Endoscopy system

Abstract

An endoscope system is disclosed having an endoscope including a reusable handpiece, a separable disposable shaft assembly, a disposable cartridge, and a console. An endoscope assembly is disclosed having a friction-fit attached articulation knob, a multi-stage rotation distance limiter, and / or an elevator. Components, packaging systems, and methods are also disclosed.

Description

Technical Field

[0006]

[0001] The present disclosure generally relates to endoscopes used in the digestive system and the like.

Background Art

[0002] Endoscopes are used in various medical scenarios to visualize internal cavities or potential spaces within the human body for diagnosis or treatment.

[0003] One factor affecting the design and use of endoscopes is the spread of infectious diseases. Reusable endoscopes have always had a risk of spreading infectious diseases, but the emergence of antibiotic-resistant bacteria has increased that risk. When these bacteria are transmitted between patients, the treatment of the infectious disease becomes difficult due to antibiotic resistance. Many of these bacteria, including staphylococci, have the ability to form a protective film called a biofilm that protects infectious bacteria during endoscope cleaning.

[0004] Another recent factor increasing the risk of infectious disease transmission is the increasing number of diagnostic methods that require smaller and more complex instruments, longer working lumens, and distal manipulators associated with articulation (joint) shafts at the distal end of endoscopes, such as elevators. Furthermore, the increasing incidence of infectious diseases that are difficult to treat and the spread of more complex and difficult-to-clean endoscopes have made the sterilization and reuse of endoscopes increasingly risky.

Summary of the Invention

Problems to be Solved by the Invention

[0005] It is desirable to reduce or limit the possibility of infectious disease transmission. Therefore, a new endoscope design is desired. Thus, improvements in this field are sought.

Means for Solving the Problems

[0006] This disclosure relates primarily to endoscopes. Many of the disclosed aspects are applicable to other art fields, particularly other medical devices.

[0007] This disclosure provides an endoscopic assembly comprising a reusable handpiece and a disposable (single-use) shaft assembly. This disclosure may include an endoscopic assembly, a cartridge, and a console. More specifically, this endoscopic assembly may include a reusable handpiece attached to a disposable shaft assembly. The reusable handpiece can be detached from the disposable shaft assembly.

[0008] The reusable handpiece can be selectively attached to and detached from the disposable shaft assembly, thereby allowing the reusable handpiece to be used continuously with multiple disposable shaft assemblies, while enabling the disposable shaft assembly, including the cartridge, to be discarded and / or readjusted after a single use. The reusable handpiece and / or disposable shaft assembly may include a locking mechanism for selectively locking the reusable handpiece and the disposable shaft assembly together. A latch handle (e.g., a lever) for operating a latch mechanism that connects the reusable handpiece to the disposable shaft assembly may be located on the reusable handpiece and / or disposable shaft assembly. Additional locking mechanisms, such as magnets, can be used alternatively or simultaneously.

[0009] The reusable handpiece includes a handpiece housing that supports an articulation knob brake assembly; control switches for operating light such as light-emitting diodes, and / or flash (discharge fluid), and / or suction fluid channels; one or more navigation switches for controlling a console that communicates with the endoscope assembly; and / or an electrical connector for electrically coupling the reusable handpiece with a disposable shaft assembly.

[0010] A disposable shaft assembly may include an insertion tube for insertion into the patient's body, a tube and electrical connector connected to a console, an access port for selective access to the lumen of the disposable shaft assembly (e.g., for taking samples such as biopsies) and / or for delivering fluid through the lumen of the disposable shaft assembly, and / or an electrical connector for electrically coupling the disposable shaft assembly to a reusable handpiece.

[0011] Tube-electrical connectors, also known as "umbilicals," extend from the endoscope assembly to a cartridge that connects to a console designed for use with the endoscope assembly. Tube-electrical connectors can extend from disposable shaft assemblies and / or reusable handpieces. Often, the electrical connector extends through the tube along with one or more fluid pathways.

[0012] The console may provide power, fluid and / or fluid pressure, vacuum pressure, and / or transmit and / or receive electrical signals to and from the endoscope assembly. The console may include a monitor for visualizing signals received from the endoscope assembly, such as video feeds from a camera located at the distal end of a disposable shaft assembly.

[0013] A disposable shaft assembly may include one or more pulley assemblies. A pulley assembly may include at least one pulley positioned to receive the end of an articulation shaft. Preferably, the rotation of an articulation knob associated with the articulation shaft causes at least one pulley to rotate. Preferably, at least one pulley and the end of the articulation shaft have a shape (e.g., a mating structure) for rotatably coupling the pulley and the articulation shaft with each other. Preferably, the mating structure does not rely solely on friction between the articulation shaft and the pulley. Preferably, the mating structure includes geometric interference between the articulation shaft and the pulley. The pulley assembly may include circular pulleys and / or non-circular pulleys (e.g., cams).

[0014] At least one pulley is associated with an articulation wire or a pair of articulation pull wires (e.g., two separate wires or one continuous wire, each having a wire segment arranged in a loop on the pulley and extending from opposite sides of the pulley) configured to bend the distal shaft portion of a disposable shaft assembly when in operation. The articulation wires can be fixed to the pulley (e.g., tied or fixed by an anchor (not shown)) and / or extend around at least a portion of the pulley (e.g., looped around the pulley). Preferably, one or more pulley assemblies include two pulleys (one for each articulation wire) and articulation wires (at least one for each pulley). In the illustrated example, each pulley includes one groove (two grooves in total) for the articulation wires. Alternatively, each pulley may include two grooves (four grooves in total), using only one wire per groove to reduce the possibility of wire overlap. Preferably, the articulation wire is configured to bend its distal shaft portion in a plane perpendicular to the surrounding area.

[0015] One or more pulleys and one or more associated articulation wires can be housed within a pulley housing. The pulley housing may consist of housing parts such as a cover piece and an inner piece. The housing parts can work together to at least partially enclose one or more pulleys.

[0016] The pulley housing may be constructed in a sandwich configuration with a pair of cover pieces on the outside / both ends and a pair of inner pieces, each coupled to one cover piece on one side and to each other on the other. Such a housing portion cooperates to enclose the pulley and associated articulation wires. Preferably, the housing portion prevents the articulation wires from separating from the pulley. The pulley housing may define an opening for receiving the articulation shaft and / or brake shaft of the articulation control assembly.

[0017] Preferably, the housing portions do not come into contact with each other along a perfectly straight butt joint. For example, the inner piece and / or cover piece may come into contact along a straight path. In some embodiments, the inner piece and cover piece are configured to have castellations (ridges) along the length of the joint between these pieces, and are joined so that the castellations of the inner piece coincide with the castellations of the cover piece. Advantageously, avoiding a perfectly straight butt joint can help prevent wire slippage between the parts of the pulley assembly. In other examples, the joint between these housing portions may be straight, curved, curved, straight, or any other desired configuration.

[0018] Furthermore, the pulley assembly may include an articulation coil end block that receives one or more articulation coils wound around each articulation pull wire connected to the pulley. The articulation coil end block is adjustable to remove slack in the articulation pull wire. In other words, the articulation coil end block is adjustable along the longitudinal axis of the endoscope assembly to control the tension of the articulation pull wire.

[0019] This disclosure includes a "two-stage articulation limit." A two-stage stop assembly allows for further rotation of the articulation knob than is possible with a single stop. The two-stage stop assembly may be entirely enclosed within a pulley housing. The two-stage stop assembly may include two pulleys and two stop idlers positioned on one side of each pulley, for example, the side opposite to the side having a recess for the articulation wire anchor. One pulley is for up-down articulation, and the other pulley is for left-right articulation. Each stop idler may include separate grooves (two in total) on the circumference of each side of the stop idler. The grooves terminate at a stop (e.g., a projection) so that the grooves do not circle 360 ​​degrees around the stop idler.

[0020] Each pulley has a boss on its side that interferes with a groove on the first side of the stop idler. During rotation of the pulley relative to the stop idler, the boss on the pulley moves along the groove of the idler until it is blocked by a stop on the stop idler. When the pulley boss contacts the stop, the rotational force of the pulley is transmitted to the idler, causing it to rotate. The rotation of the idler is permitted depending on the contact between the stop idler and the housing.

[0021] On the second side of the rotation-stopping idler, the second stop portion interferes with a boss on the pulley housing, limiting the degree of rotation of the rotation-stopping idler relative to the housing. For example, while the idler is rotating relative to the housing, the boss on the housing can move along the groove on the second side of the rotation-stopping idler until the second stop portion of the idler contacts the boss on the housing and the rotation of the idler relative to the housing stops. Thus, after the rotation of the pulley relative to the rotation-stopping idler is blocked in the first direction, and after the rotation of the rotation-stopping idler relative to the housing is blocked in the first direction, the rotation of the articulation knob and pulley relative to the housing in the first direction is also blocked.

[0022] To prevent wobbling of the stop idler, the stop idler may have continuous bearing surfaces on both sides of the idler. The continuous bearing surfaces provide a stable base for maintaining balance as the idler rotates within and relative to the pulley housing.

[0023] Advantageously, the rotation-stopping idler has the function of limiting the rotation of the articulation knob for the endoscope when the required rotation of the articulation knob exceeds the rotation limit that can be achieved with a single stop. On one side of the rotation-stopping idler, the allowable angular rotation of the pulley relative to the idler is equal to the angular length of the idler groove minus the angular length of the pulley boss. On the opposite side of the rotation-stopping idler, the allowable rotation of the idler relative to the housing is equal to the angular length of the idler groove minus the angular length of the boss on the pulley housing. Adding these two "steps" and degrees of rotation gives the total angular distance that the pulley (and / or articulation knob) can move relative to the housing. For illustrative purposes, if the bosses each have an angular length of 45 degrees and the grooves of the rotation-stopping idler each have an angular length of 315 degrees, the degree of rotation on each side of the idler is equal to 270 degrees, and the sum of both sides is a movable angle of 540 degrees of the pulley relative to the housing. The bosses, grooves, and / or stop members may have the same or different angular lengths, and the bosses, grooves, and / or stop members may have angular lengths greater than or less than 45 degrees.

[0024] Furthermore, one or more bosses may be separate parts, and the grooves may follow a helical path. Thus, as the bosses move along the groove path, they translate along the surface of the pulley and / or housing. Advantageously, such arrangements can provide grooves with angular lengths of 360 degrees or more.

[0025] While grooves and stop sections have been described as being defined by a rotation-stopping idler, and bosses as belonging to the pulley and / or housing, the arrangements disclosed herein are not limited in this way. It will be understood that grooves and stop sections may be defined by the pulley and / or housing, and one or more bosses may be part of the rotation-stopping idler.

[0026] Advantageously, the rotation stop idler limits the articulation movement to reduce the potential for damage to the endoscope (e.g., the insertion tube) and / or the potential for patient injury. For example, the articulation movement of a choledochoscope may be limited to 60 to 80 degrees or less to reduce the likelihood that the insertion tube will articulate to a degree that could damage the bile duct. The rotation stop idler may be configured to correspond to a particular type of endoscope. Thus, the first disposable shaft assembly can have a rotation stop idler configured to limit the articulation movement to a first angle, and the second disposable shaft assembly can have a rotation stop idler configured to limit the articulation movement to a second angle different from the first angle. However, a reusable handle assembly can be used with various types of endoscopes, including those having a rotation stop idler configured to limit the articulation movement to different angles. Further, the rotation stop idler is not limited to multi-piece endoscopes.

[0027] The articulation knob - brake assembly of the reusable handpiece can include an up - down articulation knob, a left - right articulation knob, an up - down articulation brake, and a left - right articulation brake. During operation, when the reusable handpiece is attached to the disposable shaft assembly, the distal portion of the disposable shaft assembly articulates in a first plane by the articulation movement of the up - down articulation knob, and the distal portion of the disposable shaft assembly operates in a second plane that intersects the first plane by the operation of the left - right articulation knob. Preferably, the second plane is orthogonal to the first plane.

[0028] When a reusable handpiece is coupled to a disposable shaft assembly, the vertical articulation brake is interlocked by the operation of the vertical articulation brake lever, and resistance occurs to the rotation of the vertical articulation knob with respect to a part of the endoscope assembly such as the housing of the reusable handpiece. By the operation of the left and right articulation brake knobs, the left and right articulation brakes are interlocked, and resistance occurs to the rotation of the left and right articulation knobs with respect to a part of the endoscope assembly such as the housing of the disposable shaft assembly.

[0029] The reusable handpiece and the disposable shaft assembly are preferably configured to fit with each other. For example, the reusable handpiece assembly can define a recess arranged to receive a part of the disposable shaft assembly, or vice versa. In many examples, the recess of the reusable handpiece assembly arranged to receive a part of the disposable shaft assembly is on the side opposite to the side having the knob of the articulation knob - brake assembly of the reusable handpiece assembly. One of the reusable handpiece and the disposable shaft assembly can partially and / or completely surround at least a part of the other on two or more opposing sides.

[0030] A part of the disposable shaft assembly can be received by the reusable handpiece along a direction parallel to or transverse to the longitudinal axis of the reusable handpiece or the disposable shaft assembly, or vice versa. For example, the reusable handpiece can receive the disposable shaft assembly along a direction orthogonal to the longitudinal axis of the reusable handpiece. In many embodiments, when the reusable handpiece and the disposable shaft assembly are combined with each other, the disposable shaft assembly is moved along a direction parallel to the rotation axis of the articulation knob - brake assembly with respect to the reusable handpiece.

[0031] When a reusable handpiece assembly is attached to a disposable shaft assembly, the articulation knob brake assembly works in cooperation with the disposable shaft assembly to articulate the distal segment of the disposable shaft assembly and / or resist rotation of one or more articulation knobs relative to the endoscope assembly. For example, as described in more detail elsewhere in this specification, one or more articulation shafts and / or brake shafts of the articulation knob brake assembly may engage with the housing of the pulley assembly and / or disposable shaft assembly. One or more shafts of the articulation knob brake assembly extend through the pulley assembly and engage with the housing of the disposable shaft assembly on the opposite side of the pulley assembly from the articulation knob brake assembly.

[0032] In many embodiments, a portion of the articulation knob brake assembly extends into a recess in a reusable handpiece that is positioned to receive a portion of a disposable shaft assembly.

[0033] Regarding upper and lower articulation control by an articulation knob brake assembly, the upper and lower articulation knobs are supported by an upper and lower articulation brake outer housing. Within the upper and lower articulation brake outer housing are an articulation brake inner housing, an articulation brake position detent, an articulation brake spring, an upper and lower articulation brake caliper, and an angled articulation brake friction disc. The angled surface of the articulation brake friction disc may not be perpendicular to the axis of rotation.

[0034] The upper and lower articulation brake levers are connected to the articulation brake inner housing. The upper and lower articulation hubs and upper and lower articulation shafts extend through the upper and lower articulation brake levers. The upper and lower articulation hubs, located within the articulation brake inner housing, support the articulation brake position detent and the upper and lower articulation brake calipers. The rotation of the upper and lower articulation hubs is fixed relative to the housing of the reusable handpiece, and as a result, the rotation of the articulation brake position detent and the upper and lower articulation brake calipers is also fixed relative to the housing of the reusable handpiece.

[0035] When the upper and lower articulation brake levers rotate relative to the upper and lower articulation hubs, the articulation brake inner housing rotates relative to the articulation brake position detent and the upper and lower articulation brake calipers. When rotating in a first direction, pins extending from the upper and lower articulation brake inner housing toward the upper and lower articulation brake calipers engage with the angled surfaces of the upper and lower articulation brake calipers, moving the articulation brake calipers axially and compressing the articulation brake springs. When rotating in a second direction, the pins move along the angled surfaces, and the articulation brake springs press the upper and lower articulation brake calipers toward the angled surfaces of the articulation brake friction discs and the upper and lower articulation brake outer housings, compressing the articulation brake friction discs between the upper and lower articulation brake calipers and the outer housings. The contact between the stationary upper and lower articulation brake calipers (relative to the reusable handpiece), the angled surface of the articulation brake friction disc, and the upper and lower articulation brake outer housings creates resistance to the rotation of the upper and lower articulation knobs, supported by the upper and lower articulation brake outer housings, relative to the reusable handpiece. In other examples, the articulation brake surface may be perpendicular to the axis of rotation. Advantageously, the angled braking surface can increase the braking force compared to a perpendicular braking surface when the same spring force is applied.

[0036] When the rotation of the upper and lower articulation brake position detent is fixed to the housing of a reusable handpiece via the upper and lower articulation brake hub, the rotation of the articulation brake inner housing relative to this housing also causes the articulation brake inner housing to rotate relative to the upper and lower articulation brake position detent. The upper and lower articulation brake position detent can hold the upper and lower articulation brake inner housing in one or more positions. For example, the detent can hold the upper and lower articulation brake inner housing in a first position where braking resistance is applied through the interaction of the upper and lower articulation brake friction discs between the upper and lower articulation brake caliper 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 detent can hold the upper and lower articulation brake inner housing in any of a plurality of positions to provide an adjustable level of rotational resistance to the articulation control (e.g., the articulation control knob).

[0037] The upper and lower articulation shafts extend through the center of the upper and lower articulation brake hubs. The upper and lower articulation shafts have first ends fixed to the upper and lower articulation brake outer housings in the rotational direction. The second ends of the upper and lower articulation shafts are associated with the pulley assembly of a disposable shaft assembly. For example, the second ends of the upper and lower articulation shafts can be attached to the upper and lower articulation pulleys so that the rotation of the upper and lower articulation shafts causes the upper and lower articulation pulleys to rotate. In this way, the rotation of the upper and lower articulation knobs causes the upper and lower articulation brake outer housings to rotate, which in turn causes the upper and lower articulation shafts to rotate, which in turn causes the upper and lower articulation pulleys to rotate, and thus acts the upper and lower articulation wires.

[0038] With respect to left and right articulation, the structure and operation of the left and right articulation knob brake assemblies are identical to those of the upper and lower articulation knob brake assemblies, except that the rotation of the left and right articulation brake hubs is fixed to the housing of the disposable shaft assembly, and such rotation is fixed via the left and right articulation brake shafts extending through the left and right articulation shafts. Similar to the upper and lower articulation knob brake assemblies, the left and right articulation knobs are supported by left and right articulation brake outer housings that house the angled articulation brake friction discs, left and right articulation brake calipers, articulation brake springs, articulation brake position detents, and articulation brake inner housings.

[0039] The left and right articulation shafts extend through the left and right articulation brake knobs and the left and right articulation brake outer housings. The left and right articulation shafts have a first end fixed rotatably to the left and right articulation brake outer housings and a second end that engages with the pulley assembly of a disposable shaft assembly (for example, the second end fixed rotatably to the left and right articulation pulleys), so that the rotation of the left and right articulation brake knobs rotates the left and right articulation brake outer housings, which in turn rotates the left and right articulation brake shafts, which in turn rotates the left and right articulation pulleys, and moves the left and right articulation wires.

[0040] The left and right articulated brake shafts, extending through the left and right articulation shafts, have a first end fixed rotatably to the left and right articulated brake hubs and a second end fixed rotatably to the housing of the disposable shaft assembly when the reusable handpiece assembly is attached to the disposable shaft assembly. Similar to the operation of the upper and lower articulated knob brake assembly, the rotation of the articulated brake inner housing relative to the left and right articulated brake calipers causes the left and right articulated brake calipers to move toward or away from the angled surfaces of the left and right articulated brake outer housings and the brake friction discs located between them. The left and right articulated brake knobs are fixed rotatably to the left and right articulated brake inner housings, and the rotation of the left and right articulated brake knobs causes the left and right articulated brake inner housings to rotate relative to the left and right articulated brake hubs, left and right articulated brake calipers, and left and right articulated brake position detents. Therefore, when the left and right articulated brakes are engaged, the angled surfaces of the left and right articulated brake calipers and brake friction discs resist the rotation of the left and right articulated brake outer housings and left and right articulated knobs relative to the left and right articulated brake shafts and disposable shaft assemblies.

[0041] The second ends of the left and right articulation brake shafts can be slidably engaged with the housing of a disposable shaft assembly, and positioned to fix the left and right articulation brake shafts to it in a rotational direction. Around the left and right articulation brake shafts, left and right articulation shafts are arranged circumferentially, their second ends engaged with left and right articulation pulleys that cooperate with left and right articulation wires. Then, around the left and right articulation shafts, upper and lower articulation shafts are arranged circumferentially, their second ends positioned to engage with upper and lower articulation pulleys associated with upper and lower articulation wires.

[0042] The articulation knob brake assembly may include multiple O-rings between the various parts when assembled. Ball bearings are also illustrated, positioned within the assembly to reduce friction during rotation.

[0043] The upper and lower articulation brake levers may have surfaces that engage with the surfaces of the upper and lower articulation brake inner housings so that the rotation of the upper and lower articulation brake levers causes the upper and lower articulation brake inner housings to rotate relative to the housing of the reusable handpiece assembly. Preferably, the geometric shape of the surfaces interferes with the geometric shape of the surfaces during rotation. The upper and lower articulation brake inner housings may define one or more openings to receive lateral pins that engage with the angled surfaces of the upper and lower articulation brake calipers. Furthermore, the inner surfaces of the upper and lower articulation brake inner housings may include recesses or projections positioned to engage with detent springs. The upper and lower articulation brake levers and upper and lower articulation brake inner housings define openings for receiving upper and lower articulation hubs.

[0044] The upper and lower articulation hubs have portions that extend through the upper and lower articulation brake position detents and the upper and lower articulation brake calipers. Preferably, these portions, the upper and lower articulation brake position detents, and / or the upper and lower articulation brake calipers have a cross-sectional shape that fixes the upper and lower articulation brake position detents, the upper and lower articulation brake calipers, and / or the upper and lower articulation brake hubs to each other in a rotational direction.

[0045] The upper and lower articulation brake outer housings can engage with the upper and lower articulation shafts and be fixed relative to them in a rotational direction. The upper and lower articulation brake outer housings have portions that are configured to fix the upper and lower articulation knobs to them in a rotational direction (for example, by recesses configured to receive projections of the upper and lower articulation knobs, or vice versa).

[0046] The inner surface of the upper and lower articulated brake outer housing may have an inner friction surface that engages with the angled / tapered surface of the upper and lower articulated brake friction disc when the upper and lower articulated brakes are engaged.

[0047] As the upper and lower articulation brake levers rotate relative to the reusable handpiece housing, the upper and lower articulation brake inner housings rotate with the levers, moving pins extending from openings in the upper and lower articulation brake inner housings relative to the upper and lower articulation brake calipers. The pins move along the inclined surfaces of the upper and lower articulation brake calipers, moving them along the upper and lower articulation hubs in cooperation with the upper and lower articulation brake springs. When the upper and lower articulation brakes are engaged from the disengaged state, the upper and lower articulation brake calipers press the upper and lower articulation brake friction discs against the upper and lower articulation brake outer housings (compressing the upper and lower articulation brake friction discs). When the upper and lower articulation brakes are disengaged from the engaged state, the upper and lower articulation brake calipers separate from the upper and lower articulation brake housings and upper and lower articulation brake friction discs, compressing the upper and lower articulation brake springs (for example, further compressing them). The upper and lower articulation brakes can be in a disengaged state in which there is a gap between the upper and lower articulation brake friction discs and the inner friction surfaces of the upper and lower articulation brake outer housings.

[0048] The upper and lower articulation brake inner housing may have detent recesses or projections that engage with one or more projections or recesses of the upper and lower articulation brake position detents. Such an arrangement may provide fixation of the upper and lower articulation brake lever in one or more positions and / or provide tactile and / or audible indication that the upper and lower articulation brakes have entered and / or disengaged from one or more forms or positions.

[0049] The left and right articulation knob brake assemblies operate similarly to the upper and lower articulation knob brake assemblies, except that the left and right articulation brake hubs are rotationally fixed to the housing of the endoscope assembly by left and right articulation shafts and upper and lower articulation shafts, through which the left and right articulation brake shafts extend to the center.

[0050] The left and right articulated brake outer housings and the left and right articulated shafts are assembled and fixed to each other in a rotational direction.

[0051] The left and right articulation brake shafts have first ends that are received within the left and right articulation brake hubs and fixed in the rotational direction. The second ends of the left and right articulation brake shafts engage with the housing of the disposable shaft assembly during the mounting of the reusable handpiece assembly and the disposable shaft assembly, thereby fixing the left and right articulation brake shafts in the rotational direction relative to the disposable shaft assembly. Thus, when the reusable handpiece assembly is mounted to the disposable shaft assembly, the left and right articulation brake hubs are fixed in the rotational direction relative to the housing of the disposable shaft assembly.

[0052] The upper and lower articulation knobs, left and right articulation knobs, and left and right articulation brake knobs are removable (or "snap off") from the rest of the articulation knob brake assembly. As described above, the upper and lower articulation brake outer housing has portions to which the upper and lower articulation knobs are secured in a rotational direction (for example, by recesses that receive projections of the upper and lower articulation knobs, or vice versa). Similarly, the left and right articulation brake outer housings are designed to secure the left and right articulation knobs in the same manner. The arrangement of recesses and projections allows the upper and lower articulation knobs, left and right articulation knobs, and left and right articulation brake knobs to be easily snapped off or snapped on to the articulation knob brake assembly. The snap-off structure allows the knobs to be removed to facilitate cleaning of the reusable handpiece between procedures.

[0053] A reusable handpiece may include a retaining clip. The retaining clip is used to secure the articulation knob / brake assembly to the reusable handpiece. The retaining clip may be coupled to the upper and lower articulation hubs to secure the articulation knob / brake assembly. Between procedures, the retaining clip can be removed from the articulation knob / brake assembly and the articulation knob / brake assembly can be detached from the housing of the reusable handpiece for quick and easy cleaning.

[0054] The insertion tube may include an instrument tube extending inside at least a portion of the insertion tube. The instrument tube defines a tool channel that allows various instruments to be inserted and extended through the insertion tube. The instrument tube can be manufactured by a co-extrusion process. The inner extruded portion may be made of high-density polyethylene (HDPE) for lubrication. The outer extruded portion may be made of polyvinyl chloride (PVC) or polylactic acid (PLA) to facilitate adhesion.

[0055] The insertion tube may include an optical sensor module to provide information readable by a console and / or project an image onto a monitor, such as a video feed from the end of the insertion tube. This video feed may be infrared, thermal, or visible light. The insertion tube may have light-emitting diode (LED) wires to power LEDs located at the end of the insertion tube.

[0056] The insertion tube may include fluid pathways discussed herein, defined by tubes such as suction tubes, tissue perfusion tubes, camera flash tubes, and / or insufflation tubes. Perfusion tubes allow the user to remove any debris in the field of view during instrument use. Often, this involves removing excess blood to make the desired area visible. Suction tubes allow for the aspiration of particulate matter and various secretions from the patient's body. Camera flash tubes and insufflation tubes can be connected by Y-fittings. Various combinations of tubes are possible to minimize the number of tubes required for the insertion tube.

[0057] Furthermore, an example of an articulation joint assembly positioned in the flexible articulation section of an insertion tube is disclosed. The articulation joint assembly has a proximal end and a distal end. Between the proximal and distal ends, a plurality of connected articulation links are formed. Each link has a contact point where it connects to an adjacent link. Adjacent links are positioned to articulate relative to each other. For example, adjacent articulation links oscillate at a certain angle relative to each other. For example, adjacent links can oscillate at an angle of 2x relative to each other, where the angle x is measured between the contact points of each adjacent link when the links are parallel to each other. Adjacent articulation links of an articulation joint assembly may be pivotable to a different degree than other adjacent articulation links of the articulation joint assembly. Preferably, adjacent articulation links can be formed such that the angles of articulation differ between different pairs of articulation links. Advantageously, such an arrangement can be used to obtain a radius that changes along the length of the flexible articulated section during articulation motion. A pair of adjacent links with different articulation angles can be used to create a curve that changes along the length of the flexible articulated section.

[0058] Furthermore, an elevator control assembly for adjusting the height of an elevator located at the distal end of an insertion tube is disclosed. The elevator control assembly may be positioned between two inner pieces of a pulley housing. The elevator control assembly includes an elevator control lever. The elevator control lever articulates around an articulation shaft via a pin constrained by a curved track. The elevator control lever is operably connected to an elevator drive rack. The elevator drive rack is coupled to an elevator pinion. The elevator pinion is also operably coupled to an elevator driven rack. The elevator driven rack is coupled to an elevator articulation control wire. Furthermore, the elevator control assembly may include an elevator control coil termination block that receives one or more elevator control coils wound around each elevator articulation control wire coupled to the elevator driven rack.

[0059] The articulation motion of the elevator control lever operates the elevator drive rack, which in turn rotates the elevator pinion. The rotation of the elevator pinion drives the elevator driven rack, causing the elevator articulation control wire, around which the elevator control coil is wound, to articulate. For example, operating the elevator control lever in one direction causes the elevator to rise, while articulating it in the opposite direction causes the elevator to descend.

[0060] To maintain the position of the elevator control lever when there is no user input, the elevator control assembly utilizes a compression O-ring. The O-ring is secured around a projection extending from one of the housing covers. The O-ring is pressed against the elevator control pinion, and the friction generated between the O-ring and the elevator control pinion maintains the position of the control lever. In other examples, the lever position is maintained by the friction generated by a spring element.

[0061] Further disclosed is an insertion tube tip assembly. The insertion tube tip assembly includes an insertion tube, a distal elevator link, a distal cap, and an elevator assembly. The insertion tube includes a distal end. The distal end includes a distal tip portion which includes the distal elevator link, the distal cap, and the elevator assembly.

[0062] The distal cap includes a first opening to allow it to slide over the elevator assembly. The distal cap further includes a second opening to allow the instrument to exit the distal cap and operate within the patient's body. The distal cap further includes a notch provided at the top of the distal cap. The distal cap may be removable from the elevator assembly and / or the distal portion of the insertion tube. In some examples, the distal cap is not included.

[0063] The elevator assembly includes an opening for extending an instrument from an instrument tube. The instrument tube may extend through a portion of the insertion tube. The opening is located within a working chamber. The chamber may be defined by opposing side walls, the distal surface of the insertion tube, and the elevator. The elevator is located adjacent to the opening of the insertion tube. The elevator may be used to adjust the elevation of the instrument within the patient's body to access a desired location within the body during a procedure. The elevator includes a proximal end and a distal end. The elevator may be secured to the elevator assembly by a pivot pin. During the articulation movement of the elevator, the elevator rotates around the pivot pin, allowing the distal end of the elevator to move up and down. The elevator may include a notch at its distal end that is opposed to a notch in the distal cap. The opposed notch may be used to restrict unintended longitudinal or lateral movement of the instrument as it enters the patient's body through the tool channel. The notch can hold the instrument protruding from the opening, enhancing control over the instrument.

[0064] The elevator assembly further includes an elevator control wire. The elevator control wire may be a single strand preformed wire for articulating motion of the elevator. The elevator wire can be configured to translate over a stationary curved ramp, thereby imparting rotational torque to the elevator. The elevator wire is operated by the elevator control assembly to control the height of the elevator.

[0065] The elevator assembly may further define a light window through which light, such as from a light-emitting diode, passes. This allows the user to illuminate the patient's body during the procedure. The elevator assembly may further define an imaging window for providing images to the endoscopist.

[0066] This disclosure further provides a system comprising an endoscope assembly, a cartridge, and a console. The system may include a cartridge inserted into a control valve assembly of the console. The cartridge may be connected to the endoscope by an umbilical. For example, the cartridge may be connected to the disposable shaft assembly of the endoscope by one or more fluid tubes and / or electrical conductors.

[0067] The cartridge may be connected to a support device. The support device may include a perfusion pump, an insufflation device, and / or a vacuum pump (e.g., standalone or centralized). The cartridge may be positioned between the endoscope and the support device.

[0068] In some examples, the console may include a user interface that allows the user to change various variables of the endoscopy system. In one example, the user interface may be a touchscreen integrated into an electrovisual display. In another example, the user interface may include a keyboard, mouse, trackball, and / or touch-sensitive pointing device, etc.

[0069] The console may include a control valve assembly for receiving and operating cartridges. The console may provide power, fluid and / or fluid pressure, vacuum pressure, and / or transmit and / or receive electrical signals to and from the endoscope assembly. The console may include a monitor for visualizing signals received from the endoscope assembly, such as a video feed from a camera located at the distal end of a disposable shaft assembly.

[0070] A control valve assembly may be used to selectively actuate the actuated portion of the fluid path of a cartridge. The control valve assembly may include an actuator and a support structure having a first surface and a second surface.

[0071] The actuator may be a linear actuator or a rotary actuator. The actuator may be a solenoid. While the applicant prefers only one actuator, in a preferred embodiment the control valve assembly includes four actuators. The actuators are configured to actuate the valve portion of the fluid path in the cartridge to selectively open and / or close the fluid path.

[0072] The valve portion of the fluid path may consist of any acceptable valve. For example, the valve portion may consist of a petcock. Alternatively, the valve portion may consist of a tubular portion (e.g., a pinch valve) positioned for compression between the anvil on the first surface of the door and the 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 the actuator, a camera flash valve associated with the actuator, a pneumoperitoneum valve associated with the actuator, and / or a pneumoperitoneum vent valve associated with the actuator.

[0073] The actuator of the control valve assembly is received by the console and includes an electrical connector that electrically connects the actuator to the console. Once connected to the console, the console can supply power and user-entered commands to the actuator to open and / or close the fluid path of the cartridge.

[0074] The cartridge may include an identifier that is readable and / or writable by the control valve assembly. The identifier may include information about 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 made readable and / or writable via the cartridge's electrical connector and / or by other means (e.g., RFID, optical system, and / or mechanical contact).

[0075] The first surface of the support structure may include an electrical connector for forming an electrical connection with the cartridge's electrical connector. The electrical connection between the console's control valve assembly and the cartridge may allow the console to receive image and control data (such as valves / actuators and / or image data) passed from the endoscope through the cartridge to the console. The electrical connection may also allow the console to supply power to the light-emitting diodes (LEDs) of the endoscope assembly.

[0076] The cartridge can be a disposable cartridge. Disposable cartridges eliminate the need for the use of reusable valve bodies contained within the endoscope and / or console. This eliminates the need to sterilize reusable valves after each use.

[0077] The cartridge has a housing. The housing may include a first side and a second side. The housing may further include a first fluid side and a second fluid side that allow fluid to enter and exit the cartridge housing. The housing may have one or more fluid paths, fluid connectors, and / or electrical connectors. For example, the cartridge housing may include an electrical connector that electrically communicates with the electrical conductor of the endoscope, and optionally an optical sensor module containing optical sensor calibration data or an optical sensor unique identifier of the endoscope. The housing may define windows. In one example, the housing has four windows. The windows may be defined by the 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 that of the other windows to accommodate a larger fluid path cross-section.

[0078] The window may be configured to receive an actuator into a chamber defined by its inner surface from the console. As described above, the actuator can pass through the window and / or contact the anvil on the door of the control valve assembly on the console to form a pinch valve on the door. When the 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 window may be positioned to define a geometric shape. For example, as illustrated, the window may define a rhombus.

[0079] As described above, one or more actuators may be solenoids configured to extend into the window of the cartridge housing and / or contact an anvil on the door of the control valve assembly to form a pinch valve when closed.

[0080] The housing may further include electrical connectors for connecting to the electrical connectors of the control valve assembly. The electrical connectors of the cartridge may be spring-finger electrical contacts configured to contact a corresponding number of flat-pad electrical contacts on the control valve assembly of the console, or structurally the other way around. The electrical connectors of the cartridge housing may transmit image and control data provided by the endoscope to the console. The electrical connectors of the housing may also supply power from the console to LEDs used by the endoscope inside the patient's body.

[0081] The cartridge can be inserted into the console's control valve assembly. The cartridge is inserted between the first faces of the support structure of the control valve assembly. The first fluid side of the cartridge may include a loose tube that continues into the umbilical and leads to the disposable shaft assembly of the endoscope.

[0082] The second fluid side of the cartridge may be connected to a support device. The support device may include a perfusion pump, an insufflation device, and / or a vacuum pump (standalone or central). The cartridge can provide fluid communication between the endoscope and the support device.

[0083] The control valve assembly may include a ledge surface and a latch. The cartridge may include a ledge surface and a latch receiving portion. In an alternative example, the control valve assembly may include a latch receiving portion and the cartridge may include a latch. When the cartridge is accepted into the control valve assembly, the latch contacts the latch receiving portion to secure the first end of the cartridge to the control valve assembly. Separately, on the opposite side of the latch and latch receiving portion, the ledge surface of the cartridge and the ledge surface of the control valve assembly contact each other to secure the second end of the cartridge to the control valve assembly.

[0084] In some examples, the cartridge may include two or more magnets located on a first side of the cartridge. In some examples, one magnet may be located at the bottom of the first side of the cartridge and a second magnet at the top of the first side of the cartridge. The first surface of the control valve assembly may include two or more magnetic sensors (Hall or Reed) corresponding to the positions of the magnets on the cartridge. For example, one may be located at the bottom of the first surface and the other at the top of the first surface. The magnet at the bottom of the cartridge interferes with the magnetic sensor at the bottom of the control valve assembly to actuate an actuator (e.g., a solenoid) valve to retract, reducing the force required to tilt the cartridge into the control valve assembly. The magnet at the top interferes with the magnetic sensor at the top of the control valve assembly to detect the presence of the cartridge on the console and actuate the console to release the appropriate actuator and initiate the actuator operating mode for endoscopy.

[0085] The console can be connected to a first cartridge and a second cartridge. The first cartridge can be connected to a first endoscope, and the second cartridge can be connected to a second endoscope. The first cartridge and the second cartridge can be securely inserted into a first control valve assembly and a second control valve assembly of the console, respectively. Although the console is illustrated with the first and second control valve assemblies, the console can have any number of control valve assemblies, each capable of accepting an independent cartridge. The first control valve assembly can accept the first cartridge, and the second control valve assembly can accept the second cartridge. It is not necessary for all control valve assemblies to accept cartridges during all medical procedures.

[0086] As illustrated, each cartridge can be connected to a separate set of support devices and to an independent medical instrument such as an endoscope.

[0087] The first and second control valve assemblies are configured to operate independently and / or in a master / slave communication configuration. The first or mother endoscope may be the master controller and the second or daughter endoscope may be the slave controller. In this case, the control device of the first endoscope can control one or more functions of the second endoscope (e.g., image control and / or LEDs). The master endoscope can control the function of the fluid path of the secondary endoscope by supplying electrical signals to the second control valve assembly (e.g., via one or more cartridges connected to a console) to selectively actuate the actuators described herein. The first endoscope can further control the functions of the second endoscope (e.g., LED and / or camera operation) by providing electrical signals from the first endoscope to change the state of the second control valve assembly (e.g., changing the electrical signals supplied from the second control valve assembly to the cartridge of the second endoscope). For example, the control valve assembly can provide electrical signals to the LED and / or camera of the second endoscope based on signals received from the first endoscope. This further enables setting up and using multiple endoscopes at once, eliminating or reducing the significant setup time typically required to swap one endoscope for another, and / or eliminating or reducing the need for additional equipment such as multiple control consoles.

[0088] The console is presented with a touchscreen user interface. The user interface can be any suitable input / output device.

[0089] A disposable shaft assembly may include an insertion tube, an umbilical connected to a cartridge and connected to a console, an access port for selective access to the lumen of the disposable shaft assembly (for example, to take a sample such as a biopsy) and / or for delivering fluid through the lumen of the disposable shaft assembly, and an electrical connector for electrically connecting the disposable shaft assembly to a reusable handpiece.

[0090] The umbilical may extend from the cartridge to the disposable shaft assembly of the endoscope. Multiple fluid pathways and / or electrical wiring may extend within the umbilical to the distal end of the insertion tube. Fluid pathways may include pathways for aspiration, tissue irrigation, camera cleaning, and / or pneumoperitoneum. Fluid pathways may be valve-free from the distal end of the endoscope to the tip of the umbilical. Fluid pathways may contain valves only within the boundaries of the cartridge.

[0091] Preferably, one or more fluid pathways are defined by a monolithic tube extending from a disposable shaft assembly to a cartridge. More preferably, the monolithic tube extends through the cartridge to the outside of the second fluid side of the cartridge.

[0092] The camera cleaning fluid pathway and the pneumoperitoneum fluid pathway can be combined using a T-joint on a disposable shaft assembly. This allows the pressure from the pneumoperitoneum to be used to push water from the water source through the camera cleaning fluid pathway from the distal end, removing debris accumulated on the camera lens during the procedure.

[0093] The umbilical may further include an image data conductor, a control data conductor, and / or an LED power conductor. The image data conductor and / or LED power conductor may extend through a disposable shaft assembly to the distal end of the insertion tube. The image data conductor enables the transmission of image data captured from the camera to the console. The LED power conductor can supply power from the console to an LED at the distal end of the insertion tube, providing illumination for the procedure. The control data conductor enables the communication of control data from the control unit of the reusable handpiece to the cartridge, and consequently, communication to the console.

[0094] Furthermore, packaging systems and methods for maintaining the sterility of medical products, such as endoscope assemblies or parts of endoscope assemblies, are disclosed. The disclosed packaging systems can be used for many medical products, but in this disclosure, the medical product is described as an endoscope assembly. In one example, the packaging assembly includes an elongated tray having a first end and a second end. The tray defines a recess for holding the endoscope assembly. In some examples, the tray may be manufactured by thermoforming and may be made of a recyclable material that allows the tray to be recycled after use.

[0095] The tray may be formed so that medical products can be simply placed in the tray in one form. The tray can be thermoformed. The tray preferably defines a recess. The recess may preferably define multiple compartments to accommodate various parts of an endoscope assembly. The recess may include an insertion tube compartment, a disposable shaft assembly compartment, an umbilical compartment, and a cartridge compartment. The recess may include additional compartments if additional parts are to be stored in the tray. If fewer parts are to be stored in the same tray, the recess may include fewer compartments. For example, cartridges may be sold separately or in separate containers within a packaging system, in which case there is no need for a cartridge compartment in the tray.

[0096] The tray may include hanger slots, for example, a pair of hanger slots, at the first end of the tray. The hanger slots may be mounted as separate parts or formed from the material forming the tray. The hanger slots allow the elongated package to be suspended from a support arm. The support arm can be mounted on the wall or ceiling of the operating room. In some examples, the support arm can be mounted on a cart. When mounted vertically to the support arm, part or all of the tray is suspended above the floor.

[0097] The packaging system may further include a cover (e.g., a sterile barrier) that extends over and covers the recess of the tray, sealing it from external contaminants and keeping the endoscope assembly aseptically sealed. The cover may be a peelable cover that allows the user easy access to the endoscope assembly. The cover may be made of high-density polyethylene fibers such as Tyvek®.

[0098] In some examples, the tray may include a two-piece endoscope containing a reusable handpiece and a disposable shaft assembly. In the illustrated example, only the disposable shaft assembly is included in the packaging system. The disposable shaft assembly may include an insertion tube at the patient-side end of the endoscope. The disposable shaft assembly may further include an umbilical extending to and connecting to a cartridge. Any combination of components in the tray may be supplied connected to other components and / or fully assembled.

[0099] The packaging system may include a first cover, and in some examples, the packaging system may include multiple covers. In the illustrated example, the first cover is used to hold the cartridges in a tray (e.g., a cartridge compartment). The packaging system may also include a second cover for holding disposable shaft assemblies in a tray (e.g., a disposable shaft assembly compartment).

[0100] During preparation for a procedure, the user may remove the cover to allow access to the endoscope assembly. In this specification, "user" means an endoscopist, nurse, technician, physician, or any other individual who may be involved in the procedure. In some examples, during setup, the cover may be removed only partially at a time. By partially removing the cover (e.g., the sterile barrier), the user can set up the endoscope for the procedure while keeping the rest of the endoscope assembly sterile and / or reducing the risk of contamination. The first cover may be removed to expose the cartridge. The cartridge and umbilical can be removed to mount the cartridge to the console.

[0101] Advantageously, by peeling off only a portion of the cover (e.g., a sterile barrier) and / or less than the entire cover, the handle and insertion tube are still protected from various contaminants. Often, the package system is suspended from a support arm. When the package is opened, the insertion tube may shake during setup / preparation, potentially colliding with the cart, the cart's wheels, or the user moving around the room. By keeping the insertion tube covered (e.g., a sterile barrier), even if the sterile seal is broken, the cover protects the insertion tube from the attachment of various contaminants through contact with anything in the surroundings.

[0102] Next, the second cover can be pulled to allow access to the disposable shaft assembly within the disposable shaft assembly compartment. Depending on whether the user removes the cover in sections or all at once, the second cover (e.g., sterile barrier) may be further removed to complete this step. In some examples, the first cover must be removed before the second cover, and the user is required to follow the same setup procedure. In other examples, the second cover is independent of the first cover, and both covers can be accessed separately. Once the second cover is removed, the disposable shaft assembly can be removed for setup. To facilitate removal of the disposable shaft assembly and insertion tube, the cover may be slid vertically along the side of the tray to expose the insertion tube more broadly.

[0103] The reusable handpiece can be held by a support arm. Once the disposable shaft assembly is removed from the packaging system, the user can attach the disposable shaft assembly to the reusable handpiece.

[0104] A second example is a package for a curved, flexible endoscope. The package assembly includes a tray, which defines a recess for holding the endoscope assembly. In some examples, the tray may be manufactured by thermoforming and may be made of a recyclable material that allows the tray to be recycled after use.

[0105] The tray may be formed so that medical products can be simply placed in the tray in one form. The tray may be thermoformed. The tray preferably defines a recess. The recess preferably defines multiple compartments / tracks for housing various parts of an endoscope assembly. The recess may include an insertion tube track, a disposable shaft assembly compartment, an umbilical track, and a cartridge compartment. The curved package system may further include a suction tube compartment for holding a suction tube. Unlike the elongated tray described above, the compartments for the insertion tube and umbilical surround the center of the tray. The umbilical and insertion tube are wound around the center of the package. The tracks for the umbilical and insertion tube may overlap. If the tracks overlap, the umbilical may be positioned above the insertion tube. The recess may include additional compartments if additional parts are to be stored in the tray. If fewer parts are to be stored in the same tray, the recess may include fewer compartments. For example, cartridges can be sold separately or in a separate container within the packaging system, in which case there is no need to include a cartridge compartment within the tray.

[0106] The tray may include hanger slots at its upper edge, for example, a pair of hanger slots. The hanger slots may be mounted as separate parts and / or defined by the material forming the tray. The hanger slots allow the elongated package to be suspended from a support arm. The support arm can be mounted on the wall or ceiling of the operating room. In some examples, the support arm can be mounted on a cart. When mounted on a support arm, the entire tray is suspended above the floor. Due to the compact configuration of the curved package system, the tray can be placed on a cart rather than suspended from a support arm.

[0107] The packaging system may further include a cover (e.g., a sterile barrier) that extends over and / or seals the endoscope assembly from external contaminants, keeping it sterile. The cover may be a peelable cover that allows the user easy access to the endoscope assembly. The cover may be made of high-density polyethylene fibers such as Tyvek®.

[0108] Similar to elongated packaging systems, curved packaging systems may include a first cover, and in some examples, the packaging system may include two or more covers. In the illustrated example, the first cover is used to hold the cartridge within the tray / cartridge compartment. The packaging system may include a second cover for holding the disposable shaft assembly within the tray / disposable shaft assembly compartment.

[0109] Similar to elongated packaging systems, curved packaging systems can be designed to encourage users to remove endoscope assemblies in the desired order. During setup, the cover (e.g., sterile barrier) can be partially and / or completely removed (e.g., peeled off) to access the entire endoscope assembly. This packaging system configuration reduces the risk of contaminants being present within the packaging system.

[0110] First, the first cover that holds the cartridge can be moved to allow access to the cartridge. The cartridge and umbilical can then be removed, and the cartridge can be mounted on the console. Next, the second cover can be moved to allow access to the disposable shaft assembly. The disposable shaft assembly can be removed from the tray and mounted on the reusable handpiece assembly. Finally, the insertion tube can be removed and left on a sterile surface until it is inserted into the patient or the procedure begins.

[0111] Advantageously, this packaging system allows one or more individuals to sequentially unpack medical devices in preparation for treatment, while protecting the components inside the package from contamination from the surrounding environment during setup.

[0112] Furthermore, a cartridge having an extension of a suction tube incorporating a T-fitting is disclosed. This configuration can be used with a flexible, disposable observation endoscope incorporating a suction tube with an in-line T-fitting. The T-fitting may include a removable cap. The removable cap protects the side port of the T-fitting from contamination when the T-fitting is not in use and is removable when use is desired. The side port of the T-fitting can be mated to a connector on a cholangioscopy suction tube.

[0113] Furthermore, a method for selecting one or more endoscopic imaging devices to display on a monitor during an endoscopic procedure is disclosed. In many cases, multiple endoscopes are used to perform the procedure. This method relates to identifying which endoscope images should be displayed on the monitor. In some embodiments, multiple monitors may be used. In other embodiments, one monitor may be used to display images from all endoscopes. When using one monitor, the endoscope being used may be identified and displayed as the dominant or largest image among other smaller images on the same screen / monitor.

[0114] This method may include identifying the endoscope being used at a given point in time during a procedure. The endoscope can be identified using a switch, such as a mechanical switch, an induction switch, or a capacitive switch (e.g., a touch switch). The switch may also be a sensor. In some embodiments, the switch is a touch switch, and when the endoscope is picked up by the endoscopist, the switch is activated to identify the endoscope currently being used in the procedure. When the switch is activated, a signal is relayed from the switch to a controller to identify which endoscope is being used. The controller relays the signal / image from the associated endoscope to a monitor. The identified image becomes the dominant image on the screen while the endoscope is being used. In some examples, multiple endoscopes may be used simultaneously. When multiple endoscopes are used simultaneously, the images from the endoscopes being used can be displayed on the monitor at the same size. In other examples, a dominant endoscope can be identified. If the dominant endoscope is being used simultaneously with other endoscopes, the image from the dominant endoscope can be made the largest image on the monitor.

[0115] Furthermore, three embodiments of an image sensor assembly used in various types of endoscopes, such as gastroscopes, colonoscopes, duodenoscopes, or cholangioscopy, are disclosed. Broadly speaking, the camera-LED board is positioned at the distal end of the insertion tube, and a cable with an electrical connector extends from the distal end of the insertion tube to the proximal end of the insertion tube, and to the electrical connector / circuit board in the cartridge. As described above, the electrical connector in the cartridge is connected to the console and transmits electrical signals between the cartridge and the console. In some embodiments, the electrical connector in the cartridge may include a spring finger electrical connector for contacting a spring finger on the console.

[0116] The image sensor assembly includes a camera-LED board. One side of the camera-LED board is bonded to a cable. The cable can be bonded to the board by any method known in the art, for example, with an adhesive. Multiple wires (not shown) extend from the distal end of the cable and are soldered to the board. These wires are soldered to the board to transmit signals between the cartridge and the camera-LED board. The other end of the same wires extends from the proximal portion of the cable and is soldered to the surface of the flexible circuit. The wires can be arranged to be appropriately spaced across the surface of the flexible circuit.

[0117] The flex circuit is operably mounted to a microconnector. The microconnector can be either a male or female connector with the opposite end positioned on the cartridge's electrical connector. The male and female connectors are connected to complete the electrical path between the camera and / or LED and the cartridge. In some embodiments, the microconnector may be a mezzanine connector.

[0118] In assembly, the proximal end of the wire, including the flex circuit and microconnector, is passed through the distal end of the insertion tube and then through the insertion tube toward the proximal end. The flex circuit and microconnector are then passed through the endoscope and umbilical and onto a cartridge operably connected to the end of the umbilical. The female or male portion of the microconnector located on the flex circuit is then connected to the corresponding portion of the microconnector located on the electrical connector of the cartridge. Advantageously, this manufacturing method avoids the potentially difficult and time-consuming task of passing the cable through the insertion tube before connecting the camera and LED board to the cable. Furthermore, this method avoids the potentially damaging and / or requiring a larger insertion tube to accommodate the camera, which may occur when passing the camera through the insertion tube.

[0119] The flex circuit and microconnector preferably have a combined height of less than 1 mm. More preferably, the combined height of the flex circuit and microconnector is less than 0.8 mm. In such an arrangement, the combined height can range from 0.6 mm to 0.8 mm. The flex circuit itself may have a height of about 0.2 mm.

[0120] The circuit board may further include a memory device for storing imaging data from the camera.

[0121] The image sensor assembly may further include a second microconnector on the cartridge electrical connector. The second microconnector is also mounted on a flexible circuit, similar to the arrangement described above. The flexible circuit includes wires extending from the flexible circuit on the cartridge circuit board to the disposable shaft assembly electrical connector. The disposable shaft assembly electrical connector is connectable to the electrical connector of a reusable handpiece for transmitting electrical signals / commands between two endoscope pieces.

[0122] Any of the features and embodiments of the invention described herein may be used independently or in combination with each other. A single medical device may include any and / or all of the embodiments disclosed herein.

[0123] Other features, purposes, and advantages of this disclosure will become more apparent from the following detailed description, in conjunction with the accompanying drawings. Further forms, purposes, features, aspects, benefits, advantages, and examples of this disclosure will become apparent from the detailed description and drawings provided herein. [Brief explanation of the drawing]

[0124] [Figure 1] Figure 1 shows the endoscope assembly, cartridge, and console. [Figure 2] Figure 2 shows the endoscope assembly from Figure 1. [Figure 3]Figure 3 shows the endoscope assembly from Figure 1. [Figure 4] Figure 4 is an exploded perspective view of the endoscope assembly shown in Figure 1. [Figure 5] Figure 5 shows a disposable shaft assembly for an endoscope assembly. [Figure 6] Figure 6 is a perspective view of the Puri Assembly Housing. [Figure 7A] Figure 7A is a perspective view of the pulley assembly. [Figure 7B] Figure 7B is a perspective view of the pulley assembly with the housing cover removed. [Figure 8] Figure 8 is an exploded perspective view of the pulley assembly shown in Figure 6. [Figure 9] Figure 9 is an exploded perspective view of the pulley assembly shown in Figure 6. [Figure 10] Figure 10 is a magnified view of the rotation-stopping idler that is interfering with the pulley housing cover. [Figure 11] Figure 11 is a cross-sectional view of the articulation knob brake assembly. [Figure 12] Figure 12 is a perspective view of the articulation knob brake assembly. [Figure 13] Figure 13 is a side view of the articulation knob brake assembly. [Figure 14] Figure 14 is an exploded view of the articulation knob brake assembly. [Figure 15] Figure 15 is a cross-sectional view of the upper and lower articulation knobs and brake portion of the articulation knob brake assembly. [Figure 16] Figure 16 is an exploded perspective view of the upper and lower articulated brake levers and the upper and lower articulated brake outer housings. [Figure 17] Figure 17 is an exploded view of the upper and lower articulation hubs, upper and lower articulation brake detents, and upper and lower articulation brake calipers. [Figure 18] Figure 18 is a perspective view of the upper and lower articulation brake outer housings and upper and lower articulation shafts. [Figure 19] Figure 19 is a perspective view of the upper and lower articulated brake outer housings shown in Figure 18. [Figure 20] Figure 20 is a side view of an articulation knob brake assembly that lacks an articulation knob, outer housing, upper and lower articulation brake levers, and an articulation brake inner housing. [Figure 21] Figure 21 is a perspective view of the left and right articulated brake outer housings and left and right articulated shafts. [Figure 22] Figure 22 is a perspective view of the left and right articulated brake shafts and left and right articulated brake hubs. [Figure 23] Figure 23 is a perspective view of the left and right articulated brake shafts and left and right articulated brake hubs shown in Figure 22. [Figure 24] Figure 24 is a partially exploded view of the articulation knob brake assembly, showing the upper and lower articulation knobs, left and right articulation knobs, and left and right articulation brake knobs separated from the articulation knob brake assembly. [Figure 25] Figure 25 is a perspective view showing a reusable handpiece assembly of an endoscope assembly. [Figure 26] Figure 26 is an exploded perspective view of the reusable handpiece assembly shown in Figure 25. [Figure 27] Figure 27 is a perspective view of the insertion tube assembly. [Figure 28] Figure 28 is a cross-sectional view of the insertion tube assembly shown in Figure 27. [Figure 29] Figure 29 is a side view of the articulation link assembly. [Figure 30]Figure 30 shows the endoscope assembly and insertion tube. [Figure 31] Figure 31 shows the endoscope assembly and insertion tube. [Figure 32] Figure 32 is a partially exploded perspective view of a disposable shaft assembly. [Figure 33] Figure 33 is a partially exploded view of the pulley assembly exposing the elevator control assembly. [Figure 34] Figure 34 is a perspective view of the insertion tube tip assembly. [Figure 35] Figure 35 is a partially exploded view of the insertion tube tip assembly shown in Figure 34. [Figure 36] Figure 36 is a perspective view of the insertion tube tip assembly from Figure 34 with the distal cap removed. [Figure 37] Figure 37 is a partially exploded perspective view of the elevator assembly. [Figure 38] Figure 38 is a perspective view of an example of a cartridge and console including a control valve assembly. [Figure 39] Figure 39 is a perspective view of the control valve assembly shown in Figure 38. [Figure 40] Figure 40 is a perimeter view of a medical packaging design. [Figure 41] Figure 41 is a perimeter view of the medical packaging design with the cover removed. [Figure 42] Figure 42 is a perimeter view of the medical packaging design with multiple covers removed. [Figure 43] Figure 43 is a perimeter view of the medical packaging design with the cartridge removed and secured to the console. [Figure 44] Figure 44 is a circumferential view of the medical packaging design with the handle of the disposable shaft assembly removed and secured to the reusable handpiece assembly. [Figure 45] Figure 45 is a perspective view of a packaging system for medical products. [Figure 46]Figure 46 is a top view of the packaging system shown in Figure 45. [Figure 47] Figure 47 is an exploded view of the packaging system shown in Figure 45. [Figure 48] Figure 48 is a perspective view of the packaging system from Figure 45 with the cover removed. [Figure 49] Figure 49 is a perspective view of the packaging system of Figure 45 with the first and second covers removed. [Figure 50] Figure 50 is a perspective view of another example of a packaging system for medical products. [Figure 51] Figure 51 is a top view of the packaging system shown in Figure 50. [Figure 52] Figure 52 is another perspective view of the packaging system shown in Figure 50. [Figure 53] Figure 53 illustrates a cartridge having a suction tube with a T-fitting. [Figure 54] Figure 54 is a flowchart showing how to select between one or more imaging devices for endoscopes. [Figure 55A] Figure 55A shows one embodiment of an image sensor assembly. [Figure 55B] Figure 55B shows one embodiment of an image sensor assembly. [Figure 55C] Figure 55C shows one embodiment of an image sensor assembly. [Figure 55D] Figure 55D shows one embodiment of an image sensor assembly. [Figure 56A] Figure 56A is one of several enlarged views of the camera and LED board of the embodiment shown in Figures 55A-55D. [Figure 56B] Figure 56B is one of several enlarged views of the camera and LED board of the embodiment shown in Figures 55A-55D. [Figure 56C] Figure 56C is one of several enlarged views of the camera and LED board of the embodiment shown in Figures 55A-55D. [Figure 56D] Figure 56D is one of several enlarged views of the camera and LED board of the embodiment shown in Figures 55A-55D. [Figure 57A] Figure 57A is one of several diagrams of the electrical connector of the cartridge in the embodiment shown in Figures 55A-55D. [Figure 57B] Figure 57B is one of several diagrams of the electrical connector of the cartridge in the embodiment shown in Figures 55A-55D. [Figure 57C] Figure 57C is one of several diagrams of the electrical connector of the cartridge in the embodiment shown in Figures 55A-55D. [Figure 57D] Figure 57D is one of several diagrams of the electrical connector of the cartridge in the embodiment shown in Figures 55A-55D. [Figure 57E] Figure 57E is one of several diagrams of the electrical connector of the cartridge in the embodiment shown in Figures 55A-55D. [Figure 58A] Figure 58A is a diagram of the electrical connector of a disposable shaft assembly according to the embodiment shown in Figures 55A-55D. [Figure 58B] Figure 58B is a diagram of the electrical connector of the disposable shaft assembly of the embodiment shown in Figures 55A-55D. [Figure 58C] Figure 58C is a diagram of the electrical connector of a disposable shaft assembly according to the embodiment shown in Figures 55A-55D. [Figure 58D] Figure 58D is a diagram of the electrical connector of a disposable shaft assembly according to the embodiment shown in Figures 55A-55D. [Figure 59A] Figure 59A shows the camera and LED board flex circuit and microconnector, as well as the disposable shaft assembly electrical connector flex circuit and microconnector, according to the embodiments shown in Figures 55A-55D. [Figure 59B]Figure 59B shows the camera and LED board flex circuit and microconnector, as well as the disposable shaft assembly electrical connector flex circuit and microconnector, according to the embodiments shown in Figures 55A-55D. [Figure 59C] Figure 59C shows the camera and LED board flex circuit and microconnector, as well as the disposable shaft assembly electrical connector flex circuit and microconnector, according to the embodiments shown in Figures 55A-55D. [Figure 59D] Figure 59D shows the camera and LED board flex circuit and microconnector, as well as the disposable shaft assembly electrical connector flex circuit and microconnector, according to the embodiment shown in Figures 55A-55D. [Figure 60A] Figure 60A shows a second embodiment of the image sensor assembly. [Figure 60B] Figure 60B shows a second embodiment of the image sensor assembly. [Figure 60C] Figure 60C shows a second embodiment of the image sensor assembly. [Figure 60D] Figure 60D shows a second embodiment of the image sensor assembly. [Figure 61A] Figure 61A is one of several enlarged views of the camera and LED board of the embodiment shown in Figures 60A-D. [Figure 61B] Figure 61B is one of several enlarged views of the camera and LED board of the embodiment shown in Figures 60A-D. [Figure 61C] Figure 61C is one of several enlarged views of the camera and LED board of the embodiment shown in Figures 60A-D. [Figure 61D] Figure 61D is one of several enlarged views of the camera and LED board of the embodiment shown in Figures 60A-D. [Figure 62A] Figure 62A is one of several diagrams of the electrical connector of the cartridge in the embodiment shown in Figures 60A-D. [Figure 62B]Figure 62B is one of several diagrams of the electrical connector of the cartridge in the embodiment shown in Figures 60A-D. [Figure 62C] Figure 62C is one of several diagrams of the electrical connector of the cartridge in the embodiment shown in Figures 60A-D. [Figure 62D] Figure 62D is one of several diagrams of the electrical connector of the cartridge in the embodiment shown in Figures 60A-D. [Figure 62E] Figure 62E is one of several diagrams of the electrical connector of the cartridge in the embodiment shown in Figures 60A-D. [Figure 63A] Figure 63A is one of several diagrams of the electrical connector of a disposable shaft assembly in the embodiment shown in Figures 60A-D. [Figure 63B] Figure 63B is one of several diagrams of the electrical connector of a disposable shaft assembly in the embodiment shown in Figures 60A-D. [Figure 63C] Figure 63C is one of several diagrams of the electrical connector of a disposable shaft assembly in the embodiment shown in Figures 60A-D. [Figure 63D] Figure 63D is one of several diagrams of the electrical connector of a disposable shaft assembly of the embodiment shown in Figures 60A-D. [Figure 64A] Figure 64A shows the camera and LED board flex circuit and microconnector, as well as the disposable shaft assembly electrical connector flex circuit and microconnector, according to the embodiment shown in Figures 60A-D. [Figure 64B] Figure 64B shows the camera and LED board flex circuit and microconnector, as well as the disposable shaft assembly electrical connector flex circuit and microconnector, according to the embodiments shown in Figures 60A-D. [Figure 64C] Figure 64C shows the camera and LED board flex circuit and microconnector, as well as the disposable shaft assembly electrical connector flex circuit and microconnector, according to the embodiments shown in Figures 60A-D. [Figure 64D] Figure 64D shows the camera and LED board flex circuit and microconnector, as well as the disposable shaft assembly electrical connector flex circuit and microconnector, according to the embodiment shown in Figures 60A-D. [Figure 65A] Figure 65A shows a third embodiment of the image sensor assembly. [Figure 65B] Figure 65B shows a third embodiment of the image sensor assembly. [Figure 65C] Figure 65C shows a third embodiment of the image sensor assembly. [Figure 66A] Figure 66A is one of several enlarged views of the camera and LED board of the embodiment shown in Figures 65A-C. [Figure 66B] Figure 66B is one of several enlarged views of the camera and LED board of the embodiment shown in Figures 65A-C. [Figure 66C] Figure 66C is one of several enlarged views of the camera and LED board of the embodiment shown in Figures 65A-C. [Figure 66D] Figure 66D is one of several enlarged views of the camera and LED board of the embodiment shown in Figures 65A-C. [Figure 66E] Figure 66E is one of several enlarged views of the camera and LED board of the embodiment shown in Figures 65A-C. [Figure 66F] Figure 66F is one of several enlarged views of the camera and LED board of the embodiment shown in Figures 65A-C. [Figure 67A] Figure 67A is one of various diagrams of the electrical connector of the cartridge of the embodiment shown in Figures 65A-C. [Figure 67B] Figure 67B is one of several diagrams of the electrical connector of the cartridge in the embodiment shown in Figures 65A-C. [Figure 67C] Figure 67C is one of several diagrams of the electrical connector of the cartridge in the embodiment shown in Figures 65A-C. [Figure 67D]Figure 67D is one of several diagrams of the electrical connector of the cartridge in the embodiment shown in Figures 65A-C. [Figure 67E] Figure 67E is one of several diagrams of the electrical connector of the cartridge in the embodiment shown in Figures 65A-C. [Figure 68A] Figure 68A shows the flexible circuit and microconnector of the camera and LED board according to the embodiment shown in Figures 65A-C. [Figure 68B] Figure 68B shows the flexible circuit and microconnector of the camera and LED board according to the embodiment shown in Figures 65A-C. [Modes for carrying out the invention]

[0125] For the purpose of understanding the principles of this disclosure, examples illustrated in the drawings will be used for further explanation below. However, it will be understood that this does not limit the scope of this disclosure. Any changes and further modifications to the examples described, as well as any further applications of the principles of this disclosure described herein, will be commonly made by those skilled in the art to which this disclosure relates. While exemplary examples of this disclosure are described in more detail, it will be apparent to those skilled in the art to which the disclosure relates that some features not relevant to this disclosure may not be shown for the sake of clarity in the description herein.

[0126] This disclosure provides an endoscope assembly including a reusable handpiece and a disposable (single-use) shaft assembly. Figures 1-4 illustrate the endoscope assembly. Figure 1 shows the endoscope assembly 100, cartridge 500, and console 1000. More specifically, Figures 1-4 show the endoscope assembly with the reusable handpiece 200 attached to the disposable shaft assembly 400. Figure 4 shows the endoscope assembly with the reusable handpiece removed from the disposable shaft assembly.

[0127] The reusable handpiece can be selectively attached to and detached from the disposable shaft assembly, thereby allowing the reusable handpiece to be used continuously with multiple disposable shaft assemblies, while enabling the disposable shaft assembly, including the cartridge, to be discarded and / or readjusted after a single use. The reusable handpiece and / or disposable shaft assembly may include a locking mechanism for selectively locking the reusable handpiece and disposable shaft assembly together. A latch handle 600 (e.g., a lever) for operating a latching mechanism that connects the reusable handpiece to the disposable shaft assembly may be located on the reusable handpiece and / or disposable shaft assembly. Additional locking mechanisms, such as magnets, can be used alternatively or simultaneously.

[0128] The reusable handpiece may have a handpiece housing 210 supporting an articulation knob brake assembly 300, control switches 202 for operating light such as light-emitting diodes and / or flash water and / or suction fluid channels, one or more navigation switches 204 for controlling a console that communicates with the endoscope assembly, and / or an electrical connector 205 (see Figure 25) for electrically coupling the reusable handpiece with a disposable shaft assembly.

[0129] A disposable shaft assembly may include an insertion tube 401 for insertion into the patient's body, a tube-electrical connector 402 connected to a console, an access port 403 for selective access to the lumen of the disposable shaft assembly (e.g., for taking a sample such as a biopsy) and / or for delivering fluid through the lumen of the disposable shaft assembly, and / or an electrical connector 404 for electrically coupling the disposable shaft assembly to a reusable handpiece.

[0130] The tubular-electrical connector 402, also called an "umbilical," extends from the endoscope assembly to a cartridge that can be connected to a console designed for use with the endoscope assembly. The tubular-electrical connector can extend from a disposable shaft assembly and / or a reusable handpiece. In some embodiments, the umbilical can connect directly to the console, eliminating the need for a cartridge.

[0131] The console may provide power, fluid and / or fluid pressure, vacuum pressure, and / or transmit and / or receive electrical signals to and from the endoscope assembly. The console may include a monitor (not shown) for visualizing signals received from the endoscope assembly, such as a video feed from a camera located at the distal end of a disposable shaft assembly.

[0132] A disposable shaft assembly may include one or more pulley assemblies 700 as shown in Figures 5-7B. The pulley assembly may include at least one pulley 750 positioned to receive the end of the articulation shaft. Preferably, the rotation of the articulation knob associated with the articulation shaft causes at least one pulley to rotate. Preferably, this at least one pulley and the end of the articulation shaft have a geometric shape (e.g., a mating structure) for rotatably coupling the pulley and the articulation shaft with respect to each other. Preferably, the mating structure does not rely solely on friction between the articulation shaft and the pulley. Preferably, the mating structure includes geometric interference between the articulation shaft and the pulley.

[0133] Each of the pulleys described above is associated with an articulation wire 753 or a pair of articulation pull wires (e.g., two separate wires or one continuous wire, each having wire segments arranged in a loop on the pulley and extending from opposite sides of the pulley) configured to bend the distal shaft portion of a disposable shaft assembly when in operation. The articulation wires can be attached to the pulley (e.g., tied or secured by anchors (not shown)) and / or extend around at least a portion of the pulley (e.g., looped around the pulley). Preferably, the pulley assembly includes two pulleys (one for each articulation wire) and articulation wires (at least one for each pulley). In the illustrated example, each pulley includes one groove (two grooves in total) for the articulation wires. Alternatively, each pulley may include two grooves (four grooves in total), using only one wire per groove to reduce the possibility of wire overlap and the resulting friction affecting performance. Preferably, the articulation wire is configured to bend the distal shaft portion in a plane perpendicular to it.

[0134] The pulley and associated articulation wire can be housed within the pulley housing 460. The pulley housing may consist of housing parts such as a cover piece 462 and an inner piece 464. These housing parts can work together to enclose the pulley at least partially.

[0135] The pulley housing may be constructed in a sandwich configuration with a pair of cover pieces on the outside / end and a pair of inner pieces, each coupled to one cover piece on one side and coupled to each other on the other side. In this embodiment, the pulley housing is configured to accommodate at least two pulleys. Such a housing portion can work together to enclose the pulleys and associated articulation wires. Preferably, the housing portion prevents the articulation wires from separating from the pulleys. The pulley housing may have openings for receiving the articulation shafts and / or brake shafts of the articulation control assembly.

[0136] Preferably, the housing portions are not joined to each other along a perfectly straight butt joint. For example, the inner piece and / or cover piece may be joined along a straight path. In some embodiments, the inner piece and cover piece have castellations (ridges) 466 and are joined such that the castellations of the inner piece coincide with the castellations on the cover piece. Advantageously, avoiding joining at a perfectly straight butt joint can help prevent wire slippage between the parts of the pulley assembly. In other examples, the joint between the housing portions may be straight, curved, curved, straight, or any other desired configuration.

[0137] Furthermore, the pulley assembly may include an articulation coil end block 505 that receives one or more articulation coils 756 wound around each articulation pull wire connected to the pulley. The articulation coil end block is adjustable to remove slack in the articulation pull wire. In other words, the articulation coil end block is adjustable along the longitudinal axis of the endoscope assembly to control the tension of the articulation pull wire.

[0138] Figures 8-10 illustrate a "two-stage articulation limit." This two-stage rotation stop assembly 760 allows the articulation knob to rotate further than with a single-stage stop. The two-stage rotation stop assembly may be completely housed within the pulley housing. The two-stage rotation stop assembly may have two pulleys and two rotation stop idlers 762 positioned on one side of each pulley, for example, the side opposite to the side with the recess for the articulation wire anchor. One pulley is for vertical articulation, and the other is for horizontal articulation. Each rotation stop idler may include individual grooves 764 (two in total) on the circumference of each side of the rotation stop idler. The grooves terminate at a stop portion 766a (e.g., a projection) so that the grooves do not circle 360 ​​degrees around the rotation stop idler.

[0139] Each pulley has a boss 752 on its side that interferes with a groove on the first side 768 of the stop idler. During rotation of the pulley relative to the stop idler, the boss on the pulley moves along the groove of the idler until it is blocked by a stop on the stop idler. When the pulley boss contacts the stop, the rotational force of the pulley is transmitted to the idler, causing it to rotate. The rotation of the idler is permitted depending on the contact between the stop idler and the housing.

[0140] On the second side surface 769 of the rotation-stopping idler, the second stop portion 766b interferes with the boss 754 located on the pulley housing, thereby limiting the degree of rotation of the rotation-stopping idler relative to the housing. For example, while the idler is rotating relative to the housing, the boss on the housing moves along the groove 766 on the second side surface of the rotation-stopping idler until the second stop portion of the idler contacts the boss on the housing and the rotation of the idler relative to the housing stops. Thus, after the rotation of the pulley relative to the rotation-stopping idler is blocked in the first direction, and after the rotation of the rotation-stopping idler relative to the housing is blocked in the first direction, the rotation of the articulation knob and pulley relative to the housing in the first direction is also blocked. The pulley can be rotated in a second direction opposite to the first direction. The description of rotation in the first direction also applies to the second direction.

[0141] To prevent wobbling of the stop idler, the stop idler can be made to have continuous bearing surfaces 770 on both sides of the idler. The continuous bearing surfaces provide a stable base for maintaining balance as the idler rotates within and relative to the pulley housing.

[0142] Advantageously, this embodiment has the function of limiting the rotation of the articulation knob for the endoscope when the required rotation of the articulation knob exceeds the rotation limit that can be achieved with a single-stage stop. On one side of the rotation-stopping idler, the allowable angular rotation of the pulley relative to the idler is equal to the angular length of the groove in the idler minus the angular length of the boss on the pulley. On the opposite side of the rotation-stopping idler, the allowable rotation of the idler relative to the housing is equal to the angular length of the groove in the idler minus the angular length of the boss on the pulley housing. Adding the degrees of rotation in these two "stages" gives the total angular distance that the pulley (and / or articulation knob) can move relative to the housing. For illustrative purposes, if the bosses each have an angular length of 45 degrees and the grooves of the rotation-stopping idler each have an angular length of 315 degrees, the degree of rotation on each side of the idler will be equal to 270 degrees, and the sum of the degrees of rotation on both sides will be the movable angle of the pulley relative to the housing, which is 540 degrees. It is understood that the bosses, grooves, and / or stop members may have the same or different angular lengths, and that the bosses, grooves, and / or stop members may have angular lengths greater than or less than 45 degrees.

[0143] Furthermore, one or more bosses may be separate parts, and the grooves may follow a helical path. Thus, as the bosses move along the groove path, they translate along the surface of the pulley and / or housing. Advantageously, such arrangements can provide grooves with angular lengths of 360 degrees or more.

[0144] While grooves and stop sections have been described as being defined by a rotation-stopping idler, and bosses as belonging to the pulley and / or housing, the arrangements disclosed herein are not limited in this way. Grooves and stop sections may be defined by the pulley and / or housing, and one or more bosses may be part of the rotation-stopping idler.

[0145] Referring here to Figures 11-23 as an example, the articulation knob / brake assembly of a reusable handpiece may include an upper and lower articulation knob 313, a left and right articulation knob 314, an upper and lower articulation brake 330, and a left and right articulation brake 340. During operation, with the reusable handpiece attached to the disposable shaft assembly, the upper and lower articulation knobs actuate the distal portion of the disposable shaft assembly in a first plane, and the left and right articulation brake knobs actuate the distal portion of the disposable shaft assembly in a second plane that intersects the first plane. Preferably, the second plane is perpendicular to the first plane.

[0146] When the reusable handpiece is coupled to the disposable shaft assembly, the operation of the upper and lower articulation brake levers activates the upper and lower articulation brakes, creating resistance to the rotation of the upper and lower articulation knobs relative to parts of the endoscope assembly, such as the housing of the reusable handpiece. The operation of the left and right articulation brake knobs 319 activates the left and right articulation brakes, creating resistance to the rotation of the left and right articulation knobs relative to parts of the endoscope assembly, such as the housing 440 of the disposable shaft assembly.

[0147] The reusable handpiece and disposable shaft assembly are preferably configured to fit together. For example, the reusable handpiece assembly may define a recess 220 positioned to receive a portion of the disposable shaft assembly, or vice versa. In many examples, the recess of the reusable handpiece assembly positioned to receive a portion of the disposable shaft assembly is on the side opposite to the side having the knob of the disposable articulation knob brake assembly. One of the reusable handpiece assembly and the disposable shaft assembly may partially and / or completely enclose at least a portion of the other on two or more opposing sides. In other embodiments, one of the reusable handpiece assembly and the disposable shaft assembly may enclose the other.

[0148] A portion of the disposable shaft assembly can be configured to be received by a 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, a reusable handpiece can receive a disposable shaft assembly along a direction perpendicular to the longitudinal axis 250 of the reusable handpiece. In many embodiments, when a reusable handpiece and a disposable shaft assembly are combined, the disposable shaft assembly is moved relative to the reusable handpiece along a direction parallel to the rotation axis 350 of the articulation knob brake assembly.

[0149] When a reusable handpiece assembly is attached to a disposable shaft assembly, the articulation knob brake assembly works in cooperation with the disposable shaft assembly to articulate (articulate) the distal segment of the disposable shaft assembly and / or resist rotation of one or more articulation knobs relative to the endoscope assembly. For example, as described in more detail elsewhere in this specification, one or more articulation shafts 302, 303 and / or brake shafts 301 of the articulation knob brake assembly may engage with the pulley assembly and / or the housing of the disposable shaft assembly. One or more shafts of the articulation knob brake assembly extend through the pulley assembly and engage with the housing of the disposable shaft assembly on the opposite side of the pulley assembly as seen from the articulation knob brake assembly.

[0150] In many embodiments, a portion of the articulation knob brake assembly extends into a recess in a reusable handpiece that is positioned to receive a portion of a disposable shaft assembly.

[0151] Regarding the control of upper and lower articulation by the articulation knob brake assembly, the upper and lower articulation knobs are supported by the upper and lower articulation brake outer housing 312. Inside the upper and lower articulation brake outer housing are the articulation brake inner housing 307, the articulation brake position detent 308, the articulation brake spring 309, the upper and lower articulation brake caliper 310, and the angled articulation brake friction disc 311. The angled surface 351 of the articulation brake friction disc can be non-perpendicular to the axis of rotation.

[0152] The upper and lower articulation brake levers are connected to the articulation brake inner housing. The upper and lower articulation hubs 304 and upper and lower articulation shafts extend through the upper and lower articulation brake levers. The upper and lower articulation hubs, located within the articulation brake inner housing, support the articulation brake position detent and the upper and lower articulation brake calipers. The rotation of the upper and lower articulation hubs is fixed relative to the housing of the reusable handpiece, and as a result, the rotation of the articulation brake position detent and the upper and lower articulation brake calipers is also fixed relative to the housing of the reusable handpiece.

[0153] When the upper and lower articulation brake levers rotate relative to the upper and lower articulation hubs, the articulation brake inner housing rotates relative to the articulation brake position detent and the upper and lower articulation brake calipers. When rotating in a first direction, a pin 318 extending from the upper and lower articulation brake inner housing toward the upper and lower articulation brake calipers engages with the angled surface 360 ​​of the upper and lower articulation brake calipers, moving the articulation brake calipers axially toward the articulation brake springs and compressing the articulation brake springs. When rotating in a second direction, the pins move along the angled surface, causing the articulation brake springs to press the upper and lower articulation brake calipers toward the angled surface of the articulation brake friction discs and the upper and lower articulation brake outer housings, compressing the articulation brake friction discs between the upper and lower articulation brake calipers and the outer housings. The contact between the stationary upper and lower articulation brake calipers (relative to the reusable handpiece), the angled surface of the articulation brake friction disc, and the upper and lower articulation brake outer housings creates resistance to the rotation of the upper and lower articulation knobs, supported by the upper and lower articulation brake outer housings, relative to the reusable handpiece. In other examples, the articulation brake surface may be perpendicular to the axis of rotation. Advantageously, the angled braking surface can increase the braking force compared to a perpendicular braking surface when the same spring force is applied.

[0154] When the rotation of the upper and lower articulation brake position detent is fixed to the housing of a reusable handpiece via the upper and lower articulation brake hub, the rotation of the articulation brake inner housing relative to this housing also causes the articulation brake inner housing to rotate relative to the upper and lower articulation brake position detent. The upper and lower articulation brake position detent can hold the upper and lower articulation brake inner housing in one or more positions. For example, the detent can hold the upper and lower articulation brake inner housing in a first position where braking resistance is applied through the interaction of the upper and lower articulation brake friction discs between the upper and lower articulation brake caliper 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 detent can hold the upper and lower articulation brake inner housing in any of a plurality of positions to provide an adjustable level of rotational resistance to the articulation control (e.g., the articulation control knob).

[0155] The upper and lower articulation shafts extend through the center of the upper and lower articulation brake hubs. The upper and lower articulation shafts have a first end 370 fixed to the upper and lower articulation brake outer housing in the rotational direction. The second end 372 of the upper and lower articulation shafts is associated with the pulley assembly of a disposable shaft assembly. For example, the second end of the upper and lower articulation shafts can be attached to the upper and lower articulation pulleys so that the rotation of the upper and lower articulation shafts causes the upper and lower articulation pulleys to rotate. In this way, the rotation of the upper and lower articulation knobs causes the upper and lower articulation brake outer housing to rotate, which in turn causes the upper and lower articulation shafts to rotate, which in turn causes the upper and lower articulation pulleys to rotate, and thus acts the upper and lower articulation wires.

[0156] With respect to left and right articulation, the structure and operation of the left and right articulation knob brake assembly are identical to those of the upper and lower articulation knob brake assembly, except that the rotation of the left and right articulation brake hubs 317 is fixed to the housing of the disposable shaft assembly, and such rotation is fixed via the left and right articulation brake shafts extending through the left and right articulation shafts. Similar to the upper and lower articulation knob brake assembly, the left and right articulation knobs are supported by left and right articulation brake outer housings 315, which house the angled articulation brake friction discs 311, left and right articulation brake calipers 316, articulation brake springs, articulation brake position detents, and articulation brake inner housings.

[0157] The left and right articulation shafts extend through the left and right articulation brake knobs and the left and right articulation brake outer housings. The left and right articulation shafts have a first end 380 fixed rotatably to the left and right articulation brake outer housings and a second end 382 that engages with the pulley assembly of a disposable shaft assembly (for example, the second end fixed rotatably to the left and right articulation pulleys), so that the rotation of the left and right articulation brake knobs rotates the left and right articulation brake outer housings, which in turn rotates the left and right articulation brake shafts, which in turn rotates the left and right articulation pulleys, and thus moves the left and right articulation wire(s).

[0158] The left and right articulated brake shafts, extending through the left and right articulation shafts, have a first end 390 fixed rotatably to the left and right articulated brake hubs and a second end 392 fixed rotatably to the housing of the disposable shaft assembly when the reusable handpiece assembly is attached to the disposable shaft assembly. Similar to the operation of the upper and lower articulated knob brake assembly, the rotation of the articulated brake inner housing relative to the left and right articulated brake calipers causes the left and right articulated brake calipers to move toward or away from the angled surfaces of the left and right articulated brake outer housings and the brake friction discs located between them. The left and right articulated brake knobs are fixed rotatably to the left and right articulated brake inner housings, and the rotation of the left and right articulated brake knobs causes the left and right articulated brake inner housings to rotate relative to the left and right articulated brake hubs, left and right articulated brake calipers, and left and right articulated brake position detents. Therefore, when the left and right articulated brakes are engaged, the angled surfaces of the left and right articulated brake calipers and brake friction discs resist the rotation of the left and right articulated brake outer housings and left and right articulated knobs relative to the left and right articulated brake shafts and disposable shaft assemblies.

[0159] The second ends of the left and right articulation brake shafts are slidably engaged with the housing of a disposable shaft assembly, and are positioned to fix the left and right articulation brake shafts to it in a rotational direction. The left and right articulation shafts are arranged circumferentially around the left and right articulation brake shafts, and their second ends are engaged with left and right articulation pulleys that cooperate with left and right articulation wires. The upper and lower articulation shafts are also arranged circumferentially around the left and right articulation shafts, and their second ends are positioned to engage with upper and lower articulation pulleys associated with upper and lower articulation wires.

[0160] As shown in Figure 14, the articulation knob brake assembly may include multiple O-rings between the various parts when assembled. Also illustrated are ball bearings positioned within the assembly to reduce friction during rotation.

[0161] Referring here to Figure 16, the upper and lower articulation brake levers may have a surface 900 that engages with the surface 902 of the upper and lower articulation brake inner housing so that the rotation of the upper and lower articulation brake levers causes the upper and lower articulation brake inner housing to rotate relative to the housing of the reusable handpiece assembly. Preferably, the geometric shape of the surface interferes with the geometric shape of the surface 902 during rotation. The upper and lower articulation brake inner housing may define one or more openings 906 that receive lateral pins that engage with the angled surfaces of the upper and lower articulation brake calipers. Furthermore, the inner surface 910 of the upper and lower articulation brake inner housing may include recesses or projections arranged to engage with a detent spring (not shown). The upper and lower articulation brake levers and the upper and lower articulation brake inner housing define an opening 920 for receiving the upper and lower articulation hubs.

[0162] As shown in Figure 17, the upper and lower articulation hubs have portions 930 that extend through the upper and lower articulation brake position detents and the upper and lower articulation brake calipers. Preferably, these portions, the upper and lower articulation brake position detents, and / or the upper and lower articulation brake calipers have a cross-sectional shape that fixes the upper and lower articulation brake position detents, the upper and lower articulation brake calipers, and / or the upper and lower articulation brake hubs to each other in a rotational direction.

[0163] Next, Figure 18 shows the upper and lower articulation brake outer housings engaged with the upper and lower articulation shafts and fixed relative to them in a rotational direction. The upper and lower articulation brake outer housings have portions 940 to which the upper and lower articulation knobs are fixed in a rotational direction (for example, by recesses that are made to receive projections of the upper and lower articulation knobs, or vice versa).

[0164] Next, Figure 19 shows that the inside of the upper and lower articulation brake outer housing has an inner friction surface 950 which engages with the angled / tapered surface of the upper and lower articulation brake friction disc when the upper and lower articulation brakes are engaged.

[0165] As shown in Figure 20, when the upper and lower articulation brake levers rotate relative to the housing of the reusable handpiece, the upper and lower articulation brake inner housing rotates with the upper and lower articulation brake levers, moving a pin extending from an opening in the upper and lower articulation brake inner housing relative to the upper and lower articulation brake caliper. The pin moves along the inclined surface of the upper and lower articulation brake caliper, moving the upper and lower articulation brake caliper along the upper and lower articulation hub in cooperation with the upper and lower articulation brake spring. When the upper and lower articulation brakes are engaged from the disengaged state, the upper and lower articulation brake calipers press the upper and lower articulation brake friction discs against the upper and lower articulation brake outer housing (compressing the upper and lower articulation brake friction discs). When the upper and lower articulation brakes are disengaged from the engaged state, the upper and lower articulation brake calipers separate from the upper and lower articulation brake housings and upper and lower articulation brake friction discs, compressing the upper and lower articulation brake springs (for example, further compressing them). Figure 11 shows the upper and lower articulation brakes in the disengaged state, with a gap 394 between the upper and lower articulation brake friction discs and the inner friction surfaces 950 of the upper and lower articulation brake outer housings.

[0166] The upper and lower articulation brake inner housing may have detent recesses or projections that engage with one or more projections or recesses of the upper and lower articulation brake position detents. Such an arrangement may provide fixation of the upper and lower articulation brake lever in one or more positions and / or provide tactile and / or audible indication that the upper and lower articulation brakes have entered and / or disengaged from one or more forms or positions.

[0167] The left and right articulation knob brake assemblies operate similarly to the upper and lower articulation knob brake assemblies, except that the left and right articulation brake hubs are rotationally fixed to the housing of the endoscope assembly by left and right articulation shafts and upper and lower articulation shafts, through which the left and right articulation brake shafts extend to the center.

[0168] Referring to Figure 21, the left and right articulation brake outer housings and the left and right articulation shafts are shown assembled and fixed relative to each other in the rotational direction.

[0169] Figures 22 and 23 show the left and right articulated brake shafts within the left and right articulated brake hubs. Each articulated brake shaft has a first end that is received within the left and right articulated brake hubs and fixed in the rotational direction. The second ends of the left and right articulated brake shafts engage with the housing of the disposable shaft assembly during the installation of the reusable handpiece assembly and the disposable shaft assembly, thereby fixing the left and right articulated brake shafts in the rotational direction relative to the disposable shaft assembly. Thus, when the reusable handpiece assembly is installed in the disposable shaft assembly, the left and right articulated brake hubs are fixed in the rotational direction relative to the housing of the disposable shaft assembly.

[0170] Next, as shown in Figures 24-26, the upper and lower articulation knobs 313, the left and right articulation knobs 314, and the left and right articulation brake knobs 319 are removable (or "snap off") from the rest of the articulation knob / brake assembly. As described above, the upper and lower articulation brake outer housing has portions to which the upper and lower articulation knobs are secured in a rotational direction (for example, by recesses arranged to receive projections of the upper and lower articulation knobs, or vice versa). Similarly, the left and right articulation brake outer housings are designed to secure the left and right articulation knobs in the same manner. The arrangement of recesses and projections allows the upper and lower articulation knobs, left and right articulation knobs, and left and right articulation brake knobs to be easily snapped off or snapped on to the articulation knob / brake assembly. Advantageously, the snap-off structure allows the knobs to be removed to facilitate cleaning of the reusable handpiece between procedures.

[0171] As shown in Figures 25 and 26, the reusable handpiece may include a retaining clip 320. The retaining clip is used to secure the articulation knob / brake assembly to the reusable handpiece. The retaining clip may be coupled to the upper and lower articulation hubs to secure the articulation knob / brake assembly. Between procedures, if it is necessary to facilitate cleaning, the retaining clip can be removed from the articulation knob and brake assembly and the articulation knob / brake assembly can be removed from the housing of the reusable handpiece. Once cleaning is complete, the articulation brake assembly can be reattached to the housing using the retaining clip.

[0172] As shown in Figures 27 and 28, the insertion tube may include an instrument tube 437 extending inside at least a portion of the insertion tube. The instrument tube defines a tool channel 430 through which various instruments can be inserted and extended. The instrument tube can be manufactured by a co-extrusion process. The inner extruded portion 432 may be made of high-density polyethylene (HDPE) for lubrication. The outer extruded portion 434 may be made of polyvinyl chloride (PVC) or polylactic acid (PLA) to facilitate adhesion.

[0173] The insertion tube may include an optical sensor module to provide information readable by a console and / or to display an image on a monitor, such as a video feed from the end of the insertion tube. This video feed may be infrared, thermal, or visible light. The insertion tube 401 may include a light-emitting diode (LED) wire to power an LED located at the end of the insertion tube.

[0174] The insertion tube may include fluid pathways discussed herein, defined by tubes such as suction tubes, tissue perfusion tubes, camera flash tubes, and / or insufflation tubes. Perfusion tubes allow the user to remove any debris in the field of view during instrument use. Often, this involves removing excess blood to visualize the desired area. Suction tubes allow for the aspiration of particulate matter and various secretions from the patient's body. Camera flash tubes and insufflation tubes can be connected by Y-fittings. Various combinations of tubes are possible to minimize the number of tubes required for the insertion tube.

[0175] Figure 29 shows an example of an articulation joint assembly 800 positioned in the flexible articulation section 802 of an insertion tube. The articulation joint assembly has a proximal end and a distal end. Between the proximal and distal ends, a plurality of connected articulation links 801 are formed. Each link has a contact point 803 where the link is connected to an adjacent link. Adjacent links are positioned to articulate relative to each other. For example, adjacent articulation links can be swung at a certain angle relative to each other. For example, adjacent links can be swung at an angle of 2x relative to each other, where the angle x is measured between the contact points of each adjacent link when the links are parallel to each other. Adjacent articulation links of an articulation joint assembly may be pivotable to a different degree than other adjacent articulation links of the articulation joint assembly. Preferably, adjacent articulation links can be formed such that the angles of articulation differ between different pairs of articulation links. Advantageously, such an arrangement can be used to obtain a radius that changes along the length of the flexible articulated section during articulation motion. A pair of adjacent links with different articulation angles can be used to create a curve that changes along the length of the flexible articulated section.

[0176] Figures 30-33 show an elevator control assembly 650 for adjusting the height of an elevator 680 located at the distal end 407 of the insertion tube. The elevator control assembly can be positioned between two inner pieces of the pulley housing. The elevator control assembly includes an elevator control lever 652. The elevator control lever articulates around the articulation shaft via a pin constrained by a curved track. The elevator control lever is operably connected to an elevator drive rack 654. The elevator drive rack is coupled to an elevator pinion 656. The elevator pinion is also operably coupled to an elevator driven rack 658. The elevator driven rack is coupled to an elevator articulation control wire 660. Furthermore, the elevator control assembly may include an elevator control coil end block 662 that receives one or more elevator control coils 664 wound around each elevator articulation control wire coupled to the elevator driven racks.

[0177] The articulation motion of the elevator control lever operates the elevator drive rack, which in turn rotates the elevator pinion. The rotation of the elevator pinion drives the elevator driven rack, causing the elevator articulation control wire, around which the elevator control coil is wound, to articulate. For example, operating the elevator control lever in one direction causes the elevator to rise, while operating it in the opposite direction causes the elevator to descend.

[0178] To maintain the position of the elevator control lever when there is no user input, the elevator control assembly utilizes a compression O-ring 668. The O-ring is secured around a projection 670 extending from one of the housing covers. The O-ring is pressed against the elevator control pinion, and the friction generated between the O-ring and the elevator control pinion is used to maintain the position of the control lever. In other examples, the lever position is maintained by the friction generated by a spring element.

[0179] Figures 34-37 show the insertion tube tip assembly 850. The insertion tube tip assembly includes the insertion tube, distal elevator link 852, distal cap 854, and elevator assembly 681. The insertion tube includes a distal end 407. The distal end includes a distal tip section 856 which includes the distal elevator link, distal cap, and elevator assembly.

[0180] The distal cap includes a first opening 858 that allows the cap to slide over the elevator assembly. The distal cap further includes a second opening 860 that allows the instrument to exit the distal cap and operate within the patient's body. The distal cap further includes a notch 862 provided at the top 864 of the distal cap. The distal cap may be removable from the elevator assembly and / or the distal portion of the insertion tube. In some examples, the distal cap is not included.

[0181] The elevator assembly includes an instrument tube opening 866 for extending the instrument from the instrument tube. The instrument tube 437 may extend through a portion of the insertion tube. The opening opens into a work chamber 868. The chamber may be defined by opposing side walls 869, the distal surface of the insertion tube, and the elevator. Adjacent to the opening of the insertion tube is the elevator 680. The elevator can be used to adjust the elevation of the instrument within the patient's body to access a desired location within the body during a procedure. The elevator may include a proximal end 682 and a distal end 684. The elevator can be fixed to the elevator assembly by a pivot pin 686. During the articulation motion of the elevator, the elevator rotates around the pivot pin, allowing the distal end of the elevator to move up and down. By moving the elevator, the user can simultaneously move the instrument. The elevator may include a notch 688 at the distal end of the elevator, opposite to a notch in the distal cap. Opposing notches may be used to restrict unintended longitudinal or lateral movement of instruments as they pass through the tool channel into the patient's body. Notch 688 can hold instruments protruding from the opening, thereby enhancing instrument control.

[0182] The elevator assembly further includes an elevator control wire 870. The elevator control wire may be a single strand preformed wire for the articulation of the elevator. The elevator control wire can translate over a stationary curved ramp to impart rotational torque to the elevator. The elevator control wire is operated by the elevator control assembly to control the height of the elevator.

[0183] The elevator assembly may further define a light window 872 through which light, such as from a light-emitting diode, passes. This allows the user to illuminate the patient's body during the procedure. The elevator assembly may further define an imaging window 874 for providing images to the endoscopist.

[0184] This disclosure further provides a system comprising an endoscope assembly, a cartridge, and a console. Figure 38 generally shows a system that is operable and connected, preferably for use by a medical professional. The system may include a cartridge that is inserted into a control valve assembly 1100 of the console. The cartridge can be connected to the endoscope by an umbilical. For example, the cartridge can be connected to the disposable shaft assembly of the endoscope by one or more fluid tubes and / or electrical conductors.

[0185] The cartridge can be connected to a support device. The support device may include a perfusion pump, an insufflation device, and / or a vacuum pump (e.g., standalone or centralized). The cartridge can be positioned between the endoscope and the support device.

[0186] In some examples, the console may include a user interface (not shown) that allows the user to change various variables of the endoscopy system. In one example, the user interface may be a touchscreen integrated into an electrovisual display. In another example, the user interface may include a keyboard, mouse, trackball, and / or touch-sensitive pointing device, etc.

[0187] The console may include a control valve assembly for receiving and operating cartridges. The console may provide power, fluid and / or fluid pressure, vacuum pressure, and / or electrical signals to and from the endoscope assembly. The console may include a monitor (not shown) for visualizing signals received from the endoscope assembly, such as a video feed from a camera located at the distal end of a disposable shaft assembly.

[0188] Referring to Figure 39, the control valve assembly is shown in more detail. The control valve assembly can be used to selectively actuate the actuated portion of the fluid path of the cartridge. The control valve assembly may include an actuator 1130 and a support structure 1150 having a first surface 1152 and a second surface 1154.

[0189] The actuator may be a linear actuator or a rotary actuator. The actuator may be a solenoid. While the applicant prefers only one actuator, in a preferred embodiment the control valve assembly includes four actuators. The actuators are configured to actuate the valve portion of the fluid path in the cartridge to selectively open and / or close the fluid path.

[0190] The valve portion of the fluid path may consist of any acceptable valve. For example, the valve portion may consist of a petcock. Alternatively, the valve portion may consist of a tubular portion (e.g., a pinch valve) positioned for compression between the anvil on the first surface of the door and the actuator (e.g., a solenoid) of the control valve assembly. The valve portion can be configured to function as a valve for any number of fluid functions of the endoscope, such as a suction valve associated with actuator 1132, a camera flash valve associated with actuator 1134, a pneumoperitoneum valve associated with actuator 1136, and / or a pneumoperitoneum vent valve associated with actuator 1138.

[0191] The actuator of the control valve assembly is received by the console and includes an electrical connector that electrically connects the actuator to the console. Once connected to the console, the console can supply power and user-entered commands to the actuator to open and / or close the fluid path of the cartridge.

[0192] The cartridge may include an identifier that is readable and / or writable by the control valve assembly. The identifier may include information about 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 made readable and / or writable via the cartridge's electrical connector and / or by other means (e.g., RFID, optical system, and / or mechanical contact).

[0193] The first surface of the support structure may include an electrical connector for forming an electrical connection with the cartridge's electrical connector. The electrical connection between the console's control valve assembly and the cartridge may allow the console to receive image and control data (such as valves / actuators and / or image data) passed from the endoscope through the cartridge to the console. The electrical connection may allow the console to power the light-emitting diodes (LEDs) of the endoscope assembly.

[0194] The cartridge can be a disposable cartridge. Disposable cartridges eliminate the need for the use of reusable valve bodies contained within the endoscope and / or console. This eliminates the need to sterilize reusable valves after each use.

[0195] The cartridge has a housing 1210. The housing may include a first side 1212 and a second side 1214. The housing may further include a first fluid side 1220 and a second fluid side 1224 that allow fluid to enter and exit the cartridge housing. The housing may have one or more fluid paths, fluid connectors, and / or electrical connectors. For example, the cartridge housing may include an electrical connector 1244 that electrically communicates with the electrical conductor of the endoscope, and optionally an optical sensor module containing optical sensor calibration data or an optical sensor unique identifier of the endoscope. The housing may define windows 1270a-1270d. In one example, the housing includes four windows. The windows may be defined by the inner surface of the housing. This inner surface can form a generally circular opening in the housing. The circumference of one window may be larger than that of the other windows to accommodate a larger fluid path cross-section.

[0196] The window may be configured to receive an actuator into a chamber 1272 defined by its inner surface from the console. As described above, the actuator may pass through the window and / or contact the anvil on the door of the control valve assembly on the console to form a pinch valve on the door. When the 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 window may be positioned to define a geometric shape. For example, as shown, the window may define a rhombus.

[0197] As described above, one or more actuators may be solenoids configured to extend into the window of the cartridge housing and / or contact an anvil on the door of the control valve assembly to form a pinch valve when closed.

[0198] The housing may further include electrical connectors for connecting to the electrical connectors of the control valve assembly. The electrical connectors of the cartridge may be spring-finger electrical contacts configured to contact a corresponding number of flat-pad electrical contacts on the control valve assembly of the console, or vice versa. The electrical connectors of the cartridge housing may be configured to send image and control data provided by the endoscope to the console. The electrical connectors of the housing may be configured to supply power from the console to LEDs used by the endoscope inside the patient's body.

[0199] Figure 38 shows a diagram of a cartridge inserted into a console control valve assembly. As shown, the cartridge is inserted between the first surfaces of the support structure of the control valve assembly. The first fluid side of the cartridge may include a loose tube that continues into the umbilical and leads to the disposable shaft assembly of the endoscope (not shown).

[0200] The second fluid side of the cartridge is connected to a support device. The support device may include a perfusion pump, an insufflation device, and / or a vacuum pump (standalone or centralized). The cartridge can provide fluid communication between the endoscope and the support device.

[0201] The control valve assembly may include a ledge surface 1110 and a latch 1120. The cartridge may include a ledge surface and a latch receiving portion. In an alternative example, the control valve assembly may include the latch receiving portion and the cartridge may include the latch. When the cartridge is accepted by the control valve assembly, the latch contacts the latch receiving portion to secure the first end of the cartridge to the control valve assembly. Separately, on the opposite side of the latch and latch receiving portion, the ledge surface of the cartridge and the ledge surface of the control valve assembly contact each other to secure the second end of the cartridge to the control valve assembly.

[0202] In some examples, the cartridge may include two or more magnets 1250 located on a first side of the cartridge. In some examples, one magnet may be located at the bottom of the first side of the cartridge, and a second magnet may be located at the top of the first side of the cartridge. The first surface of the control valve assembly may include two or more (Hall or Reed) magnetic sensors 1180 corresponding to the positions of the magnets on the cartridge. For example, one may be located at the bottom of the first surface and the other at the top of the first surface. The magnet at the bottom of the cartridge interferes with the magnetic sensor at the bottom of the control valve assembly to actuate an actuator (e.g., a solenoid) valve to retract, reducing the force required to tilt the cartridge into the control valve assembly. The magnet at the top interferes with the magnetic sensor at the top of the control valve assembly to detect the presence of the cartridge on the console and actuate the console to release the appropriate actuator and initiate the actuator operating mode for endoscopy.

[0203] Figure 38 shows a console having a first cartridge 500a and a second cartridge 500b. The first cartridge can be connected to a first endoscope (not shown), and the second cartridge can be connected to a second endoscope (not shown). The first and second cartridges can be securely inserted into a first and second control valve assembly of the console, respectively. Although the console is illustrated with the first and second control valve assemblies, the console can have any number of control valve assemblies, each capable of accepting an independent cartridge. The first control valve assembly can accept the first cartridge, and the second control valve assembly can accept the second cartridge. It is not necessary for all control valve assemblies to accept cartridges during all medical procedures.

[0204] As illustrated, each cartridge can be connected to a separate set of support devices and to an independent medical instrument such as an endoscope.

[0205] The first and second control valve assemblies are configured to operate independently and / or in a master / slave communication configuration. The first or mother endoscope may be the master controller and the second or daughter endoscope may be the slave controller. In this case, the control device of the first endoscope can control the functions of one or more sub-endoscopes (e.g., image control and / or LEDs). The master endoscope can control the function of the fluid pathways of the sub-endoscopes by supplying electrical signals to the second control valve assembly (e.g., via one or more cartridges connected to a console) to selectively actuate the actuators described herein. The first endoscope can further control the functions of the second endoscope (e.g., LED and / or camera operation) by providing electrical signals from the first endoscope to change the state of the second control valve assembly (e.g., changing the electrical signals supplied from the second control valve assembly to the cartridge of the second endoscope). For example, the control valve assembly can provide electrical signals to the LED and / or camera of the second endoscope based on signals received from the first endoscope. Furthermore, it enables setting up and using multiple endoscopes simultaneously, eliminating or reducing the significant setup time typically required to swap one endoscope for another, and / or eliminating or reducing the need for additional equipment such as multiple control consoles.

[0206] The console features a touchscreen user interface. The user interface may be any suitable input / output device.

[0207] A disposable shaft assembly may include an insertion tube, an umbilical connected to a cartridge and connected to a console, an access port for selective access to the lumen of the disposable shaft assembly (for example, to take a sample such as a biopsy) and / or for delivering fluid through the lumen of the disposable shaft assembly, and an electrical connector for electrically connecting the disposable shaft assembly to a reusable handpiece.

[0208] The umbilical may extend from the cartridge to the disposable shaft assembly of the endoscope. Multiple fluid pathways and / or electrical wiring may extend within the umbilical to the distal end of the insertion tube. Fluid pathways may include pathways for aspiration, tissue irrigation, camera cleaning, and / or pneumoperitoneum. Fluid pathways may be valve-free from the distal end of the endoscope to the tip of the umbilical. Fluid pathways may contain valves only within the boundaries of the cartridge.

[0209] Preferably, one or more fluid pathways are defined by a monolithic tube extending from a disposable shaft assembly to a cartridge. More preferably, the monolithic tube extends through the cartridge to the outside of the second fluid side of the cartridge.

[0210] The camera cleaning fluid pathway and the pneumoperitoneum fluid pathway can be combined using a T-joint on a disposable shaft assembly. This allows the pressure from the pneumoperitoneum to push water from the water source through the camera cleaning fluid pathway from the distal end, removing debris accumulated on the camera lens during the procedure.

[0211] The umbilical may further include an image data conductor, a control data conductor, and / or an LED power conductor. The image data conductor and / or LED power conductor may extend through a disposable shaft assembly to the distal end of the insertion tube. The image data conductor enables the transmission of image data captured from the camera to the console. The LED power conductor can supply power from the console to an LED at the distal end of the insertion tube, providing illumination for the procedure. The control data conductor enables the communication of control data from the control device of the reusable handpiece to the cartridge, and consequently, communication to the console.

[0212] Figures 40–52 illustrate packaging systems and methods for maintaining the sterility of medical products, such as endoscope assemblies or parts of endoscope assemblies. The disclosed packaging systems can be used for many medical products, but for illustrative purposes only, the medical product is referred to as an endoscope assembly in this disclosure. In one example, the packaging assembly 2000 includes an elongated tray 2202 having a first end 2204 and a second end 2206. The tray defines a recess 2208 for holding the endoscope assembly. In some examples, the tray may be manufactured by thermoforming and may also be made of a recyclable material that allows the tray to be recycled after use.

[0213] The tray may be formed so that a medical product can be simply placed in the tray in one form. The tray may be thermoformed from a single material or multiple materials. The tray preferably defines a recess 2208. The recess may preferably define multiple compartments to accommodate various parts of an endoscope assembly in the tray. The recess may include an insertion tube compartment 2210, a disposable shaft assembly compartment 2212, an umbilical compartment 2214, and a cartridge compartment 2216. The recess may include additional compartments if additional parts are to be stored in the tray. If fewer parts are to be stored in the same tray, the recess may include fewer compartments. For example, cartridges may be sold separately or in separate containers within a packaging system, in which case there is no need for a cartridge compartment in the tray.

[0214] The tray may include hanger slots 2218, for example, a pair of hanger slots, at the first end of the tray. The hanger slots may be mounted as separate parts or formed from the material forming the tray. The hanger slots allow elongated packages to be suspended from a support arm 2220. The support arm can be mounted on the wall or ceiling of the operating room. In some examples, the support arm can be mounted on a cart 2222. When mounted perpendicularly to the support arm, part or all of the tray is suspended above the floor. Such an arrangement can prevent contaminants from entering the tray and / or improve usability for healthcare workers.

[0215] The packaging system may further include a cover 2224 (e.g., a sterile barrier) that extends over and covers the recess of the tray, sealing it from external contaminants and keeping the endoscope assembly aseptically sealed (as shown in exploded view 47). The cover may be a peelable cover that allows the user easy access to the endoscope assembly. The cover may be made of high-density polyethylene fibers such as Tyvek®.

[0216] In some examples, the tray may include a two-piece endoscope containing a reusable handpiece and a disposable shaft assembly. In the illustrated example, only the disposable shaft assembly is included in the packaging system. A reusable handpiece may also be included in the packaging system. The disposable shaft assembly may include an insertion tube at the patient-side end of the endoscope. The disposable shaft assembly may further include an umbilical extending to and connecting to a cartridge. Any combination of components in the tray may be supplied connected to other components and / or fully assembled.

[0217] As illustrated in Figures 45-49, the packaging system may include a first cover 2226, and in some examples, the packaging system may include multiple covers. In the illustrated examples, the first cover is used to hold cartridges in a tray (e.g., a cartridge compartment). The packaging system may include a second cover 2228 for holding disposable shaft assemblies in a tray (e.g., a disposable shaft assembly compartment).

[0218] During preparation for a procedure, the user may remove a cover (e.g., a sterile barrier) to allow access to the endoscope assembly. In this specification, "user" means an endoscopist, nurse, technician, physician, or any other individual who may be involved in the procedure. In some examples, during setup, the cover may be removed only partially at a time. By partially removing the cover (e.g., a sterile barrier), the user can set up the endoscope for the procedure while keeping the rest of the endoscope assembly sterile and / or reducing the risk of contamination. In Figures 41, 42, and 48, the first cover can be removed to expose the cartridge. Before or simultaneously with preparing the rest of the endoscope assembly for the procedure, the cartridge and umbilical can be removed to mount the cartridge to the console (as shown in Figure 39).

[0219] Advantageously, by removing only a portion of the cover (e.g., a sterile barrier) and / or less than all of the cover, the handle and insertion tube remain protected from various contaminants. In many cases, as shown in FIG. 40, the package system is suspended from a support arm. When the package is opened, the insertion tube may sway during setup / preparation and strike a cart, the wheels of the cart, the floor, or a user moving within the room. By covering the insertion tube with a cover (e.g., a sterile barrier), even if the sterile seal is broken, the cover protects the insertion tube from the attachment of various contaminants by preventing contact with anything in the surroundings.

[0220] Next, the second cover can be pulled to allow access to the disposable shaft assembly within the disposable shaft assembly compartment. Depending on whether the user peels the cover only partially at a time or all at once, the second cover (e.g., a sterile barrier) can be further peeled to complete this step. In some examples, it may be necessary to peel the first cover before peeling the second cover, and the user is required to follow the same setup procedure. In other examples, the second cover is independent of the first cover, and separate access to both covers is possible. When the second cover is peeled off, the disposable shaft assembly can be removed for setup. To easily remove the disposable shaft assembly and the insertion tube, the cover can be slid vertically along the side of the tray to expose the insertion tube more (as seen in FIG. 49).

[0221] As shown in FIGS. 40 - 44, the reusable handpiece can be held by a support arm. When the disposable shaft assembly is removed from the package system, the user can couple the disposable shaft assembly to the reusable handpiece.

[0222] A second example of a packaging system is shown in FIGS. 40, 50, 51, and 52. This embodiment is a packaging 2300 for a curved flexible endoscope. The package assembly includes a tray 2302. The tray defines a recess 2304 for holding the endoscope assembly. In some examples, the tray is manufactured by thermoforming and can be made of recyclable material that allows the tray to be recycled after use.

[0223] The tray can be formed such that a medical product can simply be placed within the tray in one form. The tray can be thermoformed. The tray preferably defines a recess. The recess preferably defines a plurality of compartments / tracks for accommodating various components of the endoscope assembly. The recess may include an insertion tube track 2306, a disposable shaft assembly compartment 2308, an umbilical track 2310, and a cartridge compartment 2312. The curved packaging system may further include a suction tube compartment 2314 for holding a suction tube. Unlike the elongated tray described above, the compartments for the insertion tube and umbilical surround the center of the tray. The umbilical and insertion tube are wound around the center of the package. The tracks for the umbilical and insertion tube can be made to overlap. When the tracks overlap, the umbilical can be on top of the insertion tube. The recess can include additional compartments if additional components are stored within the tray. If fewer components are stored within the same tray, the recess can be made to include fewer compartments. For example, the cartridge can be sold separately or placed in another container within the packaging system for sale, in which case there is no need to provide a cartridge compartment within the tray.

[0224] The tray may include hanger slots 2316 (Figure 52), for example, a pair of hanger slots, at the top of the tray. The hanger slots may be mounted as separate parts and / or defined by the material forming the tray. The hanger slots allow the package to be suspended from a support arm 2220. The support arm can be mounted on the wall or ceiling of the operating room. In some examples, the support arm can be mounted on a cart. When mounted on the support arm, the entire tray is suspended above the floor. Due to the compact configuration of the curved package system, the tray can be placed on a cart rather than suspended from a support arm, if necessary.

[0225] The packaging system may further include a cover (e.g., a sterile barrier) that extends over and / or seals the endoscope assembly from external contaminants, keeping it sterile. The cover may be a peelable cover that allows the user easy access to the endoscope assembly. The cover may be made of high-density polyethylene fibers such as Tyvek®.

[0226] Similar to elongated packaging systems, curved packaging systems may include a first cover 2340 (illustrated in Figure 52), and in some examples, the packaging system may include two or more covers. In the illustrated example, the first cover is used to hold the cartridge within the tray / cartridge compartment. The packaging system may include a second cover 2342 for holding a disposable shaft assembly within the tray / disposable shaft assembly compartment.

[0227] Similar to elongated packaging systems, curved packaging systems can be designed to encourage users to remove endoscope assemblies in a desired order. During setup, covers (e.g., sterile barriers) can be partially and / or completely removed (e.g., peeled off) to access the entire endoscope assembly. This packaging system configuration reduces the risk of contaminants being present within the packaging system.

[0228] First, move the first cover that holds the cartridge to gain access to the cartridge. The cartridge and umbilical can then be removed, and the cartridge can be mounted on the console. Next, move the second cover to gain access to the disposable shaft assembly. The disposable shaft assembly can be removed from the tray and mounted on the reusable handpiece assembly. Finally, the insertion tube can be removed and placed on a sterile surface for insertion into the patient or until the start of the procedure.

[0229] Figure 53 shows a cartridge 500 having an extension of a suction tube 5300 incorporating a connector, for example, a T-fitting 5302. This configuration can be used with a flexible, disposable observation endoscope incorporating a suction tube with an in-line T-fitting. The T-fitting may include a removable cap 5304. The removable cap protects the side port 5306 of the T-fitting from contamination when the T-fitting is not in use and is removable when use is desired. The side port of the T-fitting can be mated to the connector of the suction tube of the cholangioscopy.

[0230] Figure 54 shows a method for selecting one or more endoscope imaging devices to display on a monitor during an endoscopic procedure. Often, multiple endoscopes are used during an endoscopic procedure. This method relates to identifying which endoscope images should be displayed on the monitor. In some embodiments, multiple monitors may be used. In other embodiments, one monitor may be used to display images from all endoscopes. When using one monitor, the endoscope being used may be identified and displayed as the dominant or largest image among other smaller images on the same screen / monitor.

[0231] The method may include identifying the endoscope being used at a given point in time during the procedure. The endoscope may be identified using a switch, such as a mechanical switch, an induction switch, or a capacitive switch (e.g., a touch switch) (5400). The switch may also be a sensor. In some embodiments, the switch is a touch switch, and when the endoscope is picked up by the endoscopist, the switch is activated to identify the endoscope currently being used in the procedure. When the switch is activated, a signal is relayed from the switch to a controller to identify which endoscope is being used (5402). The controller relays a signal / image from the associated endoscope to a monitor (5404). The identified image becomes the dominant image on the screen while the endoscope is being used. In some examples, multiple endoscopes may be used simultaneously. When multiple endoscopes are used simultaneously, the images from the endoscopes being used may be displayed on the monitor at the same size. In other examples, one dominant endoscope may be identified. When the dominant endoscope is being used simultaneously with other endoscopes, the image from the dominant endoscope may be the largest image on the monitor.

[0232] Figures 55 to 68 show three embodiments of an image sensor assembly 5500 used in various types of endoscopes, such as gastroscopes, colonoscopes, duodenoscopes, or cholangioscopy. Broadly speaking, the camera / LED board 5502 is positioned at the distal end of the insertion tube, and a cable 5504 with an electrical connector can extend from the distal end of the insertion tube to the proximal end of the insertion tube and to the electrical connector / circuit board 1244 in the cartridge. As described above, the electrical connector in the cartridge is connected to the console and transmits electrical signals between the cartridge and the console. In some embodiments, the electrical connector in the cartridge may include a spring finger electrical connector 5506 for contacting a spring finger on the console.

[0233] The image sensor assembly includes a camera-LED board. One side of the camera-LED board is bonded to a cable. The cable can be bonded to the board by any method known in the art, for example, with an adhesive. Several wires (not shown) extend from the distal end of the cable and are soldered to the board. The wires are soldered to the board to transmit signals between the cartridge and the camera 5508 and LED 5510. The other end of the same wires extends from the proximal portion of the cable and is soldered onto the surface of the flexible circuit 5512. The wires can be arranged to be appropriately spaced across the surface of the flexible circuit.

[0234] The flex circuit is operably mounted to the microconnector 5514. The microconnector may be either a male or female portion 5516 having a opposite portion 5518 located on the electrical connector of the cartridge. The male and female portions are connected to complete the electrical path between the camera and / or LED and the cartridge. In some embodiments, the microconnector may be a mezzanine connector.

[0235] The flex circuit and microconnector preferably have a combined height of less than 1 mm. More preferably, the combined height of the flex circuit and microconnector is less than 0.8 mm. This arrangement can have a combined height in the range of 0.6 mm to 0.8 mm. The height of the flex circuit itself can be about 0.2 mm.

[0236] In assembly, the proximal end of the wire, including the flex circuit and microconnector, is passed through the distal end of the insertion tube and then through the insertion tube toward the proximal end. The flex circuit and microconnector are then passed through the endoscope and umbilical and through a cartridge operably connected to the end of the umbilical. The female or male portion of the microconnector located in the flex circuit is then connected to the corresponding portion of the microconnector located in the electrical connector of the cartridge. Advantageously, this manufacturing method avoids the potentially difficult and time-consuming task of passing the cable through the insertion tube before connecting the camera and LED board to the cable. Furthermore, this method avoids the potentially damaging and / or requiring a larger insertion tube to accommodate the camera, which may occur when passing the camera through the insertion tube.

[0237] The circuit board may further include a memory device 5520 for storing imaging data from the camera.

[0238] The image sensor assembly may further include a second microconnector 5522 on the cartridge electrical connector, which is connectable to a second connector 5523 on the electrical connector / circuit board 1244 within the cartridge. The second microconnector is also attached to the flex circuit 5524, as in the arrangement described above. The flex circuit includes wires extending from the flex circuit on the cartridge circuit board to the disposable shaft assembly electrical connector 5526. The disposable shaft assembly electrical connector is connectable to the electrical connector of a reusable handpiece for transmitting electrical signals / commands between two endoscope pieces.

[0239] In the specification and claims, it should be noted that, unless explicitly stated otherwise, the singular forms "a," "an," "the," etc., include plural forms. For illustrative purposes, the term "apparatus" when first mentioned or referred to thereafter includes one or more such apparatuses and their equivalents. Furthermore, directional terms such as "up," "down," "top," "bottom," "left," and "right" are used herein solely 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 restrict the described, illustrated, and / or claimed features to any particular direction and / or orientation.

[0240] The terms used in the claims and specification have only their plain and ordinary meanings, except for terms expressly defined below. Such plain and ordinary meanings here shall include the definitions in all consistent dictionaries of the most recently published general Merriam-Webster dictionary (as of the filing date of this document).

[0241] When used in the claims and specification, the following terms have the following defined meanings:

[0242] As used herein, the term “friction fit” means that parts are held together by friction after being pressed together. This term does not mean fastening by fasteners (e.g., screws, bolts) or adhesives.

[0243] Although the present disclosure has been illustrated and described in detail in the drawings and foregoing description, these are exemplary and not of a limiting nature, and only the preferred embodiments have been illustrated and described, and it is desired that all changes, equivalents, and modifications that fall within the disclosure defined by the following claims be protected. All publications, patents, and patent applications cited herein are hereby incorporated by reference as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated by reference and set forth in its entirety herein.

[0244] Specific examples useful in understanding the present disclosure are numbered and shown below. 1. A package system for a medical product having a plurality of components, a tray defining a recess for holding a plurality of components of the medical product in a sterile environment, a first cover coupled to the tray, the first cover for holding a first component of the plurality of components within a first portion of the recess, a second cover coupled to the tray, the second cover being non-removable from the tray until the first cover is at least partially removed, the second cover for holding a second component of the plurality of components within a second portion of the recess, a third cover covering the first cover and the second cover and providing a sterile barrier to the recess of the tray, The package system comprising. 2. The package system according to item 1 above, further comprising a medical product box within which the tray, the first, second, and third covers are disposed. 3. The package system according to item 1 or 2 above, further comprising a slot provided at a first end of the tray and configured to receive a support for suspending the tray in a vertical direction. 4. The package system according to any one of items 1 to 3 above, wherein the first cover is configured to hold the first component of the medical product within the first portion of the recess when the tray is suspended in a vertical direction. 5. The package system according to any one of claims 1 to 4, wherein the second component is a disposable shaft assembly that can be selectively attached to a reusable handpiece of an endoscope system. 6. The package system according to any one of claims 1 to 5 above, wherein the first component is a cartridge that can be attached to a pump. 7. The packaging system according to any one of 1 to 6, further comprising a fourth cover coupled to the tray and holding a suction tube in a recess of the tray. 8. The packaging system according to item 7 above, wherein the fourth cover is located beneath the third cover. 9. Removing at least a portion of the first cover of the medical package to expose the first portion of the recess of the medical package and to expose the second cover of the medical package, Removing a cartridge configured to be attached to a fluid pump from the first part, After removing the first cover, at least a portion of the second cover of the medical package is removed to expose the second portion of the recess of the medical package, Removing the handle portion of the disposable shaft assembly of the endoscope from the second portion of the recess, A method of having. 10. The method according to 9, further comprising removing the insertion portion of the disposable shaft assembly from the second portion of the recess after removing the handle portion. 11. The method according to 10, wherein removing the insertion portion of the medical package includes removing the first cover to expose the insertion portion. 12. The method according to any one of 9 to 11 above, further comprising removing the first cover and the third cover which forms a sterile barrier over the second cover. 13. The method according to 12, wherein the removal of the third cover is performed before the removal of the first cover and the second cover. 14. A method for packaging medical devices, The second component of the medical device is placed within the second portion of the recess defined by the tray, The second part is covered with a second cover, The first component of the medical device is placed within the first portion of the recess defined by the tray, The first component and at least a portion of the second cover are covered by the first cover, At least the first cover and the second cover are covered with the third cover, defining a sterile environment within the recess, A method for packaging medical devices, which has [a certain characteristic]. 15. A method for packaging a medical device according to 14, further comprising placing a third component of the medical device within the third portion of the recess. 16. An insertion tube having a distal end including a distal tip, An opening on the surface of the distal tip, through which an instrument inserted through an instrument tube extending into the insertion tube extends, An elevator assembly, An elevator having a proximal end and a distal end, A distal cap covering at least a portion of the elevator assembly, and It has a pair of opposing notches for restricting the movement of an instrument extending from the opening, The first notch of the pair of opposing notches is defined by the distal end of the elevator. The second notch of the pair of opposing notches is defined by the distal cap. Elevator assembly and, An endoscope. 17. The endoscope according to 16, wherein the elevator assembly further comprises an elevator control wire operably coupled to the elevator, the elevator control wire adjusting the height of the elevator by an applied force. 18. The endoscope according to 17, wherein the elevator control wire is a single strand preformed wire. 19. The endoscope according to 16 or 17, wherein the elevator control wire translates over a stationary curved ramp, providing rotational torque to the elevator. 20. The endoscope according to any one of 16 to 19 above, wherein the distal cap is removable from the elevator assembly. 21. It has a reusable handpiece assembly and a disposable shaft assembly, The reusable handpiece assembly is selectively attachable to and detachable from the disposable shaft assembly. The disposable shaft assembly includes a housing and an insertion tube, The housing includes an elevator control assembly for controlling the operation of the elevator at the distal end of the insertion tube, A medical device comprising an elevator control assembly having an operable lever extending from the housing, the lever being operablely connected to actuate an elevator drive rack, the elevator drive rack being operablely connected to actuate a pinion, the pinion being operablely connected to actuate an elevator driven rack, the elevator driven rack being operablely connected to actuate an elevator control wire, and the height of the elevator being adjusted by the force acting on the elevator control wire. 22. Medical devices, The medical device comprises a first pulley associated with a first articulation wire, which, when rotated, bends the distal end of the medical device in a first plane, The first pulley is rotatable within a range that does not exceed a first rotational distance relative to the idler that is stopped from rotating. The rotation stop idler is rotatable within a range that does not exceed a second rotation distance relative to the housing of the endoscope. A medical device in which the first pulley is rotatable relative to the housing within a range not exceeding the sum of the first rotational distance and the second rotational distance. 23. The medical device according to 22, wherein the rotation-stopping idler has a first side surface that contacts the first pulley and a second side surface that contacts the housing. 24. The first side surface includes a first groove, and the second side surface includes a second groove, The boss of the first pulley is slidably received in the first groove of the rotation stop idler. The medical device according to 23, wherein the boss of the housing is slidably received in the second groove of the rotation stop idler. twenty five. The medical device comprises a second pulley associated with a second articulation wire, which, when rotated, bends the distal end of the medical device in a second plane, The second pulley is rotatable within a range that does not exceed a third rotational distance relative to the second rotation-stopping idler. The second rotation stop idler is rotatable within a range not exceeding a fourth rotation distance relative to the housing of the endoscope, The medical device according to any one of 22 to 24, wherein the second pulley is rotatable relative to the housing within a range not exceeding the sum of the third rotation distance and the fourth rotation distance. 26. The medical device according to 25 above, wherein the second plane is perpendicular to the first plane. 27. The medical device according to 25 or 26, wherein the second rotation stop idler has a first side surface that contacts the second pulley and a second side surface that contacts the housing. 28. The first side of the second rotation stop idler includes a first groove, and the second side includes a second groove, The boss of the second pulley is slidably received in the first groove of the second rotation stop idler. The medical device according to 27, wherein the boss of the housing is slidably received in the second groove of the second rotation stop idler. 29. The housing is part of a disposable shaft assembly, The medical device according to any one of 22 to 28, wherein the disposable shaft assembly is selectively attachable to and detachable from a reusable handpiece assembly having a control knob and shaft for rotating the first pulley. 30. A medical device as described in any of items 22-30 above, wherein the medical device is an endoscope. 31. Medical devices, It features a reusable handpiece assembly and a disposable shaft assembly. The reusable handpiece assembly is selectively attachable to and detachable from the disposable shaft assembly. The reusable handpiece assembly includes a housing and an articulation brake assembly, the articulation brake assembly includes a first articulation control knob, a second articulation control knob, and a first articulation brake knob. A medical device in which the first articulation control knob, the second articulation control knob, and / or the first articulation brake knob are selectively attachable to and detachable from the reusable handpiece assembly. 32. The medical device according to 31, wherein the first articulation control knob, the second articulation control knob, and / or the first articulation brake knob are attached to the reusable handpiece assembly solely by friction fitting. 33. The medical device according to 31 or 32, wherein the articulation brake assembly is attached to the housing of the reusable handpiece assembly by a retaining clip. 34. The retaining clip is coupled to the upper and lower articulation hubs for mounting the articulation knob brake assembly to the housing of the reusable handpiece assembly, as described in 33 above. 35. Endoscope, The endoscope is equipped with a first articulation brake that is displaceable from a disengaged position that allows rotation of the first articulation control knob relative to the housing to an engaged position that resists rotation of the first articulation control knob relative to the housing, The rotation of the first articulation control knob relative to the housing causes the first articulation control shaft to rotate around the first axis. The articulation brake includes a plurality of braking surfaces at angles not perpendicular to the first axis, When the first articulation brake is in the engagement configuration, the braking surfaces are pushed toward each other by a normal force having a first magnitude. An endoscope in which, when the first articulation brake is in the disengaged position, the braking surfaces are separated from each other or in contact with each other with a normal force having a magnitude smaller than the first. 36. The endoscope according to 35, wherein the housing is part of a reusable handpiece assembly that is selectively attachable to and detachable from the disposable shaft assembly of the endoscope. 37. Medical devices, Pulley and, An articulation wire connected to the pulley and extending in a direction away from the pulley, A pulley housing surrounding the pulley and the articulation wire, the pulley housing having a first housing portion and a second housing portion, Equipped with, A medical device wherein the first housing portion has a first edge, and the second housing portion has a second edge that engages with the first edge to define a non-linear path extending along the direction of the articulation wire. 38. The medical device according to 37, wherein the non-linear path is non-linear when projected onto a plane parallel to the axis of rotation of the pulley, including the articulation wire. 39. The medical device described in 37 above, wherein the non-linear path is linear. 40. The medical device described in 39 above, wherein the non-linear path defines castellation. 41. Insertion tube and, An instrument tube placed inside the insertion tube, It has, The device tube has a first part having a first composition comprising high-density polyethylene, and a second part having a second composition comprising a material selected from the group consisting of polyvinyl chloride or polylactic acid. The first composition defines the inner surface of the instrument tube that defines the tool channel, An endoscope wherein the second composition defines the outer surface of the instrument tube. 42. The endoscope according to 41, wherein the instrument tube is formed by co-extrusion of the first composition and the second composition. 43. An insertion tube for insertion into the patient's body, An articulation joint assembly is positioned within the insertion tube and has a length extending from the proximal end to the distal end, It has, The articulation joint assembly has multiple articulation links, Each articulation link is connected to an adjacent articulation link by a contact point, and is capable of pivoting by a certain pivot angle relative to the adjacent articulation link. An endoscope in which the pivot angle between a first pair of articulation links in the articulation joint assembly is not the same as the pivot angle between a second pair of articulation links in the articulation joint assembly. 44. The endoscope according to 43, wherein the pivot angle between a pair of articulation links adjacent to the distal end of the articulation joint assembly is greater than the pivot angle between a pair of articulation links located proximal to the pair of articulation links adjacent to the distal end. 45. The endoscope according to 43, wherein the pivot angle between a pair of articulation links adjacent to the distal end of the articulation joint assembly is smaller than the pivot angle between a pair of articulation links located proximal to the pair of articulation links adjacent to the distal end. 46. ​​The endoscope according to 43, wherein the pivot angle increases continuously along the length of at least four articulation links. 47. It is a console, It has a control valve assembly that is designed to accept a cartridge, The control valve assembly includes a plurality of actuators for operating the fluid path of the cartridge, The cartridge contains a magnet, The control valve assembly includes a magnetic sensor positioned to sense a magnet on the cartridge when the cartridge is connected to the console, A console in which the extension and / or retraction of multiple actuators of the console are determined based on signals from a magnetic sensor. 48. It is a console, It has a control valve assembly that is designed to accept a cartridge, The control valve assembly includes a plurality of actuators for operating the fluid path of the cartridge, The multiple actuators are made movable from the retracted position to the extended position. The cartridge has at least two magnets, The control valve assembly includes a first magnetic sensor and a second magnetic sensor, the first and second magnetic sensors being configured to sense the at least two magnets on the cartridge when the cartridge is connected to the console. If at least two of the magnets are not detected by the first and second magnetic sensors, the actuator valve of the console is retracted. A console in which the actuator valve of the console extends when at least two magnets are detected by the first and second magnetic sensors. 49. A housing and a first pipe extending through the housing and defining a first fluid path, A connector connected inline to the first pipe, It has, A cartridge in which the connector is connected to a second pipe that defines a second fluid path, and the second fluid path merges with the first fluid path. 50. The cartridge described in 49 above, wherein the connector is a T-fitting. 51. The cartridge described in 49 above, wherein the connector includes a removable cap. 52. In procedures using the first and second medical devices, the operation of the first medical device by a medical professional is detected by the first switch, The signal from the first switch indicates that the first medical device is being operated, Displaying the image generated from the first medical device on an image display device, A method of having. 53. The method according to 52 above, wherein the first switch is a mechanical switch. 54. The method according to 53 above, wherein the first switch is a touch switch. 55. The method according to 52, wherein the first switch is activated when the medical device is picked up. 56. The method according to 52, wherein the generated image is an image from a camera at the distal end of the identified medical device. 57. The operation of the second medical device by a medical professional during the procedure is detected by a second switch, The signal from the second switch indicates that the second medical device is being operated, The steps include displaying an image generated from the second medical device on the image display device, The method described in 52 above, having the characteristics of the method described in 52 above. 58. The method according to 57, wherein the image display device simultaneously displays images from both the first medical device and the second medical device, but the image from the medical device identified as being in use is displayed larger on the image display device. 59. The method according to 52, wherein only one image from the first or second medical device is displayed on the image display device at a time. 60. Insertion tube and An electrical cable having multiple wires with distal and proximal ends, It has, The distal end is connected to a camera board having a camera, and the electrical cable extends proximal through an insertion tube. The multiple wires are soldered to the camera board at the distal end of the electrical cable. An endoscope insertion tube assembly in which the plurality of wires are soldered to a flexible circuit having a microconnector at the distal end. 61. A method for assembling the insertion tube assembly of 60, comprising passing the microconnector through the lumen of the insertion tube along a direction extending from the distal end of the insertion tube to the proximal end of the insertion tube. 62. The method according to 61, comprising connecting the microconnector to an electrical connector in the handle of the endoscope.

Claims

1. It is a medical device, The medical device comprises a first pulley associated with a first articulation wire, which, when rotated, bends the distal end of the medical device in a first plane, The first pulley is rotatable within a range that does not exceed a first rotational distance relative to the idler that is stopped from rotating. The rotation stop idler is rotatable within a range that does not exceed a second rotation distance relative to the housing of the endoscope. The first pulley is rotatable relative to the housing within a range that does not exceed the sum of the first rotational distance and the second rotational distance. The housing is part of a disposable shaft assembly, A medical device in which the disposable shaft assembly is selectively attachable to and detachable from a reusable handpiece assembly having a control knob and shaft for rotating the first pulley.

2. The medical device according to claim 1, wherein the rotation-stopping idler has a first side surface that contacts the first pulley and a second side surface that contacts the housing.

3. It is a medical device, The medical device comprises a first pulley associated with a first articulation wire, which, when rotated, bends the distal end of the medical device in a first plane, The first pulley is rotatable within a range that does not exceed a first rotational distance relative to the idler that is stopped from rotating. The rotation stop idler is rotatable within a range that does not exceed a second rotation distance relative to the housing of the endoscope. The first pulley is rotatable relative to the housing within a range that does not exceed the sum of the first rotational distance and the second rotational distance. The rotation stop idler has a first side surface that contacts the first pulley and a second side surface that contacts the housing. The first side surface includes a first groove, and the second side surface includes a second groove, The boss of the first pulley is slidably received in the first groove of the rotation stop idler. A medical device in which the boss of the housing is slidably received in the second groove of the rotation stop idler.

4. The first side surface includes a first groove, and the second side surface includes a second groove, The boss of the first pulley is slidably received in the first groove of the rotation stop idler. The medical device according to claim 2, wherein the boss of the housing is slidably received in the second groove of the rotation stop idler.

5. The medical device comprises a second pulley associated with a second articulation wire, which, when rotated, bends the distal end of the medical device in a second plane, The second pulley is rotatable within a range that does not exceed the third rotational distance relative to the second rotation-stopping idler. The second rotation stop idler is rotatable within a range that does not exceed a fourth rotation distance relative to the housing of the endoscope. The medical device according to any one of claims 1 to 4, wherein the second pulley is rotatable with respect to the housing within a range not exceeding the sum of the rotational distance of the third and the rotational distance of the fourth.

6. The medical device according to claim 5, wherein the second plane is perpendicular to the first plane.

7. The medical device according to claim 5 or 6, wherein the second rotation stop idler has a first side surface that contacts the second pulley and a second side surface that contacts the housing.

8. The first side of the second rotation stop idler includes a first groove, and the second side includes a second groove. The boss of the second pulley is slidably received in the first groove of the second rotation stop idler. The medical device according to claim 7, wherein the boss of the housing is slidably received in the second groove of the second rotation stop idler.

9. The medical device according to any one of claims 1 to 8, wherein the medical device is an endoscope.

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