Endoscope Assembly and System

Abstract

An endoscope system includes an endoscope having a reusable handpiece and a separable disposable shaft assembly, a disposable cartridge, and a console. The disposable shaft assembly includes a fluid path and an electrical connector configured to extend through the disposable cartridge. The disposable cartridge includes a housing defining the fluid path and the electrical connector. The reusable handpiece includes an articulation control for articulating the disposable shaft assembly.

Description

[Technical field]

[0001] This application claims the benefit of U.S. Provisional Application No. 62 / 883,080, filed August 5, 2019, U.S. Provisional Application No. 62 / 958,948, filed January 9, 2020, U.S. Provisional Application No. 62 / 958,744, filed January 9, 2020, U.S. Provisional Application No. 62 / 959,370, filed January 10, 2020, U.S. Provisional Application No. 62 / 959,387, filed January 10, 2020, U.S. Provisional Application No. 62 / 959,198, filed January 10, 2020, and U.S. Provisional Application No. 62 / 959,346, filed January 10, 2020, which are incorporated herein by reference.

[0002] The present invention relates generally to endoscopes, including those used for gastrointestinal purposes. [Background technology]

[0003] Endoscopes are used in a variety of medical procedures to visualize internal cavities or potential spaces within the human body during diagnosis or treatment. Summary of the Invention [Problem to be solved by the invention]

[0004] One of the factors influencing the design and use of endoscopes is infection control. Although there has always been a risk of infection with reusable endoscopes, the risk has increased due to the emergence of antibiotic-resistant bacteria. If such bacteria are transmitted between patients, antibiotic resistance makes these infections difficult to treat. Many of these bacteria, including Staphylococcus aureus, have the ability to form a protective layer, often called a biofilm, which protects the infectious bacteria during cleaning.

[0005] Another recent trend that increases the risk of infectious disease transmission is the ever-increasing number of diagnostic procedures that use smaller, more complex instruments, longer working lumens, and distal manipulators (e.g., elevators attached to the distal connecting shaft of the endoscope). The rise in difficult-to-treat infections and the prevalence of more complex, harder-to-clean endoscopes make sterilization and reuse of endoscopes an increasingly risky practice.

[0006] It is desirable to reduce or limit the likelihood of infection transmission, and therefore new endoscope designs are desirable, i.e. improvements in this area are needed. [Means for solving the problem]

[0007] The present disclosure relates generally to endoscopes. In one aspect, the disclosure relates to an endoscope having a reusable handpiece removably coupled to a disposable shaft assembly. The reusable handpiece includes an articulation control and the disposable shaft assembly includes an articulation wire steering assembly that engages with the articulation control when the reusable handpiece and the disposable shaft assembly are coupled together (e.g., when a housing of the reusable handpiece and a housing of the disposable shaft assembly are coupled together).

[0008] The reusable hand piece may have optical and / or electrical connectors that mate with corresponding optical and / or electrical connectors on the disposable shaft assembly when the reusable hand piece is coupled to the disposable shaft assembly (e.g., when the housing of the reusable hand piece and the housing of the disposable shaft assembly are coupled together). The optical and / or electrical connectors of the reusable hand piece may be part of an electronics module. The electronics module may include an imaging control.

[0009] The disposable shaft assembly may include an imaging device (e.g., an image sensor or lens, such as a CCD or CMOS sensor) and / or a light emitter (e.g., an LED or a fiber optic cable). The imaging device and / or light emitter may be located at a distal end of the disposable shaft assembly. Optical and / or electrical connectors may provide communication between the electronics module of the reusable handpiece and the imaging device and / or light emitter of the disposable shaft assembly.

[0010] The light emitter may include a light generating element (e.g., an LED) or may pass light provided proximal to the articulation distal portion. For example, the light emitter may be a light guide (e.g., a fiber optic cable). The imager may include a sensor (e.g., a CCD or CMOS sensor) that converts light into an electrical signal, or a lens positioned to pass light from the articulation distal portion toward the proximal portion of the shaft.

[0011] The reusable handpiece can include controls for controlling the flow of fluid through the disposable shaft assembly, which can be in communication with valves in the disposable shaft assembly and / or with external support equipment (e.g., pumps and / or valves in the support equipment).

[0012] The endoscope assembly can include a locking portion that holds the reusable handpiece and the disposable shaft assembly together in an assembled configuration. The locking portion can include a first portion on the reusable handpiece and a second portion on the disposable shaft assembly, the first and second portions of the locking portion cooperating to hold the reusable handpiece and the disposable shaft assembly together in the assembled configuration.

[0013] The locking portion is operable to engage and / or disengage with the disposable shaft assembly. The locking portion may include a latch having a catch attached to a pivotable and / or deflectable latch arm. The latch may be biased with a biasing member (e.g., a spring) into a latched configuration that may hold the reusable hand piece and the disposable shaft assembly together. The locking portion may include one or more magnets that hold the reusable hand piece to the disposable shaft assembly when in the assembled configuration. The locking portion may be configured to be actuated (e.g., engaged and / or disengaged) without the use of a hand tool (e.g., a screwdriver). Preferably, the locking portion is actuable using a finger. The locking portion may be defined by a portion of a housing of the reusable hand piece and / or the disposable shaft assembly. For example, the housing may define a deflectable tab and / or a living hinge for the locking portion.

[0014] The locking feature can be adapted to indicate when the reusable handpiece and the disposable shaft assembly are locked together, for example, the locking feature can provide an audible "click" sound when the reusable handpiece and the disposable shaft assembly are locked together.

[0015] The disposable shaft assembly may include one or more ports in communication with a fluid flow path (e.g., a lumen) in the shaft of the disposable shaft assembly. The fluid flow path may extend along a portion of the shaft to one or more openings at the distal end of the shaft. The fluid flow path may be arranged for irrigation, pneumoperitoneum, suction, and / or to receive a surgical tool (e.g., a forceps, cutter, and / or ligation device). The reusable handpiece may not have a fluid flow path and / or a fluid connector in fluid communication with the fluid flow path in the shaft.

[0016] The articulation control of the reusable handpiece can include an articulation knob. The articulation knob can be adapted to receive articulation input (e.g., in the form of a rotary motion) from a user. The articulation knob can cooperate with cams and / or gears on a separable disposable shaft to actuate control wires on the disposable shaft assembly. The user-controlled articulation knob can include two knobs with and / or fixedly attached to a concentric articulation shaft.

[0017] The concentric articulation shafts each have a pulley / pinion engagement portion that may have a cross-sectional geometry capable of transmitting torque. Preferably, the geometry has a geometry that interferes with the geometry of the pulley / pinion such that rotation of the articulation shaft rotates the pulley / pinion. The geometry may include, but is not limited to, an ellipse, a spline, a square, or a star, to name a few non-limiting examples.

[0018] Preferably, the concentric articulation shaft configuration allows for attachment of the disposable shaft assembly to the reusable handpiece without the need to orient the articulation knob or distal articulation tip to obtain a neutral reference position. When the articulation knob and brake assembly brakes are not engaged, the articulation knob is free to rotate while the clinician manipulates the distal shaft (insertion tube) prior to use, regardless of the orientation of the disposable shaft assembly (coiled or straight) upon attachment.

[0019] The disposable shaft assembly may include one or more pulley assemblies. The pulley assembly includes at least one pulley arranged to receive an end of the articulation shaft. Rotation of an articulation knob associated with the articulation shaft rotates the at least one pulley. Associated with the at least one pulley is an articulation wire or a pair of articulation wires (e.g., two separate wires, or a single continuous wire with wire segments looped over the pulley and extending from both sides of the pulley) configured to bend the distal shaft portion of the disposable shaft assembly upon actuation. The articulation wires may be fixed (e.g., tied) to the pulley and / or extend around at least a portion of the pulley (e.g., wrapped around the pulley). Preferably, the one or more pulley assemblies include two pulleys (one for each articulation shaft) and articulation wires (at least one for each pulley). Preferably, the articulation wires are configured to bend the distal shaft portion in orthogonal planes.

[0020] The disposable shaft assembly can include one or more rack and pinion assemblies contained within a rigid housing. For example, the disposable shaft assembly can have a proximal rigid housing having a surface that supports and positions the rack and pinion assembly of the disposable shaft assembly to receive the pinion-engaging portion of the articulation shaft.

[0021] Each pinion, contained within a proximal rigid housing associated with a separable disposable shaft, has a circumferential series of teeth that engage a set of opposing racks that are associated with a pair of opposing articulation wires. Each articulation wire may be rigidly fixed at one end to the rack and at the other end to a distal tip of the articulation section of the shaft. Rotation of the pinion, such as by a user input torque applied to a corresponding knob, results in a tension force being applied to the articulation distal portion.

[0022] In a preferred embodiment, two pinions are used, each associated with a pair of racks and articulation wires. Each rack and articulation wire pair provides a means for articulating the distal shaft section in a single plane. The two pairs of articulation wires provide articulation of the distal shaft in two different planes that may be orthogonal to each other, with the longitudinal axis of the proximal shaft portion passing through the intersection of the planes.

[0023] The preferred embodiment includes a single or pair of pulleys that include an articulation shaft engagement geometry and a pair of opposing steering wires for each pulley.

[0024] The engagement geometry of the concentric articulation shafts associated with the reusable handpiece and the pulley / pinion engagement geometry associated with the separable disposable shaft assembly are suitable to transfer a force in the form of torque applied to the articulation knob into a pulling force in the articulation wire(s) and corresponding movement of the distal shaft articulation portion. Preferably, the engagement geometry does not rely solely on friction between the articulation shaft and the pulley / pinion. Preferably, the engagement geometry includes a geometric interference between the articulation shaft and the pulley / pinion.

[0025] A portion of the articulation shaft, such as the pulley / pinion engagement portion, may be tapered along a portion of the articulation shaft. For example, the articulation shaft may have a portion that tapers from smaller to larger in a direction toward the articulation knob. Advantageously, such a shape may facilitate engagement of the articulation shaft with the pulley / pinion of the disposable shaft assembly when the reusable handpiece is coupled to the disposable shaft assembly.

[0026] The reusable handpiece may include one or more brakes that apply an adjustable level of rotational resistance to an articulation control (e.g., an articulation control knob). In applications where biplanar articulation is desired, there may be a separate brake mechanism for each articulation control knob and its articulation wire or associated set of articulation wires. Additionally, the brake mechanism may be integrated within an envelope defined by the knob, thereby creating space for a disposable shaft assembly within the reusable handpiece housing. Additionally, the brake mechanism may not utilize a fixed method, such as rotating a threaded shaft, to apply force against the friction surfaces and / or braking material. Preferably, the brake mechanism utilizes a spring element to apply force between the friction surfaces and / or braking material, eliminating the need to adjust or calibrate the brake force. Preferably, the brake is released by compressing the spring element to remove the force from the friction surfaces and / or braking material.

[0027] In the arrangements disclosed herein, the articulation controls and the electronics module, which may incorporate control and / or navigation switches, are preferably mounted to the housing of the reusable handpiece. The articulation wire actuation assembly and connector of the disposable shaft assembly are preferably mounted to the housing of the disposable shaft assembly. Thus, by separating the housing of the reusable handpiece from the housing of the disposable shaft assembly, the articulation controls can be separated from the articulation wire actuation assembly and the electronic control and / or navigation switches can be separated from the connector of the disposable shaft assembly.

[0028] A preferred embodiment includes an electronics module that may include a plurality of switches mounted to the housing of the reusable handpiece, the plurality of switches electrically communicating with a wire harness associated with the disposable shaft assembly via an electrical connector. The plurality of switches may further include a unique resistance value associated with each switch, with each switch connected in parallel to a pair of electrical conductors. This configuration may minimize the number of connectors required to communicate with a particular switch, or combination of switches pressed by a user. Additionally or alternatively, the electronics module of this embodiment may further incorporate a microprocessor to minimize the number of connectors required to communicate with a particular switch, or combination of switches pressed by a user.

[0029] Preferably, the reusable handpiece of the endoscope assembly can remain completely outside the patient's body during the endoscopic procedure, while the disposable shaft assembly has a portion that is disposed within the patient's body during the endoscopic procedure. Thus, the reusable handpiece and the disposable shaft assembly can be separated from each other after the procedure, and the disposable handpiece can be discarded (or reprocessed). Because the reusable handpiece does not have any fluid lumens that must be cleaned and sterilized, the effort of cleaning (aka "reprocessing") between procedures using the reusable handpiece is dramatically reduced. Also, because no part of a reusable handpiece used on multiple patients is inserted into the patient, the risk of infection transmission can be dramatically reduced.

[0030] The disposable shaft assemblies can be arranged and / or provided in a variety of configurations to support upper and lower endoscopes. For example, the disposable shaft assemblies can be arranged for colonoscopic, gastroscopic, sigmoidoscopic, and / or duodenoscopic procedures, to name a few non-limiting examples. Additionally or alternatively, the disposable shaft assemblies can be provided in a variety of specialized configurations, such as pediatric insertion tube diameters. Because the same reusable handpiece can be used for a variety of disposable shaft assemblies and / or procedures, capital investments by clinicians, clinician groups, and / or medical centers can be significantly reduced by eliminating the need to stock multiple dedicated endoscopes, such as colonoscopes, gastroscopic, sigmoidoscopic, duodenoscopes, etc., for each type of procedure.

[0031] Methods of assembling, disassembling, and / or using an endoscope assembly are contemplated. Such methods may include connecting a housing of a reusable hand piece to a housing of a disposable shaft assembly, the reusable hand piece including an articulation control and an electronics module, and the disposable shaft assembly including an articulation wire actuation assembly and a connector, connecting the articulation control to the articulation wire actuation assembly and the electronics module to the connector of the disposable shaft assembly. Additionally or alternatively, the method may include separating the housing of the reusable hand piece from the housing of the disposable shaft assembly to separate the articulation control from the articulation wire actuation assembly and the electronics module from the connector of the disposable shaft assembly. The method may include providing some or all of any endoscope assembly described herein.

[0032] Advantageously, the systems, assemblies, devices, and methods disclosed herein can increase the amount of endoscopic procedures a clinician and / or facility can perform per day by reducing and / or eliminating the time delays associated with existing reusable endoscopes that must be reprocessed (i.e., cleaned) between uses. By using disposable shafts, the clinician and / or facility no longer needs to reprocess (i.e., clean) the shaft and shaft lumen. The clinician and / or facility can simply wipe down the reusable handpiece and connect a new, sterilized disposable shaft assembly to the reusable handpiece to prepare the endoscope assembly for another procedure.

[0033] Advantageously, the systems, assemblies, devices, and methods disclosed herein may enable clinicians to perform multiple and / or various procedures without the need for a dedicated reusable endoscope and associated reprocessing devices, supplies, and clean water. This may be particularly advantageous in battlefield settings or remote clinics with limited resources, where reprocessing devices, reprocessing supplies, trained reprocessing personnel, and reprocessing laboratory settings may not be available. Advantageously, the endoscopes disclosed herein may be prepared for a new procedure by simply cleaning the exterior of the reusable handpiece with wipes and an antiseptic solution and connecting a new disposable shaft assembly.

[0034] Advantageously, a reusable handpiece can provide functionality that users are familiar with, with high precision and reliable components associated with the articulation knobs and clutches.

[0035] Advantageously, incorporating the articulation handle and clutch into the reusable handpiece reduces the number of components in the separable disposable shaft assembly, resulting in a lower cost disposable portion of the endoscope.

[0036] The proximal rigid housing associated with the separable disposable shaft assembly may also include features for managing lumens for tools, irrigation, and aspiration. These features may incorporate features for attaching connectors or connecting to external devices and tubing. Preferably, incorporating these lumens and connectors in the proximal rigid housing of the separable disposable shaft may isolate potential bodily fluid contact surfaces for the separable disposable shaft assembly to reduce and / or prevent the transmission of infectious diseases.

[0037] The reusable handpiece may include a control module, switches, and an electrical connector, while the disposable shaft assembly may include an optical sensor, an optical sensor module, and an electrical connector. A set of conductors may carry both optical and control data from the assembled endoscope back to the console.

[0038] Preferably, the incorporation of an electronic module and switches facilitates the transmission of control data while simplifying the components associated with a detachable disposable shaft.

[0039] Advantageously, transmitting image data and associated metadata from an assembled endoscope to a console facilitates storage and sharing of patient and image data.

[0040] The reusable handpiece may include an electronics module (e.g., a circuit board) adapted to control at least a portion of the support equipment (e.g., one or more pumps and / or valves within the support equipment). One or more switches of the reusable handpiece may be associated with the electronics module to control the support equipment. Such a configuration may eliminate the need for valves for the irrigation and aspiration lumens to be physically associated with the reusable handpiece and / or the separable distal shaft assembly.

[0041] The configurations disclosed herein can utilize small, high-resolution cameras at low cost, which can advantageously enable single-use endoscopes that meet the cost, size, and resolution requirements defined by healthcare providers and / or insurance companies.

[0042] The disposable shaft assemblies disclosed herein can be intended for a single use. Advantageously, disposable medical devices can reduce the transmission of infectious diseases.

[0043] Applicants also recognize that expertise related to the evaluation of certain diseases and the implementation of new therapeutic procedures is increasingly concentrated in clinical research laboratories or large medical centers. Advantageously, the endoscopes disclosed herein can facilitate the sharing of patient and imaging data.

[0044] The present disclosure further relates generally to endoscopes. In one aspect, the present disclosure relates to a single use endoscope and a disposable cartridge attached thereto. The endoscope may include multiple fluid paths and one or more electrical conductors extending to the cartridge. The cartridge may connect some or all of the fluid paths and / or one or more electrical conductors to a control console to allow the passage of fluid (e.g., liquid or gas) and / or power and / or data between the endoscope and the control console.

[0045] The endoscope may include a first fluid path, a second fluid path, a third fluid path, and / or electrical conductors. The first fluid path, the second fluid path, and / or the third fluid path may have portions defined by a cartridge. The cartridge may include a housing. The cartridge may further include a first electrical connector associated with electrical conductors of the endoscope and a second electrical connector configured to electrically connect the electrical conductors of the endoscope to the electrical conductors of the console.

[0046] At least one fluid path (e.g., a first fluid path) of the cartridge can include a valve portion that can be mated with a first actuator of the console, the first actuator being operable to selectively close or open the valve portion of the fluid path.

[0047] The present disclosure further discloses a cartridge having a housing having one or more inner surfaces defining one or more windows. Valve portions of one or more fluid paths may be disposed within the one or more windows. The one or more windows may be configured to receive one or more actuators from a console configured to close and / or open the one or more fluid paths.

[0048] The valve portion may include a flexible membrane disposed within a window defined by the housing. The flexible membrane may be a wall of a tube that defines one or more fluid paths.

[0049] The endoscope system may utilize a control console to assist in operation of the endoscope. The console may include and / or be connected to a video monitor. The console may further include and / or be connected to a user interface for inputting commands. The console may further include and / or be connected to a valve control assembly for receiving the cartridge. The valve control assembly may include a door for securing the cartridge. The door may include a latch that can be inserted into a keeper to press against the cartridge. The press helps to facilitate a connection between an electrical connector of the cartridge and an electrical connector of the console. The latch may be a lever latch.

[0050] The endoscope (e.g., the reusable handpiece and / or disposable portion) and cartridge can be sterile sealed in a medical packaging, such as a sterile medical tray. Preferably, the endoscope sealed in the medical packaging is the disposable shaft assembly portion of an endoscope system that includes a reusable handpiece assembly and a disposable shaft assembly.

[0051] In addition to the single fluid pathway, the endoscopic system may include a second fluid pathway. The second fluid pathway may include a second valve portion defined by the cartridge. The second valve portion may be aligned with a second actuator of the console operable to selectively close and / or open the second valve portion of the second fluid pathway.

[0052] A fluid path (e.g., a third fluid path) of the cartridge may have a main portion and a branch portion. The main portion of the third fluid path of the cartridge may include a third valve portion. The third valve portion may be aligned with a third actuator of the console operable to selectively close and / or open the third valve portion.

[0053] The branched portion of the fluid pathway of the cartridge can include a fourth valve portion. The fourth valve portion can be aligned with a fourth actuator of the console operable to selectively close and / or open the fourth valve portion.

[0054] The endoscopic system may include a fluid path (e.g., a fourth fluid path) having a length that extends between the endoscope and the console when the cartridge is connected to the console, and the length may be free of valves.

[0055] The endoscope of the endoscopic system may include a reusable handpiece assembly and a disposable shaft assembly, such as any of those disclosed herein. Preferably, the reusable handpiece assembly may be selectively attachable to and detachable from the disposable shaft assembly. Preferably, the reusable handpiece assembly supports an articulation control that engages a portion of the disposable shaft assembly when the reusable handpiece assembly is attached to the disposable shaft assembly for manipulating a distal portion of the disposable shaft assembly.

[0056] Preferably, at least one fluid pathway in the endoscope extends continuously from the endoscope to the cartridge to form a continuous fluid pathway and does not include a flow control valve. The continuous fluid pathway may have at least a portion extending from the distal tip of the endoscope to the cartridge.

[0057] The fluid paths (eg, the first fluid path, the second fluid path, the third fluid path, and / or the fourth fluid path) of the endoscope may each be defined by a continuous flexible tube.

[0058] A method of using an endoscope system may include connecting the cartridge to a console. Connecting the cartridge to the console may include connecting an electrical connector of the cartridge to the console to electrically connect electrical conductors of the endoscope with electrical conductors of the console to exchange power and / or data between the console and the endoscope. The connecting may also include disposing one or more valve portions of one or more fluid pathways of the endoscope on one or more actuators of the console such that the actuators can be selectively actuated to open and / or close the one or more fluid pathways. Preferably, the connecting of the electrical conductors and disposing of the one or more valve portions occur simultaneously.

[0059] Advantageously, the disclosed arrangement can reduce the number of separate connections that must be made in a user setup.

[0060] Advantageously, the disclosed configurations can reduce the number of leak locations associated with endoscope lumens.

[0061] Advantageously, the disclosed configurations can reduce costs associated with cleaning and reusing endoscopic systems.

[0062] Advantageously, the disclosed configurations can reduce the risk of exposure to biohazardous fluids by replacing and / or eliminating multi-part valves.

[0063] Advantageously, the disclosed arrangements can enable tracking and management of single use endoscopes through the interaction of a console and a control module that includes unique identifier data.

[0064] In another embodiment, a doorless cartridge and control valve assembly may be utilized. The control valve assembly may include a ledge surface and a latch. The cartridge may include a ledge surface and a latch receiver. Alternatively, the control valve assembly may include the latch receiver portion and the cartridge may include the latch. When the cartridge is received by the control valve assembly, the latch contacts the latch receiver portion to secure the cartridge to the control valve assembly. Also, the ledge surface of the cartridge and the ledge surface of the control valve assembly contact each other to secure an end of the cartridge to the control valve assembly.

[0065] The cartridge may further include an anvil similar to the anvil described in the door-equipped control valve assembly example above. The anvil is configured to provide a counterforce to the actuator when selectively closing the fluid path of the cartridge. In one example, the anvil may be disposed in a window defined in the cartridge.

[0066] The endoscope assembly may further relate to a system including a console having a plurality of control valve assemblies, each configured to receive an independent cartridge. Each cartridge may be connected to an endoscope. Each endoscope may be a different type of endoscope. In some examples, the first endoscope is a duodenoscope and the second endoscope is a cholangiopancreatoscope. In some embodiments, the first endoscope may be a main (primary) controller and the second endoscope may be a secondary (secondary). In this configuration, the main endoscope may control the fluid and / or imaging functions of the secondary endoscope.

[0067] Advantageously, the disclosed configuration can include one or more medical devices on a console to reduce the time between procedures for the same patient.

[0068] Advantageously, the disclosed configuration allows for the addition of multiple endoscopes without additional equipment, carts, or an overall extensive setup.

[0069] Advantageously, the use of two control cartridge assemblies on the same console provides the ability to control the fluid and image controls of the secondary endoscope with the primary endoscope in the operator's hands, reducing the number of endoscopists required to complete a procedure.

[0070] The endoscope assembly may further relate to an endoscope including a handpiece assembly, a shaft assembly, and a latch capable of being in a latched state and an unlatched state. The handpiece assembly has a housing. The shaft assembly has a housing. In the latched state, the latch latches the housing of the handpiece assembly to the housing of the shaft assembly. When transitioning from the latched state to the unlatched state, the latch applies a separation force separating the housing of the handpiece assembly and the housing of the shaft assembly. The handpiece assembly may be a reusable handpiece assembly and / or the shaft assembly may be a disposable shaft assembly.

[0071] The latch may include a lever that pivots from a first position in the latched state to a second position in the unlatched state. The latch may include a latch surface and an unlatch surface. In the latched state, the latch surface holds the housing of the hand piece in proximity to the housing of the shaft assembly. When going from the latched state to the unlatched state, the unlatch surface applies a separation force to separate the housings. The latch may further include a seat portion. The latch portion and the unlatch portion may be located on opposite sides of the seat portion. The latch may further include a latch pivot. The latch portion and the unlatch portion may be located on opposite sides of the latch pivot. The latch may be located on a reusable hand piece. The latch may be located on a disposable shaft assembly.

[0072] Another embodiment of the endoscope may include a handpiece assembly and a shaft assembly. The handpiece assembly has a housing. The shaft assembly has a housing. The endoscope may further include a biasing member and a latch. The latch may include a latch displaceable between a latched state and an unlatched state. The biasing member may apply a biasing force to bias the housings toward or away from each other. The latch may be configured to apply a force countering the biasing force to urge the housings away or toward each other. For example, when actuated, the biasing member may be configured to bias the housings toward each other and the latch may be configured to urge the housings away from each other. In another example, when actuated, the biasing member may bias the housings away from each other and the latch may be configured to urge the housings toward each other and / or the latch may be configured to hold the housings together against the force of the biasing member. The biasing member may be a spring, a deflectable arm, a magnet, and / or a pressure chamber (eg, a pneumatic piston), to name a few non-limiting examples.

[0073] Further disclosed is a latch mechanism for an endoscope having a reusable handpiece assembly and a disposable shaft assembly, the latch including a latch and a latch receiver. The latch has a latch portion, an unlatch portion, and a latch handle. The latch mechanism is movable between a latched state and an unlatch state. The latch handle is movable between a first position and a second position. In the latched state, the latch receiver contacts the latch portion. In the unlatch state, the latch receiver and the latch portion are not in contact. When going from the latched state to the unlatch state, the unlatch portion can contact the receiver to apply a force to separate the assemblies.

[0074] Further disclosed is a packaging system having at least a disposal bag and a container. The container may include a first portion including a recess for holding the medical product, the recess configured to hold the medical product in a sterile environment. The container may further include a second portion configured to support the disposal bag. The second portion may further be configured to support a second bag. The container may further include a medical product box. Both the disposal bag and the container are removably disposed within the medical product box prior to use of the medical product. The disposal bag may be configured to hold the medical product after the medical product has been used.

[0075] The container may further include a tray. A recess configured to hold the medical product may be defined in the tray. The tray may be made from thermoformed plastic.

[0076] The container may further include a cover, which may be configured and / or attachable to the tray to sterilely seal the recess. The container may be made from a recyclable material. The cover may be made from Tyvek®.

[0077] The packaging system may further include a label attached to the cover, the label may include information relating to the medical product retained within the recess.

[0078] The waste bag may be attached to the second portion of the container when the waste bag and the container are disposed in the medical supply box. The waste bag may be detachable from the second portion of the container. The waste bag may be secured to the second portion. The second portion may be an exterior surface of the container. The second portion may be an interior surface of the container.

[0079] The second bag may be secured to the second portion of the container when the second bag and the container are disposed in the medical supply box. The second bag may be removable from the second portion of the container. The second bag may be secured to the second portion.

[0080] After the entire medical product or disposable shaft assembly has been used and properly placed in the disposal bag, the disposal bag may be removed from the second part of the packaging system and disposed of in the appropriate manner for biohazard waste.

[0081] After the reusable handpiece is placed in the second bag, the second bag may be removed from the second portion of the packaging system. The second bag with the reusable handpiece therein may be safely transported for reprocessing. In some examples, the healthcare professional or a person associated with the healthcare professional may send the second bag containing the reusable handpiece back to the manufacturer for reprocessing / cleaning. Once the reprocessing operation is complete, the reusable handpiece may be shipped back to the healthcare professional and / or the same clinic. In other examples, the reusable handpiece may be resold to a third party depending on the agreement between the manufacturer and the original healthcare professional.

[0082] The packaging system may further include a medical product box. The disposal bag and container are both removably positioned within the medical product box prior to use of the medical product. The second bag and container are both removably positioned within the medical product box prior to use of the medical product.

[0083] The packaging system may further include a shipping box. A plurality of medical supply boxes may be packaged within the shipping box.

[0084] The disposal bag may include a peripheral opening. The adhesive for attaching the disposal bag to the second portion of the container may be spaced along at least 20% of the peripheral opening.

[0085] The second bag may include a peripheral opening. The adhesive for attaching the second bag to the second portion of the container may be spaced along at least 20% of the peripheral opening.

[0086] The medical product may be an endoscope.

[0087] In another configuration disclosed herein, the articulation controls and electronics module incorporating the control and navigation switches is attached to the housing of the reusable handpiece, and the articulation wire actuation assembly and the connector of the disposable shaft assembly are attached to the housing of the disposable shaft assembly, such that separation of the reusable handpiece housing from the housing of the disposable shaft assembly separates the articulation controls from the articulation wire actuation assembly and separates the electronic control and navigation switches from the connector of the disposable shaft assembly.

[0088] A preferred embodiment may include an electronics module including a plurality of switches mounted to the housing of the reusable handpiece that electrically connects to a wire harness associated with the disposable shaft assembly via an electrical connector. The plurality of switches mounted to the housing of the reusable handpiece electrically connects to a wire harness associated with the disposable shaft assembly via an electrical connector. The electronics module of this embodiment may further include a microprocessor to minimize the number of connectors required to connect a particular switch or combination of switches pressed by a user.

[0089] In another embodiment of the endoscope, the reusable handpiece contains the electronics module, switches, and electrical connectors, while the disposable shaft assembly contains the optical sensor, optical sensor module, and electrical connectors, and a set of conductors carries both optical and control data from the assembled endoscope back to the console.

[0090] Advantageously, incorporating electronic modules and switches facilitates transmission of control data while simplifying the components associated with a separable disposable shaft.

[0091] The reusable handpiece can include a circuit board (electronics module) adapted to control at least a portion of the support equipment (e.g., one or more pumps and / or valves within the support equipment). One or more switches of the reusable handpiece can be associated with the electronics module to control the support equipment.

[0092] Advantageously, such a configuration can eliminate the need for valves for the irrigation and aspiration lumens to be physically associated with the reusable handpiece and / or separable distal shaft assembly.

[0093] The switches associated with the reusable handpiece circuit board (electronic module) may include two electrical switches activated by separate buttons for programmable functions on the top of the reusable handpiece. At least one of the switches (e.g., the second switch from the bottom) may activate a remote suction valve. At least one of the switches (e.g., the first switch associated with the bottom button) may initiate an insufflation function via operation of the remote valve. At least one of the switches (e.g., the second switch associated with the bottom button) initiates a camera wash function via operation of the remote valve. One or more of the switches may be activated by an operator placing a finger on an exterior molded gasket that covers the button. One or more of the switches may be activated by an operator fully depressing the button.

[0094] Advantageously, the use of a remote valve in conjunction with a disposable shaft cartridge eliminates the need for cleaning and potential contamination associated with mechanical valves in the current state of the art for endoscopes.

[0095] Current state of the art endoscopes have a vent hole located on top of the valve button that is covered by the user's finger to initiate pneumoperitoneum. Advantageously, a capacitive switch provides the same user experience as with current state of the art endoscopes, by simply placing a finger on top of the button to initiate pneumoperitoneum, but eliminates the need for cleaning and potential contamination of the mechanical valves associated with current endoscopes.

[0096] The endoscope assembly can include a coupler that holds the reusable handpiece and the disposable shaft assembly together in an assembled configuration. The coupler can include a first portion on the reusable handpiece and a second portion on the disposable shaft assembly, the first portion and the second portion of the coupler cooperating to hold the reusable handpiece and the disposable shaft assembly together in the assembled configuration.

[0097] The reusable handpiece articulation control can include an articulation knob. The articulation knob is adapted to receive articulation actuation input (e.g., in the form of a rotational motion) from a user. The articulation knob can communicate with a pulley / cam of the separable disposable shaft to actuate a control wire of the disposable shaft assembly. The user-controlled articulation knob can include two knobs with and / or rigidly attached to a concentric drive shaft.

[0098] The concentric drive shafts each have a pulley / cam engagement portion that may have a non-circular cross-sectional geometry to aid in torque transmission, which may include, but is not limited to, an ellipse, a spline, a square, or a star, to name a few non-limiting examples.

[0099] Advantageously, the concentric shaft drive configuration disclosed herein allows for attachment of a disposable shaft assembly to a reusable handpiece without the need to orient the articulation knob or distal articulation tip to obtain a neutral reference position. Regardless of the orientation of the disposable shaft assembly upon attachment (coiled or straight), the articulation knob rotates freely while the distal shaft (insertion tube) is manipulated prior to use by the clinician.

[0100] The disposable shaft assembly can include one or more pulleys / cams housed within a rigid housing. For example, the disposable shaft assembly can have a proximal rigid housing having a surface that supports and positions a pulley / cam of the disposable shaft assembly to receive a pulley / cam engaging portion of the drive shaft.

[0101] Each pulley / cam housed within a proximal rigid housing associated with a separable disposable shaft is connected to a pair of opposing articulation wires. Each articulation wire may be fixed to a pulley / cam and rigidly fixed at its other end to a distal tip of the articulation section of the shaft. Rotation of the pulley / cam, such as by a user input torque applied to a corresponding knob, provides a tension force to the articulation distal portion.

[0102] The preferred embodiment utilizes two pulleys / cams, each associated with a pair of articulation wires. Each pair of articulation wires provides a means for articulating the distal shaft portion in a single plane. The two pairs of articulation wires provide distal shaft articulation in two different, mutually orthogonal planes, with the longitudinal axis of the proximal shaft portion passing through the intersection of these planes.

[0103] The concentric drive shaft engagement associated with the reusable handpiece and the pulley / cam engagement associated with the separable disposable shaft assembly are adapted to cause a force in the form of torque applied to the articulation knob to result in a pulling force on the articulation wire(s) and corresponding movement of the distal shaft articulation portion.

[0104] A portion of the drive shaft, such as a pulley / cam engagement portion, may be tapered along a portion of the drive shaft. For example, the drive shaft may have a portion that tapers from small to large in a direction toward the articulation knob. Advantageously, such a configuration may facilitate engagement of the drive shaft with a pinion of a disposable shaft assembly when a reusable handpiece is coupled to the disposable shaft assembly.

[0105] The reusable handpiece may include a brake that applies an adjustable level of rotational resistance to an articulation control (e.g., an articulation control knob). For applications where at least two planar articulations are required, there is a separate brake mechanism for each articulation control knob and its associated articulation wire(s). Additionally, the brake mechanism is integrated within an envelope defined by the knob, thereby creating space for the disposable shaft assembly within the reusable handpiece housing. Additionally, the brake mechanism does not utilize a fixed method, such as the rotation of a threaded shaft, to apply force against a friction surface and / or brake material.

[0106] Advantageously, the reusable handpiece of the endoscope assembly remains entirely outside the patient's body during an endoscopic procedure, while the disposable shaft assembly has a portion that is disposed within the patient's body during an endoscopic procedure. Thus, the reusable handpiece and the disposable shaft assembly can be separated from one another after the procedure, and the disposable handpiece can be discarded (or reprocessed). Because the reusable handpiece does not have any fluid lumens that must be cleaned and sterilized, the effort of cleaning (aka "reprocessing") between procedures is dramatically reduced. Also, because no part of a reusable handpiece used on multiple patients is inserted into the patient, the risk of infectious disease transmission can be significantly reduced.

[0107] Disposable shaft assemblies are provided and / or configured in a variety of configurations to support upper and lower endoscopes. For example, disposable shaft assemblies can be for colonoscopic, gastroscopic, sigmoidoscopic, and / or duodenoscopic procedures, to name a few non-limiting examples. Additionally or alternatively, disposable shaft assemblies can be provided in a variety of specialty configurations, such as pediatric insertion tube diameters. Advantageously, having a variety of disposable shaft assemblies and / or reusable handpieces available can eliminate the need to stock multiple specialized endoscopes, such as colonoscopes, gastroscopic, sigmoidoscopic, duodenoscopes, etc., for each type of procedure, thereby significantly reducing capital investments for clinicians, clinician groups, and / or medical centers.

[0108] Methods of assembling, disassembling, and / or using an endoscope assembly are contemplated. Such methods may include connecting a housing of a reusable hand piece to a housing of a disposable shaft assembly, the reusable hand piece including an articulation control and an electronics module, and the disposable shaft assembly including an articulation wire actuation assembly and a connector, said connections connecting the articulation control to the articulation wire actuation assembly and the control module to the connector of the disposable shaft assembly. Additionally or alternatively, the method may include separating the housing of the reusable hand piece from the housing of the disposable shaft assembly to separate the articulation control from the articulation wire actuation assembly of the disposable shaft assembly and the control module from the connector of the disposable shaft assembly. The method may include providing some or all of any endoscope assembly described herein.

[0109] Advantageously, the systems, assemblies, devices, and methods disclosed herein can increase the amount of endoscopic procedures a clinician and / or institution can perform per day by reducing and / or eliminating the time delays associated with existing reusable endoscopes that must be reprocessed (i.e., cleaned) between uses. By using disposable shafts, clinicians and / or institutions no longer need to reprocess (i.e., clean) the shaft and shaft lumen. Now, clinicians and / or institutions can simply wipe down and / or sterilize the reusable handpiece as disclosed herein, connect a new sterilized disposable shaft assembly to the reusable handpiece, and prepare the endoscope assembly for another procedure.

[0110] Advantageously, the systems, assemblies, devices, and methods disclosed herein can enable clinicians to perform multiple and / or various procedures without the need for a dedicated reusable endoscope and associated reprocessing devices, supplies, and clean water. This can be particularly advantageous in battlefield settings or remote clinics with limited resources, where reprocessing devices, reprocessing supplies, trained reprocessing personnel, and reprocessing laboratory settings may not be available. Advantageously, the endoscopes disclosed herein can be prepared for a new procedure by simply cleaning the exterior of the reusable handpiece with wipes and an antiseptic solution and connecting a new disposable shaft assembly.

[0111] Advantageously, a reusable handpiece can provide functionality that users are accustomed to, with highly precise and reliable components associated with the articulation knobs and brakes.

[0112] Advantageously, incorporating the articulation handle and clutch into the reusable handpiece reduces the components of the separable disposable shaft assembly, resulting in a lower cost disposable portion of the endoscope.

[0113] The disposable shaft assemblies disclosed herein can be intended for one-time use. Advantageously, disposable medical devices can reduce the transmission of infectious diseases.

[0114] Advantageously, the preferred embodiment shown includes three or more torque transfer bosses with symmetric alignment ramps that facilitate alignment of the articulation shaft with the articulation pulley when the disposable shaft assembly is attached to the reusable handpiece. These symmetric alignment ramps may be made with helical sweep cuts or straight angled cuts, to name a few non-limiting examples.

[0115] Applicants also recognize that expertise related to the evaluation of certain diseases and the implementation of new therapeutic procedures is increasingly concentrated in clinical research laboratories or larger medical centers. Advantageously, the endoscopes disclosed herein can facilitate the dissemination of patient and imaging data.

[0116] The presently disclosed single use flexible endoscope shaft includes a proximal portion having an insertion tube assembly and a distal portion having an articulation assembly.

[0117] The insertion tube assembly disclosed herein includes an outer coil. A plurality of compression coils are disposed inside the outer coil. The compression coils may be adapted to increase column strength of the outer coil along a longitudinal direction. The compression coils may be helically wound metal wires and / or helically cut cannulas that provide lateral flexibility. An articulation wire may be slidably disposed within a lumen defined by the compression coils.

[0118] The insertion tube assembly may include a sleeve (e.g., a braided sleeve) disposed around the outer coil. The sleeve preferably provides torsional strength to the insertion tube assembly. The braided sleeve may include a metal braid and / or a plastic braid, such as PET.

[0119] The insertion tube assembly may include an outer sheath disposed about the sleeve. The outer sheath may be provided as a reflowed tube or by extrusion. The outer sheath may be bonded to the sleeve through an opening in the sleeve and / or to the outer coil.

[0120] The articulation section assembly may include an articulation section having a plurality of hinges. Each hinge provides rotation about a pivot axis. The hinge pivot axis may extend transversely to a longitudinal axis of the articulation section. Additionally, the pivot axis of one or more hinges may be in a different plane than the pivot axis of one or more other hinges. For example, the hinge pivot axes may alternately lie in planes perpendicular to one another when the articulation section is in a straight (e.g., unbent) configuration. Advantageously, such a configuration may provide an articulation movement element that may articulate the distal tip / camera in three dimensions.

[0121] One or more hinges of the articulation section can be living hinges. In some implementations, the articulation section is a one-piece articulation section. The one-piece articulation section can be formed from a single material. The one-piece articulation section structure can be made using injection molding or additive material manufacturing techniques. Alternatively, the one-piece articulation section can be formed by extruding a cylinder and cutting the cylinder tube with a knife, laser, milling tool, water jet, or other material removal mechanism to form the living hinges. As will be appreciated, the bending and torque fidelity characteristics of the articulation section can be configured by the angle of the cuts / recesses that define the hinges and / or the distance between adjacent hinges.

[0122] In another configuration, the articulation section structure may include a plurality of individual links that, when assembled, define a plurality of concentric tab-and-socket pivot joints that function as hinges. As discussed above, each hinge (e.g., tab and socket pivot joint) may provide rotation in a single plane about a pivot axis. Additionally, the plurality of concentric tab-and-socket joints may be staggered in two perpendicular planes with the central axes of all links aligned to provide multiple degrees of freedom for the articulation section.

[0123] An outer sheath can be disposed about the articulation portion to prevent contaminants from entering one or more hinges and / or lumens defined by the articulation portion. The articulation portion can include a distal cap defining an air / water nozzle, an instrument tube outlet, a camera outlet, and / or an LED outlet.

[0124] The insertion tube assembly and the articulation section can be bonded together (e.g., heat or friction welded, adhesive, etc.) and / or attached together with mating features (e.g., threads) on the contacting surfaces or with a transition tube as shown in the illustrated embodiment. An intermediate surface of the transition tube can be located at the transition between the insertion tube assembly and the articulation section, and the transition tube can be bonded (e.g., crimped or adhesively bonded) to both the insertion tube assembly and the distal articulation section to form a secure attachment. The transition tube can be deformable to allow deflection of the flexible endoscope shaft at the transition.

[0125] The insertion tube assemblies disclosed herein can be manufactured using a continuous (e.g., reel-to-reel) manufacturing process. The braided sleeve can be provided around the outer coil during the continuous manufacturing process. Additionally, the outer sheath can be provided during the continuous manufacturing process. For example, the assembly of the outer coil and its surrounding braided sleeve can be passed through one or more extrusion heads during the continuous manufacturing process to provide the outer sheath on a portion of the insertion tube assembly. Such a process allows for the creation of a smooth outer sheath that is integrally bonded to the outer coil and / or braided sleeve. The outer sheath may have different durometers along a portion of the shaft.

[0126] After placing an outer sheath around the assembly, the shaft may be cut to the desired length and a compression coil and / or articulation wires may be inserted inside the outer coil.

[0127] Advantageously, by providing continuous manufacturing of the insertion tube assembly, the manufacturing cost of the endoscope shaft assembly can be reduced and the manufacturing speed can be increased. Thus, in certain aspects, the present disclosure provides a low-cost flexible endoscope shaft and a method for manufacturing the same. Because the insertion tube assembly can be manufactured continuously, a desired length of the insertion tube assembly, or a portion thereof, can be cut to length after the outer sheath extrusion process or cut from a finished reel. Advantageously, a continuous technique for manufacturing the insertion tube (e.g., a reel-to-reel technique) can avoid using labor-intensive steps to braid and coat the insertion tube in different sections.

[0128] As can be appreciated, the disclosed insertion tube assembly can confine the wiring, tubing and operating wires of the endoscope shaft while having sufficient torsional and compressive strength to advance the articulation assembly through the tortuous vasculature of a patient.

[0129] Further disclosed is an articulation joint including an articulation portion assembly, one or more individual struts, a proximal link including fingers that engage with the compression coil cavity and the interior of the insertion tube, and a distal link having a keyed portion that engages with the distal cap.

[0130] The articulation joint assemblies disclosed herein may comprise a central core having lumens for use for, but not limited to, instrument tubes, air tubes, water tubes, camera wire harnesses, LED wire harnesses, compression coils, steering wires, or any combination thereof. One or more lumens may be located completely within the periphery of the central core and / or have a closed circumference.

[0131] The articulation joint assembly can include a proximal link, a plurality of links, and a distal link, each link having a channel for passing a steering wire (e.g., articulation wire) through a portion of the articulation joint.

[0132] The proximal link can include a compression coil cavity and fingers that engage the interior of the insertion tube for connection to the shaft, and the front end of the proximal link can include means for connecting with a rearward link of the plurality of links to allow articulation movement between the links.

[0133] The articulation assembly may comprise a series of one or more links of the same diameter having a front and a rear face, the rear face being connected to the front face of the preceding link, each means of connection preferably allowing an individual link of the articulation assembly to articulate.

[0134] The articulation section assembly can include an articulation section having a plurality of hinges. Each hinge provides rotation about a pivot axis. The hinge pivot axes can extend transversely to a longitudinal axis of the articulation section. Additionally, the pivot axes of one or more hinges can be in a different plane than the pivot axes of one or more other hinges. For example, the hinge pivot axes can alternately lie in mutually perpendicular planes when the articulation section is in a straight (e.g., unbent) configuration. Advantageously, such a configuration can provide an articulation movement element that can articulate the distal tip / camera in three dimensions.

[0135] One or more hinges of the articulation section can be living hinges. In some implementations, the articulation section is in the form of a one-piece articulation section. The one-piece articulation section can be formed from a single material. The one-piece articulation section structure can be made using injection molding or additive material manufacturing techniques. Alternatively, the one-piece articulation section can be formed by extruding a cylinder and cutting the cylinder tube with a knife, laser, milling tool, water jet, or other material removal mechanism to form the living hinges. As will be appreciated, the bending and torque fidelity characteristics of the articulation section can be defined by configuring the angle of the cuts / recesses that define the hinges and / or the distance between adjacent hinges.

[0136] In another configuration, the articulation section structure may include a plurality of individual links that, when assembled, define a plurality of concentric tab-and-socket pivot joints that function as hinges. As discussed above, each hinge (e.g., tab-and-socket pivot joint) may provide rotation in a single plane about a pivot axis. Additionally, the plurality of concentric tab-and-socket joints may be staggered in two or more perpendicular planes with the central axes of all links aligned to provide multiple degrees of freedom to the articulation section.

[0137] The proximal link can include a rear surface having one or more recesses for capturing a compression coil that engages the proximal link and resists pulling force on the steering wire, a front surface having means for connecting multiple links, and a cylindrical portion.

[0138] The distal link may have a front surface having a keyed portion for engaging the distal cap, a rear surface having means for connecting the plurality of links, and a cylindrical portion. The rear surface may have means for connecting with the front surface of a forward link of the plurality of links to allow articulation movement between the links.

[0139] The articulation joint assembly can include one or more looped steering wires (e.g., a pair of looped steering wires) that eliminate the need for terminating the steering wires (e.g., articulation wires) at the distal link where space is limited.

[0140] A single looped steering wire for single plane steering may have portions held by portions in the distal link 180 degrees apart, with the radial bend of the loop held by one or more portions in the distal cap, thus maintaining an open lumen for passage of the inner tube and control wires. The looped steering wire may be secured to the distal link using either adhesive and / or mechanical means.

[0141] Two looped steering wires for bi-planar steering may be provided with each looped wire held by a section either 90 degrees or 180 degrees apart, with the radial bends of each steering wire held by one or more sections that maintain an open lumen for passage of the inner tube and control wires. The looped steering wires may be secured to the distal link utilizing either adhesive and / or mechanical means. When fully assembled, a pair of looped steering wires may provide four individual wire terminations at the proximal end for applying steering tension to the distal link.

[0142] The links may be manufactured using injection molding or additive material manufacturing techniques. The manufacturing process facilitates the addition of support struts that maintain spacing and alignment between the links to facilitate insertion of steering wires into the steering wire lumens and tubes and / or routing within the central lumen. The struts may ensure that the correct number and type of links are used when assembling the articulation section. When assembled, the struts can be separated from the links at the attachment points to allow the links to articulate.

[0143] One or more isolation struts can be positioned laterally along a portion of the multiple links and individually attached to each link to facilitate alignment of control cables, tools, and inner tubes passing through the lumen of the articulation joint for use with a medical device.

[0144] One or more separation struts can be positioned laterally along the proximal link, multiple links, and a portion of the distal link and attached to each link by one or more connection points to facilitate alignment of control cables, tools, and inner tubes passing through the lumen of the articulation joint.

[0145] Any of the aspects and embodiments of the invention discussed herein may be used independently or in combination with each other. Other aspects, objects, and advantages of the present disclosure will become more apparent from the following detailed description when considered in conjunction with the accompanying drawings. Further aspects, objects, features, aspects, benefits, advantages, and embodiments of the present invention will become apparent from the detailed description and drawings provided herein. [Brief description of the drawings]

[0146] [Figure 1] FIG. 1 illustrates an endoscope assembly. [Diagram 2] FIG. 1 illustrates an endoscope assembly. [Diagram 3] FIG. 1 illustrates an endoscope assembly. [Figure 4] FIG. 1 illustrates an endoscope assembly. [Diagram 5] FIG. 1 illustrates an endoscope assembly. [Figure 6] FIG. 1 illustrates an endoscope assembly. [Figure 7] FIG. 2 is an exploded view of the endoscope assembly of FIG. 1. [Figure 8] FIG. 2 is an exploded view of the endoscope assembly of FIG. 1. [Figure 9] FIG. 2 is an exploded view of the endoscope assembly of FIG. 1. [Figure 10] FIG. 2 is a cross-sectional view of the articulation control and brake portion of the endoscope assembly of FIG. [Figure 11] FIG. 1 illustrates a reusable handpiece of an endoscope assembly. [Figure 12] FIG. 1 illustrates a reusable handpiece of an endoscope assembly. [Figure 13] FIG. 1 illustrates a reusable handpiece of an endoscope assembly. [Figure 14] FIG. 1 illustrates a reusable handpiece of an endoscope assembly. [Figure 15] FIG. 1 illustrates a disposable shaft assembly of an endoscope assembly. [Figure 16]FIG. 1 illustrates a disposable shaft assembly of an endoscope assembly. [Figure 17A] FIG. 2 is a perspective view of a pulley assembly. [Figure 17B] FIG. 17B is an exploded view of the pulley assembly of FIG. 17A. [Figure 17C] FIG. 2 is an exploded schematic view of an articulation shaft and brake shaft associated with the pulley assembly. [Figure 17D] FIG. 2 is an exploded schematic view of a rack and pinion assembly. [Figure 17E] FIG. 2 is an exploded schematic view of a rack and pinion assembly. [Figure 17F] FIG. 2 is an exploded schematic view of a rack and pinion assembly. [Figure 17G] FIG. 2 is an exploded schematic view of a rack and pinion assembly. [Figure 18] A cross-sectional view of the articulation knob brake assembly. [Figure 19] A perspective view of the articulation knob brake assembly. [Figure 20] FIG. 1 is a side view of the articulation knob brake assembly. [Figure 21] An exploded view of the articulation knob brake assembly. [Figure 22] A cross-sectional view of the upper and lower articulation knob and brake portions of the articulation knob-brake assembly. [Figure 23] FIG. 1 is a perspective exploded view of the upper and lower articulation brake lever and the upper and lower articulation brake outer housing. [Figure 24] FIG. 1 is a perspective view of the upper and lower articulation brake lever and the upper and lower articulation brake outer housing. [Diagram 25] FIG. 2 is an exploded perspective view of the upper and lower articulation hubs, the upper and lower articulation brake detents, and the upper and lower articulation brake calipers. [Figure 26]FIG. 1 is a perspective view of the upper and lower articulation brake outer housing and the upper and lower articulation shafts. [Figure 27] FIG. 27 is a perspective view of the upper and lower articulation brake outer housing of FIG. 26. [Figure 28] FIG. 1 is a side view of the articulation knob and brake assembly without the outer housing, upper and lower articulation brake levers, and articulation brake inner housing. [Figure 29] FIG. 1 is a cross-sectional view of the upper and lower articulation brake knob-and-brake assembly in a configuration in which the brake is disengaged from the upper and lower articulation brake outer housing. [Diagram 30] FIG. 13 is a perspective view of the left and right articulation brake outer housings and the left and right articulation shafts. [Diagram 31] FIG. 2 is a perspective view of left and right articulation brake shafts and left and right articulation brake hubs. [Diagram 32] FIG. 32 is a perspective view of the left and right articulation brake shafts and the left and right articulation brake hubs of FIG. 31 . [Diagram 33] FIG. 2 is a schematic diagram of the electrical circuitry of the endoscope assembly. [Diagram 34] FIG. 13 is a schematic diagram of another embodiment of an electrical circuit of an endoscope assembly. [Diagram 35] FIG. 13 is a schematic diagram of another embodiment of an electrical circuit of an endoscope assembly. [Diagram 36] FIG. 1 is an exploded view of the disposable shaft assembly and its fluid paths. [Figure 37] FIG. 1 illustrates a method and apparatus for sterilizing a reusable handpiece using an autoclave. [Figure 38] FIG. 1 illustrates a method and apparatus for sterilizing a reusable handpiece using ultraviolet light from a quartz lamp. [Figure 39]FIG. 1 illustrates a method and apparatus for sterilizing a reusable handpiece using ultraviolet light from a light emitting diode (LED). [Figure 40A] FIG. 1 is a perspective view of a console including an endoscope, a cartridge, and a control valve assembly; [Figure 40B] FIG. 13 is a perspective view of another embodiment of a console including an endoscope, a cartridge, and a control valve assembly. [Figure 41A] FIG. 40B is a perspective view of the console of FIG. 40A. [Figure 41B] FIG. 40C is a perspective view of the console of FIG. 40B. [Figure 42A] FIG. 40B is a perspective view of the control valve assembly of FIG. 40A. [Figure 42B] FIG. 40C is a perspective view of the control valve assembly of FIG. 40B. [Figure 43A] FIG. 40B is a front view of the control valve assembly of FIG. 40A. [Figure 43B] FIG. 40C is a front view of the control valve assembly of FIG. 40B. [Figure 44A] FIG. 40B is a right side view of the control valve assembly of FIG. 40A. [Figure 44B] FIG. 40C is a right side view of the control valve assembly of FIG. 40B. [Figure 45A] FIG. 40B is a top view of the control valve assembly of FIG. 40A. [Figure 45B] FIG. 40C is a top view of the control valve assembly of FIG. 40B. [Figure 46A] FIG. 40B is a rear view of the cartridge of FIG. 40A. [Figure 46B] FIG. 40C is a rear view of the cartridge of FIG. 40B. [Figure 46C] FIG. 40C is a rear view of the cartridge of FIG. 40B with the cover removed. [Figure 47A] FIG. 40B is a front right perspective view of the cartridge of FIG. 40A. [Figure 47B] FIG. 40C is a front right-hand perspective view of the cartridge of FIG. 40B. [Figure 48A] FIG. 40B is a rear left perspective view of the cartridge of FIG. 40A. [Figure 48B]FIG. 40C is a rear left perspective view of the cartridge of FIG. 40B. [Figure 49A] FIG. 40B is an exploded perspective view of the cartridge and control valve assembly of FIG. 40A. [Figure 49B] FIG. 40C is an exploded perspective view of the cartridge and control valve assembly of FIG. 40B. [Figure 50A] FIG. 40B is a perspective view of a cartridge firmly inserted into the control valve assembly of FIG. 40A. [Figure 50B] FIG. 40C is a perspective view of the cartridge firmly inserted into the control valve assembly of FIG. 40B. [Figure 51] FIG. 2 is a schematic diagram of the fluid portion of the endoscope system. [Figure 52] FIG. 2 is a schematic diagram of the electrical portion of the endoscope system. [Figure 53] FIG. 1 is a schematic diagram of a sealed medical package containing a sterile cartridge and a sterile disposable shaft assembly. [Figure 54A] FIG. 13 is a perspective view of another embodiment of a console including two endoscopes, two cartridges, and two control valve assemblies. [Figure 54B] FIG. 54B is a perspective view of another embodiment of FIG. 54A. [Figure 55] 1 is a perspective view of an endoscope assembly having a latch mechanism in a latched state; FIG. [Figure 56] FIG. 56 is a perspective view of the endoscope of FIG. 55 in an unlatched state. [Figure 57] FIG. 56 is a perspective view of the endoscope of FIG. 55 in an unlatched and separated state. [Figure 58] FIG. 58 is an enlarged perspective view of the endoscope of FIG. 57. [Figure 59A] FIG. 1 is a perspective view of a packaging system for medical products. [Figure 59B] FIG. 59B is a perspective view of the packaging system of FIG. 59A having two bags. [Figure 60] FIG. 59B shows the packaging system of FIG. 59A with a portion of the cover peeled away from the top of the tray to reveal a recess defined in the tray. [Figure 61]FIG. 59B is a cross-sectional view of a tray of the packaging system of FIG. 59A placed on a cart. [Figure 62] FIG. 59B shows a waste bag of the packaging system of FIG. 59A. [Figure 63] FIG. 59B shows the packaging system of FIG. 59A packaged within a medical product box. [Figure 64] FIG. 64 illustrates a medical product box as shown in FIG. 63 packaged within a shipping box. [Figure 65] FIG. 59B shows the packaging system of FIG. 59A with the cover and medical product removed. [Figure 66] FIG. 63 shows the disposal bag of FIG. 62 with a used medical product inserted therein. [Figure 67] FIG. 59B shows a tray of the packaging system of FIG. 59A being reused after use. [Figure 68] FIG. 1 is an isometric view of a reusable endoscope having mechanical valves for suction, insufflation, and camera flushing control. [Figure 69] FIG. 1 is an isometric view of a detachable, reusable handpiece having a button that activates an electrical switch that includes an integrated capacitive touch switch. [Figure 70] FIG. 13 illustrates the function of a combined air delivery / camera flush button incorporating a capacitive switch. [Figure 71] FIG. 1 is an exploded isometric view of a detachable, reusable handpiece showing the location of buttons, molded gaskets, switches, control board, and capacitive switch antenna. [Figure 72] FIG. 1 illustrates an endoscope assembly. [Figure 73] FIG. 1 illustrates an endoscope assembly. [Figure 74] FIG. 1 illustrates an endoscope assembly. [Figure 75] FIG. 13 is a rear view of the disposable shaft assembly separated from the reusable handpiece. [Figure 76] FIG. 1 shows a front view of a disposable shaft assembly separated from a reusable handpiece. [Figure 77]FIG. 1 is a cross-sectional front view of a disposable shaft assembly separated from a reusable handpiece. [Figure 78] FIG. 78 is a cross-sectional front isometric view of a disposable shaft assembly separated from a reusable handpiece. [Figure 79] FIG. 1 is a cross-sectional rear isometric view of the articulation knob-brake assembly separated from the pulley assembly. [Figure 80] FIG. 2 is a cross-sectional rear isometric view of the shaft assembly separated from the pulley-and-socket torque transfer assembly. [Figure 81] FIG. 2 is an exploded perspective view of the shaft assembly separated from the pulley-and-socket torque transfer assembly. [Figure 82] FIG. 13 shows the left and right brake shafts separated from the socket torque transmission boss. [Figure 83] FIG. 13 shows the upper and lower articulation shafts separated from the upper and lower articulation pulleys. [Figure 84] FIG. 1 illustrates a pulley and socket torque transfer assembly with steering wires shown. [Figure 85] FIG. 1 is a perspective view of a disposable flexible endoscope shaft assembly. [Figure 86A] FIG. 2 is a perspective view of the insertion tube assembly. [Figure 86B] FIG. 2 is a perspective view of the distal end of the insertion tube assembly. [Figure 87] 1 illustrates an exploded perspective view of the insertion tube assembly. [Figure 88] FIG. 2 is a perspective view of the articulation portion assembly. [Figure 89A] FIG. 2 is an exploded view of the articulation portion assembly. [Figure 89B] FIG. 2 is a partially exploded perspective view of the articulation portion assembly. [Figure 90A] FIG. 13 is a perspective view of a single articulation portion in a straight configuration. [Figure 90B] FIG. 13 is a perspective view of a single articulation portion in a deflected configuration. [Figure 90C] FIG. 2 is a close-up view of a single articulation portion. [Figure 91A] FIG. 90C is a close-up view of the proximal end of the single articulation portion of FIGS. 90A-90C. [Figure 91B] FIG. 92 is a close-up view of the distal end of the integrated articulation portion of FIGS. 90A-91A. [Figure 92] FIG. 2 is a perspective view of an articulation link assembly. [Figure 93A] FIG. [Figure 93B] FIG. 13 is a perspective view of a proximal articulation link. [Figure 93C] FIG. 13 is a perspective view of a distal articulation link. [Figure 94] FIG. 1 is a perspective view of an articulation pull wire and termination ring assembly. [Figure 95] 1 is a flow chart illustrating the steps for manufacturing a single-use flexible endoscope shaft as disclosed herein. [Figure 96] FIG. 1 shows the first part of the manufacture. [Figure 97] FIG. 2 shows the second part of the manufacture. [Figure 98A] FIG. 1 illustrates an articulation joint assembly having one or more isolation struts connected to an articulation part assembly having one or more connection points on each individual articulation link. [Figure 98B] FIG. 1 illustrates an articulation joint assembly having one or more isolation struts connected to an articulation part assembly having one or more connection points on each individual articulation link. [Figure 98C] FIG. 1 illustrates an articulation joint assembly having one or more isolation struts connected to an articulation part assembly having one or more connection points on each individual articulation link. [Fig. 98D] FIG. 1 illustrates an articulation joint assembly having one or more isolation struts connected to an articulation part assembly having one or more connection points on each individual articulation link. [Figure 98E] FIG. 13 shows an articulation joint assembly having one or more isolation struts connected to a proximal link, an articulation portion assembly, and a distal link with one or more connection points on each articulation link. [Fig. 98F] FIG. 13 shows an articulation joint assembly having one or more isolation struts connected to a proximal link, an articulation portion assembly, and a distal link with one or more connection points on each articulation link. [Figure 98G] FIG. 13 shows an articulation joint assembly having one or more isolation struts connected to a proximal link, an articulation portion assembly, and a distal link with one or more connection points on each articulation link. [Fig. 98H] FIG. 13 shows an articulation joint assembly having one or more isolation struts connected to a proximal link, an articulation portion assembly, and a distal link with one or more connection points on each articulation link. [Figure 99] FIG. 13 is an exploded view of the articulation joint, distal cap, and tube assembly. [Figure 100A] FIG. 13 shows a proximal link. [Figure 100B] FIG. 13 shows a proximal link. [Figure 100C] FIG. 13 shows a proximal link. [Figure 101A] FIG. 13 illustrates a distal link. [Figure 101B] FIG. 13 illustrates a distal link. [Figure 101C] FIG. 13 illustrates a distal link. [Figure 102A]FIG. 13 illustrates the distal link and articulation steering wire assembly. [Figure 102B] FIG. 13 illustrates the distal link and articulation steering wire assembly. [Figure 103A] FIG. 1 shows a distal cap. [Figure 103B] FIG. 1 shows a distal cap. [Figure 103C] FIG. 1 shows a distal cap. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0147] In order to facilitate an understanding of the principles of the present invention, reference will now be made to the embodiments illustrated in the drawings and they will be described in specific terms. However, this description is not intended to limit the scope of the invention. Any changes and further modifications in the described embodiments, and any further applications of the principles of the present invention described herein, are contemplated as would normally occur to one skilled in the art to which the invention pertains. It will be apparent to one skilled in the art that some features may not be shown for clarity of description.

[0148] The present disclosure provides an endoscope assembly including a reusable handpiece and a disposable shaft assembly. Figures 1-10 are diagrams illustrating an endoscope assembly 100. More specifically, Figures 1-6 illustrate the endoscope assembly 100 with a reusable handpiece 200 attached to a disposable shaft assembly 400. Figures 7-9 illustrate the endoscope assembly 100 with the reusable handpiece 200 detached from the disposable shaft assembly 400.

[0149] The reusable handpiece 200 is selectively detachable from the disposable shaft assembly 400 and may be used sequentially with multiple disposable shafts, while the disposable shaft assembly may be discarded after a single use. The reusable handpiece and / or the disposable shaft assembly may include a locking feature for selectively locking the reusable handpiece and the disposable shaft assembly to one another. A latch handle 3001 (e.g., a lever) for actuating a latch mechanism that couples the reusable handpiece to the disposable shaft assembly may be disposed on the reusable handpiece and / or the disposable shaft assembly.

[0150] The reusable handpiece may include a handpiece housing 210 supporting an articulation knob and brake assembly 300; a control switch 202 for operating a light, such as a light emitting diode, and / or an irrigation and / or aspiration fluid pathway; one or more navigation switches 203 for controlling a console in communication with the endoscope assembly; and / or an electrical connector 204 for electrically connecting the reusable handpiece to a disposable shaft assembly.

[0151] The disposable shaft assembly may include an insertion tube 401 for insertion into a patient's body, a tube and electrical connector 402 for connection to a console, an access port 403 for selectively accessing the lumen of the disposable shaft assembly (e.g., for sampling such as a biopsy) and / or for delivering fluids through the lumen of the disposable shaft assembly, and / or an electrical connector 404 for electrically connecting the disposable shaft assembly to a reusable handpiece.

[0152] Tubing and / or electrical connectors 402, sometimes referred to as "umbilicals," extend from the endoscope assembly to a console suitable for use with the endoscope assembly. The tubing and / or electrical connectors can extend from a disposable shaft assembly and / or from a reusable handpiece.

[0153] The console (e.g., shown in FIGS. 44-45) can provide electrical power, fluid and / or fluid pressure, vacuum pressure, and / or send and receive electrical signals from the endoscope assembly. The console may include a monitor for visualizing signals received from the endoscope assembly, such as a video image from a camera at the distal end of the disposable shaft assembly.

[0154] The disposable shaft assembly may include one or more pulley assemblies and / or rack and pinion assemblies, as shown in Figures 15-17G. The pulley assembly may include at least one pulley 450 arranged to receive an end of the articulation shaft. Preferably, rotation of an articulation knob associated with the articulation shaft rotates the at least one pulley. Preferably, the at least one pulley and the end of the articulation shaft have a shape (e.g., a coupling) for rotationally coupling the pulley and the articulation shaft to one another. Preferably, the coupling does not rely solely on friction between the articulation shaft and the pulley / pinion. Preferably, the coupling includes a geometric interference between the articulation shaft and the pulley.

[0155] Associated with at least one pulley is an articulation wire or pair of articulation wires 507 (e.g., two separate wires, or one continuous wire with wire segments looped over the pulley and extending from either side of the pulley) configured to bend the distal shaft portion of the disposable shaft assembly upon actuation. The articulation wires may be fixed to the pulley (e.g., tied or secured by anchors 456) and / or extend around at least a portion of the pulley (e.g., wrapped around the pulley). Preferably, the one or more pulley assemblies include two pulleys (one for each articulation shaft) and articulation wires (at least one for each pulley). Preferably, the articulation wires are configured to bend the distal shaft portion in orthogonal planes.

[0156] The one or more pulleys and associated one or more articulation wires may be housed within a pulley housing having a first housing portion 460 and a second housing portion 464. Such housing portions may cooperate to enclose the pulleys and associated articulation wire(s). Preferably, the housing portions prevent the articulation wire(s) from separating from the pulleys. The pulley housing may define an opening 470 for receiving an articulation shaft and / or a brake shaft of the articulation control assembly.

[0157] 17D-17G, the disposable shaft assembly may include a rack assembly 500 for actuating a distal articulation end of the disposable shaft assembly. The rack assembly may be comprised of a rack 502 forming a left and right articulation rack 520 and an up and down articulation rack 524. One or more of the articulation racks may include an articulation pinion 503, 504 and a first articulation rack portion 530 and / or a second articulation rack portion 540 associated with the articulation pinion. Rotation of the articulation pinion causes the one or more articulation rack portions to actuate one or more articulation wires 507 that extend through a portion of the shaft of the disposable shaft assembly. For example, rotation of the upper and lower articulation pinions may move a first articulation rack portion in a first direction (e.g., upward) and a second articulation rack portion in a second direction (e.g., downward) to deflect the distal end region of the disposable shaft assembly either upward or downward.

[0158] In addition to the articulation rack and articulation pinion described above, the rack assembly may include an articulation coil termination block 505 that receives one or more articulation coils 506 wound around respective articulation pull wires 507 connected to the articulation rack 502. The articulation pull wires may be attached to the articulation rack by articulation pull wire adhesive 508 and / or articulation pull wire crimp tubes 509. The rack assembly may include a housing 501 arranged to hold the rack and pinion and restrict the rack to translational movement.

[0159] When the reusable handpiece is attached to the disposable shaft assembly, the articulation knob and brake assembly of the reusable handpiece engages the rack assembly of the disposable shaft assembly such that rotation of one or more knobs of the articulation knob and brake assembly actuates one or more components relative to the rack assembly. For example, the articulation knob and brake assembly can engage with pinions of the rack assembly such that rotation of one or more knobs of the articulation knob and brake assembly rotates one or more articulation pinions of the rack assembly to actuate one or more articulation racks and articulation wires of the disposable shaft assembly.

[0160] 18-32, the articulation knob and brake assembly of the reusable handpiece can include up / down articulation knob 313, left / right articulation knob 314, up / down articulation brake 330, and left / right articulation brake 340. In operation, when the reusable handpiece is attached to the disposable shaft assembly, operation of the up / down articulation knobs operates a distal portion of the disposable shaft assembly in a first plane, and operation of the left / right articulation knobs operates a distal portion of the disposable shaft assembly in a second plane transverse to the first plane. Preferably, the second plane is orthogonal to the first plane.

[0161] When the reusable handpiece is coupled to the disposable shaft assembly, operation of the up / down articulation brake lever 305 engages up / down articulation brake 330 which resists rotation of the up / down articulation knob relative to a portion of the endoscope assembly, such as the reusable handpiece housing 210. Operation of the left / right articulation brake knob 319 engages left / right articulation brake 340 which resists rotation of the left / right articulation knob relative to a portion of the endoscope assembly, such as the disposable shaft assembly housing 440.

[0162] The reusable handpiece and disposable shaft assemblies may also be adapted to engage one another. For example, the reusable handpiece assembly may define a recess 220 arranged to receive a portion of the disposable shaft assembly, or vice versa. In many embodiments, the recess of the reusable handpiece assembly arranged to receive a portion of the disposable shaft assembly may be provided on a side of the reusable handpiece assembly opposite a side having the knob of the articulation knob and brake assembly. Either the reusable handpiece assembly or the disposable shaft assembly may partially and / or completely surround at least a portion of the other on two or more opposing sides.

[0163] A portion of the disposable shaft assembly may be adapted to be received by the reusable handpiece along a direction parallel to or transverse to the longitudinal axis of the reusable handpiece or disposable shaft assembly, or vice versa. For example, the reusable handpiece may receive the disposable shaft assembly along a direction perpendicular to the longitudinal axis 250 of the reusable handpiece. In many embodiments, when the reusable handpiece and the disposable shaft assembly are mated together, the disposable shaft assembly is moved relative to the reusable handpiece along a direction parallel to the axis of rotation 350 of the articulation knob and brake assembly.

[0164] When the reusable handpiece assembly is attached to the disposable shaft assembly, the articulation knob and brake assembly cooperates with the disposable shaft assembly to articulate a distal portion of the disposable shaft assembly and / or resist rotation of one or more articulation knobs relative to the endoscope assembly. For example, as discussed in more detail elsewhere herein, one or more articulation shafts 302, 303 and / or brake shaft 301 of the articulation knob and brake assembly may engage a rack assembly and / or a housing of the disposable shaft assembly. As shown in FIG. 10, one or more shafts of the articulation knob and brake assembly extend through the rack assembly and engage a housing of the disposable shaft assembly on an opposite side of the rack assembly from the articulation knob and brake assembly.

[0165] As shown in Figures 13 and 14, in many embodiments, a portion of the articulation knob and brake assembly extends into a recess in the reusable handpiece that is positioned to receive a portion of the disposable shaft assembly.

[0166] 18-32, the articulation knob and brake assembly is shown in greater detail. With respect to control of up and down articulation by the articulation knob and brake assembly, the up and down articulation knob 313 is supported on the up and down articulation brake outer housing 312. Disposed within the up and down articulation brake outer housing 312 are the articulation brake inner housing 307, the articulation brake position detents 308, the articulation brake springs 309, the up and down articulation brake calipers 310, and the articulation brake friction discs 311.

[0167] Connected to the articulation brake inner housing 307 are upper and lower articulation brake levers 305. Extending through the upper and lower articulation brake levers 305 are upper and lower articulation hubs 304 and upper and lower articulation shafts 303. Disposed within the articulation brake inner housing 307 are the upper and lower articulation hubs 304, which support articulation brake position detents 308 and upper and lower articulation brake calipers 310. The upper and lower articulation hubs 304 are rotationally fixed relative to the housing 210 of the reusable handpiece 200, which in turn fixes the rotation of the articulation brake position detents 308 and upper and lower articulation brake calipers 310 relative to the housing of the reusable handpiece.

[0168] As the upper and lower articulation brake levers 305 rotate relative to the upper and lower articulation hubs 304, the articulation brake inner housing 307 rotates relative to the articulation brake position detents 308 and the upper and lower articulation brake calipers 310. When rotated in a first direction, a pin 318 extending from the upper and lower articulation brake inner housing 307 toward the upper and lower articulation brake calipers 310 engages an angled surface 360 ​​on the upper and lower articulation brake calipers, moving the articulation brake caliper 310 axially toward the articulation brake spring 309 compressing the articulation brake spring 309. Upon rotation in the second direction, the pin moves the angled surface 360 ​​causing the articulation brake spring 309 to urge the upper and lower articulation brake calipers 310 towards the articulation brake friction discs 311 and the upper and lower articulation brake outer housing 312, compressing the articulation brake friction discs 311 between the upper and lower articulation brake calipers 310 and the upper and lower articulation brake outer housing 312. This contact between the stationary (relative to the reusable handpiece) upper and lower articulation brake calipers 310, the articulation brake friction discs 311 and the upper and lower articulation brake outer housing 312 creates a resistance to rotation of the upper and lower articulation knobs 313, which are supported on the upper and lower articulation brake outer housing 312, relative to the reusable handpiece 200.

[0169] Because the rotation of the upper and lower articulation brake position detents 308 is fixed relative to the housing of the reusable handpiece via the upper and lower articulation brake hubs 304, rotation of the articulation brake inner housing 307 relative to the housing also causes the articulation brake inner housing 307 to rotate relative to the upper and lower articulation brake position detents 308. The upper and lower articulation brake position detents 308 may be arranged to hold the upper and lower articulation brake inner housing 307 in one or more positions. For example, the detents may hold the upper and lower articulation brake inner housing in a first position where braking resistance is applied by the interaction of the upper and lower articulation brake friction discs between the upper and lower articulation brake calipers and the upper and lower articulation brake outer housing, and / or in a second position where no braking resistance is applied. The brake inner housing and / or detents may be arranged to hold the upper and lower articulation brake inner housing in any of a number of positions to provide an adjustable level of rotational resistance to the articulation control (e.g., articulation control knob).

[0170] An upper and lower articulation shaft 303 extends through the center of the upper and lower articulation brake hub. The upper and lower articulation shaft 303 has a first end 370 that is rotationally fixed relative to the upper and lower articulation brake outer housing. A second end 372 of the upper and lower articulation shaft 303 interfaces with the rack assembly of the disposable shaft assembly. For example, the second end of the upper and lower articulation shaft may be attached to the upper and lower articulation pulley / pinion such that rotation of the upper and lower articulation shaft rotates the upper and lower articulation pulley / pinion. In this manner, rotation of the upper and lower articulation knob rotates the upper and lower articulation brake outer housing, which in turn rotates the upper and lower articulation shaft, which in turn rotates the upper and lower articulation pulley / pinion, which in turn actuates the upper and lower articulation wires.

[0171] For left and right articulation, the structure and operation of the left and right articulation knob and brake assemblies are the same as the up and down articulation knob and brake assemblies, with the following exceptions: the left and right articulation brake hub 317 is fixed for rotation relative to the disposable shaft assembly housing 440, and such rotation is fixed via the left and right articulation brake shaft 301 which extends through the left and right articulation shaft 302. As with the up and down articulation knob and brake assemblies, the left and right articulation knob 314 is supported by the left and right articulation brake outer housing 315, which includes the articulation brake friction disc 311, the left and right articulation brake caliper 316, the articulation brake spring 309, the articulation brake position detent 308, and the articulation brake inner housing 307.

[0172] A left and right articulation shaft 302 extends through the left and right articulation brake knob 314 and the left and right articulation brake outer housing 315. The left and right articulation shaft 302 has a first end 380 that is rotationally fixed to the left and right articulation brake outer housing 315 and a second end 382 that engages a pulley / pinion assembly of the disposable shaft assembly (e.g., the second end rotatably fixed to the left and right articulation pinion of the rack assembly) such that rotation of the left and right articulation brake knob rotates the left and right articulation brake outer housing, which in turn rotates the left and right articulation brake shaft, which rotates the left and right articulation pulley / pinion and translates the left and right articulation wires.

[0173] The left and right articulation brake shaft 301 extending through the left and right articulation shaft 302 has a first end 390 that is rotationally fixed to the left and right articulation brake hub when the reusable handpiece assembly is attached to the disposable shaft assembly, and a second end 392 that is rotationally fixed relative to the housing of the disposable shaft assembly. Similar to the operation of the top and bottom articulation knob and brake assemblies, rotation of the articulation brake inner housing relative to the left and right articulation brake caliper moves the left and right articulation brake caliper toward or away from the left and right articulation brake outer housing and the brake friction disc located therebetween. The left and right articulation brake knob 319 is rotationally fixed to the left and right articulation brake inner housing 307 such that rotation of the left and right articulation brake knob rotates the left and right articulation brake inner housing relative to the left and right articulation brake hub 317, the left and right articulation brake caliper 316, and the left and right articulation brake position detents 308. Thus, when the left and right articulation brakes are engaged, the left and right articulation brake calipers and brake friction discs resist rotation of the left and right articulation brake outer housing and left and right articulation knobs relative to the left and right articulation brake shaft and disposable shaft assembly.

[0174] The second end of the left and right articulation brake shaft may be slidably engaged with a housing of the disposable shaft assembly to rotationally secure the left and right articulation brake shaft thereto. Left and right articulation shafts are circumferentially disposed about the left and right articulation brake shaft, the second end of the left and right articulation shafts being positioned to engage left and right articulation pulleys / pinions associated with the left and right articulation wire(s). Also circumferentially disposed about the left and right articulation shafts are upper and lower articulation shafts, the second ends of the upper and lower articulation shafts being positioned to engage upper and lower articulation pulleys / pinions associated with the upper and lower articulation wire(s).

[0175] As shown in FIG. 21, the articulation knob and brake assembly may include a number of O-rings 399 that reside between the various components when assembled.

[0176] 23 and 24, the upper and lower articulation brake lever can have a surface 900 configured to engage a surface 902 of the upper and lower articulation inner housing such that rotation of the upper and lower articulation brake lever rotates the upper and lower articulation brake inner housing relative to the housing of the reusable handpiece assembly. Preferably, the shape of the surface 900 engages the shape of the surface 902 during rotation. The upper and lower articulation brake inner housing can define one or more openings 906 arranged to receive the cross pin 318 that engages the angled surface 360 ​​of the upper and lower articulation brake caliper 310. Additionally, the inner surface 910 of the upper and lower articulation brake inner housing can include a recess or protrusion arranged to engage a detent spring (not shown). The upper and lower articulation brake lever and the upper and lower articulation brake inner housing define an opening 920 for receiving the upper and lower articulation hub.

[0177] 25, the upper and lower articulation hub 304 has a portion 930 that extends through the upper and lower articulation brake position detents 308 and the upper and lower articulation brake calipers 310. Preferably, the portion 930, the upper and lower articulation brake position detents 308, and / or the upper and lower articulation brake calipers have a cross-sectional geometry that locks the upper and lower articulation brake position detents, the upper and lower articulation brake calipers, and / or the upper and lower articulation brake hubs from rotation relative to one another.

[0178] 26, the upper and lower articulation brake outer housing 312 is shown engaged and rotationally fixed relative to the upper and lower articulation shaft 303. The upper and lower articulation brake outer housing has a portion 940 arranged to rotationally secure the upper and lower articulation knobs thereto (e.g., via a recess arranged to receive a protrusion on the upper and lower articulation knobs, or vice versa).

[0179] Referring now to FIG. 27, the inside of the upper and lower articulation brake outer housing is shown as having an inner friction surface 950 positioned to engage the upper and lower articulation brake friction discs when the upper and lower articulation brakes are engaged.

[0180] Referring to FIG. 28, when the upper and lower articulation brake lever rotates relative to the housing of the reusable handpiece, the upper and lower articulation brake inner housing rotates with the upper and lower articulation brake lever, moving a pin extending from an opening in the upper and lower articulation brake inner housing against the upper and lower articulation brake caliper. The pin moves along an inclined surface of the upper and lower articulation brake caliper, causing the upper and lower articulation brake caliper to move along the upper and lower articulation brake hub in cooperation with the upper and lower articulation brake spring. When the upper and lower articulation brake is moved from a disengaged state to an engaged state, the upper and lower articulation brake caliper presses the upper and lower articulation brake friction disc against the upper and lower articulation brake outer housing (compressing the upper and lower articulation brake friction disc). When the upper and lower articulation brakes are disengaged from an engaged state, the upper and lower articulation brake calipers move away from the upper and lower articulation brake housing and the upper and lower articulation brake friction discs, compressing (e.g., further compressing) the upper and lower articulation brake springs. Figure 29 shows the upper and lower articulation brakes in a disengaged state with a gap 394 between the upper and lower articulation brake friction discs and the inner friction surface 950 of the upper and lower articulation brake outer housing.

[0181] The upper and lower articulation brake inner housing can have a detent recess or protrusion that engages one or more protrusions or recesses of the upper and lower articulation brake position detent. Such a configuration can lock the upper and lower articulation brake lever in one or more positions and / or provide a tactile and / or audible indication that the upper and lower articulation brake has entered and / or left one or more states or positions.

[0182] The left and right articulation knob and brake assembly functions in a manner similar to the up and down articulation knob and brake assembly, except that the left and right articulation brake hub is rotationally fixed relative to the housing of the endoscope assembly by a left and right articulation brake shaft that extends centrally through the left and right articulation shaft and the up and down articulation shaft.

[0183] Referring to FIG. 30, the left and right articulation brake outer housings and the left and right articulation shafts are shown assembled and rotationally fixed relative to one another.

[0184] 31 and 32 show the left and right articulation brake shaft 301 within the left and right articulation brake hub 317. The left and right articulation brake shaft 301 has a first end 390 that is received and rotationally fixed within the left and right articulation brake hub 317. A second end 392 of the left and right articulation brake shaft is positioned to engage the housing 240 of the reusable handpiece assembly and rotationally fix the left and right articulation brake shaft relative to the disposable shaft assembly when the reusable handpiece assembly and disposable shaft assembly are combined. Thus, when the reusable handpiece assembly is attached to the disposable shaft assembly, the left and right articulation brake hub is rotationally fixed relative to the housing of the disposable shaft assembly.

[0185] 33-35, exemplary wiring diagrams for an endoscope assembly are provided. The reusable handpiece may include an electronics module 205, such as a circuit board, that supports and / or electrically connects to one or more of the control switches 202 and / or navigation switches 203 of the reusable handpiece. Electrically connected to the electronics module is a connector 204 for electrically connecting the reusable handpiece to the disposable shaft assembly when the reusable handpiece and disposable shaft assembly are attached to one another.

[0186] The disposable shaft assembly includes a corresponding electrical connector 404 configured to electrically connect the disposable shaft assembly to the reusable handpiece assembly when the disposable shaft assembly is attached to the reusable handpiece assembly. The disposable shaft assembly's electrical connector can communicate with the optical sensor module 408, the optical sensor 409, and / or the LEDs 410 via conductors 411 on the disposable shaft assembly. The disposable shaft assembly may include conductors that extend to the console (e.g., through the umbilical 402) to transmit image and / or control data, etc. to the console.

[0187] Figures 33 and 34 show an embodiment in which tubing and / or electrical connector 402 (e.g., umbilical) extends from the disposable shaft assembly to the console. While not limited to the arrangements of Figures 33 and 34, these figures show that the optical sensor module 408 may be located outside the housing of the disposable shaft assembly (e.g., Figure 33) or inside the housing of the disposable shaft assembly (e.g., Figure 34). Figure 35 shows an embodiment in which tubing and / or electrical connector (e.g., umbilical) including electrical conductors 206 extends from the reusable handpiece assembly to the console.

[0188] 36 is an exploded view of a disposable shaft assembly and its exemplary fluid circuit 413. As described above, the disposable shaft assembly includes a shaft for insertion into a patient's body and may include tubing and / or electrical connectors 402 (e.g., umbilicals) that extend to a console. Within the disposable shaft assembly, a camera flushing fluid channel 414, an insufflation fluid channel 415, a tissue flushing fluid channel 418, a biopsy / incision fluid channel 419, and / or a sample port fluid channel 422 may be provided. One or more of the fluid channels may be combined (e.g., a combination of camera flushing and insufflation channels 417) and / or connected, such as with a T-joint 416 or Y-joint 421, to reduce the number of working lumens that extend through the insertion shaft of the disposable shaft assembly.

[0189] Referring now to Figures 37-39, Figure 37 illustrates an apparatus and method useful for sterilizing a reusable handpiece assembly. Figure 37 illustrates an autoclave apparatus 800 suitable for heating a reusable handpiece assembly to a temperature sufficient to sterilize it. Figure 38 illustrates a method of sterilizing a reusable handpiece assembly using ultraviolet light. Such ultraviolet light irradiation can be provided by a quartz lamp 801. As shown in Figure 39, sterilization of a reusable handpiece assembly can also be achieved by ultraviolet light irradiation provided by a light emitting diode (LED) 802.

[0190] The present disclosure further provides a system comprising an endoscope assembly, a cartridge 1200, and a console 1000. Referring initially to the 'A' series of Figures 40-50, Figure 40 generally illustrates a system operably connected, preferably for use by a medical professional. The system may include a cartridge 1200 inserted into a control valve assembly 1100 of the console 1000. The cartridge 1200 may be connected to the endoscope 100 by an umbilical 402. For example, the cartridge 1200 may be connected to a disposable shaft assembly 400 of the endoscope by one or more fluid conduits and / or electrical conductors.

[0191] The cartridge 1200 can be connected to a support device. The support device can be an irrigation pump, an insufflator, and / or a vacuum pump (e.g., stand-alone or centralized). The cartridge can be adapted to be disposed between an endoscope and the support device.

[0192] The console 1000 is shown in more detail in Figure 41. The console 1000 may include a user interface 1004 that allows a user to change various variables of the endoscopic system. In one embodiment, the user interface 1004 may be a touch screen integrated with an electro-visual display. In another embodiment, the user interface may include a keyboard, a mouse, a trackball, and / or a touch-sensitive pointing device, etc.

[0193] The console 1000 may include a control valve assembly 1100 for receiving and actuating the cartridge. The console 1000 may be adapted to provide electrical power, fluid and / or fluid pressure, vacuum pressure, and / or send and / or receive electrical signals to the endoscope assembly. The console 1000 may include a monitor (not shown) for visualizing signals received from the endoscope assembly, such as a video image from a camera at the distal end of the disposable shaft assembly.

[0194] 42-45, the control valve assembly 1100 is shown in more detail. The control valve assembly 1100 can be used to selectively actuate an actuatable portion of a fluid path of a cartridge. The control valve assembly 1100 can include a door 1110, an actuator 1130, and a support structure 1150 including a first surface 1152 and a second surface 1154.

[0195] The door 1110 of the control valve assembly may include a first surface 1112, a second surface 1114, and a side surface 1116. The first surface of the door may include a set of anvils 1118 for providing a counterforce to the actuator 1130 when selectively closing the fluid pathway of the cartridge 1200. In one embodiment, the first surface 1112 of the door includes four anvils 1118.

[0196] The door 1110 may include a latch 1120 engageable with a keeper 1124 of the control valve assembly. The latch may be a lever latch. The door 1110 may provide a compressive force to the cartridge 1200 when the cartridge is held in place on the control valve assembly 1100 with the door 1110 such that the latch 1120 secures the door 1110 in a closed position. Preferably, such compressive force may ensure that electrical spring fingers of the cartridge electrical connector and / or electrical spring fingers of the control valve assembly electrical connector 1144 engage electrical contacts of the other to provide electrical communication between the endoscope and / or electrical conductors of the cartridge and the console electrical conductors.

[0197] The door 1110 may be attached to a first surface of the support structure using a mechanical bearing 1128, such as a hinge, that allows the door to rotate between an open configuration and a closed configuration.

[0198] The actuator 1130 may be a linear actuator or a rotary actuator. The actuator may also be a solenoid. Although it is appreciated that there may be only one actuator, in a preferred embodiment the control valve assembly includes four actuators. The actuators are arranged to actuate valve portions of the fluid pathways within the cartridge to selectively open and / or close the fluid pathways.

[0199] The valve portion of the fluid path may comprise any acceptable valve. For example, the valve portion may comprise a petcock. The valve portion may also comprise a section 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 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 flush valve associated with actuator 1134, an insufflation valve associated with actuator 1136, and / or an insufflation valve associated with actuator 1138.

[0200] The actuator 1130 of the control valve assembly includes an electrical connector 1140 that is received by the console and electrically connects the actuator to the console 1000. When connected to the console 1000, the console 1000 can provide power and user input commands to the actuator 1130 to open or close a fluid path in the cartridge 1200.

[0201] A first surface 1152 of the support structure 1150 includes a keeper 1124 for receiving the latch 1120 and securing the cartridge 1200 to the control valve assembly 1100 having the door 1110. The latch assembly may be used to ensure that the cartridge is inserted in the correct configuration.

[0202] The cartridge 1200 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 cartridge identifier (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 on the cartridge and / or via other means (e.g., RFID, light, and / or mechanical contact).

[0203] The first surface 1152 of the support structure 1150 may include an electrical connector 1144 for forming an electrical connection to an electrical connector of the cartridge. The electrical connection between the control valve assembly of the console and the cartridge may allow the console to receive image and control data (valve / actuator and / or image data) passed from the endoscope through the cartridge to the console. The electrical connection may allow the console to provide power to light emitting diodes (LEDs) of the endoscope assembly.

[0204] 46-48, an exemplary cartridge 1200 is shown in greater detail. The cartridge may be a disposable cartridge. A disposable cartridge may eliminate the need for the use of a permanent valve body contained within a reusable endoscope and / or console. This may advantageously eliminate the need to sterilize a reusable valve after each use.

[0205] The cartridge 1200 has a housing 1210. The housing 1210 can include a first side 1212 and a second side 1214, as well as a top surface 1216 and a bottom surface 1218. The housing 1210 further includes a first fluid side 1220 and a second fluid side 1224 that allow fluid to move in and out of the cartridge housing. The housing 1210 can define one or more fluid pathways, fluid connectors, and / or electrical connectors. For example, the cartridge housing can include an electrical connector 1244 that electrically communicates with electrical conductors of the endoscope and can optionally include an optical sensor module 1246 that includes optical sensor calibration data or a unique identifier for the endoscope. The housing 1210 can also include a removal tab 1260 for easy removal of the cartridge 1200 from the control valve assembly 1110 after a single use.

[0206] The housing may include a first fluid path 1232, a second fluid path 1234, a third fluid path 1236, and a fourth fluid path 1238. The fourth fluid path 1238 may have a main portion 1238a extending from the first fluid side 1220 to the second fluid side 1224 of the cartridge housing 1210 and a branch portion 1238b for discharging out of the bottom side 1218 of the cartridge. The cross-section of the fluid path may be larger than the cross-sections of the other fluid paths. The fluid paths may generally form a U-shape within the cartridge housing. The first, second, third, and fourth fluid paths are preferably not in fluid communication with each other within the cartridge.

[0207] 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 one window may be larger than the other windows to accommodate a larger fluid path cross-section.

[0208] The windows 1270a-1270d may be configured to receive an actuator from the console into a chamber 1272 defined by the inner surface of the housing. As described above, the actuator may 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 a cartridge is placed on the control valve assembly and the door is closed, the window aligns with the anvil on the door and the actuator of the control valve assembly. The windows may be arranged to define a geometric shape. For example, as shown, the windows may be diamond shaped.

[0209] The fluid path of the housing is preferably defined by a flexible membrane, which may be flexible medical tubing, a thermoplastic sheet, or the like. The material of the housing is preferably stiffer than the material of the tubing. In a further preferred embodiment, the flexible tubing is made of polyvinyl chloride.

[0210] The first fluid path 1232 can be an aspiration path, the second fluid path 1234 can be an irrigation path (optionally operated by a foot switch), the third fluid path 1236 can be a camera irrigation path, and / or the fourth fluid path 1238 can be an insufflation path. The insufflation path can include a main portion 1238a extending from a first fluid side to a second fluid side of the housing. It can further include a branch portion 1238b for evacuating gas from the patient.

[0211] The fluid paths of the cartridge may include at least one valve portion 1276. However, the second fluid path may not include a valve portion. The fourth fluid path may include two valve portions 1276c, 1276d. As described above, the fluid paths may be defined by a flexible membrane (e.g., a tube). The valve portions may be constructed from the flexible membranes described above.

[0212] The first fluid pathway 1232 may include a first valve portion 1276a extending through a first window 1270a defined by the housing 1210. The first valve portion aligns with a first actuator of the console. The first actuator is operable to selectively close and / or open the first valve portion of the first fluid pathway by extending into the first window.

[0213] The second fluid path 1234 may be one that does not have a valve portion. Preferably, the fluid path that does not have a valve portion is a irrigation path. The irrigation path may optionally include a pump operated by a foot switch.

[0214] The third fluid path 1236 may include a valve portion 1276b extending through a window 1270b defined by the housing 1210. The valve portion aligns with an actuator of the console. The actuator is operable to selectively close and / or open the valve portion of the third fluid path by entering the window.

[0215] The fourth fluid path 1238 may include a main portion 1238a and a branch portion 1238b, as described above. The main portion of the fourth fluid path of the cartridge may include a valve portion 1276c that extends through a window 1270c defined by the housing. The valve portion aligns with an actuator of the console. The actuator is operable to selectively close and / or open the valve portion of the main portion of the fourth fluid path by entering the window.

[0216] The branched portion of the fourth fluid path of the cartridge may include a valve portion 1276d extending through a window 1270d defined by the housing. The valve portion aligns with an actuator of the console. The actuator is operable to selectively close and / or open the valve portion of the branched portion of the fourth fluid path by entering the window.

[0217] As described above, the one or more actuators may be a solenoid configured to extend into a window in the cartridge housing and / or may be configured to contact an anvil on a door of the control valve assembly to form a pinch valve when closed.

[0218] The housing 1210 may further include an electrical connector 1244 for connecting to the electrical connector 1144 of the control valve assembly 1100. 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 be adapted to transmit image and control data provided by the endoscope to the console. The housing electrical connector may be adapted to transmit power from the console to LEDs used by the endoscope inside the patient's body.

[0219] Data and / or power conductors may extend from the cartridge through the umbilical to the endoscope.

[0220] The cartridge may include connectors 1280 on the first fluid side 1220 and / or the second fluid side 1224 for any and / or all of the fluid pathways defined in the cartridge housing. The connectors may extend beyond the cartridge (e.g., the free end of a continuous tube extending beyond the cartridge having a fitting (e.g., a luer fitting)) and / or be part of the cartridge.

[0221] The cartridge may optionally incorporate an optical sensor module 1246 that incorporates camera calibration data and an optical sensor module identifier that is unique to the single-use endoscope and cartridge. The unique optical sensor module identifier allows the console to recognize when the same single-use endoscope and single-use cartridge are used, thus eliminating the potentially hazardous use of non-sterile endoscopes. Additionally, this unique identifier allows the type of endoscope that is connected to the console to be identified. The unique identifier may be incorporated into the printed circuit board.

[0222] Additionally, FIG. 49 shows the cartridge separated from the control valve assembly. As discussed above, the user aligns the window of the cartridge with the actuator of the control valve assembly for insertion. Once inserted, the door can swing over the cartridge to secure the cartridge between the first side of the support structure and the first side of the door. As discussed above, the latch is received by a latch keeper. The latch can be a lever latch, a hasp latch, a toggle latch, a cam lever latch, or the like. In one embodiment, the latch provides a compressive force against the cartridge that secures the cartridge to the console. In a preferred embodiment, this allows spring fingers on the electrical connector of the cartridge to engage a corresponding flat pad electrical connector on the control valve assembly portion of the console, or vice versa, thus creating contact upon placement of the cartridge relative to the console, eliminating the need to connect one or more separate electrical connectors.

[0223] A detailed view of the cartridge inserted into the control valve assembly of the console is shown in Figure 50. As shown, the cartridge is inserted between a first side of the support structure of the control valve assembly and a first side of the door. A first fluid side 1220 of the cartridge is shown as a loose tube that leads to the umbilical and then to the disposable shaft assembly (not shown) of the endoscope.

[0224] 51-52 are schematic diagrams illustrating an example of an endoscopic system. Electrical connections between the cartridge and the disposable shaft assembly are shown in schematic form. The electrical connector 411 may include image data conductors, control data conductors, and / or LED power conductors. The image data conductors and / or control data conductors may allow information to be sent from the endoscope to the cartridge and to the console without any other connection action by the user other than attaching the cartridge to the console. This layout advantageously reduces the number of direct connections and loose wires required for operation of the endoscopic system.

[0225] The insertion tube 401 may include an optical sensor module that provides information readable by the console and / or projects an image, such as a video image from the end of the insertion tube onto a monitor. The video image may be infrared, thermal, or visible light. The insertion tube 401 may include an LED wire to provide power to an LED at the end of the insertion tube.

[0226] The insertion tube may include fluid paths as described herein defined by tubes, such as suction tube 1232, tissue irrigation tube 1234, camera irrigation tube 1236, and / or pneumoperitoneum tube 1238. The camera irrigation tube allows the user to clear debris from the field of view while using the instrument. Often this involves removing excess blood so that the desired location can be visualized. The suction tube allows for the aspirating of small material or various secretions from the patient's body. The camera irrigation tube 1236 and the pneumoperitoneum tube 1238 may be joined by a Y-fitting. Various combinations are envisioned by the applicant to minimize the number of tubes required for the insertion tube.

[0227] The second fluid side of the cartridge may be connected to a support device, which may include an irrigation pump, an insufflator, and / or a vacuum pump (standalone or central). The cartridge may provide fluid communication between the endoscope and the support device.

[0228] The disposable shaft assembly includes an insertion tube, an umbilical 402 connected to the cartridge and thus to the console, an access port for selectively accessing the lumen of the disposable shaft assembly (e.g., to take a sample such as a biopsy) and / or for supplying fluids through the lumen of the disposable shaft assembly, and / or an electrical connector for electrically coupling the disposable shaft assembly to a reusable handpiece.

[0229] The umbilical can extend from the cartridge to the disposable shaft assembly of the endoscope. Several fluid paths and / or electrical wiring extend through the umbilical to the distal tip of the insertion tube. The fluid paths can include a path 1232 for suction, a path 1234 for tissue irrigation, a path 1236 for camera irrigation, and / or a path 1238 for pneumoperitoneum. The fluid paths can be valve-free from the distal tip of the endoscope to the end of the umbilical. The fluid paths can include valves only in the cartridge.

[0230] Preferably, the one or more fluid pathways are defined by a monolithic tube extending from the disposable shaft assembly to the cartridge, and more preferably, the monolithic tube extends through the cartridge and out to the second fluid side of the cartridge.

[0231] The camera irrigation fluid pathway and the pneumoperitoneum fluid pathway may also be combined by a T-piece in the disposable shaft assembly to form a combined camera irrigation and pneumoperitoneum fluid pathway 1240. This allows pressure from the pneumoperitoneum to be used to force water from a water source through the camera irrigation fluid pathway and out the distal end to clear the camera lens of any debris that may have collected during the procedure.

[0232] The umbilical may further include image data conductors 1300, control data conductors 1304, and / or LED power conductors 1308. The image data conductors and / or LED power conductors may extend through the disposable shaft assembly to the distal tip of the insertion tube. The image data conductors may enable captured image data to be sent from the camera to the console. The LED power conductors may provide power from the console to the LEDs at the distal tip of the insertion tube to provide illumination for the procedure. The control data conductors enable communication of control data from a controller of the reusable handpiece to the cartridge and, in turn, to the console.

[0233] 53 shows the disposable shaft assembly, umbilical, and cartridge sterile sealed in a medical packaging, such as a medical tray. The cartridge and disposable shaft assembly may be connected using the umbilical in the packaging, or in some cases may be connected at a later time by medical personnel.

[0234] The cartridge 2200 and control valve assembly 2100 illustrated in the 'B' series of Figures 40-50 and Figure 46C are similar to the cartridge 1200 and control valve assembly 1100 illustrated in the 'A' series of Figures 40-50 described above. The 'B' series of Figures 40-50 and Figure 46C illustrate the control valve assembly 2100 and cartridge 2200 that eliminate the need for a door, for example, by relocating the anvil from the door to the cartridge. Eliminating the door reduces the number of steps required to both install and remove the fluid control cartridge. Eliminating the door reduces the number of parts and interfaces that can become contaminated with dirt or fluids and require cleaning. Additionally, eliminating the door reduces the risk that someone moving around the unit may unintentionally come into contact with the console, which could cause the console to become dislodged from the cart or cause discomfort to the person.

[0235] A doorless cartridge 2200 and a control valve assembly 2100 are shown in the 'B' series of Figures 40-50. The control valve assembly 2100 may include a ledge surface 2110 and a latch 2120. The cartridge 2200 may include a ledge surface 2210 and a latch receiver 2220. In the alternative, the control valve assembly may include the latch receiver portion and the cartridge may include the latch. When the cartridge is received by the control valve assembly, the latch contacts the latch receiver portion to secure a first end of the cartridge to the control valve assembly. Separately, and opposite the latch and latch receiver portion, 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.

[0236] The cartridge may include an anvil 2218 similar to the anvil described in the door-controlled valve assembly example above. The anvil 2218 is configured to provide a counterforce to the actuator when selectively closing a fluid path of the cartridge. Preferably, the anvil 2218 is disposed within a window defined in the cartridge.

[0237] 54A and 54B show another example of a console having a first cartridge, a second cartridge, a first endoscope, and a second endoscope. The first cartridge and the second cartridge can be securely inserted into the first and second control valve assemblies of the console, respectively. Although the console is shown with first and second control valve assemblies, the console may include any number of control valve assemblies, each capable of receiving an independent cartridge. The first control valve assembly can receive the first cartridge, and the second control valve assembly can receive the second cartridge. Not all control valve assemblies need to receive cartridges during every medical procedure.

[0238] As shown, each cartridge may be connected to a separate set of support instruments and to one independent medical device, such as an endoscope. Non-limiting examples of types of endoscopes that may be used include gastroscopes, colonoscopes, sigmoidoscopes, duodenoscopes, and cholangiopancreatoscopes. Depending on the procedure being performed, the endoscopes may be the same type of endoscope or two or more different types of endoscopes, such as a duodenoscope and a cholangiopancreatoscope used during an endoscopic retrograde cholangiopancreatography (ERCP) procedure. In use, the first and second endoscopes may be secured together by straps, zip ties, or the like. The handle of the first endoscope may be configured to engage with the handle of the second endoscope. The shaft of the second endoscope may be inserted into and extend the length of the shaft of the first endoscope, such as a cholangiopancreatoscope inserted into the shaft of a duodenoscope. This advantageously allows one user to control one or more endoscopes at a time during a procedure.

[0239] The duodenoscope is sometimes known as the first endoscope or mother endoscope. The smaller cholangiopancreatic endoscope is sometimes known as the second endoscope or daughter endoscope. During surgery, the larger mother endoscope may be inserted through the patient's mouth and aimed at the duodenum. The daughter endoscope may then move in the patient's bile duct. The daughter endoscope may have its own fluid flow path, LEDs and / or camera.

[0240] The first control valve assembly and the second control valve assembly are configured to operate independently and / or in a master-slave relationship. The first endoscope or mother endoscope may be the master controller and the second endoscope or daughter endoscope may be the slave controller. In this configuration, the controller of the master endoscope may control the fluidic functions (e.g., image control and / or LEDs) of one or more of the slave endoscopes. The master endoscope may control the function of the fluidic pathways 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 actuators as described herein. The first endoscope may further control the function of the second endoscope (e.g., activation of 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 from the second control valve assembly to the cartridge of the second endoscope). For example, the control valve assembly may provide electrical signals to the LEDs and / or camera of the second endoscope based on signals received from the first endoscope. Such a configuration may further allow multiple endoscopes to be set up and utilized for a procedure at once, eliminating or reducing much of the setup time typically required to exchange one endoscope for another, and / or eliminating or reducing the need for additional equipment, such as multiple control consoles.

[0241] The control valve assemblies, endoscopes, cartridges, consoles, fluid pathways, electrical conductors, functions, and operations described and illustrated herein apply equally to the 'A' series of embodiments of Figures 40-50 and the 'B' series of embodiments of Figures 40-50, except that the 'B' series consoles are doorless and the 'B' series cartridges include latches and / or latch receivers. Thus, any discussion of the control valve assemblies, endoscopes, and cartridges may refer to any of the cartridge or endoscope embodiments herein and are applicable to both the 'A' series (with doors) and B series (without doors) devices.

[0242] Due to the various image sensors and necessary fluid control required by different types of endoscopes, the number and / or type of fluid paths and electrical conductors used in each cartridge may vary. Adaptation to image sensor variations may be made by a video processing unit that can be adapted to the particular type of optical sensor incorporated in the connected endoscope. The type of optical sensor may be associated with a unique identifier that is communicated to the console via the cartridge by, for example, a port control protocol or an electrical signal associated with the endoscope. In the case of fluid path control, the unique identifier may cause the console to turn off the function of a particular actuator on the control valve assembly. Additionally, depending on the type of endoscope connected, one or more fluid paths may be completely eliminated from the cartridge.

[0243] The console is shown with a touch screen user interface, although the user interface may be any suitable input / output device.

[0244] 55-58 show an endoscope assembly including a coupler for selectively securing a reusable handpiece assembly to a disposable shaft assembly. The coupler can include a first portion on the reusable handpiece assembly and a second portion on the disposable shaft assembly, the first and second portions of the coupler cooperating to hold the reusable handpiece and disposable shaft assembly together in an assembled configuration. The coupler can be positioned to be operated (e.g., connected and / or disconnected) without the use of hand tools (e.g., a screwdriver). The coupler is operable to engage and / or disengage the reusable handpiece assembly from the disposable shaft assembly.

[0245] This embodiment of the endoscope assembly may be any of the embodiments discussed herein that include a reusable handpiece assembly and a disposable shaft assembly. Additionally, the endoscope assembly may be any endoscope that includes two or more separable pieces. As described in various places herein, the reusable handpiece assembly and the disposable shaft assembly each include a handpiece assembly housing and a disposable shaft assembly housing.

[0246] The coupler may be a latch 3000, such as a cam-type draw latch. The latch may be selectively switchable between a latched state and an unlatched state. In the latched state, the latch latches the housing of the handpiece assembly to the housing of the shaft assembly. When moved from the latched state to the unlatched state, the latch may apply a separation force that separates the housing of the handpiece assembly and the housing of the shaft assembly.

[0247] The handpiece assembly may be a reusable handpiece assembly and the shaft assembly may be a disposable shaft assembly.

[0248] The latch may include a lever 3001. The lever is pivotable between a first position in a latched state (shown in FIG. 55) and a second position in an unlatched state (shown in FIG. 56).

[0249] The latch may further include a latching surface 3004 and an unlatch surface 3008. In the latched state, the latching surfaces hold the housing of the hand piece in close proximity to the housing of the shaft assembly. When moved from the latched state to the unlatched state, the unlatch surfaces apply a separation force to separate the housings.

[0250] The at least two-piece endoscope assembly can include a biasing member 3030 and a latch displaceable between a latched state and an unlatched state, such as any of the latches disclosed herein. The biasing member applies a biasing force to bias the handpiece assembly housing and the shaft assembly housing toward or away from each other. The latch can be configured to apply a force greater than the biasing member force that opposes the direction of the biasing member force to urge the housings away or toward each other. For example, the biasing member can be configured to urge the housings toward each other and the latch can be configured to urge the housings away from each other. In an alternative example, the biasing member can be configured to urge the housings away from each other and the latch can be configured to urge the housings toward each other. The biasing member can be a spring, a magnet, and / or a pressure chamber, to name a few non-limiting examples. The pressure chamber can be a piston cylinder (e.g., pneumatic), a compressible bladder, and / or a suction cup.

[0251] More specifically, the latch may include a latch portion 3002 and a latch receiving portion 3020 (i.e., a first portion and a second portion). The housing of the reusable handpiece assembly and / or the housing of the disposable shaft assembly may define the latch and the latch receiving portion. For example, the latch may be part of the housing of the reusable handpiece assembly, while the latch receiving portion is part of the housing of the disposable shaft assembly. As another example, the latch receiving portion may be part of the housing of the reusable handpiece assembly, while the latch is part of the housing of the disposable shaft assembly.

[0252] The latch portion may include a latch surface, an unlatch surface, and a lever. During the latched state, the latch surface contacts the latch receiving portion to draw the disposable shaft assembly and the reusable handpiece assembly together. During the unlatched state, the latch receiving portion and the latch surface are not in contact.

[0253] The unlatching surface can advantageously assist in separating the disposable shaft assembly and the reusable handpiece assembly. During movement from the latched state to the unlatched state, the unlatching surface contacts the latch receiving portion and applies a force to separate the reusable handpiece assembly and the disposable shaft assembly.

[0254] A lever may control the movement of the latch and unlatch surfaces. The lever may be freely displaceable between a first position in a latched state and a second position in an unlatched state. The lever may be pivotable about a latch pivot 3010 from the latched state to the unlatched state and / or vice versa. The latch and unlatch surfaces may be located on opposite sides of the latch pivot. In such a configuration, during actuation, the latch and unlatch surfaces rotate in opposite directions about the latch pivot.

[0255] The latch portion may further include a seat portion 3014. The latch surface may be a curved surface that forms a U-shaped seat on one side. The opposite leg of the U-shaped seat slopes upward to transition into the unlatch surface. In this configuration, the latch surface and the unlatch surface may be located on opposite sides of the U-shaped seat.

[0256] To latch the reusable handpiece to the disposable shaft, the lever can be pivoted about the latch pivot from a first vertical, unlatched position tilted away from the housing to a second latched position flush with the housing / handle. In these examples, squeezing the lever when it is latched indicates that the reusable handpiece and disposable shaft assemblies are coupled together. The latch can be adapted to indicate when the reusable handpiece and disposable shaft assemblies are properly coupled together. In one embodiment, the latch can provide an audible "click" when the reusable handpiece and disposable shaft assemblies are properly coupled together.

[0257] When the lever is operated to the latched position, the latch surface rotates toward and is received by the latch receiving portion to couple the housing of the disposable shaft assembly to the housing of the reusable handpiece assembly. While the latch surface engages the latch receiving portion, the latch surface helps draw the reusable handpiece and disposable shaft together. The latch surface is inserted into the latch receiving portion and rotated upward so that the latch receiving portion rests within the seat portion. At the same time, the lock release surface can rotate away from the opposing housing piece to allow connection of the two housings.

[0258] To unlatch the reusable handpiece and disposable shaft assemblies, the user pivots the lever away from the surface of the endoscope housing to a second unlatched state. Pivoting the lever vertically away from the housing rotates the latch surface back through and out of the latch receiving portion. At the same time, the unlatch surface rotates back against the latch portion to contact the opposing housing piece. When the lever is pivoted to the unlatched position, the unlatch surface assists in separating the housing of the reusable handpiece assembly and the housing of the disposable shaft assembly. The unlatch surface is rotated to push the opposing housing piece aside.

[0259] As mentioned above, the latch may be biased by a biasing member, such as a spring, into a latched state that may hold the reusable hand piece and the disposable shaft together. The latch mechanism may further include one or more magnets that assist in retaining and / or separating the reusable hand piece from the disposable shaft assembly.

[0260] 59A and 59B show a packaging system 4000 for a medical product, such as an endoscope assembly or a portion of an endoscope assembly (e.g., a disposable endoscope assembly). The packaging system 4000 includes a container 4005 including a first portion 4006 for holding the medical product and a second portion 4008 for supporting a bag 4030 for biohazardous materials resulting from use of the medical product and a bag 4032 for a reusable handpiece held within the first portion 4006. The first portion 4006 preferably includes a sterile portion for holding the medical product in a sterile sealed condition. The second portion 4008 may be a sterile or non-sterile portion of the packaging system 4000.

[0261] In the embodiment shown in FIG. 59, the container 4005 includes a tray 4010 defining a recess 4014 (see FIG. 60) for receiving a medical product. In some embodiments, the tray 4010 may be manufactured by thermoforming and may be made of a recyclable material that allows the tray 4010 to be recycled after use. The recess 4014 is enclosed by a peelable cover 4018, such as formed by Tyvek® as a sterile barrier material, such that the medical product may be sterilely enclosed within the recess 4014. A label 4022 may be disposed on the exterior of the cover 4018 to identify the medical product within the recess 4014 of the tray 4010 and to provide other desired information to the user.

[0262] The second portion 4008 of the container 4005 may be located outside the first portion 4006 or may be housed within the first portion 4006. For example, the second portion 4008 may be an area within the first portion 4006 that is accessible after the cover 4018 is removed. As another example, the second portion 4008 may be located on the outer surface of the first portion 4006 or the tray 4010 (e.g., outside the recess 4014). In the embodiment shown in FIG. 59, the second portion 4008 of the container 4005 includes the outer surface 4012 of the tray 4010. The biohazard disposal bag 4030 is removably attached to the container 4005 on this outer surface side of the tray 4010. As an example, the biohazard disposal bag 4030 may be removably attached to the tray 4010 using adhesive, adhesive tape, hook-and-loop fasteners, and / or perforations (e.g., straight and / or curved). Although shown in FIG. 59 as being attached to the outer surface of the tray 4010, in other embodiments, the biohazard disposal bag 4030 may be removably attached to the inner surface of the tray 4010 within the recess 4014.

[0263] In other embodiments, the biohazard disposal bag 4030 may include a means for securing the biohazard disposal bag 4030 to a surface in a medical examination room and / or operating room, such as a cart, furniture, table, bed, and / or wall, to name a few non-limiting examples. Such means may include adhesives, sticky tapes, hook and loop fasteners, magnets, hooks, clamps, and clips. Such means may also include openings positioned to receive protrusions (e.g., hooks) extending from the surface, and vice versa. The means for securing the bag to a surface may be the same or different than the means for removably attaching the biohazard disposal bag to the second portion 4008 (e.g., the exterior of the tray 4010).

[0264] As shown in the cross-sectional view illustrated in Fig. 61, the packaging system 4000 may be supported on a cart or roll stand surface 4050 that allows the packaging system 4000 to be easily moved to a desired location. This allows the packaging system 4000 to be moved within reach of a doctor or nurse providing treatment to a patient so that the medical products within the packaging system 4000 can be easily accessed and disposed of after use. Additionally, Fig. 61 illustrates possible curvatures of the side walls of the tray 4010 to allow optimal space for a minimum bend radius of the insertion tube 4054 for the medical products to be inserted into the recesses 4014 of the tray 4010.

[0265] 62 shows the biohazard disposal bag 4030 deployed and ready to receive biohazard waste. As shown, preferably the means for fastening the biohazard disposal bag 4030 to a surface and / or the means for removably attaching the biohazard disposal bag 4030 to the second portion 4008 4038 are spaced along at least 20% of the peripheral opening 4034 of the biohazard disposal bag. Advantageously, such an arrangement allows the peripheral opening 4034 of the biohazard disposal bag 4030 to be held open so that a medical product can be easily inserted into the biohazard disposal bag 4030 after the medical product has been used.

[0266] 63, the container 4005 and biohazard disposal bag 4030 of the packaging system 4000 may be packaged within the same medical product box 4070 (e.g., a paper box and / or cardboard box). The medical product box 4070 holds both the container 4005 and the biohazard disposal bag 4030 while the packaging system 4000 is shipped to the medical practitioner for use and for storage by the medical practitioner before the medical product in the container 4005 is used. Although the term "box" is used, it will be recognized that the medical product box 4070 may be a cardboard box, paper packaging, plastic wrap or plastic container, or any other suitable structure for holding the container 4005 and the biohazard disposal bag 4030.

[0267] One or more medical product boxes 4070 may be placed within a shipping box 4080 (e.g., a cardboard shipping box) (see FIG. 64). One or more labels 4075, 4085 having information related to the medical product (e.g., product name, product dimensions, and / or instructions for use) may be placed on the medical product box 4070 and / or the shipping box 4080.

[0268] 65 illustrates the packaging system 4000 after a medical product has been used and the packaging system 4000 is ready for disposal. The tray 4010 shown in this embodiment includes a cavity 4014 positioned to hold a single-use endoscope. The endoscope is removed from the cavity 4014 of the tray 4010 during use for a desired procedure.

[0269] 66, after the procedure is completed, the used endoscope is placed into a biohazard disposal bag 4030 for disposal. The biohazard disposal bag 4030 may be retained on the second portion 4008 of the packaging assembly 4000 while the endoscope is placed within the biohazard disposal bag 4030. As described above, the means for securing the biohazard disposal bag 4030 to the second portion 4008 of the packaging assembly 4000 may retain the biohazard disposal bag 4030 while the endoscope is positioned within the biohazard disposal bag 4030 such that assistance from an additional party is not required.

[0270] In certain embodiments, one biohazard disposal bag 4030 may be used to discard the disposable shaft assembly. A second bag 4032 may be used to hold the reusable handpiece.

[0271] After the entire medical product or disposable shaft assembly has been used and properly placed within the biohazard disposal bag 4030, the biohazard disposal bag 4030 may be separated from the second portion 4008 of the packaging system 4000 and disposed of in an appropriate manner for biohazard waste.

[0272] After the reusable handpiece is placed in the second bag 4032, the bag 4032 may be separated from the second portion 4008 of the packaging system 4000. The bag 4032 with the reusable handpiece therein may be safely transported for reprocessing. In some examples, a medical professional or a person associated with a medical professional may send the bag 4032 containing the reusable handpiece back to the manufacturer for reprocessing / cleaning. Once the reprocessing operation is complete, the reusable handpiece may be shipped back to the medical professional and / or the same clinic. In other examples, the reusable handpiece may be resold to a third party, depending on the agreement between the manufacturer and the original medical professional.

[0273] As long as the used medical product is properly placed within the biohazard disposal bag 4030 and does not come into contact with the packaging system 4000, the packaging system 4000 will not become contaminated and can be reused after separation from the biohazard disposal bag 4030 (see FIG. 67).

[0274] 68-71, the articulation controls and electronic module including the control and navigation switches are attached to the housing of the reusable handpiece 16200, and the articulation wire actuation assembly and connector of the disposable shaft assembly 16400 are attached to the housing of the disposable shaft assembly. Thus, when the housing of the reusable handpiece is separated from the housing of the disposable shaft assembly, the articulation controls are separated from the articulation wire actuation assembly and the electronic control and navigation switches are separated from the connector of the disposable shaft assembly.

[0275] Some embodiments may include an electronics module including a plurality of switches mounted to a housing of the reusable hand piece in electrical communication with a wire harness associated with the disposable shaft assembly via an electrical connector. The plurality of switches mounted to the housing of the reusable hand piece in electrical communication with a wire harness associated with the disposable shaft assembly via an electrical connector. The electronics module of this embodiment may further incorporate a microprocessor to minimize the number of connectors that need to communicate with a particular switch or combination of switches pressed by a user.

[0276] In another embodiment of the endoscope, the reusable handpiece includes the electronics module, switches, and electrical connectors, while the disposable shaft assembly includes the optical sensor, optical sensor module, and electrical connectors, with a set of conductors transmitting both optical and control data from the assembled endoscope to the console.

[0277] Advantageously, the incorporation of this electronic module and switch facilitates the transmission of control data while simplifying the components associated with the separable disposable shaft.

[0278] The reusable handpiece can include a circuit board (electronics module) adapted to control at least a portion of the support equipment (e.g., one or more pumps and / or valves within the support equipment). One or more switches of the reusable handpiece can be associated with the electronics module to control the support equipment.

[0279] Advantageously, such a configuration can eliminate the need for valves for the irrigation and aspiration lumens to be physically associated with the reusable handpiece and / or separable distal shaft assembly.

[0280] The switches associated with the reusable handpiece control board / circuit board 1206 (electronics module) include two electrical switches actuated by separate buttons 16204, 16205 for programmable functions on the top of the reusable handpiece. The second switch from the bottom is actuated by button 16203 for actuation of the remote suction valve 16101. The bottom button 16201 includes two electrical switches. The first switch 16202 associated with the bottom button is a capacitive switch that initiates the insufflation function by actuation of the remote valve 16102 when the operator places his finger on the outer molded gasket that covers the button. The vent 16103 allows insufflation gas to vent out of the endoscope assembly. The second switch associated with the bottom button is a switch mounted on the control board that is actuated to initiate the camera wash function by actuation of the remote valve when the operator fully depresses the bottom button.

[0281] Advantageously, the use of a remote valve in conjunction with a disposable shaft cartridge eliminates the cleaning and potential contamination associated with the current state of the art mechanical valves for reusable endoscopes.

[0282] Advantageously, the capacitive switch associated with the bottom button provides the same user experience as with current art reusable endoscopes that require simply placing a finger on the button to initiate pneumoperitoneum in current art reusable endoscopes that have a vent located on top of the valve button, but the capacitive pneumoperitoneum switch eliminates the cleaning and potential contamination associated with the mechanical valves associated with the current art for reusable endoscopes.

[0283] The endoscope assembly 17100 shown in Figures 72-84 may include a coupler that holds the reusable hand piece 17200 and the disposable shaft assembly 17400 together in an assembled state. The coupler may include a first portion on the reusable hand piece and a second portion on the disposable shaft assembly, the first and second portions of the coupler cooperating to hold the reusable hand piece and the disposable shaft assembly together in an assembled state. The coupler may include a lever 17201. The description of the lever 3001 is applicable to the lever 17201 and is incorporated herein.

[0284] The reusable handpiece articulation control can include an articulation knob and brake assembly 17300. The reusable handpiece articulation knob and brake assembly can include an up and down articulation knob 17301, a left and right articulation knob 17302, an up and down articulation brake lever 17303, and a left and right articulation brake knob 17304. When the reusable handpiece assembly is attached to the disposable shaft assembly, the articulation knob and brake assembly cooperates with the disposable shaft assembly to articulate a distal portion of the disposable shaft assembly and / or resist rotation of one or more articulation knobs relative to the endoscope assembly. For example, as discussed in more detail elsewhere herein, the up and down articulation shafts 17306 and left and right articulation shafts 17307, and / or left and right articulation brake shafts 17305 of the articulation knob and brake assembly can engage the pulley assembly 17500 and / or the housing of the disposable shaft assembly. The articulation knob can be adapted to receive articulation input (e.g., in the form of a rotational movement) from a user. The articulation knob can cooperate with the pulley assembly 17500 of the separable disposable shaft to actuate the control wires of the disposable shaft assembly. The user-controlled articulation knob can include two knobs having concentric drive shafts and / or rigidly attached to the same shaft.

[0285] In another embodiment, the first articulation control knob controls the left and right movement of the endoscope and the first articulation brake can include a left and right articulation brake shaft concentrically located within the first articulation shaft that engages with a socket 17403 in the disposable shaft housing to provide a fixed reference relative to the disposable shaft housing. The first articulation shaft is concentrically disposed in a socket having a series of torque transmitting bosses that alternately engage between the second shaft and the second pulley.

[0286] Each of the concentric drive shafts has a pulley-engaging portion that may have a non-circular cross-sectional geometry capable of transmitting torque, which may include, but is not limited to, an ellipse, a spline, a square, or a star, to name a few non-limiting examples.

[0287] Advantageously, the concentric shaft drive configuration allows for attachment of the disposable shaft assembly to the reusable handpiece without the need to orient the articulation knob or articulation distal end to obtain a neutral reference position. Regardless of the orientation of the disposable shaft assembly when installed (coiled or straight), the articulation knob rotates freely while the clinician manipulates the distal shaft 17401 (insertion tube) prior to use.

[0288] The disposable shaft assembly can include one or more pulleys housed within a rigid housing 17501. For example, the disposable shaft assembly can have a proximal rigid housing having a surface that supports and positions a pulley of the disposable shaft assembly to receive a pulley-engaging portion of the drive shaft.

[0289] Each pulley housed within a proximal rigid housing associated with a separable disposable shaft has a pair of opposing articulation wires 17504. Each articulation wire may be rigidly fixed to a pulley / cam and its other end rigidly fixed to a distal tip of the articulation section of the shaft. Rotation of the pulley / cam, such as by a user input torque applied to a corresponding knob, provides a tension force to the articulation distal portion.

[0290] The preferred embodiment utilizes two pulleys 17502 and 17503, each associated with a pair of articulation wires. Each pair of articulation wires provides a means for articulating the distal shaft portion in a single plane, e.g., up-down and left-right. The two pairs of articulation wires provide articulation to the distal shaft portion in two mutually orthogonal planes, with the longitudinal axis of the proximal shaft portion passing through the intersection of the planes. The articulation pull wires can be attached to the pulleys by articulation pull wire adhesive and / or articulation pull wire crimp tube 17505.

[0291] The engagement of the concentric drive shaft associated with the reusable handpiece and the pulley associated with the separable disposable shaft assembly is adapted to cause a force in the form of a torque applied to the articulation knob to become a pulling force in the articulation wire(s) causing corresponding movement of the distal shaft articulation portion.

[0292] A portion of the drive shaft, such as a pulley-engaging portion, may be tapered along a portion of the drive shaft. For example, the drive shaft may have a portion that tapers from smaller to larger in a direction toward the articulation knob. Advantageously, such a configuration facilitates engagement of the drive shaft with the pinion of the disposable shaft assembly when the reusable handpiece is coupled to the disposable shaft assembly.

[0293] The reusable handpiece may include a brake that applies an adjustable level of rotational resistance to an articulation control (e.g., an articulation control knob). For applications where articulation on two planes is required, there is a separate brake mechanism for each articulation control knob and its associated pair of articulation wires. Additionally, the brake mechanism is integrated into the knob's housing, thereby creating space for the disposable shaft assembly within the reusable handpiece housing. Additionally, the brake mechanism does not utilize a fixed method, such as the rotation of a threaded shaft, to apply force against a friction surface and / or brake material.

[0294] Advantageously, the reusable handpiece of the endoscope assembly can remain entirely outside the patient's body during an endoscopic procedure, while the disposable shaft assembly can have a portion disposed within the patient's body during an endoscopic procedure. Thus, the reusable handpiece and the disposable shaft assembly can be separated from one another after the procedure, and the disposable handpiece can be discarded (or reprocessed). Because the reusable handpiece has no fluid lumens that must be cleaned and sterilized, the effort of cleaning (aka "reprocessing") between procedures is dramatically reduced. Also, because no portion of a reusable handpiece used on multiple patients is inserted into the patient, the risk of infectious disease transmission can be dramatically reduced.

[0295] The disposable shaft assembly can be in a variety of configurations to support upper and lower endoscopes. For example, the disposable shaft assembly can be configured for colonoscopic, gastroscopic, sigmoidoscopic, and / or duodenoscopic procedures, to name a few non-limiting examples. Additionally or alternatively, the disposable shaft assembly can be provided in a variety of specialty configurations, such as pediatric insertion tube diameters. Advantageously, allowing the same reusable handpiece to be used for a variety of disposable shaft assemblies and / or procedures can eliminate the need to stock multiple dedicated endoscopes, e.g., colonoscopes, gastroscopes, sigmoidoscopic, duodenoscopes, etc., for each type of procedure, significantly reducing capital investments by clinicians, clinician groups, and / or medical centers.

[0296] Methods of assembling, disassembling, and / or using an endoscope assembly are contemplated. Such methods may include connecting a housing of a reusable hand piece to a housing of a disposable shaft assembly, the reusable hand piece including an articulation control and an electronics module, and the disposable shaft assembly including an articulation wire actuation assembly and a connector, connecting the articulation control to the articulation wire actuation assembly and the control module to the connector of the disposable shaft assembly. Additionally or alternatively, the method may include separating the housing of the reusable hand piece from the housing of the disposable shaft assembly to separate the articulation control from the articulation wire actuation assembly and the control module from the connector of the disposable shaft assembly. The method may include providing some or all of any endoscope assembly described herein.

[0297] Advantageously, the systems, assemblies, devices, and methods disclosed herein can increase the amount of endoscopic procedures a clinician and / or facility can perform per day by reducing and / or eliminating the time delays associated with existing reusable endoscopes that must be reprocessed (i.e., cleaned) between uses. By using disposable shafts, clinicians and / or facilities no longer need to reprocess (i.e., clean) the shaft and shaft lumen. Now, clinicians and / or facilities can simply wipe down the reusable handpiece and connect a new, sterilized disposable shaft assembly to the reusable handpiece to prepare the endoscope assembly for another procedure.

[0298] Advantageously, the systems, assemblies, devices, and methods disclosed herein can enable clinicians to perform multiple and / or various procedures without the need for a dedicated reusable endoscope and associated reprocessing devices, supplies, and clean water. This can be particularly advantageous in battlefield settings or remote clinics with limited resources, where reprocessing devices, reprocessing supplies, trained reprocessing personnel, and reprocessing laboratory settings may not be available. Advantageously, the endoscopes disclosed herein can be prepared for a new procedure by simply cleaning the exterior of the reusable handpiece with wipes and an antiseptic solution and connecting a new disposable shaft assembly.

[0299] Advantageously, a reusable handpiece can provide functionality that users are accustomed to, with highly precise and reliable components associated with the articulation knobs and brakes.

[0300] Advantageously, incorporating the articulation handle and clutch into the reusable handpiece reduces the components of the separable disposable shaft assembly, resulting in a lower cost disposable portion of the endoscope.

[0301] The disposable shaft assemblies disclosed herein can be intended for a single use. Advantageously, disposable medical devices can reduce the transmission of infectious diseases.

[0302] Advantageously, the preferred embodiment shown includes a series of three or more torque transfer bosses 17309 and 17506 with symmetric alignment ramps 17308 and 17507 that facilitate alignment of the articulation shaft with the articulation pulley when the disposable shaft assembly is attached to the reusable handpiece. These symmetric alignment ramps may be created by helical sweep cuts or may be created by linear angled cuts.

[0303] Applicants also recognize that expertise related to the evaluation of certain diseases and the implementation of new therapeutic procedures is increasingly concentrated in clinical research laboratories or larger medical centers. Advantageously, the endoscopes disclosed herein can facilitate the dissemination of patient and imaging data.

[0304] FIG. 85 illustrates a disposable flexible endoscope shaft assembly 2010 having a distal portion comprising an articulation assembly 2020 and a proximal portion comprising an insertion tube assembly 2030.

[0305] 86A, 86B, and 87, the insertion tube assembly 2030 includes an outer coil 2060. The articulation wire 20140 and the compression coil 2080 extend inside the outer coil 2060 along its length.

[0306] A braided sleeve 2070 surrounds the outer coil 2060 and is disposed between the outer coil and an outer sheath 2090. The outer sheath 2090 is applied over the braided sleeve 2070 and the outer coil 2060 as a reflow tube (e.g., thermal lamination) or by extrusion.

[0307] 88 shows the cap 20120 at the distal end of the articulation portion assembly 2020 and the articulation portion outer sheath 20130. The articulation portion assembly 2020 is connected to the insertion tube assembly 2030 using a transition tube 20100. The transition tube 20100 may be mechanically secured to both the articulation portion assembly 2020 and the insertion tube assembly 2030 by a process such as crimping.

[0308] 89A and 89B show an articulation section assembly 2020. The articulation section assembly 2020 includes an articulation wire and termination ring assembly 2040 having a termination ring 20150 disposed at a distal end of an articulation wire 20140, an integrated articulation section 20110, an articulation section outer sheath 20130, a cap 20120, an instrument tube 20230, an air / water tube 20220, a camera 20240 and a camera wiring harness 20250, lights 20260 (e.g., LEDs), and a light wire harness 20270. When the disposable flexible endoscope shaft assembly 2010 is assembled, the air / water conduit 20220 extends through the lumen 20210 defined by the articulation portion 20110, the instrument conduit 20230 extends through the lumen 20210, the camera wire harness 20242 extends through the lumen 20210, and the light emitter wire harness 20270 extends through the lumen 20210.

[0309] The cap 20120 defines an air / water nozzle 20280, an instrument tube outlet 20290, a camera outlet 20300, and a light emitter outlet 20310. The cap 20120 includes a cap alignment tab 20124 arranged to engage a cap alignment notch of an articulation portion (e.g., the integral articulation portion 20110).

[0310] 90A-90C show an integral articulation portion 20110 with a plurality of living hinges 20320 that are arranged alternately in two perpendicular planes when the integral articulation portion is in a straight configuration. Each deformable living hinge element 20320 provides a means for rotation about a pivot axis in a single plane. An articulation wire lumen 20330 traverses each living hinge element 20320 and is arranged to receive an articulation wire 20140.

[0311] A lumen 20210 located within the integral articulation portion 20110 can receive air / water conduits, instrument conduits, and / or wiring 20210. A cap alignment notch 20390 is located at a distal end of the integral articulation portion 20110 and is positioned to receive a cap alignment tab 20124.

[0312] FIG. 90B shows the integrated articulation portion 20110 in a deformed state corresponding to 180° articulation for retrograde viewing with a distally mounted camera 20240.

[0313] 91A shows the proximal end of the integral articulation portion 20110 and FIG. 91B shows the distal end of the integral articulation portion 20110. As seen in FIG. 91B, a distal facing surface 20334 extends inwardly from an inner surface 20336 of the integral articulation portion 20110. The distal facing surface 20334 is positioned to contact the termination ring 20150 and transfer tensile forces from the articulation wire and termination ring assembly 2040 to the integral articulation portion 20110.

[0314] 92-93C show an articulation link assembly 2050 including a proximal articulation link 20350, an intermediate articulation link 20340, and a distal articulation link 20360. The proximal articulation link 20350, the intermediate articulation link 20340, and the distal articulation link 20360 each define a lumen 20210 disposed to receive air / water conduits, instrument conduits, and / or wiring.

[0315] The proximal articulation link 20350 includes a pivot tab 20370 located in a first (e.g., vertical) plane. The intermediate articulation link 20340 includes an articulation pullwire lumen 20330, a pivot tab 20370 located in the first plane, and a pivot socket 20380 located in the second plane. The distal articulation link 20360 includes a cap alignment notch 20390 for controlling alignment of the camera 20240 with respect to each of the four articulation pullwires 20140, and two pivot sockets 20380 located in either the first or second plane. When assembled, the pivot tab 20370 is received in the pivot socket 20380 and is pivotable relative to the pivot socket 20380.

[0316] 94 shows an articulation pull wire and termination ring assembly 2040 including four articulation pull wires 20140 and an articulation pull wire termination ring 20150. The interior of the articulation pull wire termination ring 20150 defines a lumen 20210 for passing air / water conduits, instrument conduits, and wiring.

[0317] A method of manufacturing the insertion tube assembly disclosed herein will now be described with reference to Figure 95. The insertion tube assembly can be manufactured using a continuous (e.g., reel-to-reel) manufacturing process. The process can begin in step 20501 with a continuous coiling operation (e.g., a continuous wire coiler) where a coil is continuously manufactured.

[0318] At step 20506, a braided sleeve is placed around the outer coil, which may also be done during a continuous manufacturing process.

[0319] At step 20508, an outer sheath can be provided. This can also be done during a continuous manufacturing process. For example, the outer coil and braided sleeve assembly can be passed through one or more extrusion heads, around which the outer sheath is extruded. Such a process can produce a smooth outer sheath that is integrally bonded to the outer coil and / or braided sleeve. The outer sheath can have different durometers along its length such that some regions (e.g., lengths) of the outer sheath have a greater durometer than other regions. This can be accomplished by extruding resins (e.g., different resins) of different durometers through separate extrusion heads of one or more extrusion heads, or by extruding resins of different durometers through at least one extrusion head of one or more extrusion heads. At step 20510, the desired length of the insertion tube assembly, or a portion thereof, is cut to length. This can be done immediately after the outer sheath extrusion process, or from a reel of finished product, for example. After the assembly is cut to length, articulation wires and / or compression coils can be inserted into the lumen of the outer coil. The process ends at step 20512.

[0320] As will be appreciated by those skilled in the art, this continuous technique for manufacturing the insertion tube avoids the laborious and time consuming batch processes currently used to form the individual sections of an endoscope shaft, which Applicant believes may reduce the cost and / or increase the speed of production of endoscope shaft assemblies.

[0321] 96 and 97 show a manufacturing arrangement suitable for carrying out the above-described process. In FIG. 96, a first portion 20600 of the manufacturing arrangement is shown. The first portion 20600 includes an outer coil 2060 extending from an outer coil reel 20602 to a fixture 20610. The fixture 20610 is configured to form a braided sleeve around the outer coil as the outer coil and the compression coil advance sequentially through the fixture 20610. For example, the fixture 20610 may include a braiding machine having a plurality of bobbins 20612 that weave relative to one another to form a braided (e.g., woven) sleeve 20608 around the outer coil. The outer coil-braided sleeve assembly 20614 then extends to a reel 20616.

[0322] 97 shows a second portion 20620 of the manufacturing arrangement. In the second portion 20620, the outer coil and braided sleeve assembly 20614 extends from a reel 20616 to an extrusion die 20624. The extrusion die 20624 is configured to continuously extrude an outer sheath around the assembly 20614 as the assembly is advanced therethrough. The outer sheath assembly 20626 extends from the extrusion die 20624 to a finished product reel 20630.

[0323] Although one manufacturing arrangement has been shown and described, the disclosure is not limited to such. For example, the reel 20616 may be omitted and the outer coil and braided sleeve assembly 20614 may extend directly from the fixture 20610 to the extrusion die 20624.

[0324] 98A and 98B show embodiments of articulation joint assemblies 5100 and 5101. The articulation joint assemblies 5100 and 5101 may include a proximal link 5130, an articulation portion assembly 5120, a distal link 5110, and one or more isolation struts 5150 and 5151. Each isolation strut 5150 may be attached to an individual articulation link of the articulation assembly 5120 with one or more individual connection tabs 5140 for alignment of the individual articulation links.

[0325] Further, one or more separation struts 5150 and 5151 may be attached to the proximal link 5130 or 5131, the distal link 5110 or 5111, or both, by one or more individual connection tabs 5140 or 5141 for aligning the proximal link 5130 and the distal link 5110 with the individual articulation links 5120 or 5121.

[0326] The proximal link 5130 may include one or more insertion tube engagement fingers 5160. The distal link 5110 may include one or more distal link key portions 5170 for specific connection with a connecting distal cap.

[0327] 99 is an exploded view of the articulation joint assemblies 5100 and 5101 in conjunction with the distal cap 5210, articulation steering wires 5220, and proximal insertion tube 5230. The articulation joint assemblies 5100 and 5101 include individual articulation links 5240, and selective tension adjustment of one or more articulation steering wires 5220 may control the alignment of the distal link 5110, the distal cap 5210, or both.

[0328] One or more isolation struts 5150 and 5151 align the articulation joint assemblies 5100 and 5101 for inserting wires through the articulation steering cable channels.

[0329] FIG. 100 shows a proximal articulation link 5130 with a pivot tab 5320 located on its distal surface, an articulation steering cable channel 5310 that traverses a portion of the proximal articulation link, and an insertion tube engagement finger 5160 located on its proximal surface.

[0330] A utility lumen 5330 traverses the proximal articulation link 5130. The utility lumen 5330 provides space for instrument tubing, air tubing, water tubing, a camera wire harness, an LED wire harness, compression coils, medical tools, or any combination thereof.

[0331] Additionally, an embodiment may include a proximal articulation link 5130 that includes a pivot socket on its distal face rather than a pivot tab 5320.

[0332] FIG. 101 shows a distal articulation link 5110 including a pivot socket 5420 located on the proximal face, an articulation steering cable channel 5310 that traverses a portion of the distal articulation link, and a distal link key portion 5170.

[0333] A utility lumen 5330 traverses the distal articulation link 5110. The utility lumen 5330 provides space for instrument tubing, air tubing, water tubing, a camera wire harness, an LED wire harness, a compression coil, medical tools, or any combination thereof.

[0334] Additionally, an embodiment may include a distal articulation link 5110 that includes a pivot tab on the proximal face rather than a pivot socket 5420.

[0335] 102 illustrates a distal articulation link 5110 assembly having articulation steering wires 5220 and wire terminations 5510. The wire terminations 5510 may include individual articulation wire terminations at a termination ring. An embodiment of the wire terminations 5510 may include wire continuation between articulation steering wires 5220 that cross adjacent articulation steering cable channels 5310. Additionally, an embodiment of the wire terminations 5510 may include wire continuation between articulation steering wires 5220 that run along the inner circumference of the utility lumen 5330 to the opposing articulation steering cable channel 5310. The wire terminations 5510 may be recessed into the distal face or along the inner circumference of the distal region of the distal link 5110.

[0336] 103 is a perspective view of the distal end cap 5210. The distal end cap 5210 includes a camera outlet 5610, a light source outlet 5620, an outlet 5640 for water, air, or both, an instrument tube outlet, and a cap key portion 5650 that allows for attachment to the distal link 5110 by engagement with a distal link key portion 5170.

[0337] It should be noted that, with respect to the specification and claims, the singular includes the plural unless expressly stated otherwise. By way of example, reference to a "device" or "the device" includes one or more of such devices and equivalents thereof. Additionally, directional terms such as "up," "down," "top," "bottom," "left," "right," and the like are used herein merely for the convenience of the reader to aid in the reader's understanding of the illustrated embodiments, and the use of these directional terms is not intended in any way to limit the features described, illustrated, and / or claimed to any particular direction and / or orientation.

[0338] While the invention has been illustrated and described in detail in the drawings and foregoing description, these are exemplary and not restrictive in nature, only the preferred embodiments having been illustrated and described, and all changes, equivalents and modifications which come within the scope of the invention as defined by the following claims are sought to be protected.

[0339] All publications, patents, and patent applications cited herein are hereby incorporated by reference as if each individual publication, patent, or patent application was set forth in its entirety herein.

[0340] The following numbered descriptions set forth specific embodiments that are useful in understanding the invention. 1. A method of using a reusable handpiece assembly and a disposable shaft assembly, the reusable handpiece assembly being selectively attachable to and detachable from the disposable shaft assembly; The reusable handpiece assembly includes a housing, a first articulation control knob, a second articulation control knob, a first articulation brake, and a second articulation brake; The disposable shaft assembly includes a housing and an endoscope shaft; the first articulation brake is operable from a disengaged position that permits rotation of the first articulation control knob relative to the housing of the reusable handpiece to an engaged position that resists rotation of the first articulation control knob relative to the housing of the reusable handpiece; the second articulation brake is capable of moving from a disengaged position that allows rotation of the second articulation control knob relative to the housing of the disposable shaft assembly to an engaged position that resists rotation of the second articulation control knob relative to the housing of the disposable shaft assembly when the reusable handpiece assembly is attached to the disposable shaft assembly. 2. An endoscope as described in claim 1, wherein the second articulation brake includes a brake articulation shaft extending through the first articulation control knob. 3. An endoscope as described in claim 2, wherein an end of the brake articulation shaft is adapted to engage a housing of the disposable shaft assembly such that the brake articulation shaft is rotationally fixed relative to the disposable shaft assembly when the reusable handpiece assembly is engaged with the disposable assembly. 4. The brake articulation shaft extends through a first articulation control shaft associated with the first articulation control knob; An endoscope as described in claim 2 or 3, wherein rotation of the first articulation control knob relative to the housing of the reusable handpiece assembly causes the first articulation control shaft to rotate relative to the housing of the reusable handpiece assembly. 5. A second articulation control shaft associated with the second articulation control knob extends through the first articulation control shaft; 5. An endoscope as described in claim 4, wherein rotation of the second articulation control knob relative to the housing of the reusable handpiece assembly causes the second articulation control shaft to rotate relative to the housing of the reusable handpiece assembly. 6. The endoscope of claim 5, wherein the brake articulation shaft extends through the second articulation control shaft. 7. The first articulation brake includes an outer brake housing and a caliper; the outer brake housing is associated with the first articulation control knob and the first articulation control shaft such that rotation of the first articulation control knob rotates the outer brake housing and the first articulation control shaft; the caliper is rotationally fixed relative to the reusable handpiece assembly; An endoscope as described in any of claims 4-6, wherein the caliper moves toward the outer brake housing when the first articulation brake is moved from the disengaged position to the engaged position. 8. The first articulation brake includes an inner brake housing disposed within the outer brake housing; 8. An endoscope as described in claim 7, wherein the inner brake housing is adapted to rotate relative to the caliper so as to move the caliper toward the outer brake housing when the first articulation brake moves from the disengaged position to the engaged position. 9. The endoscope of claim 8, wherein the inner brake housing is rotationally fixed to a brake control lever. 10. The endoscope described in claim 8 or 9, wherein the outer brake housing, the inner brake housing, and the caliper are all disposed within the first articulation control knob. 11. The second articulation brake includes an outer brake housing and a caliper; the outer brake housing is associated with the second articulation control knob and the second articulation control shaft such that rotation of the second articulation control knob rotates the outer brake housing and the second articulation control shaft; the caliper is rotationally fixed to the brake articulation shaft; An endoscope as described in any of claims 5-10, wherein the caliper moves toward the outer brake housing when the second articulation brake moves from the disengaged position to the engaged position. 12. The second articulation brake includes an inner brake housing disposed within the outer brake housing; 12. An endoscope as described in claim 11, wherein the inner brake housing is adapted to rotate relative to the caliper so as to move the caliper toward the outer brake housing when the second articulation brake moves from the disengaged position to the engaged position. 13. The endoscope of claim 12, wherein the inner brake housing is rotationally fixed to the brake control knob. 14. The endoscope of claim 12 or 13, wherein the outer brake housing, the inner brake housing, and the caliper are all disposed within the second articulation control knob. 15. An endoscope as described in any of claims 1-14, wherein the first articulation control knob is disposed between the housing of the reusable handpiece and the second articulation control knob. 16. A handpiece assembly including a housing, a first articulation control knob, a second articulation control knob, a first articulation control shaft, a second articulation control shaft, a first articulation brake, and a second articulation brake; the first articulation control shaft is associated with the first articulation control knob; the first articulation control shaft is adapted to rotate relative to the housing by rotation of the first articulation control knob relative to the housing; the second articulation control shaft is adapted to rotate relative to the housing by rotation of the second articulation control knob relative to the housing; the first articulation brake is operable from a disengaged position allowing rotation of the first articulation control shaft relative to the housing to an engaged position resisting rotation of the first articulation control shaft relative to the housing; the second articulation brake is operable to move from a disengaged position allowing rotation of the second articulation control shaft relative to the housing to an engaged position resisting rotation of the second articulation control shaft relative to the housing; The second articulation brake includes a brake articulation shaft extending through the second articulation control shaft. 17. The endoscope of claim 16, wherein the brake articulation shaft is rotationally fixed relative to the housing. 18. The endoscope of claim 16, wherein the second articulation control shaft extends through the first articulation control shaft. 19. The endoscope of claim 16, wherein the first articulation control shaft extends through a steering knob hub that is rotationally fixed relative to the housing. 20. The endoscope of claim 19, wherein the first articulation control knob is rotationally fixed relative to the steering knob hub when the first articulation brake is in the engaged position. 21. A handpiece assembly including a housing, a first articulation control shaft, a second articulation control shaft, a first articulation brake, and a second articulation brake; the first articulation control shaft has a portion located inside the housing and a portion located outside the housing; the second articulation control shaft has a portion located inside the housing and a portion located outside the housing; the first articulation brake is movable from a disengaged position allowing rotation of the first articulation control shaft relative to the housing to an engaged position resisting rotation of the first articulation control shaft relative to the housing; the second articulation brake is movable from a disengaged position allowing rotation of the second articulation control shaft relative to the housing to an engaged position resisting rotation of the second articulation control shaft relative to the housing; The first articulation brake is disposed at least partially about a portion of the first articulation control shaft outside the housing. 22. The endoscope of claim 21, wherein the second articulation brake is disposed at least partially about a portion of the second articulation control shaft outside the housing. 23. The endoscope of claim 21, further comprising a first articulation control knob disposed at least partially around a portion of the first articulation control shaft outside the housing. 24. The endoscope of claim 21, further comprising a second articulation control knob disposed at least partially around a portion of the second articulation control shaft outside the housing. 25. The endoscope of claim 23, wherein the first articulation brake is disposed within the first articulation control knob, between the first articulation control knob and the first articulation control shaft. 26. The endoscope of claim 24, wherein the second articulation brake is disposed within the second articulation control knob, between the second articulation control knob and the second articulation control shaft. 27. A spring element that is changeable between a first configuration and a second configuration; the spring element, in the first configuration, urges friction surfaces together to resist rotation of the articulation control knob relative to the housing of the endoscope; An endoscope as described in any of the above, wherein in the second configuration the spring element is compressed compared to the first configuration so as to apply no force or reduced force to the friction surface so as to release the brake. 28. Having an articulation control knob and an articulation brake; the articulation brake is movable from a disengaged position that allows rotation of the articulation control knob relative to a housing of an endoscope to an engaged position that resists rotation of the articulation control knob relative to the housing; The articulation brake includes a spring element, and moving the articulation brake from the engaged position to the disengaged position compresses the spring element. 29. A surgical instrument having a reusable handpiece assembly and a first disposable shaft assembly; The endoscope, wherein the reusable handpiece assembly includes electronics for transmitting valve control signals and image data to an external storage device. 30. The endoscope described in claim 29, wherein the housing of the reusable handpiece assembly is attachable to and detachable from the housing of the first disposable shaft assembly without the use of hand tools. 31. The endoscope described in claim 29 or 30, wherein the housing of the reusable handpiece assembly is removably connected to the housing of the first disposable shaft assembly by one or more latches. 32. The endoscope described in claim 29 or 30, wherein the housing of the reusable handpiece assembly is removably connected to the housing of the first disposable shaft assembly by one or more snap elements. 33. An endoscope as described in any one of claims 29-32, further comprising an optical sensor module. 34. Both control data and image data are transmitted to a console and to an external storage device via a set of conductors associated with the disposable shaft assembly; An endoscope as described in any of claims 29-33, wherein the control data is transmitted from the reusable handpiece assembly to the disposable shaft assembly via an electrical connector. 35. Both control data and image data are transmitted to a console and to an external storage device via a set of conductors associated with the reusable handpiece assembly; An endoscope as described in any of claims 29-33, wherein the image data is transmitted to the reusable handpiece assembly via an electrical connector. 36. An endoscope as described in claim 34 or 35, wherein one or more separate switches are associated with the electronic device and are useful for navigating and selecting a series of options on the console's user interface. 37. An endoscope as described in any of claims 34-36, wherein one or more switches are associated with the electronics and are useful for initiating image or video capture or for enhancing imaging. 38. An endoscope as described in any of claims 34-37, wherein switches associated with the electronics are adapted to actuate remote valves associated with a console to control the flow of fluids through the various lumens of the endoscope. 39. The optical sensor module is associated with the disposable shaft assembly and adapted to store a unique identifier associated with the disposable shaft assembly; An endoscope as described in any one of claims 33 or claims 34-38 dependent on claim 33, wherein the unique identifier is transmitted to a console which prevents reuse of the disposable shaft assembly. 40. The system described in claim 39, wherein the determining factor preventing reuse of the disposable shaft assembly is repeated electrical connection to the console, excessive total time of electrical connection to the console, or connection to the console for more than one day (24 hours). 41. The consoles are connected to a database that shares connection data between the consoles; 41. The system of claim 39 or 40, wherein the shared data prevents attempts to reuse disposable shaft assemblies both on a single console and across multiple consoles. 42. A system as described in any of claims 39 to 41 above, wherein said reuse of the disposable shaft assembly is prevented by notifying the user of the problem, not displaying the image data on the screen, and not providing an option to save the image data. 43. A method of using a medical instrument comprising: the endoscope has a first fluid path, a second fluid path, a third fluid path, and an electrical conductor; the first fluid path, the second fluid path, the third fluid path, and the electrical conductors extend from the endoscope to the cartridge; the cartridge has a housing and an electrical connector adapted to electrically connect electrical conductors of the endoscope to electrical conductors of a console; The system, wherein the first fluid pathway has a first valve portion defined by a housing of the cartridge, the valve portion being adapted to align with a first actuator of the console when the cartridge is attached to the console, the first actuator being operable to selectively close the first valve portion of the first fluid pathway. 44. The system described in claim 43, wherein the first valve portion includes a first flexible membrane disposed within a first window defined by the housing, the first window adapted to receive the first actuator from a console adapted to compress the first flexible membrane to close the first fluid path. 45. The system described in 43 or 44 above, further comprising the console. 46. ​​A system as described in any of claims 43-45 above, wherein the endoscope and the cartridge are sterilely sealed in medical packaging. 47. A first tube defining the first fluid pathway, the first tube extending from the endoscope through the cartridge; a second tube defining the second fluid pathway, the second tube extending from the endoscope through the cartridge; a third tube defining the third fluid pathway, the third tube extending from the endoscope through the cartridge; 47. The system according to any one of claims 43-46, comprising: 48. The cartridge defines a second valve portion of the second fluid path; A system as described in any of claims 43-47, wherein when the cartridge is attached to the console, the second valve portion is aligned with a second actuator of the console, and the second actuator is operable to selectively close the second valve portion of the second fluid path. 49. The third fluid pathway has a cartridge portion defined by the cartridge, the cartridge portion having a main portion and a branch portion; the main portion of the third fluid path having a third valve portion; the third valve portion is aligned with a third actuator of the console, the third actuator being operable to selectively close the third valve portion; the branched portion of the third fluid path having a fourth valve portion; the fourth valve portion is aligned with a fourth actuator of the console, the fourth actuator being operable to selectively close the fourth valve portion; 49. A system according to any one of claims 43-48. 50. A system as described in any of claims 43-49, wherein when the cartridge is connected to the console, a portion of the fourth fluid path extends between the endoscope and the console, and said portion is free of valves. 51. A system as described in any of claims 43-50, wherein when the cartridge is connected to the console, the portion of the second fluid path extending between the endoscope and the console is free of valves. 52. The endoscope further comprises the reusable handpiece assembly and the disposable shaft assembly; the reusable handpiece assembly being selectively attachable to and detachable from the disposable shaft assembly; The system described in any of claims 43-51 above, wherein the reusable handpiece assembly supports an articulation control, and when the reusable handpiece assembly is attached to a disposable shaft assembly, the articulation control is adapted to engage a portion of the disposable shaft assembly for manipulation of a distal portion of the disposable shaft assembly. 53. The first fluid pathway extends from a distal tip of the endoscope through the cartridge; A system described in any of claims 43-52, wherein the portion of the first fluid path from the distal tip of the endoscope to the cartridge does not have a flow control valve. 54. A system as described in any one of claims 45 or 45-53 dependent on claim 45, wherein the console has a door with a latch. 55. The system of claim 54, wherein when the cartridge is attached to the console and the door is closed and latched, the door and console press against the cartridge. 56. A method for using the system according to any one of claims 43-55, comprising: mounting the cartridge to a console adapted to selectively open and close at least the first flow path when the cartridge is mounted to the console; mounting the cartridge on the console, the electrical connector of the cartridge being connected to electrical conductors of the console; A method in which electrical power can be passed between the electrical conductors of the console and the electrical conductors of the endoscope by connecting the electrical connector of the cartridge to the electrical conductors of the console. 57. A housing, a first fluid path, a second fluid path, and a third fluid path; a first electrical connector adapted to be electrically connected to electrical conductors of the endoscope; a second electrical connector adapted to electrically connect to electrical conductors of the console; having the first fluid pathway having a first valve portion disposed within a first window defined by an inner surface of the housing; The window is adapted to receive the first actuator from the console configured to close the first fluid path, the cartridge. 58. A method for treating a vascular endoscopic infection comprising the steps of: providing a cartridge as described in claim 57; connecting said cartridge to an endoscope; and providing said endoscope having a reusable handpiece assembly and a disposable shaft assembly; the reusable handpiece assembly is selectively attachable to and detachable from the disposable shaft assembly; An assembly in which the means for articulation is conveyed from the reusable handpiece to the disposable shaft assembly by a concentric articulation shaft. 59. A system as described in any of the above, wherein the cartridge includes an anvil. 60. A system as described in any of the above, wherein the cartridge includes a ledge surface and the console includes an opposing ledge surface for receiving the ledge surface of the cartridge. 61. The cartridge includes a latch receiver and the control valve assembly includes a latch; A system as described in any of the above, wherein when the cartridge is received by the control valve assembly, the latch of the control valve assembly contacts the latch receiver of the cartridge. 62. A surgical instrument comprising a console, a first endoscope, a second endoscope, a first cartridge, and a second cartridge; the console has a first control valve assembly and a second control valve assembly; the first endoscope and the first cartridge define a first fluid pathway; the second endoscope and the second cartridge define a second fluid pathway; The first control valve assembly is adapted to receive the first cartridge and the second control valve assembly is adapted to receive the second cartridge. 63. The system described in claim 62, wherein the first endoscope has a control unit that controls a function of the second control valve assembly when the first cartridge is received in the first control valve assembly. 64. The first endoscope has a first electrical conductor; 64. The system described in claim 63, wherein the cartridge has a first electrical connector configured to electrically connect the first conductor of the first endoscope to the first conductor of the console. 65. The system described in claim 63, wherein the second endoscope and the second cartridge define an aspiration fluid path, a tissue lavage fluid path, a camera lavage fluid path, and a pneumoperitoneum fluid path, and the second control valve assembly is adapted to selectively close one or more of these fluid paths. 66. The system described in claim 65, wherein operation of a control unit of the first endoscope controls one or more functions of the fluid paths of the second endoscope. 67. The system described in claim 62, wherein the second endoscope is equipped with a light emitting diode and / or a camera. 68. The system described in claim 67, wherein the function of the light-emitting diode and / or the camera of the second endoscope is controlled by operation of the control unit of the first endoscope. 69. The system described in claim 62, wherein the first endoscope and the second endoscope are different types of endoscopes. 70. The system described in claim 69, wherein the first endoscope is a duodenoscope and the second endoscope is a cholangiopancreatoscope. 71. The system of claim 70, wherein the shaft of the cholangiopancreatoscope extends through the shaft of the duodenoscope. 72. The system described in claim 62, wherein the handle of the first endoscope is adapted to engage with the handle of the second endoscope. 73. The system described in claim 62, wherein the shaft of the second endoscope extends through the shaft of the first endoscope. 74. The first endoscope has a reusable handpiece assembly and a disposable shaft assembly; the reusable handpiece assembly being selectively attachable to and detachable from the disposable shaft assembly; 63. The system of claim 62, wherein the reusable handpiece assembly includes an articulation control adapted to control a distal shaft of the disposable shaft assembly configured for insertion into a patient. 75. The system of claim 62, wherein the first cartridge and the second cartridge are defined by separate cartridge housings. 76. A valve assembly having a first control valve assembly and a second control valve assembly; the first control valve assembly is configured to receive a first cartridge; the second control valve assembly is configured to receive a second cartridge; a console adapted to receive an electrical signal from the first cartridge of the first control valve assembly and operate an actuator of the second control valve assembly or provide an electrical signal in response thereto. 77. A handpiece assembly having a housing; a shaft assembly having a housing; a latch displaceable between a latched state and an unlatched state; having in the latched state, the latch latches the housing of the handpiece assembly to the housing of the shaft assembly; When going from the latched state to the unlatched state, the latch applies a separation force separating the housing of the handpiece assembly and the housing of the shaft assembly. 78. The endoscope according to claim 77, wherein the handpiece assembly is a reusable handpiece assembly and the shaft assembly is a disposable shaft assembly. 79. The endoscope of claim 77, wherein the latch includes a lever that pivots from a first position in the latched state to a second position in the unlatched state. 80. The latch has a latching surface and an unlatching surface; in the latched state, the latching surface holds the handpiece housing in close proximity to the shaft assembly housing; 79. The endoscope according to claim 77 or 78, wherein the unlatching surface applies a separation force for separating the housings when going from the latched state to the unlatched state. 81. The endoscope of claim 77, wherein the latch further comprises a seat portion. 82. The endoscope according to claim 79, wherein the latch portion and the unlatch portion are located on opposite sides of the seat portion. 83. The endoscope of claim 77, wherein the latch further comprises a latch pivot. 84. The endoscope according to claim 77, wherein the latch portion and the unlatch portion are located on opposite sides of the latch pivot. 85. The endoscope according to claim 77, wherein the latch is disposed on the reusable handpiece assembly. 86. The endoscope according to claim 77, wherein the latch is disposed on the disposable shaft assembly. 87. A handpiece assembly having a housing; a shaft assembly having a housing; A biasing member; a latch displaceable between a latched state and an unlatched state; having the biasing member is adapted to apply a force biasing the housings toward or away from each other; The latch is adapted to apply a force opposing the biasing force to urge the housings either apart or towards each other. 88. The endoscope according to claim 87, wherein the biasing member biases the housings toward each other and the latch urges the housings away from each other. 89. The endoscope according to claim 87, wherein the biasing member biases the housings away from each other and the latch presses the housings toward each other. 90. An endoscope as described in any one of claims 87-89, wherein the biasing member is a spring, a magnet, or a pressure chamber. 91. A latch mechanism for an endoscope having a reusable handpiece assembly and a disposable shaft assembly, comprising: A latch and a latch receiving portion, the latch has a latch portion, a latch release portion, and a latch handle; the latch mechanism being movable between a latched state and an unlatched state; the latch handle is movable between a first position and a second position; While in the latched state, the latch receiving portion contacts the latch portion, While in the unlatched state, the latch receiving portion and the latch portion are prevented from contacting each other; A latch mechanism in which, when changing from the latched state to the unlatched state, the unlatching portion contacts the latch receiving portion and applies a force thereto. 92. A packaging system for a pharmaceutical product, comprising: A medical product box; a disposal bag and container removably disposed within the medical product box prior to use of the medical product; having the container has a first portion including a recess for holding the medical product in a sterile environment; A packaging system, wherein the disposal bag is sized to hold at least a disposable and / or reusable portion of the medical product after the medical product has been used. 93. The packaging system of claim 92, wherein the container includes a tray, the recess for holding the medical product being defined in the tray. 94. The packaging system of claim 93, wherein the tray is made from thermoformed plastic. 95. A packaging system as described in any of claims 92-94, wherein the container includes a cover that sterilely seals the medical product within the recess. 96. The packaging system of claim 95, wherein the cover is made from Tyvek (registered trademark). 97. The packaging system of any of claims 95-96, further comprising a label attached to the cover, the label including information related to the medical product retained in the recess. 98. The packaging system of any of claims 92-97, wherein the disposal bag is secured to a second portion of the container when the container and the disposal bag are within the medical product box. 99. The packaging system of claim 98, wherein the second portion is an exterior surface of the container. 100. The packaging system of claim 98, wherein the second portion is an inner surface of the container. 101. The packaging system of any of claims 98-100, wherein the disposal bag is removable from the second portion of the container. 102. A packaging system as described in any one of claims 92-101 above, wherein the container is made from a recyclable material. 103. The packaging system of any of claims 92-102, further comprising a label attached to the medical product box, the label including information related to the medical product. 104. A shipping box is further included. A packaging system as described in any one of claims 92-103, wherein a plurality of said medical product boxes are packaged within said shipping box. 105. The packaging system of any of claims 92-104, wherein the medical product is an endoscope. 106. The packaging system of any of claims 98-105, wherein the disposal bag includes a peripheral opening, the disposal bag being secured to the second portion of the container along at least 20% of the peripheral opening. 107. The packaging system of any of claims 98-106, wherein the disposal bag is secured to the second portion of the container. 108. The packaging system of claim 107, wherein adhesive for adhering the disposal bag to the second portion of the container is spaced along at least 20% of the peripheral opening. 109. A surgical instrument comprising: a reusable handpiece assembly; and a first disposable shaft assembly removably coupled to the reusable handpiece assembly; the reusable handpiece assembly includes one or more buttons for controlling operations of the endoscope, the operations including at least one of suction and pneumoperitoneum; An endoscope wherein one or more of the buttons includes a capacitive sensor. 110. A method including an endoscope as described in claim 109, and using a capacitive sensor to actuate a valve external to the reusable handpiece assembly and the first disposable shaft assembly of the endoscope. 111. A method of using a handpiece assembly comprising: the reusable handpiece assembly is selectively attachable to and detachable from the disposable shaft assembly; The reusable handpiece assembly includes a housing, a first articulation control knob, and a first shaft having a first end coupled to the first articulation control knob so as to be rotated by rotation of the first articulation control knob; the disposable shaft assembly includes a housing and an endoscope insertion tube; the housing of the disposable shaft assembly includes a first pulley and an associated set of articulation wire segments secured to a distal tip of an articulation section of the endoscope insertion tube; the first shaft has a second end having a plurality of spaced apart torque transmission bosses adapted to engage the torque transmission bosses of a first pulley such that the first articulation control knob controls rotation of the first pulley via the first shaft when the reusable handpiece assembly is attached to a disposable shaft assembly; A separable medical device, wherein the torque transfer boss of the reusable handpiece assembly and / or the disposable shaft assembly includes an alignment ramp at an end of the torque transfer boss that faces an opposing housing when the reusable handpiece assembly and the disposable shaft assembly are coupled. 112. The separable medical device of claim 111, wherein the torque transfer boss has a symmetric alignment ramp on the end. 113. The handpiece assembly includes a first articulation brake and an articulation brake shaft concentrically located within the first articulation shaft and engaging a socket in the disposable shaft housing; 13. The separable medical device of claim 111 or 112, wherein the articulation brake shaft is rotationally fixed relative to the socket via a series of torque transmitting bosses having alignment ramps on at least one end thereof. 114. An endoscope as described in any one of claims 1-42, having a torque transmitting boss associated with any or all of the articulation controls and / or articulation brakes. 115. A method of manufacturing at least a portion of a flexible endoscope shaft, comprising: forming successive first, second and third lengths of an outer coil with a continuous wire coiler, wherein forming the first length defines a first period, forming the second length defines a second period, and forming the third length defines a third period; forming an outer braid about the outer coil along the first length during the second period to create a braided assembly; A method comprising: 116. The method of claim 115, including the step of disposing two or more pull wires within the outer coil, each pull wire being disposed within a concentric compression coil. 117. The method of any of claims 115-116, wherein the flexible endoscope shaft includes a distal articulation portion extending distally of the proximal insertion tube. 118. The method of any of claims 115-117, wherein the outer braid is formed from individual wires. 119. The method of any of claims 115-118, comprising advancing the braided assembly through a die opening of an extrusion die during the third period. 120. The method of claim 119, including forming an outer braid around said outer coil along said second length during said third period. 121. The method of claim 119 or 120, further comprising disposing resins of different durometers along the first length. 122. A method according to any of claims 115-121, comprising the step of placing an identifier on the assembly that identifies the cutting position. 123. A method according to claim 122 which is dependent on claim 121, wherein parts of the assembly having resins of different durometers do not have the identifier. 124. An articulation joint for a medical device, comprising: a plurality of articulation links including concentric tab-and-socket pivot joints having tabs extending from each link for engaging sockets in adjacent links; a proximal link including a retention cavity for the compression coil; a distal link including a keyed portion for orienting the distal cap; a distal cap having a corresponding keyed portion for engaging the distal link, the distal cap allowing only one rotational orientation between the distal cap and the distal link; An articulation joint having 125. An articulation joint for a medical device, comprising: a plurality of articulation links including concentric tab-and-socket pivot joints having tabs extending from each link for engaging sockets in adjacent links; a looped steering wire wrapped 180 degrees or a multiple of 180 degrees around the distal link; having The looped steering wire is fixedly coupled to the distal link. 126. An articulation joint for a medical device, comprising: a plurality of articulation links including concentric tab and socket pivot joints having tabs extending from each link for engaging sockets in adjacent links; a pair of looped steering wires wrapped 90 degrees or multiples of 90 degrees around the distal link; having The looped steering wire is fixedly coupled to the distal link. 127. An articulation joint for a medical device, comprising: a plurality of articulation links including concentric tab and socket pivot joints having tabs extending from each link for engaging sockets in adjacent links; one or more isolation struts attached to the periphery of each of the plurality of links by one or more distinct connection points; A proximal link; A distal link; An articulation joint having 128. An articulation joint for a medical device, comprising: a plurality of articulation links including concentric tab and socket pivot joints having tabs extending from each link for engaging sockets in adjacent links; a proximal link having one or more channels; a distal link having one or more channels; one or more isolation struts attached to the periphery of the proximal link, each of the plurality of articulation links, and the distal link by one or more distinct connection points; An articulation joint having: 129. An articulation joint as described in any of claims 127-128, wherein the concentric tabs and sockets of each link of the plurality of articulation links are arranged perpendicular to one another. 130. An articulation joint as described in any of claims 127-129, wherein a front surface of the proximal link is connected to a rear surface of an adjacent link of the plurality of articulation links to enable articulation movement between the links. 131. The articulation joint of claim 130, wherein the proximal link includes fingers that engage the interior of an insertion tube for connecting with a shaft. 132. An articulation joint as described in any of claims 127-131, wherein the distal link includes a key-shaped portion that engages with the distal cap, a rear surface that connects with a front surface of an adjacent link of the plurality of articulation links, and / or a cylindrical portion. 133. The articulation joint of claim 132, wherein said rear surface is connected to a front surface of a front link of a plurality of articulation links to enable articulation movement between said links. 134. An articulation joint as described in any of claims 127-133, wherein the proximal link includes fingers that engage the interior of an insertion tube for connecting with a shaft. 135. An articulation joint as described in any of claims 127-134, wherein the proximal link, the plurality of articulation links, and the distal link comprise one or more lumens.

[0341] Glossary Language used in the claims and specification, except for terms expressly defined below, has only its plain and ordinary meaning, which herein includes all consistent dictionary definitions from the most recently published (as of the filing date of this application) commonly used Merriam-Webster dictionary. As used in the claims and specification, the following terms have the following defined meanings. As used herein, "actuator" includes linear actuators and rotary actuators. A solenoid is one example of an actuator. "Distal" generally means the end opposite the proximal end (the "patient end / treatment end"). "Electrical connector" generally refers to an electromechanical device used to join electrical terminations to form an electrical circuit. Electrical connectors are gendered, i.e., a male component, called a plug, may connect to a female component, or socket. The connection may be removable. An "electrical signal" generally refers to a voltage or current that conveys information, and also includes the passing of power from one component to another. "Proximal" generally refers to the end or direction associated with a physician or other medical personnel operating the device, or the end or direction connected to an insertion tube. As used herein, the term "pulley" may include a cam. The term "valve" as used herein can include a mechanical device that can start, stop, or regulate the flow of liquid, gas, or loose material in bulk by means of moving parts that open, close, or partially obstruct one or more ports or passages, such as a butterfly valve, needle valve, ball valve, or pinch valve, to name a few non-limiting examples.

Claims

1. a reusable handpiece assembly and a disposable shaft assembly; the reusable handpiece assembly being selectively attachable to and detachable from the disposable shaft assembly; The reusable handpiece assembly includes a housing, a first articulation control knob, a second articulation control knob, a first articulation brake, and a second articulation brake; The disposable shaft assembly includes a housing and an endoscope shaft; the first articulation brake is operable from a disengaged position that permits rotation of the first articulation control knob relative to the housing of the reusable handpiece to an engaged position that resists rotation of the first articulation control knob relative to the housing of the reusable handpiece; the second articulation brake is operable to move from a disengaged position that permits rotation of the second articulation control knob relative to the housing of the disposable shaft assembly to an engaged position that resists rotation of the second articulation control knob relative to the housing of the disposable shaft assembly when the reusable handpiece assembly is attached to the disposable shaft assembly; the second articulation brake includes a brake articulation shaft extending through the first articulation control knob; the brake articulation shaft extends through a first articulation control shaft associated with the first articulation control knob; An endoscope, wherein rotation of the first articulation control knob relative to the housing of the reusable handpiece assembly causes the first articulation control shaft to rotate relative to the housing of the reusable handpiece assembly.

2. 2. The endoscope of claim 1, wherein an end of the brake articulation shaft is adapted to engage a housing of the disposable shaft assembly such that the brake articulation shaft is rotationally fixed relative to the disposable shaft assembly when the reusable handpiece assembly is engaged with the disposable shaft assembly.

3. a second articulation control shaft associated with the second articulation control knob extends through the first articulation control shaft; 2. The endoscope of claim 1, wherein rotation of the second articulation control knob relative to the housing of the reusable handpiece assembly causes the second articulation control shaft to rotate relative to the housing of the reusable handpiece assembly.

4. 4. The endoscope of claim 3, wherein the brake articulation shaft extends through the second articulation control shaft.

5. The first articulation brake includes an outer brake housing and a caliper. the outer brake housing is associated with the first articulation control knob and the first articulation control shaft such that rotation of the first articulation control knob rotates the outer brake housing and the first articulation control shaft; the caliper is rotationally fixed relative to the reusable handpiece assembly; 2. The endoscope of claim 1, wherein the caliper is adapted to move toward the outer brake housing when the first articulation brake is moved from the disengaged position to the engaged position.

6. the first articulation brake includes an inner brake housing disposed within the outer brake housing; 6. The endoscope of claim 5, wherein the inner brake housing is adapted to rotate relative to the caliper to move the caliper toward the outer brake housing when the first articulation brake is moved from the disengaged position to the engaged position.

7. 7. The endoscope of claim 6, wherein the inner brake housing is rotationally fixed to a brake control lever.

8. The endoscope of claim 6 , wherein the outer brake housing, the inner brake housing, and the caliper are all disposed within the first articulation control knob.

9. the second articulation brake includes an outer brake housing and a caliper; the outer brake housing is associated with the second articulation control knob and the second articulation control shaft such that rotation of the second articulation control knob rotates the outer brake housing and the second articulation control shaft; the caliper is rotationally fixed to the brake articulation shaft; 4. The endoscope of claim 3, wherein the caliper is adapted to move toward the outer brake housing when the second articulation brake moves from the disengaged position to the engaged position.

10. the second articulation brake includes an inner brake housing disposed within the outer brake housing; 10. The endoscope of claim 9, wherein the inner brake housing is adapted to rotate relative to the caliper to move the caliper toward the outer brake housing when the second articulation brake is moved from the disengaged position to the engaged position.

11. The endoscope of claim 10, wherein the inner brake housing is rotationally fixed to a brake control knob.

12. The endoscope of claim 10, wherein the outer brake housing, the inner brake housing, and the caliper are all disposed within the second articulation control knob.

13. 2. The endoscope of claim 1, wherein the first articulation control knob is disposed between the housing of the reusable handpiece and the second articulation control knob.

14. a spring element changeable between a first configuration and a second configuration; the spring element, in the first configuration, urges friction surfaces together to resist rotation of the articulation control knob relative to the housing of the endoscope; 2. The endoscope of claim 1, wherein the spring element is compressed in the second configuration compared to the first configuration so as to exert no or reduced force on the friction surface such that the brake is released.

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