Distal end comprising encapsulated components of a medical device

Abstract

To provide a distal portion of an endoscope which is manufactured by an efficient technique and satisfies requirements for using the endoscope in a subject.SOLUTION: The distal end portion of the medical device can include an image capture component; a light source; and an enclosure having an inner surface contacting and at least partially surrounding the image capture component and the sight source. The shape of the inner surface may be a mirror image of the shape of the outer surface of the image capture component and sight source that the inner surface contacts.SELECTED DRAWING: Figure 3B

Description

[Technical Field]

[0001] The present disclosure relates generally to devices, systems, and methods for encapsulated components of medical devices. More specifically, aspects of the present disclosure relate to devices, systems, and / or methods for encapsulated distal portions of endoscopes. [Background technology]

[0002] An endoscope may include a handle portion that an operator can grasp and may also include controls for functions such as steering, suction, water, air, light, and imaging. An endoscope may also include a portion that can be inserted into a subject. For example, an endoscope may include a long tube suitable for insertion into a subject. Such an insertion portion may include one or more lumens. The lumens in the insertion portion of an endoscope may support functions such as transmitting air, water, suction, electricity, data, light, and / or images. Instruments may also be inserted through a working channel in the insertion portion of an endoscope. For example, instruments may be inserted through a port in or near the handle of the endoscope.

[0003] The insertion section of an endoscope can terminate in a distal section. The distal section of an endoscope can include an outlet for air, water, suction, electricity, data, light, images, and / or working tools from the endoscope lumen. The distal section can have tight manufacturing tolerances. However, because the distal section of an endoscope can include multiple components, achieving these manufacturing tolerances can be difficult, especially at small sizes. Therefore, there is a need for a distal section of an endoscope that is manufactured with efficient techniques and meets the requirements for using the endoscope in a subject. Summary of the Invention

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

[0005] The distal end of the medical device can include an image capture component, a light source, and an enclosure having an inner surface that contacts and at least partially surrounds the image capture component and the light source, and the shape of the inner surface can be a mirror image of the shape of the outer surfaces of the image capture component and the light source that it contacts.

[0006] Any example of the distal end described herein may additionally or alternatively include one or more of the following features: The enclosure may form a liquid-tight shell. The enclosure may include at least one of a lens, a prism, an aperture, a filter, a diffuser, a light-dispersing feature, a mirror, a window, a grating, or a light-collimating feature, or a combination thereof. The enclosure may include at least one of a post, a wedge, a cam, a pin, a notch, a piston, a cylinder, a gear, a rack, a pulley, a socket, or a sheave, or a combination thereof. The distal end may include a circuit board. The inner surface of the enclosure may contact and at least partially surround the circuit board. The shape of the inner surface may be a mirror image of the shape of the outer surface of the circuit board. The inner surface of the enclosure may contact at least a side surface of the image capture component. The inner surface of the enclosure may contact at least a top surface and at least a side surface of the light source. The enclosure may fill all of the space between the image capture component and the light source. The inner surface of the enclosure can contact at least the bottom surface of the circuit board. The distal end can include a layer configured to change opacity or reflectivity when a current or voltage is applied to the layer. The enclosure can be formed of a molded monolithic material. The distal end can include a cap portion. The inner surface of the enclosure can contact at least a side surface of the image capture component. The inner surface of the enclosure can contact at least a top surface and at least a side surface of the light source. The enclosure can fill all of the space between the image capture component and the light source. The outer surface of the enclosure can contact an inner surface of the cap portion. The enclosure can include at least one of a ridge and a flange. The ridge or flange can be shaped to mate with the cap portion. The distal outer surface of the enclosure can have a rounded shape. The distal outer surface of the enclosure can contact an inner surface of the cap portion. The distal end can include a connector. The shape of the outer surface of the connection portion may be a mirror image of the shape of the inner surface of the receptacle disposed at the distal end of the medical device. The enclosure may be transparent. The enclosure may be formed of an electrically insulating material.

[0007] In another example, a method for forming a distal end of a medical device can include placing an image capture component and a light source in a cavity of a mold and introducing an encapsulant material into the cavity. The introduced encapsulant material can encompass at least a portion of the image capture component and a portion of the light source. The encapsulant material can be allowed to harden.

[0008] Any method described herein may include one or more of the following features or steps: The cavity may include an inverse of at least one of a lens, a prism, an aperture, a filter, a diffuser, a light-dispersing feature, a mirror, a window, a grating, or a light-collimating feature, or a combination thereof; The cavity may include an inverse of at least one of a post, a wedge, a cam, a pin, a notch, a piston, a cylinder, a gear, a rack, a pulley, a socket, or a sheave, or a combination thereof; A circuit board may be disposed within the cavity; The introduced material may encompass at least a portion of the circuit board; The cavity may include an inverse of at least one of a ridge and a flange, the ridge or flange being shaped to mate with the cap portion;

[0009] In yet another example, a medical device can include a proximal control portion, a distal insert portion, and a distal end portion. The distal end portion can include a component and an enclosure. The enclosure can have an inner surface that contacts and at least partially surrounds the component. The shape of the inner surface can be a mirror image of the shape of the outer surface of the component that it contacts.

[0010] Any medical device may additionally or alternatively include one or more of the features described below. The enclosure may form a liquid-tight shell. The enclosure may include at least one of a lens, a prism, an aperture, a filter, a diffuser, a light-dispersing feature, a mirror, a window, a grating, or a light-collimating feature, or a combination thereof. The enclosure may include at least one of a post, a wedge, a cam, a pin, a notch, a piston, a cylinder, a gear, a rack, a pulley, a socket, or a sheave, or a combination thereof. The distal end may further include a cap portion. The inner surface of the enclosure may contact at least the top and at least the side of the component. The outer surface of the enclosure may contact the inner surface of the cap portion.

[0011] It is to 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," "including," or any other variant thereof, are intended to include a non-exclusive inclusion. That is, a process, method, article, or apparatus that includes a list of elements does not include only those elements, but may include elements not expressly listed as well as other elements inherent in such process, method, article, or apparatus. The term "exemplary" is used in the sense of "example" rather than "ideal." [Brief explanation of the drawings]

[0012] 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. [Figure 1] 1 shows an exemplary encapsulated distal portion of a medical device. [Figure 2] 1 shows a cross section of an exemplary mold for an encapsulated distal portion of a medical device. [Figure 3A] 1 illustrates an exemplary enclosed distal portion of an endoscope. [Figure 3B] 1 illustrates an exemplary enclosed distal portion of an endoscope. [Figure 4]1 illustrates an exemplary enclosed distal portion of an endoscope. [Figure 5] 1 illustrates an exemplary endoscope. DETAILED DESCRIPTION OF THE INVENTION

[0013] Detailed Description The distal end of an endoscope can include various electronic and other components and can be connected to the distal insert of the endoscope. Because the distal end can be inserted into a patient's body lumen, these distal ends must be sterilizable. These distal ends can also be subject to stringent manufacturing requirements. This disclosure describes, for example, distal ends encapsulated with materials that meet the sterilization requirements of the distal end and facilitate manufacturing. Such encapsulated ends can prevent the ingress of fluids and other contaminants that could damage the endoscope or other device components (including the electronic components of such devices). Distal ends according to the disclosure herein can also aid in miniaturization by enabling the integration of functional components, such as optical and mechanical functions, into the encapsulation. While endoscopes are referenced herein, endoscopy or endoscopy should not be construed as limiting the possible applications of the disclosed systems. Other applications include, for example, any medical or non-medical device requiring the encapsulation of components, particularly small electrical components. Such medical devices include, for example, colonoscopes, ureteroscopes, bronchoscopes, catheters, sheaths, imagers, and the like.

[0014] FIG. 1 illustrates an exemplary distal portion 10 of a medical device. The distal portion 10 can be used, for example, as the distal portion of an endoscopic device. For example, the distal portion 10 can be a distal end portion disposed at the distal end of an elongated insertion section of an endoscope. The distal portion 10 can include, for example, one or more electronic components 12. The one or more electronic components 12 can be part of an electronic module 14. The electronic module 14 can include multiple electronic components 12. The multiple electronic components 12 can be fixed together to form a single electronic module 14, or some of the electronic components 12 can be separate, individual components.

[0015] The electronic component 12 may include an image capture component, such as a camera 16. The camera 16 may include, for example, one or more lenses 18, as well as an imager 20 and / or other imager-related circuitry. The camera 16 may also include other components, such as an aperture, a prism, etc. The lens 18 may help focus or otherwise manipulate light received from a location of interest (e.g., within a subject's body lumen). The imager 20 may include electronic components that receive and / or process light received from the location of interest. The camera 16 may be an integrated module. Alternatively, the camera 16 may include multiple separate components. The camera 16 may be capable of capturing still and / or video images. Instead of using a camera 16, the distal portion 10 may include one or more lenses and / or light guides that serve to transmit images from the location of interest to the proximal end of the endoscope (e.g., the handle).

[0016] The electronic component 12 of the module 14 may also include one or more light sources, such as light-emitting diodes (LEDs) 22. The term LED may be used herein for convenience, but it will be understood that any other light source (e.g., fiber optics, laser, or other mechanism) may be used. The electronic component 12 may also include circuitry 24 for operating the LEDs 22. The electronic component 12 may also include, for example, sensors capable of sensing electromagnetic frequencies other than visible light. The electronic component 12 may also include mapping electronics, including, for example, radio frequency (RF) sensors, accelerometers, and / or ultrasound sensors. The electronic component 12 may also include elements capable of generating and using RF energy for therapeutic procedures.

[0017] The electronic components 12 of the module 14 may further include circuitry 26 operable to control one or more electronic components 12, such as the camera 16 and / or the LEDs 22. The circuitry 26 may include one or more circuit boards 28. The circuit boards 28 may be printed circuit boards or may be flexible, rigid, or semi-rigid circuit boards. Portions of the circuitry 26 may be connected to other electronic components mounted on the distal portion 10 or to components within the proximal control end (e.g., handle or controller) of the endoscope, e.g., via leads or wires. For example, wires 30 may provide connections between the electronic components 12, including the circuit boards 28, camera 16, and / or LEDs 22, of the distal portion 10 and components at the proximal end (e.g., handle) of the endoscope. The wires 30 may be carried via conduits 32, which may be tubular, for example. The camera 16 and / or LEDs 22 may be mounted on the circuit boards 28.

[0018] Some or all of the electronic components 12, as well as other components, of the module 14 may be provided within an encapsulant 40. The encapsulant 40 may be formed of any suitable material. For example, the encapsulant 40 may be made of a rigid or flexible material. The encapsulant 40 may be made of, for example, a plastic material and / or an epoxy. For example, the encapsulant 40 may be made of a medical-grade, two-part, optically transparent material (e.g., Loctite® M-31CL or equivalent). Such materials may insulate heat-generating electronic components. Materials such as epoxy may be doped to dissipate or transfer heat. For example, a fine powder material with high thermal conductivity (e.g., copper) may be blended into the material. Such a fine powder material may be blended so that it remains suspended within the epoxy or other material that forms the encapsulant 40. Alternatively, the encapsulant 40 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, thermosetting resin, or UV-curable adhesive (e.g., Dymax 203A-CTH-F Multi-Cure). The encapsulant 40 may be made from rigid epoxies as well as flexible silicones. The encapsulant 40 may be formed to dissipate heat or insulate, depending on design considerations related to the use, the heat-generating characteristics of the subcomponents, and / or the recommended operating temperature limits of the electronic component 12.

[0019] The encapsulant 40 can be made from a seamless or integral structure and can include one or more materials. For example, the encapsulant 40 can be molded (see, e.g., the description of FIG. 2 below). The encapsulant 40 can be, for example, an overmolded item. The encapsulant 40 can be formed from one monolithic material. Alternatively, the encapsulant 40 can be formed from multiple materials, which can be mixed together, applied in layers, applied to different portions of the distal tip 10, or otherwise applied. Even when multiple materials are used, the encapsulant 40 can be seamless, with no gaps between different layers of material, or can be seamless in that gaps remain but the materials combine to form a cohesive structure. Gaps in the encapsulant 40 should not prevent the encapsulant 40 from having a seamless structure that forms a cohesive unit or structure. The gaps can be filled with, for example, air or other fluids and / or other components, such as the electronic component 12.

[0020] The encapsulation body 40 can form a mechanically and electrically insulating shell and can be formed to include a wide variety of functional features, including mechanical and / or optical features, as discussed in more detail below. The encapsulation body 40 can surround the electronic component 12, as discussed in more detail below. For example, the encapsulation body 40 can surround all exposed surfaces of the electronic component 12. The interior surfaces of the encapsulation body 40 can be a mirror image of the exposed exterior surfaces of the electronic component 12. For example, with reference to the camera 16, the encapsulation body 40 can surround and / or surround all surfaces or a subset of surfaces (e.g., sides) of the camera 16 and LEDs 22 that are not attached to other components, such as the circuit board 28. The encapsulation body 40 can also secure the electronic component 12 or other components of the distal end 10 in place by fully embedding those components in the encapsulation body 40 and securing them while embedded in the encapsulation body 40. For example, the encapsulant 40 can be cured so that it fills all gaps or other spaces between the electronic component 12 or other components at the distal end 10. The encapsulant 40 can be formed so that there are no spaces between the electronic component 12 and the encapsulant 40. The encapsulant 40 can be immovably abutted against a surface of the electronic component 12, such as the camera 16 and / or the LEDs 22. For example, the encapsulant 40 can be immovably abutted against the top and / or side of the electronic component 12, such as the camera 16 and / or the LEDs 22. There may or may not be other elements, such as adhesive, between the encapsulant 40 and the surface of the electronic component 12, such as the camera 16 and / or the LEDs 22, against which it abuts. The inner surface of the encapsulant 40 can contact and at least partially surround the electronic component 12, such as the camera 16 and / or the LEDs 22. For example, the inner surface of the encapsulant 40 can be shaped to be a mirror image of the shape of the outer surface of the electronic component 12 that contacts the inner surface of the encapsulant 40.

[0021] The enclosure 40 may be formed from a transparent or translucent material to allow the passage of light to or from the electronic components 12 of the distal portion 10, such as the camera 16 and / or the LEDs 22. Alternatively, portions of the enclosure 40 that surround and / or surround the electronic components 12, such as the camera 16 and / or the LEDs 22, may be formed from a transparent or translucent material, while other portions of the enclosure 40 may be formed from an opaque or partially opaque material.

[0022] All or a portion of the distal portion 10 may be housed within a cap portion (such as cap portion 440 as described below with respect to FIG. 5). For example, the cap portion may cover at least the distal portion and sides of the distal portion 10. The outer surface of the enclosure 40 may contact the inner surface of the cap portion. For example, the outer surface of the enclosure 40 may have a shape that is a mirror image of the inner surface of the cap portion. The cap portion may be made of, for example, plastic. The cap portion may facilitate attachment of the distal portion 10 to an elongated insertion portion of an endoscope. The cap portion may be glued or otherwise secured to the distal portion 10. A portion of the enclosure 40 and / or other components of the distal portion 10 may form a connector 42, which may be used to connect the distal portion 10 to another portion of an endoscope, such as the distal insertion portion of the endoscope. For example, the distal end of a medical device, such as an endoscope, may include a receptacle for receiving the connector 42. For example, the inner surface of such a receptacle may be a mirror image of the outer surface of the connector 42. For example, distal portion 10 or a cap portion on distal portion 10 may be press-fit onto the shaft of an endoscope (such as shaft 430 shown in FIG. 5). Distal portion 10 may be secured to the distal insertion portion of the endoscope by adhesive, tape, an overmolding, a sleeve, or any other securing mechanism, including a mechanical lock. Connection portion 42 may have a smaller cross-section than the distal portion of distal portion 10.

[0023] The cap portion may also include housings for features such as elevators, working channels, and outlets for air, water, and / or suction. The enclosure 40 may be formed to mate with the cap portion. For example, a curved end 46 of the enclosure 40 may mate with a corresponding feature on the cap portion, and the curved end 46 may help align, position, and / or connect the distal portion 10 with the cap portion or another component. The enclosure 40 may also include, for example, a straight edge 44, which may mate with a complementary feature on the cap portion, and may help align, position, and / or connect the distal portion 10 with the cap portion or another component. The enclosure 40 may also include features such as ridges 48 that may further mate with the cap portion to aid in aligning, positioning, and / or connecting the distal portion 10 with a cap portion or another component, or may allow for a press or slip fit with the cap portion or another portion of the endoscope or other device to which the distal portion 10 is connected.

[0024] FIG. 2 shows a cross section of the distal portion 10 of the endoscope through a portion of a mold 100 that can be used to encapsulate an electronic component module 14, including electronic components 12 and / or other components, in an encapsulant 40. The mold 100 can be made of any suitable material. For example, the mold 100 can be formed from a low-adhesion material such as silicone. To achieve encapsulation, the module 14 and / or other components (such as electronic components 12 not coupled to the module 14) can be placed in the mold 100. The mold 100 can include indicators (not shown) to aid in the placement of the module 14 within the mold 100 prior to encapsulation. The module 14 can be placed in a first half (e.g., a lower half) of the mold 100. A second half (e.g., an upper half) of the mold 100 can then be placed in place and secured together, for example, by snap-fitting onto the first half using protrusions 102 on the mold 100, or via any suitable mechanical connection. For example, a first half of mold 100 may include protrusions 102, and a second half of mold 100 may include mirror image recesses (not shown) into which protrusions 102 may snap fit. Alternatively, module 14 and / or other components (such as electronic components 12 not coupled to module 14) may be placed in any other type of mold for the purpose of forming encapsulant 40.

[0025] Mold 100 may include a cavity 104 formed with an inverse topography of the desired encapsulant 40. Thus, encapsulant material is provided to mold 100, and upon hardening, encapsulant 40 is formed. Mold 100 may also include one or more channels 106. Channels 106 may be used to inject encapsulant material into cavity 104. Alternatively, any suitable method may be used to introduce encapsulant material into cavity 104.

[0026] The cavity 104 can be shaped to form mechanical features in the enclosure 40. For example, the mechanical features of the enclosure 40 can aid in assembling the distal tip 10 with other portions of the endoscope. For example, the enclosure 40 can include one or more flange portions 112, 114. The flange portions 112, 114 can aid in aligning, positioning, and / or connecting the distal tip 10 with the distal end of the insert section of the endoscope. The mechanical features of the enclosure 40 can also include, for example, snap fits or other assembly-aiding features. Such features of the enclosure 40 can be used to aid in positioning the distal tip 10 in a cap or attaching the distal tip 10 to the elongated insert section of the endoscope. For example, the mechanical features of the enclosure 40 can include pins, notches, holes, grooves, and / or other features, such as pistons and / or cylinders, gears, racks, pulleys, sockets, and / or sheaves, or combinations thereof. The mechanical features of the enclosure 40 may also include features such as posts, wedges, and / or cams. For example, the enclosure 40 may include curved ends 46, straight edges 40, and / or ridges 48, as described above. The enclosure 40 may also include flanges 112, 114, as described below with respect to FIG. 3A.

[0027] The encapsulant 40 may also include a camera cover 116 and / or an LED cover 118, which may cover the top of the camera 16 and / or the LED 22, respectively. Alternatively, the encapsulant 40 may lack the camera cover 116 and / or the LED cover 118. Without such covers 116, 118, portions of the camera 16 and the LED 22 may be exposed and protrude outside the encapsulant 40. For example, the encapsulant 40 may be formed without the covers 116, 118. The cavity 104 of the mold 100 may lack structure for forming the covers 116, 118. Alternatively, portions of the encapsulant 40 may be removed after molding the encapsulant 40 in the mold 100. For example, portions of the encapsulant 40 near optical components such as the camera 16 and / or the LED 22 may be removed after molding the encapsulant 40.

[0028] Mold 100 can be formed to tightly surround conduit 32. For example, conduit 32 can be snap-fit ​​into mold 100, and the encapsulant material may not flow around conduit 32, or only a thin layer of encapsulant material may be provided around conduit 32. Alternatively, conduit 32 may also be contained within enclosure 40.

[0029] The distal portion 10 may also include, for example, a working channel, an end effector, an elevator, a suction port, or other features known or that may become known in the distal portion of an endoscope. Such features may be formed from other components, such as the enclosure 40 and / or a cap portion. If other components are used, they may be attached to the distal portion 10 after forming the enclosure 40, or may be placed in the mold 100 and integrated into the enclosure 40 before forming the enclosure 40. The distal portion 10 may also be formed to include a solenoid for delivery and / or dispensing of other media, such as drugs or contrast media. The distal portion 10 and / or the cavity 104 of the mold 100 may also include sites for securing mechanical villi to the distal portion 10. Such mechanical villi may be used, for example, to steer or move one or more autonomous disposable devices through a liquid medium or cavity. When such villi are used, the distal portion 10 may be used as part of an autonomous device rather than an endoscope steerable by a physician or other user.

[0030] The enclosure 40 can prevent water, bodily fluids, other liquids, or solid or gaseous substances from entering crevices or other portions of the distal portion 10. For example, the enclosure 40 can protect the electronic components 12 from liquid damage by being watertight, fluidtight, and / or liquidtight. The enclosure 40 can also aid in sterilization of the distal portion 10 by limiting the number of crevices from which contaminants may be more difficult to remove. Additionally or alternatively, the cost-effectiveness of manufacturing the distal portion 10, as well as other qualities of the distal portion 10, can make it particularly suitable for incorporation into sterilizable, biocompatible, disposable devices, which reduces clinical risks and the costs of disinfection and resterilization. The distal portion 10 can be used in conjunction with an endoscope or other device to perform a wide variety of medical procedures, including, for example, biopsy, ablation, ultrasound, device placement, or other diagnostic or therapeutic procedures.

[0031] A method for constructing the distal end 10 may include placing or otherwise positioning or locating the electronic component 12 (which may form the module 14) within a mold 100. The mold 100 may be injected with an encapsulant material made from, for example, plastic or epoxy, or other materials described above with respect to the encapsulant 40, such as UV-curable adhesives, thermoplastics, and / or thermosetting resins. Instead of injection molding, any other encapsulation method may be used to encapsulate the electronic component 12 with the encapsulant material. For example, the encapsulant material may be extruded to form the encapsulant 40. The electronic component 12 may be surrounded by the encapsulant 40. After the encapsulant material is introduced using the mold 10 or other mechanism, the encapsulant material may be cured or otherwise hardened. The encapsulated distal end 10 may then be removed from the mold 100. The encapsulation may be performed in multiple stages. For example, multiple molds may be used, or multiple layers of encapsulant material may be otherwise applied. As another example, different materials may be used in different portions of encapsulant 40, or the materials may be mixed before, during, or after application to electronic component 12.

[0032] Use of the techniques described herein can reduce the number of parts, the complexity of part assembly, and / or the cost of materials and manufacturing techniques. For example, molding the encapsulant 40 can be done efficiently in large quantities, whereas performing separate machining operations of other techniques can be less efficient. The techniques described herein can maintain equivalent functional performance of the distal tip 10 compared to devices manufactured by other techniques.

[0033] 3A-3B show cross-sectional views of a distal tip 200 that can be used as the distal tip of an endoscope. The distal tip 200 can have any of the characteristics of the distal tip 10 described above. The distal tip 200 can be formed by a mold 100, for example, according to the method described above with respect to FIG. 2. The distal tip 200 can include electronic components 12, such as, for example, one or more lenses and / or a camera 16 and / or one or more LEDs 22, as well as other electronic components 12 described above. The camera 16, the LEDs 22, and / or other electronic components 12 (which can form the electronic module 14) can be encapsulated in an encapsulant 40, which can be formed from any suitable encapsulant material, such as those described above with respect to FIGS. 1-2.

[0034] The enclosure 40 can be formed with physical features that make the distal tip 200 compatible with a particular application. For example, a mold such as mold 100 can be formed with a cavity 104 that includes indentations that are the opposite of the desired physical features of the distal tip 200. Alternatively, such physical features can be formed by removing material from the enclosure 40 after molding is complete. For example, the enclosure 40 can be formed so that the distal tip 200 can be used with a distal portion of an endoscope. The distal tip 200, including the enclosure material 40, can have an elongated shape relative to the longitudinal axis of the distal tip 200. The longitudinal axis of the distal tip 200 can be coaxial or parallel to the longitudinal axis of the endoscope with which the distal tip 200 is used. The distal tip 200 can also have features that provide a liquid-tight, fluid-tight, and / or water-tight fit with devices, such as endoscopes, that do not allow water or other fluids to pass through. For example, the enclosure 40 can be liquid-tight and / or water-tight, and / or the distal tip 200 can be sealed to an endoscope. A portion of the distal tip 200, such as the flanges 112 and 114, can aid in positioning and / or securing the distal tip 200 to a device such as an endoscope and can help establish a seal between the distal tip 200 and the endoscope. Alternatively, the flanges 112 or 114 can help attach a cap portion to the distal tip 200, as described above. As a further example, the distal tip 200 can include a rounded distal portion 202, which can have atraumatic features and / or can be shaped to mate with a complementary cap portion.

[0035] The encapsulation body 40 may also include an optical feature 204, such as a lens. Similar to the physical features of the distal end 200 formed from the encapsulation body 40, the optical feature 204 may be formed in a mold 100 having a cavity 104 that includes the inverse contours of the optical feature 204. Additionally or alternatively, the optical feature 204 may be formed by a technique applied to the encapsulation body 40 after molding and / or curing of the encapsulation body 40. For example, a portion of the encapsulation body 40 may be removed by mechanical or chemical methods. The curved shape of the optical feature 204 shown in FIGS. 3A and 3B is merely exemplary. The optical feature 204 may have a shape that includes any number of flats, convex surfaces, concave surfaces, or facets.

[0036] Although the term lens may be used herein to describe exemplary optical features 204, any light conditioning structure or other optical structure may be used. For example, optical feature 204 may be a prism, e.g., splitting light into components of different polarizations. Optical feature 204 may also be any other refractive structure or a reflective structure, such as a mirror. It will be understood that the above examples are not intended to limit the types of optical features 204 that may be used.

[0037] The optical features 204 may be formed from the same encapsulant material that forms the remainder of the encapsulant 40. Alternatively, the optical features 204 may be formed from a different encapsulant material than the material that forms the remainder of the encapsulant 40. The optical features 204 may also be formed by doping portions of the encapsulant 40 with other materials before or after molding and / or curing of the encapsulant 40. If a different material is used for the optical features 204, it may not be necessary to modify the mold 100 to form the optical features 204. The optical features 204 may not be distinct in shape from the remainder of the distal portion 200. Alternatively, if a different material is used for the optical features 204, the optical features may also have a special shape formed by the mold 100 during the molding process or by a technique applied after molding.

[0038] The optical feature 204 may have focusing and / or diffusing properties. As shown in FIG. 3A , the optical feature 204 may function to affect light entering the camera 16 and received by a processing component, such as the imager 20. The optical feature 204 may also be an aperture, a filter, a diffuser, a light-dispersing feature, a mirror, a window, or a grating, or a combination thereof. The camera 16 may include additional lenses or other light-conditioning features in addition to the optical feature 204. Additionally or alternatively, as shown in FIG. 3B , the optical feature 204 may function to condition or otherwise affect light emitted by the LED 22 or another structure. Additionally or alternatively, the optical feature 204 may function as a light-collimating feature and / or a light-dispersing feature. For example, the optical feature 204 may function to make light rays emitted by the LED 22 (or another light source) parallel or substantially parallel to each other. Alternatively, the optical feature 204 may function to expand or disperse the light beam emitted by the LED 22 (or another light source).

[0039] FIG. 4 shows a cross-sectional view of an exemplary distal tip 300. The distal tip 300 may include any of the features of the distal tips 10 and / or 200 described above. The distal tip 300 may also include a refractive feature 210. The refractive feature 210 may be embedded in the encapsulant 40. For example, the inner surface of the encapsulant 40 may contact the outer surface of the refractive feature 210. The inner surface of the encapsulant may be a mirror image of the outer surface of the refractive feature 210. The refractive feature 210 may be a separate element or may be part of the encapsulant 40. For example, the refractive feature 210 may be a doped portion of the encapsulant 40. Alternatively, the refractive feature 210 may be a separate component that may be positioned in its desired location prior to forming the encapsulant 40 from the mold 100 or prior to forming the encapsulant 40 using any other known technique. As a further alternative, the refractive feature 210 may be positioned in its desired location during a second application of encapsulant material. For example, an encapsulant material can be used to form a first layer of encapsulant 40. Refractive features 210 can then be disposed on the first layer. Subsequently, additional encapsulant material can be applied, for example, via a second mold, dipping, extrusion, or any other suitable technique.

[0040] The refractive feature 210 can be connected to an electrical current / voltage (e.g., via wires 30, circuitry 26, and / or circuit board 28). The refractive feature 210 can operate to change properties upon application of an electrical current or via another activation mechanism. For example, the refractive feature 210 can change its opacity and / or reflectivity level. A change to the refractive feature 210 (e.g., via an electrical current) can result in a change in the refraction of light. For example, the refractive feature 210 can be disposed over the LED 22 to cause refraction of light emitted from the LED 22. Additionally or alternatively, the refractive feature 210 can be disposed over the camera 16 to cause reflection of light reaching components of the camera 16 (e.g., including the imager 20).

[0041] FIG. 5 illustrates an exemplary endoscope 400 having a proximal control section 402, a distal insert section 404, and a distal tip section 406. The distal tip section 406 may have any of the qualities of the distal tip sections 10, 200, or 300 described above with respect to FIGS. 1-4. The endoscope 400 may be connected to a controller 408 via an umbilicus 410. The proximal control section 402 may include a handle 420. The handle 420 may have one or more control mechanisms 422. The control mechanisms 422 may provide control over steering the insert section 404 or allow for the delivery of air, water, suction, etc. The distal insert section 404 may include a shaft 430. The shaft 430 may have a lumen 432. The distal tip section 406 may include an enclosure 40 (not shown) and any of the other features described above with respect to FIGS. 1-4. The distal tip section 406 may also include a cap portion 440. The distal end 406 may be fixedly or removably attached to a portion of the distal insert 404 , such as the shaft 430 .

[0042] The techniques described herein can be used to create patient insert portions of medical devices that can be efficiently manufactured according to cost-effective methods. The encapsulation methods described herein can enable the elimination of manufacturing steps that require the assembly of disparate components. Instead, the encapsulation methods can function to create a single, integrated member that does not need to be combined with other elements before being attached to a medical device, such as an endoscope. Furthermore, the resulting patient insert portion can be sealed against water, bodily fluids, and other liquids or fluids, as well as other potential contaminants. The techniques described herein can also enable further miniaturization of the patient insert portion of a medical device and / or the components of the patient insert portion as a whole. For example, by integrating mechanical features (e.g., flanges 112, 114), optical features (e.g., optical feature 204 and / or refractive feature 210) into the encapsulation body 40, further miniaturization can be achieved by eliminating the need to manufacture these components as separate components that require separate integration.

[0043] While the principles of the present disclosure have been described herein with reference to illustrative examples of particular applications, it should be understood that the disclosure is not limited thereto. Those skilled in the art and with access to the teachings provided herein will recognize that additional modifications, adaptations, and substitutions of equivalents are all within the scope of the examples described herein. Accordingly, the present invention should not be deemed limited by the foregoing description.

Claims

1. A distal end of a medical device, comprising: Image capture component; light source; an enclosure having an inner surface in contact with and at least partially surrounding the image capture component and the light source; and a cap portion covering at least a distal portion and a side portion of the distal end portion; a distal end including:

2. The distal tip of claim 1 , wherein the shape of the inner surface is a mirror image of the shape of the outer surfaces of the image capture component and the light source that it contacts.

3. The distal end of claim 1 , wherein the enclosure includes a straight edge configured to assist in aligning, locating, or connecting the distal end with the cap portion.

4. The distal end of claim 3 , wherein the straight edge is on an opposite side of the enclosure from the side having the image capture component and the light source.

5. The distal end of any one of claims 1 to 4, wherein the enclosure includes a curved end configured to assist in aligning, positioning, or connecting the distal end with the cap portion.

6. The distal end of any one of claims 1 to 4, wherein the enclosure includes at least one of a ridge and a flange, the ridge or flange being shaped to mate with the cap portion.

7. The distal end of claim 1 , wherein a distal outer surface of the enclosure contacts one or more inner surfaces of the cap portion.

8. The distal tip of claim 7 , wherein the distal outer surface of the enclosure has a shape that is a mirror image of the one or more inner surfaces of the cap portion.

9. The distal tip of claim 7 or 8, wherein the distal outer surface of the enclosure has a rounded shape.

10. The distal end of claim 1 , further comprising a connecting portion, the shape of the outer surface of the connecting portion being a mirror image of the shape of the inner surface of a receptacle of the shaft of the medical device.

11. The distal end of claim 10 , wherein a portion of the enclosure having the inner surface has a larger cross section than a distal portion of the connecting portion.

12. The distal end of claim 1 , further comprising a circuit board, the inner surface of the enclosure contacting and at least partially surrounding the circuit board.

13. the inner surface of the enclosure contacts at least a side of the image capture component; the inner surface of the enclosure contacts at least a top surface and a side surface of the light source; the enclosure fills all of the space between the image capture component and the light source; and The distal end of claim 12 , wherein the inner surface of the enclosure contacts at least a bottom surface of the circuit board.

14. The distal tip of any one of claims 1-4, 7, 8 and 10-13, further comprising a layer configured to change opacity or reflectivity when a current or voltage is applied to the layer.

15. The distal tip of any one of claims 1 to 4, 7, 8 and 10 to 13, wherein the enclosure is formed from a molded monolithic material.

16. The distal end of claim 12 or 13, wherein the shape of the inner surface is a mirror image of the shape of the outer surface of the circuit board.

Images