One-piece elevator for duodenoscope

Abstract

An elevator for an endoscope, the elevator comprising: a first end portion secured to the endoscope; a second end portion movable by an actuator; a flexible portion positioned between the first end portion and the second end portion, the flexible portion rotatable when the second end portion is moved by the actuator; and a guide portion extending between the flexible portion and the second end portion to receive an endotherapy instrument extending from the endoscope, the guide portion comprising a chute to guide the endotherapy instrument away from the endoscope. A method of forming an elevator, the method comprising: forming an elongate body from a planar sheet material, the elongate body comprising a length between a first end portion and a second end portion, a width, and a thickness; forming a guide body in the elongate body; bending the elongate body such that the first length and the second length of the elongate body oppose one another to form an interior space; and bending the guide body to extend into the interior space.

Description

[0001] Cross Reference to Related Applications

[0002] This patent application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 958,041, titled “Endoscope With Low-Profile Distal Section,” filed January 7, 2020; U.S. Provisional Patent Application No. 62 / 958,782, titled “Endoscope with an Elevator,” filed January 9, 2020; U.S. Provisional Patent Application No. 63 / 024,674, titled “Endoscope With Low-Profile Distal Section,” filed May 14, 2020; and U.S. Provisional Patent Application No. 63 / 024,682, titled “One-Piece Elevator For A Duodenoscope,” filed May 14, 2020; the entire contents of which are hereby incorporated by reference. TECHNICAL FIELD

[0003] The present disclosure relates generally to medical devices that include an elongate body configured to be inserted into an incision or opening in a patient’s anatomy to provide diagnostic or therapeutic procedures.

[0004] More particularly, the present disclosure relates to endoscopes for imaging and / or providing access to various anatomical portions for therapeutic devices, including the gastrointestinal tract (e.g., esophagus, stomach, duodenum, pancreaticobiliary duct, intestine, colon, etc.), renal region (e.g., kidney, ureter, bladder, urethra), and other internal organs (e.g., reproductive system, sinus cavities, submucosal regions, respiratory tract), etc. BACKGROUND

[0005] Conventional endoscopes can be used for various clinical procedures including, for example, illumination, imaging, detection and diagnosis of one or more disease states, providing fluid delivery (e.g., delivery of saline or other agents via a fluid channel) to an anatomical region, providing access (e.g., via a working channel) for one or more therapeutic devices for sampling or treatment of an anatomical region, and providing suction access for collection of fluids (e.g., saline or other agents), etc.

[0006] In conventional endoscopy, the distal portion of the endoscope can be configured for supporting and orienting a treatment device, such as by using an elevator to support and orient a treatment device. However, in some cases, such distal portions can result in the distal portion being difficult to sterilize or reprocess after use. For example, conventional endoscopic devices can be fully reusable, such that crevices between components or spaces within functional components of the distal portion are difficult to access and clean. SUMMARY

[0007] The present inventors have recognized that problems to be solved with conventional medical devices, and particularly endoscopes and duodenoscopes, include, among other things: 1) the need and difficulty of cleaning and sterilizing the endoscope after use, 2) the cost of maintaining multiple endoscopes in inventory to perform different surgical techniques or treatment methods on different patients, and 3) the cost of purchasing medical devices for a particular patient with excess capacity or capacity that is not needed. The present disclosure can help provide solutions to these and other problems by providing systems, devices, and methods for designing, building, using, and disassembling modular endoscopes. In particular, the present application relates to detachable camera modules for medical devices such as endoscopes and duodenoscopes. The camera modules can be configured for reuse after appropriate cleaning and sterilization, while the insertion sheath and shaft, to which the camera module can be configured to connect, can be configured for single use. In this way, the more expensive camera components can be attached in a modular fashion to inexpensive single-use insertion sheaths and shafts. The modular camera components can be configured for cleaning, for example, by being encapsulated, while the insertion sheaths and shafts can be cheaply manufactured to perform only the desired procedure and then disposed of after use. Such a configuration can eliminate the need to clean hard-to-reach places in a fully assembled device, and the need to maintain a large inventory of devices with different capacities or excess capacity.

[0008] The present inventors have also recognized that problems to be solved with conventional medical devices, and particularly endoscopes and duodenoscopes, include, among other things: the complexity of some components can result in increased difficulty of cleaning. To avoid the difficult cleaning process, it can be desirable to make these components disposable. Thus, it is desirable to make such disposable components cheaper. The present disclosure can help provide solutions to these and other problems by providing systems, devices, and methods including an elevator for side-viewing duodenoscopes and other devices, which is simple in design and thus cheaper and easier to manufacture than conventional elevator mechanisms.

[0009] The present inventors have also recognized that conventional side-viewing endoscopes, such as duodenoscopes, present problems to be solved that include, among other things, an increase in the size of the distal end of the device due to the presence of the elevator, which is typically positioned immediately adjacent to the longitudinal axis of the device, i.e., radially relative to the longitudinal axis of the device, thereby increasing the diameter of the device. The increase in the size of the distal end of the device can make the device difficult to navigate through the patient’s anatomy, particularly when faced with small size orifices or anatomical passageways that intersect at acute angles. The present disclosure can help provide solutions to these and other problems by providing systems, devices, and methods that include side-viewing endoscopes that position the imaging and illumination units distal to the elevator mechanism, thereby enabling a smaller distal end of the medical device as compared to typical duodenoscopes.

[0010] In an example, an endoscope can include a proximal section, an insertion section extending longitudinally from the proximal section and including an elongate tubular body disposed along a longitudinal axis of the insertion section and a lumen extending through the elongate tubular body, and a distal section extending from the insertion section and including an elevator portion including an elevator configured to position and orient one or more endo-therapeutic tools extending from the lumen and a camera module including an illumination unit and an imaging unit, the camera module positioned longitudinally spaced apart from the elevator portion in an inline configuration such that the longitudinal axis of the insertion tube passes through the elevator portion and the camera module.

[0011] In another example, an endoscope can include a proximal section, an insertion section extending longitudinally from the proximal section and including an elongate tubular body disposed along a longitudinal axis of the insertion section and a lumen extending through the elongate tubular body, and a distal section extending from the insertion section and including an elevator portion including an elevator configured to position and orient one or more endo-therapeutic tools extending from the lumen and a camera module including an illumination unit and an imaging unit, the camera module detachable by a user from the elevator portion.

[0012] In another example, a method of processing modular endoscope components for performing a surgical procedure can include identifying a particular patient for a particular treatment, selecting an insertion sheath for implementing the particular treatment, attaching a camera module to the insertion sheath, treating the particular patient using the insertion sheath with the camera module attached, and disassembling the components of the modular endoscope into reusable components and single-use components. BRIEF DESCRIPTION OF DRAWINGS

[0013] Figure 1This is a schematic diagram of an endoscope system, which includes an imaging and control system and an endoscope, such as a duodenoscope.

[0014] Figure 2 for Figure 1 A schematic diagram of an endoscope system including an endoscope connected to a control unit of an imaging and control system.

[0015] Figure 3 A schematic top view of a camera module including optical components for a side-viewing endoscope.

[0016] Figure 4 In order to be in Figure 3 An enlarged cross-sectional view taken at plane 4-4 shows the optical components.

[0017] Figure 5 For use as Figures 1-4 A schematic diagram of a modular endoscope, which includes a camera module, an insertion section module, and a navigation and control module, the modules being configured to be separable from each other.

[0018] Figure 6A This is a schematic diagram of a first example of a low-profile side-view endoscope of the present disclosure, which includes an illumination unit and an imaging unit arranged side-by-side relative to an elevator portion.

[0019] Figure 6B for Figure 6A A schematic cross-sectional view of the endoscope taken at plane 6B-6B, showing the illumination unit passage and imaging unit passage located next to the insertion passage.

[0020] Figure 7A This is a schematic diagram of a second example of a low-profile side-view endoscope of the present disclosure, which includes an end-to-end illumination unit and an imaging unit relative to the lift portion.

[0021] Figure 7B for Figure 7A A schematic cross-sectional view of the endoscope taken at plane 7B–7B, showing the illumination unit passage and imaging unit passage aligned with the insertion passage.

[0022] Figure 8 for Figure 6A A schematic cross-sectional view of the low-profile side-view endoscope taken at plane 8-8, showing the imaging unit and imaging pathway relative to the lift.

[0023] Figure 9 for Figure 6A A schematic cross-sectional view of the low-profile side-view endoscope taken at plane 9-9, showing the lighting unit and lighting path relative to the lift.

[0024] Figure 10 Schematic view of a distal end portion of an endoscope of the present disclosure, the distal end portion of the endoscope including an attachment mechanism for a detachable camera module.

[0025] Figure 11 Schematic view of a distal end portion of an endoscope of the present disclosure including a wide-angle lens.

[0026] Figure 12 Schematic cross-sectional view of the distal end portion of the endoscope of Figure 11

[0027] Figure 13 Perspective view of a riser mechanism of the present disclosure adapted for use with a disposable low-profile endoscope.

[0028] Figure 14 Top view of the riser mechanism of Figure 13

[0029] Side cross-sectional view of the riser mechanism of Figure 15 Figure 13 Schematic cross-sectional view of the riser mechanism of

[0030] Figure 16 Figure 13 Schematic cross-sectional view of the riser mechanism of

[0031] Figure 17 Schematic cross-sectional view of the riser mechanism of Figure 14

[0032] Figure 18 Schematic cross-sectional view of the riser mechanism of Figure 17

[0033] Figure 19 Schematic cross-sectional view of the riser mechanism of Figure 18

[0034] Figure 20 Block diagram illustrating a method of processing modular endoscope components for performing surgical procedures. DETAILED DESCRIPTION

[0035] Figure 1 ​​​​​​Endoscope system 10 is shown in a schematic view, and endoscope system 10 includes an imaging and control system 12 and an endoscope 14. Figure 1 is an illustrative example of an endoscope system suitable for use with the systems, devices, and methods described herein, such as modular endoscope systems, modular endoscopes, and methods for designing, building, and disassembling endoscopes. According to some examples, endoscope 14 is capable of being inserted into an anatomical region for imaging and / or to provide a passageway for one or more sampling devices for biopsy or one or more treatment devices for treating a disease state associated with the anatomical region. In advantageous aspects, endoscope 14 can interface with and connect to imaging and control system 12. Although in the illustrated example endoscope 14 includes a duodenoscope, other types of endoscopes can be used with the features and teachings of the present disclosure.

[0036] Imaging and control system 12 can include a controller 16, an output unit 18, an input unit 20, a light source 22, a fluid source 24, and a suction pump 26.

[0037] Imaging and control system 12 can include various ports for coupling with endoscope system 10. For example, controller 16 can include data input / output ports for receiving data from and transmitting data to endoscope 14. Light source 22 can include output ports for transmitting light to endoscope 14, such as via fiber optic links. Fluid source 24 can include ports for transmitting fluid to endoscope 14. Fluid source 24 can include a pump and a fluid tank, or fluid source 24 can be connected to an external tank, container, or storage unit. Suction pump 26 can include ports for drawing a vacuum from endoscope 14 to create suction, such as for drawing fluid from an anatomical region into which endoscope 14 is inserted. An operator of endoscope system 10 can use output unit 18 and input unit 20 to control the functions of endoscope system 10 and to observe the output of endoscope 14. Controller 16 can additionally be used to generate signals or other outputs from treatments performed on an anatomical region into which endoscope 14 is inserted. In examples, controller 16 can generate electrical outputs, acoustic outputs, fluid outputs, and the like, for treating an anatomical region with, for example, cauterization, cutting, freezing, and the like.

[0038] Endoscope 14 can include an insertion section 28, a functional section 30, and a handle section 32, which can be coupled to a cable section 34 and a coupler section 36.

[0039] Insertion segment 28 extends distally from handle segment 32, and cable segment 34 extends proximally from handle segment 32. Insertion segment 28 may be elongated and include a curved segment and a distal end for attachment to functional segment 30. The curved segment may be controllable (e.g., via a control knob 38 on handle segment 32) to manipulate the distal end through tortuous anatomical pathways (e.g., stomach, duodenum, kidney, ureter, etc.). Insertion segment 28 may also include one or more working channels (e.g., internal lumens), which may be elongated and support the insertion of one or more therapeutic instruments of functional segment 30. The working channels may extend between handle segment 32 and functional segment 30. Insertion segment 28 may also provide additional functionality (e.g., via aspiration or flushing pathway, etc.), such as fluid pathways, guides, and drawstrings.

[0040] The handle module 32 may include a knob 38 and a port 40. The knob 38 may be connected to a pull cable extending through the insertion section 28. The port 40 may be configured to connect various cables, fluid conduits, etc., to the handle module 32 for connection to the insertion section 28.

[0041] According to the example, the imaging and control system 12 can be mounted on a mobile platform (e.g., a trolley 41) having shelves for housing the light source 22, the suction pump 26, the image processing unit 42, etc. Alternatively, Figure 1 and Figure 2 Several components of the imaging and control system 12 shown can be directly mounted on the endoscope 14 so that the endoscope is "independent".

[0042] Figure 2 for Figure 1 A schematic diagram of an endoscope system 10 including an imaging and control system 12 and an endoscope 14. Figure 2 The components of the imaging and control system 12 connected to the endoscope 14 are schematically illustrated. In the illustrated example, the endoscope 14 includes a duodenoscope. The imaging and control system 12 may include a controller 16, which may include an image processing unit 42, a treatment generator 44 and a drive unit 46, as well as a light source 22, an input unit 20 and an output unit 18, or the controller 16 may be connected to the image processing unit 42, the treatment generator 44 and the drive unit 46, as well as the light source 22, the input unit 20 and the output unit 18.

[0043] The image processing unit 42 and the light source 22 can each interface with the endoscope 14 through wired or wireless electrical connections. The imaging and control system 12 can accordingly illuminate the anatomical region, collect signals representative of the anatomical region, process signals representative of the anatomical region, and display images representative of the anatomical region on the display unit 18. The imaging and control system 12 can include the light source 22 to illuminate the anatomical region with light of a desired spectrum (e.g., broadband white light, narrowband imaging using preferred electromagnetic wavelengths, etc.). The imaging and control system 12 can be connected to the endoscope 14 (e.g., via an endoscope connector) for signal transmission (e.g., light output from the light source, video signals from the imaging system in the distal end, etc.).

[0044] The fluid source 24 can include one or more air sources, saline sources, or other fluid sources, as well as associated fluid pathways (e.g., air channels, irrigation channels, suction channels) and connectors (barb fittings, fluid seals, valves, etc.). The imaging and control system 12 can also include a drive unit 46, which can be an optional component. The drive unit 46 can include a motorized drive for advancing the distal section of the endoscope 14, as described in at least PCT Publication No. WO 2011 / 140118 Al to Frassica et al., entitled "Rotate-to-Advance Catheterization System," the entire disclosure of which is hereby incorporated by reference.

[0045] Figure 3 and Figure 4 FIG. 1 illustrates a first example of a functional section 30 of the endoscope 14. Figure 2 FIG. 2 illustrates a top view of the functional section 30, and Figure 3 FIG. 3 illustrates a cross-sectional view of the functional section 30 taken along the cross-sectional plane 3-3 of FIG. 2. Figure 4 and Figure 3 Each of FIGS. 4 and 5 illustrates a "side-view endoscope" (e.g., duodenoscope) camera module 50. In the side-view endoscope camera module 50, the illumination system and the imaging system are positioned such that the viewing angle of the imaging system corresponds to a target anatomical structure that is located laterally to the central longitudinal axis Al of the endoscope 14. Figure 3 Figure 4 In

[0046] In Figure 3 and Figure 4 ​In the example, the side-viewing endoscope camera module 50 may include a housing 52, a lifter 54, a fluid outlet 56, an illumination lens 58, and an objective lens 60. The housing 52 may form a fluid-tight connection with the insertion section 28. The housing 52 may include an opening for the lifter 54. The lifter 54 may include mechanisms for moving an inserted device through the insertion section 28. Specifically, the lifter 54 may include means for bending an elongated device extending along axis A1 through the insertion section 28. The lifter 54 may be used to bend the elongated device at an angle relative to axis A1, thereby treating an anatomical region adjacent to the side-viewing endoscope camera module 50. Without considering the detachable camera module capability for use with the camera module 50 as described herein, and the disposable lifter portion structure, the camera module includes the lifter 54 in a conventional orientation relative to the illumination lens 58 and the objective lens 60.

[0047] like Figure 4 As can be seen, the insertion section 28 may include a central lumen 62 through which various components can extend to connect the functional section 30 and the handle section 32. Figure 2 For example, illumination lens 58 can be connected to light emitter 64, which may include fiber optic cable or cable bundle extending to light source 22. Figure 1 Similarly, objective lens 60 can be connected to prism 66 and imaging unit 67, and imaging unit 67 can be connected to wiring 68. Furthermore, fluid outlet 56 can be connected to fluid line 69, which may include a tube extending to fluid source 24. Figure 1 Other elongated components, such as tubes, wires, and cables, can extend through the lumen 62 to connect the functional section 30 with components of the endoscope system 10, such as the suction pump 26. Figure 1 ) and treatment generator 44 ( Figure 2 )connect.

[0048] Figure 3 and Figure 4 The side-viewing endoscope camera module 50 may include optical components (e.g., objective lens 60, prism 66, imaging unit 67, wiring 68) for collecting image signals, and illumination components (e.g., illumination lens 58, light emitter 64) for transmitting or generating light. The endoscope camera module 50 may also include photosensitive elements, such as charge-coupled devices (“CCD” sensors) or complementary metal-oxide-semiconductor (“CMOS”) sensors. In either example, the imaging unit 67 may be coupled (e.g., via a wired or wireless connection) to the image processing unit 42. Figure 2), to transmit signals (e.g., video signals) representative of images from the photosensitive elements to the image processing unit 42 for display on a display such as the output unit 18. In various examples, the imaging and control system 12 and the image processing unit 67 can be configured to provide output suitable for an endoscopic procedure at a desired resolution (e.g., at least 480p, at least 720p, at least 1080p, at least 4K UHD, etc.).

[0049] As previously mentioned, the present inventors have recognized that conventional endoscopes, and particularly duodenoscopes, can include elevator sections that include delicate and complex structures that are expensive and difficult to clean. The present inventors have developed a solution to these and other problems by developing an endoscope that can have a detachable low-profile camera module, where the camera module includes illumination and imaging components that can be separated from a disposable insertion section sheath having an elevator design that is easy to produce and inexpensive. In this way, the camera module can include high-quality or high-performance imaging components that can be reused and are encapsulated in a housing that is easy to clean. For example, the camera module can include a 4K high imaging unit that can be housed in a sealed container having cutouts or windows for imaging and illumination lenses, thereby eliminating or reducing crevices and gaps that allow biological matter to remain. Further, the elevator mechanism can include a stamped and formed flat sheet metal structure to attach to a disposable insertion sheath that can be easily cleaned when needed due to the simple geometry or that can be disposed of without significant cost due to the simple structure.

[0050] Figure 5 For use as an endoscope 14 and with an endoscope camera module 50 of Figure 3 and Figure 4 A schematic view of a modular endoscope 100 for use as an endoscope 14 and with an endoscope camera module 50 of

[0051] The functional module 102 can include the functional module 30, the camera module 50, or other types of modules. The functional module 30 can include one or both of an imaging device, a treatment device, and an ancillary treatment device, among other devices as described herein. Further, the functional module 102 can include the camera module 162 of the endoscope 150 of Figure 6A and Figure 6B and the camera module 192 of the endoscope 180 of Figure 7A and Figure 7B .

[0052] The insertion section module 104 can include the insertion section 28, which can be configured to include one or more of the sheath and shaft components in U.S. Patent 63 / 017,901, titled “Insertion Sheath for Modular Endoscope with Detachable and Selectively Disposable Components,” filed April 30, 2020, the entire contents of which are hereby incorporated by reference.

[0053] The navigation and control module 106 can include the handle section 32, the cable section 34, and the coupler section 36 of Figure 1 and Figure 2 .

[0054] As previously described, the components of the endoscope 14 can be modular such that they can be attached by an operator to make an initial configuration of the device for a patient and can be detached by the operator after use for a patient. In other examples, the modular components can be assembled and disassembled by a manufacturer or a retirement service without the action of an operator. In an example, Figure 5 FIG. 1 1 illustrates the endoscope 14 of Figure 2 where the components of the endoscope 14 are shown in a detached state. While Figure 5The endoscope 14 is illustrated as being comprised of three modular components (functional module 102 [functional section 30], navigation and control module 106 [handle section 32], insertion section module 104 [insertion section 28]), but additional components or fewer components can be envisioned depending on the surgical procedure to be performed using the endoscope 14 constructed or designed by the operator. Each of the functional module 102, the navigation and control module 106, and the insertion section module 104 can be separable from one another. Further, each of the modules 102, 104, and 106 can be disposable after a single clinical use. Alternatively, each of the modules 102, 104, and 106 can be constructed using materials that allow for multiple clinical uses. In such cases, the modules 102, 104, and 106 can be constructed to be subjected to sterilization after each clinical use.

[0055] In certain advantageous aspects, Figure 2 and Figure 5 The modular structure of the endoscope 14, as discussed herein, can allow for a mix and match of disposable modules and reusable modules, such that some modules can be reused, for example, expensive and / or easy to clean modules can be reused, while some modules can be disposable, such as simple and / or difficult to clean modules can be disposable. For example, certain modules can be detached from the endoscope after a clinical use for sterilization, reprocessing, and reuse for a subsequent clinical use, while the remaining modules can be disposed. For example, there are concerns of improper reprocessing of portions of a duodenoscope (e.g., elevator portions). Accordingly, single-use endoscopes have been developed that can be disposed after a single clinical use (to prevent infection between uses). However, currently available single-use endoscopes, in which the entire endoscope is disposed, can be constructed using low cost materials resulting in a low price of the endoscope in order to remain competitive in each clinical use. In many clinical instances, the lower cost materials can result in poor clinical performance (e.g., lower quality images, inadequate maneuverability, damage to the insertion section module during insertion, poor ergonomics of the endoscope handle, etc.). Accordingly, the inferior components can result in reluctance by physicians to use such devices.

[0056] Accordingly, Figure 2 and Figure 5The modular endoscope 14, as well as other endoscopes described herein (e.g., endoscopes 150 and 180), are advantageously configured to allow end users (e.g., healthcare providers and institutions) to recycle certain modules of the endoscope 14 for reuse, while disposing of susceptible areas after a single clinical use. Furthermore, the reusable portions of the endoscope can be configured to reduce the buildup of biomaterials (e.g., by being fully encapsulated) and can also be fluidly isolated from susceptible areas. Such a configuration facilitates the combined use of higher-quality (higher-cost) reusable components for multiple clinical uses with lower-cost disposable components, while reducing the risk of infection and achieving the desired clinical performance. Not only can disposable components be configured to include features required only for a specific procedure, but materials and structures can also be constructed to withstand only a single use, both of which contribute to reducing the cost of disposable components. For example, an insertion sheath can be configured to withstand the pressure of a single procedure and does not need to be robustly constructed to withstand the repetitive pressure of multiple procedures.

[0057] In the example, Figure 5 The endoscope 100 may include a duodenoscope, the functional module 102 may be configured as a reusable camera module, the navigation and control module 106 may include a reusable handle module, and the insertion segment module 104 may include a disposable unit having multiple lumens. Therefore, the camera module and the navigation and control module may each include connectors that maintain each of the camera module and the navigation and control module in an attached state to the insertion segment module during use with a patient. After each use, the camera module and the navigation and control module can be detached (e.g., using connectors, such as...). Figure 10 The attachment mechanism 240 is then reprocessed for subsequent use with a new insert segment module. Conversely, a used insert segment module can be disposed of after a single use.

[0058] Furthermore, the connectors for the camera module, navigation and control module, as well as the camera module, navigation and control module, can be constructed of materials and designed to reduce any intrusion of biological materials and can optionally be constructed in a fluid-tight manner.

[0059] Modular endoscope 100 can be configured in a conventionally known "side-view" configuration (e.g.) Figure 3 and Figure 4 (as shown) or "end-viewing" configurations (such as gastroscopes, colonoscopes, cholangioscopes, etc.). In the example, the modular endoscope 100 is configured as a side-viewing device (e.g., a side-viewing duodenoscope), and the illumination and imaging units of the distal modular segment (e.g., a camera module) can be offset from the insertion segment module. Figure 6A and Figure 6B The longitudinal axis of ) (e.g.Figure 6A The axis 174), or the illumination unit and imaging unit of the distal modular section (e.g., the camera module), can be inserted with the section module ( Figure 7A and Figure 7B The longitudinal axis of ) (e.g. Figure 7A Align the axis 204) to facilitate the low profile of the device.

[0060] Figure 6A This is a schematic diagram of a low-profile side-view endoscope 150 of the present disclosure. The endoscope 150 includes an illumination unit 152 and an imaging unit 154 arranged in a side-by-side configuration relative to a lifter portion 156. The endoscope 150 may include a sheath 158, a lifter housing 160, a camera module 162, and fluid passages 163A and 163B. A band 164 may be provided adjacent to the sheath 158 and the lifter housing 160 to facilitate connection and sealing between the sheath 158 and the lifter housing 160. The camera module 162 may use, for example... Figure 10 The attachment mechanism 240 is connected to the elevator housing 160 at the engagement line 166.

[0061] Fluid passages 163A and 163B may include the ability to connect nozzles 167A and 167B to fluid source 24. Figure 1 The proximal ends of fluid passages 163A and 163B can be connected to an air source or a liquid source (e.g., a tube or conduit to another fluid source). Figure 1 The fluid source 24 is used to dispense one or both of compressed air and brine or other liquids for cleaning functions, such as removing debris or biological material from the lighting unit 152 and the imaging unit 154.

[0062] Fluid passages 163A and 163B can be positioned on opposite sides of the lifter portion 156, such that nozzle 167A points towards illumination unit 152 and nozzle 167B points towards imaging unit 154. Fluid passages 163A and 163B can be positioned in a direction extending generally parallel to the longitudinal axis 174. However, in other configurations, fluid passages 163A and 163B can be positioned to guide nozzles 167A and 167B in other directions. In the illustrated example, fluid passages 163A and 163B include circular conduits connected to nozzles 167A and 167B. However, in other examples, fluid passages 163A and 163B can have other cross-sectional shapes, and nozzles 167A and 167B can have other configurations, such as nozzles or circular orifices. (See reference...) Figure 7A In other configurations, a single fluid passage and nozzle can be used.

[0063] Figure 6B for Figure 6AFIG. 6B is a schematic cross-sectional view of the endoscope 150 taken at the plane 6B-6B, showing the illumination unit channel 168 and the imaging unit channel 170 positioned radially alongside the insertion channel 172. The insertion channel 172 can extend along a central axis 174 within a space 175 of the sheath 158. The illumination unit channel 168 and the imaging unit channel 170 can extend along central axes 176 and 178, respectively, within the space 175 of the sheath 158.

[0064] Figure 7A FIG. 7 is a schematic view of a low-profile side-view endoscope 180 of the present disclosure, including an illumination unit 182 and an imaging unit 184 arranged in an end-to-end configuration relative to a riser portion 186. The endoscope 180 can include a sheath 188, a riser housing 190, a camera module 192, and a fluid channel 193. A band 194 can be disposed adjacent to the sheath 188 and the riser housing 190. The camera module 192 can be coupled to the riser housing 190 at a junction line 196 using, for example, Figure 10 an attachment mechanism 240.

[0065] The fluid channel 193 can include a tube or conduit that can connect a nozzle 197 to a fluid source 24 Figure 1 ) or another fluid source. A proximal end of the fluid channel 193 can be connected to an air or liquid source (e.g., the fluid source 24 of Figure 1 ) for dispensing one or both of compressed air and saline or other liquids for cleaning functions, such as removing debris or biological matter from the illumination unit 182 and the imaging unit 184. The fluid channel 193 can be positioned on a side of the riser portion 186 such that the nozzle 197 is directed toward the illumination unit 182 and the imaging unit 184. The fluid channel 193 can be disposed in a direction extending generally parallel to a longitudinal axis 204, and the nozzle 197 is angled relative to the fluid channel 193 to aim fluid or liquid toward the camera module 192. However, in other configurations, the fluid channel 193 can be disposed to direct the nozzle 197 in other directions. In the illustrated example, the fluid channel 193 includes a circular conduit connected to the nozzle 197. However, in other examples, the fluid channel 193 can have other cross-sectional shapes, and the nozzle 197 can have other configurations, such as a spout or a circular aperture. In contrast to the distal portion of Figure 6A , positioning only a single nozzle (e.g., the nozzle 197) and a single channel (e.g., the fluid channel 193) to a side of the riser portion 186 can result in a low-profile structure of the distal portion.

[0066] Figure 7B FIG. 8 is a schematic view of a low-profile side-view endoscope 180 of the present disclosure, including an illumination unit 182 and an imaging unit 184 arranged in an end-to-end configuration relative to a riser portion 186. The endoscope 180 can include a sheath 188, a riser housing 190, a camera module 192, and a fluid channel 193. A band 194 can be disposed adjacent to the sheath 188 and the riser housing 190. The camera module 192 can be coupled to the riser housing 190 at a junction line 196 using, for example, Figure 7AFIG. 7B is a schematic cross-sectional view of the endoscope 180 taken at the plane 7B-7B, showing the illumination unit channel 198 and the imaging unit channel 200 positioned radially aligned with the insertion channel 202. The insertion channel 202 can extend along a central axis 204 within a space 205 of the sheath 188. The illumination unit channel 198 and the imaging unit channel 200 can extend along central axes 206 and 208, respectively, within the space 205 of the sheath 188.

[0067] Figure 6A and Figure 7A The endoscopes 150 and 180 each illustrate a distal end of a low-profile endoscope with side-viewing capability according to the present disclosure. As shown in Figure 6A and 7A According to some embodiments, the elevator portion 156 and 186 and the camera module 162 and 192, respectively, can be arranged in an axial in-line configuration, as shown in

[0068] For example, for the endoscope 150, the longitudinal axis 174 of the insertion section module 104 can generally pass through both the elevator portion 156 and the camera module 162. In Figure 6A In a particular example of the endoscope 150, the longitudinal axis 174 can pass between the illumination unit 152 and the imaging unit 154. As can be seen in Figure 6A The distal-most end surface 179 can form a flat end tip, which can be generally planar. For example, the end surface 179 can be disposed at an angle generally perpendicular to the longitudinal axis 174.

[0069] Likewise, for the endoscope 180, the longitudinal axis 204 of the insertion section module 104 can generally pass through both the elevator portion 186 and the camera module 192. In Figure 7A In a particular example of the endoscope 180, the longitudinal axis 204 can pass through both the illumination unit 182 and the imaging unit 184. As can be seen in Figure 7A The distal-most end surface 209 can form a rounded end tip, which can be generally non-planar. For example, the end surface 209 can generally have an arcuate shape (e.g., a "bullet head" shape), and can advantageously be atraumatic.

[0070] Accordingly, the arrangement of the camera modules 162 and 192 is rotated (e.g., oriented perpendicularly or 90°) from the embodiments shown in Figure 3 and Figure 4 In either embodiment, the "axial in-line arrangement" of the camera module and elevator portion can result in a more efficient packaging and compact structure at the distal end, and reduce the outer diameter of the distal section (e.g., as compared to the outer diameter of the distal end of the endoscopes illustrated in Figure 3 and Figure 4 ​

[0071] Figure 8 and Figure 9 The diagram shows... Figure 6A The enlarged cross-sectional view of the endoscope 150 shown in the figure is shown. The endoscope 150 may include an illumination unit 152, an imaging unit 154, a lifter portion 156, a sheath 158, a lifter housing 160, a camera module 162, fluid passages 163A and 163B, a band 164, a connecting wire 166, and nozzles 167A and 167B.

[0072] like Figure 8 As shown, the imaging unit 154 may include an imaging unit path 170, a lens 210, a prism 212, a photosensitive element 214, and a cable 216.

[0073] like Figure 9 As shown, the lighting unit 152 may include a lighting unit path 168, a lens 220, and a light conductor 222.

[0074] For reference Figures 13-15 In more detail, the elevator portion 156 may include an elongated body 300, a first end portion 302, a second end portion 304, an arc-shaped section 306, a guide portion 308, and an inlet 310.

[0075] Figure 8 for Figure 6A A schematic cross-sectional view of the low-profile side-view endoscope 150 taken at plane 8-8, showing the imaging unit 152 and imaging unit passage 170 relative to the lift portion 156. The cross-sectional plane 8-8 passes through a first axis 178, which extends through the imaging unit 154 and the lift portion 156 and is parallel to the longitudinal axis 174.

[0076] In this example, imaging unit 152 may include a photosensitive element 214. According to some examples, the photosensitive element 214 may be a charge-coupled device (“CCD” sensor). In alternative examples, the photosensitive element 214 may be a complementary metal-oxide-semiconductor (CMOS) sensor. In either example, the photosensitive element 214 may be coupled to image processing unit 42 (e.g., via a wired or wireless connection). Figure 2 The signal representing the image (e.g., a video signal) from the photosensitive element 214 is transmitted to the image processing unit 42, and then displayed on the display (e.g., ...). Figure 1 The output unit 18) is used for this purpose. In some examples, the imaging processing unit 42 and the imaging unit 154 can be configured to provide an output suitable for an endoscopic procedure at a desired resolution (e.g., at least 480p, at least 720p, at least 1080p, at least 4K UHD, etc.).

[0077] The imaging unit 154 can be positioned longitudinally in-line with the elevator portion 156. The elevator portion 156 can include a first end portion 302 and a second end portion 304 that are longitudinally spaced apart by an elongate portion 300. An arcuate section 306 of the elongate portion 300 can position the first end portion 302 and the second end portion 304 in opposing relation such that each portion extends in the direction of the longitudinal axis 174 and an interior space 311 is formed between the first end portion 302 and the second end portion 304. Thus, in Figure 8 the illustrated example, the imaging unit 154 including at least one lens, including the lens 210, can be positioned adjacent the arcuate section 306 and spaced apart from the first end portion 302 and the second end portion 304 of the elevator portion 156 in a direction along or parallel to the longitudinal axis 174.

[0078] According to embodiments, and with continued reference to Figure 6A and Figure 8 , while the illustrated example can be suitable for a variety of endoscopes, including side-viewing and forward-viewing endoscopes, in one example, the imaging unit 154 (positioned in-line with the elevator portion 156) can be advantageously configured to allow for side viewing. Thus, the imaging unit 154 can include optical components (e.g., the lens 210, the prism 212, and / or optional optical fibers) to allow for viewing of a target region in a direction that is substantially non-parallel (e.g., perpendicular) to the longitudinal axis 174. Figure 8 One example is illustrated in which the imaging unit 154 includes an objective lens 210 in which the optical axis 230 is oriented non-parallel (e.g., perpendicular) to the first axis 178 through the imaging unit 154 and the elevator portion 156.

[0079] With reference to Figure 6B and Figure 8 , the second axis 176 can be substantially parallel to the longitudinal axis 174 and the first axis 178 through the elevator portion 156 and the illumination unit 152. Thus, the photosensitive element 214 can view (e.g., as illustrated by the imaging unit field of view 228) a target region in a direction centered on the objective lens optical axis 230 and the photosensitive element 214 is substantially non-parallel (e.g., perpendicular) to the longitudinal axis 174 of the insertion tube and the first axis 178. In Figure 8 the illustrated example, one or more optical elements (e.g., additional lenses, a roof prism) can optically couple the objective lens 210 to the photosensitive element 214 (e.g., a CCD or CMOS sensor). The photosensitive element 214 can be disposed immediately below the imaging lens 210 to achieve additional space savings in the distal section of the endoscope 150 and facilitate a modular construction of the camera module 162.

[0080] Figure 9 For Figure 6A illustrative cross-sectional view of the low-profile side-view endoscope 150 taken at a plane 9-9 showing the illumination unit 152 and illumination passageway 172 relative to the elevator portion 156. The cross-sectional plane 9-9 passes through a second axis 176 that extends through both the illumination unit 152 and the elevator portion 156 and is parallel to the longitudinal axis 174 and a first axis 178 (shown in Figure 8 ).

[0081] The illumination unit 152 can include optical components including the lens 220 and other optical components and can be connected to the light guide 222. The light guide 222 can include an optical fiber or other light guide capable of being connected to the light source 22 (shown in Figure 2 ). Thus, the illumination unit 152 can be used to illuminate a target area, e.g., an anatomical region of a patient, with light from the light source 22 via the light guide 222. The light source 22 can be connected to a proximal portion of the light guide 222. Alternatively, in other examples, the illumination unit 152 can be “self-contained.” In such self-contained units, the illumination unit 152 can include one or more light sources or lamps such as light emitting diodes, and a power source such as a battery. The illumination unit 152 can be connected to a distal end of the light guide 222. In examples, the illumination unit 152 can include a portion of a detachable camera module as described in commonly-assigned U.S. Patent Application 62 / 951,157, filed December 20, 2019, entitled “Modular Endoscope with Detachable and Selectively Disposable Components,” the entire contents of which are hereby incorporated by reference.

[0082] With reference to Figure 6A , Figure 9 and Figure 13 , the illumination unit 152 can be positioned longitudinally in-line with the elevator portion 156. The elevator portion 156 can include a first end portion 302 and a second end portion 304 that are longitudinally spaced apart by an elongate portion 300. An arcuate section 306 of the elongate portion 300 can position the first end portion 302 and the second end portion 304 in opposing relation such that each portion extends in the direction of the longitudinal axis 174 and an interior space 311 is formed between the first end portion 302 and the second end portion 304. Thus, in Figure 9In the example of FIG. 3, the illumination unit 154, including at least one lens, the at least one lens including the lens 210, can be positioned adjacent to the arcuate section 306 and spaced apart from the first end portion 302 and the second end portion 304 of the elevator portion 156 in a direction along or parallel to the longitudinal axis 174.

[0083] According to embodiments, and with continued reference to Figure 6A and Figure 9 , while the illustrated example can be suitable for various endoscopes, including side-viewing endoscopes and forward-viewing endoscopes, in one example, the illumination unit 152, positioned in-line with the elevator portion 156, can advantageously be configured to allow for side viewing. Accordingly, the illumination unit 152 can include optical components (e.g., the lens 220 and / or optional optical fibers) to provide light output in a direction substantially non-parallel (e.g., perpendicular) to the longitudinal axis 174. Figure 9 FIG. 3 illustrates one example in which the illumination unit 152 includes the illumination lens 220, where the optical axis 224 is oriented non-parallel (e.g., perpendicular) to the second axis 176 passing through the illumination unit and the elevator portion.

[0084] With reference to Figure 6B and Figure 9 , the first axis 178 can be generally parallel to the longitudinal axis 174 and the second axis 176. Accordingly, light from a light source carried within the illumination unit 152 or from the light source 22 of Figure 2 may be output from the distal section of the endoscope 150 as a cone of light 226 centered on the optical axis 224 of the illumination lens and substantially non-parallel (e.g., perpendicular) to the longitudinal axis 174 and the second axis 176. In Figure 9 , the light guide 222 can include one or more optical fibers (e.g., a bundle of optical fibers) that can optically couple the illumination lens 220 to a light source (e.g., disposed on the light source 22 of Figure 2 ) via an illumination unit passage 168 extending beneath the elevator portion 156. Alternatively, the light source can include a light emitting diode disposed immediately beneath the illumination lens 220 to achieve additional space savings in the distal section of the endoscope 150 and facilitate modular construction of the camera module 162.

[0085] Notably, with reference to Figure 6A , Figure 8 and Figure 9 , the second axis 176 can pass through the illumination unit 152 and the elevator portion 156. Similarly, the first axis 178 can pass through the imaging unit 154 and the elevator portion 156. The first axis 178 and the second axis 176 can each be parallel to the longitudinal axis 174. Further, with reference to Figure 6AFigure 8 And Figure 9 The optical axis 224 of the illumination lens and the objective optical axis 230 can be parallel to each other. Thus, the optical axis 224 of the illumination lens and the objective optical axis 230 can each be non-parallel to any of the first axis 178, the second axis 176, and the longitudinal axis 174. In an example, the optical axis 224 of the illumination lens and the objective optical axis 230 can each be substantially perpendicular to any of the first axis 178, the second axis 176, and the longitudinal axis 174.

[0086] With Figure 3 And Figure 4 Compared to the diameter of the distal section of the endoscope 50 illustrated, Figure 6A , Figure 6B , Figure 8 And Figure 9 Embodiments of the illumination lens 152 and the objective lens 150 can advantageously result in a reduced diameter of the distal section of the endoscope 150.

[0087] According to an example, Figure 10 An attachment mechanism 240 is illustrated for attaching the camera module 162 comprising the imaging unit 154 and the illumination unit 152 to the elevator housing 160. In the illustrated example, the attachment mechanism 240 is shown as simultaneously coupling the imaging unit 154 and the illumination unit 152 to the elevator housing 160 via the camera module 162. However, in other examples, the imaging unit 154 and the illumination unit 152 can be coupled to the elevator housing 160 separately by separate attachment mechanisms. The attachment mechanism 240 can be configured to allow a user to detach the camera module 162 from the elevator housing 160 (and / or other portions of the insertion sheath 158).

[0088] ​The attachment mechanism 240 can include a snap-fit feature provided by a locking tab 242. In other examples, the locking tab 242 can be provided at an end of a stem 244 that is attached to the camera module 162, or the illumination unit 154 or the imaging unit 152. A recess 246 can be provided on an outer surface of the riser housing 160 to form a ledge 248. The recess 246 can be sized to receive the locking tab 242 and form a secure connection. In examples, the locking tab 242 can be configured to be detached by a tool to release the locking tab 242 from the recess 246 and separate the camera module 162, or the illumination unit 154 or the imaging unit 152 from the riser housing 160. For example, the stem 244 can be deflected to allow the locking tab 242 to slide past the recess 246. However, the stem 244 can have sufficient resilience to hold the locking tab 242 within the recess 246 unless acted upon by, for example, an external force. Such an implementation can be suitable where a secure connection between the camera module 162 (e.g. the combination of the imaging unit 154 and the illumination unit 152) and the riser portion 156 is required during insertion. In other examples, other types of attachment mechanisms can be used instead of or in conjunction with the attachment mechanism 240, such as fasteners with flanges, latches, threaded couplings, etc. Low profile coupling mechanisms such as the attachment mechanism 240 are advantageous in reducing the diameter and reducing friction, which facilitates insertion into the anatomy.

[0089] The endoscope 150 can also include couplings 250A and 250B for connecting portions of the light guide 222 (light guide tube) at the junction 166 for wired operation of the camera module 162. Thus, a portion of the light guide 222 distal to the coupling 250A can be connected to the lens 220, and a portion of the light guide 222 proximal to the coupling 250B can be connected to the light source 22 Figure 1 ). The couplings 250A and 250B can include suitable couplings for joining the segments of the light guide 222. In examples, the couplings 250A and 250B can include magnetic couplings. In other examples, the ends of the light guide 222 can be end-to-end disposed without the need for couplings. The imaging unit 152 can additionally be provided with couplings for the cable 216 similar to the couplings 250A and 250B. The use of such couplings can be advantageous for use with a stand-alone camera module in which the photosensitive element 214, the wireless communication device 252 and the light generator 254 are included within the camera module 162. Reference is made to Figure 10 The described couplings can also be used with the camera module 162 of Figure 8 and Figure 9 , as well as the wireless communication device 252 and the light generator 254.

[0090] According to some embodiments, the detachable camera module 162 (including the imaging unit 154 and the illumination unit 152) can be attached to the elevator housing 160 via the locking tab 242 prior to insertion of the endoscope 150. The endoscope 150 can be inserted into the target area and can collect images of the target area. The endoscope 150 can be removed, for example with or without use of a tool, and the camera module 162 can be detached from the elevator housing 160. The camera module 162 can be sterilized prior to repeated use. The elevator housing 160, including the elevator portion 156 in the elevator housing 160, and the insertion sheath 158 can be disposed of after use. Alternatively, the elevator housing 160 and elevator portion 156 and insertion sheath 158 can also be sterilized and reused.

[0091] Figure 11 and Figure 12 FIG. 1 illustrates a distal end section of an endoscope 150 according to an example. Figure 11 and Figure 12 Generally similar to the embodiment illustrated in FIG. 1, except that a wide angle lens 260 is added. In the example of FIG. 2, the longitudinal axis 204 passes through each of the elevator portion 186, the illumination unit 182, and the imaging unit 184. The imaging unit 184 can include an imaging unit channel 262, a lens 264, a prism 266, a photosensitive element 268, and a cable 270. The illumination unit 182 can include an illumination unit channel 272, a lens 274, and a light guide 276. Further, an illumination lens optical axis 278 and an objective lens optical axis 280 can each be substantially non-parallel (e.g., perpendicular) to the longitudinal axis 204. Figure 7A Figure 11 and Figure 12 In the example of FIG. 3, the longitudinal axis 204 passes through each of the elevator portion 186, the illumination unit 182, and the imaging unit 184. The imaging unit 184 can include an imaging unit channel 262, a lens 264, a prism 266, a photosensitive element 268, and a cable 270. The illumination unit 182 can include an illumination unit channel 272, a lens 274, and a light guide 276. Further, an illumination lens optical axis 278 and an objective lens optical axis 280 can each be substantially non-parallel (e.g., perpendicular) to the longitudinal axis 204.

[0092] In the example of FIG. 4, the longitudinal axis 204 passes through each of the elevator portion 186, the illumination unit 182, and the imaging unit 184. The imaging unit 184 can include an imaging unit channel 262, a lens 264, a prism 266, a photosensitive element 268, and a cable 270. The illumination unit 182 can include an illumination unit channel 272, a lens 274, and a light guide 276. Further, an illumination lens optical axis 278 and an objective lens optical axis 280 can each be substantially non-parallel (e.g., perpendicular) to the longitudinal axis 204. Figure 11 Figure 12 ​​In the illustrated example of FIG. 18, the illumination unit 182 and the imaging unit 184 can be configured to allow for "wide angle" illumination and / or imaging of the side-viewing endoscope. Wide angle imaging can allow for imaging of a portion of the target anatomy located directly above the elevator portion. In one implementation, wide angle illumination and / or imaging can be achieved by providing the illumination lens 274 and / or the objective lens 264 with a field of view of between about 150 degrees and about 180 degrees, inclusive. In an example, the illumination lens 274 and the objective lens 264 can each have a field of view of about 170 degrees. In another example, either or both of the illumination lens 274 and the objective lens 264 can be configured as a "fisheye" type lens. Thus, the imaging unit 184 and the illumination unit 182 can allow for wide angle imaging of an image area located above (e.g., directly above) the elevator portion 186, such as wide angle imaging of a portion located immediately radially outward of the elevator portion 186 relative to the axis 204.

[0093] Figure 13 An isometric view of an elevator portion 156 of the present disclosure, the elevator portion 156 is suitable for use with low profile endoscopes 150 and 180, as well as other endoscopes. The elevator portion 156 can include an elongate body 300, a first end portion 302, a second end portion 304, an arcuate section 306, a guide 308, an entrance 310, and a space 311. The elevator portion 156 can include an elevator mechanism for deflecting an instrument extending along an axis 174 and 204 within an insertion passage 172 and 202, respectively, as described with reference to Figures 16-19

[0094] The elongate body 300 can include a generally planar sheet of material as illustrated in Figure 14 and Figure 15 shaped into a geometry of Figure 13 The first end portion 302 can be shaped to include a retention feature, such as a flange 312 forming a shoulder 314. The second end portion 304 can include a coupler 316 and a planar portion 318. The planar portion 318 can join the second end portion 304 with a guide portion 320, and the planar portion 318 can include a flare portion that necks a width W2 of the guide portion 320 to a width Wl of the second end portion 304. The guide portion 320 can be selectively widened to accommodate features of the elevator mechanism. The guide portion 320 can include the guide 308 and the entrance 310. The guide 308 can include a chute including a tab or flange 322 and a recess or channel 324.

[0095] ​The first end portion 302 can be configured, for example, to be secured to the distal portion of the endoscope 150 at the sheath 158, or, for example, to the distal portion of the endoscope 180 at the sheath 188. In an example, the flange 312 can be secured to the sheath 158 by compression, curling, or any other suitable method. In an additional example, the first end portion 302 can be provided with a connector, such as a clamping element. Thus, the lift portion 156 can be configured to be secured to the sheath 158. Therefore, the first end portion 302 can be secured to the endoscope 150 by a non-rotational or non-hinged connection to anchor the lift portion 156 in a fixed manner. In some examples, the connection between the first end portion 302 and the sheath 158 can be user-non-removable; for example, the lift portion 156 cannot be removed from the sheath 158 without a destructive procedure. Therefore, the first end portion 302 can be secured to the distal portion of the sheath 158 during manufacturing and assembly and cannot be separated thereafter. The fixation of the first end portion 302 can facilitate the actuation of the second end portion 304 to cause the bow-shaped section 306 to flex in order to activate the flange 322.

[0096] The second end portion 304 can be configured to connect to the lifting mechanism. In an example, the lifting mechanism may include a cable assembly that includes components fixed to the handle 32. Figure 1 and 2 The pull wire 326. More specifically, the pull wire 326 can be connected to one or more actuators (e.g., Figure 2 The actuator (knob 38) can be turned by an operator (e.g., using their thumb or finger) to control tension. A pull cable 326 can be secured to the second end portion 304 at the connector 316, for example, by fastening or welding. The pull cable 326 can transmit tension to the second end portion 304 of the elongated body 300, causing the second end portion 304 to move along... Figure 13 Arrows 328 and 330 shown are pulled proximally or pushed distally. Pushing / pulling applied to the second end portion 340 of the lift portion 156 can aid in the orientation of one or more internal therapy tools supported by the lift portion 156 within space 311 (e.g., at flange 322), as shown in Figure 156. Figures 16-19 As discussed. Therefore, space 311 can form a guiding pathway for guiding the internal therapeutic device 340 ( Figure 16 It passes through the elongated body 300 and enters the opening 310, which can form a guide groove for guiding the internal therapy device 340 out of the elongated body 300.

[0097] Figure 14 For being in a flat state Figure 13 A top view of the elongated body 300.Figure 15 is Figure 13 a side cross-sectional view of the elongated body 300 taken at a plane 15-15 showing the instrument guide flange 322. The discussion of Figure 14 and Figure 15 is simultaneous. The sheet material of the elongated body 300 can have a thickness t that is substantially smaller than the width W1 or the length L. In some advantageous implementations, the sheet material can be made of stainless steel. Alternatively, other materials (alloys or non-metallic elements) can also be contemplated. The riser portion 156 can be formed from the sheet material by a variety of manufacturing techniques to produce the shape shown in Figure 13 . In an example, the riser portion 156 can be formed by precisely stamping the sheet material into the shape shown in Figure 14 . In an example, a flat sheet material having a rectangular shape can be positioned relative to a stamping machine. A die having the shape of the elongated body 300 can be loaded in the stamping machine. The stamping machine can be activated to press the die against the flat sheet material to form the elongated body 300 shown in Figure 14 and Figure 15 . In an example, the elongated body 300 can be simultaneously stamped to form the channel 324 in the flange 322. Likewise, the elongated body 300 can be simultaneously stamped to bend the flange 322 to the angle A shown in Figure 15 and form the coupler 316. In other examples, the profile of the elongated body 300, the flange 322, and the inlet 310 can be formed by separate stamping steps, and the shape of the channel 324, the angle of the flange 322, and the coupler 316 can be formed by one or more subsequent steps.

[0098] Figures 16-19 a cross-sectional view of the riser portion 156 positioned in the distal section of the side-view endoscope 150 is illustrated, in accordance with any of the disclosed implementations. Although described with reference to the endoscope 150, the operation of the riser portion 156 can function similarly with the endoscope 180. When the side-view scope has an “in-line” arrangement of the riser portion and the camera module, Figures 16-19 may be particularly suitable (e.g., such as the implementations of Figure 6A and Figure 7A further described in U.S. Patent 62 / 958,041, filed January 7, 2020, entitled “Endoscope with a Low-Profile Distal Section,” the entirety of which is hereby incorporated by reference). Accordingly, Figures 16-19 implementations can include more space further away from the riser portion 156 to accommodate the camera module 160. Accordingly, Figures 16-19The distal tip of the elevator housing 162 shown in FIG. 6 can include an engagement line 166.

[0099] Referring to Figures 16-19 In some examples, the distal section of the endoscope 150 can include a ramp 332. The ramp 332 can include a first surface 334 and a second surface 336 opposite the first surface 334. The first surface 334 of the ramp 332 can abut the first end portion 302 of the elongated body 300. During assembly, the first end portion 302 can be sandwiched between the first surface 334 of the ramp 332 and an inner surface of the distal section of the endoscope 150. In some examples, the first end portion 302 can be fixed relative to the first surface 334 of the ramp 332 or fixed relative to the inner surface of the distal section of the endoscope 150. Further, the assembly process can fix the first end portion 302 and the first surface 334 of the ramp 332 to the inner surface of the elongated body 300 such that there is no gap or other region between the first end portion 302, the first surface 334 of the ramp 332, and the inner surface of the elevator portion 156 to reduce or avoid the intrusion of biological matter. The second surface 336 of the ramp 332 can be generally adapted to provide initial guidance for therapeutic instruments 340 (e.g., a guidewire, a catheter, or a secondary scope) as they approach the distal section in the instrument lumen 338. Thus, the second surface 336 can be oriented non-parallel to the first surface 334 of the ramp 332. The elevator portion 156 can be positioned such that the flange 322 extends in the available space in the distal section of the endoscope 150 and the flange 322 is proximate to or abuts the second surface 336 of the ramp 332.

[0100] Referring to Figure 17 When the second end portion 304 of the elevator portion 156 is actuated (e.g., by the pull wire 326), the flexible arcuate section 306 of the elevator portion 156 (which extends between the first end portion 302 and the flange 322) can at least partially move relative to the first end portion 302 and the ramp 332. At least some portions of the arcuate section 306 of the elevator portion 156 cannot directly abut or directly connect to any other portion of the distal section of the elevator portion 156, but can move in the space around the arcuate section 306. The ramp 332 can be positioned proximate to an opening 341 on the elevator housing 160. The elevator housing 160 can also include a pocket 169 for storing the arcuate section 306 in an undeflected state. The opening 341 can be configured to receive a therapeutic instrument 340 from the ramp 332. As Figure 17As can be seen, the second surface 336, the flange 322, and the opening 341 can form an exit angle β relative to the perpendicular line of the longitudinal axis 174. Therefore, the internal treatment device 340 can be pushed to engage the second surface 336, which can rotate the distal end of the internal treatment device 340 toward the flange 322 and initially orient the distal end of the internal treatment device 340 at angle β.

[0101] Reference Figure 18 The internal therapeutic instrument 340 can be further advanced in the direction of arrow 342 until the distal end of the internal therapeutic instrument 340 protrudes through the opening 341. The internal therapeutic instrument 340 can protrude from the opening 341 at an angle β1 relative to the longitudinal axis 174. Angle β1 can be equal to angle β plus 90 degrees.

[0102] Reference Figure 19 The lift section 156 can be further actuated to provide additional guidance and orientation to the endoscopic instrument 340. For example, the lift section 156 can be pulled, for example via the endoscope handle 32 ( Figure 2 The knob 38 on the device is actuated, which applies a force to the second end portion 304 of the lifter portion 156 in the direction indicated by arrow 344, opposite to the direction of the advance arrow 342 of the internal treatment device 340. When the second end portion 304 of the lifter portion 156 is actuated, the arcuate section 306 can rotate relative to the first end portion 302 in the direction indicated by arrow 346, and advance the guide portion toward the device 340. In some advantageous aspects, the tension applied to the second end portion 304 of the lifter portion 156 can additionally move the channel 324 proximally in the direction of arrow 344 to capture the device 340, thereby self-seating the device 340 within the channel 324. Once seated, no relative movement is permitted between the channel 324, the flange 322, and the device 340. Further actuation of the lifting section 156 (e.g., by further pulling the second end portion 304 of the lifting section 156) can move the flange 322 and the instrument 340 seated in the channel 324 synchronously and adjust the angle of the instrument 340 relative to the first surface 334 of the ramp 332 without removing or disengaging the instrument 340 from the channel 324. The lifting section 156 can be actuated to position the distal end of the internal therapy instrument 340 at an angle β2 relative to the longitudinal axis 174.

[0103] Such as Figures 16-19Embodiments such as those described herein can be adapted for use with single-use or reusable endoscopes. Embodiments such as those described herein can also be adapted for use with reusable endoscopes. Unlike conventional endoscope mechanisms, elevator portion 156 according to the examples illustrated herein can be easier to clean because there are no several small interconnected parts, unlike conventionally available elevator mechanisms. Thus, the disclosed elevator mechanisms of the present disclosure can improve procedure and patient safety by reducing the intrusion of biological material (e.g., antibiotic-resistant bacteria) between the user and / or the patient. The single-piece construction of the elevator can reduce manufacturing costs.

[0104] Figure 20 A block diagram of a process 900 for performing a modular endoscope procedure is illustrated. At step 902, a particular patient can be diagnosed with a particular condition or in need of a particular evaluation. The diagnosis can be performed by a surgeon or other qualified medical professional.

[0105] At step 904, the particular condition of the patient can be identified as requiring interaction in accordance with a particular therapy or evaluation procedure. For example, a particular organ or anatomical region can be identified as requiring a particular intervention or evaluation.

[0106] At step 906, a particular treatment plan can be developed to address the condition identified at step 904. The treatment plan can include selecting a therapy to be performed, such as ablation, cryogenic, cauterization, cutting, attachment, etc. The treatment plan can also include a plan for performing the surgical technique, such as instructions for delivering the selected therapy to the particular organ or anatomical region, such as through an endoscope supporting a camera.

[0107] At step 908, components of a medical device can be selected to deliver the selected therapy. For example, a particular treatment module can be selected to provide the selected therapy, a particular sheath or shaft can be selected to deliver the treatment module, and a particular control module can be selected to control the operation of the modular medical device. Features and characteristics of the selected sheath or shaft can be selected, such as the number of delivery lumens needed to provide the treatment, steering, and manipulation capabilities needed to provide the selected treatment plan and therapy. Likewise, a camera module can be selected to facilitate steering of the treatment module and observation of the anatomical region or organ.

[0108] At step 910, the selected components of step 908 can be assembled. At step 912A, the selected components can be assembled at a medical facility where the procedure is to be performed. For example, the modular components can be assembled by a user. In particular, an attachment mechanism such as a deflectable tab can be used to attach a camera module. At step 912B, the selected components can be assembled at a manufacturing facility.

[0109] At step 914, the procedure planned at step 906 can be performed using the medical device assembled at step 910.

[0110] At step 916, the assembled medical device used in the procedure at step 914 can be disassembled. The medical device can be disassembled at the medical facility of step 912A, or the medical device can be shipped off-site to be disassembled at the manufacturing facility of step 912B or another re-use facility. The user can disassemble the modular components by operating the attachment mechanisms.

[0111] At step 918, the disassembled components can be sorted into components that can be disposed of at step 920A and components that can be reused at step 920B.

[0112] At step 922, the disposable components can be disposed of, such as by destruction or abandonment. The disposable components can include a disposable insertion sheath.

[0113] At step 924, the reusable components of step 920B can be cleaned and sterilized for reuse. The reusable components can include a detachable camera module. The cleaned and sterilized components can thus be returned to inventory at the medical facility or manufacturing facility for use in additional procedures.

[0114] Various annotations and examples

[0115] Example 1 can include or use subject matter such as for an elevator for a side-viewing endoscope, the elevator can include a first end portion secured to an inner surface of a distal portion of the side-viewing endoscope, a second end portion generally opposite the first end portion, the second end portion movable relative to the first end portion by an actuator of the side-viewing endoscope, a flexible portion positioned between the first end portion and the second end portion, the flexible portion rotatable relative to the first end portion when the second end portion is moved by the actuator, and a guide portion extending between the flexible portion and the second end portion to receive an endoluminal instrument extending from an instrument channel of the side-viewing endoscope, the guide portion including a chute configured to guide a distal end of the endoluminal instrument as the distal end exits the distal portion of the side-viewing endoscope.

[0116] Example 2 can include or can optionally be combined with the subject matter of Example 1, to optionally include each of the first end portion, the second end portion, the flexible portion, and the guide portion coextending with one another.

[0117] Example 3 can include the subject matter of one or any combination of Examples 1-2, or can optionally be combined with the subject matter of one or any combination of Examples 1-2, to optionally include the flexible portion shaped such that portions of the elongated body extending from the first and second end portions oppose one another to form the guide path.

[0118] Example 4 can include the subject matter of one or any combination of Examples 1-3, or can optionally be combined with the subject matter of one or any combination of Examples 1-3, to optionally include the elevator further comprising a first planar portion extending between the guide portion and the second end portion.

[0119] Example 5 can include the subject matter of one or any combination of Examples 1-4, or can optionally be combined with the subject matter of one or any combination of Examples 1-4, to optionally include the elevator further comprising a second planar portion extending between the flexible portion and the first end portion, wherein the second planar portion is parallel to the first planar portion.

[0120] Example 6 can include the subject matter of one or any combination of Examples 1-5, or can optionally be combined with the subject matter of one or any combination of Examples 1-5, to optionally include the flexible portion non-parallel to the first planar portion.

[0121] Example 7 can include the subject matter of one or any combination of Examples 1-6, or can optionally be combined with the subject matter of one or any combination of Examples 1-6, to optionally include the guide portion comprising a guide surface extending non-parallel from the guide portion and the first planar portion.

[0122] Example 8 can include the subject matter of one or any combination of Examples 1-7, or can optionally be combined with the subject matter of one or any combination of Examples 1-7, to optionally include the guide surface comprising an instrument retention portion configured to immovably couple an intraluminal instrument to the guide surface.

[0123] Example 9 can include the subject matter of one or any combination of Examples 1-8, or can optionally be combined with the subject matter of one or any combination of Examples 1-8, to optionally include the guide portion comprising a guide slot substantially surrounding the guide surface.

[0124] Example 10 can include or use subject matter such as an endoscope that can include an insertion sheath defining a lumen, and an elongate body defining a lift positioned at least partially within the lumen, the elongate body including a first end portion for anchoring to an internal passageway of the endoscope, a second end portion for coupling to an actuator of the endoscope, an arcuate section positioned between the first end portion and the second end portion, the arcuate section being curved to define an internal space between opposing sections of the elongate body, a guide extending from the elongate body into the internal space, and an entrance extending through the elongate body proximate the guide.

[0125] Example 11 can include or can optionally be combined with the subject matter of Example 10 to optionally include the lift extending along an axis from a proximal end proximate the first end portion and the second end portion to a distal end proximate the arcuate section.

[0126] Example 12 can include or can optionally be combined with the subject matter of one or any combination of Examples 10 or 11 to optionally include the guide including a deflectable tab angled inward in a proximal direction from the entrance.

[0127] Example 13 can include or can optionally be combined with the subject matter of one or any combination of Examples 10 through 12 to optionally include the guide further including a capture groove extending along a path intersecting the axis.

[0128] Example 14 can include or can optionally be combined with the subject matter of one or any combination of Examples 10 through 13 to optionally include opposing sections of the elongate body including a first section connected to the first end portion and a second section connected to the second end portion.

[0129] Example 15 can include or can optionally be combined with the subject matter of one or any combination of Examples 10 through 14 to optionally include the arcuate section including a u-shaped body connecting the first section and the second section.

[0130] Example 16 can include the subject matter of one or any combination of Examples 10-15, or can optionally be combined with the subject matter of one or any combination of Examples 10-15, to optionally include a coupler to join the second end portion of the elongated body to the actuator.

[0131] Example 17 can include the subject matter of one or any combination of Examples 10-16, or can optionally be combined with the subject matter of one or any combination of Examples 10-16, to optionally include the first end portion including a flange extending axially from the shoulder to define an end of the first end portion.

[0132] Example 18 can include the subject matter of one or any combination of Examples 10-17, or can optionally be combined with the subject matter of one or any combination of Examples 10-17, to optionally include a ramp disposed within the interior space, the ramp having a curved surface positioned to align with the guide, and an opening in the lumen.

[0133] Example 19 can include subject matter such as a method of forming an elevator for an endoscope, or using a method of forming an elevator for an endoscope, the method can include forming an elongated body from a planar sheet material, the elongated body including a length between a first end and a second end, a width less than the length, and a thickness less than the length and the width; forming a guide body in the elongated body; bending the elongated body such that the first length and the second length are opposite each other to form an interior space; and bending the guide body to extend into the interior space.

[0134] Example 20 can include the subject matter of Example 19, or can optionally be combined with the subject matter of Example 19, to optionally include forming the elongated body and forming the guide body as a single process.

[0135] Example 21 can include the subject matter of one or any combination of Examples 19 or 20, or can optionally be combined with the subject matter of one or any combination of Examples 19 or 20, to optionally include the single process including a stamping process or an etching process.

[0136] Example 22 can include the subject matter of one or any combination of Examples 19-21, or can optionally be combined with the subject matter of one or any combination of Examples 19-21, to optionally include the single process further forming an actuator coupler proximate the first end and a retention feature proximate the second end.

[0137] Example 23 may include the subject of one or any combination of examples 19 to 22, or may optionally combine with the subject of one or any combination of examples 19 to 22, to optionally include forming a guide groove in the guide body.

[0138] Example 24 may include the subject of one or any combination of examples 19 to 23, or may optionally combine with the subject of one or any combination of examples 19 to 23, to optionally include forming a guide groove by bending the guide body to form a channel therein.

[0139] Each of these non-restrictive examples can exist independently, or can be combined with one or more examples from other examples in various permutations or combinations.

[0140] The detailed description above includes reference to the accompanying drawings, which form part of the detailed description. For illustration, the drawings show specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements other than those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. Furthermore, the inventors contemplate examples using any combination or arrangement of those elements (or one or more aspects of those elements) shown or described with respect to a specific example (or one or more aspects of that specific example) or with respect to other examples shown or described herein (or one or more aspects of those other examples).

[0141] In the event of any inconsistency between the usage in this document and any other document incorporated by reference, the usage in this document shall prevail.

[0142] In this document, as is common in patent literature, the terms "a" or "one" are used to include one or more, regardless of any other instance or use of "at least one" or "one or more". In this document, unless otherwise indicated, the term "or" is used to indicate a non-exclusive "or", such that "A or B" includes "A but not B", "B but not A", and "A and B". In this document, the terms "comprising" and "in..." are used as concise linguistic equivalents to the corresponding terms "including" and "wherein". Furthermore, in the appended claims, the terms "comprising" and "including" are open-ended, meaning that a system, apparatus, article, composition, formulation, or process that includes elements other than those listed after this term in a claim is still considered to fall within the scope of that claim. Additionally, in the appended claims, the terms "first", "second", and "third", etc., are used only as designations and are not intended to impose numerical requirements on their objects.

[0143] Method examples described herein can be machine or computer- implemented at least in part. Some examples can include a computer- readable medium or machine-readable medium encoded with instructions that operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code can form portions of computer program products. Further, in an example, the code can be tangibly embodied in one or more volatile or non-volatile computer-readable media. Examples of such media can include, but are not limited to, a hard disk, a removable magnetic disk, a removable optical disk, such as a compact disk and a digital video disk, a magnetic cassette, memory cards or sticks, a random access memory (RAM), read only memory (ROM), and the like.

[0144] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) can be used in combination with each other. Other implementations can be used by those of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b) requiring an abstract that will allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features can be grouped together or described in a single implementation for the purpose of streamlining the disclosure. This should not be interpreted as intending that the claimed subject matter requires features to be used in any combination. Rather, inventive subject matter can be practiced without all features of a particular disclosed implementation. Accordingly, the appended claims are hereby expressly incorporated into each and every claim as if the claim were incorporated by reference in its entirety.

Claims

1. A lifter for a side-viewing endoscope, the lifter comprising: A first end portion, the first end portion being fixed to the inner surface of the distal end portion of the side-viewing endoscope; A second end portion substantially opposite the first end portion, the second end portion being movable relative to the first end portion by means of an actuator of the side-viewing endoscope; A flexible portion, positioned between a first end portion and a second end portion, is capable of rotating relative to the first end portion from a non-deflected position to an actuated position when the second end portion is moved by the actuator, wherein the flexible portion bends such that the second end portion and the first end portion are opposite each other in both the non-deflected position and the actuated position; and A guiding portion, extending between the flexible portion and the second end portion, for receiving an endoscopic instrument extending from the instrument channel of the lateral endoscope, the guiding portion including a groove configured to guide the distal end of the endoscopic instrument as it exits the distal portion of the lateral endoscope. The first end portion and the second end portion extend in the longitudinal direction, forming an internal space between the first end portion and the second end portion.

2. The lifting device according to claim 1, wherein, Each of the first end portion, the second end portion, the flexible portion, and the guiding portion extends together with each other.

3. The lifting device according to any one of claims 1 and 2, wherein, The flexible portion is configured such that the portions of the elevator extending from the first end portion and the second end portion are opposite each other to form a guide passage.

4. The lifting device according to any one of claims 1 and 2, wherein, The lifter also includes a first planar portion extending between the guide portion and the second end portion.

5. The lifting device according to claim 4, wherein, The lifter also includes a second planar portion extending between the flexible portion and the first end portion, wherein the second planar portion is parallel to the first planar portion.

6. The lifting device according to claim 4, wherein, The flexible portion is not parallel to the first planar portion.

7. The lifting device according to claim 5, wherein, The guiding portion includes a guiding surface extending from the guiding portion and not parallel to the first planar portion, wherein the guiding surface is configured to guide the instrument through the lift in a direction extending transversely to the first planar portion and the second planar portion.

8. The lifting device according to claim 7, wherein, The guide surface includes a device retainer configured to immovably attach the internal therapy device to the guide surface.

9. The lifting device according to any one of claims 7 and 8, wherein, The guiding portion includes a guiding groove that generally surrounds the guiding surface.

10. An endoscope, comprising: An insert sleeve is provided, which defines a lumen. as well as An elongated body defining a lifter that is at least partially located within the lumen. The elongated body includes: A first end portion, the first end portion being used for anchoring to the internal passage of the endoscope; The second end portion is used to connect to the actuator of the endoscope; An arc-shaped section is positioned between the first end portion and the second end portion, and the arc-shaped section is bent to define an internal space between opposing sections of the elongated body; A guide section extending from the elongated body into the interior space; and An inlet, forming an opening adjacent to the guide portion extending through the elongated body to allow the instrument to pass through the elongated body. The first end portion and the second end portion extend in a longitudinal direction, forming the internal space between the first end portion and the second end portion.

11. The endoscope according to claim 10, wherein, The lifter extends along an axis from the proximal end near the first end portion and the second end portion to the distal end near the bow-shaped section.

12. The endoscope according to claim 11, wherein, The guide portion includes a deflectable protrusion angled inward from the inlet in the proximal direction.

13. The endoscope according to claim 12, wherein, The guide portion also includes a capture groove extending along a path intersecting the axis.

14. The endoscope according to any one of claims 10 to 13, wherein, The opposing segments of the elongated body include a first segment connected to the first end portion and a second segment connected to the second end portion.

15. The endoscope according to claim 14, wherein, The bow-shaped segment includes a U-shaped body that connects the first segment and the second segment.

16. The endoscope according to any one of claims 10 to 13, 15, further comprising a connector for connecting the second end portion of the elongated body to an actuator.

17. The endoscope according to any one of claims 10 to 13, 15, wherein, The first end portion includes a flange that extends axially from the shoulder to define an end of the first end portion.

18. The endoscope according to any one of claims 10 to 13, 15, further comprising: A ramp is provided within the interior space, the ramp having a curved surface positioned to align with the guide portion; as well as An opening located in the lumen.

19. A method of forming an lifter for an endoscope, the method comprising: An elongated body is formed from a planar sheet material, the elongated body comprising: The length between the first end and the second end; Width less than the stated length; and A thickness less than the length and the width; A guide body is formed within the elongated body; The elongated body is bent such that the first length and the second length of the elongated body are opposite each other to form an internal space; and The guide body is bent to extend into the internal space to form an opening in the elongated body to allow instruments to pass through it. The first end and the second end extend in the longitudinal direction, forming the internal space between the first end and the second end.

20. The method according to claim 19, wherein, Forming the elongated body and forming the guiding body comprise a single process.

21. The method according to claim 20, wherein, The individual process includes either a stamping process or an etching process.

22. The method according to any one of claims 20 and 21, wherein, The single process also forms: The actuator coupling near the first end; and The retaining feature near the second end.

23. The method according to any one of claims 19 to 21, further comprising forming a guide groove in the guide body.

24. The method according to claim 23, wherein, Forming the guide groove includes: Cut the entrance in the guide body to form a flange; and The flange of the guide body is bent to form a channel in the guide body.

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