Articulating endoscope with working channel

Abstract

The present technology relates to an articulation endoscope and a method for manufacturing an articulation endoscope. An example endoscope is disclosed, the endoscope comprising: an outer sheath extending a length of the endoscope; an outer wall of extrudate located inside the outer sheath, extending at least 80% of the length of the endoscope and ending at a bendable region of the endoscope; an inner wall located inside the outer wall, extending at least 90% of the length of the endoscope and passing through the bendable region, the inner wall defining a working channel through the endoscope; a plurality of fins extending from the inner wall to the outer wall and defining a plurality of auxiliary channels between the inner wall and the outer wall; a first stay wire extending through a first auxiliary channel of the plurality of auxiliary channels; and a second stay wire extending through a second auxiliary channel of the plurality of auxiliary channels.

Description

Cross Reference to Related Applications

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 498,681, filed April 27, 2023, and U.S. Patent Application No. 18 / 612,289, filed March 21, 2024, the entire contents of which are incorporated herein by reference. BACKGROUND

[0002] Laryngoscopes are commonly used for intubation of patients requiring respiratory assistance. During intubation, a laryngoscope can be used to manipulate the anatomy of the larynx and associated structures of a patient’s airway in order to obtain a view sufficient to insert a breathing tube (e.g., an endotracheal tube) into the trachea. In some cases, the patient’s anatomy or the patient’s injuries or other health conditions can prevent the clinician from obtaining a clear view of the larynx. In cases where intubation of the patient can be difficult, an endoscope can be used to assist in visualization of the larynx and insertion of the breathing tube. An endoscope is a narrow, flexible tube that typically includes a light and a camera at an insertable end of the tube and is inserted into the body for visualization of the patient’s anatomy. Use of an endoscope can assist the clinician in intubation.

[0003] Aspects of the technology disclosed herein are contemplated with respect to this general technological environment. Moreover, while a general environment is discussed, it should be understood that the examples described herein should not be limited to the general environment indicated herein. SUMMARY

[0004] This summary is provided to introduce some concepts of the technology in a simplified form that are further described below in the specific embodiments. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to determine the scope of the claimed subject matter. Additional aspects, features, and / or advantages of examples are set forth in the descriptions that follow, and in part will be apparent to those with skill in the art upon examination of the description, or can be learned from practice of the disclosure.

[0005] In one aspect, the technology relates to a method for manufacturing an endoscope. The method includes extruding a cross-section to form an extrudate. The extrudate includes an inner wall defining a first lumen, an outer wall defining a second lumen between the inner wall and the outer wall, and a plurality of fins extending from the inner wall to the outer wall and defining a plurality of auxiliary channels in the second lumen. The method further includes removing the outer wall from a portion of a distal end of the extrudate to form a bendable region, cutting slots in the outer wall over at least two of the auxiliary channels, inserting a pull wire into one of the auxiliary channels through one of the slots, and installing an outer sheath covering the extrudate, including the bendable region.

[0006] In one example, the method further includes cutting the extrudate to a length of the endoscope. In another example, the method further includes installing a spring over the auxiliary channels of the bendable region. In yet another example, the method includes inserting electrical conductors into the auxiliary channels through the slots. In still another example, the method further includes routing a distal end of the pull wire around posts protruding from a mounting ring; and heat reflowing the posts to secure the pull wire to the mounting ring. In still yet another example, the plurality of fins includes at least 4 fins.

[0007] In another aspect, the technology relates to an endoscope, comprising: an outer sheath extending a length of the endoscope; an outer wall of an extrudate inside the outer sheath extending at least 80% of the length of the endoscope and ending at a bendable region of the endoscope; an inner wall inside the outer wall extending at least 90% of the length of the endoscope and through the bendable region, the inner wall defining a working channel through the endoscope; a plurality of fins extending from the inner wall to the outer wall and defining a plurality of auxiliary channels between the inner wall and the outer wall; a first pull wire extending through a first auxiliary channel of the plurality of auxiliary channels; and a second pull wire extending through a second auxiliary channel of the plurality of auxiliary channels.

[0008] In one example, the first auxiliary channel and the second auxiliary channel are positioned on opposite sides of the working channel. In another example, the endoscope further includes: a third pull wire extending through a third auxiliary channel of the plurality of auxiliary channels; and a fourth pull wire extending through a fourth auxiliary channel of the plurality of auxiliary channels, wherein the fourth auxiliary channel is positioned on an opposite side of the working channel as the third auxiliary channel. In yet another example, a access window is cut into the outer wall, above the first auxiliary channel, adjacent to and proximal of the bendable region. In still another example, the first pull wire is positioned within a first separate lumen and the second pull wire is positioned within a second separate lumen. In a further example, the endoscope further includes: a camera positioned at a distal end of the endoscope; and an electrical conductor electrically coupled to the camera and extending through a third auxiliary channel of the plurality of auxiliary channels.

[0009] In another example, the endoscope includes a spring wrapped around the bendable region and positioned inside the outer sheath. In still another example, the plurality of fins includes at least 6 fins. In yet another example, the endoscope further includes a guide tube at a distal end of the endoscope supporting one or more sensors. BRIEF DESCRIPTION OF DRAWINGS

[0010] The following drawings, which form a part of this application, illustrate aspects of the systems and methods described below and are not meant to limit the scope of the disclosure, the scope of which should be based on the claims.

[0011] Figure 1 An example video system including a steerable endoscope is depicted.

[0012] Figure 2A An example cross-section for forming an extrudate is depicted.

[0013] Figure 2B An example extrudate of an example cross-section is depicted.

[0014] Figure 3 A view of a distal end of an example extrudate is depicted.

[0015] Figures 4A-4B A view of a distal end of a modified example extrudate is depicted.

[0016] Figures 5A-5C An example method for securing a pull wire to a mounting ring is depicted.

[0017] Figures 6A-6B A view of a steerable tip of an example endoscope is depicted.

[0018] Figure 7 An example method for making a steerable endoscope is depicted. DETAILED DESCRIPTION

[0019] A patient in need of respiratory assistance can be connected to a mechanical ventilator via a respiratory tube (e.g., an endotracheal tube). In a medical procedure known as intubation, a clinician inserts a respiratory tube into a patient’s mouth, past the larynx, and into the trachea. The respiratory tube can then be connected to a ventilator or other device for supplying respiratory gases to the patient. A laryngoscope can be used during intubation to help the clinician manipulate portions of the patient’s anatomy (such as the tongue and epiglottis) and to obtain a view of the larynx sufficient for inserting the respiratory tube into the trachea. To further aid in visualizing the larynx, some laryngoscopes can be configured with a video camera. A laryngoscope including a video camera can be referred to as a video laryngoscope (VL).

[0020] For some patients, intubation can be difficult due to a variety of different factors, such as an inability to position the patient's head or neck (e.g., due to injury), airway obstruction, atypical anatomy of the patient, other health considerations, or a combination of these or other factors. In these types of scenarios, a clinician can augment the use of a VL with a steerable endoscope, which is a narrow, flexible tube that typically includes its own camera system integrated into a steerable distal tip that is inserted into the patient's body. The proximal end of the endoscope is removably connected to an external device that is capable of displaying video images from the endoscope camera and receiving control inputs from a user for controlling the steerable tip. In some examples, the endoscope can be connected to a VL that is designed to receive the endoscope and serve as both the VL and the display / control device for the endoscope.

[0021] During intubation, the endoscope can be navigated into the airway and positioned such that it provides supplemental visualization of the airway and facilitates insertion of a breathing tube. In some examples, the breathing tube is passed over the endoscope and into place in the airway, with the endoscope itself serving as a passageway or guide for insertion of the breathing tube. An endoscope serving as a guide for breathing tube insertion can perform the same or similar functions as a introducer, and can alternatively be referred to as an introducer in some examples.

[0022] The endoscope can include an internal passageway that extends from the proximal end of the endoscope (at which the passageway is accessible to the clinician during intubation) to the distal tip (at which the passageway is open to the airway). This passageway, which can be referred to as a working passageway, provides additional functionality to the endoscope that can further facilitate intubation. For example, intubation can be performed on a conscious patient, such as during awake tracheal intubation (ATI). During ATI, the clinician can use the working passageway to apply a topicalizing agent (e.g., lidocaine or other topical anesthetic) to portions of the airway to reduce patient discomfort and anxiety and increase patient tolerance of the breathing tube. In other examples (such as in non-airway applications), the working passageway can be used to deliver small instruments, such as tissue sampling instruments, catheters, or other types of instruments. In yet other examples, the working passageway can be used to apply suction during operation of the endoscope.

[0023] In addition to the working channel, elements associated with control of the steerable tip of the endoscope can also be routed between the proximal and distal ends. In one example, the proximal end of the endoscope can include a drive system that controls the steerable tip via one or more pairs of pull wires that are routed along the exterior of the working channel and connected to an interior portion of the steerable tip. Each pair of pull wires can be connected to the drive system such that the pull wires in each pair work in opposition to one another to cause articulation of the steerable tip in a plane of movement. For example, the pull wires in a pair of pull wires can be connected to opposite sides of the steerable tip to cause articulation in a first plane of movement (e.g., a left / right plane of movement). The drive system can increase tension on a first pull wire and decrease tension on a second (opposite) pull wire to cause articulation in a first direction (e.g., left). Similarly, releasing tension on the first pull wire and increasing tension on the second pull wire causes articulation of the steerable tip in a second direction (e.g., right). The endoscope can include a second pair of pull wires arranged to cause articulation of the steerable tip in a second plane of movement (e.g., an up / down plane of movement).

[0024] The present disclosure describes systems and methods for manufacturing steerable endoscopes having a steerable distal tip. One example manufacturing method includes fabricating an interior structure of an endoscope using a single extrudate, where a working channel forms a center of the structure and a set of auxiliary channels surround the working channel. The auxiliary channels are used to route pull wires that articulate the steerable tip as well as electrical conductors associated with operation of a camera system and other electrical elements located in the steerable tip. The manufacturing method can improve manufacturing and assembly efficiency of the endoscope by implementing subtractive or material-removing manufacturing processes. For example, the flexibility of the extrudate can be modified in one or more regions, such as in a region forming the steerable tip, by removing material from an exterior portion of the extrudate. Further, the exterior portion of the extrudate can be cut or sliced to simplify insertion of the pull wires and electrical conductors into the auxiliary channels. Additional details are now provided by discussion of the accompanying drawings.

[0025] Figure 1An example medical video system 100 is depicted, including a video laryngoscope (VL) 102 that can connect to and provide steering control for a steerable endoscope 106 through a detachable cartridge 104. The endoscope distal end 116 includes a steerable tip 118 and accessories 119 that can be used during operation of the endoscope 106. For example, the accessories 119 can include a camera system (e.g., video camera, lights, etc.) that captures image data (e.g., video images of the airway) during use. The accessories 119 can also include sensors, such as accelerometers or inertial measurement units (IMUs), that provide measurement data associated with acceleration, angular velocity, position, and / or other variables associated with the position / orientation / movement of the steerable tip 118. In some examples, the accessories 119 can further include one or more instrument ports, such as ports for a working channel and one or more auxiliary channels, as described herein.

[0026] The steerable tip 118 is connected to a drive system 122 through one or more pairs of pull wires (depicted in Figures 4A-4B FIG. 2) that are routed along the length of the endoscope 106. At the endoscope distal end 116, the pull wires terminate at different points on the interior of the steerable tip 118 and / or at other points on the interior of the distal end 116. At the endoscope proximal end 114, the pull wires are connected to elements of the drive system 122. The drive system 122 can include mechanical and / or electromechanical elements, such as one or more electric motors, spools, gears, and / or other elements suitable for applying steering forces to the pull wires. As described above, the elements of the drive system 122 cause the wires in each pair of pull wires to work against each other to cause articulation of the endoscope steerable tip 118 within a plane of movement.

[0027] The endoscope proximal end 114 also includes an electrical interface 123A through which the endoscope 106 can receive electrical power and can transmit / receive signals to / from the VL 102. For example, the electrical interface 123A provides power and / or steering control signals from the VL 102 to the drive system 122 to control movement of the endoscope steerable tip 118. The electrical interface 123A also provides an input power source for operating the accessories 119 (such as the camera system, sensors, etc.) and / or other sensors or electronic elements included within the endoscope 106.

[0028] Further, the electrical interface 123A provides a data path for transmitting sensor data, video images, and / or other types of data from the endoscope 106 to the VL 102. For example, video image data captured by the endoscope camera system can be transmitted to the VL 102 via the electrical interface 123A. In some examples, signals or data, such as clock signals, enable signals, timing signals, and / or other signals, can be transmitted / received through the electrical interface 123A in order to enable or configure operation of the endoscope 106.

[0029] The electrical interface 123A can include a plurality of electrical contacts, such as conductive pads, jacks, pins, balls, ports, and / or other types of electrical contacts, that are connected to elements of the endoscope 106 by a plurality of conductors routed within the interior of the endoscope 106. The conductors (depicted in Figures 4A-4B FIG. 6) can include one or more electrical wires, flexible printed circuits (FPCs), and / or other types of electrical conductors suitable for distributing power and establishing signal connections between the electrical interface 123A and elements of the endoscope 106.

[0030] Additionally, the endoscope 106 can include an access port 126 that allows access to the working channel and one or more auxiliary channels of the endoscope 106. As described above, in some examples, a local agent can be delivered to the airway via the access port 126 through the working channel during intubation. For example, a syringe, catheter, or other type of medical device can be inserted through the access port 126 into the working channel to deliver a local agent that is dispensed into the airway at the outlet port where the accessory 119 is disposed. In other examples, the access port 126 and working channel can be used for other purposes, such as the application of suction, insertion of a tissue sampling instrument, and / or for other purposes.

[0031] In the example video system 100, the access port 126 is located at the proximal tip of the endoscope 106, where the working channel can be routed around or through the drive system 122 and the electrical interface 123A. In other examples, the access port 126 can be located at other locations in or near the endoscope proximal end 114. For example, the access port 126 can be located distal of the drive system 122.

[0032] To connect the endoscope 106 to the VL 102, the endoscope proximal end 114 is connected to the detachable cartridge 104, which acts as an electrical and / or mechanical interface between the VL 102 and the endoscope 106. In other examples, the endoscope 106 can be connected to the VL 102 by another type of cartridge 104, or the endoscope 106 can be connected directly to the VL 102, such as at a connection port included within the VL 102.

[0033] The endoscope 106 can be connected to the cassette 104 by any of a variety of different methods. In one example, the endoscope 106 can slide into receiving elements on the cassette front surface 125 that hold the endoscope 106 to the cassette 104. In other examples, the steerable endoscope 106 can be connected to the cassette 104 by another method. When the endoscope proximal end 114 is connected to the cassette 104, the electrical interface 123A is conductively connected to a corresponding electrical interface (not depicted) on the cassette front surface 125. The cassette 104 further includes an electrical interface 123B on the cassette rear surface 124 for electrical connection with the VL 102. Within the cassette 104, the electrical interface 123B is connected to an electrical interface on the cassette front surface 125, such as by wiring, pins, a printed circuit board (PCB), flexible and / or other types of electrical connections.

[0034] The cassette 104 can be connected and held to the VL rear surface 103 by any of a variety of different methods, such as by permanent magnets located within the VL 102 and / or the cassette 104, or by other elements that exert a force between the VL 102 and the cassette 104. When the cassette 104 is connected to the VL 102, the electrical interface 123B is conductively connected to a corresponding electrical interface (not depicted) on the VL rear surface 103. The VL 102 provides electrical power to the endoscope 106 and can transmit / receive signals between the VL 102, the cassette 104, and the endoscope 106 through the described electrical connections of the cassette 104.

[0035] In examples where the endoscope drive system 122 includes electric motors for articulating the steerable tip 118, the VL provides power and control signals to the motors via the electrical interfaces 123A-123B. In other examples, the drive system 122 can include passive mechanical elements (such as spools, gears, etc.) that are coupled to mechanical elements of the cassette 104 and receive steering forces generated in the VL 102 or the cassette 104. In such examples, the endoscope 106, the cassette 104, and / or the VL 102 can include mechanical interfaces for transmitting these steering forces from the motors in the VL 102 or the cassette 104 to the passive mechanical elements of the drive system 122.

[0036] The VL 102 includes a display 112, a handle 108, and a blade or extension that includes a camera 111 positioned at a distal end of the blade or extension 110. The VL 102 can include additional functionality or features typically associated with a video laryngoscope, such as a power source (e.g., a battery), a processor, a memory, and other electronic components.

[0037] In one example, the VL 102 receives data (such as video images and sensor data) from the steerable endoscope 106 through the cassette 104 and displays the received data on the display 112. The display can be capable of displaying images from multiple cameras simultaneously (such as images from the VL camera 111 and the endoscope camera), such as by split screen, picture-in-picture, or other display methods. The display 112 can be any of a variety of different display technologies (such as LCD, LED, OLED, or other display technologies). In an example, the display 112 can be a touch-sensitive display (e.g., a capacitive touch-sensitive display) that allows a user to provide steering inputs through the display 112. The elements of the VL 102 can convert the steering inputs into corresponding motor outputs for articulating the endoscope steerable tip 118.

[0038] Additionally or alternatively, the endoscope 106 can be connected to other types of external devices that are capable of receiving the endoscope proximal end and establishing mechanical and / or electrical connections with the endoscope 106. In an example, the external devices can provide steering control of the endoscope steerable tip 118 and can receive image data from the endoscope 106.

[0039] Figure 2A An example cross-section 200A of a structure that forms an endoscope is depicted, and Figure 2B An example extrusion 200B of the example cross-section 200A is depicted, which an endoscope (such as the endoscope 106) can be made from. The example cross-section 200A includes an inner wall 202 and an outer wall 204 connected by a plurality of fins 206. The inner wall 202 can be substantially cylindrical, and the inner wall 202 defines an inner lumen, which can be considered a working channel 208. The outer wall 204 can also be substantially cylindrical, and a second lumen is formed between the inner wall 202 and the outer wall 204. The fins 206 separate the space or lumen between the inner wall 202 and the outer wall 204 into a plurality of auxiliary channels 210. The fins 206 can extend along the length of the extrusion 200B. The fins 206 can be material protrusions that extend from an outer surface of the inner wall 202 to an inner surface of the outer wall 204.

[0040] As described above, the working channel 208 can be used to administer a topical agent, perform suction, insert an instrument (such as a tissue sampling instrument), and / or perform other functions associated with the use of the endoscope during operation of the endoscope. The auxiliary channels 210 can be used to perform similar functions as the working channel 208, such as for providing a topical agent, suction, or a topical agent for some other purpose. The auxiliary channels 210 can also carry mechanical actuation components (such as pull wires) and electrical components (such as electrical wires) throughout the length of the endoscope.

[0041] The flexibility of the extrusion 200B (and the endoscope made therefrom) depends on a number of parameters associated with the design of the example cross-section 200A. For example, the thickness Dl of the inner wall 202, the thickness D2 of the outer wall 204, and the thickness D3 of the fins 206 each contribute to the overall flexibility of the example extrusion 200B. To achieve a desired flexibility, Dl, D2, and D3 can be independently selected. For example, an example cross-section 200A having a larger Dl, D2, and / or D3 can result in an example extrusion 200B that is less flexible, and an example cross-section 200A having a smaller Dl, D2, and / or D3 can result in an example extrusion 200B that is more flexible.

[0042] Further, the flexibility of the extrusion 200B is affected by the number of fins 206 included in the example cross-section 200A, where a larger number of fins 206 results in an example extrusion 200B that can be less flexible, and a smaller number of fins 206 results in an example extrusion 200B that can be more flexible. The number and spacing of the fins 206 also affects the number and size of the auxiliary channels 210. In examples where the fins 206 are evenly spaced from one another (such as in the example cross-section 200A), a larger number of fins 206 decreases the distance W between the fins 206, and a smaller number of fins 206 increases the distance W between the fins 206. Thus, the number of fins 206 affects the space available for routing pull wires and / or electrical conductors within each auxiliary channel 210 (depicted in FIG. 2B). In some examples, the number of fins 206 can be between 4 to 10 fins, or 6 to 8 fins. Figures 4A-4B

[0043] In some examples, the fins 206 can not be evenly spaced from one another. For example, the fins 206 can be grouped into a number of groups, each group including two or more fins 206, where the distance between the fins 206 within each group is less than the distance between the groups. As one example, the fins 206 can be grouped into groups, each group including three fins 206 that are closely spaced. The distance between the fins 206 within each group can form auxiliary channels 210 that can or can not be sized sufficient for routing pull wires or conductors or for performing other functions associated with the endoscope. However, the groups of fins 206 can be sufficiently separated from one another to form larger auxiliary channels 210 that can accommodate pull wires, conductors, etc.

[0044] ​The number and spacing of the fins 206 included in the example cross-section 200A can be selected based on the number and type of elements routed in the auxiliary channels 210, and the desired locations of the elements around the circumference of the example cross-section 200A. For example, the example cross-section 200A includes eight fins 206 that separate the space between the inner wall 202 and the outer wall 204 into eight auxiliary channels 210. Because the fins 206 are equally spaced around the circumference of the example cross-section 200A, the eight auxiliary channels 210 are spaced at 45° intervals around the example cross-section 200A. This arrangement allows opposite pull wires in a first pair of pull wires to each be routed in an auxiliary channel 210 positioned on opposite (180° apart) sides of the cross-section. For example, a first pull wire in a first pair of pull wires can be routed in an auxiliary channel 210 at location PI, and a second (opposite) pull wire in the first pair of pull wires can be routed in an auxiliary channel at location P2. A second pair of pull wires can be similarly routed in a second pair of auxiliary channels 210 oriented perpendicular to the first pair of auxiliary channels. For example, the pull wires in the second pair of pull wires can be routed in auxiliary channels 210 at locations P3 and P4. In other examples, pairs of pull wires can be routed in other auxiliary channels 210 depending on the movement planes in which the pairs of pull wires enable articulation of an endoscope steerable tip.

[0045] Additionally, the fins 206 can not all have the same thickness D3 as one another. In some examples, selected fins 206 can be designed to have a greater or lesser thickness D3 than other fins 206. Fins 206 having a greater thickness D3 can be more rigid than fins 206 having a lesser thickness D3. Further, in some examples, the thickness D3 of each of the fins 206 can vary along the height H to control the overall flexibility of the example extrusion 200B. For example, one or more fins 206 can be tapered such that the fins 206 can be designed to be wider (e.g., greater D3) near the inner wall 202 and narrower (e.g., lesser D3) near the outer wall 204. In other examples, the profile of the thickness D3 of each fin 206 along the height H can be selected to achieve a desired flexibility of the example extrusion 200B. Figure 2A In the example cross-section 200A, the fins 206 are depicted as having a uniform thickness D3 along the entire height H. However, the thickness D3 of each of the fins 206 can vary along the height H to control the overall flexibility of the example extrusion 200B. For example, one or more fins 206 can be tapered such that the fins 206 can be designed to be wider (e.g., greater D3) near the inner wall 202 and narrower (e.g., lesser D3) near the outer wall 204. In other examples, the profile of the thickness D3 of each fin 206 along the height H can be selected to achieve a desired flexibility of the example extrusion 200B.

[0046] The height H of the fins 206 can also be selected to control the flexibility of the extrusion 200B. For example, increasing H can increase the flexibility of the extrusion 200B, and decreasing H can decrease the flexibility of the example extrusion 200B. In some examples, the diameter D4 of the inner wall 202 can also be selected in conjunction with H in order to achieve a desired diameter D5 that impacts the finished diameter of an endoscope.

[0047] The flexibility of the example extrudate 200B can also be controlled by selecting a material that includes the example cross-section 200A. For example, a material with a higher durometer results in an example extrudate 200B that is less flexible, and a material with a lower durometer results in an example extrudate 200B that is more flexible. In some examples, a material with a durometer in the range of 35D to 50D can provide a suitable flexibility for the example extrudate 200B. In one example, the example cross-section 200A and the example extrudate 200B can be made with an elastomer such as PEBAX® or with a material having similar elastomeric properties.

[0048] As described, the example cross-section 200A is extruded from a single material to form the example extrudate 200B. In some examples, during fabrication, the example cross-section 200A can be extruded to a length LI (depicted in Figure 2B FIG. 2B) that can be a substantial proportion of the finished length of the endoscope. In other examples, the example cross-section 200A can be extruded to a length greater than LI and then cut to a length LI to form a substantial portion of the finished length of the endoscope. Once extruded or cut to a length LI, one end of the extrudate 200B can be considered the distal end 216 and the other end the proximal end 214 for additional fabrication steps.

[0049] Figure 3 An enhanced view of the distal end 316 of an example extrudate 300 is depicted, which can be similar or identical to the example extrudate 200B that has been further modified during fabrication. The example extrudate 300 can be based on the example cross-section 200A.

[0050] At the distal end 316 of the example extruder 300, a length L2 of the outer wall 304 is removed to form a flexible region 317 extending proximally from the distal end 309 of the example extruder 300. In some examples, the length L2 can be between approximately 20 mm to 80 mm, 30 mm to 70 mm, 35 mm to 50 mm, 50 mm to 150 mm, and 75 mm to 100 mm. In the case of a linear pull range, a shorter length of L2 can facilitate increased deflection. A longer length of L2 can facilitate visualization at the shallowest possible angle and improve the ability of the endpiece to guide the remainder of the endoscope. Removing the outer wall 304 from the flexible region 317 increases the flexibility of the example extruder 300 within the flexible region 317, relative to the portion of the example extruder 300 where the outer wall 304 was not removed (which may be referred to as the body portion of the endoscope). The body portion of the endoscope may extend at least 80% to 90% of the length of the endoscope. For example, the outer wall 304 can extend at least 70% to 90% of the endoscope's length. The inner wall 302 extends further than the outer wall 304. For example, the inner wall 302 can extend at least 80%, 90%, or 95% of the endoscope's length. (See below for more details.) Figure 4A and Figure 6A As described, the bendable region 317 can be further modified to form a controllable end (such as controllable end 118).

[0051] In some examples, removing the outer wall 304 in the flexible region 317 can result in the removal of a portion of the material from the fin 306 in the same region. For example, the height of the fin 306 in the flexible region 317 can be reduced from the original height H (in Figure 2A (Depicted in the middle) The height of fin 306 is reduced to a height sufficient to define the auxiliary channel 310 in the flexible region 317. In other examples, removing the outer wall 304 in the flexible region 317 may not affect the height of fin 306, and the fin may remain at its original height H. The inner wall 302 and the working channel 308 may remain unaffected by the removal of the outer wall 304 in the flexible region 317.

[0052] In some examples, an additional portion of the outer wall 304 can be removed within the length L3 of the example extrusion 300 to form an entry window 320. The entry window 320 is adjacent to the proximal end of the flexible region 317 and is formed above an auxiliary channel 310 in which a drawwire can be laid (in...). Figures 4A-4B(As depicted in the image). Alternatively, a slot 322 may be cut along the entire length of the example extrusion 300 through the outer wall 304. The slot 322 allows for the insertion of a draw wire, electrical conductor, and / or other components of the endoscope into the auxiliary channel 310. For example, instead of having to pass the draw wire through a fully closed auxiliary channel 310, the draw wire can be pushed along the length of the endoscope through the slot 322. In examples where one or more auxiliary channels in the auxiliary channel 310 are used for providing topical medication, suction, or for some other purpose, the slot 322 may not be cut in the corresponding auxiliary channel 310.

[0053] In some examples, additional outer wall material can be removed from the region near the proximal end of the example extrusion 300. For example, additional windows can be formed near the proximal end of the example extrusion 300, above the auxiliary channel 310 where draw wires can be laid; these additional windows can be similar to or the same as the entry window 320. In some examples, the length of the additional windows can be longer or shorter than the length L3 of the window 320.

[0054] Figure 4A An enhanced view of the distal end 416 of the example extrusion 400 is depicted, wherein elements have been added to the example extrusion 400 to form a controllable end 418. Figure 4B An enhanced view of region 430 near window 420 of example extruder 400 is depicted, wherein region 430 has been rotated clockwise for improved visibility. Example extruder 400 can be compared with... Figure 3 The illustrated example extruder 300 is similar to or the same as the example extruder 300. For example, the example extruder 400 includes an outer wall 404, fins 406, a working channel 408, an auxiliary channel 410, a window 420, and other elements that may be similar to or the same as the corresponding elements of the example extruder 300.

[0055] Example extruder 400 further includes two pairs of draw wires 445A to 445D, which draw wires in Figure 4BThis allows for easier visualization. The pull wires 445A to 445D can be arranged such that the first pair of pull wires 445A to 445B are positioned on opposite sides of the working channel 408. The second pair of pull wires 445C to 445D are also positioned on opposite sides of the working channel 408, but the second pair of pull wires 445C to 445D are oriented at 90° to the first pair of pull wires 445A to 445B, as shown. This arrangement allows the first pair of pull wires 445A to 445B to cause articulation of the controllable end 418 in a first movement plane (e.g., a left / right movement plane), and allows the second pair of pull wires 445C to 445D to cause articulation of the controllable end 418 in a second movement plane orthogonal to the first movement plane (e.g., an up / down movement plane). In other examples, the pull wires 445A to 445D can be arranged to control articulation of the controllable end 418 in other movement planes.

[0056] As described above, the drawstrings 445A to 445D can be routed along the length of the example extruder 400 and connected to a drive system (such as drive system 122) located proximally. The drive system includes elements for controlling the tension on the drawstrings 445A to 445D. During endoscopy, flexing of the endoscope along its length can affect the amount of tension on the drawstrings 445A to 445D, which may result in unwanted articulation of the controllable end 418. To reduce the likelihood of unwanted articulation, each of the drawstrings 445A to 445D can be routed within a separate lumen 442, which can be a coiled tube or a similar structure. The separate lumen 442 can be a helical spring that presents low contact friction to the drawstrings 445A to 445D. Flexion of the endoscope can cause the individual lumen to slide freely over the drawwires 445A to 445D without transmitting additional tension to the drawwires 445A to 445D and / or significantly affecting the articulation of the maneuverable end 418.

[0057] The individual lumen 442 may be a coiled metal wire or other material suitable for providing low contact friction for the drawstrings 445A to 445D. In some examples, the individual lumen 442 may be another suitable type of structure, rather than a coiled spring, to reduce friction and / or be substantially incompressible during endoscope bending. For example, the coiled tube maintains its same length between its two ends regardless of the degree to which the endoscope body is bent or manipulated during operation. During endoscope fabrication, the drawstrings 445A to 445D may be combined with the individual lumen 442, such as by winding the metal wire of the individual lumen 442 around each drawstring 445A to 445D. Each drawstring / individual lumen assembly may be pressed or rolled through the slot 422 until the individual lumen 442 and the drawstrings 445A to 445D are laid from the proximal end to the maneuverable end 418 along the full length of each auxiliary channel 410. Individual lumens 442 and drawstrings 445A to 445D are positioned in auxiliary channels 410 where material from the outer wall 404 has been removed to form windows 420. Once positioned in the appropriate auxiliary channels 410, adhesive can be applied through windows 420 to attach the individual lumens 442 to the example extruder 400. In some examples, the individual lumens 442 may similarly be attached to the example extruder 400 at the proximal end, such as by applying adhesive through windows located at the proximal end.

[0058] Similarly, the first set of electrical conductors 446A and the second set of electrical conductors 446B are pressed or rolled into the remaining (unused) auxiliary channels 410 via slots 422. Electrical conductors 446A to 446B may include an arrangement of one or more individual conductive elements 447, such as one or more wires, FPCs, and / or other types of flexible conductive elements. In some examples, the conductive elements 447 may be grouped into more or fewer sets of electrical conductors 446A to 446B, and / or may be arranged in more or fewer auxiliary channels 410. Electrical conductors 446A to 446B provide power and signal connections between electrical elements located in the proximal portion of the endoscope (such as electrical interface 123A) and electrical elements located in the controllable end 418.

[0059] The flexible region 417 may also include a spring 440. In an example including the spring 440, electrical conductors 446A to 446B and draw wires 445A to 445D are arranged within the auxiliary channel 410, passing through the flexible region 417 below the spring 440. The following is about... Figure 6A Spring 440 is described in further detail. Electrical conductors 446A to 446B and pull wires 445A to 445D terminate in the accessory area 419 of the controllable end 418.

[0060] The attachment area 419 may include a guide tube 450 that connects to a distal end (such as distal end 309) of the example extruder 400. The guide tube 450 may be attached to the example extruder 400 by any suitable method, such as by adhesive, thermal bonding, or other fastening methods. The guide tube 450 extends the working channel 408 and introduces bends therein to create space for electrical components (such as attachment 119) associated with the features and functions of the endoscope. Electrical components may include a camera 452 and a light source 454 (e.g., an LED, etc.), and may include additional active and / or passive circuit components 456. Circuit components 456 may include sensors, such as accelerometers, IMUs, and / or other types of sensors, and may include other types of electrical components.

[0061] Camera 452, light source 454, and circuit components 456 can be mounted to a common PCB, FPC, or other type of circuit board, or in some examples, to two or more electrically connected separate circuit boards. The circuit boards (multiple) can be secured to a mounting bracket 448 that contacts a portion of the guide tube 450 and / or a portion of the example extrusion 400. The mounting bracket 448 can be attached to the portion of the example extrusion 400 and / or the guide tube 450, such as by adhesive or other methods. In some examples, the guide tube 450 can be substantially straight, or it can be shaped or bent into a variety of possible configurations. The mounting bracket 448 can be accordingly designed to accommodate camera 452, light source 454, and circuit components 456.

[0062] Mounting bracket 448 can also be connected to mounting ring 458, which can be attached to a portion of guide tube 450 and / or a portion of example extrusion 400. Mounting ring 458 includes a plurality of posts 459 for attaching the ends of draw cables 445A to 445D to mounting ring 458. An example method for securing the ends of draw cables 445A to 445D to mounting ring 458 via posts 459 is described in... Figures 5A-5B The image is depicted in the image and described below. Mounting bracket 448 and mounting ring 458 may be a single continuous element, or in some examples, they may be separate elements.

[0063] Mounting bracket 448 and mounting ring 458 may include wiring routes (not depicted) that allow electrical conductors 446A to 446B to be passed from auxiliary channel 410 to multiple circuit boards associated with camera 452, light source 454, and / or circuit component 456. The conductive elements 447 of the electrical conductors 446A to 446B can be connected to the circuit boards via any of a variety of known methods for establishing electrical connections, such as soldered connections, pluggable connectors, and / or other forms of electrical connections. Accordingly, the electrical conductors 446A to 446B are electrically connected to sensors or other electrical components of the endoscope, such as the camera.

[0064] Additionally, as described above, one or more auxiliary channels in the auxiliary channels 410 (e.g., auxiliary channels 410 not used for laying pull wires 445A to 445D or electrical conductors 446A to 446B) can be used to perform functions requiring direct access to the airway. For example, one or more auxiliary channels 410 can be used to deliver topical agents, apply suction, or for another purpose. In such examples, one or more auxiliary channels in the auxiliary channels 410 can also be laid through the accessory region 419 to reach the distal end 409.

[0065] Figure 5A , Figure 5B and Figure 5C An example system 500 for attaching a pull wire 545 to a mounting ring 558 is depicted. More specifically, Figures 5A-5C Side views depicting the mounting ring at various progressive stages of the manufacturing process are shown. The pull wire 545 and the mounting ring 558 can be respectively connected to... Figures 4A-4B The draw cables 445A to 445D and the mounting ring 458 depicted are similar to or identical to each other. For example, the mounting ring 558 may be annular and may be attached to a portion of the extrudate (such as example extrudate 400) or a portion of the guide tube (such as guide tube 450). Although an example system 500 is shown for a single draw cable 545, additional draw cables may be similarly attached to the mounting ring 558 as described below.

[0066] Mounting ring 558 includes a set of three posts 559A to 559C, these posts as follows Figure 5A The arrangement is depicted on the mounting ring 558. In the depicted example, the first post 559A is located at the proximal side 570 closest to the mounting ring 558 and positioned along reference line A, wherein the first post 559A may intersect with the guy wire 545 arranged in an auxiliary channel (such as one of the auxiliary channels 410). In the example, reference line A may represent the approximate route of the guy wire 545 on the proximal side 570 of the mounting ring 558, such as... Figure 5BAs shown, the second post 559B can be vertically positioned below reference line A and horizontally positioned between the first post 559A and the third post 559C. The third post 559C can be located at the far side 572 closest to the mounting ring 558 and vertically positioned above reference line A.

[0067] The columns 559A to 559C may be formed of a material having a specific melting point lower than that of the material surrounding the columns 559A to 559C. For example, the columns 559A to 559C may melt at a lower temperature compared to other components of the endoscope proximal to the columns 559A to 559C. The material of the columns 559A to 559C may be plastic, thermoplastic, or other types of heat-sensitive materials. At elevated temperatures, such as temperatures sufficiently above normal body temperature (37°C), the columns 545A to 545C may soften and / or become flexible. In some examples, at elevated temperatures, the columns 545A to 545C may enter a liquid or semi-liquid state, in which they may deform or melt. The process of applying heat to a material previously formed into a certain shape or element (such as columns 559A to 559C) to intentionally deform or melt the material into a new shape or element can be called thermal remelting or remelting. When the heat is removed from the material after remelting, the material cools and solidifies to maintain the new shape.

[0068] In some examples, the posts 559A to 559C and the mounting ring 558 may be made of the same type of heat-sensitive material and formed using the same molding or extrusion process, while in other examples, the posts 559A to 559C and the mounting ring 558 may be made of different types of materials. The posts 559A to 559C may be attached to the mounting ring 558 using adhesives or another fastening method. In some examples, the posts 559A to 559C may be part of the mounting ring 558 or may be extensions of the mounting ring 558. For example, the posts 559A to 559C and the mounting ring 558 may be formed as a single element, such as a single molded part. In further examples, the posts 559A to 559C and the mounting ring 558 may be continuous with, or part of, other structures or elements of the endoscope (e.g., mounting bracket 448).

[0069] exist Figure 5B In the depicted example, the pull wire 545 is routed clockwise around the first post 559A to the second post 559B, counterclockwise around the second post 559B to the third post 559C, and clockwise around the third post 559C again. After a final bend at the third post 559C, the pull wire 545 is routed to the distal end 572 away from the mounting ring 558. In some examples, tension can be maintained at the distal end 564 of the pull wire 545, for example, by means of an external element (not depicted).

[0070] With guy wires 545 laid around columns 559A to 559C, heat is applied to columns 559A to 559C to remelt the material of columns 559A to 559C and cover or submerge the portion of the guy wires 55 surrounding columns 559A to 559C. For example... Figure 5C As depicted, when heat is removed, the remelted material of columns 559A to 559C solidifies to form a remelted region 580, which is continuous with the mounting ring 558 and secures the draw wire 545 within the remelted region 580 and to the mounting ring 558. In some examples, columns 559A to 559C may be remelted into two or more remelted regions 580, which secure two or more portions of the draw wire 545 within the remelted region 580 and to the mounting ring 558. After remelting, the distal end 564 of the draw wire 545 can be cut off and discarded. For example, the distal end of the draw wire 545 can be cut at or near the distal side 572 of the mounting ring 558.

[0071] The arrangement of posts 559A to 559C and the routing of the pull wire 545 around posts 559A to 559C are designed to enhance adhesion of the pull wire 545 to the mounting ring 558 when posts 559A to 559C are remelted. For example, the arrangement of posts 559A to 559C causes the pull wire 545 to follow a generally S-shaped path through the remelted region 580, which increases the surface area of ​​contact between the pull wire 545 and the mounting ring 558 and the remelted region 580. Furthermore, during articulation of the endoscope's maneuverable tip, the S-shaped path of the pull wire 545 distributes the force applied to the pull wire 545 throughout the remelted region 580. This wider distribution of force within the remelted region 580 reduces the likelihood of the pull wire 545 loosening or detaching from the mounting ring 558 when tension is applied to it.

[0072] In some examples, posts 559A to 559C can be designed to further increase the contact between the draw wire 545 and the mounting ring 558 and the remelt zone 580, and further distribute the control force (i.e., tension) applied to the draw wire 545 to the mounting ring 558 and the remelt zone 580. For example, posts 559A to 559C can be designed to have a larger diameter D6 (in Figure 5A (as depicted in the image), thereby lengthening the route of the draw wire 545 around the posts 559A to 559C. The longer route around the posts 559A to 559C results in a larger surface area of ​​contact between the draw wire 545 and the remelting area 580 when the posts 559A to 559C remelt, and can increase the distribution of control force from the draw wire 545 to the remelting area 580 and the mounting ring 558.

[0073] Additionally or alternatively, the mounting ring 558 can be designed with an increased or decreased width W2. In the example where the width W2 of the mounting ring 558 is increased, the posts 559A to 559C can be spread laterally further apart, which can increase the length of the draw wire path within the remelting zone 580, but may result in a less pronounced or gentler S-shaped path around the posts 559A to 559C. Therefore, after remelting, the control force applied to the draw wire 545 can be distributed less widely across the remelting zone 580. In the example where the width W2 of the mounting ring 558 is decreased, the posts 559A to 559C can be spaced laterally closer together, which can decrease the length of the draw wire path within the remelting zone 580, but may result in a more pronounced S-shaped path around the posts 559A to 559C. Therefore, after remelting, the control force applied to the draw wire 545 can be distributed more widely across the remelting zone 580 and the mounting ring 558.

[0074] Additionally or alternatively, posts 559B to 559C may be vertically spaced further from reference line A. This increases the length of the path taken by the pull wire 545 through the remelt region 580 and can help distribute the control force from the pull wire 545 to the remelt region 580 and the mounting ring 558. In some examples, posts 559A to 559C may include features that facilitate the connection between the pull wire 545 and the remelt region 580 and the mounting ring 558. For example, as... Figure 4A As depicted, posts 559A to 559C may include hooks or hook portions that, when posts 559A to 559C are remelted, can further ensure contact between the draw wire 545 and the remelted area 580. In other examples, posts 559A to 559C may include other features, or may be shaped and / or arranged in a manner that facilitates securing the draw wire 545 to posts 559A to 559C, the remelted area 580, and / or the mounting ring 558.

[0075] Figure 6A The distal end 616 of the example endoscope 600A is depicted, wherein pull wires 645A to 645D are attached to a mounting ring 658. The example endoscope 600A may be similar to or identical to the example extrusion 400 and may include elements described above. Figures 4A-4B The same or similar elements are depicted. For example, the example endoscope 600A includes four pull wires 645A to 645D, which may be similar to or the same as pull wires 445A to 445D. Figure 6A In the example endoscope 600A, pull wires 645A and 645C are visible, while pull wires 645B and 645D are located on the opposite side of the example endoscope 600A and are not visible.

[0076] Pull wires 645A to 645D are attached to mounting ring 658 via the remelting process described above for mounting ring 558. In short, each pull wire 645A to 645D is laid around a set of dedicated posts (such as posts 449 or 559A to 559C) and maintained under relatively equal tension (such as through external elements not depicted). In the example endoscope 600A (in... Figure 1 At the proximal end of the (as depicted in the image), pull wires 645A to 645D are attached to elements of an endoscope drive system (such as drive system 122), which can remain static during the remelting process. Heat is applied to remelt the material of the column, and then the heat is removed, allowing the material to cool and solidify, and securing each pull wire 645A to 645D to a mounting ring 658. As described above, the distal ends of the pull wires 645A to 645D can be cut off near the mounting ring 658 and removed.

[0077] Example endoscope 600A also includes a flexible region 617 and an accessory region 619 that together form a maneuverable tip 618. While maintaining relatively equal tension on the drawwires 645A to 645D during reflow, the maneuverable tip 618 remains in a neutral or non-articular orientation. In a neutral orientation (in... Figure 6A As depicted in the diagram, the bendable region 617 is substantially straight along its entire length and can be substantially parallel to the axis C of the working channel 608 in the accessory region 619. The spring 640 helps maintain the neutral position of the controllable end 618.

[0078] Figure 6B An example endoscope 600B is depicted, in which an outer sheath 684 has been added to an example endoscope 600A. The outer sheath 684 is a thin-walled tube that seals the example endoscope 600 while allowing articulated movement of the maneuverable tip 618 and buckling along the length of the example endoscope 600B. Therefore, the outer sheath 684 can be made using a material with high flexibility, such as a thin polyurethane extrusion, or other types of flexible materials. In some examples, the outer sheath 684 can be designed to achieve low stiffness, such as a stiffness in the range of 30a to 40a. In other examples, the outer sheath 684 can be made of materials exhibiting even lower or higher stiffness ranges.

[0079] The thickness of the outer sheath 684 can be substantially less than 1 mm, so that the outer sheath 684 increases the outer diameter of the base extrusion to a minimum. For example, the outer diameter D9 of the example endoscope 600B can be at least greater than... Figure 2AThe outer wall diameter D5 depicted for example section 200A is (e.g., less than 5% larger). In some examples, the outer diameter D9 of example endoscope 600B can be approximately 5 mm, while in other examples, the outer diameter D9 of example endoscope 600B can be greater than or less than 5 mm.

[0080] A transparent or translucent sealant can be applied to a portion of orifice 682 located in the space between working channel 608 and outer sheath 684, thereby opening the distal end of working channel 608 to the patient's airway. The sealant protects the electrical components of accessory area 619 while allowing light generated by light source 654 to illuminate the patient's airway and allowing camera 652 to capture an image of the airway. In examples where one or more auxiliary channels (such as auxiliary channel 410) are used for administering topical medications, aspiration, or performing another function within the patient's airway, the auxiliary channel may be positioned through accessory area 619 and terminate at orifice 682. Sealants can also be applied around the auxiliary channel(s), simultaneously opening the distal ends of the auxiliary channel(s) to the airway.

[0081] As described above with respect to wires 445A to 445D, wires 645A to 645B can form a first wire pair, wherein tension can be applied to wire 645A and released from wire 645B to cause joint movement in a first direction (e.g., to the left), and conversely, to cause joint movement in a second direction (e.g., to the right). Wires 645C to 645D can form a second wire pair, which can function in the same way as the first wire pair 645A to 645B, but cause joint movement in another plane of movement (e.g., up / down).

[0082] With the draw cables 645A to 645D attached to the mounting ring 658, a tension applied to (and released from) one of the draw cables 645A to 645D is transmitted to the mounting ring 658, causing buckling of the bendable region 617 and the spring 640. Consequently, the attachment region 619 articulates in the direction of the applied tension.

[0083] In addition to helping maintain the flexible area in a neutral position during the attachment of the cables 645A to 645D, the spring 640 can also provide smooth articulation of the maneuverable tip 618 during operation of the example endoscope 600B. For example, the spring 640 can apply a restoring force to the maneuverable tip 618 in the direction of the neutral position, which can reduce areas within the range of motion where the responsiveness of maneuver control may be poor.

[0084] In some examples, the bendable region 617 may not include the spring 640, but instead include one or more elements of another type capable of applying forces to the bendable region 617 and the attachment region 619. For example, the bendable region 617 may include a tubular structure with elastic properties that is capable of flexing during joint movement and applying a restoring force to the controllable end 618.

[0085] Figure 7 An example method 700 for fabricating a maneuverable endoscope is depicted. At operation 702, a cross-section (such as example cross-section 200A) is extruded to form the basic structure of a maneuverable endoscope (such as endoscope 106). This cross-section may include the features discussed above. For example, the cross-section may be substantially circular and include an inner wall (e.g., inner wall 202) connected to a larger diameter outer wall (e.g., outer wall 204) by a plurality of radially oriented fins (e.g., fins 206). The fins divide the space between the inner and outer walls into a plurality of auxiliary channels (e.g., auxiliary channels 210), which may be used for laying pull wires (e.g., pull wires 445A to 445D), electrical conductors (e.g., electrical conductors 446A to 446B), or for other purposes as described above.

[0086] This cross-section can be extruded using known extrusion techniques. For example, the cross-section can be extruded using a single-screw or twin-screw extruder that forces material through a die that shapes the material into the form of the described cross-section. In some examples, the extrusion process may include applying heat to the material to soften and / or combine the material, or it may include using another process to soften and / or combine the material to form an extrudate.

[0087] At operation 704, the extrudate is cut to a desired length (e.g., length L1). In some examples, the extrudate can be cut to a certain length during the extrusion process, such as by means of a cutting element associated with the extruder. The length of the cut extrudate can be a considerable fraction of the length of the finished endoscope. For example, the length of the cut extrudate can be greater than 80% to 90% of the length of the finished endoscope (e.g., including a guide tube and drive system).

[0088] At operation 706, an outer wall is removed from a portion (such as length L2) of the distal end of the cut extrudate to form a flexible region (e.g., flexible regions 317 and 417), wherein removing the outer wall increases the flexibility of the extrudate within the flexible region. In some examples, the outer wall may be removed from a portion greater than 1 cm to 2 cm or 1 cm to 5 cm from the distal end of the extrudate. In some examples, removing the outer wall may result in the removal of a portion of the fin within the flexible region, while in other examples, the fin may be substantially unaffected by the removal of the outer wall.

[0089] At operation 708, an additional portion (such as length L3) of the outer wall is removed from the distal end of the cut extrudate to form a window (e.g., window 320) above each auxiliary channel in which the draw wire will be laid (described below with respect to operation 712). The window is formed adjacent to the proximal end of the flexible region. Additional windows may be formed at the proximal end of the cut extrudate, above the same auxiliary channel in which the draw wire will be laid. In some examples, windows may be formed above other auxiliary channels in which the draw wire is not laid. In other examples, windows may not be formed at the distal end of the cut extrudate.

[0090] At operation 710, slots (e.g., slots 322 and 422) are cut along the length of the extruded material, from distal to proximal end, and above each auxiliary channel. If a window is present, the slot is cut from the opening of each window to the proximal end. If no window is present, the slot is cut from the flexible region to the proximal end. The slots can be cut using any of a variety of different cutting methods suitable for cutting the extruded material. In examples where one or more auxiliary channels are used for providing topical agents, suction, or for some other purpose, slots cannot be cut in the corresponding auxiliary channels.

[0091] At operation 712, for an auxiliary channel designated for laying the pull wire, a separate lumen 442 containing the pull wire is inserted into the appropriate auxiliary channel through a slot. During insertion, this can be done by any of a variety of different methods suitable for pressing the separate lumen and / or the pull wire through the slot. The pull wire may be installed in the separate lumen prior to operation 712. For example, the separate lumen may be formed or wrapped around the pull wire during a process prior to endoscope assembly.

[0092] With individual lumens and culms inserted into auxiliary channels, the distal end of an individual lumen can be attached to its corresponding auxiliary channel by applying adhesive through the window formed at operation 712. In the example, adhesive or other methods of securing individual lumens can also be used to secure the proximal end of an individual lumen to its corresponding auxiliary channel. As described above, with one or both ends of each individual lumen (e.g., a coiled tube) secured within the auxiliary channel, buckling of the endoscope causes buckling of the individual lumen without significantly affecting the tension on the culms.

[0093] Additionally, for auxiliary channels designated for laying electrical conductors (e.g., conductors 446A to 446B), the conductors are also pressed into the appropriate auxiliary channels via slots. As described above, the electrical conductors may include one or more wires, FPCs, and / or other types of conductive elements. This can be done by any of a variety of different methods suitable for pressing the conductors through slots and inserting them into the auxiliary channels (such as the same or similar methods used for inserting individual lumens and pull wires).

[0094] At operation 714, a guide tube (e.g., guide tube 450) is attached to the distal end of the extruded material being cut. The guide tube is introduced into the working channel at the distal end of the endoscope to accommodate a camera system (e.g., camera 452, light source 454, etc.) and other components surrounding the working channel. The guide tube can be attached to the distal end of the extruded material by any of a variety of different methods (e.g., by adhesive, thermal bonding, or other methods). The guide tube and associated components can serve as an attachment area (e.g., attachment area 419). The flexible area and the attachment area together can serve as a maneuverable end (e.g., maneuverable ends 118 and 618).

[0095] At operation 716, a spring (e.g., springs 440 and 640) is positioned over a flexible area at the distal end of the cut extrusion. The spring helps maintain the flexible area in a neutral (unbent) position, as described above, when the cable is secured at the distal end of the endoscope. Figures 5A-5C and Figure 6A As described. During joint movement, when tension is released from one or more of the cables, the spring also applies a restoring force to help return the controllable end to the neutral position. In some examples, the function of the spring can be performed by another element capable of applying a force toward the neutral position when the joint moves away from the neutral position in a bendable region. For example, a thin-walled elastic tube or other type of elastic element can be used instead of the spring.

[0096] At operation 718, the guy wires can be connected to a mounting ring (e.g., mounting ring 458, 558, or 658) or a similar element suitable for attaching one or more guy wires. As described above, each guy wire can be laid around one or more posts associated with the mounting ring, and heat is applied to remelt the posts. The remelted material of the posts is then allowed to cool and solidify to secure the guy wires. The guy wires can be cut or trimmed to remove excess wire length extending distally from the remelted area. In other examples, other methods can be used to secure the guy wires to the mounting rings or other elements at the controllable ends. For example, the guy wires can be secured by adhesives, welding, or other fastening methods.

[0097] In some examples, the proximal end of the draw wire can be connected to an element of the endoscope drive system (e.g., drive system 122) before the distal end of the draw wire is connected to the mounting ring. The drive system can statically hold the proximal end of the draw wire so that tension can be applied to the draw wire during the remelting process.

[0098] Additionally, electrical conductors are connected to circuit elements located in the accessory area. For example, wires can be soldered to pads, posts, or other types of connection elements. In examples where the electrical conductors include one or more FPCs, the connection between each FPC and its corresponding circuit element(s) can be made using mating connectors. In other examples, electrical conductors can be connected to circuit elements using any of a variety of well-established methods for making electrical connections. At the proximal end of the endoscope, electrical conductors can be connected to elements of an electrical interface (e.g., electrical interface 123A).

[0099] At operation 720, an outer sheath (e.g., outer sheath 684) is attached to the assembly to complete the endoscope fabrication. The outer sheath is a thin-walled tube that seals the endoscope while allowing it to remain flexible and permitting articulation of the maneuverable tip. Therefore, the outer sheath can be made of a highly flexible material (such as a thin polyurethane extrusion) or other types of materials that can be made thin and flexible.

[0100] At the distal end of the endoscope, the end of the outer sheath forms an opening (e.g., opening 682) that coincides with the end of the working channel. A transparent or translucent sealant may be filled at least partially between the outer sheath and the working channel to protect the components in the accessory area while allowing the endoscopic camera system to illuminate and image the airway through the sealant.

[0101] Before installing the sheath, an opening can be made in the outer sheath at the proximal end to allow the outer sheath to be assembled around the electrical interface. The outer sheath can be further sealed around the electrical interface and proximal end of the endoscope using adhesives, sealants, etc.

[0102] Those skilled in the art will recognize that the methods and systems disclosed herein can be implemented in many ways and should therefore not be limited to the foregoing aspects and examples. In other words, functional elements are performed by one or more components. In this regard, any number of features of the different aspects described herein can be combined into one or more aspects, and alternative aspects having fewer or more features than all those described herein are possible. Functionality can also be distributed entirely or partially among multiple components in ways now known or to be known.

[0103] Furthermore, as used herein and in the claims, the phrase "at least one of element A, element B, or element C" is intended to convey any of the following: element A, element B, element C, elements A and B, elements A and C, elements B and C, and elements A, B, and C. Additionally, those skilled in the art will understand the extent conveyed by terms such as "about" or "substantially" according to the measurement techniques used herein. Where the extent to which these terms may not be clearly defined or understood by those skilled in the art, the term "about" should refer to plus or minus ten percent.

[0104] Many other changes may be made, which will readily be apparent to those skilled in the art, and are embodied in the spirit of this disclosure and as defined in the appended claims. Although various aspects have been described for the purposes of this disclosure, various changes and modifications may be made fully within the scope of this disclosure. Many other changes may be made, which will readily be apparent to those skilled in the art, and are embodied in the spirit of this disclosure and as defined in the claims.

Claims

1. A method for manufacturing an endoscope, the method comprising: Extrusion section to form extrudate, said extrudate comprising: Inner wall, the inner wall defining a first lumen; An outer wall, the outer wall defining a second lumen between the inner wall and the outer wall; and Multiple fins extending from the inner wall to the outer wall and defining multiple auxiliary channels in the second lumen; Remove a portion of the outer wall from the distal end of the extrusion to form a flexible region; Slots are cut into the outer walls above at least two of the auxiliary channels; The draw wire is inserted into one of the auxiliary channels through one of the slots; and An outer sheath is installed, which covers the extrudate and includes the flexible region.

2. The method of claim 1, further comprising cutting the extrudate to the length of the endoscope.

3. The method of claim 1, further comprising mounting a spring on the auxiliary channel in the bendable region.

4. The method of claim 1, further comprising inserting an electrical conductor into the auxiliary channel through the slot.

5. The method of claim 1, further comprising: The distal end of the pull wire is arranged around the post protruding from the mounting ring; as well as The column is heat-remelted to secure the pull wire to the mounting ring.

6. The method of claim 1, wherein, The plurality of fins includes at least four fins.

7. An endoscope, comprising: An outer sheath that extends the length of the endoscope; The outer wall of the extrudate, the outer wall being located inside the outer sheath, extending at least 80% of the length of the endoscope and ending at the flexible region of the endoscope; An inner wall, located inside the outer wall, extending at least 90% of the length of the endoscope and passing through the flexible region, defines a working passage through the endoscope; Multiple fins extending from the inner wall to the outer wall and defining multiple auxiliary channels between the inner wall and the outer wall; A first pull wire extends through a first auxiliary channel among the plurality of auxiliary channels; as well as The second pull wire extends through the second auxiliary channel of the plurality of auxiliary channels.

8. The endoscope as claimed in claim 7, wherein, The first auxiliary channel and the second auxiliary channel are located on opposite sides of the working channel.

9. The endoscope of claim 8, further comprising: The third pull wire extends through the third auxiliary channel among the plurality of auxiliary channels; as well as A fourth pull wire extends through a fourth auxiliary channel among the plurality of auxiliary channels, wherein the fourth auxiliary channel and the third auxiliary channel are located on opposite sides of the working channel.

10. The endoscope as claimed in claim 7, wherein, An access window is cut into the outer wall, above the first auxiliary channel, adjacent to the flexible region, and near the flexible region.

11. The endoscope as claimed in claim 7, wherein, The first pull wire is positioned within a first separate cavity, and the second pull wire is positioned within a second separate cavity.

12. The endoscope of claim 7, further comprising: A camera, which is positioned at the distal end of the endoscope; as well as An electrical conductor is electrically connected to the camera and extends through a third auxiliary channel of the plurality of auxiliary channels.

13. The endoscope of claim 7, further comprising a spring wound around the flexible region and positioned inside the outer sheath.

14. The endoscope as claimed in claim 7, wherein, The plurality of fins includes at least 6 fins.

15. The endoscope of claim 7, further comprising a guide tube located at the distal end of the endoscope and supporting one or more sensors.

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