Packaging assemblies for medical devices, and methods thereof

Abstract

A distal end portion of a medical device may include: an image capture component; a light source; and a package having an inner surface contacting and at least partially surrounding the image capture assembly and the light source. The shape of the inner surface is a mirror image of the shape of the outer surfaces of the image capture assembly and the light source contacted by the inner surface.

Description

This case is a divisional application of invention patent application number 201980042287.5 Cross-references to related literature

[0001] This application claims priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 62 / 691,045, filed on June 28, 2018, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0002] The present invention generally relates to apparatus, systems and methods for packaging assemblies of medical devices. More specifically, aspects of the present invention relate to apparatus, systems and / or methods for packaging distal portions of endoscopes. Background Art

[0003] The endoscope may include a handle portion that can be grasped by an operator and may include control elements for functions such as steering, suction, water, air, light, and imaging. The endoscope may also include a portion that can be inserted into the body. For example, the endoscope may include an elongated tube suitable for insertion into the body. Such an insertion portion may include more than one cavity. The cavity of the insertable portion of the endoscope may support functions such as the delivery of air, water, suction, electricity, data, light, and / or images. Tools may also be inserted through the working channel of the insertable portion of the endoscope. For example, tools may be inserted through a port in or near the handle of the endoscope.

[0004] The insertable portion of the endoscope may terminate at a distal portion. The distal portion of the endoscope may include an outlet for outputting air, water, suction, electricity, data, light, images, and / or working tools from the lumen of the endoscope. The distal portion may have narrow manufacturing tolerances. However, since the distal portion of the endoscope may include multiple components, these manufacturing tolerances may be difficult to achieve, especially in small sizes. Therefore, there is a need to manufacture the distal portion of the endoscope with an efficient technology and meet the requirements of using the endoscope in the main body. Summary of the invention

[0005] Examples of the present disclosure relate to, among other things, devices, systems, and methods for package assemblies of medical devices, including package distal portions of endoscopes.Each of the examples disclosed herein may include one or more features associated with the disclosed examples.

[0006] The distal portion of the medical device may include: an image capture assembly; a light source; and an enclosure having an inner surface that contacts and at least partially surrounds the image capture assembly and the light source. The shape of the inner surface is a mirror image of the shape of the outer surface of the image capture assembly and the light source contacted by the inner surface.

[0007] Any examples of the distal portion described herein may additionally or alternatively include one or more of the following features. The package forms a liquid-tight shell. The package includes at least one of a lens, a prism, an aperture, a filter, a diffuser, a light-scattering feature, a mirror, a window, a grating, or a collimated light feature, or a combination thereof. The package includes at least one of a fulcrum, a wedge, a cam, a pin, a groove, a piston, a cylinder, a gear, a rack, a pulley, a sleeve, or a pulley assembly, or a combination thereof. The distal portion may include a circuit board. The inner surface of the package may contact and at least partially contain the circuit board. The shape of the inner surface is a mirror image of the shape of the outer surface of the circuit board. The inner surface of the package contacts at least one side surface of the image capture component. The inner surface of the package contacts at least one top surface and at least one side surface of the light source. The package may fill the entire space between the image capture component and the light source. The inner surface of the package may contact at least one bottom surface of the circuit board. The distal portion may include a layer configured to change opacity or reflectivity when an electric current is applied to the layer. The package may be formed of a molded, unitary material. The distal portion may include a cover portion. An inner surface of the package may contact at least one side of the image capture assembly. The inner surface of the package may contact at least one top surface and at least one side of the light source. The package fills the entire space between the image capture assembly and the light source. An outer surface of the package contacts the inner surface of the cover portion. The package includes at least one of a ridge and a flange. The shape of the ridge or the flange is set to match the cover portion. The distal outer surface of the package is circular. The distal outer surface of the package contacts the inner surface of the cover portion. The distal portion may include a connecting portion. The shape of the outer surface of the connecting portion is a mirror image of the shape of the inner surface of the socket provided on the distal portion of the medical device. The package is transparent. The package is formed of an electrically insulating material.

[0008] In another example, a method for forming a distal portion of a medical device may include positioning an image capture assembly and a light source in a cavity of a mold and introducing a packaging material into the cavity. The introduced packaging material may include at least a portion of the image capture assembly and a portion of the light source. The packaging material may be allowed to harden.

[0009] Any of the methods described herein may include one or more of the features or steps described below. The cavity may include an inverted image of at least one of a lens, a prism, an aperture, a filter, a diffuser, a scattered light feature, a mirror, a window, a grating, or a collimated light feature, or a combination thereof. The cavity may include an inverted image of at least one of a fulcrum, a wedge, a cam, a pin, a groove, a piston, a cylinder, a gear, a rack, a pulley, a sleeve, or a pulley block, or a combination thereof. The circuit board may be positioned in the cavity. The introduced material may surround at least a portion of the circuit board. The cavity may include an inverted image of at least one of a ridge and a flange, wherein the shape of the ridge or flange is set to match the cover portion.

[0010] In another example, a medical device may include a proximal control portion; a distal insertion portion; and a distal portion. The distal portion may include a component and an enclosure. The enclosure may have an inner surface that contacts and at least partially surrounds the component. The shape of the inner surface may be a mirror image of the shape of an outer surface of the component contacted by the inner surface.

[0011] Any medical device may additionally or alternatively include one or more of the features described below. The package may form a liquid-tight shell. The package includes at least one of a lens, a prism, an aperture, a filter, a diffuser, a light-scattering feature, a mirror, a window, a grating, or a collimated light feature, or a combination thereof. The package includes at least one of a fulcrum, a wedge, a cam, a pin, a groove, a piston, a cylinder, a gear, a rack, a pulley, a sleeve, or a pulley block, or a combination thereof. The distal portion may also include a cover. The inner surface of the package may contact at least one top surface and at least one side surface of the component. The outer surface of the package may contact the inner surface of the cover portion.

[0012] It is understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the claimed invention. As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to the process, method, article, or apparatus. The term "exemplary" is used in the sense of "example" rather than "ideal." BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate examples of the invention and, together with the description, serve to explain the principles of the invention.

[0014] Figure 1 An exemplary package distal portion of a medical device is depicted.

[0015] Figure 2 Depicted is a cross section of an exemplary mold for a distal portion of a package for a medical device.

[0016] Figure 3A , 3B and 4 depict an exemplary package distal portion of an endoscope.

[0017] Figure 5 An exemplary endoscope is depicted. DETAILED DESCRIPTION

[0018] The distal portion of the endoscope may include various electronic and other components and may be connected to the distal insertion portion of the endoscope. Since the distal portion may be inserted into the patient's body cavity, these distal portions must be sterilizable. These distal portions may also be subject to strict manufacturing requirements. For example, the present invention describes a distal portion that is packaged with a material that meets both sterilization requirements and facilitates the manufacture of the distal portion. The end of this package can prevent the entry of liquids or other contaminants that may damage the components of the endoscope or other equipment, including the electronic components of this equipment. According to the distal portion disclosed herein, miniaturization can also be facilitated by allowing functional components such as optical and mechanical features to be integrated into the package. Although endoscopes are mentioned herein, mentioning endoscopes or endoscopes should not be interpreted as limiting the possible applications of the disclosed system. Other applications include, for example, any medical or non-medical device that requires package components, especially small-scale electrical components. Such medical devices include, for example, colonoscopes, ureteroscopes, bronchoscopes, catheters, sheaths, imagers, etc.

[0019] Figure 1 An exemplary distal portion 10 of a medical device is described. For example, the distal portion 10 can be a distal portion of an endoscopic device. For example, the distal portion 10 can be a distal portion positioned at the distal end of an elongated insertable portion of an endoscope. The distal portion 10 can include, for example, one or more electronic components 12. One or more electronic components 12 can be part of an electronic module 14. The electronic module 14 can include many electronic components 12. The electronic components 12 can be fixed together to form an electronic module 14, or some of the electronic components 12 can be independent individual components.

[0020] The electronic assembly 12 may include, for example, an image capture assembly, 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 circuits. The camera 16 may also include other components, such as an aperture, a prism, etc. The lens 18 may be used to focus or otherwise process light received from a location of interest (e.g., in a body cavity of a subject). The imager 20 may include an electronic assembly that receives and / or processes light received from a location of interest. The camera 16 may be an integrated module. In an alternative embodiment, the camera 16 may include many separate components. The camera 16 may be capable of capturing still images and / or videos. In an alternative to using the camera 16, the distal portion 10 may include one or more lenses and / or light guides that are used to transmit images from the location of interest to the proximal end (e.g., a handle) of the endoscope.

[0021] The electronic assembly 12 of the module 14 may also include one or more light sources, such as a light emitting diode (LED) 22. Although the term LED may be used herein for convenience, it will be understood that any other light source (e.g., optical fiber, laser, or other mechanism) may be used. The electronic assembly 12 may also include a circuit 24 for operating the LED 22. The electronic component 12 may also include, for example, a sensor capable of sensing electromagnetic frequencies other than visible light. The electronic assembly 12 may also include, for example, drawing electronic components including a radio frequency (RF) sensor, an accelerometer, and / or an ultrasound sensor. The electronic component 12 may also include components capable of generating and using RF energy for a treatment process.

[0022] The electronic assembly 12 of the module 14 may further include a circuit 26 that is operable to control one or more electronic assemblies 12, such as a camera 16 and / or an LED 22. The circuit 26 may include one or more circuit boards 28. The circuit board 28 may be a printed circuit board, and may be a flexible, rigid, or semi-rigid circuit board. Portions of the circuit 26 may be connected to other electronic assemblies carried in the distal portion 10 or components in the proximal control end (e.g., a handle or controller) of the endoscope, such as leads or wires. For example, a wire 30 may provide a connection between the electronic assembly 12 (including the circuit board 28, the camera 16, and / or the LED 22) in the distal portion 10 and components in the proximal end (e.g., a handle) of the endoscope. The wire 30 may be carried through a catheter 32, which may be, for example, tubular. The camera 16 and / or the LED 22 may be mounted on the circuit board 28.

[0023] The electronic components 12 of the module 14 and part or all of other components can be provided in the package 40. The package 40 can be made of any suitable material. For example, the package 40 can be made of a rigid material or a flexible material. The package 40 can be made of, for example, a plastic material and / or an epoxy resin. For example, the package 40 can be made of a medical grade 2-part optically transparent material (e.g., Loctite M-31CL or equivalent). This material can insulate the heat-generating electronic devices. In order to dissipate heat or conduct heat, materials such as epoxy resins can be incorporated. For example, a fine powdered material (e.g., copper) with high thermal conductivity can be incorporated into the material. This fine powdered material can be mixed so that it remains suspended in the epoxy resin or other material forming the package 40. In an alternative solution, the package 40 can be formed using a low-pressure thermoplastic molding process of a viscous version / grade of polyamide (e.g., nylon) or other low-temperature, low-viscosity thermoplastics, thermosetting plastics, or ultraviolet light-curing adhesives (e.g., Dymax 203A-CTH-F multi-curing). Encapsulation 40 may be made of rigid epoxy resin as well as flexible silicone. Encapsulation 40 may be formed to dissipate heat or provide insulation based on design considerations related to use, subassembly heat generation characteristics, and / or recommended operating temperature limits of electronic assembly 12.

[0024] The package 40 may be made of a continuous or unitary structure, which may include one or more materials. For example, the package 40 may be formed (e.g., see below). Figure 2 ). The package 40 may be, for example, overmolded. The package 40 may be formed from a single unitary material. In alternative embodiments, the package 40 may be formed from multiple materials that may be mixed together, applied in layers, applied to different portions of the distal tip 10, or applied in other ways. Even where multiple materials are used, the package 40 may be continuous and may have no gaps between different layers of material, or may be continuous and, even where gaps are present, the materials may be joined to form a polymeric structure. Gaps in the package 40 may not prevent it from having a continuous structure in which the package 40 forms a polymeric unit or structure. The gaps may be filled with, for example, air or other fluids and / or other components, such as the electronic components 12.

[0025] The package 40 can form an electromechanical insulating shell and can be formed to include a variety of functional features, including mechanical and / or optical features, which will be discussed in further detail below. As discussed in further detail below, the package 40 can include the electronic component 12. For example, the package 40 can surround all exposed surfaces of the electronic component 12. The inner surface of the package 40 can be a mirror image of the exposed outer surface of the electronic component 12. For example, with reference to the camera 16, the package 40 can surround and surround all surfaces or a portion of the surfaces (e.g., side surfaces) of the camera 16 and LED 22 that are not connected to other components such as the circuit board 28. The package 40 can also fix the electronic component 12 or other components of the distal end 10 in place and embed it in the package 40 by completely embedding the electronic component 12 or other components of the distal end 10. For example, the package 40 can be hardened to fill all gaps or other spaces between the electronic component 12 or other components of the distal end 10. The package 40 can be formed so that there is no space between the electronic component 12 and the package 40. The package 40 can be fixedly attached to the surface of the electronic component 12, such as the camera 16 and / or the LED 22. For example, the package 40 can be fixedly adjacent to the top surface and / or side surface of the electronic component 12 (such as the camera 16 and / or the LED 22). There may or may not be other elements, such as adhesives, between the package 40 and the adjacent surface of the electronic component 12, such as the camera 16 and / or the LED 22. The inner surface of the package 40 can contact and at least partially surround the electronic component 12, such as the camera 16 and / or the LED 22. For example, the shape of the inner surface of the package 40 can be set to be a mirror image of the shape of the outer surface of the electronic component 12 that contacts the inner surface of the package 40.

[0026] The enclosure 40 may be formed of a transparent or translucent material to allow light to pass to or from the electronic components 12 of the distal portion 10 (such as the camera 16 and / or the LED 22). In an alternative embodiment, the portion of the enclosure 40 that surrounds and / or surrounds the electronic components 12 such as the camera 16 and / or the LED 22 may be formed of a transparent or translucent material, while other portions of the enclosure 40 may be formed of an opaque or partially opaque material.

[0027] All or part of the distal portion 10 may be housed in a cover portion (e.g., cover portion 440, as described below with respect to Figure 5The cover portion may be formed by gluing or otherwise attaching the distal portion 10 to the distal portion 10. Portions of the package 40 and / or other components of the distal portion 10 may form a connecting portion 42 that may be used to connect the distal portion 10 to other portions of the endoscope, such as the distal insertable portion of the endoscope. For example, the distal end of a medical device such as an endoscope may include a socket for receiving the connecting portion 42. For example, the inner surface of such a socket may be a mirror image of the outer surface of the connecting portion 42. For example, the distal portion 10 or a cover portion on the distal portion 10 may be press-fitted into the shaft of the endoscope (such as Figure 5 The distal portion 10 may be fixed to the distal insertable portion of the endoscope by glue, tape, overmolding, sleeves or any other fixing mechanism including mechanical locking. The connecting portion 42 may have a smaller cross-section than the distal portion of the distal portion 10.

[0028] The cover portion may also include a housing for features such as an elevator, a working channel, and outlets for air, water, and / or suction. Encapsulation 40 may be formed to cooperate with the cover portion. For example, the curved end 46 of encapsulation 40 may cooperate with the corresponding features on the cover portion, and the curved end 46 may help to align, position, and / or connect the distal portion 10 with the cover portion or another component. Encapsulation 40 may also include, for example, a straight edge portion 44, which may cooperate with the complementary features on the cover portion, and may help to align, position, and / or connect the distal portion 10 with the cover portion or another component. Encapsulation 40 may also include features such as a ridge 48, which may further match the cover portion or allow a press fit or a slide fit with the cover portion or another part of other equipment connected to the distal portion 10 with the other part of the endoscope or the distal portion 10, to help the distal portion 10 with the cover portion or another component, to align, position, and / or connect.

[0029] Figure 2A cross section of the distal portion 10 of the endoscope is depicted in a portion of a forming mold 100 that can be used to encapsulate an electronic component module 14 that includes an electronic component 12, and / or other components with an encapsulation 40. The forming mold 100 can be made of any suitable material. For example, the forming mold 100 can be formed of a low-viscosity material such as silicone. To obtain the encapsulation, the module 14 and / or other components (such as the electronic component 12 that is not connected to the module 14) can be placed in the forming mold 100. The forming mold 100 can include an indicator (not shown) to help place the module 14 in the mold 100 before encapsulation. The module 14 can be placed in a first half (e.g., the lower half) of the forming mold 100. The second half (e.g., the upper half) of the forming mold 100 can then be placed in place and can be snap-fitted with the first half using, for example, a protrusion 102 in the forming mold 100, or otherwise fixed together by any suitable mechanical connection. For example, the first half of the forming die 100 may include a protrusion 102, and the second half of the forming die 100 may include a mirrored recess (not shown) into which the protrusion 102 may snap fit. In alternative solutions, the module 14 and / or other components (e.g., the electronic components 12 not connected in the module 14) may be placed in any other type of mold to achieve the purpose of forming the package 40.

[0030] The forming mold 100 may include a cavity 104 formed as an inverted version of the desired package 40. Thus, when a package material is provided in the forming mold 100 and the package material is hardened, the package 40 will be formed. The forming mold 100 may also include one or more channels 106. The channels 106 may be used to inject the package material into the cavity 104. In an alternative solution, any suitable method may be used to introduce the package material into the cavity 104.

[0031] Cavity 104 can be formed to form mechanical features in package 40. For example, the mechanical features of package 40 can help to assemble distal end 10 with other parts of the endoscope. For example, package 40 can include one or more flange portions 112, 114. Flange portions 112, 114 can help to align, position and / or connect distal end 10 with the distal end of the insertable portion of the endoscope. Mechanical features of package 40 can also include, for example, snap fit or other assembly auxiliary features. Such features of package 40 can be used to help place distal end 10 into a cover or attach distal end 10 to an elongated insertion portion of an endoscope. For example, mechanical features of package 40 can include pins, grooves, holes, grooves and / or other features, such as pistons and / or cylinders, gears, racks, pulleys, sleeves, and / or pulley blocks, or combinations thereof. Mechanical features of package 40 can also include features such as fulcrums, wedges and / or cams. For example, the enclosure 40 may include curved ends 46, straight edge portions 40, and / or ridges 48, as described above. The enclosure 40 may also include flanges 112, 114, as described below with respect to Figure 3A As discussed.

[0032] The package 40 may also include a camera cover 116 and / or an LED cover 118, which may cover the top portion of the camera 16 and / or the LED 22, respectively. In an alternative embodiment, the package 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 outside the package 40. For example, the package 40 may be formed without the covers 116, 118. The cavity 104 of the molding die 100 may not have a structure forming the covers 116, 118. In an alternative embodiment, portions of the package 40 may be removed after the package 40 is formed in the molding die 100. For example, after molding of the package 40, optical components, such as portions of the package 40 near the camera 16 and / or the LED 22, may be removed.

[0033] The forming die 100 may be formed to tightly surround the conduit 32. For example, the conduit 32 may be snap-fitted into the forming die 100, and the potting material may not flow around the conduit 32, or only a thin layer of potting material may be provided around the conduit 32. In an alternative solution, the conduit 32 may also be contained inside the potting member 40.

[0034] The distal portion 10 may also include, for example, a working channel, an end effector, an elevator, a suction port, or other known or potentially known features of the distal portion of an endoscope. Such features may be formed by the package 40 and / or other components, such as a cover portion. In the case of using other components, it may be attached to the distal portion 10 after the package 40 is formed, or it may be placed in the mold 100 before the package 40 is formed so that it is integrated into the package 40. The distal portion 10 may also be formed to include a solenoid for delivering and / or dispensing a drug formulation or other medium (e.g., a contrast agent). The distal portion 10 and / or the cavity 104 of the mold 100 may also include a portion for attaching mechanical hair to the distal portion 10. For example, such mechanical hair can be used to turn or move one or more autonomous disposable devices through a liquid medium or cavity. In the case of using such hair, the distal portion 10 can be used as part of an autonomous device rather than being used with an endoscope manipulated by a doctor or other user.

[0035] The package 40 can prevent water, body fluids, other liquids or solid or gaseous materials from entering the gaps or other parts of the distal portion 10. For example, the package 40 can protect the electronic components 12 from damage caused by liquids by water tightness, fluid tightness and / or liquid tightness. The package 40 can also help the sterilization of the distal portion 10 by limiting the number of gaps where contaminants may be more difficult to remove. In addition or in an alternative solution, the cost-effectiveness of producing the distal portion 10, as well as other characteristics of the distal portion 10, can make it particularly suitable for incorporation into sterilizable, biocompatible, disposable devices, which can reduce clinical risks and the cost of disinfection and re-sterilization. The distal portion 10 can be used with an endoscope or other equipment to perform various medical procedures, including, for example, biopsy, ablation, ultrasound, placement of equipment or other diagnostic or therapeutic procedures.

[0036] The method of constructing the distal end 10 may include placing or otherwise positioning or placing the electronic component 12 (which may form a module 14) in a molding die 100. The molding die 100 may be injected with an encapsulation material made of, for example, plastic or epoxy resin or any other material described above with respect to the encapsulation 40, such as an ultraviolet light-cured adhesive, a thermoplastic and / or a thermosetting material. In an alternative to injection molding, any other encapsulation method may be used to encapsulate the electronic component 12 with the encapsulation material. For example, the encapsulation material may be extruded to form the encapsulation 40. The electronic component 12 may be surrounded by the encapsulation 40. After the encapsulation material is introduced by using the molding die 10 or other mechanism, the encapsulation material may be allowed to solidify or otherwise harden. Subsequently, the encapsulated distal end portion 10 may be removed from the molding die 100. Encapsulation may occur in multiple stages. For example, multiple molds may be used, or multilayer encapsulation materials may be applied in other ways. As another example, different materials may be used in different parts of the encapsulation 40, or materials may be mixed before, during, or after being applied to the electronic component 12.

[0037] Using the techniques described herein can reduce the number of parts, the complexity of assembling parts, and / or the cost of materials and manufacturing techniques. For example, the molding of the package 40 can be completed efficiently in large quantities, while the discrete processing operations of other processes may be performed at a lower efficiency. Compared with devices manufactured by other technologies, the techniques described herein can maintain the equivalent functional performance of the distal end 10.

[0038] Figure 3A-3B 1 shows a cross-sectional view of a distal end 200 that can be used as a distal end of an endoscope. The distal end 200 can have any of the characteristics of the distal end 10 discussed above. The distal end 200 can be formed from the mold 100 according to, for example, the above description of Figure 2 The distal end 200 may include, for example, electronic components 12, such as one or more lenses and / or cameras 16 and / or one or more LEDs 22, as well as other electronic components 12 described above. The camera 16, LED 22 and / or other electronic components 12 (which may form the electronic module 14) may be encapsulated in an encapsulation 40, which may be formed of any suitable encapsulation material, such as the above-mentioned Figure 1-2 The materials discussed.

[0039] The package 40 can be formed to make the distal end 200 compatible with a particular application. For example, a mold such as mold 100 can form a cavity 104 having an inverted image of the desired physical features of the distal end 200. In an alternative solution, such physical features can be formed by removing material from the package 40 after molding is completed. For example, the package 40 can be formed so that the distal end 200 can be used with the distal portion of an endoscope. The distal end 200 including the package material 40 can have an elongated shape relative to the longitudinal axis of the distal end 200. The longitudinal axis of the distal end 200 can be coaxial or parallel to the longitudinal axis of the endoscope used in conjunction with the distal end 200. The distal end 200 can also have a feature that provides liquid tightness, fluid tightness, and / or water tightness with a device such as an endoscope, which does not allow water or other fluids to enter or flow out. For example, the package 40 can be liquid tight and / or water tight and / or the distal end 200 can be sealed to the endoscope. A portion of the distal end 200, such as the flange 112 or 114, can help position and / or secure the distal end 200 to a device such as an endoscope and help establish a seal between the distal end 200 and the endoscope. In an alternative embodiment, the flange 112 or 114 can help fit a cap portion as described above on the distal end 200. As another example, the distal end 200 can include a rounded distal portion 202 that can have atraumatic features and / or can be formed to fit a complementary cap portion.

[0040] Package 40 may also include an optical feature 204, such as a lens. As with the physical features of distal end 200 formed by package 40, optical feature 204 may be formed using mold 100 having cavity 104 including an inverted image of optical feature 204. Additionally or in the alternative, optical feature 204 may be formed by a technique applied to package 40 after molding and / or curing of package 40. For example, portions of package 40 may be removed mechanically or chemically. Figure 3A and 3B The curved shape of the optical feature 204 shown in FIG. 2 is merely exemplary. The optical feature 204 can be any number of shapes, including planar, convex, concave, or faceted.

[0041] Although the term lens may be used herein to describe exemplary optical features 204, any light-modifying or other optical structure may be used. For example, optical feature 204 may be a prism, and may, for example, split light into components having different polarizations. Optical feature 204 may also be any other refractive or reflective structure, such as a mirror. It will be appreciated that the examples provided above are not intended to limit the types of optical features 204 that may be used.

[0042] The optical feature 204 can be formed from the same encapsulation material that forms the rest of the package 40. In an alternative embodiment, the optical feature 204 can be formed from an encapsulation material that is different from the material that forms the rest of the package 40. The optical feature 204 can also be formed by doping a portion of the package 40 with other materials before or after molding and / or curing of the package 40. In the case where the optical feature 204 uses a different material, the mold 100 may not need to be modified in order to form the optical feature 204. The optical feature 204 can be indistinguishable in shape from the rest of the distal portion 200. In an alternative embodiment, in the case where the optical feature 204 uses a different material, the optical feature 204 can also have a special shape formed by a technique applied by the mold 100 during the molding process or after molding.

[0043] The optical features 204 may have focusing properties and / or diffusing properties. Figure 3A As shown in FIG. 1 , optical feature 204 can be used to affect light entering camera 16 and received by a processing component such as imager 20. Optical feature 204 can also be an aperture, a filter, a diffuser, a light dispersing feature, a mirror, a window, or a grating, or a combination thereof. Camera 16 can include additional lenses or other light modifying features in addition to optical feature 204. Additionally or alternatively, as shown in FIG. Figure 3B As shown, optical feature 204 can be used to modify or otherwise affect the light emitted by LED 22 or another structure. In addition or in the alternative, optical feature 204 can be used as a collimating and / or dispersing light feature. For example, optical feature 204 can act to cause the light emitted by LED 22 (or another light source) to be parallel or substantially parallel to each other. In the alternative, optical feature 204 can be used to cause the light emitted by LED 22 (or another light source) to be broadened or dispersed.

[0044] Figure 4A cross-sectional view of an exemplary distal end 300 is shown. The distal end 300 may include any of the features of the distal end 10 and / or the distal end 200 discussed above. The distal end 300 may also include a refractive feature 210. The refractive feature 210 may be embedded in the package 40. For example, the inner surface of the package 40 may contact the outer surface of the refractive feature 210. The inner surface of the package 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 a part of the package 40. For example, the refractive feature 210 may be a doped portion of the package 40. In an alternative solution, the refractive feature 210 may be a separate element that may be placed in its desired position before the package 40 is formed from the mold 100 or using any other known technology to form the package 40. As another alternative solution, the refractive feature 210 may be placed in its desired position between two applications of the encapsulation material. For example, the encapsulation material may be used to form the first layer of the package 40. Thereafter, the refractive feature 210 may be positioned on the first layer. The encapsulating material may then be applied with further encapsulating material, for example through a second mould, dipping, extrusion or any other suitable technique.

[0045] The refractive feature 210 can be connected to an electric current / voltage (e.g., through the wire 30, the circuit 26, and / or the circuit board 28). The refractive feature 210 can be operated to change properties when an electric current is applied or by another actuation mechanism. For example, the refractive feature 210 can change its level of opacity and / or reflectivity. Changes to the refractive feature 210 (e.g., by passing an electric current) can result in different refractions of light. For example, the refractive feature 210 can be placed above the LED 22 to cause refraction of light emitted from the LED 22. In addition or in the alternative, the refractive feature 210 can be placed above the camera 16 to cause refraction of light reaching components of the camera 16 (e.g., including the imager 20).

[0046] Figure 5 An exemplary endoscope 400 is depicted having a proximal control portion 402, a distal insertable portion 404, and a distal portion 406. The distal portion 406 may have the Figure 1-4 The distal end portion 406 may include any of the features of the distal end portion 10, 200, or 300 described above. The endoscope 400 may be connected to the controller 408 via the umbilicus 410. The proximal control portion 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 the steering of the insertable portion 404, or may allow for the provision of air, water, suction, etc. The distal insertion portion 404 may include a shaft 430. The shaft 430 may have a lumen 432. The distal end portion 406 may include a housing 40 (not shown) and the above-described Figure 1-4The distal portion 406 may also include a cap portion 440. The distal portion 406 may be fixedly or removably attached to a portion of the distal insertable portion 404, such as the shaft 430.

[0047] The patient insertable portion of the medical device can be produced using the technology described herein, which can be efficiently manufactured according to a cost-effective method. The packaging process described herein allows the manufacturing steps that require the assembly of different components to be omitted. On the contrary, the packaging process can be used to produce an integral component that does not need to be combined with other elements before being attached to a medical device such as an endoscope. In addition, the resulting patient insertable portion can seal water, body fluids and other liquids or fluids and other potential contaminants. The technology described herein can also allow the patient insertable portion of the medical device to be further miniaturized as a whole. For example, by integrating mechanical features (e.g., flanges 112, 114), optical features (e.g., optical features 204 and / or refractive features 210) into the package 40, further miniaturization can be achieved because these components no longer need to be manufactured as separate components that must be integrated separately.

[0048] Although the principles of the present invention are described herein with reference to illustrative examples of specific applications, it should be understood that the present invention is not limited thereto. Those of ordinary skill in the art and those who obtain the teachings provided herein will recognize that additional modifications, applications, and substitutions of equivalents all fall within the scope of the examples described herein. Therefore, the present invention should not be considered to be limited by the above description.

Claims

1. The distal part of the medical device includes: Image capture component; Light source; and A package having: a connecting portion, wherein the shape of an outer surface of the connecting portion is a mirror image of the shape of an inner surface of a socket of a shaft of the medical device; and An inner surface contacts and at least partially surrounds the image capture assembly and the light source, wherein a shape of the inner surface is a mirror image of a shape of an outer surface of the image capture assembly and the light source that the inner surface contacts.

2. The distal portion of claim 1, wherein the enclosure forms a fluid-tight shell.

3. The distal portion of claim 1, wherein a proximal portion of the connecting portion has a smaller cross-section than a distal portion of the connecting portion.

4. The distal portion of any one of claims 1-3, wherein the package comprises at least one of a lens, a prism, an aperture, a filter, a diffuser, a light-scattering feature, and a light-collimating feature.

5. The distal portion of any one of claims 1-3, wherein the package comprises at least one of a fulcrum, a wedge, a cam, a pin, a groove, a piston, a cylinder, a gear, a rack, a pulley, and a pulley block.

6. The distal portion of any one of claims 1-3, further comprising a circuit board, wherein an inner surface of the package contacts and at least partially contains the circuit board, wherein a shape of the inner surface is a mirror image of a shape of an outer surface of the circuit board.

7. The distal portion of claim 6, wherein: An inner surface of the package contacts at least one side surface of the image capture assembly; The inner surface of the package is in contact with at least one top surface and at least one side surface of the light source; The package fills the entire space between the image capture assembly and the light source; and An inner surface of the package contacts at least one bottom surface of the circuit board.

8. The distal portion of any one of claims 1-3, wherein the encapsulation is formed from a molded, unitary material.

9. The distal portion of any one of claims 1-3, wherein a distal outer surface of the package is rounded.

10. The distal portion of any one of claims 1-3, further comprising a cap portion, wherein an outer surface of the packaging member contacts an inner surface of the cap portion.

11. The distal portion of claim 10, wherein a distal outer surface of the enclosure contacts an inner surface of the cap portion.

12. The distal portion of claim 10, wherein the enclosure comprises at least one of a ridge and a flange, wherein the ridge or the flange is shaped to mate with the cap portion.

13. The distal portion of claim 12, wherein the enclosure comprises a ridge and a flange.

14. The distal portion of claim 13, wherein the package includes a straight side portion opposite a side of the package having the image capture assembly and the light source.

15. The distal portion of claim 3, wherein a portion of the enclosure has the inner surface having a larger cross-section than a distal portion of the connecting portion.

Images