Endoscope with disposable portion and method of use thereof

Abstract

The endoscopic device includes a reusable unit and a disposable unit. The reusable unit includes a receiver adapted to receive image data, and the disposable unit includes an insertion tube. The insertion tube includes an optical guide for imaging a distal object and a housing adapted to accommodate the reusable unit. The reusable unit is disposed within the housing and adapted to be mechanically secured within the housing. The receiver is adapted to receive the optical image from the optical guide and convert it into digital image data.

Description

[Background technology]

[0001] Endoscopes can be reusable, but hygienic requirements require the devices to be cleaned or otherwise sterilized after each patient use. There is a need for devices and methods that allow for the reuse of endoscopes without tampering with hygienic requirements and with a minimum of repeated sterilization procedures. Summary of the Invention

[0002] Disclosed is an endoscope device including a disposable unit including an endoscopic insertion tube including an optical guide having a proximal end and a distal end for imaging a distal object. The disposable unit may also include an interface unit and a housing defining a confined space. The endoscopic device may also include a reusable unit configured to be disposed and secured within the housing of the disposable unit and including a receiver for receiving image data of the imaged distal object via the interface unit.

[0003] In some embodiments of the invention, the interface unit includes an optical coupler.

[0004] In some embodiments of the invention, the receiver is adapted to receive an optical image from the optical guide via the optical coupler and convert it into digital optical image data.

[0005] In some embodiments of the invention, the receiver comprises an optical sensor.

[0006] In some embodiments of the invention, the disposable unit further includes a navigation mechanism for manipulating the distal tip of the endoscope insertion tube.

[0007] In some embodiments of the present invention, the reusable unit further comprises a navigation lever for operating the navigation mechanism.

[0008] In some embodiments of the invention, the endoscopic device further comprises a light source.

[0009] In some embodiments of the invention, the light source is located within the reusable unit, and the endoscope insertion tube further includes an illumination guide for directing light from an illumination source to the distal end of the endoscope insertion tube.

[0010] In some embodiments of the invention, the light source is located at the distal end of the endoscope insertion tube.

[0011] In some embodiments of the invention, the optical guide comprises a fiber with multiple cores (multicore fiber).

[0012] In some embodiments of the present invention, the endoscopic device further includes a focusing unit that enables focusing the image by controlling the distance between the proximal end of the optical guide and the receiver.

[0013] In some embodiments of the present invention, the endoscopic device further includes an aligning device for aligning the proximal end of the optical guide with the optical axis of the receiver.

[0014] In some embodiments of the invention, the endoscopic device further includes an extendable sterilization protecting flexible sleeve configured to be rolled off an aft end of the disposable unit and to enclose cables leading from the reusable unit to a control unit.

[0015] The subject matter which is regarded as the invention is particularly pointed out and distinctly claimed in the concluding portion of the specification. However, the invention, both as to organization and method of operation, together with its objects, features, and advantages, may best be understood by reference to the following detailed description when read in connection with the accompanying drawings. [Brief explanation of the drawings]

[0016] [Figure 1A] 1A-1C are schematic diagrams of an endoscope including a reusable unit and a disposable unit in a disassembled (1A) position, according to some embodiments of the present invention. [Figure 1B]1A-1B are schematic diagrams of an endoscope including a reusable unit and a disposable unit in an assembled (1B) position, according to some embodiments of the present invention. [Figure 2A] 1 is a schematic diagram of an endoscope with a reusable unit and a disposable unit shown in a top view in an exploded position, according to some embodiments of the present invention. FIG. [Figure 2B] 1 is a schematic diagram of an endoscope with a reusable unit and a disposable unit shown in a side view in an exploded position, according to some embodiments of the present invention. FIG. [Figure 2C] 1 is a schematic diagram of an endoscope with a reusable unit and a disposable unit shown in a top view in an assembled position, according to some embodiments of the present invention. FIG. [Figure 2D] FIG. 1 is a schematic diagram of an endoscope with a reusable unit and a disposable unit shown in a side view in an assembled position, according to some embodiments of the present invention. [Figure 2E] FIG. 2 is an isometric three-dimensional view of an endoscope 200 shown in an exploded position, according to some embodiments of the present invention. [Figure 2F] FIG. 2 is an isometric three-dimensional view of an endoscope 200 shown in an assembled position, according to some embodiments of the present invention. [Figure 3] 1 is a schematic diagram of an overall view of the internal elements of the reusable and disposable portions of an endoscope according to some embodiments of the present invention. FIG. [Figure 3A] 1 is a schematic diagram of internal elements of the front end of an endoscope, according to some embodiments of the present invention. [Figure 3A1] 1A-1C are simplified schematic diagrams illustrating aspects of an interface between a disposable unit and a reusable unit, according to some embodiments of the present invention. [Figure 3A2] 1A-1C are simplified schematic diagrams illustrating aspects of an interface between a disposable unit and a reusable unit, according to some embodiments of the present invention. [Figure 3B] 1 is a schematic diagram of internal elements of a central section of an endoscope according to some embodiments of the present invention. [Figure 3C] 1 is a schematic diagram of the internal elements of the rear section of an endoscope, according to some embodiments of the present invention. [Figure 4A] FIG. 1 is a schematic isometric view of an endoscope showing a navigation lever of a shaft navigation system, according to some embodiments of the present invention. [Figure 4B] 1A-1C illustrate the front end of an endoscope with the cover removed, showing a shaft navigation mechanism, according to some embodiments of the present invention. [Figure 4C] FIG. 1 is a schematic partial isometric view of a back cover of a single use endoscopic unit, in accordance with an embodiment of the present invention. [Figure 4C1] FIG. 10 is a schematic partial isometric view of a rear cover of a single use endoscopic unit, in accordance with an embodiment of the present invention. [Figure 4C2] FIG. 10 is a schematic partial isometric view of a rear cover of a single use endoscopic unit, in accordance with an embodiment of the present invention. [Figure 5] 1A-1C are schematic diagrams of sleeves for maintaining a required level of cleaning of a reusable portion of an endoscope, according to some embodiments of the present invention. [Figure 6] 1A-1C are schematic diagrams illustrating means for maintaining a required level of cleaning of a reusable endoscopic instrument while using a single-use endoscope insertion tube, according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0017] It will be understood that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.

[0018] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention.

[0019] According to some embodiments of the present invention, an endoscope may be reusable in an affordable manner, i.e., with minimized sterilization effort and without tampering with hygienic requirements. According to some embodiments of the present invention, only a part of the endoscope, for example, the endoscope insertion tube, may be disposable. The insertion tube of a disposable endoscope may include only the minimum necessary elements, thereby minimizing the manufacturing costs of the disposable insertion tube. The use of a disposable insertion tube may be highly advantageous because it may reduce cross-contamination between patients and may also reduce the need for sterilization procedures, requiring the replacement of only a portion of the endoscope (the disposable insertion tube).

[0020] Some embodiments of the present invention relate to endoscopes, multicore endoscopic fibers, and methods of construction and operation. The multicore fiber, according to some embodiments, may have a large number of cores (e.g., hundreds or thousands) and may incorporate working channel(s) and / or additional fibers. The fibers used may be provided with different optical configurations to capture images of tissues or objects at the distal end of the endoscope and enhance a wide range of optical characteristics of the resulting images, such as resolution, field of view, depth of field, wavelength range, etc. Both near-field and far-field imaging may be implemented in endoscopes according to some embodiments of the present invention, and the respective optical characteristics may be used to optimize imaging. Optical elements may be used at the distal tip, or the distal tip may lack any lenses. A feedback loop of diagnostics and optical treatment may be implemented, and illumination may be adapted to provide full color images, depth estimation, enhanced field of view and / or depth of field, and additional diagnostic data.

[0021] Various embodiments of multicore endoscopic fibers may be used. According to some embodiments of the present invention, endoscopes may implement far-field imaging, i.e., have images formed at the proximal end of the endoscopic fiber, while according to some embodiments, other endoscopes may implement near-field imaging, i.e., have images formed at the distal end of the endoscope. Both far-field and near-field implementations may have distal optical elements between the object or tissue being imaged and the distal tip of the endoscope, or may operate without such distal optical elements. Each of the four combinations (far-field with and without distal optical elements, and near-field with and without distal optical elements) has different characteristics, advantages, and disadvantages and may be selected according to a particular implementation scenario. Combinations may also be changed between applications or in real time to combine the advantages of different configurations. It should also be noted that endoscopes may be designed with several combinations, for example, having a portion of the fiber face (or certain fiber modules) with distal optics for imaging distant objects and another portion of the fiber face (or certain fiber modules) lacking distal optics for microscopic imaging.

[0022] The endoscope, according to some embodiments, may lack any optical elements at the distal tip. Such lensless embodiments may implement either far-field or near-field imaging, may increase optical resolution while reducing crosstalk between cores, may apply super-resolution methods, and may utilize structural features to obtain wavefront information.

[0023] Endoscopes according to some embodiments of the present invention may have a full tip cross section or may have a working channel within the imaging fiber characterized by different configurations and uses, integration of additional fibers, etc. In that case, the core and optical elements may be configured to overcome the reduction in field of view due to the incorporation of a working channel.

[0024] According to some embodiments of the present invention, various configurations of multiple cores in an endoscopic fiber may provide solutions to various problems such as reducing crosstalk between fibers, reducing overcoming material losses, achieving improved resolution in different ways, providing necessary mechanical properties, and optimizing the imaging performance of the endoscopic fiber. Endoscopes according to some embodiments of the present invention may serve different purposes and may be designed as, for example, laparoscopes or ureteroscopes, etc.

[0025] Microendoscopes, according to some embodiments of the present invention, may be composed of a large number of cores (e.g., 100 or more cores, hundreds of cores, thousands of cores, and in some embodiments, tens of thousands, hundreds of thousands, and even more than a million cores per fiber or fiber module), each responsible for transmitting single or multiple spatial degrees of freedom at its exterior, and constituting at its output a high-resolution color image at the proximal end (the end outside the patient's body). Multicore fibers, according to some embodiments of the present invention, may exhibit a high degree of flexibility in their optical configuration and may be used and adapted for specific applications, such as, for example, ureteroscopes with large working channels and small outer diameters, or laparoscopes with the very high resolution obtainable with small outer diameters.

[0026] According to some embodiments of the present invention, an endoscope can be divided into two main parts: a reusable endoscope handle, which may contain the majority and more expensive functionality of the endoscope, i.e., the more complex and expensive optical unit (e.g., camera, image processing means, and electronics), and a removable and disposable endoscope insertion tube (or head), which may contain a simpler and relatively inexpensive optical setup, an endoscope image-guiding guide, i.e., an optical fiber or fiber bundle (e.g., a multicore fiber), and optionally a light guide (e.g., one or more cores in a fiber) for guiding illumination to the distal end of the insertion tube.

[0027] The endoscope insertion tube may include fiber-based light conduit means and special optical and mechanical connection means adapted to securely attach the single-use endoscope insertion tube to the reusable endoscope handle. According to some embodiments, a light source may be located at the distal end of the endoscope, using, for example, a suitable LED (light emitting diode) as the light source. By locating a universal mounting interface at the front end of the endoscope handle, interchangeable endoscope insertion tubes with different application-specific capabilities may be used. Electronically dense reusable handles allow for the application of a variety of different single-use disposable insertion tube functionality. The single-use endoscope insertion tube may include a housing located at the proximal end of the insertion tube and adapted to receive and surround the endoscope handle to protect it, shield it from external physical contact and contamination, and maintain its sterility. The entire endoscope may be enclosed in a sealable (e.g., plastic, rubber) cover that covers both sections (disposable and reusable), including the electrical cable connected to the reusable handle. If desired, for example, at the end of use, the handle can be detached from the single-use endoscope insertion tube and withdrawn from the housing, and the single-use endoscope insertion tube with the housing can be discarded or disposed of.

[0028] The connection between the handle and the single use endoscope insertion tube may include a mechanical connector based on a variety of configurations, including magnets located on either side of the connection interface, a mechanical translation-based clip (which captures both parts when one part is rotated relative to the other), a rotation-based threaded / bayonet-type connection, and the like.

[0029] 1A and 1B, which are schematic diagrams of an endoscope 100 in disassembled and assembled positions, respectively, in accordance with some embodiments of the present invention. The endoscope 100 includes two main parts: a reusable endoscope handle 102 and a single-use endoscope insertion tube 104. The single-use endoscope insertion tube 104 includes an endoscope handle housing 104A that is adapted to sealingly receive the reusable endoscope handle 102 therein. The single-use endoscope insertion tube 104 further includes an endoscope handle interface unit 104B, an endoscope optical probe unit 104C, and an endoscope locking means 104D.

[0030] The reusable endoscope handle 102 includes an endoscope body 102A, which may include electronics, a power source, a communication unit, etc., depending on the particular design. The reusable endoscope handle 102 further includes an endoscope disposable insertion tube interface unit adapted to hold, transfer, communicate, and convert optical and electrical signals and data depending on the particular design. The interface unit 102B, according to some embodiments, may provide a contactless interface, for example, using only optical coupling with the disposable endoscope insertion tube. In such an embodiment, the disposable insertion tube may need to include a power source (not shown in FIGS. 1A and 1B).

[0031] The reusable endoscope handle 102 further comprises pull-out means 102C adapted to allow it to be pulled out of the housing 104A in a manner that preserves the sterility of the reusable handle 102. After the handle 102 is pulled out of the housing 104A, the disposable insertion tube 104 may be discarded and the reusable handle 102 may be reused in a future procedure.

[0032] When the handle 102 is inserted into the housing 104A, in preparation for a medical procedure, the handle 102 should be fully inserted into the housing so that the locking means 104D can be operated to securely lock the handle 102 inside the housing 104A, for example, by pressing a jig into a recess 102D formed in the outer surface of the handle 102 and / or by using a back cover locking system.

[0033] When the handle 102 is properly positioned and locked inside the housing 104A, the interface units 102B and 104B should, in a preferred embodiment, be positioned opposite each other in a manner that allows connection, communication, and exchange of signals between the handle 102 and the disposable insertion tube 104 according to the particular design. In some embodiments, the interface may be configured without mechanical / electrical connections, relying, for example, on optical coupling.

[0034] 2A, 2B, 2C, and 2D, which are schematic diagrams of an endoscope 200 with a reusable unit and a disposable unit shown in front and side views, respectively, in a disassembled position and in an assembled position, in accordance with some embodiments of the present invention. Similar to endoscope 100, endoscope 200 comprises two main parts: a reusable unit 202 and a disposable unit 204. As can be seen in FIGS. 2A and 2B, the shape and size of reusable unit 202 slidably fits within a housing formed in the main portion of the rear end of disposable unit 204. When reusable unit 202 is inserted into the housing of disposable unit 204, reusable unit 202 is completely enclosed within disposable unit 204.

[0035] Reference is now also made to Figures 2E and 2F, which are isometric three-dimensional views of endoscope 200 shown in disassembled and assembled positions, respectively, in accordance with some embodiments of the present invention. The selected viewing angles of Figures 2E and 2F clearly show that reusable unit 202 is fully contained within a housing made within disposable unit 204.

[0036] Reference is now made to Figure 3, which is a schematic diagram of an overall view of the internal elements of the reusable portion 302 and disposable portion 304 of an endoscope 300, in accordance with some embodiments of the present invention. To allow a clear understanding of the embodiment shown in Figure 3, the internal view of endoscope 300 is divided into three different perspectives: a front-most view (the perspective closest to the connection to the endoscope insertion tube) illustrated in detail in Figure 3A, a central view shown in Figure 3B, and a rear-most view shown in Figure 3C.

[0037] Reference is now made to Figure 3A, which is a schematic illustration of the internal elements of the front end of an endoscope, according to some embodiments of the present invention. An endoscope insertion tube 3010 exits the front end of the endoscope 300, and internally, the insertion tube 3010 bifurcates into a fiber / multicore fiber 3020 and a light waveguide 3030. The light waveguide 3030 terminates in a light waveguide interface unit 3032, e.g., an optical coupler. The fiber / multicore fiber 3020 terminates in a fiber interface unit 3022, e.g., an optical coupler. Both interface units 3032 and 3022 are held by an interface bed unit 3060, which is part of the disposable unit 304, as described in detail below. The ends of the interface units 3022 and 3032 form an interface to the reuse unit 302. While the embodiment described herein provides optical coupling of the optical image transmitted by the fiber 3020 with the light transmitted toward the waveguide 3030, it will be apparent that other suitable means for coupling may be used and remain within the scope of the present invention. On the other side of the interface bed 3060 (to its right in the drawings) are shown elements of the reusable unit 302. The optical module 3050 is adapted to receive the optical data transmitted by the fiber 3020 and convert it into a digital representation of the image. On the side facing the interface bed 3060, the optical module 3050 terminates in a shaped protruding end adapted to assist in optically aligning the fiber 3020 with the central optical axis of the optical module, as described in detail below. The light source 3040 is positioned adjacent to the optical module 3050 and is substantially parallel thereto, with its light beam directed toward the optical waveguide interface unit 3032.When the reusable unit 302 is fully inserted and properly positioned inside the disposable unit 304, the light source interface unit 3042 located at the front end of the light source unit 3040 interfaces closely with the rearmost end of the waveguide interface unit 3032, thereby ensuring good transmission of light to the waveguide.

[0038] Reference is now made to FIGS. 3A1 and 3A2, which are simplified schematic diagrams illustrating aspects of the interface between the disposable unit 304 and the reusable unit 302, according to some embodiments of the present invention. To ensure sufficiently good optical coupling between the light transmitted to the endoscope insertion tube and the optical image received from the optical guide, certain requirements must be met. In the optical path, good and efficient transmission of optical energy should be provided to minimize loss of optical energy at the interface between the light source interface unit 3042 and the waveguide interface unit 3032. As is known in the art, to minimize light loss during passage from one medium to another, both should have the same refractive index or refractive indexes as close to each other as possible. This requirement can be easily met by appropriate selection of the transparent material used for manufacturing. In some embodiments, with a light source, e.g., an LED, located at the distal end of the endoscope, electrical coupling may be used to provide power to the LED instead of optical coupling for light transmission to the endoscope.

[0039] In some embodiments of the present invention, the layers at the interface plane may be as thin as possible so that light passing through them experiences minimal loss. To meet this requirement, the light source unit 3040 is slidably positioned inside the reusable unit 302 so that it can slide back and apply a force parallel to the imaginary longitudinal axis (ILA) of the reusable unit 302. The light source unit 3040 may be positioned with a spring element 3048 that provides support between the light source 3040 and the body of the reusable unit 302. When the reusable unit 302 is not coupled with the disposable unit 304, the spring element 3048 is unloaded and the front end of the light interface unit 3042 protrudes beyond the light interface plane (LIP). When units 302 and 304 are mated, the optical interface unit is pushed backward by the waveguide interface unit 3032, causing the spring element 3048 to retract and provide a predetermined coupling force that ensures sufficient optical coupling for the light.

[0040] To ensure good transfer of the image collected by the fiber unit 3020 to the optical module 3050, in addition to providing good light transmission at the interface plane, accurate transfer of the optical image should also be provided. When coupling the optical image source and optical image destination units, the coupling should be set in the three major axes X, Y, and Z of the interface so that the optical axes of the source and destination are aligned and an optical focus is provided. When the fiber interface unit 3022 and the optical module 3050 are coupled, the interface surface of the fiber interface unit 3022 may be shaped as a conical depression 3022A created with its wider opening facing the housing of the disposable unit 304 (such as housing 104A in FIG. 1A ) to ensure self-alignment of the optical axis. The fiber 3020 may terminate at the exact center of the narrower opening of the conical depression 3022A. The waveguide interface unit 3022 may be slidably positioned within the interface bed 3060 so that it is free to move (shade) in the XY plane of the interface bed 3060 but maintains a precise position in the Z axis. Prior to mating, the interface unit 3022 may be positioned in the XY plane so that the XY coordinates of the center of the conical recess 3022A approximately coincide with the expected XY coordinates of the optical axes of both the units 302 and 304 to be mated. The front end 3052 of the optical module 3050 may be formed as a protrusion (e.g., a conical protrusion) that matches the conical recess 3022A in terms of the wide / narrow size of the base and the angle of the cone. When the reusable unit 302 is inserted into the housing in the disposable unit 304 and approaches the interface bed 3060, the front, narrow end of the conical protrusion 3052 may enter the wide opening of the conical recess 3022A.The fiber interface unit 3022 may perform the necessary movements in the XY plane to gradually align its optical axis with the optical axis of the fiber unit 3020 until it is perfectly aligned with the optical module 3050. The focus adjustment in this embodiment will be described later in this specification.

[0041] Referring to FIG. 3A2 , this is a schematic simplified block diagram of a focusing unit for adjusting the optical focus of an image transmitted by the fiber interface unit 3020 to the optical module 3050 when the reusable unit 302 and the disposable unit 304 are coupled. The mechanical precision of the reusable unit 302 can be guaranteed during manufacturing. However, the disposable unit 304 may be subject to less precise manufacturing standards to reduce manufacturing costs. As a result, when the reusable unit 302 and the disposable unit 304 are coupled, the actual distance between the end of the fiber interface unit 3022 and the optical module 3050 may vary within an unacceptable range from one disposable unit to another. To ensure accurate focusing, the optical module 3050 may be fabricated with a transparent front surface 3053 so that the photosensitive surface 3052′ is located at a precise pre-determined optical gap (PDOG) distance from the front surface 3053. The fiber interface unit 3022 may be positioned within the interface bed 3060 with some degree of freedom of movement along the Z axis, and may be positioned such that its front end protrudes slightly forward (toward the housing of the unit 302) of the image interface plane (IIP) when the units 302 and 304 are uncoupled. The fiber interface unit 3022 may be made flexible for movement along the Z axis, and rearward movement (toward the fiber unit 3020) may therefore generate a spring-like return force due to a level of fiber unit flexibility. When the reusable unit 302 is fully inserted into its position within the housing inside the disposable unit 304, the front face 3053 pushes the fiber interface unit 3022 slightly backward against the return force of the fiber unit 3020. As a result, the fiber interface unit is forced into contact with the front face 3053, thus ensuring an optical gap between the fiber interface unit and the optical module 3050.

[0042] Reference is now made to Figure 3B, which is a schematic illustration of internal elements of the central portion of the endoscope 300, according to some embodiments of the present invention. To ensure good optical coupling between the light source 3040 and the optical waveguide interface 3032, the optical coupling self-adjusting means may include an optical unit 3044 coupled to a sliding shaft 3046 and pushed toward the front end of the disposable unit 302 by a spring element 3048. When the reusable unit 302 is fully inserted into the housing inside the disposable unit 304, the optical unit 3044 is pushed back slightly by the waveguide interface unit 3032, retracting the spring element 3048 and inducing a coupling force of the optical unit 3044 onto the waveguide interface unit 3032.

[0043] To allow adjustment of the optical focus of the interface between the optical module 3050 and the fiber interface unit 3022 (i.e., to set the distance between the units along the optical axis), the focusing unit may include a spring element 3056 within a cavity 3054 provided within the optical module 3050. The spring element 3056 is positioned and designed to provide a continuous force that pushes the optical element toward the rear end of the reusable unit 302. The optical module may be pushed forward toward the front end of the reusable unit 302, as described below with reference to FIG.

[0044] Reference is now made to Figure 3C, which is a schematic diagram of internal elements at the rear of an endoscope, according to some embodiments of the present invention. The optical sensor 3072 (e.g., a CMOS sensor) of the optical module 3050 is configured to be pushed forward by a focus adjustment means 3070, which includes a threaded unit 3074 that is screwed into a threaded housing 3076. The threaded housing 3076 is rotatably disposed inside the reusable unit 302 and terminates at the exterior rear surface of the reusable unit 302 with an adjustment knob 3078. When focus adjustment requires that the optical module 3050 approach the fiber interface unit 3022, the knob 3078 can be rotated by the user, who can then rotate the knob 3078 in a direction that unscrews the threaded unit 3074 from the threaded housing 3076, thereby forcing the optical module to move forward. If the required direction of adjustment is opposite, the adjustment knob 3078 may be rotated in the other direction, thereby retracting the threaded unit 3074 into the threaded housing 3076 and allowing the spring element 3056 to push the optical element 3050 backward, thus focusing the imaged object onto the optical sensor 3072.

[0045] Reference is now made to FIG. 4A, which is a schematic isometric view of an endoscope 400 showing a navigation lever 4010 of the navigation system 4000, and FIG. 4B, which illustrates the navigation mechanism 4000 with the cover at the front end of the endoscope 400 removed, according to some embodiments of the present invention. The navigation system 4000 is of a single-plane, two-way type, as is known in some endoscope types. This type of navigation is based on the difference in pulling force applied to one of two navigation wires compared to the pulling force applied to the other navigation wire. When the pulling forces are equal, the endoscope is in a "rest position." The navigation system 4000 includes a navigation lever 4010 that is disposed outside the body of the disposable unit 304 and is coupled to a navigation disc 4020 by a common pivot. The navigation wires 4030A and 4030B are coupled at their proximal ends (shown in FIG. 4B ) to the navigation disk 4020, each on one side of the center of rotation of the disk 4020, and at their distal ends, to opposite sides of the distal end of the insertion tube. When the navigation level is moved by the user, the navigation disk 4020 is rotated, thereby pulling one of the navigation wires 4030A / 4030B and releasing the other. This results in a differential force being exerted on the wires, bending the distal end of the endoscope insertion tube in a first direction or the opposite direction, thereby enabling navigation. To orient the distal end of the endoscope insertion tube in the other direction, the user may rotate the reusable unit about its longitudinal axis parallel to the direction of insertion of the endoscope insertion tube.

[0046] 4C, 4C1, and 4C2, which are schematic partial isometric views of a rear cover of a single-use endoscopic unit in assembled and disassembled positions, respectively, according to some embodiments of the present invention. FIG. 4C depicts a disposable unit 4100 having a body 4110 and a rear cover 4120 in a rear cover closed position, according to some embodiments of the present invention. The rear cover 4120 may be constructed to securely cover a rear opening 4122 (FIG. 4C1), for example, after being inserted into a reusable unit (not shown). The rear cover 4120 may be hingedly connected at one end by a hinge 4126 to a hinge rest 4116 on the periphery of the opening 4112. The main portion 4122 of the rear cover 4120 may include an opening 4128, for example, to allow an endoscope cable to pass therethrough outward from the reusable unit. To securely lock the rear cover 4120 in its closed position, a locking mechanism may be used which includes a first locking member 4114 which connects at one end to the disposable unit 4110 and at the other end to a second locking member 4124. The second locking member 4124 may be provided with a locking pin 4124A at its other end which is adapted to engage locking dents 4125 and pull the main cover unit 4122 tightly closed when pulled towards the body 4110 of the disposable unit 4100.

[0047] Referring now to FIG. 5, FIG. 5 is a schematic diagram of a means for maintaining a required level of cleanliness of a reusable portion of an endoscope, according to some embodiments of the present invention. To enable reuse of a reusable unit, such as reusable unit 302, without the need for a full and lengthy sterilization protocol after each use, it is essential to protect the reusable unit so that it will not be tampered with during the endoscopic procedure. According to some embodiments of the present invention, this requires enabling endoscopic surgery in a manner that ensures that the reusable unit is protected to the required level of cleanliness throughout the entire procedure, including during separation of the reusable unit from the disposable unit after the procedure. According to some embodiments of the present invention, the disposable unit 5000 may be provided with a flexible, thin sleeve 5010, which may be made of a material that protects sterility (e.g., as used in sterile gloves). Prior to use, the sleeve 5010 may be placed near an opening in the reusable unit's housing (such as housing 104A in FIG. 1A), and in its collapsed position, it may be wrapped, for example, in a serpentine fashion around the rear of the disposable unit. In the unfolded position, the sleeve 5010 may have a length substantially equal to the length of the endoscope cable connecting the endoscope to its control unit 5100 (e.g., about 3 meters). After insertion of the reusable unit into the disposable unit 5000, the sleeve 5010 may be unfolded and stretched along the cable 5002 (designated as 5010') until it completely or substantially completely covers the cable. After an endoscopic procedure, the user may hold the end of the sleeve 5010' and carefully pull it back toward the disposable unit 5000 without compromising the sterility of the cable 5002. When the sleeve 5010' is completely folded back and optionally rolled up over the rear end of the reusable unit 5000 with its inner surface facing outward, the rear end of the reusable unit (not shown) is exposed.At this stage, the user may, with their own or another person's sanitized hands, carefully withdraw the reusable unit from its housing in the disposable unit 5000, for example using an extraction means, i.e., extraction means such as means 102C in Figure 1A. After the reusable unit has been removed and the disposable unit 5000 has been discarded, the risk of the disposable unit compromising the sterility of the reusable unit has ended, and the process may end until such time as the reusable unit is to be reused.

[0048] Reference is now made to FIG. 6, which schematically illustrates an endoscopic system 6000 including a reusable endoscopic device unit 6110 and a single-use endoscope 6010, according to some embodiments of the present invention. The single-use endoscope 6010 may include a fiber unit (single or multi-core fiber), optional optical means (e.g., lenses), illumination means which may be located at either the distal or proximal end of the endoscope, an endoscope handle 6011, an endoscope cable 6014, and an endoscope insertion tube 6012 which may include a single-use endoscope connector 6020. The cable 6014 may include optical guiding means for providing optical images acquired at the distal end of the single-use endoscope to the connector 6020 (e.g., the fiber unit may extend from the distal end to the connector 6020). The cable 6014 may further include an electronic conduit for providing power to the illumination means of the single-use endoscope 6010, or a light guide that allows light from a light source located in the reusable endoscopic device 6110 to be transmitted to the distal end of the endoscope insertion tube 6012. According to this embodiment, the single use endoscope 6010 extends from the distal end of the insertion tube 6012 to the connector 6020 and may be discarded after use in a medical procedure on a first patient, and another, pre-sterilized single use endoscope 6010 may be connected to the reusable endoscopic device unit 6110 via the connector 6120 and the connector 6020. The specific details of the internal coupling of the connector 6120 and the connector 6020 may vary according to the particular embodiment of the invention. For example, the connectors 6120 and 6020 may include an optical interface that assists in providing optical images acquired at the distal end of the insertion tube 6012 to an optical receiver internal to the reusable endoscopic device unit 6110. The connectors 6120 and 6020 may include an optical interface for conveying light generated by a light means located within the reusable endoscopic device unit 6110 to the distal end of the single use endoscope 6010, or in other embodiments, the connectors may include an electronic interface for providing power to a light source located within the single use endoscope 6010.

[0049] In some embodiments, the single use endoscope 6010 may include a navigation means (not shown), such as, for example, the navigation means system 4000 described in conjunction with FIGS. 4A and 4B.

[0050] According to this embodiment, sterilization of the reusable endoscopic device unit 6110 may not require any special sterile preservation measures. Typically, the control unit 6100 and the reusable endoscopic device unit 6110 are located distal to the patient being treated, and the end of the cable 6014 coupled to the connector 6020 cannot become contaminated during the endoscopic procedure. Nevertheless, at the end of the endoscopic procedure, the single-use endoscope 6010 may be removed from the reusable endoscopic device unit 6110 without compromising its sterility, thereby allowing further use of the reusable endoscopic device unit 6110 without the need for sterilization after each endoscopic procedure.

[0051] According to some embodiments of the present invention, a reusable endoscope unit may be used with various types of single-use endoscope insertion tubes for many different needs and purposes. It is desirable for the various types of single-use insertion tubes to be mechanically and optically compatible only with the interface design of the reusable unit.

[0052] In some embodiments, the endoscope disposable unit may include a videoscope unit located at the distal end of the endoscope insertion tube or at its proximal end for acquiring images of an object and transmitting them via data signals to the endoscope reusable unit.

[0053] Conversion of the optical image at the proximal end of the multicore fiber into digital image data may be performed, according to some embodiments, by providing an optical sensor at the proximal end of the optical guide of the endoscope insertion tube and converting the optical image into digital data, for example, by rolling shutter techniques known in the art. A communication interface may be provided to facilitate coupling the optical sensor to the reusable unit receiver and communication of the digital data from the optical sensor to the receiver.

[0054] While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents will now occur to those skilled in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and variations that fall within the true spirit of the invention.

Claims

1. An endoscopic device, the endoscopic device comprising: A disposable unit comprising: an endoscope insertion tube including an optical guide having a proximal end and a distal end for imaging a distal object; Interface Unit and a disposable unit including a housing defining an enclosed space; a reusable unit configured to be positioned and secured within the housing of the disposable unit, the reusable unit including a receiver for receiving image data of the imaged distal object via the interface unit; Including, Endoscopic devices.

2. The device described in claim 1, wherein the interface unit includes an optical coupler.

3. The receiver is adapted to receive an optical image from the optical guide via the optical coupler and convert it into digital optical data. The device of claim 2 .

4. The device of claim 3 , wherein the receiver comprises an optical sensor.

5. the disposable unit further includes a navigation mechanism for manipulating the distal tip of the endoscope insertion tube; A device according to any one of claims 1 to 4.

6. the endoscopic device further includes a navigation lever for operating the navigation mechanism. The device of claim 5.

7. The device of claim 1 further comprising a light source.

8. 8. The device of claim 7, wherein the light source is disposed within the reusable unit, and the endoscope insertion tube further includes a light guide for directing light from the light source to a distal end of the endoscope insertion tube.

9. The device of claim 7 , wherein the light source is disposed at the distal end of the endoscope insertion tube.

10. 10. The device of claim 1, wherein the optical guide comprises a fiber with multiple cores.

11. 11. The device according to claim 1, further comprising a focusing unit that allows for focusing an image by controlling the distance between the proximal end of the optical guide and the receiver.

12. The device of claim 1 , further comprising an alignment device for aligning the proximal end of the optical guide with an optical axis of the receiver.

13. 13. The device of any preceding claim, further comprising a stretchable sterile protective flexible sleeve configured to enclose a cable exiting a rear end of the disposable unit and leading from the reusable unit to a control unit.

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