Articulating medical devices and related methods

Abstract

This document describes a medical device and its method of use, including a medical device having a handle, an insertion portion, and a distal end. The distal end may include a light source, an imaging device, and a core. First and second hinge members may extend longitudinally from the handle, through the insertion portion and the distal end, for example, located in corresponding first and second channels of the core. The insertion portion may define a first lumen. The core may include a second lumen located between the first and second channels, the second lumen communicating with the first lumen of the insertion portion. Each of the first and second hinge members may terminate proximally at the distal end of the core.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 597,491, filed November 9, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to components and related methods for use in medical devices. More specifically, aspects of this disclosure relate to components including parts positioned at the distal end of a medical device (such as an endoscope). Background Technology

[0004] In medical procedures, an operator may insert a medical device (such as an endoscope or other type of endoscope) into a subject's body cavity. The operator may guide the distal end to the location of the procedure to be performed. The operator may pass auxiliary devices (such as instruments) through the working channel of the medical device to assist in performing certain diagnostic or therapeutic procedures. The distal end of the medical device may include elements for providing visualization of the body cavity, such as illumination elements and / or imaging devices. The distal end of the medical device may also include other features such as one or more articulated members, openings in the working channel, one or more openings for air / water and suction, sensors, and / or lifters. Currently, many endoscopes have limitations on the arrangement of elements and / or various types of elements that can be incorporated into the distal end of the device. It may be desirable to arrange the articulated members within the distal end to optimize space within the distal end without increasing the outer diameter of the medical device. For example, it may be desirable to provide space for additional and / or larger components (e.g., additional and / or larger illumination elements, imaging devices, and / or sensors). Summary of the Invention

[0005] Each aspect disclosed herein may include one or more features described in conjunction with any other disclosed aspects.

[0006] This disclosure relates in particular to components and related methods for use in medical devices. Specifically, it relates to components including parts positioned at the distal end of a medical device (such as an endoscope).

[0007] For example, this disclosure includes a medical device comprising a handle, an insertion portion extending distally from the handle, and a distal end located at a distal end of the insertion portion. A first hinge member and a second hinge member may each extend longitudinally from the handle through the insertion portion. The insertion portion may define a first lumen. The distal end may include a core and may optionally include a light source and / or imaging device. The core may include a first channel receiving a distal portion of the first hinge member and a second channel receiving a distal portion of the second hinge member. A second lumen may extend through the core between the first and second channels. The second lumen may communicate with the first lumen of the insertion portion. Each of the first and second hinge members may terminate proximally at the distal end of the core. The first hinge member may include a first bend located distal to a first distal side that defines a distal end of the first channel. The second hinge member may include a second bend located distal to a second distal side that defines a distal end of the second channel.

[0008] The medical device discussed above and elsewhere herein may include any of the following features. The medical device may further include a first distal member fixed to a distal portion of a first hinge member. A proximal side of the first distal member may abut a first distal side of the core. A second distal member may be fixed to a distal end of a second hinge member. A proximal side of the second distal member may abut a second distal side of the core. Each of the first and second distal sides of the core may extend along a plane transverse to the longitudinal axis of the core. Each of the first and second bends may be from approximately 90 degrees to approximately 180 degrees. The first bend may be located in a first direction, while the second bend may be located in a second direction opposite to the first direction. The core may further include a first groove on an outer surface of the core receiving a distal portion of the first hinge member, and a second groove on an outer surface of the core receiving a distal portion of the second hinge member. Each of the light source and imaging device may be located distal to the distal portion of each of the first and second hinge members.

[0009] In some aspects, the core may further include a first recess adjacent to the first channel and a second recess adjacent to the second channel. The first recess may communicate with a first lumen of the core and may receive a first distal member fixed to a distal portion of the first hinge member. The second recess may communicate with a second lumen of the core and may receive a second distal member fixed to a distal portion of the second hinge member. The proximal side of the first distal member of the first hinge member may abut the distal end of the first recess. The proximal side of the second distal member of the second hinge member may abut the distal end of the second recess.

[0010] In some aspects, the core may further include a third channel adjacent to the first channel and a fourth channel adjacent to the second channel. The third channel may receive a portion of the first hinge member after the first bend. The fourth channel may receive a portion of the second hinge member after the first bend. The proximal side of the first distal member may abut a first proximal side of the core defining the proximal end of the first channel, and the proximal side of the second distal member may abut a second proximal side of the core defining the proximal end of the second channel. Each of the first and second proximal sides may extend along a plane transverse to the longitudinal axis of the core. The first hinge member may further include a third bend proximal to the first proximal side of the core. This third bend is located in a third direction perpendicular to the first bend. The second hinge member may further include a fourth bend proximal to the second proximal side of the core. This fourth bend is located in a fourth direction opposite to the third direction.

[0011] In some aspects, the cross-sectional dimension of the proximal portion of the first channel may be smaller than the cross-sectional dimension of the distal portion of the first channel, and the cross-sectional dimension of the proximal portion of the second channel may be smaller than the cross-sectional dimension of the distal portion of the second channel. The distal end may further include a cap that covers at least a portion of the receiving core.

[0012] This disclosure also includes a medical device comprising a distal end including a light source, an imaging device, a first hinge member, a second hinge member, and a core. The distal end of the first hinge member can be secured to a first sleeve. The distal end of the second hinge member can be secured to a second sleeve. The core may define a lumen extending along a longitudinal axis of the core, a first channel configured to receive the first hinge member, and a second channel configured to receive the second hinge member. The first channel may be parallel to the lumen. At least one of a first distal side or a first proximal side defined by the first channel may be transverse to the lumen. The second channel may be parallel to the lumen. At least one of a second distal side or a second proximal side defined by the second channel may be transverse to the lumen.

[0013] Any medical device described above and elsewhere herein may include any of the following features: a proximal end of the first cannula may abut a first distal end, and a proximal end of the second cannula may abut a second distal end. The medical device may further include a handle and an insertion portion extending distally from the handle. Each of the first and second hinge members may extend from the handle through the insertion portion to the distal end. The first hinge member may include a first bend located distal to the first distal end, and the second hinge member may include a second bend located distal to the second distal end.

[0014] This disclosure also includes a medical device comprising a handle and an insertion portion extending distally from the handle to a distal end and defining a first lumen. A first hinge member and a second hinge member may each extend from the handle through the insertion portion. The distal end may include a light source, an imaging device, and a core. The core may include a first channel for receiving the distal portion of the first hinge member and a second channel for receiving the distal portion of the second hinge member. The first channel may define a first distal side, and the second channel may define a second distal side. Each of the light source and the imaging device may be located distal to the distal portion of each of the first and second hinge members. The first hinge member may include a first bend located distal to the first distal side, and the second hinge member includes a second bend located distal to the second distal side.

[0015] Any medical device described above and elsewhere herein may include any of the following features: Each of the first and second bends may be from approximately 90 degrees to approximately 180 degrees. The core may further include a third and a fourth channel. The third channel may be adjacent to the first channel. The third channel may receive a portion of the first hinge member after the first bend. The fourth channel may be adjacent to the second channel. The fourth channel may receive a portion of the second hinge member after the first bend. Attached Figure Description

[0016] The accompanying drawings, which are incorporated in and form a part of this application, illustrate examples of this disclosure and, together with the specification, serve to explain the principles of this disclosure.

[0017] Figure 1A and Figure 1B An exemplary medical device according to aspects of this disclosure is depicted.

[0018] Figures 2A-2D An exemplary distal portion of a medical device according to aspects of this disclosure is shown.

[0019] Figures 3A-3D Another exemplary distal portion of a medical device according to aspects of this disclosure is shown.

[0020] Figure 4A and Figure 4B Another distal portion of the medical device according to aspects of this disclosure is shown.

[0021] Figure 5 A perspective view of another distal portion of the medical device according to aspects of this disclosure is shown.

[0022] Figure 6 A perspective view of another distal portion of the medical device according to aspects of this disclosure is shown.

[0023] Figure 7Aand Figure 7B A perspective view depicting features of another exemplary medical device according to aspects of this disclosure ( Figure 7A ) and cross-sectional view ( Figure 7B ).

[0024] Figure 8A and Figure 8B Another exemplary distal portion of a medical device according to aspects of this disclosure is shown.

[0025] Figure 9A and Figure 9B Another exemplary distal portion of a medical device according to aspects of this disclosure is shown.

[0026] Figures 10A-10C Various views of another distal portion of the medical device according to aspects of this disclosure are shown.

[0027] Figure 11 Another configuration of the distal portion of the medical device according to aspects of this disclosure is shown.

[0028] Figures 12A-12D Another distal portion of the medical device according to aspects of this disclosure is shown. Detailed Implementation

[0029] It is understood that the above description of the invention and the following detailed description are merely exemplary and explanatory, and do not limit the invention as claimed. As used herein, the terms "comprises," "comprising," "includes," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements may include not only those elements but also other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" means "example," not "ideal." The term "distal" refers to a direction away from the operator / towards the treatment site, while the term "proximal" refers to a direction towards the operator. Drawings may include arrows marked "P" and "D" to indicate the proximal and distal directions, respectively. The term "approximately" or similar terms (e.g., "substantially") include a specified value of + / - 10%.

[0030] This disclosure provides a construction of articulated components to increase the relative dimensions of the working channel, for example, to facilitate treatment of a subject. Medical devices (such as ureteroscopes) can be inserted into a subject's body cavity (e.g., into the kidney) to perform medical procedures (e.g., laser lithotripsy). The distal end may include the distal portion of one or more articulated members, for example, the articulated members comprising one or more traction wires. In some aspects, the distal portion of the articulated member may include a distal member. The distal member may include a sleeve or crimping member fixed to the distal portion of each articulated member (e.g., fixed to the distal end). The articulated members may be configured to articulate the distal end in one or more directions (e.g., to allow the distal end to move left, right, up, and / or down).

[0031] The distal portion (including the distal end) of a medical device may include one or more components, each comprising various electronic components such as light or illumination elements (e.g., light-emitting diodes (LEDs), optical fibers (e.g., plastic optical fibers (POF), other light guides, or combinations thereof), imaging elements (e.g., cameras, other components with imagers, and / or other optical elements (e.g., lenses)), and / or other electronic components (e.g., capacitors, diodes, resistors, etc.). The electronic components of the components herein may include electrical connectors, and may also include various elements mounted on or otherwise connected to electrical connectors, for example.

[0032] It may be desirable for the articulated member to occupy a relatively small or limited space while maintaining performance and manufacturing quality. For example, due to the relatively small amount of space occupied by the articulated member, the medical device may be able to accommodate additional components (e.g., working channels, lumens, electronic components, and / or other components), and / or have additional space within the cross-section of the distal end. Additionally or alternatively, because the articulated member occupies a relatively small amount of space within the distal end, the medical device (e.g., the distal portion of the medical device) may include a smaller overall size to facilitate insertion and / or guidance within the body. For example, the diameter or other cross-sectional dimensions of the medical device may be reduced and / or the total length of the distal end may be reduced compared to the devices described above. An exemplary way to save space while maintaining performance and manufacturing quality is to position and / or configure the articulated member within the distal end or end cap of a medical device (e.g., an endoscope or ureteroscope).

[0033] Additionally or alternatively, it may be desirable to configure the hinge members to modify or otherwise compensate for the proximal forces applied to each hinge member. For example, when a medical device is hinged, one or more hinge members can be pulled proximally. Tension can thus be applied. When the tension exceeds the coupling force between the individual hinge members and the distal member connected to (e.g., fixed to) the distal portion of the hinge member, separation may occur between the two components. Similarly, when tension is applied to the hinge members, one or more hinge members may separate from the distal end and / or one or more components at the distal end may break or fracture. When such separation, breakage, or fracture occurs, the performance of the device may be affected (e.g., the distal end and / or other parts of the medical device may no longer be able to hinge).

[0034] In some examples herein (including those described below), the articulated member may be configured with one or more bends to modify or otherwise compensate for (e.g., reduce) the applied tension. In some respects, one or more bends may reduce the likelihood of separation between each respective articulated member and the distal member and / or the likelihood of each articulated member separating from the distal end (e.g., from the core of the distal end).

[0035] Figure 1A and Figure 1B Aspects of an exemplary medical device 10 according to this disclosure are depicted. Although this disclosure may refer to ureteroscopes in different places, it should be understood that, unless otherwise stated, endoscopes, duodenoscopes, gastroscopes, endoscopic ultrasound (“EUS”), colonoscopes, bronchoscopes, laparoscopes, cystoscopes, aspiration endoscopes, sheaths, catheters, and any other suitable medical devices may include and / or be used in conjunction with the elements, parts, and components described herein. Figure 1A The proximal portion of the medical device 10 is depicted, including a handle 12 and an insertion portion 14. Figure 1B The distal portion of the insertion part 14 is depicted. The handle 12 can be configured for the operator to grip and use.

[0036] The insertion portion 14 may include a shaft 42 extending distally from the handle 12. At least a portion of the shaft 42 may be flexible, for example, to facilitate guidance within the subject's anatomy. The shaft 42 may define one or more lumens, which may optionally contain filaments, tubes, or other features passing through them. In some aspects, the insertion portion 14 may include a single lumen (e.g., a first lumen) through which tubes (e.g., a working channel and / or one or more fluid tubes), filaments, or other features may pass. The insertion portion 14 may be configured to be at least partially inserted into the subject's body (e.g., a body cavity).

[0037] As discussed in further detail below, the insertion portion 14 may include one or more electronic components operatively connected to one or more components of the handle 12. Furthermore, as discussed in detail below, one or more hinge members may extend from the handle 12 and pass through at least a portion of the shaft 42 of the insertion portion 14. For example, the hinge members may extend longitudinally through the insertion portion 14 (e.g., via one or more lumens of the shaft 42). In some aspects, the hinge members may (e.g., directly or indirectly) be coupled to a distal end 44 disposed at the distal end of the insertion portion 14. The hinge members may be configured to hinge the distal end 44 in one or more directions. For example, the distal portion of the shaft 42 may include a hinge portion 54, which may include one or more hinge joints, for example, located within an outer sheath of the shaft 42 (e.g., see...). Figure 2A , Figure 3A , Figure 7A , Figure 8A , Figure 9A and Figure 11 ).

[0038] Handle 12 may include a mechanism for controlling the hinge of medical device 10. For example, this mechanism may include an actuator, such as a lever 22 coupled to the hinge member. For example, lever 22 may be coupled to a proximal end and / or proximal portion of the hinge member, such that actuation of lever 22 controls the hinge / steering of the distal end 44. In some aspects, the proximal portion of handle 12 may include, for example... Figure 1A The joystick 22 is shown. It should be understood that any suitable actuator, such as one or more knobs, buttons, sliders, switches, or joysticks, can be used in addition to or as an alternative to the joystick 22. The handle 12 may include one or more locking mechanisms, for example, to lock the position of the joystick 22 and thus lock the orientation of the hinged portion 54 of the shaft 42 (e.g., the distal end 44).

[0039] Port 24 of handle 12 provides access to the lumen (e.g., working channel) of insertion portion 14 of medical device 10. An operator can insert an instrument or other device into port 24 and can extend the instrument or other device distally through the working channel of axis 42 of insertion portion 14. For example, the working channel may extend longitudinally through the length of axis 42 and terminate at a distal opening 48 at a distal end 44. In some examples, handle 12 may include, for example, a suction valve 26 located on the proximal portion of handle 12, such as on the side of handle 12 opposite to lever 22. An operator can connect handle 12 to a suction source and can operate suction valve 26 to control suction through insertion portion 14 (e.g., through the working channel or other lumen, which may be the same as or different from the lumen or working channel communicating with port 24). Handle 12 may additionally or alternatively include other types of valves, such as fluid supply valves (e.g., air and / or water valves) and / or valves that perform a combination of functions.

[0040] The actuator of the imaging device 52, operably connected to the handle 12 to the insertion portion 14, enables the operator to capture an image. For example, as Figure 1B As shown, the handle 12 includes a button 28 to allow the operator to capture still images and / or video images. Although the button 28 is shown located on the proximal portion of the handle 12, the button 28 (or other actuator) may be located on another portion of the handle 12 that is accessible to the operator's hand during use.

[0041] Still referencing Figure 1A The integrated wiring harness 30 can extend from the handle 12 and can include or carry wires, cables, and / or conduits configured to provide, for example, power, signals, or fluid to the handle 12 and / or to provide, for example, power, signals, or fluid outward from the handle. For example, the integrated wiring harness 30 can connect the handle 12 to one or more user interfaces, monitors, control units, displays, etc.

[0042] like Figure 1B As shown, the distal end 44 may include the distal side 46 defining the opening 48 (e.g., a working channel opening). An instrument or other device may pass through the port 24, through the working channel, and extend out of the opening 48. An instrument extending distally from the opening 48 may be used to perform medical procedures on a subject.

[0043] The distal end 44 may also include imaging components, such as one or more light sources 50 (e.g., LEDs) and one or more imaging devices 52 (e.g., a camera). Although in Figure 1BThe image depicts two light sources 50 and one imaging device 52; however, it should be understood that other combinations of light sources 50 and imaging device 52 may be used. Light sources 50 and imaging device 52 may be separate components or may be combined into a single unit or device. Light source 50 may include LEDs, optical fibers (e.g., plastic optical fibers (POF)), or any other suitable light source. Imaging device 52 may be configured to capture video and / or still images. Imaging device 52 may provide signals to a monitor or display (e.g., connected via integrated wiring harness 30) so that an operator can view the images provided by imaging device 52 while guiding medical device 10 through the subject's body cavity.

[0044] like Figure 1B As shown, in some aspects, the medical device 10 may be forward-facing. For example, features of the distal end 44 (e.g., opening 48, light source 50, and / or imaging device 52) may face the same direction, such as the distal direction (i.e., the distal / forward direction facing the farthest side 46). The invention also includes other configurations of the distal end 44. For example, the medical device 10 may be side-facing. In the side-facing example, the opening 48, light source 50, and / or imaging device 52 may be located on the side of the distal end 44, or otherwise incorporated into the distal end 44 such that they point radially outward relative to the longitudinal axis of the insertion portion 14. In some aspects, the medical device 10 may include one or more forward-facing components and one or more side-facing components.

[0045] Figure 2A A cross-sectional view of the distal portion of the insert portion 114 in an assembled state is shown. The insert portion 114 may have any or all of the features of the insert portion 114, except as described below. The insert portion 114 may include a distal end 144 comprising a cap 160 and a core 162. In some aspects, the core 162 may taper inward (e.g., toward the longitudinal axis A of the insert portion). The cap 160 includes a distal side 146, which may include one or more light sources and / or one or more imaging devices. The proximal portion 160A of the cap 160 may be configured to receive the distal portion 162A of the core 162, for example, via complementary matching features. For example, the core 162 may be attached to the cap 160 via mechanical engagement (e.g., snap-fit, press-fit, screw engagement, etc.) and / or using adhesive. Figures 2B-2D Various views of the core 162 are shown. For example, Figure 2B The front or top view of core 162 is shown; Figure 2C The side cross-section is shown; and Figure 2D A perspective view is shown (the hinge members 168A and 168B discussed below are not shown). The insertion portion 114 may include a hinge portion 154 located on the proximal side of the distal end 144.

[0046] The farthest side 146 may define an opening 148 communicating with the working channel 149, thereby allowing fluid to flow from the working channel 149 through the insertion portion 114. Although the opening 148 is shown as having a smaller inner diameter than the working channel 149, the opening 148 may have the same or a larger inner diameter than the working channel 149. The distal portion of the working channel 149 may be tapered, for example, such that the diameter of the opening 148 is larger than the diameter of the working channel 149 located on the proximal side of the opening 148, and vice versa. In some examples, the farthest side 146 may include additional openings, for example, to allow fluid (e.g., gas or liquid) to be delivered from the distal end 144.

[0047] In some examples herein, the distal portion 114A of the insertion portion 114 may be configured to receive the proximal portion 162B of the core 162, for example, via a mechanical engagement (e.g., snap-fit, press-fit, screw engagement, etc.) and / or using an adhesive. In some aspects, the central portion 162C of the core 162 may be disposed between the insertion portion 114 and the cover 160. For example, the proximal side 160P of the cover 160 may abut the distal side 163A of the central portion 162C. Similarly, the distal side 114D of the insertion portion 114 may abut the proximal side 163B of the central portion 162C. The central portion 162C may have a larger cross-sectional dimension compared to the distal and proximal portions 162A and 162B. In some aspects, the outer surface 163C of the central portion 162C may form part of the outer surface of the insertion portion 114.

[0048] The hinge portion 154 may include one or more hinge joints 164 disposed within the insertion portion 114 (e.g., proximal to the distal end 144). Therefore, the nearest side 162P of the core 162 and the farthest side 164D of the farthest hinge joint 164 may be shaped complementaryly to each other. For example, the nearest side 162P may be tilted and / or shaped according to the farthest side 164D of the farthest hinge joint 164. A space 166 may be defined between the nearest side 165P and the farthest side 164D. For example, the size of the space 166 may change (e.g., increase or decrease) when the distal end 144 is hinged.

[0049] One or more hinge members may extend through at least a portion of the insertion portion 114 and the core 162, for example, via one or more channels or lumens. The hinge members may be configured to hinge the distal end 144 in one or more directions. For example, a first hinge member 168A may extend through a first channel 170A of the core 162. A second hinge member 168B may extend through a second channel 170B of the core 162. The cross-section of the first channel 170A and / or the second channel 170B of the core 162 may be oval, such as… Figure 2B As shown. Alternatively, the cross-section of the first channel 170A and / or the second channel 170B may be circular, square, rectangular, or any other shape. In some respects, the cross-sections of the first channel 170A and the second channel 170B may be complementary to the cross-sectional dimensions / shape of each corresponding hinge member (e.g., the first hinge member 168A and / or the second hinge member 168B).

[0050] In some aspects, each of the first hinge member 168A and the second hinge member 168B may be loosely received within the first channel 170A and the second channel 170B, respectively. For example, each of the first hinge member 168A and the second hinge member 168B may be movable (e.g., translational and / or rotatable) within the first channel 170A and the second channel 170B, respectively. In other aspects, the first hinge member 168A and / or the second hinge member 168B may be secured within each respective channel, for example, via an adhesive. Additionally or alternatively, the first hinge member 168A and the second hinge member 168B may be overmolded or otherwise secured within the core 162. In some aspects, each of the first hinge member 168A and the second hinge member 168B may terminate proximally at the distal end of the core 162.

[0051] Each of the first hinge member 168A and the second hinge member 168B may include wire, cable, thread, or rope. In some examples, the first hinge member 168A may be coupled to the first sleeve 172A and / or a portion of the first hinge member 168A may be crimped. Similarly, the second hinge member 168B may be coupled to the second sleeve 172B and / or a portion of the second hinge member 168B may be crimped. Although two hinge members are shown in this example, only one or more hinge members may be included, for example, having corresponding sleeves and / or crimped portions.

[0052] The core 162 can be configured to guide at least the distal portion of the first hinge member 168A and / or the second hinge member 168B inward (e.g., toward longitudinal axis A). For example, the proximal side of the first sleeve 172A and / or the proximal side of the second sleeve 172B can abut a corresponding face of the core 162, such as abutting the first inclined surface 174A and the second inclined surface 174B of the core 162. The first channel 170A and / or the second channel 170B can be located at the center of the first inclined surface 174A and the second inclined surface 174B of the core 162, respectively.

[0053] Each of the first inclined surface 174A and the second inclined surface 174B may be inclined inward within the core 162. For example, the first inclined surface 174A may extend along a first plane transverse to the longitudinal axis of the core 162. Similarly, the second inclined surface 174B may extend along a second plane transverse to the longitudinal axis of the core 162. For example, the outermost edge of each of the first inclined surface 174A and the second inclined surface 174B (e.g., the edge furthest from the longitudinal axis A on each respective surface) may be located distally relative to the innermost edge of each of the first inclined surface 174A and the second inclined surface 174B (e.g., the edge closest to the longitudinal axis A on each respective surface). In some examples, each of the first inclined surface 174A and the second inclined surface 174B may be inclined at angles α1 and α2 relative to the respective first inner surface 176A and the second inner surface 176B of the core 162 (e.g., see...). Figure 2C Angles α1 and α2 can be greater than 90 degrees and less than 180 degrees, for example, from approximately 91 degrees to approximately 120 degrees. In some aspects, each of the first hinge member 168A and the second hinge member 168B can be inclined relative to the first inner surface 176A and the second inner surface 176B at angles β1 and β2, respectively. For example, each of angles β1 and β2 can be greater than 0 degrees and less than 90 degrees (for example, from approximately 15 degrees to approximately 45 degrees).

[0054] like Figure 2A and Figure 2CAs shown, the first inclined surface 174A and the second inclined surface 174B can be located proximal to the farthest end of the core 162. Therefore, when the proximal end of the first sleeve 172A is adjacent to the first inclined surface 174A and / or when the proximal end of the second sleeve 172B is adjacent to the second inclined surface 174B, the farthest ends of the first hinge member 168A, the second hinge member 168B, the first sleeve 172B, and / or the second sleeve 172 can be adjacent to or proximal to the farthest end of the core 162. Therefore, when the distal end of each of the first sleeve 172A and the second sleeve 172B is adjacent to or proximal to the farthest end of the core 162, additional space can be created distal to the first sleeve 172B and the second sleeve 172B within the distal end 144. In some aspects, this additional space can be used to accommodate additional components (e.g., imaging devices, light sources, etc.) within the distal end 144.

[0055] The lumen 178 may extend, for example, from the proximal end of the core 162 through the core 162 to the distal end of the core 162. The lumen 178 may be centrally located within the core 162, for example, extending along the central longitudinal axis of the core 162. The lumen 178 may be configured to receive and / or contain wires or cables providing an electrical connection between the light source 50 and / or the imaging device 52 and the handle 12. The distal portion of the lumen 178 may be circular or oval. The proximal portion of the lumen 178 (e.g., the portion of the core 162 including the first channel 170A and the second channel 170B) may resemble the shape of FIG. 8. For example, the first diameter D1 of the proximal portion of the lumen 178 may be smaller than the second diameter D2 and / or the third diameter D3 of the proximal portion of the lumen 178. For example, the first diameter D1 may be smaller because the first wall 180A and the second wall 180B formed opposite to the first wall 180A protrude into the lumen 178. The first wall 180A can form at least a portion of the first channel 170A. The second wall 180B can form at least a portion of the second channel 170B.

[0056] The inner and / or outer surfaces of the core 162 may include one or more surface features (e.g., protrusions, recesses, grooves, openings, walls, cavities, cuts, etc.) to assist in attaching the cover 160 to the core 162 and / or attaching the core 162 to the insertion portion 114. For example, as Figure 2D As shown, the outer surface of the core 162 may include surface features 182. The cover 160 and / or the insertion portion 114 may include complementary features (e.g., mating features) to facilitate attachment of the core 162 to the insertion portion 114.

[0057] Figure 3AA cross-section of another exemplary device according to this disclosure is shown, illustrating an insertion portion 214. Insertion portion 214 may have any or all of the features of insertion portion 14 and / or insertion portion 114 described above. Insertion portion 214 may include a distal end 244 of one or more hinge joints 264 coupled to insertion portion 114. The distal end 244 may include a cap 260 and a core 262, which may have any or all of the features of cap 160 and core 162, respectively, except as described below. For example, in such a configuration, core 262 may be configured to align one or more hinge members parallel to the longitudinal axis B. With one or more hinge members aligned parallel to the longitudinal axis B, additional space may be created, for example, on the distal side of one or more hinge members and / or within the cross-section of the distal end 144.

[0058] Figures 3B-3D Various views of the core 262 are shown, including Figure 3B The front view or top view in the image; Figure 3C The side sectional view in the middle; and Figure 3D A perspective view is shown (the hinge members are omitted for clarity). The core 262 can be configured to orient the first hinge member 268A and the first sleeve 272A and / or the second hinge member 268B and the second sleeve 272B in a straight line configuration (e.g., parallel to the longitudinal axis B). The core 262 can also be configured to orient the first sleeve 272A against a first outermost wall 276A and the second sleeve 272B against a second outermost wall 276B of the core 262. Therefore, the inner diameter of the lumen 278 (e.g., a central lumen) can receive the cable and / or tube of the insertion portion 214.

[0059] The core 262 may further include a first channel 270A configured to receive a portion of the first hinge member 268A (e.g., proximal to the first sleeve 272A). A second channel 270B may be configured to receive a portion of the second hinge member 268B (e.g., proximal to the second sleeve 272B). The proximal end of the first sleeve 272A may abut a first distal side 274A of the first channel 270A. Similarly, the proximal end of the second sleeve 272B may abut a second distal side 274B of the second channel 270B. Each of the first distal side 274A and the second distal side 274B may be substantially perpendicular to the longitudinal axis A of the core 262. Thus, the distal ends of each of the first sleeve 272A, the second sleeve 272B, and the first hinge member 268A and the second hinge member 268B may be substantially parallel to the longitudinal axis A. The core 262 can be configured such that the distal end of each of the first hinge member 268A, the first sleeve 272A, the second hinge member 268B, and the second sleeve 272B terminates near the proximal end of the distal end of the core 262.

[0060] Each of the first channel 270A and the second channel 270B may be offset from the center of the first distal side 274A and the second distal side 274B, respectively. For example, the first wall 271A forming the first channel 270A may be continuous with the first outermost wall 276A, and the second wall 271B forming the second channel 270B may be continuous with the second outermost wall 276B. The first channel 270A may be further defined by a first inner wall 273A. For example, the distal end of the first inner wall 273A may include the first distal side 274A. In this way, the proximal side of the first sleeve 272A may abut the distal side of the first inner wall 273A (e.g., the first distal side 274A). Thus, only a portion of the proximal side of the first sleeve 272A may be configured to abut the first distal side 274A. The remaining portion of the proximal side of the first sleeve 272A may extend over the distal opening of the first channel 270A. Similarly, the second channel 270B may be further defined by a second inner wall 273B. The proximal side of the second sleeve 272B can be configured to abut the distal side of the second inner wall 273B (e.g., the second distal side 274B). Therefore, only a portion of the proximal side of the first sleeve can be configured to abut the first distal side 274A. The remaining portion of the proximal side of the second sleeve 272B can extend over the distal opening of the second channel 270B.

[0061] The distal portion of the central lumen 278 (e.g., distal to each of the first inner wall 273A and the second inner wall 273B) may be circular or oval. The proximal portion of the central lumen 278 (e.g., between the proximal and distal ends of each of the first inner wall 273A and the second inner wall 273B) may resemble the shape of FIG8. For example, the cross-sectional shape of the proximal portion of the central lumen 278 may resemble... Figure 2B The shape within the central lumen 278. For example, the first diameter D1 of the central lumen 278 may be smaller than the second diameter D2 and / or the third diameter D3. For example, the first diameter D1 may be even smaller because the first inner wall 273A and the second inner wall 273 opposite to the first inner wall 273A protrude into the central lumen 278.

[0062] In some aspects, each of the first hinge member 268A and the second hinge member 268B can be loosely accommodated within the first channel 270A and the second channel 270B, respectively. For example, each of the first hinge member 268A and the second hinge member 268B can move (e.g., rotate) within the first channel 270A and the second channel 270B, respectively. In other aspects, the first hinge member 268A and / or the second hinge member 268B can be fixed within each respective channel, for example, via an adhesive. Additionally or alternatively, the first hinge member 268A and the second hinge member 268B can be overmolded or otherwise fixed within the core 262. Thus, with the first sleeve 272A and the second sleeve 272B oriented parallel to the longitudinal axis B of the core 262, additional space can be created within the distal end 244 (e.g., distal to the core 262). For example, the additional space within the distal end 244 can be used to accommodate additional components (e.g., imaging devices, light source sensors, etc.).

[0063] Figure 4A and Figure 4B Another example according to this disclosure is shown, illustrating core 362. Figure 4A A perspective view of the core 362 connected to the insertion portion 314 is shown. Figure 4B A front view or top view of core 362 is shown. Except as described below, core 362 may have any or all of the features of core 162 and / or core 262. Figure 4A and Figure 4B An example is shown where a hinge member is secured to a core at a distal end without having a sleeve or crimped portion. For example, the core 362 may include a first channel 370A configured to receive a first hinge member 368A and a second channel 370B configured to receive a second hinge member 368B. The first hinge member 368A may be configured to form a first bend 369A, and the second hinge member 368B may be configured to form a second bend 369B. Each of the first bend 369A and the second bend 369B may be located distal to the first surface 374A and the second surface 374B of the core 362, respectively.

[0064] like Figure 4BAs shown, the cross-sectional dimensions and / or shape of each of the first channel 370A and the second channel 370B can vary. For example, the first proximal portion 377A of the first channel 370A can have a smaller cross-sectional dimension than the first distal portion 379A of the first channel 370B. Furthermore, the first proximal portion 377A can have a circular, square, polygonal, or other cross-sectional dimensions. The first proximal portion 377A can be configured to receive the first hinge member 368A. The first distal portion 379A of the first channel 370A can have a larger cross-sectional dimension than the first proximal portion 377A. The first distal portion 377A can be configured to receive at least two portions of the first hinge member 368A, for example, portions of the first hinge member 368A before and after the first bend 369A. In some aspects, the diameter of the first distal portion 379A can be twice the diameter of the first proximal portion 377A.

[0065] In some respects, each of the first hinge member 368A and the second hinge member 368B may be fixed to the core 362, for example, with an adhesive. Additionally or alternatively, the first hinge member 368A having a first bend 369A and the second hinge member 368B having a second bend 369B may be overmolded or otherwise fixed within the core 362.

[0066] Figure 5 A perspective view of another exemplary core 462 at the distal end of a medical device according to the present disclosure is shown. In addition to the features described below, core 462 may have any or all of the features of core 162, core 262, and / or core 362. Core 462 may be configured to receive a first hinge member 468A via a first channel extending longitudinally through core 462, and a second hinge member 568B via a second channel extending longitudinally through core 462. The first hinge member 468A may include a first distal bend 469A located distal to a first distal surface 474A of core 462. Similarly, the second hinge member 468B may include a second distal bend 469B located distal to a second distal surface 474B of core 462.

[0067] The core 462 may include a recess 484 having a plurality of bends 484A extending proximally along one or more outer or lateral surfaces of the core 462. The recess 484 may be configured to receive a first hinge member 468A (e.g., a portion of the first hinge member 468A after the first bend 469A). In some aspects, the first hinge member 468A may be secured to the core 562 within the recess 484, for example, via an adhesive. Additionally or alternatively, the first hinge member 468A may be overmolded within the core 462, for example, such that the distal portion of the first hinge member 468A (e.g., after the first bend 469A) may be at least partially embedded within the core 462.

[0068] The core 462 may include a second groove having a second plurality of bends on an opposite side of the core 462 (e.g., the side of the core 462 facing the page). The second groove may similarly extend along an outer or outer surface of the core 462. The second groove may similarly be configured to receive a second hinge member 468B. In some aspects, the second groove may similarly secure the second hinge member 468B to the core 462, optionally using an adhesive or via overmolding.

[0069] For example, each of the first hinge member 468A and the second hinge member 468B can be fixed to the core 462 without having a sleeve or crimping member fixed to each hinge wire.

[0070] Figure 6 A perspective view of another exemplary core 562 of the distal portion of the medical device according to this disclosure is shown. Unless otherwise stated, core 562 may have any or all of the features of core 162, core 262, core 362 and / or core 462.

[0071] The core 562 can be configured to receive one or more hinge members extending longitudinally through the core 562. For example, the core 562 may include a first channel 570A and a second channel 570B extending longitudinally through the core 562. The first channel 570A and the second channel 570B can be configured to receive a first hinge member 568A and a second hinge member 568B, respectively. The first hinge member 568A may include a first distal member 589A fixed or coupled to the distal end of the first hinge member 568A, and the second hinge member 568B may include a second distal member 589B fixed to the distal end of the second hinge member 568B. Each of the first distal member 586A and the second distal member 589B may be formed in the shape of a sphere or ball, but other shapes may also be used, such as, for example, a rhombus shape, a square shape, etc.

[0072] In some aspects, the first distal side 574A of the core 562 may include a first recess 575A configured to receive a first distal member 589A of the first hinge member 568A (e.g., having complementary dimensions). The second distal side 574B of the core 562 may include a second recess 575B configured to receive a second distal member 586B of the second hinge member 568B. Each of the first recess 575A and the second recess 575B may be configured such that, for example, each of the first distal member 586A and the second distal member 586B extends distally beyond the first distal side 574A and the second distal side 574B, respectively.

[0073] In some aspects, each of the first hinge member 568A and the second hinge member 568B can be loosely accommodated within the first channel 570A and the second channel 570B, respectively. In other aspects, an adhesive can be used to secure the first hinge member 568A and the second hinge member 568B to the core 562 and / or the first distal member 586A and the second distal member 586B can be at least partially overmolded within the core 562.

[0074] Figure 7A and Figure 7B Another example of the core 662 at the distal end of the medical device according to this disclosure is shown. Figure 7A A perspective view of a core 662 having a first hinge member 668A and a second hinge member 668B is shown. The core 662 may include a first channel 670A configured to receive the first hinge member 668A and a first recess 690A configured to receive, for example, a first sleeve 672A fixed to the distal end of the first hinge member 668A. The first recess 690A may be adjacent to at least a portion of the first channel 670A. For example, the first recess 690A may have a shorter longitudinal length than the first channel 670A. In some aspects, the first channel 670A may be separate from the first recess 690A and from the central lumen 678 of the core 662. At least a portion of the first recess 690A may open to or communicate with the lumen 678.

[0075] Similar to the features of the first hinge member 668A, the core 662 may also include a second channel 670B configured to receive the second hinge member 668B and a second recess 690B configured to receive the second sleeve 672B.

[0076] Each of the first recess 690A and the second recess 690B may be parallel to the lumen 678. In this way, the first sleeve 672A and the second sleeve 672B may be parallel to the lumen 678. In other examples, the first recess 690A and / or the second recess 690B may be configured such that the first sleeve 672A and / or the second sleeve 627B are inclined inward (e.g., toward a longitudinal axis extending proximally and distally through the core 662). In some aspects, each of the first recess 690A and the second recess 690B may extend proximally through a portion of the core 662. Thus, each of the first sleeve 672A and the second sleeve 672B may be completely contained within the core 662. For example, the core 662 may be configured such that at least a portion of one or both of the first sleeve 672A and the second sleeve 672B is located distal to the nearest side 662P of the core 662.

[0077] Each of the first hinge member 668A and the second hinge member 668B can be configured to bend approximately 180 degrees. For example, the first hinge member 668A can be configured to form a first bend 669A. The second hinge member 668B can be configured to form a second bend 669B. Each of the first bend 669A and the second bend 669B can be located on the far side of the first surface 674A and the second surface 674B of the core 662, respectively. Each of the first bend 669A and the second bend 669B can be in the same direction (e.g., towards the side of the page). In other examples, each of the first bend 669A and the second bend 669B can be in different directions (e.g., see discussion below). Figure 9A and Figure 9B ).

[0078] The portion of the lumen 678 including the first channel 670A, the first recess 690A, the second channel 270B, and the second recess 690B may have a first diameter D1, a second diameter D2, and a third diameter D3, wherein the second diameter D2 may be smaller than the first diameter D1 and the third diameter D3. For example, the cross-sectional diameters of the first recess 690A and the second recess 690B are both larger than the cross-sectional diameters of the first channel 670A and the second channel 670B. The third diameter D3 may be larger than the first diameter D1 and the second diameter D2. The first diameter D1 may be larger than the second diameter D2 but smaller than the third diameter D3.

[0079] The core 662 can be configured such that a portion of each of the first hinge member 668A and the second hinge member 668B bends proximally within the core 662. When the first hinge member 668A bends proximally, the first sleeve 672A can be located proximally relative to the distal end of the core 662. Therefore, additional space can be created within the distal end (e.g., distal to the core 662). Similarly, when the second hinge member 668B bends proximally, the second sleeve 672B can be located proximally relative to the distal end of the core 662. With the second sleeve 672B oriented in this manner, additional space can be created within the distal end (e.g., distal to the core 662). For example, the first recess 690A can have a smaller longitudinal length than the first channel 670A. The additional space within the distal end can allow the distal end 144 to accommodate additional components (e.g., imaging devices, light sources, sensors, etc.).

[0080] Additionally or alternatively, as the first hinge member 668A and the second hinge member 668B bend proximally, the tension applied to each respective sleeve (e.g., the first sleeve 672A and the second sleeve 672B) can be reduced. In some aspects, the first bend 669A and the second bend 669B can reduce the likelihood of separation between each respective hinge member and the distal member (e.g., separation of the first hinge member 668A from the first sleeve 672A or separation of the second hinge member 668B from the second sleeve 672B) and / or the likelihood of separation of each hinge member from the core 662 (e.g., separation of one or both of the first hinge member 668A and the second hinge member 668B from the core 662).

[0081] Figure 8A A side view of another exemplary core 762 of a medical device, including, for example, an insertion portion 714, is shown. Dashed lines are used to show internal components of the insertion portion 714 and / or the cover 760, or components contained therein. Figure 8BA cross-sectional view of the distal portion of the insert portion 714, taken at cross-section SS, is shown. The insert portion 714 may have any or all of the features of insert portions 14, 114, 214, and / or 314. The distal portion of the insert portion 714 may include a cap 760 and a core 762. The cap 760 may have any or all of the features of any cap described above (e.g., cap 160, 260). In addition to those described below, the core 762 may have any or all of the features of any core described above (e.g., core portions 162, 262, 362, 462, 562, 662). For example, the core 762 may be configured to receive a first hinge member 768A via a first channel 770A. The core 762 may also be configured to receive a second hinge member 768B via a second channel 770B. Each of the first hinge member 768A and the second hinge member 768B may be configured to bend approximately 180 degrees. For example, the first hinge member 768A may include a first distal bend 769A located distal to the first distal surface 774A of the core 762. Similarly, the second hinge member 768B may include a second distal bend 769B located distal to the second distal surface 774B of the core 762.

[0082] The core 762 may further include a third channel 770C and a fourth channel 770D. The third channel 770C may extend adjacent to and / or parallel to the first channel 770A within the core 762, for example. Similarly, the fourth channel 770D may extend adjacent to and / or parallel to the second channel 770B. The third channel 770C may be configured to receive a second portion of the first hinge member 768A (e.g., receiving the portion of the first hinge member 768A after the first bend 769A). The fourth channel 770D may be configured to receive a second portion of the second hinge member 768B (e.g., receiving the portion of the second hinge member 768B after the second bend 769B). Each of the first channel 770A, the second channel 770B, the third channel 770C, and the fourth channel 770D may be parallel to and adjacent to the lumen 778 of the core 762. The lumen 778 may have a reference... Figure 2B Lumen 178 and / or Figure 3B The cross-sectional shape is similar to that described in lumen 278.

[0083] The first sleeve 772A can be fixed to the distal end of the first hinge member 768A. The second sleeve 772B can be fixed to the distal end of the second hinge member 768B. The distal side of each of the first sleeves 772A can abut the first nearest side 781A of the core 762. Similarly, the distal side of the second sleeve 772B can abut the second nearest side 781B of the core 762. In this way, at least a portion of each of the first sleeves 772A and the second sleeve 772B can be located proximally to the core 762. In some aspects, at least a portion of the first sleeves 772A and the second sleeve 772B can extend proximally into or through one or more hinge links 764.

[0084] Each of the first nearest side 781A and the second nearest side 781B of the core 762 may be inclined relative to each other and relative to the longitudinal axis C. The first nearest side 781A may extend along a first plane transverse to the longitudinal axis C of the core 762. The second nearest side 781B may extend along a second plane transverse to the longitudinal axis C of the core 762. For example, the first nearest side 781A and the second nearest side 781B may be inclined such that the outermost edge of each of the first nearest side 781A and the second nearest side 781B (e.g., the edge farthest from the longitudinal axis A) is located proximal to the innermost edge of each of the first nearest side 781A and the second nearest side 781B (e.g., the edge closest to the longitudinal axis A).

[0085] With each of the first nearest side 781A and the second nearest side 781B tilted, the first sleeve 772A and the second sleeve 772B can be tilted similarly. For example, each of the first sleeve 772A and the second sleeve 772B can be tilted inward (e.g., toward the longitudinal axis A). Furthermore, the core 762 can be configured such that each of the first sleeve 772A and the second sleeve 772B is located proximal to the core 762 (e.g., proximal to the first nearest side 781A and the second nearest side 781B). Each of the first sleeve 772B and the second sleeve 772A is oriented in this way, thereby creating additional space within the distal end (e.g., distal to the core 762). Additionally or alternatively, if each of the first hinge member 768A, the first sleeve 772A, the second hinge member 768B, and the second sleeve 772B is oriented in this manner, the tension applied to each respective sleeve (e.g., the first sleeve 772A and / or the second sleeve 772B) can be reduced. Therefore, the likelihood of separation between and / or from the core 762 can be reduced.

[0086] Figure 9AA side view of another exemplary core 862 of the distal end 844 of the insertion portion 814 is shown. Figure 9B Shown in Figure 9A A cross-sectional view of the core 862 taken at section TT. The insertion portion 814 may have any or all of the features of the insertion portions discussed above. For example, the distal portion of the insertion portion 814 may include a distal end 844. The distal end 844 may include a cap 860 and the core 862. The core 862 may be located distal to one or more hinge joints 864. Dashed lines are used to show internal components or components contained therein of the distal portion of the insertion portion 814. For example, since the core 862 is contained within the insertion portion 814, the core 862 is... Figure 9A It is shown in dashed lines.

[0087] In addition to the features described below, core 862 may have any or all of the features of any of the cores discussed above (e.g., cores 162, 262, 362, 462, 562, 662, 762). For example, core 862 may be configured to receive a first hinge member 868A via a first channel 870A and a second hinge member 868B via a second channel 870B. The first hinge member 868A and the second hinge member 868B may be configured to be bent approximately 180 degrees in opposite directions. For example, the first hinge member 868A may include a first distal bend 869A bent in the first direction. The first distal bend 869A may be located distal to the first distal surface 874A of core 862. Similarly, the second hinge member 868B may include a second distal bend 869B bent in a second direction opposite to the first direction. The second distal bend 869B can be located distal to the second distal surface 874B of the core 862.

[0088] The first sleeve 872A can be secured to the distal end of the first hinge member 868A. The second sleeve 872B can be secured to the distal end of the second hinge member 868B. The core 862 may further include a first recess 890A configured to receive the first sleeve 872A and a second recess 890B configured to receive the second sleeve 872B. Each of the first recess 890A and the second recess 890B may be parallel to and / or adjacent to each corresponding channel (e.g., the first channel 870A and / or the second channel 870B). Similarly, each of the first recess 890A and the second recess 890B may be parallel to the longitudinal axis E of the distal end 844. The distal end of the first recess 890A may be defined by a first proximal side 881A. The distal end of the second recess 890B may be defined by a second proximal side 881B. Therefore, when the first sleeve 872A is received within the first recess 890A, the proximal side of the first sleeve 872A may abut or contact the first proximal side 881A of the first recess 890A. Similarly, when the second sleeve 872B is received within the second recess 890B, the proximal side of the second sleeve 872B may abut or contact the second proximal side 881B of the second recess 890B.

[0089] The core 862 can be configured such that a portion of each of the first hinge member 868A and the second hinge member 868B can be bent and fixed within the core 862 in opposing directions. For example, the first hinge member 868A and / or the second hinge member 868B can be bent approximately 180 degrees proximally in opposing directions. With the first hinge member 868A and the second hinge member 868B bent proximally in opposing directions, each of the first sleeve 872A and the second sleeve 872B can be located proximally relative to the farthest end of the core 862 and distally relative to the nearest end of the core 862. In this way, additional space can be created within the distal end (e.g., distal to the core 862). The additional space within the distal end 844 can allow the distal end 844 to accommodate additional components (e.g., additional imaging devices, light sources, tubes, sensors, etc.). Additionally or alternatively, if each of the first hinge member 868A, the first sleeve 872A, the second hinge member 868B, and the second sleeve 872B is oriented in this manner, the tension applied to each respective sleeve (e.g., the first sleeve 872A and / or the second sleeve 872B) can be reduced. Therefore, the likelihood of separation between and / or from the core 862 can be reduced.

[0090] Furthermore, this construction allows for the maximization of the cross-sectional shape of the lumen 878. For example, the cross-sectional shape of the central lumen 878 can be similar to that described above. Figure 2B The lumen discussed is 178 or the above text about... Figure 3BThe cross-sectional shape of the lumen 278 is discussed. Specifically, the cross-sectional shape of the central lumen 878 can be similar to that in Figure 8.

[0091] Figures 10A-10C Another core 962, having a first hinge member 968A and a second hinge member 968B, is depicted according to this disclosure. Figure 10A A side perspective view of the core 962 is shown; Figure 10B A rear perspective view of the core 962 is shown; and Figure 10C A rear view of core 962 is shown. In addition to the features described below, core 962 may have any or all of the features of any core discussed above. For example, the distal portion of any of the insert portions discussed above (e.g., insert portions 14, 114, 214, 314, 714, 814) may include core 962. Similarly, any of the caps discussed above (e.g., caps 160, 260, 760, 860) may be attached to core 962.

[0092] The core 962 can be configured to receive a first portion of the first hinge member 968A via a first channel 970A. The core 962 can be configured to receive a first portion of the second hinge member 968B via a second channel 970B. Each of the first channel 970A and the second channel 970B can extend longitudinally through at least a portion of the core 962. For example, the proximal opening of each of the first channel 970A and the second channel 970B can be located on a first proximal side 981A and a second proximal side 981B, respectively. The distal opening of each of the first channel 970A and the second channel 970B can be located on a first distal side 974A and a second distal side 974B, respectively. Each of the first channel 910A and the second channel 970B can extend through the core 962, for example, parallel to the central lumen 978 of the core 962.

[0093] Each of the first hinge member 968A and the second hinge member 968B can be configured to bend approximately 180 degrees. For example, the first hinge member 968A may include a first distal bend 969A. The first distal bend 969A may be located distal to the first distal surface 974A of the core 962. Similarly, the second hinge member 968B may include a second distal bend 969B. The second distal bend 969B may be located distal to the second distal surface 974B of the core 962. The first bend 969A and the second bend 969B may be in opposite directions.

[0094] The core 962 may further include a third channel 970C and a fourth channel 970D. The third channel 970C may extend adjacent to and / or parallel to the first channel 970A within the core 962, for example. Similarly, the fourth channel 970D may extend adjacent to and / or parallel to the second channel 970B. The third channel 970C may be configured to receive a second portion of the first hinge member 968A (e.g., receiving the portion of the first hinge member 968A after the first bend 969A). The fourth channel 970D may be configured to receive a second portion of the second hinge member 968B (e.g., receiving the portion of the second hinge member 968B after the second bend 969B). Each of the third channel 970C and the fourth channel 970D may be parallel to and adjacent to the central lumen 978 of the core 962.

[0095] In some aspects, the distal ends of each of the first hinge member 968A and the second hinge member 968B may extend proximally, over the first proximal side 981A and the second proximal side 981B, respectively. A first sleeve 972A may be secured to the distal end of the first hinge member 968A. A second sleeve 972B may be secured to the distal end of the second hinge member 968B. The first hinge member 968A may include a third bend 969C. The third bend 969C of the first hinge member 968A may be immediately abutted from the first sleeve 972A. The third bend 969C may be located in a direction perpendicular to the first bend 969A. Therefore, the third bend 969C may be configured to orient or position the first sleeve 972A within and / or across the lumen 978 (e.g., perpendicular to the longitudinal axis of the core 962).

[0096] The second hinge member 968B may include a fourth bend 969D. The fourth bend 969D may be immediately preceding the second sleeve 972B. The fourth bend 969D may be located in a direction perpendicular to the second bend 969B. In some aspects, the fourth bend 969D may be located in a direction opposite to the third bend 969C. Therefore, the fourth bend 969D may be configured to orient or position the second sleeve 972B within and / or across the central lumen 978, such that the second sleeve 972B is perpendicular to the longitudinal axis of the core 962. Therefore, the first sleeve 972A and the second sleeve 972B may be parallel to each other. The first sleeve 972A may extend in a direction opposite to the second sleeve 972B.

[0097] Figure 11Alternative components for the distal portion of insert portion 1014 are shown. Dashed lines are used to show internal components of insert portion 1014 or components contained within insert portion. In addition to the above, the distal portion of insert portion 1014 may have any or all of the features of any insert portion discussed above (e.g., insert portions 14, 114, 214, 314, 714, 814). In this embodiment, for example, the internal components of the distal portion of insert portion 1014 can be rearranged as linear assembly 1095. Linear assembly 1095 may include imaging device 1052 and / or one or more light sources 1050. Linear assembly 1095 may be configured to create additional space, for example, within the distal portion of insert portion 1014 (e.g., radially around linear assembly 1095). In some aspects, for example, linear assembly 1095 may be easier to assemble due to the additional space created within the distal portion (e.g., when using linear assembly 1095).

[0098] The distal end 1044 of the insertion portion 1014 may include a cap 1060 and a core 1062. The core 1062 may be configured to receive a first hinge member 1068A and / or a second hinge member 1068B. For example, the first hinge member 1068A and the second hinge member 1068B may extend longitudinally through the core 1062 (e.g., via one or more channels of the core 1062). In some aspects, each of the first hinge member 1068A and the second hinge member 1068B may be parallel to the longitudinal axis F of the insertion portion 1014. Each of the first hinge member 1068A and the second hinge member 1068B may extend at least partially along both sides of the linear assembly 1095, for example, parallel to the longitudinal axis F extending through the distal end 1044. Although not shown, the core 1062 may include additional channels or cavities, such as being configured to receive one or more wires, cables, sensors, etc., in relation to other aspects of the distal portion of the linear assembly 1095 and / or the insertion portion 1014.

[0099] Figures 12A-12D Various views are shown of another component of the distal portion of the insertion portion 1114, which includes at least a cover 1160, a first core portion 1162A, and a second core portion 1162B. For example, Figure 12A An exploded view of the distal portion of the insertion section 1114 is shown; Figure 12B The assembled cross-section of the distal portion of the insertion part 1114 is shown; Figure 12C A perspective view of the first core portion 1162A is shown; and Figure 12D A perspective view of the second core portion 1162B is shown. Therefore, in Figures 12A-12DElements or features of the first core portion 1162A and / or the second core portion 1162B can be observed in one or more figures.

[0100] In some respects, the first core portion 1162A and the second core portion 1162B can be configured to be joined together, for example, via a screw engagement. The second core portion 1162B can be configured to be joined to the cover 1160, for example, via a press-fit. For example, in the assembled state, the first core portion 1162A can be located near the second core portion 1162B and the cover 1160 (e.g., see...). Figure 12B Therefore, the proximal portion of the second core portion 1162B can be configured to receive the distal portion of the first core portion 1162A. The proximal portion of the cover 1160 can be configured to receive the distal portion of the second core portion 1162B.

[0101] Each of the first core portion 1162A and the second core portion 1162B can be configured to receive at least a portion of the first hinge member 1168A and the second hinge member 1168B. For example, the first core portion 1162A may include a first channel 1170A, such as Figure 12C As shown. The first channel 1170A can be configured to receive a portion of the first hinge member 1168A (e.g., the portion of the first hinge member 1168A proximal to the first sleeve 1172A). Although not shown, the first core portion 1162A may further include a second channel, for example, located on the opposite side of the first central lumen 1178A of the first core portion 1162A. The second channel can be configured to receive a portion of the second hinge member (e.g., the portion of the second hinge member proximal to the second sleeve 1172B).

[0102] The first core portion 1162A may include a first recess 1190A. The first recess 1190A may be configured to receive a first sleeve 1172A of the first hinge member 1168A. In some aspects, the proximal side of the first sleeve 1172A may be configured to abut or contact a first distal side 1174A defining the proximal end of the first recess 1190A. The first recess 1190A may communicate with a first lumen 1178A of the first core portion 1162A.

[0103] The first distal surface 1174A may be perpendicular to the longitudinal axis of the first core portion 1162A. Therefore, when the first sleeve 1172A is placed within the first recess 1190A (e.g., such that the proximal end of the first sleeve 1172A abuts the first distal surface 1174A), the first sleeve 1172A and the first hinge member 1168A may be aligned parallel to the longitudinal axis of the first core portion 1162A. In an alternative example, the first distal surface 1174A may be inclined relative to the longitudinal axis of the first core portion 1162A. Therefore, when the first sleeve 1172A is placed within the first recess 1190A (e.g., such that the proximal end of the first sleeve 1172A abuts the first distal surface 1174A), the first sleeve 1172A and the first hinge member 1168A may be inclined toward the longitudinal axis of the first core portion 1162A.

[0104] The first core portion 1162A may further include a second recess 1190B configured to receive a second sleeve 1172B. In some aspects, the second recess 1190B may be located on the opposite side of the first central lumen 1178A, for example, directly opposite the first recess 1190A. Although not shown, the second recess 1190B may have any or all of the same aspects as the first recess 1190A. For example, the second recess 1190B may communicate with the first central lumen 1178A. The second recess 1190B may include a second distal side defining a proximal end of the second recess 1190B. The second sleeve 1172B may be configured to abut or contact the second distal side. In some aspects, the second distal side may be substantially perpendicular to the longitudinal axis of the first core portion 1162A, such that the second sleeve 1172B is parallel to the longitudinal axis when placed within the second recess 1190B. In other respects, the second distal side of the second recess 1190B may be tilted, for example, tilting the second sleeve 1172B inward (e.g., toward the longitudinal axis of the first core portion 1162A).

[0105] The distal end of the first core portion 1162A may include one or more connecting features 1197. The proximal end of the second core portion 1162B may include one or more complementary connecting features 1198. In some aspects, the connecting features 1197 of the first core portion 1162A may include a plurality of internal threads, for example, to engage with a plurality of external threads (e.g., complementary connecting features 1198) disposed on the proximal end of the second core portion 1162B. Thus, the first core portion 1162A and the second core portion 1162B may be configured to be connected via a screw engagement. In other examples, the connecting features 1197 of the first core portion 1162A may include a lip or groove, and the connecting features 1198 of the second core portion 1162B may include complementary grooves or lips. Thus, the first core portion 1162A and the second core portion 1162B may be configured to be connected via a snap-fit ​​or press-fit. Alternatively or additionally, the first core portion 1162A and the second core portion 1162B may be joined by an adhesive substance (such as glue, adhesive, epoxy resin, etc.) without the need for the joining feature 1197 or the complementary joining feature 1198.

[0106] The second core portion 1162B may further include a first receiving recess 1191A. For example, when the first core portion 1162A and the second core portion 1162B are coupled together, the first receiving recess 1191A of the second core portion 1162B may be configured to align with the first recess 1190A of the first core portion 1162A. The first receiving recess 1191A may communicate with the central lumen 1178B of the second core portion 1162B.

[0107] The first receiving recess 1191A can be configured to receive the distal portion of the first sleeve 1172A. For example, the distal side of the first sleeve 1172A can abut or contact the first proximal side 1192A defining the distal end of the first receiving recess 1191A. In this way, for example, when the first core portion 1162A is secured to the second core portion 1162B, the first sleeve 1172A can be secured to the first distal side 1174A of the first recess 1190A (see...). Figure 12C The first sleeve 1172A is located between the first proximal side 1192A of the first receiving recess 1191A of the first core portion 1162B and the second core portion 1162B. Therefore, the first sleeve 1172A can be fixed within the distal portion, thus securing the first hinge member 1168A within the distal end 1144. In some respects, the first sleeve 1172A can be fixed so that it cannot move longitudinally within the distal portion, but still allows rotation within the first core portion 1162A and the second core portion 1162B.

[0108] The second core portion 1162B may further include a second receiving recess 1191B. The second receiving recess 1191B may be configured to receive a distal portion of the second sleeve 1172B. Therefore, the second receiving recess 1191B may have any or all of the same features as the first receiving recess 1191A. For example, although not shown, the distal side of the second sleeve 1172B may abut or contact a second proximal side defining the distal end of the second receiving recess 1191B. In this way, for example, when the first core portion 1162A is secured to the second core portion 1162B, the second sleeve 1172B may be secured between the second distal side of the second recess 1190B and the proximal side of the second receiving recess 1191B. Therefore, the second sleeve 1172B may be secured within the distal portion, thus securing the second hinge member 1168B within the distal end 1144. In some respects, the second sleeve 1172B can be fixed so that it cannot move longitudinally within the distal portion, but still allows rotation within the first core portion 1162A and the second core portion 1162B.

[0109] In some aspects, the first core portion 1162A and the second core portion 1162B can be configured, for example, to include or confine each of the first hinge member 1168A and the second hinge member 1168B within the proximal portion of the distal end 1144 of the insertion portion 1114. Thus, additional space can be created within the distal portion (e.g., distal to the second core portion 1162B).

[0110] Additionally or alternatively, the first core portion 1162A and the second core portion 1162B can be configured, for example, to minimize or reduce the possibility of damage to internal components of the distal portion. For example, because each of the first hinge member 1168A and the second hinge member 1168B is respectively confined between the first core portion 1162A and the second core portion 1162B, the first hinge member 1168A and the second hinge member 1168B are prevented from jamming or hooking internal components (e.g., wiring or cables of the lighting element and / or imaging element of the distal portion).

[0111] Each embodiment discussed herein is exemplary. For example, the exemplary embodiments discussed herein provide various alternative configurations of one or more articulated members and / or electronic components within the distal portion of the insertion section of a medical device. For example, various configurations can be utilized such that the articulated members occupy a relatively small or limited space within the distal end while maintaining performance and manufacturing quality. For example, the additional space created by such a configuration can accommodate additional components and / or facilitate easier assembly of the distal portion of the medical device. In some aspects, the configurations discussed herein can have reduced cross-sectional dimensions. Additionally or alternatively, the overall length of the distal end configurations discussed herein can be reduced.

[0112] While this document illustrates the principles of the disclosure in a specific context and for a particular medical procedure, with reference to exemplary examples, it should be understood that the disclosure is not limited thereto. Those skilled in the art and those who have received the teachings provided herein will recognize that other modifications, applications, and equivalents fall within the scope of the examples described herein. Therefore, the invention should not be considered as limited to the foregoing description.

Claims

1. A medical device comprising: handle; An insertion portion extending distally from the handle, wherein a first hinge member and a second hinge member each extend longitudinally from the handle through the insertion portion, and wherein the insertion portion defines a first lumen; and The distal end, located at the distal end of the insertion portion, comprises: The core includes a first channel for receiving a distal portion of the first hinge member, a second channel for receiving a distal portion of the second hinge member, and a second lumen located between the first channel and the second channel, the second lumen communicating with the first lumen of the insertion portion; Wherein, each of the first hinge member and the second hinge member terminates near the proximal side of the most distal end of the core; and Wherein, the first hinge member includes a first bend located on the distal side of a first distal side, the first distal side defining the distal end of the first channel, and / or the second hinge member includes a second bend located on the distal side of a second distal side, the second distal side defining the distal end of the second channel; Optionally, the distal end further includes a light source and / or an imaging device.

2. The medical device according to claim 1, further comprising: A first distal member, fixed to the distal portion of the first hinge member, wherein the proximal side of the first distal member abuts the first distal side of the core; and A second distal member is fixed to the distal end of the second hinge member, wherein the proximal side of the second distal member is adjacent to the second distal side of the core.

3. The medical device according to claim 1 or claim 2, wherein, Each of the first and second distal sides of the core extends along a plane transverse to the longitudinal axis of the core.

4. The medical device according to any one of the preceding claims, wherein, Each of the first bend and the second bend is approximately 90 degrees to approximately 180 degrees.

5. The medical device according to any one of the preceding claims, wherein, The first bend is located in a first direction, while the second bend is located in a second direction opposite to the first direction.

6. The medical device according to any one of the preceding claims, wherein, The core further includes: A first groove located on the outer surface of the core, the first groove receiving the distal portion of the first hinge member; and A second groove located on the outer surface of the core, the second groove receiving the distal portion of the second hinge member.

7. The medical device according to any one of the preceding claims, wherein, Each of the light source and the imaging device is located on the far side of the far portion of each of the first hinge member and the second hinge member.

8. The medical device according to any one of the preceding claims, wherein, The core further includes: A first recess adjacent to the first channel, wherein the first recess communicates with a first lumen of the core and receives a first distal member fixed to the distal portion of the first hinge member; and A second recess adjacent to the second channel, wherein the second recess communicates with the second lumen of the core and receives a second distal member fixed to the distal portion of the second hinge member.

9. The medical device according to claim 8, wherein, The proximal side of the first distal member of the first hinge member is adjacent to the distal end of the first recess, and the proximal side of the second distal member of the second hinge member is adjacent to the distal end of the second recess.

10. The medical device according to any one of the preceding claims, wherein, The core further includes: A third channel adjacent to the first channel, wherein the third channel receives the portion of the first hinge member after the first bend; and A fourth channel adjacent to the second channel, wherein the fourth channel receives the portion of the second hinge member after the first bend.

11. The medical device according to any one of the preceding claims, wherein, The proximal side of the first distal member is adjacent to the first proximal side of the core that defines the proximal end of the first channel, and the proximal side of the second distal member is adjacent to the second proximal side of the core that defines the proximal end of the second channel.

12. The medical device according to claim 11, wherein, Each of the first proximal side and the second proximal side extends along a plane transverse to the longitudinal axis of the core.

13. The medical device according to claim 11 or claim 12, wherein, The first hinge member further includes a third bend located on the proximal side of the first proximal side of the core, wherein the third bend is located in a third direction perpendicular to the first bend, and The second hinge member further includes a fourth bend located on the proximal side of the second proximal side of the core, wherein the fourth bend is located in a fourth direction opposite to the third direction.

14. The medical device according to any one of the preceding claims, wherein, The cross-sectional dimension of the proximal portion of the first channel is smaller than the cross-sectional dimension of the distal portion of the first conduit, and the cross-sectional dimension of the proximal portion of the second channel is smaller than the cross-sectional dimension of the distal portion of the second channel.

15. The medical device according to any one of the preceding claims, wherein, The distal end further includes a cap that receives at least a portion of the core.

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