Distal tips of medical devices, and methods therefor

Abstract

A medical device may include a control portion, a shaft extending distally from the control portion and having working channel extending through the shaft, and a distal end portion fixed to a distal end of the shaft. The distal end portion may include an encapsulated portion having a lumen extending through the encapsulated portion, and a cap portion. A distalmost face of the cap portion may be distal to a distalmost face of the encapsulated portion. The working channel of the shaft and the lumen of the encapsulated portion may be aligned and in fluid communication with each other.

Description

DISTAL TIPS OF MEDICAL DEVICES, AND METHODS THEREFORCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 555,623, filed on February 20, 2024, which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] The disclosure relates generally to devices, systems, and methods for distal tips of medical devices. More specifically, aspects of the present disclosure pertain to devices, systems, and / or methods for encapsulated or overmolded distal tips of medical scopes.BACKGROUND

[0003] An endoscope may include a handle and an insertion portion that may be inserted into a subject. For example, an insertion portion of an endoscope may include a shaft and a distal tip. The distal tip may include a cap assembly fixed, directly or indirectly, to the distal end of the shaft. The cap assembly may form a distalmost end of the medical device. The cap assembly may include an imaging device and / or a lighting element. Additionally or alternatively, the cap assembly may have outlets for air, water, suction, electricity, data, light, images, and / or working tools from lumen(s) of the endoscope. One or more outlet(s) of the cap assembly may correspond to one or more outlet(s) of the distal end of the shaft. Alignment between corresponding outlets of the distal end of the shaft and the cap may be difficult to achieve, particularly in small sizes.SUMMARY

[0004] Examples of the present disclosure relate to, among other things, devices, systems, and methods for encapsulated or overmolded distal tips of medical devices, including encapsulated or overmolded cap assemblies of endoscopes or other scope devices. Each of the examples disclosed herein may include one or more of the features described in connection with the disclosed examples.

[0005] According to one aspect, a medical device may include a control portion, a shaft extending distally from the control portion and have a working channel extending through the shaft, and a distal end portion fixed to a distal end of the shaft. The distal end portion may include an encapsulated portion having alumen extending through the encapsulated portion, and a cap portion. A distalmost face of the cap portion may be distal to a distalmost face of the encapsulated portion. The working channel of the shaft and the lumen of the encapsulated portion may be aligned and in fluid communication with each other.

[0006] The medical device may include one or more of the following features. The shaft may include a pull wire extending through the shaft. The encapsulated portion may encapsulate a distal end of the pull wire. At least a portion of the encapsulated portion may be adjacent to the cap portion. The distalmost face of the encapsulated portion may have a non-zero angle relative to a plane extending perpendicularly to a longitudinal axis of the shaft. The distalmost face of the cap portion may be parallel to the plane extending perpendicularly to the longitudinal axis of the shaft.

[0007] An illuminating device and an imaging device may be disposed on the distalmost face of the cap portion. The cap portion may include at least one chamfered edge. The lumen of the encapsulated portion may be a first lumen. The shaft may further include a second lumen and a third lumen. The encapsulated portion may include at least a fourth lumen and a fifth lumen in fluid communication with the second lumen and the third lumen of the shaft, respectively. The cap portion may include a proximal extension. The proximalmost end of the proximal extension may abut a distal face of the shaft. A distal face of the shaft may include a surface treatment or chemical etching.The cap portion may include a planar wall having a cutout. The planar wall may extend distally relative to a distalmost edge of the encapsulated portion. A side surface of the imaging device may be exposed via the cutout. The cutout may include a material forming the encapsulated material. The encapsulated portion may be comprised of one or more radiopaque materials. A ring may at least partially surround an outer surface of the distal end portion.

[0008] According to another aspect, a distal end of an insertion portion of a medical device may include an encapsulated portion and a cap portion. The encapsulated portion may at least partially encapsulate a steering component and an electronic component. The encapsulated portion may include at least one lumen that is in fluid communication with a lumen of a shaft of the insertion portion. At least a portion of the cap portion may be distal to the encapsulated portion.

[0009] The distal end of the insertion portion of the medical device may include one or more of the following features. The cap portion may include a lumen that is in in fluid communication with the lumen of the encapsulated portion and the lumen of the insertion portion. A collar may at least partially surround an outer surface of the encapsulated portion and the cap portion. The collar may include an opening in fluid communication with the encapsulated portion. The steering component may be at least one pull wire. The electronic component may be at least one cable or wire.

[0010] At least a first portion of a distalmost face of the cap portion may be angled relative to a plane extending perpendicularly to a longitudinal axis of the insertion portion. At least a second portion of the distalmost face of the cap portion may be parallel to the plane. An illuminating device and an imaging device may be disposed on the second portion of the distalmost face of the cap portion.

[0011] According to another aspect, a method for forming a distal end of a medical device may include inserting a mandrel through both a lumen of the mold and a lumen of the shaft of the medical device; positioning a distal portion of the shaft of the medical device within a channel of the mold; injecting an encapsulating material through a channel of the mold to form an encapsulated portion of the distal end; and removing the mandrel to form a lumen within the encapsulated portion of the distal end.

[0012] The method may further include positioning a cap portion within a cavity of the mold. The cap portion may include an illuminating device and an imaging device.

[0013] It may be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. As used herein, the terms “comprises,” “comprising,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term “exemplary” is used in the sense of “example,” rather than “ideal.”BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate examples of the present disclosure and together with the description, serve to explain the principles of the disclosure.

[0015] FIG. 1A depicts an exemplary handle of a medical device, according to aspects of this disclosure.

[0016] FIGs. 1 B and 1 C both depict an exemplary distal portion, including a cap assembly, of a medical device, according to aspects of this disclosure.

[0017] FIG. 2 depicts an exemplary mold assembly, according to aspects of this disclosure.

[0018] FIG. 3 is a flow diagram of an exemplary method, according to aspects of this disclosure.

[0019] FIGs. 4A and 4B both depict an exemplary distal portion, including a cap assembly, of a medical device, according to aspects of this disclosure.

[0020] FIG. 5 depicts a further alternative exemplary distal portion of a medical device, according to aspects of this disclosure.DETAILED DESCRIPTION

[0021] Distal tips of endoscopes or other scope devices may include a variety of components and may be coupled to a distal end of a shaft of an endoscope. In aspects, the distal tips may include cap assemblies for containing or otherwise confining the components within the distal tip. For example, the distal tip and / or the shaft of the endoscope may each include one or more outlets for air, water, suction, electricity, data, light, images, and / or working tools from lumen(s) of the endoscope.

[0022] Alignment between one or more corresponding outlets of the distal tip and the shaft may be difficult to achieve, particularly in small sizes. Misalignment between features of the distal tip and the shaft may result in increased procedural times, impact patient safety, and / or damage tools being inserted through the medical device. To facilitate alignment between the outlet(s) of the distal tip and the shaft, each component may be subject to tight manufacturing requirements, which may increase manufacturing costs of each component. The endoscope, including the distal tip and the shaft, may also be subjected to harsh sterilization requirements. This disclosure describes, for example, a distal tip, including a cap assembly, which is at least partially encapsulated and / or overmolded with a material which both easesmanufacturing of the distal end portion of the endoscope and withstands sterilization. In aspects, such an encapsulated cap portion may allow for consistent alignment between outlet(s) of the distal tip and outlet(s) of the shaft. Additionally or alternatively, the encapsulated cap portion may assist in maintaining the position of one or more components (e.g., imaging device(s), illumination device(s), electrical components, cables, wires, steering components, etc.) within the distal tip.

[0023] Although endoscopes are referenced herein, reference to endoscopes or endoscopy should not be construed as limiting the possible applications of the disclosed systems. Other applications include, for example, any medical or nonmedical device requiring alignment between lumens of two disparate components. Such medical devices include, for example, cholodochoscopes, colonoscopes, ureteroscopes, bronchoscopes, gastroscopes, duodenoscopes, catheters, sheaths, imagers, etc. It will be appreciated that the term “endoscope” includes, for example, a cholangioscope.

[0024] This disclosure is described with reference to exemplary medical devices, components, and / or systems having a handle and an insertion portion. It should be noted that reference to any particular device and / or any particular procedure is provided only for convenience and not intended to limit the disclosure. A person of ordinary skill in the art would recognize that the concepts underlying the disclosed devices and application methods may be utilized in any suitable procedure, medical or otherwise. The assemblies and systems described herein may be used in conjunction with other types of medical devices. This disclosure may be understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals.

[0025] Proximal and distal portions of an exemplary medical device 100 (e.g., an endoscope such as a cholangioscope) are shown in FIGs. 1A-1C. For example, a proximal portion of medical device 100 is shown in FIG. 1A. Medical device 100 includes a handle 102 and an insertion portion 104 (including, e.g., a shaft 140). Insertion portion 104 may be connected to and extend from a distal portion of handle 102. Insertion portion 104 may terminate distally in a distal tip 150, shown in FIGs. 1 B, 1C. In embodiments, distal tip 150 include a cap assembly 152. Cap assembly 152 may be fixed to a distal end portion 153 of shaft 140. In aspects, cap assembly 152 may form a distalmost end of insertion portion 104. As discussed in further detailbelow, cap assembly 152 may incorporate components or features at the distalmost end of medical device 100. Broken lines in FIGs. 1A and 1 B depict structures (e.g., steering components, electronic components, etc.) that are internal to cap assembly 152.

[0026] Referring to FIG. 1A, handle 102 includes an opening or a port 106 (e.g., a biopsy port), which may be fluidly connected to one or more lumens and / or a working channel 108 (FIG. 1 B) of shaft 140. In aspects, port 106 may be configured to receive one or more accessory devices (e.g., baskets, guide wires, biopsy forceps, etc.). For example, the accessory device(s) may be inserted into working channel 108 via port 106 and extended distally past a distalmost end of shaft 140.

[0027] Handle 102 may include a first actuator 122A and / or a second actuator 122B. Actuator(s) 122A, 122B may each be manipulated (e.g., individually or simultaneously rotated about an axis) to control the deflection, movement, position, etc. of one or more portions of shaft 140 (e.g., distal end portion 153). In these aspects, actuator(s) 122A, 122B may each be connected to one or more pull wires 118 (e.g., one or more steering components), the distal ends of which are shown in broken lines in FIGs. 1 B, 1 C. Pull wire(s) 118 may extend proximally and distally through one or more lumens of shaft 140, for example, from handle 102 to distal end portion 153 of shaft 140.

[0028] In aspects, rotation of first actuator 122A in a first direction (e.g., clockwise) may pull at least one pull wire 118 proximally, such that distal end portion 153 deflects in a first deflection direction (e.g., up). Rotation of first actuator 122A in a second direction (e.g., counterclockwise) may pull another pull wire 118 proximally, such that distal end portion 153 deflects in a second deflection direction (e.g., down). The second deflection direction may be opposite to the first deflection direction. Additionally, in some examples, rotation of second actuator 122B in a first direction (e.g., clockwise) may pull a third pull wire proximally, such that distal end portion 153 deflects in a third deflection direction (e.g., left). Rotation of second actuator 122B in a second direction (e.g., counterclockwise) may pull a fourth pull wire proximally, such that distal end portion 153 deflects in a fourth deflection direction (e.g., right).

[0029] Although not shown, handle 102 may include one or more locking mechanisms to secure actuators 122A, 122B in position, and thus help to secure the position of distal end portion 153. Rotation of actuators 122A, 122B may cause aportion of insertion portion 104 (e.g., distal end portion 153) to bend, for example, via an articulating portion 124. Articulating portion 124 may include one or more articulation joints (not shown). Although actuators 122A, 122B are illustrated as knobs, actuators 122A, 122B may instead be buttons, levers, sliders, etc. Additionally or alternatively, handle 102 may include one or more additional actuators (e.g., buttons, knobs, levers, etc.), for example, to capture an image and / or video, and / or provide other functionality to an end effector, distal end portion 153, and / or cap assembly 152.

[0030] An umbilicus 130 may extend from handle 102 (e.g., from a proximal portion of handle 102). Umbilicus 130 may be removably coupled (e.g., directly or indirectly) to a processing unit (not shown). The processing unit may be configured to process information (e.g., sensor data, imaging data, light data, etc.) received from medical device 100. In some aspects, the processing unit may be a controller associated with medical device 100. Illumination device(s) 110 and / or imaging device(s) 112 of cap assembly 152 may be electrically coupled (e.g., directly or indirectly) to the processing unit, for example, via one or more wires and / or cables extending through insertion portion 104, through handle 102, and through umbilicus 130. For example, umbilicus 130 may include one or more electrical cables and / or light cables for coupling to the processing unit via, e.g, a removable connector. Cap assembly 152 may further include one or more sensors (e.g., for measuring or detecting temperature, pressure, orientation, velocity, acceleration of motion, humidity, etc.). The one or more sensors may be disposed on one or more faces or sides of cap assembly 152.

[0031] Although not shown, the processing unit may include or be coupled to a visual output (e.g., an embedded monitor or screen, or an external or separate monitor or screen). Umbilicus 130 may additionally or alternatively include one or more lumens for supplying a gas or a liquid, or applying suction or negative pressure, to handle 102 and / or shaft 140. For example, the gas or the liquid may be applied, or delivered, through one or more channels, or lumens, of medical device 100.

[0032] Handle 102 may be coupled to a proximal portion of insertion portion 104 (e.g, shaft 140) via a strain relief portion 132. Strain relief portion 132 mayextend from a distal end of handle 102, and may overlap with a proximal portion of shaft 140, for example, helping to maintain the coupling of handle 102 to shaft 140.

[0033] Referring to FIGs. 1 B and 1C, cap assembly 152 may include a first cap portion 152A (e.g., an encapsulated portion) and a second cap portion 152B. Described in further detail below, first cap portion 152A may be comprised of a continuous or integral structure, such as an encapsulation and / or overmolding. First cap portion 152A may include one or more encapsulating materials. For example, first cap portion 152A may be formed of one monolithic material. Alternatively, first cap portion 152A may be formed from multiple materials, which may be mixed together, applied in layers, or otherwise applied or formed.

[0034] The encapsulating material of first cap portion 152A may include any suitable material. For example, the encapsulating material may be made from a rigid material or a flexible material (e.g., a polyurethane, a plastic material, a copolyester, a polyamide, and / or an epoxy). The epoxy may be a light cured epoxy, a cyanoacrylate, a 2-part epoxy, and / or any other encapsulating material. In aspects, the encapsulating material may be made from a medical grade 2-part material (e.g., EPO-TEK 301 , Loctite M-31CL, or equivalent). Such a material may insulate heat producing electronics (e.g., illumination device(s) 110 and / or imaging device(s) 112). A material, such as an epoxy, may be doped in order to dissipate or channel heat. For example, a fine-powdered material with a high thermal conductivity (e.g., copper) may be blended into the encapsulating material. Such a fine-powdered material may be blended so that it stays in suspension in an epoxy or other material forming first cap portion 152A. In aspects, the encapsulating material forming first cap portion 152A may be optically clear, semi-opaque, or opaque.

[0035] In an alternative, first cap portion 152A may be formed using a low- pressure thermoplastic molding process using a viscous version / grade of polyamide (e.g., nylon) or other low temperature low viscosity thermoplastic, thermoset, or an ultraviolet light cured adhesive (e.g., Dymax 203A-CTH-F Multi-Cure or similar). First cap portion 152A may be made from a rigid epoxy as well as a pliable silicone. First cap portion 152A may be formed so as to dissipate or insulate heat depending on design considerations related to use, subcomponent thermal generation properties, and / or recommended operating temperature limits of illumination device(s) 110 and / or imaging device(s) 112.

[0036] One or more channels or lumens, for example, one or more fluid delivery lumens 114 and / or one or more working channel lumens 116, may be formed within first cap portion 152A. For example, lumens 114, 116 may extend longitudinally through cap assembly 152 (e.g., approximately parallel to a longitudinal axis of shaft 140 and / or cap assembly 152). The one or more lumens of first cap portion 152A (e.g., fluid delivery lumen(s) 114 and / or working channel lumen(s) 116) may be in fluid communication with one or more corresponding lumens of shaft 140. For example, working channel lumen 116 of first cap portion 152A may be in fluid communication with working channel 108 of shaft 140. Fluid delivery lumen(s) 114 may be in fluid communication with corresponding lumens of shaft 140. In these aspects, working channel lumen 116 may be a first lumen of first cap portion 152A, a first fluid delivery lumen 114 may be a second lumen, a second fluid delivery lumen 114 may be a third lumen, etc. First cap portion 152A may include fewer or additional lumens, for example, to correspond with a number of lumens of shaft 140.

[0037] In some aspects, openings for each respective lumen 114, 116 may be disposed on a cap distal face 154 of first cap portion 152A. For example, each fluid delivery lumen 114 may terminate at a respective opening 115 on cap distal face 154. Similarly, lumen 116 may terminate at an opening 117 on cap distal face 154. As shown in FIGs. 1 B and 1 C, opening 117 of working channel lumen 116 may be disposed between openings 115 of two fluid delivery lumens 114. In these aspects, a straight line extending perpendicular to a longitudinal axis of insertion portion 104 may intersect each of the two fluid delivery lumens 114 and at least a portion of lumen 116. In some aspects, a straight line extending perpendicular to a longitudinal axis of insertion portion 104 may be a common tangent to each lumen 114, 116.

[0038] In aspects, the encapsulating material of first cap portion 152A may assist in fixing one or more electronic components (e.g., illumination device(s) 110, imaging device(s) 112, sensors, etc.) and / or other mechanical components of cap assembly 152 in place by at least partially surrounding such components with the encapsulating material of first cap portion 152A. As will be described in further detail below, the encapsulating material of first cap portion 152A may be injected and allowed to harden so that it fills crevices or other spaces within second cap portion 152B and / or between illumination device(s) 110 and imaging device(s) 112. Theencapsulating material of first cap portion 152A may be injected so that there is no open or empty space between first cap portion 152A and second cap portion 152B and / or between illumination device(s) 110 and imaging device(s) 112. In these aspects, the encapsulating material of first cap portion 152A may assist in fixing illumination device(s) 110 and imaging device(s) 112 within second cap portion 152B. The encapsulating material of first cap portion 152A may be injected and surround wiring or cabling associated with illumination device(s) 110 and / or imaging device(s) 112 that extends proximally through first cap portion 152A and into a lumen of shaft 140.

[0039] Additionally or alternatively, encapsulating material of first cap portion 152A may surround one or more pull wires 118 and their respective termination (e.g., a crimp 120). For example, distal end of each pull wire 118 may include crimp 120 around the distal end of each pull wire 118. Both crimp 120 and a distal end of each pull wire 118 may extend distally past a distal face 153D of shaft 140. Crimp 120 may assist in preventing the distal end of each pull wire 118 from being pulled proximally into shaft 140. The distal end of each pull wire 118 and respective crimp 120 may be embedded, or contained within, the encapsulating material forming first cap portion 152A.

[0040] In other aspects, pull wire(s) 118 may be embedded within the encapsulating material forming first cap portion 152A, for example, without crimp(s) 120. For example, the distal end of each pull wire 118 may be bare (e.g., without a crimp) and the encapsulating material of first cap portion 152A may provide adequate strength to prevent the distal end of each pull wire 118 from being pulled proximally into shaft 140. In other aspects, each pull wire 118 may be looped. For example, a single pull wire 118 may extend through two or more lumens of shaft 140, with a distal loop of the single pull wire within first cap portion 152A and proximal ends of the single pull wire coupled to one of actuators 122A, 122B. The loop may be contained within the encapsulating material of first cap portion 152A. In these aspects, the encapsulating material of first cap portion 152A may assist in preventing movement of each pull wire. In further configurations, a distal end of each pull wire 118 may include a laser welded ball termination in lieu of crimp 120. The laser welded ball termination of each pull wire 118 may be encapsulated by theencapsulating material of first cap portion 152A, e.g., to maintain the position of each pull wire 118.

[0041] Additionally or alternatively, the encapsulating material may assist in fixing second cap portion 152B to first cap portion 152A and / or first cap portion 152A to distal face 153D of shaft 140. No other element, such as adhesive, may be present between the encapsulating material of first cap portion 152A and any abutting surface of the components in which the material comes in contact with (e.g., distal end portion 153, second cap portion 152B, illumination device(s) 110, imaging device(s) 112, etc.). In some aspects, the encapsulating material forming first cap portion 152A may extend proximally along an outer surface of distal end portion 153. In these aspects, the encapsulating material forming first cap portion 152A that extends proximally along an outer surface of distal portion 153 may assist with securing first cap portion 152A to distal end portion 153 and / or assist with preventing leaks into cap assembly 152.

[0042] The encapsulating material comprising first cap portion 152A may include one or more radiopaque materials or additives (e.g., barium sulfate, bismuth oxychloride, bismuth subcarbonare, etc.) such that first cap portion 152A is capable of being viewed during medical imaging procedures (e.g., X-ray, fluoroscopy, ultrasound, magnetic resonance imaging, etc.). In some aspects, a metallic ring 156 may at least partially surround an outer surface of cap assembly 152 and / or distal end portion 153 of shaft 140. In other aspects, metallic ring 156 may surround or be embedded within first cap portion 152A and / or second cap portion 152B. Metallic ring 156 may be comprised of one or more metals, e.g., capable of being viewed during medical imaging procedures. The one or more metals may include tungsten, gold, stainless steel, platinum, iridium, or any other metal capable of being viewed during medical imaging procedures. In other aspects, a metal hypotube may be embedded within the encapsulating material of first cap portion 152A. The metal hypotube may be aligned with working channel 108 and assist with visualization of distal tip 150 during medical imaging procedures. In other examples, ferrules, stamped metal components, fluoro markers, fiducials, and / or pull wires 118 may be radiopaque and provide for increased visualization.

[0043] Cap distal face 154 of first cap portion 152A may be a non-zero angle. For example, cap distal face 154 may be angled approximately 0.5 - 60 degrees(e g., approximately 10 - 45 degrees) relative to a plane extending perpendicular to the longitudinal axis of insertion portion 104 (e.g., the plane may be parallel to distal face 153D). In other words, cap distal face 154 of first cap portion 152A may not be perpendicular to or parallel to a longitudinal axis of cap assembly 152 or shaft 140. In aspects, cap distal face 154 may be angled, for example, to provide for an atraumatic tip. In these aspects, openings 115, 117 may be elongated, or ovular.

[0044] A distal portion of second cap portion 152B may extend distally relative to a distalmost edge 157 of first cap portion 152A. For example, second cap portion 152B may include a planar wall 158 that extends distally relative to the distalmost edge 157 of first cap portion. Planar wall 158 may extend approximately parallel to a longitudinal axis of cap assembly 152 and shaft 140. A proximal portion of planar wall 158 may be embedded within / contact a material of first cap portion 152A, and a distal portion of planar wall 158 may be outside of and distal to first cap portion 152A. In aspects, planar wall 158 that extends distally relative to the distalmost edge 157 of first cap portion may allow for a reduced distalmost area of second cap portion 152B. The reduced distalmost area of second cap portion 152B may allow for atraumatic access to anatomical openings. In other aspects, the reduced distalmost area of second cap portion 152B may assist with manufacturing cap assembly 152 and / or decrease the cost of manufacturing second cap portion 152B and / or cap assembly 152.

[0045] A bottom planar wall 160 of first cap portion 152A may abut and extend along a proximal portion of planar wall 158 of second cap portion 152B such that, for example, first cap portion 152A and second cap portion 152B at least partially overlap. In aspects, second cap portion 152B may include a cutout 163. Cutout 163 may have an open top side, such that second cap portion 152B has an opening on planar wall 158. In these aspects, a side surface of imaging device(s) 112 may be exposed via cutout 163. In some aspects, cutout 163 may assist in the placement of imaging device(s) 112. For example, imaging device(s) 112 may be placed, or potted, within second cap portion 152B via cutout 163 (e.g., prior to assembly with first cap portion 152A).

[0046] In other aspects, the encapsulating material forming first cap portion 152A may flow into cutout 163. For example, cutout 163 may permit the flow of encapsulating material against a side surface of imaging device(s) 112). In theseaspects, planar wall 158 of second cap portion 152B may be at least partially formed by the encapsulating material forming first cap portion 152A (illustrated in FIGs. 1 B, 1C with dashed lines). For example, the side surface of imaging device(s) 112 may be at least partially covered by the encapsulating material forming first cap portion 152A. As the encapsulating material flows into cutout 163, first cap portion 152A and second cap portion 152B may be more securely fixed to one another.

[0047] In other aspects, the material forming second cap portion 152B may extend across an entirety of bottom planar wall 160. For example, the material forming planar wall 158 of second cap portion 152B may extend across the side surface of imaging device(s) 112. In these aspects, second cap portion 152B may be without cutout 163.

[0048] A distalmost face 162 of second cap portion 152B may be approximately perpendicular to planar wall 158. Distalmost face 162 of second cap portion 152B may also be approximately perpendicular to a longitudinal axis of cap assembly 152 and / or shaft 140. In these aspects, distalmost face 162 of second cap portion 152B may be more distal than cap distal face 154 of first cap portion 152A. For example, a portion of planar wall 158 of second cap portion 152B may extend distally relative to distalmost edge 157 of cap distal face 154 of first cap portion 152A. Distalmost face 162 may be approximately 0.01 mm to 10.0 mm (e.g., 0.05 mm to 5 mm) distal of cap distal face 154. Distalmost face 162 of second cap portion 152B may include one or more illumination devices 110 (e.g., lights, LEDs, optical fibers, etc.) and / or one or more visualization devices 112 (e.g., cameras, imagers, etc.). In aspects, a visualization device 112 may be disposed between two illumination devices 110. Illumination device(s) 110 and visualization device(s) 112 may be disposed on other surfaces of second cap portion 152B, such as, for example, a side surface 164.

[0049] Second cap portion 152B may include a proximal extension 166 (FIG. 1C). Proximal extension 166 may provide support for second cap portion 152B. In some aspects, proximal extension 166 may be a strain relief, e.g., assisting to prevent breaking of second cap portion 152B from first cap portion 152A. Proximal extension 166 may extend proximally from a proximal face 155 of second cap portion 152B. Proximal extension 166 may be partially enclosed by the encapsulating material of first cap portion 152A. Proximal extension 166 may extend through firstcap portion 152A such that a proximal face of proximal extension 166 abuts distal face 153D of distal end portion 153. In other aspects, proximal extension 166 may extend proximally within just a portion of first cap portion 152A (e.g., proximally towards distal face 153D of distal end portion 153). In other aspects, proximal extension 166 of second cap portion 152B may extend alongside, or adjacent to, first cap portion 152A.

[0050] In some aspects, second cap portion 152B may terminate at proximal face 155. In these aspects, second cap portion 152B may not include proximal extension 166. Second cap portion 152B may resemble a half-cylinder (e.g., without proximal extension 166).

[0051] One or more edges of second cap portion 152B may include radii, rounded edges, and / or chamfers 168, for example, to provide for an atraumatic second cap portion 152B. In these aspects, a maximum width of distalmost face 162 may be smaller than a maximum width of proximal face 155 of second cap portion 152B. Chamfers 168 may be along just a portion of the one or more edges of second cap portion 152B or may be along an entirety of one or more edges of second cap portion 152B. First cap portion 152A may also include chamfers along one or more edges of second cap portion 152B. In other aspects, second cap portion 152B may be formed without chamfers 168. In these aspects, the maximum width of distalmost face 162 may be the same as or equal to the maximum width of proximal face 155 of second cap portion 152B.

[0052] A radially outer surface of cap assembly 152 may be rounded. For example, a radially outer surface of each of first cap portion 152A and second cap portion 152B may be rounded. In these aspects, a cross-section of cap assembly 152 (e.g., taken proximally of cap distal face 154) may be circular or elliptical. At the cross-section of cap assembly 152, the cross-sectional shape of each of first cap portion 152A or second cap portion 152B may resemble a half-circle, semi-circle, or full circle. For example, a cross-sectional shape of first cap portion 152A taken proximally of proximal face 155 of second cap portion 152B may resemble a full circle (e.g., when second cap portion 152B is without proximal extension 166) or a half circle (e.g., when second cap portion 152B includes proximal extension 166). Cap assembly 152 (e.g., first cap portion 152A and / or second cap portion 152B) may be fixed directly or indirectly to distal end portion 153 of shaft 140. For example, aproximal face of first cap portion 152A may be fixed to distal face 153D of distal end portion 153. In aspects, first cap portion 152A and / or second cap portion 152B may be fixed to distal end portion 153 via an adhesive, an epoxy, and / or mechanical fastener(s) (e.g., screw(s), crimp(s), anchor(s), etc.).

[0053] Distal face 153D may be treated, for example, to improve adhesion between cap assembly 152 (e.g., first cap portion 152A and / or second cap portion 152B) and distal end portion 153. For example, distal face 153D may include chemical etching, laser texturing, and / or other surface treatments (e.g., illustrated using stippling on distal face 153D of FIGs. 1 B, 1C). The chemical etching, laser texturing, and / or other surface treatment may extend to an external surface of distal end portion 153, for example. Additionally or alternatively, distal end portion 153 and / or cap assembly 152 may include one or more features to enable a snap-fit or a press / friction-fit between the components. For example, distal end portion 153 may include a projection and cap assembly 152 (e.g., first cap portion 152A and / or second cap portion 152B) may include an opening to receive the projection to secure the two components together, or vice versa. Other mechanical fasteners may be utilized, for example, to couple cap assembly 152 (e.g., first cap portion 152A and / or second cap portion 152B) with distal end portion 153 of shaft 140.

[0054] In aspects, second cap portion 152B may be formed as a subassembly, e.g., prior to assembling with first cap portion 152A or shaft 140. For example, second cap portion 152B may be separately or individually formed / molded from an encapsulated material (e.g., similar to first cap portion 152A). The encapsulated material may be formed / injected around illumination device(s) 110 and / or visualization device(s) 112. In other aspects, second cap portion 152B may be separately formed as a plastic or metal molded or machined component. For example, second cap portion 152B may be molded / machine and illumination device(s) 110 and / or visualization device(s) 112 may be assembled or potted within second cap portion 152B. Second cap portion 152B may be formed via other means commonly used in the art.

[0055] FIG. 2 illustrates an exploded view of an exemplary mold assembly 200, which may be used to form distal tip 150 of FIGs. 1 B, 1C. FIG. 3 is a flow chart of an exemplary method 300 to form distal tip 150. Mold assembly 200 may be comprised of a base 202 and a removable block 204. Base 202 may include one ormore features 206 (e.g., projection(s), notch(es), opening(s), etc.). Removable block 204 may include one or more corresponding features 208 (e.g., opening(s), notch(es), projection(s), etc.) to receive features 206 of base 202, or vice versa. Corresponding features 208 of removable block 204 may assist with aligning and securing removable block 204 to base 202. Feature(s) 206 of base 202 and corresponding feature(s) 208 of removable block 204 may be facilitate alignment and / or attachment of the two components. In aspects, features 206, 208 may facilitate a secured snap- or press-fit between base 202 and removable block 204.

[0056] Base 202 and removable block 204 may each be made of any suitable material. For example, base 202 and removable block 204 may each be formed from a low adhesion material, such as silicone. Other materials commonly used for molding components may be used to form base 202 and / or removable block 204.

[0057] Base 202 may include a channel 210 having an opening 212 on a side surface 202A of base 202. Channel 210 and opening 212 may be sized / shaped to receive the distal end portion 153 of shaft 140. In aspects, channel 210 may form a seal against a surface of distal end portion 153 of shaft 140. The seal between base 202 and distal end portion 153 may prevent a proximal flow of encapsulating material during the formation of first cap portion 152A, described below.

[0058] Base 202 may further include a cap cavity 214, which may be complementarily shaped to second cap portion 152B, shown in FIGs. 1 B, 1C. In aspects, cap cavity 214 may include features 216 (e.g., projections and / or protrusions) that align with illumination device(s) 110 and / or imaging device(s) 112. Features 216 may be sized / shaped similarly to illumination device(s) 110 and / or imaging device(s) 112. Features 216 may assist in preventing encapsulating material from covering or flowing over illumination device(s) 110 and / or imaging device(s) 112, e.g., during the injection of encapsulating material forming first cap portion 152A. Features 216 may be made from a same material as base 202 or from a different, softer material, for example, to mitigate damage to illumination device(s) 110 and / or imaging device(s) 112.

[0059] Base 202 may further include an angled wall 218. Angled wall 218 may be angled similarly to cap distal face 154 of first cap portion 152A. A plurality of lumens may extend through angled wall 218. For example, a first lumen 220 may extend through angled wall 218 and partially or entirely through base 202. Firstlumen 220 may align with lumen 116 of first cap portion 152A and with working channel 108 of shaft 140. In these aspects, first lumen 220 of base 202 may be sized and shaped according to a size / shape of working channel 108. Additional lumens 222 (e.g., a second lumen, a third lumen, etc.) may extend through angled wall 218 and partially or entirely through base 202. Additional lumens 222 may align with lumens 114 of first cap portion 152A and with corresponding lumens of shaft 140. In these aspects, lumens 222 may be sized and shaped according to a size / shape of lumens 114 of first cap portion 152A and the lumens of shaft 140.

[0060] In a first step 302, second cap portion 152B, including illumination device(s) 110 and imaging device(s) 112, may be positioned in a cap cavity 214 of base 202. For example, illumination device(s) 110 and imaging device(s) 112 may be positioned to align with features 216 of cap cavity 214.

[0061] In a next step 304, mandrels may be inserted into one or more lumens 220, 222 of base 202. The mandrels may each be a solid rod formed from one or more metals (e.g., stainless steel, cupro-nickel alloy, nickel, brass, etc.) In aspects, the mandrels may be coated with one or more non-stick materials (e.g., polytetrafluoroethylene, silicone, etc.). The non-stick materials may assist in preventing the encapsulating material from sticking to the mandrels.

[0062] In a next step 306, distal end portion 153 of shaft 140 may be positioned within channel 210 of base 202. With shaft 140 positioned within channel 210, the mandrels may extend proximally through lumens 220, 222 of base 202 and into respective lumens of shaft 140. For example, the mandrels may first be positioned within lumens 220, 222 of base 202 and then aligned with the respective lumens shaft 140 (e.g., when distal end portion 153 of shaft 140 is positioned within base 202). In other aspects, the mandrels may be positioned first within respective lumens of shaft 140 and then aligned with and inserted into respective lumens 220, 222 of base 202. The mandrels may assist with aligning and maintaining a position of shaft 140 within base 202. Channel 210 may include on or more markers 224, for example, to assist with aligning distal end portion 153 of shaft 140 within channel 210. The placement of distal end portion 153 of shaft 140 within channel 210 may control a length and / or volume of first cap portion 152A. For example, with distal end portion 153 positioned further away from cap cavity 214, the length and volume of first cap portion 152A may increase. Alternatively, with distal end portion 153positioned closer to cap cavity 214, the length and volume of first cap portion 152A may decrease.

[0063] With shaft 140 positioned within channel 210 of base 202 and second cap portion 152B positioned within cap cavity 214, in a next step 308, removable block 204 may be secured to base 202. A channel 226 of removable block 204 may receive at least a portion of shaft 140. For example, channel 226 of removable block 204 may be complementarily sized / shaped according to shaft 140. Together, channel 210 of base 202 and channel 226 of removable block 204 may surround an entirety of distal end portion 153 of shaft 140 and form a seal against a surface of shaft 140. For example, channel 210 and channel 226 may together form a tubular shape. The seal may assist in preventing encapsulating material of first cap portion 152A (e.g., during injection of the encapsulating material) from flowing to proximal portions of shaft 140.

[0064] With base 202 and removable block 204 secured together, encapsulating material may be injected into a space formed by second cap portion 152B (e.g., positioned within cavity 214), angled wall 218 of base 202, and distal face 153D of shaft 140 in a step 310. The encapsulating material may be injected via one or more openings 228 extending perpendicularly to channel 210 of base 202. In some aspects, a proximal portion of one or both of channels 210, 226 (e.g., a portion of one or both of channels 210, 226 that is farthest away from cavity 214 and angled wall 218) may be narrower than a distal portion of one or both of channel 210, 226). For example, one or both of channels 210, 226 may taper or include step-downs. In these aspects, when the encapsulating material is injected by the one or more openings 228, the encapsulating material may partially or entirely surround a portion of shaft 140. The encapsulating material may surround the mandrels and / or aspects of second cap portion 152B and shaft 140. The encapsulating material may flow around the components of distal tip 150, thus encapsulating the components.

[0065] Once the encapsulating material is cured / dried, the newly formed distal tip 150 may be removed from mold assembly 200 in a step 312. For example, removable block 204 may be removed from base 202. The molded distal tip resembling distal tip 150 shown in FIGs. 1 B, 1 C, may then be removed from base 202. The mandrels may then be removed from first cap portion 152A, thus forminglumens 114, 116 of first cap portion 152A (shown in FIGs. 1 B, 1C). Lumens 114, 116 of first cap portion 152A are aligned with respective lumens of shaft 140.

[0066] FIG. 4A illustrates a perspective view of an alternative distal tip 450 of a medical device 400. FIG. 4B illustrates a cross-sectional view of distal tip 450 (e.g., taken at a mid-plane of distal tip 450). Referring to FIGs. 4A and 4B, distal tip 450 may have any or all of the characteristics of distal tip 150, except as described below. For example, distal tip 450 may be fixed to a distal end portion 453 of a shaft 440. Shaft 440 and distal end portion 453 may have any or all of the same characteristics of shaft 140 and distal end portion 153, respectively. Aspects of distal tip 450 and / or distal end portion 453 may be controlled by a handle, such as handle 102 shown in FIG. 1A.

[0067] Distal tip 450 may further include a cap 452. Cap 452 may include a first lumen 470 (e.g., a working lumen). First lumen 470 may extend through cap 452, terminating at an opening 471 on a distal face 452D of cap 452. Cap 452 may include additional lumens 473 (e.g., lumens for delivering gasses or liquids via distal tip 450). Each lumen 473 may terminate at an opening 475 on distal face 452D.

[0068] At least a portion of distal face 452D of cap 452 may be angled relative to a plane extending perpendicular to a longitudinal axis of distal tip 450. For example, distal face 452D may be angled similarly to cap distal face 154 shown in FIGs. 1 B, 1 C. For example, a portion of distal face 452D at least partially comprising distal opening 471 of lumen 470 may be angled approximately 0.5 - 60 degrees (e.g., approximately 10 - 45 degrees) relative to the plane that is perpendicular to the longitudinal axis. The angle of distal face 452D may assist in providing an atraumatic surface, e.g., when distal face 452D is inserted into the subject.

[0069] A second portion of distal face 452D may be perpendicular relative to the longitudinal axis of distal tip 450 (e.g., parallel to the plane that is perpendicular to the longitudinal axis). The second portion of distal face 454D may comprise distal opening(s) 475 of lumen(s) 473. In some aspects, a portion of distal opening 471 of lumen 470 may be disposed on the second portion of distal face 454D.

[0070] Distal face 452D of cap 452 may include illumination device(s) 410 and / or imaging device(s) 412. Illumination device(s) 410 and / or imaging device(s) 412 may be disposed on the second portion of distal face 452D. Illumination device(s) 410 and / or imaging device(s) 412 may have any or all of the characteristicsof illumination device(s) 410 and / or imaging device(s) 412 shown in FIGs. 1 B, 1C. Cabling or wiring associated with illumination device(s) 410 and / or imaging device(s) 412 may extend proximally through a lumen 472 of cap 452. Lumen 472 may extend through an entirety of cap 452. (Illumination device(s) 410 are not shown in FIG. 4B, for example, due to the cross-sectional view of distal tip 450.)

[0071] Referring to FIG. 4B, distal tip 450 may further include an encapsulated portion 454. Encapsulated portion 454 may be between a distal face 453D of distal end portion 453 of shaft 440 and a proximal face 452P of cap 452. Encapsulated portion 454 may include a lumen 474. Lumen 474 may extend through an entirety of encapsulated portion 454. Lumen 474 may be aligned with a working channel 408 of shaft 440. Lumen 474 of encapsulated portion 454 may permit fluid communication between working channel 408 and lumen 470 of cap 452. Accordingly, each lumen 470, 474 may be aligned with working channel 408 of shaft 440. For example, each lumen 470, 474 may be similarly sized / shaped as compared to an inner diameter of working channel 408. Although not shown, cap 452 and encapsulated portion 454 may include additional lumens aligned with and in fluid communication with additional lumens extending through shaft 440.

[0072] Cabling or wiring 476 (or other electronic components) associated with illumination device(s) 410 and / or imaging device(s) 412 may extend proximally through encapsulated portion 454. For example, a discrete length of cabling or wiring 476 may be embedded within the encapsulating material forming encapsulated portion 454. Encapsulating material forming encapsulated portion 454 may be injected and surround the electronic components (e.g., cabling or wiring 476, circuit boards, etc.) associated with illumination device(s) 410 and / or imaging device(s) 412.

[0073] In aspects, cap 452 may include a proximal extension 478. Proximal extension 478 may overlap at least partially with shaft 440 and encapsulated portion 454. For example, shaft 440 may include a distal extension 479, which may overlap with proximal extension 478 and encapsulated portion 454. In aspects, a proximalmost face 478P of proximal extension 478 may abut a first edge 480 of shaft 440, and a distalmost edge 482 of distal extension 479 of shaft 440 may abut a distal edge 478D of cap 452. Accordingly, proximal extension 478 of cap 452 and distal extension 479 of shaft 440 may at least partially overlap. Proximal extension 478 anddistal extension 479 may enable cap 452 to be assembled such that a distance between shaft 440 and cap 452 is consistent and reproducible. With the distance between shaft 440 and cap 452 consistent, a length of encapsulated portion 454 may be consistent and reproducible. In these aspects, a volume of the encapsulating material comprising encapsulated portion 454 may be consistent and reproducible.

[0074] Distal tip 450 may further include a collar 484 surrounding at least a portion of an outer perimeter / surface of distal end portion 453. For example, collar 484 may extend over at least a portion of an outer surface of distal end portion 453 of shaft 440, encapsulated portion 454, and cap 452. In some aspects, one or more steering components (e.g., similar to pull wire(s) 118 of FIG. 1 B and 1 B) may be laser welded or otherwise fixed to an internal surface of collar 484. Collar 484 may include an opening 486 for injecting the encapsulating material, e.g., to form encapsulated portion 454. In aspects, collar 484 may be glued to shaft 440 and / or cap 452. Additionally or alternatively, collar 484 may be swaged or otherwise deformed to fix collar 484 to shaft 440 and cap 452.

[0075] To form distal tip 450, cap 452 may be joined with shaft 140 (e.g., via proximal extension 478 and distal extension 479). An adhesive or epoxy may be used between the joining surfaces of proximal extension 478 and distal extension 479. Collar 484 may surround and be fixed to a distal portion of shaft 140 and a proximal portion of cap 452. One or more mandrels (not shown) may be inserted through the lumen(s) of cap 452 (e.g., lumen 470 of cap 452 and / or other lumens of cap 452, not shown). The mandrel(s) may extend through corresponding lumen(s) of shaft 440. For example, a mandrel extending through lumen 470 of cap 452 may extend through working channel 408 of shaft 440. With the mandrels in place, the encapsulating material may be injected into opening 486 of collar 484. The encapsulating material of encapsulated portion 454 may surround the mandrels and any components between distal face 453D of shaft 440 and a proximal face 452 P of cap 452. The encapsulating material may have any or all of the characteristics of the encapsulating material described above, with respect to FIGs. 1 B, 1C.

[0076] The encapsulating material may be cured or dried, thus forming encapsulating portion 454. Once the encapsulating material is cured / dried, the mandrels may be removed from the lumens of shaft 440 and cap 452. With the mandrels removed, a lumen is formed within the encapsulated material that permitsfluid flow between working channel 408 of shaft 440 and lumen 470 of cap 452. Similar lumens may be formed for other lumens within the encapsulating material (e.g., similar to fluid delivery lumens 114 shown in FIGs. 1 B and 1C). The encapsulating material may assist in coupling or fixing cap 452 to distal end portion 453 of shaft 440. Distal face 453D of shaft 440 and / or the proximal face of cap 452 may be chemically treated or etched, for example, to improve adhesion between the encapsulating material and respective surfaces of shaft 440 and cap 452. The chemical etching, laser texturing and / or other surface treatment may extend to an external surface of distal end portion 453.

[0077] FIG. 5 illustrates an alternative distal tip 550 of a medical device 500. Distal tip 550 may have any or all of the characteristics of distal tip 150, except as described below. For example, distal tip 550 may be fixed (e.g., directly or indirectly) to a distal end portion 553 of a shaft 540. Shaft 540 and distal end portion 553 may have any or all of the same characteristics of shaft 140 and distal end portion 153, respectively. Aspects of distal tip 550 and / or distal end portion 553 may be controlled by a handle, such as handle 102 shown in FIG. 1A.

[0078] Distal tip 550 may include an encapsulation 552 and an electronics module 590 at least partially disposed within encapsulation 552. In aspects, encapsulation 552 may resemble cap assembly 152 (FIGs. 1 B and 1C) formed as a single, encapsulated (e.g., overmolded) portion. For example, encapsulation 552 may have any or all of the external surfaces and / or contours as cap assembly 152 (e.g., first cap portion 152A and second cap portion 152B). Encapsulation 552 may include an angled face 554 that terminates proximally of distalmost face 562. Angled face 554 may be angled approximately 0.5 - 60 degrees (e.g., approximately 10 - 45 degrees) relative to a plane extending perpendicular to the longitudinal axis of distal tip 550 (e.g., the plane may be parallel to distal face 553D). Distalmost face 562 may be perpendicular to the longitudinal axis of distal tip 550. Distalmost face 562 may be distal of a distalmost edge 554E of angled face 554, thus forming a planar wall 558 extending between a distalmost edge of angled face 554 and an edge 562E defining distalmost face 562.

[0079] In some aspects, encapsulation 552 may include chamfers 568 along one or more edges of encapsulation 552. Chamfers 568 may be formed such that distalmost edge 554E of angled face 554 is longer than edge 562E formed betweenplanar wall 558 and distalmost face 562. In other aspects, encapsulation may not include chamfers 568 such that distalmost edge 554E of angled face 554 is the same length as edge 562E formed between planar wall 558 and distalmost face 562.

[0080] Electronics module 590 may include one or more illumination device(s) 510 and / or imaging device(s) 512 (having any of the properties of illumination device(s) and imaging device(s) 112). Illumination device(s) 510 and / or imaging device(s) 512 may be disposed on distalmost face 562 of encapsulation 552. A distal face of each of Illumination device(s) 510 and / or imaging device(s) 512 of electronics module 590 may be free from the encapsulating material comprising encapsulation 552. In other aspects, the encapsulating material comprising encapsulation 552 may at least partially cover illumination device(s) 510.

[0081] Similar to first cap portion 152A, described above, encapsulation 552 may be formed using a low-pressure thermoplastic molding process using a viscous version / grade of polyamide (e.g., nylon) or other low temperature low viscosity thermoplastic, thermoset, or an ultraviolet light cured adhesive (e.g., Dymax 203A- CTH-F Multi-Cure or similar). Encapsulation 552 may be formed using other materials and / or be doped with other materials to assist with dissipating or insulating heat from electronics module 590 (e.g., from illumination device(s) 510 and / or imaging device(s) 512).

[0082] The encapsulating material comprising encapsulation 552 may surround and at least partially embed components of distal tip 550. For example, the encapsulating material may surround and at least partially embed electronics module 590 and any associated cabling of electronics module 590, one or more steering components (e.g., pull wire(s) 518 and / or respective crimp(s) 520), and / or other components disposed in distal tip 550. Encapsulation 552 may include one or more lumens such as one or more fluid delivery lumens 514 and / or working channel lumens 516. Each lumen 514, 516 may extend longitudinally through encapsulation 552 and be in fluid connection with a respective lumen of shaft 540. A distal opening corresponding to each lumen 514, 516 may be disposed on angled face 554. Each lumen 514, 516 may have any or all of the characteristics described above with respect to fluid delivery lumen(s) 114 and / or working channel lumen(s) 116.

[0083] Encapsulation 552 may be fixed (e.g., directly or indirectly) to distal end portion 553 of shaft 540. Shaft 540 may have any or all of the characteristics of shaft140, discussed above. In aspects, a distalmost face 553D may include chemical etching, laser texturing, and / or other surface treatments (e.g., illustrated using stippling on distal face 553D of FIG. 5). The surface treatment may not be limited to distalmost face 553D and, in some aspects, may extend along an external surface of distal end portion 553.

[0084] Distal tip 550 may be formed similarly to distal tip 150, described above. For example, mold assembly 200 may be used to form distal tip 550. In using mold assembly 200 to manufacture distal tip 550, electronics module 590 may first be loaded into cavity 214. Illumination device(s) 510 and imaging device(s) 512 of electronics module 590 may be aligned with features 216 of base 202. Features 216 may assist in preventing the encapsulating material from covering or flowing over illumination device(s) 510 and / or imaging device(s) 512, e.g., during the injection of encapsulating material to form encapsulation 552.

[0085] Mandrels may be inserted into one or more lumens 220, 222 of base 202. Shaft 540 may then be positioned within channel 210 of base 202. With shaft 540 positioned within channel 210, the mandrels may extend proximally through lumens 220, 222 of base 202 and into respective lumens of shaft 540. Removable block 204 may then be secured to base 202. Channel 226 of removable block 204 may receive at least a portion of shaft 540. Together, channel 210 of base 202 and channel 226 of removable block 204 may surround an entirety of distal end portion 553 of shaft 540 and form a seal against a surface of shaft 540.

[0086] With base 202 and removable block 204 secured together, encapsulating material may be injected into a space formed by electronics module 590, mold assembly 200, and distalmost face 553D of distal end portion 553. The encapsulating material may surround electronics module 590, thus at least partially embedding electronics module 590 within the encapsulating material of encapsulation 552. The encapsulating material may be injected and allowed to harden so that it fills crevices or other spaces within distal tip 550 and / or around electronics module 590. For example, the encapsulating material may flow around the mandrels and around any additional components (e.g., pull wire(s) 518, crimp(s) 520, and / or other steering or electrical components) extending distally past distalmost face 553D.

[0087] Once the encapsulating material forming encapsulation 552 has cured or dried, the formed distal tip (e.g., resembling distal tip 550 of FIG. 5) may be removed from mold assembly 200 and the mandrels removed. The mandrels may form fluid delivery lumen(s) 514 and / or working channel lumen(s) 516 within encapsulation 552. Lumens 514, 516 may be continuous with corresponding lumens of shaft 540.

[0088] Use of the techniques described herein may produce patient-insertable portions of medical devices which may be manufactured efficiently according to cost- effective methods. The encapsulation process described herein may allow for omission of manufacturing steps that require assembly of disparate components. Instead, the encapsulation process may serve to produce one integral member which need not be combined with other elements prior to attachment to a medical device such as an endoscope. Moreover, the resulting patient-insertable distal tip (e.g., distal tip 150, 450, 550) may be sealed against water, bodily fluids, and other liquids or fluids, as well as other potential contaminants. The techniques described herein may also permit further miniaturization of components of patient-insertable portions of medical devices and / or patient-insertable portions as a whole. For example, by embedding components within an encapsulating material, further miniaturization of such components may be accomplished because those components no longer need to be manufactured as separate components which must be separately integrated.

[0089] While principles of the present disclosure are described herein with reference to illustrative examples for particular applications, it should be understood that the disclosure is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, and substitution of equivalents all fall within the scope of the examples described herein. Accordingly, the invention is not to be considered as limited by the foregoing description.

Claims

CLAIMSWe claim:1 . A medical device, comprising: a control portion; a shaft extending distally from the control portion and having a working channel extending through the shaft; and a distal end portion fixed to a distal end of the shaft, wherein the distal end portion includes: an encapsulated portion having a lumen extending through the encapsulated portion; and a cap portion, wherein a distalmost face of the cap portion is distal to a distalmost face of the encapsulated portion, wherein the working channel of the shaft and the lumen of the encapsulated portion are aligned and in fluid communication with each other.

2. The medical device of claim 1 , wherein the shaft includes a pull wire extending through the shaft, wherein the encapsulated portion encapsulates a distal end of the pull wire.

3. The medical device of claim 1 or claim 2, wherein at least a portion of the encapsulated portion is adjacent to the cap portion.

4. The medical device of any one of claims 1-3, wherein the distalmost face of the encapsulated portion has a non-zero angle relative to a plane extending perpendicularly to a longitudinal axis of the shaft.

5. The medical device of claim 4, wherein the distalmost face of the cap portion is parallel to the plane extending perpendicularly to the longitudinal axis of the shaft.

6. The medical device of any one of claims 1-5, wherein an illuminating device and an imaging device are disposed on the distalmost face of the cap portion.

7. The medical device of any one of claims 1-6, wherein the cap portion includes at least one chamfered edge.

8. The medical device of any one of claims 1-7, wherein the lumen of the encapsulated portion is a first lumen, wherein the shaft further includes a second lumen and a third lumen, and wherein the encapsulated portion includes at least a fourth lumen and a fifth lumen in fluid communication with the second lumen and the third lumen of the shaft, respectively.

9. The medical device of any one of claims 1-8, wherein the cap portion includes a proximal extension, wherein a proximalmost end of the proximal extension abuts a distal face of the shaft.

10. The medical device of any one of claims 1 -9, wherein a distal face of the shaft includes a surface treatment or chemical etching.11 . The medical device of claim 6, wherein the cap portion includes a planar wall having a cutout, wherein the planar wall extends distally relative to a distalmost edge of the encapsulated portion.

12. The medical device of claim 11 , wherein a side surface of the imaging device is exposed via the cutout.

13. The medical device of claim 11 , wherein the cutout includes a material forming the encapsulated portion.

14. The medical device of any one of claims 1-13, wherein the encapsulated portion is comprised of one or more radiopaque materials.

15. The medical device of any one of claims 1-14, wherein a ring at least partially surrounds an outer surface of the distal end portion.

Images