain relief 102 and an umbilical strain relief 103. The strain relief may help to stabilize and support the connections between the rigid members of the endoscope and the insertion tube and umbilical. In another exemplary embodiment, the strain relief is inverted inside the handle body.

[0158] The handle body may be pistol shaped rather than the typical cylindrical shape. Advantageously, this shape helps improve the endoscopist's ability to apply torque to the insertion tube of the endoscope, which may aid in steering the endoscope while advancing it into and / or through the patient's body and / or help in changing the direction in which the camera of the endoscope is pointed. A non-cylindrical handle may also provide a reference for the rotational orientation of the insertion tube.

[0159] 1-3 show the umbilical 501 as an integrated umbilical incorporating both the fluid lumen 502 and the electrical signal conductor 202 within the electrical conductor extrusion 503 that extends between the cartridge and the handle assembly of the endoscope. Advantageously, the integrated umbilical reduces the number of tubes and / or cables that a user must manage during a procedure. Often, the electrical signal conductors and the fluid lumen extend through separate tubes or umbilicals, resulting in a more cluttered operating space. By combining the electrical signal conductors and the fluid lumen within a single umbilical and attaching to the console at a single point with the cartridge, the user is constrained to operate the machine / device at only one point. This allows for greater freedom of operation.

[0160] 4 shows the upper portion 141 of the handle body. The upper portion has the articulation control lever 126, tool port 154, and fluid control button / trigger 151 with flow adjustment mechanism 162. Advantageously, the articulation control lever is mounted in the center of the handle body to facilitate both left and right handed use.

[0161] The tool port is operably located on the top of the endoscope. The tool port may be located in the center of the endoscope, similar to the articulation control lever, to facilitate use with both hands. The tool port is an opening to a tool channel that extends through the endoscope to the distal end of the insertion tube, allowing a tool to pass through the endoscope and into the patient's body. Advantageously, by locating the tool port on the top of the endoscope handle body, the tool port and the excess of the tool not passing through the tool channel are less likely to impede the endoscopist's movements compared to an arrangement in which the tool port is located on the side of the handle body. If the tool port is located on the side of the handle body, it may be more difficult for the endoscopist to grip the handle body, which may cause the endoscopist to accidentally bump the tool. The location of the tool port shown allows the endoscopist to adjust the tool port using the thumb and index finger of the same hand that grips the handle body, making use of the tool port less taxing and freeing up one hand for the endoscopist. The tool port is used to lock in place a tool that is delivered from the port.

[0162] The fluid control button allows the index finger of the same hand holding the handle to control irrigation fluid flow and aspiration, unlike typical remote commands required for irrigation. Again, this allows the endoscopist to keep one hand free to perform other tasks during the procedure. Repeatedly pressing and releasing the fluid control button creates a pulsatile flow. In many cases, the pulsatile flow is beneficial in dislodging objects inside the patient's body, such as urinary stones lodged in the patient's ureter.

[0163] The flow rate adjustment mechanism may be a lever or knob. In embodiments using a knob flow rate adjustment mechanism, the knob may be rotated. Such rotation of the knob may move the fluid control button to an at least partially depressed state. Advantageously, the flow rate adjustment mechanism may hold the fluid control button at least partially depressed to provide a constant minimum irrigation or aspiration flow rate without requiring the user to exert force on the fluid control button. If a higher flow rate is desired, the fluid control button may be further depressed until it is fully depressed to a maximum flow rate, whatever the desired constant flow rate. Additionally, pulsating flow may be used as described above. For example, the flow rate adjustment mechanism may hold the fluid control button depressed to generate a constant flow rate of 20%. If a higher flow rate or a pulsating flow rate is desired, the user may further press the fluid control button to provide a higher flow rate or a pulsating flow, as described above. It will be appreciated that the flow rate adjustment mechanism may be utilized to achieve any desired constant flow rate.

[0164] As shown in FIGS. 5-7, the endoscope assembly may include one or more pulley assemblies 142. The pulley assembly may include at least one pulley 127 operably arranged to rotate in response to movement of an articulation control lever. Associated with the at least one pulley is an articulation wire 131 or a pair of articulation wires (e.g., two separate wires or one continuous wire looped over the pulley with wire segments extending from opposite sides of the pulley) configured to bend a distal shaft portion of the endoscope assembly upon actuation. The articulation wires may be secured to the pulley (e.g., tied or secured by an anchor (not shown)) and / or extend around at least a portion of the pulley (e.g., form a loop around the pulley). The pulley may be a cam.

[0165] The articulation wires extend through the handle body to and through the proximal portion of the insertion tube. Within the handle body, the articulation wires extend through an articulation wire management tube.

[0166] Additionally, the pulley assembly can include an articulation termination coil 133 that receives one or more articulation coils that are wound around the respective articulation wires connected to the pulley. The articulation termination coils provide tension to the articulation wires. The articulation termination coils are adjustable to remove slack in the articulation wires. In other words, the articulation termination coils are adjustable along the longitudinal axis of the endoscope assembly to control the tension of the articulation pull wires. In other embodiments, the interior of the handle assembly can include multiple locking slots 135 for the proximal end of the insertion tube. This helps maintain tension in the articulation wires during assembly of the endoscope. Locking slots are useful when an insertion tube is utilized to counteract the pulling force of the articulation wires. In some embodiments, articulation coils are used and in other embodiments, locking slots can be used. In other embodiments, there can be both locking slots and articulation coils. An insertion tube end fitting 134 can be provided to receive the articulation wires.

[0167] 6 and 7 show friction elements 136 for maintaining the position of the articulation control lever when the articulation control lever is released by the user. Advantageously, these friction elements prevent the distal tip of the insertion tube from returning to a neutral state when the user releases the articulation control lever. Thus, the user can maintain the optical sensor module over the target viewing area without having to maintain the position of the articulation control lever.

[0168] The second housing member can extend through one or more pulleys. The pulleys can rotate around the second housing member when rotated by the articulation control lever. A friction element can be disposed between the static friction surface 137 of the second housing member and the rolling friction surface 138 of the pulley. In some embodiments, friction grease can be used in place of the friction element. In some examples, the friction element can be an O-ring. When the pulley is not being rotated to articulate the distal end of the insertion tube, the friction element maintains the position of the pulley by opposing the rotation of the rolling friction surface relative to the static friction surface, preventing the pulley from rotating back to a neutral position.

[0169] 8-9 show a flow path assembly 150 within the handle body. It will be appreciated that the flow path assembly may be used for irrigation and / or aspiration. For purposes of example only, the flow path is described in connection with irrigation.

[0170] The endoscope may include a first / main irrigation lumen 158 from a first irrigation source (not shown) extending through the handle body. A valve 153 incorporated within the handle body of the endoscope is positioned to restrict and / or direct the flow of fluid within the first irrigation lumen. For example, the valve may be a pinch valve. The valve is preferably a normally closed valve such that actuation of a fluid control button during operation actuates a valve on the first irrigation lumen to allow fluid to flow through the first irrigation lumen. However, the valve may also be a normally open valve. Advantageously, a user may operate the valve with the thumb and index finger of the same hand that holds the handle.

[0171] The first irrigation lumen is attached to a first Tee 156. The first Tee is used to connect a first flow path of the first irrigation lumen to the tool channel. A connecting lumen 160 extends from the first Tee towards the insertion tube. A second Tee 157 can be provided to integrate a second irrigation source and / or suction source (not shown). The second Tee can be located along the flow path between the first Tee and the insertion tube.

[0172] The endoscope may include a second / secondary irrigation lumen 159 from a second irrigation source (not shown) extending through the handle body. The second irrigation lumen is attached to a second T-piece. The second T-piece is used to connect the second flow path of the second irrigation lumen to the tool channel. Thus, after the second T-piece, the first flow path, the second flow path and the tool channel are all in fluid communication. The placement of the second irrigation lumen allows for the incorporation of a second irrigation / aspiration source without interfering with the user's access to the first irrigation source. As an example, the first irrigation source is a constant pressure bag, while the second irrigation source is a suction pump or a single-acting (pulsatile) irrigation pump. Often, the second fluid source is controlled by an assistant who supports the user during the procedure.

[0173] 8B-8E show the second / secondary irrigation lumen in further detail. The second irrigation lumen exits the handle through an umbilical strain relief and terminates in a connector 170, such as a female luer. The connector may be covered with a cap 171 to prevent leakage when the primary irrigation source is in use or when the insertion tube is inserted into the fluid-filled cavity. During use, the cap may be removed and a secondary fluid source, such as a fluid-filled syringe 172, may be connected to the connector.

[0174] 8F-8H show a second embodiment of a secondary / secondary irrigation lumen. The second irrigation lumen exits the handle through an umbilical strain relief and terminates in a connector 170, such as a female luer. A syringe-actuated valve 173 may be integrated with the connector to prevent leakage when the primary irrigation source is in use or when the insertion tube is inserted into a fluid-filled cavity. During use, a syringe may be connected to the connector and valve to provide a secondary fluid source.

[0175] 8 and 9 is a one-way valve 155 disposed between the tool port and the first tee. The one-way valve can be incorporated into the first tee. In some preferred embodiments, the one-way valve is a duckbill valve. The one-way valve resists unintended flow of fluid from the first irrigation source out of the tool port (e.g., an unfastened Tuohy borst adapter).

[0176] 10-13 show an insertion tube 201. The insertion tube can have multiple sections including a proximal section 203, a transition section 204, and an articulation section 205 located at the distal end of the insertion tube. The proximal section of the insertion tube can be made of a higher durometer polymer to prevent bending of the proximal section during articulation movement of the articulation section. The articulation section can include an articulation link assembly 300 (described in more detail below) for articulating the distal end of the insertion tube. The articulation section can be made of a low durometer polymer such that the articulation section is bent by an articulation wire. A transition section is operably disposed between the articulation section and the proximal section. The transition section can be made of a polymer with a higher durometer than the articulation section and a lower durometer than the proximal section. This allows the transition section to passively bend during articulation movement of the articulation section of the insertion tube. Thus, as the articulation portion articulates, there is a smooth, fluid transition between the proximal portion, which has no or minimal movement, and the articulation portion.

[0177] As shown in FIG. 11A, the articulation compression coil extends to and terminates at the proximal end of the proximal link of the articulation link assembly. FIGS. 11B and 11C show a cross section of the insertion tube and a cross section of the articulation section in more detail. As shown, the insertion tube includes an outer polymer jacket 209 and a braid 208 inside the jacket. Thus, during assembly, a single combined insertion tube (which may include links, articulation wires, articulation coil, camera assembly, and electrical signal conductors) can be pulled through and attached to the handle assembly in a single motion. This facilitates assembly and repair and reduces labor costs.

[0178] 12 shows the distal end of the insertion tube in more detail. The distal end includes a termination band 210. The articulation wires may be attached to an inner wall 213 of the termination band, for example, by welding and / or adhesive. The diameter of the termination band is larger than the diameter of the cap assembly 206 so that the cap assembly may be inserted into and secured to the opening in the termination band.

[0179] FIG. 13 is a partial exploded view of an assembly of an insertion tube covering the articulation link assembly, including electrical signal conductors 202 that extend from the cap assembly through the articulation link assembly for the camera and LED.

[0180] The articulation link assembly is shown in more detail in Figures 14 and 19. Figure 14 shows an articulation link assembly including a plurality of links 301 and a support beam 302 that extends at least partially along the length of the plurality of links. The support beam includes support struts 303 attached to the plurality of links. The plurality of links may be manufactured through an additive manufacturing process. The support beam and support struts are used to support the links and to keep the links aligned during the manufacturing process. After assembly of the articulation link assembly, the support beam and support struts are removed and discarded. The additive manufacturing process allows for the manufacture of a series of unique links (described in more detail below) that would be very difficult and / or expensive to manufacture using traditional molding techniques.

[0181] 15A and 15B show bottom (FIG. 15A) and top (FIG. 15B) views of an articulation link 301. The articulation link includes two openings 305 for articulation wires to extend through the link. As will be described in more detail with reference to FIG. 16, the bottom of the link includes a concave / recessed articulation pivot 306 and the top of the link includes a convex / protruding articulation pivot 307. Each link further includes a hollow interior or lumen 308 that extends through the length of the link 301.

[0182] FIG. 16 shows two assembled links 301. A plurality of links consists of a series of two or more links. In some cases, the links are designed and arranged such that the angle (i.e., angle X°) between the opposing faces of adjacent links increases gradually along the length of the assembly and / or the length (L1, L2) decreases along the length of the assembly (e.g., angle X° increases and / or length decreases along the direction from the proximal end to the distal end). Advantageously, such an arrangement may allow the user to bend the distal end more than the proximal end and / or to bend the distal end before the proximal end begins to bend. Along the length of the articulation section, the radius R1 of the concave / recessed articulation pivot 306 may increase and / or the radius R2 of the convex / protruding articulation pivot 307 may decrease.

[0183] Typically, the links are modified to allow for greater articulation movement at the distal end of the articulation assembly. The links can be adapted to reduce the articulation wire force required to obtain a desired degree of articulation movement at the distal end of the insertion tube. For example, the links closer to the distal end can have a shorter length than the links closer to the proximal end. The links can also be adapted to increase the articulation angle at the distal end. The radius of the convex articulation pivots can be smaller for the links closer to the distal end than the proximal end, and / or the pivot radius of the concave articulation pivots can be larger for the links closer to the distal end than the proximal end.

[0184] All of these features can be varied on individual links or in combination with multiple links to achieve a desired articulation response and shape. Advantageously, this arrangement provides the ability to initiate distal articulation movement prior to or simultaneously with proximal articulation movement. Additionally, this arrangement provides the ability to mitigate increased tensile forces building up at the proximal end of the articulation section. Additionally, this arrangement may provide a uniform radius of curvature along the articulation section from the proximal end to the distal end.

[0185] FIG. 17 shows a cross-sectional view of the articulation link assembly. A number of links are shown throughout the articulation link assembly. The number of links includes a proximal end link 309 at the proximal end of the articulation link assembly and a distal end link 312 at the distal end of the articulation link assembly. The proximal end link may be held laterally by a composite insertion tube. The distal end link is secured to the camera assembly by a termination band. The articulation wires that run through the links may be laser welded to this termination band.

[0186] FIG. 18 illustrates the attachment of the distal end of the articulation wire at the distal end of the insertion tube. In one embodiment, the distal end of the articulation wire can extend through the distal termination link and be laser welded to the termination band. FIG. 19 illustrates a second embodiment for attaching the distal end of the articulation wire to the distal end of the insertion tube. The articulation wire can be disposed in a groove 313, e.g., a U-shaped groove, in the step-down portion of the distal termination link. The articulation wire is secured, e.g., by adhesive, and locked into place by sliding the termination band over the step-down portion 314 of the distal termination link. In both embodiments, the termination band provides a secure connection between the distal termination link and the cap assembly. Advantageously, both embodiments allow for fixation of the distal end of the articulation wire within the limited space of a small bore endoscope.

[0187] FIG. 20 shows an alternative embodiment for steering / articulating the articulation section of the insertion tube. This alternative embodiment may not utilize an articulation link. As described above, the insertion tube includes a proximal section, a transition section, and an articulation section. The insertion tube includes an outer polymer jacket and a braid inside the jacket. Inside the braid, a polytetrafluoroethylene (PTFE) sleeve 402 extends from the proximal section to the articulation section. An articulation wire extends through the sleeve and is secured to the wall of the termination band behind the braid, for example by welding. The articulation wire may be a flat pull wire. A main shaft PTFE liner 401 is located on the side of the PTFE sleeve opposite the braid and defines the main lumen of the insertion tube. Advantageously, this configuration eliminates the need for a link and increases the available cross-sectional area at the distal end of the insertion tube. This increased available cross-sectional area facilitates free movement of tool channels, electrical signal conductors, and other elongated objects that may be placed within the main lumen of the insertion tube. Such a configuration allows the distal end of the insertion tube to bend in excess of 300 degrees, and in some cases up to 310 degrees.

[0188] 21-24 show an umbilical assembly 500. The umbilical assembly includes an umbilical 501 and a first cartridge 511. As discussed above and shown in FIG. 22, the umbilical includes fluid lumens and electrical signal conductors that extend between the cartridge and the handle assembly of the endoscope. The umbilical is attached at one end to the cartridge at a location on the cartridge 511. The cartridge 511 can include a housing 506. A second portion 504 of a second umbilical or tube can extend through the cartridge housing and out of the housing from another location on the housing. In some embodiments, the second tube is connected to the first irrigation source described above. The second tube can include a luer lock connector 505 at one end for connection to the first irrigation source. The second tube can extend through the cartridge housing (as shown in FIG. 24) and into the umbilical. Advantageously, in the case of a manual or mobile irrigation source, the second tube reduces the likelihood that the first irrigation source will pull on the endoscope handle during the procedure.

[0189] 23 and 24 show further details of the assembled and disassembled cartridge 511, respectively. The cartridge 511 can include a printed circuit board (PCB) 509. The PCB can include electrical signal spring tabs 510. The cartridge spring tabs can be connected with the console 600 or 700 to establish an electrical connection between the console 600 or 700, the cartridge 511, and the endoscope. The cartridge 511 can include a combination of static retention tabs 507 and / or dynamic retention tabs 508. The retention tabs operably connect the cartridge to a receiving receptacle 601 (shown in FIG. 25) of the console by connecting with corresponding retention slots, including static retention slots 604 and dynamic retention slots 603. In some embodiments, some of the retention tabs can provide a "snap-on" connection of the cartridge to the console. The ability to snap the cartridge onto the console allows for a quick and safe method of installation and removal of the cartridge from the console.

[0190] 25, 26A and 26B show the first console 600 without the fluid control in more detail. Without the fluid control, the console 600 can be relatively small to save space in the operating room and on the cart during use. The console 600 can include a receptacle 601. The receptacle can include an electrical signal connector 602 for connecting the electrical signal spring tab of the first cartridge 511 to the console 600. The receptacle can further include a retention slot for receiving and connecting the dynamic retention tab of the cartridge 511 and a retention slot for the static retention tab of the cartridge. This connection provides an electrical connection between the console 600 and the cartridge 511. If the umbilical is subjected to excessive tension, the dynamic retention tab can be automatically released from the dynamic retention slot. Advantageously, this safety release can prevent unintentional damage to the console or cartridge. In some embodiments, only the static retention tab and the static retention slot are utilized. In other embodiments, only the dynamic retention tab and the dynamic retention slot are utilized. In further embodiments, both static retention tabs and slots and dynamic retention tabs and slots are utilized.

[0191] The console 600 may further include an illumination control 605 for controlling power to an LED at the distal end of the insertion tube. The illumination control may also control the wavelength of light emitted from the LED. The console may also include a power control 606 for powering the console on or off. For example, the power control may be a switch, a knob, a button, or the like.

[0192] FIG. 26B shows the cartridge mounted on a pole 607. The cartridge may include a bracket 608 for mounting the console to the pole in a vertical position. As seen in FIGS. 26A and 26B, the receptacle may be oriented to allow the cartridge to be connected to the pole in the same manner whether the console is horizontal or vertical. In other words, the receptacle may be rotated to a desired orientation based on the orientation of the console. Advantageously, this allows a desired ergonomic tube placement to be maintained regardless of the orientation of the console in the operating room.

[0193] The present disclosure further provides a second cartridge 800 and a second console 700. FIG. 27 shows an overview of a system preferably operably connected for use by a medical practitioner. The second cartridge 800 and the second console 700 may be larger than the first console 600 and the first cartridge 511 due to the use of a fluid control mechanism by the second console 700 and the second cartridge 800. The system may include a cartridge 800 inserted into a control valve assembly 1100 of the console 700. The cartridge 800 may be connected to an endoscope by an umbilical. For example, the cartridge 800 may be connected to a single-use endoscope by one or more fluid tubes and / or electrical conductors.

[0194] The cartridge 800 can be connected to a support tool that can include an irrigation pump (e.g., stand-alone or central), an insufflator, and / or a vacuum pump. The cartridge 800 can be disposed between an endoscope and the support tool.

[0195] In some embodiments, the console 700 can include a user interface (not shown) that allows a user to change various variables of the endoscopic system. In one embodiment, the user interface can be a touch screen integrated with an electro-visual display. In another example, the user interface can include a keyboard, a mouse, a trackball, and / or a touch-sensitive pointing device, etc.

[0196] The console 700 may include a control valve assembly for receiving and actuating the cartridge. The console 700 may provide electrical power, fluid and / or fluid pressure, vacuum pressure, and / or transmit and / or receive electrical signals to and from the endoscope assembly. The console 700 may include a monitor (not shown) for visualizing signals received from the endoscope assembly, such as a video feed from a camera at the distal end of the disposable shaft assembly.

[0197] The control valve assembly is shown in more detail in Figure 28. The control valve assembly may be used to selectively actuate actuatable portions of the flow path of the cartridge 800. The control valve assembly may include an actuator 1130 and a support structure 1150 having a first surface 1152 and a second surface 1154.

[0198] The actuators may be linear or rotary actuators. The actuators may be solenoids. Although there may be a single actuator, in a preferred embodiment the control valve assembly includes four actuators. The actuators are adapted to actuate valve portions of the flow paths within the cartridge to selectively open and / or close the flow paths.

[0199] The valve portion of the flow path may comprise any acceptable valve. For example, the valve portion may comprise a petcock. The valve portion may also comprise a portion of tubing (e.g., a pinch valve) disposed for compression between the anvil of the first face of the door and an actuator (e.g., a solenoid) of the control valve assembly. The valve portion may function as a valve for any number of fluid functions of the endoscope, such as a suction valve associated with actuator 1132, a camera irrigation flow valve associated with actuator 1134, an insufflation valve associated with actuator 1136, and / or an insufflation vent valve associated with actuator 1138.

[0200] The actuator of the control valve assembly is received by the console 700 and may include an electrical connector for electrically connecting the actuator to the console 700. When connected to the console 700, the console 700 may provide power and user input commands to the actuator to open and / or close the flow path of the cartridge.

[0201] The cartridge 800 may include an identifier that is readable and / or writable by the controlled valve assembly. The identifier may include information regarding the type of cartridge and / or usage information (e.g., whether the cartridge has been used before). Preferably, the controlled valve assembly is configured to read and process the identifier of the cartridge 800 (e.g., to determine the type of cartridge and / or whether the cartridge has been used before). The identifier may be readable and / or writable via an electrical connector of the cartridge and / or via other means (e.g., RFID, optics, and / or mechanical contact).

[0202] The first surface of the support structure may include an electrical connector for forming an electrical connection to an electrical connector of the cartridge 800. The electrical connection between the control valve assembly of the console 700 and the cartridge 800 allows the console to receive image and control data (valve / actuator and / or image data) sent from the endoscope to the console 700 via the cartridge 800. The electrical connection allows the console 700 to provide power to light emitting diodes (LEDs) of the endoscope assembly.

[0203] The cartridge can be a disposable cartridge, which can eliminate the need for the use of a permanent valve body contained within a reusable endoscope and / or console, thereby eliminating the need to sterilize a reusable valve after each use.

[0204] The cartridge 800 has a housing 1210. The housing may include a first side 1212 and a second side 1214. The housing further includes a first fluid side 1220 and a second fluid side 1224 that allow fluid to move into and out of the cartridge housing. The housing may define one or more fluid channels, fluid connectors, and / or electrical connectors. For example, the cartridge housing may include an electrical connector 1244 that electrically communicates with electrical conductors of the endoscope, and an optical sensor module that optionally includes optical sensor calibration data or a unique identifier of the endoscope. The housing may define windows 1270a-1270d. In one embodiment, the housing includes four windows. The windows may be defined by an inner surface of the housing. The inner surface may form a generally circular opening in the housing. The circumference of some windows may be larger than other windows to accommodate a larger flow channel cross-section.

[0205] The window can be configured to receive an actuator from the console into a chamber 1272 defined by the inner surface. As described above, the actuator can pass through the window and / or contact an anvil on a door of the control valve assembly of the console 700 to form a pinch valve with the door. When the cartridge 800 is placed on the control valve assembly and the door is closed, the window aligns with the anvil of the door and the actuator of the control valve assembly. The window can be arranged to define a geometric shape. For example, as shown, the window can define a diamond shape.

[0206] As described above, the actuator or actuators may be solenoids configured to extend into a window in the cartridge housing and / or contact an anvil on the door of the control valve assembly, forming a pinch valve when closed.

[0207] The housing may further include an electrical connector for connecting to the electrical connector of the control valve assembly. The electrical connector of the cartridge 800 may be spring finger electrical contacts configured to contact a corresponding number of flat pad electrical contacts of the control valve assembly of the console, or vice versa. The electrical connector of the cartridge housing may transmit image data and control data provided by the endoscope to the console. The electrical connector of the housing may transmit power from the console to LEDs used by the endoscope inside the patient's body.

[0208] 27 shows cartridge 800 inserted into the control valve assembly of console 700. As shown, the cartridge is inserted flush with a first surface of the support structure of the control valve assembly. A first fluid side of the cartridge can include loose tubing that runs into the umbilical and into the disposable shaft assembly (not shown) of the endoscope.

[0209] The second fluid side of the cartridge 800 can be connected to a support. The support can include an irrigation pump, an insufflator, and / or a vacuum pump (standalone or centralized). The cartridge 800 can provide fluid communication between an endoscope and the support.

[0210] The control valve assembly can include a ledge surface 1110 and a latch 1120. The cartridge 800 can include a ledge surface and a latch receiver. In another embodiment, the control valve assembly can include the latch receiver and the cartridge can include the latch. When the cartridge is received in the control valve assembly, the latch contacts the latch receiver to secure a first end of the cartridge to the control valve assembly. Separately, opposite the latch and the latch receiver, a ledge surface of the cartridge and a ledge surface of the control valve assembly contact each other to secure a second end of the cartridge to the control valve assembly.

[0211] In some examples, the cartridge 800 may include two or more magnets 1250 located on the first side of the cartridge. In some examples, one magnet may be located on the bottom of the first face of the cartridge 800 and a second magnet may be located on the top of the first face of the cartridge. The first face of the control valve assembly may include two or more (Hall or Reed) magnetic sensors 1180 corresponding to the location of the magnets on the cartridge. For example, one is located on the bottom of the first face and another is located on the top of the first face. The magnet on the bottom of the cartridge 800 interacts with the magnetic sensor on the bottom of the control valve assembly, retracting the actuator (e.g., solenoid) valve and reducing the force required to tilt the cartridge into the control valve assembly. The magnet on the top interacts with the magnetic sensor on the top of the control valve assembly, confirming the presence of the cartridge 800 on the console 700 and operating the console 700 to release the appropriate actuator and initiate the actuator operating mode for endoscopy.

[0212] FIG. 27 shows the console 700 with one cartridge 800 and an additional cartridge 800. One cartridge 800 can be connected to a first endoscope (not shown) and the additional cartridge 800 can be connected to a second endoscope (not shown). The one cartridge 800 and the additional cartridge 800 can be securely inserted into a first control valve assembly and a second control valve assembly, respectively, of the console. Although the console is illustrated with a first and a second control valve assembly, the console can have any number of control valve assemblies, each capable of accepting an independent cartridge. The first control valve assembly can be adapted to accept a first cartridge 800 and the second control valve assembly can be adapted to accept a second cartridge 800. Not all control valve assemblies need to accept cartridges in all medical procedures.

[0213] As shown, each cartridge may be connected to a separate set of supports and separate medical devices, such as an endoscope.

[0214] The first control valve assembly and the second control valve assembly are adapted to operate independently and / or in a master / slave relationship. The first endoscope or mother endoscope can be the master controller and the second endoscope or daughter endoscope can be the slave controller. In this arrangement, the controller of the master endoscope can control one or more functions of the slave endoscope (e.g., image control and / or LEDs). The master endoscope can control the function of the flow path of the slave endoscope by providing electrical signals to the second control valve assembly (e.g., via one or more cartridges connected to the console) to selectively activate the actuators described herein. The first endoscope can further control the function of the second endoscope (e.g., operation of the LEDs and / or camera) by providing electrical signals from the first endoscope to change the state of the second control valve assembly (e.g., change the electrical signal provided by the second control valve assembly to the cartridge of the second endoscope). For example, the control valve assembly can provide electrical signals to the LEDs and / or camera of the second endoscope based on signals received from the first endoscope. This arrangement further allows multiple endoscopes to be set up and utilized for a procedure at once, eliminating or reducing much of the setup time typically used to exchange one endoscope for another, and / or eliminating or reducing the need for additional equipment such as multiple control consoles.

[0215] The console is shown with a touch screen user interface, which may be any suitable input / output device.

[0216] In FIG. 29, the second console 700 is shown with the first cartridge 511. The second console 700 includes a fluid control and may be larger than the console 600 without the fluid control. The second console 700 may include one or more receptacles / control valve assemblies. The receptacles may include electrical signal connectors for connecting electrical signal spring tabs of the cartridge 511 or 800 to the console. The second console 700 may allow a user to install cartridges with or without a fluid control. In some examples, a larger cartridge 800 (shown in FIGS. 27 and 28) may be connected to a receptacle of the larger second console 700. The larger second cartridge 800 may cover a portion of the receptacle. In this example, the console 700 includes valves that may be actuated to control the flow of fluid through the cartridge 800, as described above. In another example, the first cartridge 511 described above may be installed to cover a smaller portion of the receptacle of the second console 700 than the larger cartridge 800. In a third example, the larger cartridge 800 may be used to cover the entire receptacle, but no fluid control is utilized. As discussed above and shown in FIG. 29, the console 700 may include multiple receptacle / control valve assemblies. Any of a variety of cartridges 511 and 800 may be installed in the console 700 and used at one time.

[0217] Advantageously, for example, mounting the cartridge 511 without fluid controls on a larger console 700 provides the clinician the ability to connect a cytoscope to either a pole mounted console in a medical office environment, or a dual console 700 (as shown) in an operating room environment for ureteroscopy. Additionally, a single-use cholangioscope can be used in conjunction with a hybrid duodenoscope during endoscopic retrograde cholangiopancreatography, such as by connecting both to the dual console 700. Additionally, a single-use cholangioscope can also be used with a smaller console 600, without fluid controls, in combination with a third-party reusable duodenoscope and its associated video processing unit.

[0218] It will be understood that many features of the various cartridge embodiments and the various console embodiments can be used interchangeably between the embodiments, in other words, features of the various cartridges and consoles can be used within any of the embodiments.

[0219] 30-36, an improved four-way steering flexible endoscope is disclosed. The endoscope is shown as a small bore endoscope, and more specifically a cholangioscope. However, the four-way steering can be incorporated into other small bore endoscopes, large bore endoscopes, and other medical devices in general.

[0220] 30 and 31 show an endoscope assembly 900 having an umbilical 901 and an insertion tube 902. All descriptions of the umbilical and insertion tube above are incorporated herein. The insertion tube 902 includes an articulation section 904. The insertion tube further includes an articulation wire 917. The articulation wire is used to articulate the articulation section of the insertion tube. In one embodiment, the insertion tube includes two articulation wires for up-down or left-right articulation. In one exemplary embodiment, the insertion tube includes four articulation wires. This configuration allows for up-down and left-right articulation by the user.

[0221] 32A and 32B show a mounting structure for mounting one endoscope to the handle of another endoscope. The ability to mount and secure one endoscope to the other allows the endoscopist to easily handle both endoscopes and reduces the complexity of handling two endoscopes. Often, a smaller diameter endoscope is deployed through a tool channel of a larger diameter endoscope, e.g., a cholangioscope through a duodenoscope. The mounting structure is adapted to secure the smaller diameter endoscope to the handle and / or strain relief of the larger diameter endoscope.

[0222] The mounting structure includes an elastic strap 906 having an alignment pad 922, such as an elastomeric pad. In some embodiments, the alignment pad is curved to match the typical shape of the body of a large bore endoscope. The alignment pad prevents movement of the small bore endoscope on the large bore endoscope. The mounting structure further includes a cam latch 907 and a cam latch land 908. FIG. 32a shows the mounting structure in an open position with the cam latch released from the cam latch land. FIG. 32b shows the mounting structure in a closed / locked position with the cam latch locked to the cam latch land. In the closed position, the small bore endoscope is securely secured to the large bore endoscope body.

[0223] Figures 33 and 34 show a variable integrated suction control integrated into the handle of the endoscope. The suction control allows for variable manual suction, allows for variable suction strength selection, and allows for valves to control the flow of irrigation fluid.

[0224] The suction control includes an integrated variable suction valve 905 and a suction tube 909. The integrated suction valve includes a valve variable screw 912, a valve sliding button 911, a valve spring 910, and a valve anvil 913. The screw may be rotatable or may be non-rotatable and compressed. As the screw rotates, the suction tube is compressed against the valve anvil to reduce the strength of suction or released from the valve anvil to increase the strength of suction. The level of suction can range from the suction tube being completely closed against the valve anvil and providing no suction to the screw not compressing the suction tube against the anvil and being completely open. By adjusting the screw, the user can obtain a variable amount of suction.

[0225] FIG. 35 is a cross-sectional view of the insertion tube 903. The insertion tube may be a solid polytetrafluoroethylene (PTFE) extrusion with an integral lumen extending therethrough (as described below). As shown, the insertion tube may include a lumen defining a tool channel 914 for deploying various medical instruments through the insertion tube and into the patient's body. The insertion tube may further include another lumen for one or more electrical conductors 915 for sending electrical signals to a camera and / or photodiode at the distal end of the insertion tube, for example, a complementary metal oxide semiconductor (CMOS) sensor wire. The insertion tube further includes a fluid tube 916, such as an irrigation or suction tube 909. As described above, the insertion tube further includes an articulation wire 917 for articulating the insertion tube. Additionally, the insertion tube includes a core profile 918 surrounded by a braid 919.

[0226] The core profile may be made of a lubricious polymer and includes a central lumen 924 with four articulation wire lumens 923 through which the articulation wires pass. In some embodiments, the central lumen is PTFE. In one exemplary embodiment, the articulation wire lumens 923 are equally spaced around the central lumen. The four lumens (the lumen for the tool channel, the lumen for the electrical conductors, and the two fluid lumens) may be made of nylon, EVA, and / or PVC.

[0227] A braid 919 surrounds at least a portion of the outside of the central lumen of the core profile. The braid is surrounded by a sheath / outer jacket 920. The outer jacket may be constructed from HDPE, EVA, PVC, and / or PBAX.

[0228] During manufacture of the insertion tube, the lumens that define the tool channel, the lumens through which the electrical conductors are routed, the various fluid tubes, and the articulation wire lumen are pulled through the central lumen of the central profile. In one embodiment, the lumens are all pulled at once. This manufacturing method limits the number of leak points.

[0229] FIG. 36 shows a side view of the articulation section of the insertion tube. The articulation section can include two opposing series of articulation cuts 921 in the core profile. The cuts are formed over at least a portion of the length of the articulation section. The cuts form a series of articulation living hinges that facilitate bending in a single plane, for example at 90 degree angles to one another. The articulation section can be formed of a different material than the core profile, for example nylon. The articulation section can be detachably attached to the remainder of the insertion tube by adhesive, by mechanical connection, or by articulation wires that extend through the articulation section and the remainder of the insertion tube.

[0230] 37-48 disclose an alternative insertion tube 1000. The disclosure of the insertion tube described above is incorporated herein. Differences will be described in relation to the insertion tube 1000.

[0231] As shown in FIGS. 37 and 38, the insertion tube can have multiple sections including a proximal section 1005, a transition section 1004, and an articulation section 1003 located at the distal end of the insertion tube. The proximal section of the insertion tube can be made of a higher durometer polymer than the articulation section to prevent bending of the proximal section during articulation movement of the articulation section. The articulation section can be made of a lower durometer polymer than the proximal section to allow bending by an articulation wire. The transition section is operatively disposed between the articulation section and the proximal section. The transition section can be made of a polymer having a higher durometer value than the articulation section and a lower durometer value than the proximal section. This allows the transition section to passively bend during articulation movement of the articulation section of the insertion tube. Thus, articulation of the articulation portion creates a smooth, flowing transition between the proximal portion, which has no or minimal movement, and the articulation portion.

[0232] The insertion tube can further include a camera cap assembly 1001 located at the distal end of the insertion tube. The insertion tube further includes a transition band 1002 between the articulation portion and the cap assembly. The diameter of the transition band is larger than the diameter of the cap assembly such that the cap assembly can be inserted into and secured to the opening in the termination band.

[0233] 37 and 38 further show an insertion tube end fitting 1006. The insertion tube end fitting can accommodate articulation compression coils 1007 that receive one or more articulation coils wound around respective articulation wires 1008. The articulation wires are configured to bend the distal shaft portion of the endoscope assembly upon actuation. The insertion tube end fitting also aids in securing the insertion tube to the endoscope handle body.

[0234] 39 is a cross-sectional side view of the insertion tube. The camera cap assembly 1001 can include a camera cap 1009, an optical sensor (camera) 1010 in the camera cap, and a tool channel 1011. The tool channel extends from the endoscope handle body through the insertion tube and through the camera cap.

[0235] The insertion tube includes an articulation section polymer jacket 1012, a transition section polymer jacket 1013, and a proximal section polymer jacket 1014, which surround the articulation section, transition section, and proximal section, respectively. The three jackets make up an outer composite tube 1046. The outer composite tube can be assembled in one operation on a mandrel prior to inserting any of the internal components of the insertion tube.

[0236] The insertion tube includes a number of articulation links 1019 that extend throughout the insertion tube. The number of links is comprised of a series of two or more links. The links facilitate articulation movement of the distal portion of the insertion tube (the articulation portion) within the patient. The use of distal articulation links creates a greater degree of articulation based on a given input when the tool is in place within the tool channel compared to other methods.

[0237] 39 further shows a coil 1017 and a heat stake 1018 that attaches the coil to the proximal shaft section. Following the initial shaft layup, the coil can be inserted and heat staked to the proximal shaft section, simplifying manufacturing.

[0238] 40A shows a cross-sectional view of the proximal shaft section. The proximal shaft includes an outer proximal polymer jacket. The polymer jacket extends circumferentially around the proximal shaft section. A braided wire 1016 extends within the polymer jacket 1014. A coil 1017 is shown within the braided wire 1016.

[0239] 40B shows a cross-sectional view of the transition shaft section, which may be identical to the proximal shaft section with a transition polymer jacket in place of the proximal polymer jacket.

[0240] 40C is a cross-sectional view of an articulation shaft section. The articulation shaft includes an outer articulation section polymer jacket. The polymer jacket extends circumferentially around the articulation shaft section. A braided wire 1016 extends within the polymer jacket. The braided wire surrounds an assembly of articulation links 1019.

[0241] FIG. 41 is a partial exploded view of the insertion tube. As shown, in manufacturing the insertion tube, the articulation components (coil 1017, articulation wire 1008, link 1019, and inner tube) are pulled into the outer composite tube 1046 as a single unit. As shown, during manufacturing, the proximal shaft section including the compression coil and articulation wire is extended through the articulation section and pulled through the composite insertion tube until the proximal section reaches the insertion tube end fitting and the compression coil and pull wire extend beyond the insertion tube end fitting. Having all the internal articulation parts pulled as a whole facilitates assembly. Advantageously, the articulation coil 1007 can prevent unintended movement of the proximal shaft section by isolating the articulation forces from the proximal shaft.

[0242] 42A shows the attachment of the distal end of the articulation wire at the distal end of the insertion tube. The articulation wire is placed in a groove 1021, e.g., a U-shaped groove, in the step down portion of the distal articulation link 1020. The articulation wire is secured, e.g., by adhesive, and locked into place by positioning a transition band over the distal articulation link. This provides a simple method of fastening with a continuous wire and limits the risk of the wire end coming loose.

[0243] 42B illustrates another method of attaching the distal end of the articulation wire to the distal end of the insertion tube. The distal end of the articulation wire extends through the distal articulation link and is secured (e.g., laser welded) to the transition band.

[0244] In both embodiments, the transition band provides a secure connection between the distal articulation link and the cap assembly. Advantageously, both embodiments allow for fixation of the distal end of the articulation wire within the limited space of a small bore endoscope.

[0245] 43A and 43B show a plurality of links or printed links 1019 having a support beam 1024 that extends at least partially through the length of the links. The support beam includes support struts 1025 attached to the links. The links may be formed during the manufacture of the links. As mentioned above, some of the links may be different from each other. The manufacturing method may be injection molding, additive manufacturing, and / or subtractive manufacturing. The support beam and separate support struts may support the links and maintain alignment of the links during manufacture. In the assembly of the articulation link assembly, the support beam and support struts are removed and discarded.

[0246] 44 and 45 show multiple links with runners 1026 having separate support struts 1025 attached to the multiple links. The runners, support struts, and links may be formed by injection molding. The links may be connected by flexible link connectors 1027. The flexible link connectors may be foldable to allow adjacent links of the articulation link to pivot towards each other after removing the support struts and / or runners. Advantageously, the flexible link connectors can aid in proper ordering and orientation of the links during assembly.

[0247] FIG. 46 shows a side view of multiple links with coils 1070 and wires 1080 in place.

[0248] Figures 47 and 48 illustrate two assembled articulation links 1019. The disclosures of Figures 15 and 16 are incorporated herein. The proximal (bottom) end of the link includes two spaced apart concave / recessed articulation pivots 1028 and the distal (top) end of the link includes two corresponding convex / protruding articulation pivots 1029. Each concave / recessed articulation pivot 1028 and corresponding convex / protruding articulation pivot 1029 form a pair.

[0249] As shown in FIGS. 47B and 48B, when articulating to one side, only one pair of convex / concave articulation pivots may contact each other. When articulating to a different side, a different pair of convex / concave articulation pivots may contact each other. Thus, when pivoted to one side, adjacent links articulate about a different pivot point than when the assembly is pivoted to a different side. In such an example, one articulation wire may be located at a first distance from the pivot point when the assembly articulates to a first side and at a second distance when the assembly articulates to a second side. Advantageously, such an arrangement may allow the articulation wire to generate a larger moment (i.e., rotational force) relative to a tensile force applied to the wire to pivot adjacent links relative to each other when the assembly articulates to one side and the other.

[0250] A plurality of links is comprised of a series of two or more links. In one embodiment, the links are designed such that the distance 1030 between pairs of convex / concave articulation pivots varies to control where the articulation movement first occurs. By decreasing the distance 1030 between the pivots about the centerline of the links, a given force can generate a larger articulation torque, as described above. In a preferred embodiment, the distance 1030 between successive convex / concave pivots along a direction toward the distal tip of the insertion tube decreases. An articulation angle 1031 occurs between the links during articulation movement.

[0251] All of these features can be varied on individual links or in combination with multiple links to achieve a desired articulation response and shape. Advantageously, this arrangement provides the ability to initiate a distal articulation movement prior to or simultaneously with a proximal articulation movement. Additionally, this arrangement allows for mitigation of increased pulling forces that build up at the proximal end of the articulation section. Additionally, this arrangement may provide a uniform radius of curvature along the articulation section from the proximal end to the distal end.

[0252] 49-54 disclose another insertion tube 2000. The disclosure of the insertion tube 1000 is incorporated herein. The differences will be described in relation to the insertion tube 2000. The insertion tube is composed of two continuous sections (proximal and distal articulation sections). The insertion tube includes a proximal multi-lumen shaft section 2001 with a proximal multi-lumen extrusion section 2004 and a flexible section 2002 shown as a steerable sheath. Between the two sections is a flexible transition section 2003. The two sections 2001 and 2002 are linearly connected by an outer braid and a multi-segment polymer jacket.

[0253] The use of a proximal multi-lumen (including a central lumen and four articulation wire lumens as described above) shaft section 2001 simplifies the construction of the proximal shaft. The use of a central lumen facilitates pulling the internal components including the fluid lumens, lumens defining the tool channels, articulation wire lumens, and electrical conductors as a single operation during assembly (as described above). The distal flexure section can be pre-assembled on a mandrel with the proximal multi-lumen extrusion section prior to overbraiding and reflow.

[0254] The insertion tube includes an outer proximal polymer jacket 2005 , an inner flexure transition liner 2006 , an outer flexure transition jacket 2007 , an inner flexure liner 2008 , and an outer flexure jacket 2009 .

[0255] Similar to the insertion tube 1000 described above, one or more pairs of articulation wires are coupled to a distal transition band. The transition band serves as a fixed point for the articulation wires and as a transition connecting the distal tip of the flexure and the camera cap assembly. The transition band provides a low profile connection between the flexure and the camera cap assembly. The transition band and articulation wire assembly can be inserted into the combined proximal / articulation tube, allowing for ease of assembly.

[0256] The flexure is configured as a steerable sheath. This steerable sheath configuration can provide a larger lumen size compared to alternative steerable structure technologies.

[0257] 52A shows a cross-sectional view of the proximal shaft portion 2001. The proximal shaft portion includes an articulation wire lumen 2010 through which the articulation wire extends. In some embodiments, there are four articulation wire lumens. The proximal shaft portion 2001 further includes a central lumen 2011.

[0258] 52B shows a cross-sectional view of the flexure. The flexure further includes an articulation wire jacket 2012.

[0259] FIG. 52C shows a cross-sectional view of the flexure transition.

[0260] 53 is a partially exploded perspective view of the insertion tube 2000. As shown, in manufacturing the insertion tube, the articulation components, including the articulation wires, can be pulled as a unit into the insertion tube 2000. As shown, in manufacturing, the proximal multi-lumen shaft section, including the articulation wires, is extended through the flexure and pulled into the insertion tube until the articulation wires extend from the end of the insertion tube. Pulling all the internal articulation parts together facilitates assembly.

[0261] Figure 54A shows the distal end of the insertion tube in a straight body and Figure 54B shows the distal end of the insertion tube in an articulated state.

[0262] 55-62 disclose a system for adjusting articulation wire tension with an adjustable stop that moves either the compression coil or the catheter shaft distally relative to a proximal pull wire anchor point, thereby tensioning one or more articulation wires.

[0263] The use of various systems for adjusting the position of the articulation coil or insertion tube relative to the articulation wire is disclosed. The required function of tensioning the articulation control assembly is achieved by moving the articulation coil or insertion tube relative to the articulation wire. Moving the articulation coil or insertion tube instead of adjusting the articulation wire has the following advantages: 1) the articulation wire is more fragile than the articulation coil and therefore may be at greater risk of damage during tension adjustment / repositioning than the articulation coil; 2) if crimping or adhesive is used to secure the articulation wire, it is more difficult to secure and repeat than a cut coil / insertion tube; and 3) since the articulation wire typically terminates at a pulley, it is easier to incorporate tension adjustment into the handle body where the articulation coil terminates.

[0264] In Fig. 55A, the articulation compression coil 1007 contacts an adjustable stop 1032. The stop is positioned to counter the force of the articulation wire. Fig. 55A also shows an articulation pulley 1033 on which the articulation wire 1008 is fixedly positioned. In some embodiments, this configuration is used with the insertion tube 1000.

[0265] 55B, the insertion tube 2000 contacts an adjustable insertion tube stop 2013. To facilitate cooperation with the stop 2013, the insertion tube includes an insertion tube collar 2014.

[0266] 56A and 56B show a structure for adjusting the stop 1032. In a first position (FIG. 56A), an adjustable coil spacer 1034 is positioned between the stop 1032 and the spacer retainer 1035. The spacer retainer holds the coil spacer in place relative to the stop. In a second position (FIG. 56B), the coil spacer is positioned such that the stop 1032 is between the coil spacer and the spacer retainer. In this configuration, the coil spacer prevents the compression coil 1007 from hitting the stop 1032. This configuration allows the insertion tube to move relative to the articulation wire and handle body to tension the articulation control assembly.

[0267] 57A and 57B, a sliding coil retainer 1036 is shown with a compression coil 1007 secured within the coil retainer. The compression coil may be secured within the coil retainer by any known mechanism. The coil retainer may include a number of grooves 1038 extending along the length of the coil retainer.

[0268] The handle body allows the coil retainer to be selectively repositioned within the handle body to tension the articulation wire. The handle body includes a number of grooves 1039 along the length of the handle body. When the coil retainer is selectively repositioned within the handle body, the grooves 1038 of the coil retainer and the grooves 1039 of the handle body align. In the aligned state, a pin can be inserted into the aligned groove to lock the coil retainer, and thus the compression coil 1007, in place. Other known locking mechanisms may be used to lock the coil retainer relative to the handle body, such as a set screw and / or adhesive, to name a few non-limiting examples. FIG. 57A shows the coil retainer in a first position. FIG. 57B shows the coil retainer in a second position different from the first position.

[0269] FIG. 58A and FIG. 58B show another embodiment for sliding and retaining a compression coil 1007. An articulation coil collar 1040 is disclosed with an upper portion wider than a lower portion. The collar receives and retains the compression coil. In some embodiments, the compression coil is inserted and / or rotated into the coil collar. The handle body includes a number of grooves 1039b along the length of the handle body. The grooves are shaped to receive and retain the upper portion of the collar. FIG. 58A shows the stop in a first position. FIG. 58B shows the stop in a second position different from the first position.

[0270] 59A and 59B show another embodiment for sliding and holding a compression coil 1007. As shown, an articulation wire extends through an opening in a portion of a handle 1041. A sliding stepped wedge 1042 is positioned against the portion of the handle 1041 to cover the opening in the handle through which the wire is threaded. The sliding stepped wedge includes stepped surfaces of different heights. The compression coil 1007 can move between the steps to change the tension in the articulation wire 1008.

[0271] Figure 59A shows the compression coil on a first tier, and Figure 59B shows the compression coil on a second tier that is different from the first tier.

[0272] FIG. 60A and FIG. 60B show another embodiment for holding the compression coil 1007. FIG. 60A and FIG. 60B show a rotating stepped wedge 1043. The rotating stepped wedge includes a stepped surface 1047. In some embodiments, the rotating stepped wedge includes three steps of different heights. The compression coil is fixed against the stepped surfaces. Each stepped surface includes a groove 1048 for the articulation wire 1008 to extend through. As the rotating stepped wedge rotates, the compression coil 1007 can move between the steps to change the tension in the articulation wire 1008. FIG. 60A shows the compression coil on a first step. FIG. 60B shows the compression coil on a second step that is different from the first step.

[0273] FIGs. 61A and 61B show another embodiment for varying the position of the compression coil to control the tension in the articulation wire. This embodiment includes a cannulated set screw 1044 configured relative to a handle 1041. In this embodiment, the compression coil 1007 is inserted into the set screw and rotated until it is securely held by the set screw. The compression coil can be rotated within the set screw so that more or less of the compression coil is within the set screw, depending on the tension required. FIG. 61A shows the compression coil within the set screw in a first position. FIG. 61B shows the compression coil within the set screw in a second position different from the first position.

[0274] FIGs. 62A and 62B show yet another embodiment for varying the position of the compression coil to control tension in the articulation wires. This embodiment includes a rotating threaded hub 1045 configured to rotate within a number of grooves 1039 in the handle. The threaded hub can be rotated to move within the grooves 1039. A compression coil 1007 is inserted and held within the rotating threaded hub. To change tension in the articulation wires, the threaded hub is rotated clockwise or counterclockwise to change the position of the compression coil proximally or distally. FIG. 62A shows the compression coil and threaded hub in a first position. FIG. 62B shows the compression coil and threaded hub in a second position different from the first position.

[0275] 63-72 disclose a series of (disposable / reusable) hybrid handle variations associated with a small diameter bi-directional (single plane) flexible endoscope. These hybrid handle variations exhibit various degrees of functionality associated with the disposable portion of the handle. For example, one variation requires remote fluid control while another variation simply incorporates electronic switches for imaging, lighting, etc. into the reusable handle. The bi-directional flexible hybrid handle variations disclosed herein support multiple clinical applications including cholangioscopy, ureteroscopy, cystoscopy, and bronchoscopy.

[0276] In addition to the hybrid handle variations disclosed, several bi-directional operating engagement mechanisms are disclosed, including both self-aligning shaft configurations and spring-loaded engagement configurations.

[0277] 63A-63C show an endoscope assembly 1200 having a detachable reusable handle 1201 and a disposable endoscope handle 1202. The reusable handle includes an electronically controlled switch 1207 and electrical conductors 1209. The electronically controlled switches are for image capture, lighting power, video capture, etc.

[0278] The single-use endoscope handle includes a tool port 1205, an insertion tube 1203, an umbilical 1204, an articulation control lever 1206, a fluid control button / trigger 1208, and electrical conductors 1290. The above descriptions of the tool port, the various insertion tubes, the umbilical, the articulation control lever, and the fluid control button are incorporated herein. The electrical conductors 1290 are connected to electrical conductors 1209 to transmit electrical signals between the single-use endoscope handle and the reusable handle. The electrical signals from the reusable handle are sent to the cartridge (511 or 800) described above and to the console (600 or 700) when the cartridge (511 or 800) is connected to the console. The electrical signals are also sent from the console to the distal end of the insertion tube 1203.

[0279] The use of a reusable handle reduces waste by transferring some of the structure, mechanics, and electronics of the endoscope handle from the single-use, single-piece endoscope to the reusable handle of the multi-piece endoscope. By transferring the electronic control from the single-use, single-piece endoscope to the reusable handle of the multi-piece endoscope, additional functionality and higher quality components can be incorporated while not incurring additional costs in the disposable handle. In other words, more expensive, higher quality electronics can be used in the reusable handle, and the single-use endoscope handle can be cheaper to manufacture, as opposed to a single-use, single-piece endoscope that must be discarded after each use. Thus, costs can be reduced by allowing the continuous use of a reusable handle and a series of single-use endoscope handles. The use of electrical conductors 1290 associated with the single-use endoscope handle to provide power and signal connections to the reusable handle eliminates the need for secondary cables or batteries that require replacement or charging. The use of a wired connection also eliminates latency and / or connectivity issues often associated with wireless connections.

[0280] Figures 64A-64C show another embodiment endoscope assembly 1211 having a detachable reusable handle 1291 and a single-use endoscope handle 1213. Many components are similar to the embodiment shown in Figures 63A-63C, and therefore only the differences between the endoscope assemblies will be described with reference to endoscope assembly 1211.

[0281] The reusable handle includes electronic controls for image capture, light levels, video capture, etc., and an articulation lever with an optional brake. The reusable handle includes an articulation control lever 1292 with similar functionality to the articulation control lever previously described, and an articulation drive shaft 1215 with an engagement configuration. The single use endoscope handle includes an articulation pulley 1216 with an engagement portion configured to mate with the articulation drive shaft 1215. Movement of the lever 1292 drives the drive shaft 1215 which in turn drives the pulley 1216. The pulley 1216 controls the articulation movement of the articulation wire within the insertion tube 1203.

[0282] The use of a self-aligning, detachable articulation drive (drive shaft 1215 and pulley 1216) between the reusable handle and the single-use endoscope handle allows for additional features and higher quality components, such as brake levers / mechanisms, to be incorporated while not imposing additional cost on the single-use endoscope handle. In other words, more expensive, higher quality parts can be used in the reusable handle, making the single-use endoscope handle cheaper to manufacture, as opposed to a single-use, single-piece endoscope that must be discarded after each use. Thus, costs can be reduced by allowing the continuous use of a reusable handle with a series of single-use endoscope handles.

[0283] Figures 65A-65C show another embodiment endoscope assembly 1217 having a detachable reusable handle 1218 and a disposable endoscope handle 1219. Many components are similar to the embodiment shown in Figures 63-64. Therefore, only the differences between the endoscope assemblies will be described with reference to endoscope assembly 1217.

[0284] The reusable handle includes electronic controls for image capture, light levels, video capture, etc., an articulation lever with an optional brake, and a fluid button 1295 for mechanically pinching (controlling) the fluid conduits contained within the single-use endoscope handle.

[0285] The single-use endoscope handle includes a slot 1221 and a fluid control tube 1222. When the reusable handle and single-use endoscope handle are connected, a pinch valve is formed between the fluid control button and the fluid control tube. The fluid control button is pressed by the user to pinch the fluid control tube to limit the amount of fluid passing through the fluid control tube. The user can control the amount of fluid passing through the fluid control tube by pressing the fluid control button with varying force. The fluid control button allows a maximum flow rate through the tube when the button is not pressed. The fluid passing through the tube is gradually reduced depending on how far the user presses the control button inward.

[0286] This embodiment also moves the mechanical pinch valve button and mechanism from the single-use endoscope handle to the reusable handle. This configuration allows for higher quality components to be incorporated without the added cost of a disposable cartridge. In other words, more expensive, higher quality components can be used in the reusable handle, making the single-use endoscope handle less expensive to manufacture, as opposed to a single-use, one-piece endoscope that must be discarded after each use. Thus, costs can be reduced by allowing the use of a reusable handle in series with a series of single-use endoscope handles.

[0287] 66A-66C show another embodiment endoscope assembly 1223 having a detachable reusable handle 1293 and a single-use endoscope handle 1225. Many components are similar to the embodiment shown in FIGS. 63-65. Therefore, only the differences between the endoscope assemblies will be described with reference to endoscope assembly 1223.

[0288] The reusable handle includes electronic controls for image capture, light levels, video capture, etc., and an articulation lever with an optional brake. The reusable handle further includes an electrical switch 1226 for pinching (controlling) the fluid conduit using a remotely located electromechanical actuator.

[0289] The reusable handle includes an electrical switch 1226. When a user presses the electrical switch, a signal is sent to an electromechanical actuator which acts on the fluid passage to restrict or prevent fluid flow therethrough (as described in detail in connection with Figures 24 and 29).

[0290] This embodiment replaces the mechanical pinch valve button and mechanism of Figures 65A-65C with an electrical switch 1226 associated with the reusable handle and an electromechanical pinch valve located away from the endoscope assembly 1223. By eliminating the mechanical pinch valve from the single-use endoscope handle and / or the reusable handle, the cost of the disposable cartridge is reduced.

[0291] 67 and 68 show a self-centering articulation drive shaft and articulation pulley with its associated engagement portion. As previously described, the reusable handle 1227 may include an articulation drive shaft 1215. The drive shaft 1215 is driven by an articulation control lever 1292 as previously described.

[0292] In the illustrated embodiment, the reusable handle housing 1239 supports a drive shaft 1215 that is coupled to an articulation control lever 1292. The drive shaft extends into the area of ​​the reusable handle that receives the single use endoscope handle. The drive shaft extends into a recess in the single use endoscope handle to engage a pulley located on the single use endoscope handle when the reusable handle and single use endoscope handle are joined together.

[0293] The drive shaft has a pulley engaging portion 1228. This portion can have a non-circular cross-sectional geometry that is capable of transmitting torque. This geometry can include, but is not limited to, an ellipse, a spline, a square, or a star, to name a few non-limiting examples.

[0294] The single use endoscope handle may include one or more pulleys 1229. The pulley 1229 may be positioned to receive an end of a drive shaft. Preferably, actuation of an articulation control lever associated with the drive shaft rotates the pulley. Preferably, the pulley has an engagement portion 1230 that mates with an engagement portion 1228 of the drive shaft 1215 to rotationally couple the pulley and the drive shaft to one another. Preferably, the engagement portions 1228 and 1230 do not rely solely on friction between the drive shaft and the pulley. Preferably, the engagement portion includes a geometric interference between the articulation shaft and the pulley.

[0295] Associated with at least one pulley is an articulation wire 1231 or a pair of articulation wires (e.g., two separate wires or one continuous wire looped over a pulley with wire segments extending from opposite sides of the pulley) configured to bend the distal end of the insertion tube. The articulation wires may be fixed to the pulley and / or may extend around at least a portion of the pulley (e.g., looped around the pulley). Preferably, the articulation wires are configured to bend the distal end of the insertion tube in mutually orthogonal planes.

[0296] 69 and 70 show an alternative embodiment in which the drive shaft 1215 engages the pulley 1229 with a spring biased engagement portion. All applicable descriptions set forth above (FIGS. 67-68) are incorporated herein. The drive shaft 1215 includes a spring loaded engagement tab 1232. The spring loaded engagement tab includes one or more spring loaded retractable blades 1241. The spring loaded engagement tab 1232 mates with an engagement portion 1233 on the pulley to operably lock the drive shaft to the pulley. The engagement portion 1233 can include one or more slots 1240 for receiving the retractable blades of the spring loaded engagement tab.

[0297] The spring-loaded (with guide ramp) retractable blade allows the user to simply push the two components together. As the control lever is articulated through its range of motion, the retracted spring-loaded blade reaches a slot on the bore of the articulation pulley and extends to engage the articulation pulley. This allows the user to attach the single-use endoscope handle without having to pre-align the reusable handle and single-use endoscope handle.

[0298] 71 and 72 show yet another embodiment of mating the drive shaft 1215 with the pulley 1229. The reusable handle includes a drive disk 1234. The drive disk 1234 has a center alignment pin 1235 (e.g., an alignment boss with a guide chamfer) and one or more spring loaded retraction pins 1236 (e.g., spring loaded torque pins with a guide chamfer) offset from the centerline of the disk for transmitting torque. The articulation pulley 1229 has a mating portion that includes a center alignment hole 1237 and an offset hole with a guide chamfer 1238 with a guide for the torque pin.

[0299] The spring-loaded retract pin (with guide chamfer) allows the user to simply press the two components together. Articulation of the control lever through its range of motion causes the retracted spring-loaded retract pin to extend and engage a mating portion on the face of the articulation pulley. This allows the user to install the single-use endoscope handle without pre-aligning the reusable handle and the single-use endoscope handle.

[0300] 73-76 disclose a novel braid pattern to achieve the mutual benefits of coils and braids for an endoscope insertion tube 1300. A novel braid pattern is disclosed that incorporates a unique multi-filar aligned braid pattern in one or more of the helical paths to impart the kink resistance associated with coils while providing the torqueability associated with traditional braids. This new and improved braid pattern can be made using traditional braiding mechanisms with a modified carrier position to produce it. This novel braid can improve the kink resistance of small bore endoscopes including, but not limited to, cholangioscopes, ureteroscopes, cystoscopes, and bronchoscopes.

[0301] One embodiment for a small diameter endoscope insertion tube is a single helical thread 1302 over a multi-filament group 1304 all oriented in the same direction. In some embodiments, the multi-filament group can be from 2 to 10 or more threads. In one exemplary embodiment, the multi-filament group is 3 threads.

[0302] The single helical thread 1302 combined with the opposing multiple thread groups provides the torque properties associated with a typical one-to-one braid pattern or other variations.

[0303] The multiple filament groups 1304 are all in a helical pattern aligned in the same direction. This configuration creates a simulated coil to provide kink resistance for the insertion tube. The ability to create a simulated coil during the braiding process reduces process steps, eliminates the need for additional equipment, and eliminates the cost of using coils in manufacturing endoscope insertion tubes.

[0304] The present disclosure has been illustrated and described in detail in the drawings and specification, which are illustrative rather than restrictive, and which merely show and describe preferred embodiments, and all changes, equivalents, and modifications that fall within the scope of the invention as defined in the appended claims are intended to be protected. All publications, patents, and patent applications cited in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated by reference.

[0305] The following numbered descriptions are of embodiments that are useful for understanding the present invention. 1. A device comprising an insertion tube assembly and an umbilical connected to an elongated handle portion having upper and lower end portions; The top end of the long, slender handle is an articulation control for articulating a distal portion of an insertion tube assembly connected to the handle portion; an irrigation, suction, and / or pneumoperitoneum control unit; A tool port opening; and The insertion tube assembly and the umbilical are adapted to extend from the lower end portion. 2. An endoscope as described in claim 1, wherein the upper end portion of the elongated handle portion includes at least an articulation control section and irrigation, suction, and / or pneumoperitoneum controls. 3. An endoscope as described in any of claims 1 or 2 above, wherein the upper end portion of the elongated handle portion includes at least the articulation control portion and the tool port opening. 4. An endoscope as described in any of claims 1-3 above, wherein the upper end portion of the elongated handle portion includes at least irrigation, suction, and / or pneumoperitoneum controls and the tool port opening. 5. An endoscope as described in any of claims 1-4 above, wherein the upper end portion of the elongated handle portion includes each of the articulation control portion, the irrigation, suction and / or pneumoperitoneum control portions, and the tool port opening. 6. An endoscope according to any one of 1-5 above, wherein the irrigation, suction, and / or pneumoperitoneum control unit is an irrigation control unit. 7. An endoscope according to any one of 1 to 5 above, wherein the irrigation, suction, and / or pneumoperitoneum control unit is a suction control unit. 8. An endoscope according to any one of 1 to 5 above, wherein the irrigation, suction, and / or pneumoperitoneum control unit is a pneumoperitoneum control unit. 9. An endoscope according to any one of 1 to 8 above, wherein the control unit for irrigation, suction and / or pneumoperitoneum has a flow rate adjustment mechanism. 10. The endoscope of claim 9, wherein the flow rate adjustment mechanism is configured to maintain the fluid control button in an at least partially depressed state. 11. An endoscope as described in claim 9 or 10, wherein the flow rate adjustment mechanism comprises a rotatable knob. 12. An endoscope as described in any of claims 1-11, wherein the irrigation, suction, and / or pneumoperitoneum control unit comprises a pinch valve disposed within the elongated handle portion and configured to compress a flexible fluid tube. 13. An endoscope according to any of claims 1-12, wherein the irrigation, suction and / or pneumoperitoneum control section includes a normally closed valve disposed within the elongated handle portion. 14. The irrigation, aspiration, and / or pneumoperitoneum control is adapted to control fluid flow along a first flow path extending through the first lumen; the first lumen extends through the umbilical; An endoscope as described in any one of claims 1-13, wherein the first flow path extends through the insertion tube assembly and is in fluid communication with the first tool lumen and is in fluid communication with the tool port opening. 15. An endoscope as described in claim 14, further comprising a valve disposed between the tool port opening and the first flow path. 16. A second flow path extends through the second lumen of the umbilical; 16. An endoscope as described in claim 14 or 15, wherein the second flow path is in fluid communication with the first tool lumen. 17. An endoscope as described in any one of claims 1-16, wherein the articulation control for effecting articulation movement of a distal portion of an insertion tube assembly connected to the elongated handle portion is a lever. 18. An endoscope as described in claim 17, wherein the lever articulates in the same plane as the longitudinal axis of the elongated handle portion. 19. A surgical instrument comprising: a handle portion connected to an insertion tube assembly; the handle portion includes an articulation control for articulating a distal end portion of the insertion tube assembly; the articulation control includes a lever and / or knob coupled to a rotatable pulley disposed within the handle portion; one or more articulation wires extend around the rotatable pulley and through the distal end portion of the insertion tube assembly; A friction element is disposed between the rotatable pulley and a portion of the handle portion to resist rotation of the rotatable pulley relative to the handle portion. 20. The friction element is adapted to permit articulation movement of the distal portion of the insertion tube assembly when the articulation control portion is subjected to a force of 1 Newton or greater; 20. The endoscope of claim 19, wherein the friction element is adapted to hold the distal end portion of the insertion tube assembly in an articulated state after removal of the force from the articulation control. 21. An endoscope as described in claim 19 or 20, wherein the friction element comprises rubber. 22. An endoscope as described in any one of claims 19 to 21, wherein the friction element includes an O-ring. 23. An endoscope as described in any one of claims 19 to 22, wherein the friction element comprises friction grease. 24. An endoscope as described in any one of claims 19 to 23, wherein a portion of the handle portion extends through the rotatable pulley. 25. A method of assembling an insertion tube for an endoscope, comprising the steps of: advancing one or more fluid lumens and / or tool lumens and electrical conductors through an articulation link of a distal portion of the insertion tube along a distal to proximal direction; advancing one or more fluid and / or tool lumens and electrical conductors through a proximal portion of the insertion tube along a distal-to-proximal direction; The method comprising: 26. The method of claim 25, further comprising simultaneously advancing the one or more fluid lumens and / or tool lumens and electrical conductors through the proximal portion. 27. The method of claim 25 or 26, wherein advancing the one or more fluid lumens and / or tool lumens and electrical conductors through the proximal portion includes advancing the one or more fluid lumens and / or tool lumens and electrical conductors through a multi-lumen shaft portion of the proximal portion. 28. A method as claimed in any of claims 25 to 27, wherein the one or more fluid lumens and / or tool lumens and the electrical conductors are advanced simultaneously through the articulation link. 29. Routing said articulation control wires through said plurality of articulation links; 29. The method of any of claims 25 to 28, comprising: fixing a distal end of the articulation control wire to a distal articulation link and / or a termination band; 30. The method of claim 29, wherein advancing the articulation control wire through the plurality of articulation links comprises advancing the articulation control wire through the plurality of articulation links along a distal-to-proximal direction. 31. The method of claim 29 or 30, further comprising advancing the articulation control wire through the proximal portion of the insertion tube along a distal to proximal direction. 32. The method of claim 31, wherein advancing the articulation control wire through the proximal portion is performed simultaneously with advancing the one or more fluid lumens and / or tool lumens and electrical conductors through the proximal portion. 33. The method of any of claims 29 to 32, wherein securing the articulation control wire to the distal articulation link includes positioning the articulation control wire in a groove in the distal articulation link. 34. The method of any of claims 30 to 33, wherein securing the articulation control wire comprises sliding a termination band over the distal articulation link while positioned within a groove of the distal articulation link to hold the articulation control wire within the groove. 35. The method of any of claims 29 to 34, wherein securing the articulation control wire to the distal articulation link comprises adhering the articulation control wire to the distal articulation link with an adhesive. 36. The method of any of claims 29 to 35, wherein securing the articulation control wire to the termination band comprises welding the articulation control wire to the termination band. 37. A method according to any of claims 25 to 36, wherein the one or more fluid lumens and / or tool lumens comprise a continuous tube or multiple tubes, each having a length greater than the sum of the lengths of the distal and proximal portions. 38. A method according to any of claims 25 to 37, wherein the one or more conductors comprise a plurality of continuous wires, each having a length greater than the combined length of the distal portion and the proximal portion. 39. The method of any of claims 25 to 38, wherein the one or more fluid lumens and / or tool lumens and electrical conductors are disposed within a metal coil while being advanced through the proximal portion of the insertion tube along a distal-to-proximal direction. 40. The method of any of claims 25 to 39, further comprising advancing the articulation link of the distal portion of the insertion tube along a distal-to-proximal direction into a distal portion polymer jacket. 41. The proximal portion comprises a proximal portion polymer jacket having a different durometer than the distal portion polymer jacket; 41. The method of claim 40, further comprising attaching the distal portion polymer jacket to the distal end of the proximal portion polymer jacket before advancing the articulation link of the distal portion of the insertion tube into the distal portion polymer jacket along a distal-to-proximal direction. 42. After advancing the one or more fluid lumens and / or tool lumens and electrical conductors through an articulation link of a distal portion of the insertion tube along a distal to proximal direction and advancing the one or more fluid lumens and / or tool lumens and electrical conductors through a proximal portion of the insertion tube along a distal to proximal direction, braiding a wire around the proximal portion of the insertion tube; reflowing the proximal polymer jacket around the proximal portion; 40. The method of any one of claims 25 to 39, wherein the distal polymer jacket is allowed to reflow around the distal portion. 43. The method of claim 42, further comprising simultaneously reflowing the proximal polymer jacket around the proximal portion and reflowing the distal polymer jacket around the distal portion. 44. A method according to any of claims 25 to 39, wherein a distal portion polymer jacket is reflowed around the articulation link of the distal portion of the insertion tube prior to advancing the one or more fluid lumens and / or tool lumens and electrical conductors through the articulation link. 45. A first support beam; a plurality of articulation links for an endoscope insertion tube coupled to the first support beam via a plurality of support struts; Equipped with each of the articulation links having a length extending from a first end to a second end; each of the articulation links defining a central opening and separate openings for first and second articulation wires extending therethrough along its length; the separate openings for the first and second articulation wires are on opposite sides of the central opening; a first end of some of the plurality of articulation links has a convex articulation pivot; The second end of the link has a concave articulation pivot configured to receive the convex pivot of the other articulation link. 46. ​​The device of claim 45, wherein the central opening and the separate openings of the articulation link extend along a transverse direction relative to the first support beam. 47. The device of claim 45 or 46, wherein some of the plurality of links are arranged on the support beam according to the order of the positions of the articulation links within the endoscope insertion tube. 48. The device of any of claims 45-47, wherein the plurality of support struts extend from an outer side of the articulation link. 49. A device as described in any of claims 45 to 48, wherein at least a first articulation link of the plurality of articulation links has a different shape and / or size than a second articulation link of the plurality of articulation links. 50. A proximal portion attachable to a handle of an endoscope; a distal section including a plurality of articulation links; a transition portion disposed between the proximal portion and the distal portion; having the proximal portion comprises a polymer having a higher durometer than the transition portion; The transition section comprises a polymer having a higher durometer than the distal section. 51. A proximal portion attachable to a handle of an endoscope; a distal section including a plurality of articulation links; having a length of the proximal section including one or more fillers helically extending in a first direction around a lumen of the proximal section; an endoscope insertion tube assembly, wherein the length includes more fillers extending helically around the lumen in a second direction than the one or more fillers extending helically around the lumen in the first direction. 52. An endoscope insertion tube assembly as described in claim 51, wherein at least twice as many fillers extend spirally around said lumen in said second direction as there are fillers extending spirally around said lumen in said first direction. 53. An endoscope insertion tube assembly as described in claim 51 or 52, wherein only the single filler extends helically around the lumen along the length in the first direction. 54. An endoscope insertion tube assembly as described in any of claims 51 to 53, wherein at least three fillers extend helically around the lumen along the length in the second direction. 55. An articulation joint assembly having a length extending from a proximal end to a distal end; the articulation joint assembly having a plurality of articulation links; each articulation link is connected to an adjacent articulation link and is pivotable relative to the adjacent articulation link through a pivot angle; a first and second articulation link of the plurality of articulation links pivotable about a first pivot point to a first side relative to longitudinal alignment and pivotable about a second pivot point to a second side relative to longitudinal alignment; an endoscope insertion tube assembly, the first and second pivot points being on different sides of a longitudinal axis extending through the first and second articulation links; 56. The endoscope of claim 55, wherein the spacing between the first and second pivot points of the pair of articulation links increases along the length of the endoscope insertion tube assembly. 57. An outer polymeric jacket having an inner surface defining a hollow jacket passage; a braid disposed within the hollow jacket passage, the braid having a hollow interior cross-section defining a braid passage; an articulation wire sleeve disposed within the braid passage and between the liner and the inner surface of the braid, the sleeve having a hollow interior cross-section defining a sleeve passage for an articulation wire; having An endoscope insertion tube assembly, wherein an articulation wire extends through the sleeve and is secured to a termination band disposed distally of the braid. 58. The assembly of claim 57, wherein the sleeve comprises polytetrafluoroethylene. 59. The assembly described in claim 57 or 58, wherein the liner comprises polytetrafluoroethylene. 60. The assembly of any of claims 57 to 59, wherein the articulation wire extends through the braid at the distal portion of the insertion tube. 61. A console for operating an endoscope assembly, comprising: a receiving portion configured to receive a first cartridge of a first endoscope assembly and having an electrical connector that forms an electrical connection between the console and the first endoscope assembly when the first cartridge is received; A console, wherein the receiving portion is configured to receive a second cartridge of a different size than the first cartridge and form an electrical connection with the second cartridge connected to the second endoscope assembly using the same electrical connector as when connecting with the first cartridge. 62. The console of claim 61, wherein when the second cartridge is received in the receiver, a console actuator within the receiver does not control the flow of fluid through the second cartridge. 63. An endoscopy system comprising: a first endoscope having a handle body; An endoscopic system, wherein the handle body defines a recess configured to receive a handle body of a second endoscope. 64. The endoscopic system of claim 63, wherein the recess includes a mounting structure. 65. The mounting structure is: An endoscopic system as described in claim 63, comprising a strap attached to the handle body at a first end and to a latch at a second end, and a latch land, wherein when the second endoscope is secured to the handle body of the first endoscope, the mounting structure is in a closed position, and in the closed position, the latch is operably secured within the latch land. 66. The endoscope according to claim 65, wherein the latch is a cam latch. 67. The mounting structure further comprises: 66. An endoscope as described in claim 65, having an alignment pad that matches the profile of the handle body of the second endoscope. 68. A device comprising: a handle portion; and an insert portion having a proximal end attached to the handle portion; at least one articulation wire extending through the insertion portion and attached to a pulley in the handle portion; having The tension of the articulation wire is repositioning a coil containing a portion of the articulation wire relative to the handle portion; adjusting an insertion tube of the insertion portion relative to the handle portion; and adapted to be adjustable by at least one of Endoscope assembly. 69. An endoscope assembly as described in claim 68, wherein tension in the articulation wire is adjustable by repositioning a coil encompassing a portion of the articulation wire relative to the handle portion. 70. The endoscope assembly as described in claim 68, wherein tension in the articulation wire is adjustable by adjusting the insertion tube of the insertion portion relative to the handle portion. 71. Equipped with adjustable spacers; 70. An endoscope assembly as described in claim 68, wherein the adjustable spacer is configured to hold the coil in any of a variety of positions relative to the handle portion. 72. An endoscope assembly as described in claim 71, wherein in a first configuration, a stop is located between the spacer and the coil to hold the coil in a first position relative to the housing, and in a second configuration, the spacer is located between the coil and the stop to hold the coil in a second position relative to the housing. 73. An endoscope assembly as described in claim 68, wherein a retainer is used to secure the coil, the retainer including at least two grooves along the length of the retainer, the handle portion including at least two grooves along the length of the handle portion, and the pin is inserted between the grooves of the retainer and the grooves of the handle portion to secure the position of the coil. 74. An endoscope assembly as described in claim 68, wherein an articulation coil collar is used to secure the coil, the collar including an upper portion which is larger than a lower portion of the collar, and the handle portion includes at least two grooves for receiving and retaining the upper portion of the collar. 75. An endoscope assembly as described in claim 68, wherein a stepped wedge having at least two steps is used to fix the position of the coil, on a first step the coil is positioned at a first position relative to the housing, and on a second step the coil is positioned at a second position relative to the housing. 76. An endoscope assembly as described in claim 75, wherein the stepped wedge rotates relative to the housing. 77. An endoscope assembly as described in claim 75, wherein the stepped wedge slides relative to the housing. 78. An endoscope assembly as described in claim 68, wherein the coil is threadedly received by a threaded portion of the handle. 79. An endoscope comprising: A reusable handle and a disposable endoscope handle, the reusable handle is selectively attachable to and detachable from the single-use endoscope handle; The reusable handle comprises: an electronic conductor and an electronically controlled switch; a drive shaft configured to engage a pulley disposed within the endoscope handle; an articulation control lever; a fluid control button for mechanically controlling fluid conduits contained within the disposable endoscope handle; an electrical switch that, when actuated, actuates the actuator into the flow path; The endoscope has at least one of the following: 80. An endoscope assembly as described in claim 79, wherein said reusable handle includes said electronic conductors and said electronic control switch. 81. The endoscope assembly of claim 79, wherein the reusable handle includes the electronic conductors and the electronic control switch, and the drive shaft configured to engage a pulley disposed within the single-use endoscope handle. 82. The endoscope assembly of claim 79, wherein the reusable handle includes the electronic conductors and the electronic control switch, the drive shaft configured to engage a pulley disposed within the disposable endoscope handle, and the articulation control lever. 83. The endoscope assembly of claim 79, wherein the reusable handle includes the electronic conductors and the electronic control switch, the drive shaft configured to engage a pulley disposed within the single-use endoscope handle, the articulation control lever, and the fluid control button. 84. The endoscope assembly of claim 79, wherein the reusable handle includes the electronic conductors and the electronic control switch, the drive shaft configured to engage a pulley disposed within the disposable endoscope handle, the articulation control lever, and the electrical switch. 85. An endoscope assembly as described in claim 79, wherein the articulation control lever includes a brake. 86. An endoscope assembly as described in claim 79, wherein the drive shaft includes an engagement portion and the pulley includes an engagement portion configured to mate with the engagement portion of the drive shaft. 87. An endoscope assembly as described in claim 86, wherein the drive shaft engagement portion includes a spring loaded engagement tab and the pulley engagement portion includes a slot configured to mate with the spring loaded engagement tab. 88. An endoscope assembly as described in claim 87, wherein the engagement tab includes at least one retractable blade. 89. An endoscope assembly as described in claim 86, wherein the drive shaft engagement portion includes a boss having a spring-loaded retractable pin, and the pulley engagement portion includes an alignment hole configured to engage with the boss of the drive shaft.

Claims

1. an insertion tube assembly and an umbilical connected to an elongated handle portion having an upper end portion and a lower end portion; An upper end portion of the elongated handle portion an articulation control for articulating a distal portion of an insertion tube assembly connected to the handle portion; an irrigation, suction, and / or pneumoperitoneum control unit; A tool port opening; and the insertion tube assembly and umbilical are adapted to extend from the lower end portion; The irrigation, suction, and / or pneumoperitoneum control unit has a flow rate adjustment mechanism; An endoscope, wherein the flow rate adjustment mechanism is configured to hold a fluid control button in an at least partially depressed state to provide a constant minimum flow rate, and the fluid control button can be further depressed from the at least partially depressed state to provide a higher flow rate, if desired.

2. The endoscope of claim 1 , wherein the flow adjustment mechanism comprises a rotatable knob.

3. 3. The endoscope of claim 1 or 2, wherein the irrigation, suction, and / or pneumoperitoneum controls comprise pinch valves disposed within the elongated handle portion and configured to compress flexible fluid tubes.

4. 4. The endoscope of claim 1, wherein the irrigation, suction, and / or pneumoperitoneum controls include normally closed valves disposed within the elongated handle portion.

5. the irrigation, aspiration, and / or pneumoperitoneum control is adapted to control fluid flow along a first flow path extending through the first lumen; the first lumen extends through the umbilical; 5. The endoscope of claim 1, wherein the first flow path is in fluid communication with a first tool lumen extending through the insertion tube assembly and in communication with the tool port opening.

6. The endoscope of claim 5 comprising a valve disposed between the tool port opening and the first flow passage.

7. a second flow path extending through the second lumen of the umbilical; 7. The endoscope of claim 5 or 6, wherein the second flow path is in fluid communication with the first tool lumen.

8. 8. An endoscope according to claim 1, wherein the articulation control for effecting articulation of a distal portion of an insertion tube assembly coupled to the elongate handle portion is a lever.

9. 9. The endoscope of claim 8, wherein the lever articulates in the same plane as a longitudinal axis of the elongated handle portion.

10. An endoscope as described in any one of claims 1 to 9, wherein the upper end portion of the elongated handle portion includes at least the articulation control portion and the irrigation, suction, and / or pneumoperitoneum control portions.

11. An endoscope as described in any one of claims 1 to 10, wherein the upper end portion of the elongated handle portion includes at least the articulation control portion and the tool port opening.

12. An endoscope as described in any one of claims 1 to 11, wherein the upper end portion of the elongated handle portion includes at least the irrigation, suction, and / or pneumoperitoneum control units and the tool port opening.

13. An endoscope as described in any one of claims 1 to 12, wherein the upper end portion of the elongated handle portion includes each of the articulation control portion, the irrigation, suction and / or pneumoperitoneum control portions, and the tool port opening.

14. An endoscope as described in any one of claims 1 to 13, wherein the irrigation, suction, and / or pneumoperitoneum control unit is an irrigation control unit.

15. An endoscope as described in any one of claims 1 to 14, wherein the irrigation, suction, and / or pneumoperitoneum control unit is a suction control unit.

16. An endoscope as described in any one of claims 1 to 15, wherein the irrigation, suction, and / or pneumoperitoneum control unit is a pneumoperitoneum control unit.

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