Optical components for endoscopic companion devices

Abstract

A coupler device for an endoscope includes a body having a proximal end configured to attach to the distal end portion of the endoscope and a protective cover that reduces the ingress of debris, fluids, bacteria, or other undesirable substances from the working end of the endoscope, which could lead to infection and reduced scope performance. The coupler device further includes a visualization section on the body between the endoscope's camera lens and light source and a target site within a patient. The visualization section includes one or more optical components configured to reduce the amount of reflected light from surfaces and / or to inhibit condensation of water droplets on surfaces. Reducing glare and / or fogging in the visualization section significantly improves the surgeon's view of the target site through the optical coupler.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 949,238, filed December 17, 2019, the entire disclosure of which is incorporated herein by reference for all purposes.

[0002] The present disclosure relates generally to companion devices such as optical couplers for use with endoscopes, and more particularly to optical couplers having optical components for reducing reflected light and / or inhibiting moisture condensation on the camera lens of an endoscope. [Background technology]

[0003] Recent advances in optical imaging technology have made it possible for many medical procedures to be performed in a minimally invasive manner today. The evolution of more sophisticated flexible scopes with advanced visual capabilities has enabled access to areas deep within the human body that were previously thought to be achievable only using invasive surgical intervention. This modern convenience has led to an increase in the demand for, and the number of, endoscopic, laparoscopic, arthroscopic, ophthalmoscopic, or other remote imaging visualization procedures performed annually in the United States and worldwide. While these procedures are relatively safe, they are not without risks.

[0004] For example, endoscopy is a procedure in which an illuminated visualization device called an endoscope is inserted into a patient's body to examine the inside of a body cavity, lumen, or organ, or a combination thereof, for the purposes of examination, diagnosis, or treatment. The endoscope can be inserted through a small incision or through a natural orifice in the patient. In bronchoscopy, the endoscope is inserted through the mouth, while in sigmoidoscopy, the endoscope is inserted through the rectum. Unlike most other medical imaging devices, the endoscope is inserted directly into an organ, body cavity, or lumen.

[0005] Today, most endoscopes are reused. This means that after an endoscopy, the endoscope undergoes cleaning, disinfection or sterilization, and reconditioning procedures so that it can be reintroduced into the field for use in another endoscopy on another patient. In some cases, endoscopes are reused several times a day on several different patients.

[0006] Although cleaning, disinfection, and refurbishment procedures are rigorous, there is no guarantee that an endoscope will be absolutely free of any form of contamination. Modern endoscopes have sophisticated and complex optical visualization components inside a very small and flexible tubular body, a feature that allows these scopes to be effective in diagnosing and treating patients. However, the price of their comfort is that they are difficult to clean due to their small size and myriad components. These scopes are introduced deep into the body exposing the surface of these scopes to elements that may become trapped within the scope or adhere to its surface, such as bodily fluids, blood, and even tissue, increasing the risk of infection with each repeated use.

[0007] Endoscopes used in the gastrointestinal tract, such as side-viewing endoscopic ultrasound (EUS) scopes and duodenoscopes, have additional complications in terms of their entry into a bacterial-rich environment. Typical duodenoscopes and EUS scopes have internal moving components, such as an elevator with a hinge attached to a cable for actuation. The elevator is used to deflect and therefore change the direction of instruments passed through the working channel of the scope. This elevator is advantageous in that it allows the user to redirect and guide wires or catheters into specific openings so that one or more instruments can be inserted into specific body lumens or redirected to penetrate or sample tissue. However, given the size, location, and movement of the elevator during use, the elevator creates cleaning challenges, including the risk of bacteria getting into the elevator hinge and other difficulties in cleaning the area on the scope. This provides an opportunity for bacteria to colonize and develop drug resistance, posing a risk of serious illness or even death to the patient. This risk of infection also exists in the cable mechanisms used to move the elevator mechanism back and forth and in other aspects of current scope designs. Furthermore, in addition to the health risks posed by bacterial contamination, the accumulation of fluids, debris, bacteria, particulates, and other undesirable materials in these difficult-to-clean scope areas also affects the performance of these reusable scopes and shortens their useful life.

[0008] To reduce the risk of infection and protect the working end of an endoscope, disposable optical coupler devices have been designed to cover and at least partially seal a portion of an existing endoscope. These coupler devices typically have a visualization section attached to the working end of the endoscope and constructed of an optical material such as glass, polycarbonate, acrylic, clear gel, or silicone, or other material with sufficient optical clarity to transmit an image, which is generally aligned with the scope's camera lens and light source to allow light to pass through the section and provide an endoscopic view of a target site.

[0009] One drawback of existing coupler devices is that fluid in or around the target site can accumulate on the surfaces of the visualization section and condense into small droplets, "clouding" these surfaces and limiting the view of the lumen, organ, particular tissue, surgical site, or other desired visualization point. This view limitation can occur between the scope and the optical coupler device, on the exterior surface of the optical coupler device, or a combination thereof.

[0010] Another drawback associated with existing coupler devices is that light passing through the visualization section of the device reflects off tissue surfaces within the patient and back onto the camera lens or light source. This phenomenon can occur, for example, when an operator advances an endoscope from a smaller volume area within the patient, such as the intestine, to a larger volume area, such as an organ (e.g., the stomach). The larger volume area results in a large amount of reflected light being reflected back into the coupler device and onto the camera lens of the scope. This reflected light creates glare that further limits the operator's ability to see the target area.

[0011] It would therefore be desirable to provide a device that serves as a convenient accessory to existing endoscopes that reduces the risk of contamination and infection while also improving the performance of the endoscope. It would be particularly desirable to provide an endoscopic accessory or companion device, such as an optical coupler for the working end of an endoscope, that provides a clear view of a desired observation point within a patient's anatomy with little glare and / or fogging on the endoscope's light source or camera. Summary of the Invention [Means for solving the problem]

[0012] The present disclosure provides a coupler device for covering and at least partially sealing a portion of the working end of an endoscope. The coupler device protects the scope and its components, particularly the scope elevator, to reduce the risk of debris, fluids, and other materials ending up in the elevator, behind the elevator, the working channel, and other difficult-to-clean areas. Additionally, the coupler device includes one or more optical components configured to reduce the amount of reflected or stray light from the optical coupler surface and / or surrounding tissue surfaces. The coupler device may include one or more optical components that inhibit condensation of water droplets on the optical coupler, the camera lens, or both. Reducing glare and / or fogging on the optical coupler significantly improves the surgeon's view of the target site through the endoscope.

[0013] In one embodiment, a coupler device according to the present disclosure includes a body having an at least partially closed distal end and a proximal end configured to attach to a distal end portion of an endoscope. The coupler device further includes a substantially transparent visualization section positioned between the light and camera lens of the endoscope and the target site to enable viewing of the target site. The visualization section or body of the coupler device includes an optical component on at least one of its surfaces or within the visualization section. The optical component is configured to reduce the amount of light reflected from the surface of the visualization section or surrounding tissue surfaces to reduce glare and improve the view of the observed site.

[0014] The visualization section can comprise a substantially transparent film, sheet, layer, coating, wall, or other substrate positioned on the coupler device to allow light to pass therethrough. Alternatively, the visualization section can comprise a transparent area within the body of the optical coupler, comprising a material capable of transmitting optical images, such as a clear gel or other substantially transparent material, that will allow light to pass therethrough. In certain embodiments, the camera lens and light guide are directed laterally from the shaft of the endoscope (i.e., a side-viewing endoscope) so that light from the light guide reaches the target site through the coupler device, and the visualization section is located on the outer surface of the coupler device. In other embodiments, the camera lens and light guide can be directed longitudinally from the shaft of the endoscope (i.e., an end-viewing scope), and the visualization section is located on the distal surface of the coupler device. In still other embodiments, the coupler device or endoscope can comprise a mirror or other light-reflecting surface to redirect the light passing to and from the camera and light guide to "align" the visualization section with the light guide and camera lens. In this latter embodiment, the visualization section may not necessarily be directly opposite the camera light guide, as long as a mirror or other redirecting surface is configured to direct light through the visualization section to the target site.

[0015] The visualization section can be any optical material capable of transmitting an optical image, such as polycarbonate, glass, or a clear gel. In one embodiment, the visualization section comprises polycarbonate, and the optical component comprises a layer of material having a different refractive index than polycarbonate, preferably a different refractive index than polycarbonate. This optical layer creates an interference effect with the polycarbonate, thereby reducing the total percentage of reflected light without substantially reducing the transmission of the visualization section.

[0016] The optical layer can be disposed on the inner surface, the outer surface, or both the inner and outer surfaces of the visualization section. Alternatively, the optical layer can be disposed within the visualization section. In other embodiments, the optical layer can be disposed on the surface of the camera lens and / or the light source. In one embodiment, the optical layer comprises an anti-reflective coating applied to the inner surface of the visualization section to reduce a significant portion of reflected light in the visible range of light waves (i.e., between approximately 400 nanometers and 700 nanometers). In a preferred embodiment, the anti-reflective coating comprises magnesium fluoride.

[0017] In other embodiments, the optical layer comprises two or more anti-reflective coatings. Preferably, at least one of the coatings comprises magnesium fluoride. Other suitable coatings may include zinc oxide, aluminum oxide, or cerium trifluoride, etc. In an exemplary embodiment, the optical layer comprises successive layers of coatings such as cerium fluoride, zinc oxide, and magnesium fluoride.

[0018] In yet another embodiment, the optical component can comprise a light-absorbing material positioned in or on one or more areas of the coupler device, such as the visualization section, the body, one of the exterior surfaces of the body, the open area covering the camera lens and light guide, the flexible working channel region, e.g., in or on the working channel extension or flexible membrane. The light-absorbing material is positioned to absorb reflected, scattered, or stray light from the patient's tissue and / or the surface of the optical coupler, thereby minimizing glare that might otherwise be caused by the reflected light. The light-absorbing material can be a thin black strip, square, circular, rectangular, or other suitable shape positioned to absorb reflected light so that it does not interfere with the camera lens.

[0019] Alternatively, the optical components can include a baffle positioned on or within the coupler device. Preferably, the baffle includes one or more channels or vanes positioned and configured to direct reflected stray light away from the camera lens on the endoscope. The baffle can be designed to block light arriving from light sources outside the field of view (FOV) of the camera lens. Light outside the system's field of view must make multiple reflections on the system's surfaces, minimizing the intensity of light effectively reaching the camera lens. The internal surfaces can include a light-absorbing material or color, e.g., a blackened surface.

[0020] In another aspect of the present invention, a coupler device for an endoscope having a light and a camera lens includes a body with an at least partially closed distal end and a proximal end configured to attach to the distal end portion of the endoscope. The coupler device further includes a substantially transparent visualization section located between the light and camera lens of the endoscope and the target site, allowing the target site to be viewed using the scope. The visualization section includes an optical layer on at least one of its surfaces or within the visualization section. The optical layer is configured to inhibit condensation of fluids, such as water, on the surface of the visualization section. The optical layer reduces "haze" on or within the visualization section, thereby improving visibility of the target site.

[0021] In certain embodiments, the optical layer comprises one or more chemicals applied to or within the visualization section. The chemicals are configured to inhibit condensation of water droplets on the exterior surface of the visualization section (i.e., the surface facing the target site). In other embodiments, the optical layer comprises an anti-fog film applied to the exterior surface of the visualization section, and in other embodiments, to the interior surface or both the exterior and interior surfaces of the visualization section.

[0022] In another embodiment, the optical layer comprises a surfactant configured to minimize the surface tension of water on the exterior surface of the visualization section. The surfactant may be nonionic, anionic, cationic, or amphoteric in polarity and may include detergents, fatty acid soaps, dispersants, or other suitable materials that reduce the surface tension from water molecules on the visualization section, thereby reducing the number of water droplets that form on the exterior surface.

[0023] In another embodiment, the optical layer comprises a hydrophilic coating that maximizes surface energy on the exterior surface of the visualization section. Suitable hydrophilic coatings can include demisters, defoggers, defrosters, polymers, and hydrogels, such as gelatin, colloids, and nanoparticles, such as titanium dioxide, or other suitable hydrophilic materials.

[0024] In another aspect of the invention, a coupler device for an endoscope having a light and a camera lens includes a body with an at least partially closed distal end and a proximal end configured to attach to a distal end portion of the endoscope. The coupler device further includes a visualization section between the light and camera lens of the endoscope and the target site to enable viewing of the target site using the scope. The coupler device further includes a first optical component on or within the visualization section configured to reduce reflected light and a second optical component on or within the visualization section configured to inhibit condensation of fluid on the visualization section.

[0025] In certain embodiments, the coupler device includes an open area, cavity, or channel that couples to the working channel of the endoscope to allow an instrument to pass through the coupler device and reach a desired viewing site captured through the coupler and scope. The instrument can be articulated by a variety of suitable means, such as a cable, elevator, piezoelectric material, micromotor, organic semiconductor, electroactive polymer, or other energy source or power source located either within the coupler device, on or within the endoscope, or both externally and appropriately coupled to the instrument.

[0026] In other embodiments, the coupler device includes a flexible working channel extension that extends through the working channel of the scope to provide angular adjustment. The flexible working channel extension can be adjustable by an elevator or a cable passing through the endoscope. Alternatively, the coupler device can include its own actuator, such as an elevator, cable, or similar actuation means, for adjusting the working channel extension and thereby articulating an instrument passing through the endoscope. The actuator can be powered by any suitable energy source, such as a motor. The energy source can be coupled to the actuator either directly through the scope or indirectly through a magnetic energy source, an electrical energy source, or any other energy source. The energy source can be located within the coupler device or external to the coupler device (i.e., located either at the proximal end of the scope or external to the patient).

[0027] In another aspect of the invention, a system includes the optical coupler described above with an endoscope, such as a side-viewing scope, such as a duodenoscope or an endoscopic ultrasound scope (EUS). The side-viewing scope includes a working channel, a light source, and a camera. One or more optical layers are disposed on either the light source, the camera, or both. The optical layer may include any of the anti-fog and / or anti-reflective layers described above. In this embodiment, the optical layer is disposed on the endoscope itself (i.e., between the camera lens and light source and the visualization section of the coupler device) rather than on the coupler device to reduce glare and / or condensation within the coupler device.

[0028] The scope can further include an actuator for adjusting the angle of the working channel extension of the optical coupler. In one embodiment, the actuator includes an elevator located within the distal end portion of the scope. In another embodiment, the actuator includes a cable extending through the scope. In these embodiments, the coupler device is configured to cooperate with the actuator or cable of the scope to articulate an instrument passing through the coupler device. In other embodiments, the coupler device includes its own actuator for articulating the instrument, eliminating the need for having a scope with an elevator or cable actuator. In yet other embodiments, the working channel extension of the coupler device does not articulate.

[0029] Coupler devices can be provided with endoscopes as single-use disposable accessories that allow users to change the exit angle of a device during advancement from the endoscope's working channel without exposing the distal end of the scope to bacteria, debris, fluids, and particulate matter. In some embodiments, the device attaches to the end of the endoscope and covers the endoscope's working channel with a working channel extension within the coupler device, allowing instruments to be advanced along the endoscope's working channel and into the working channel extension of the coupler device. The working channel extension can provide a seal against the scope working channel, so instruments can be advanced back and forth through the scope working channel and out the working channel extension of the coupler device without fluids and bacteria entering the area outside the scope working channel. This seal, in some embodiments, is achieved through the extension of the device working channel into the scope working channel, through a gasket on the end of the working channel extension, by temporary adhesive, through pressure and sealing of the entire device against the distal end of the scope, through selection of resilient and elastomeric materials, and other suitable alternatives.

[0030] In some embodiments, the device allows the user of the endoscope to articulate the working channel of the device in their preferred direction so that wires, catheters, or other instruments being advanced along the working channel of the endoscope can orient themselves in a preferred direction that is different from the angle at which the instruments would exit the endoscope if the coupler device or intra-scope elevator were not used. This redirection of the instrument has the benefit of aiding in device navigation without allowing fluids, debris, particulate matter, bacteria, and other undesirable elements to enter hard-to-clean areas of the endoscope, particularly the distal tip of the endoscope.

[0031] Benefits of the present invention include allowing a physician to change the exit angle so that one or more devices can be redirected to enter specific body lumens, such as the bile or pancreatic ducts or other difficult to reach areas, including non-medical procedures, while sealing the distal end of the scope to prevent infection and the ingress of debris and particulate matter into the internal elements of the scope that are difficult to reach for substantial cleaning.

[0032] In some embodiments, the device can be formed of an optically transparent material that covers and seals the end of the endoscope, allowing visualization by the endoscopic camera without the device obscuring the field of view. The optically transparent material can also cover the light guide of the endoscope to allow light projected by the endoscope to illuminate the field of view of the endoscope. In some embodiments, the optically transparent material can include navigational markers to guide a user when visualizing tissue, such as markers to identify the relative position of the scope as the user visualizes tissue.

[0033] In some embodiments, unlike current endoscope elevators, which can only deflect instruments within a single axis and thus change their path due to the limited range of motion of the endoscope elevator, which can only move up and down and cannot move left and right or articulate into other quadrants, the devices of the present invention can have multiple cables that allow the exit angle to be freely articulated in multiple directions, including various quadrants. In some embodiments, the cables can be attached directly to the working channel extension or to other devices that can be articulated to change the exit angle of the working channel extension, for example, including dowels encased within a device that is below the working channel extension but can be advanced back and forth to move the working channel extension as the cables are advanced and retracted. In some embodiments, the articulation capabilities of the coupler device can be created using an elevator that is embedded within the coupler device and is disposable, and therefore discarded after the procedure. Alternatively, the working channel extension can be fixed to prevent it from articulating.

[0034] The articulation capability of the coupler device may also occur using cable-less elements, including, for example, piezoelectric materials, micromotors, organic semiconductors, and electroactive polymers. In some embodiments, the articulation capability of the coupler device can be generated by the transmission of force to the working channel extension or recessed elevator through interlocking connectors that transmit force, twisting wires, slidable sheaths, and shape-memory alloys that change shape through the transmission of temperature. In some embodiments, the device includes a power connector or motor that delivers energy, including electromagnetic energy, to the device during or before passing an instrument through the device, resulting in the transmission of a force that changes the exit angle from the coupler device. This force transmission can include rotating the device as it exits the working channel extension. The device can be navigated and articulated directly by the user or as part of a robotic system in which user input is translated by the system through a variety of means including cables, power connectors, motors, electromagnetic energy, slidable sheaths, tactile means, computer-guided and guided input, and other means for guiding and directing the device to its intended location, including to specific diagnostic and therapeutic purposes within a patient or to a desired remote location in non-medical applications.

[0035] In some embodiments, the device can be configured to be integrated into the scope and detachable and reusable for separate cleaning, including manual cleaning, in an autoclave, ETO sterilizer, gamma sterilizer, and other sterilization methods.

[0036] In some embodiments, the coupler device can cover the entire distal end of the endoscope, or can cover only areas that are difficult to clean. In some embodiments, the coupler device can cover the distal end of the endoscope or a portion thereof, or it can include a sheath attached to the coupler device that covers the entire scope exposed to fluids, debris, particulate matter, bacteria, and other undesirable elements.

[0037] 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 present disclosure. Additional features of the present disclosure will be set forth in part in the following description, or may be learned by practice of the present disclosure.

[0038] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure. [Brief explanation of the drawings]

[0039] [Figure 1] 1 is a partial cross-sectional view of a proximal portion of an exemplary endoscope in accordance with the present disclosure. [Figure 2] 1 is a perspective view of a distal end portion of a side viewing endoscope in accordance with the present disclosure; [Figure 3A] 1 is an isometric view of an exemplary embodiment of a coupler device of the present disclosure in use with a duodenoscope. [Figure 3B] 1 is an isometric view of an exemplary embodiment of a coupler device of the present disclosure in use with a duodenoscope. [Figure 4A] 3B is a partial cutaway view of the coupler device and duodenoscope of FIG. 3A. [Figure 4B] FIG. 3C is a partial cutaway view of the coupler device and duodenoscope of FIG. 3B. [Figure 5] FIG. 3C is another cutaway view of the coupler device and duodenoscope of FIGS. 3A and 3B. [Figure 6] FIG. 3C is yet another cutaway view of the coupler device and duodenoscope of FIGS. 3A and 3B. [Figure 7] 3C is a cutaway side view of the coupler device and duodenoscope of FIGS. 3A and 3B in a first position. FIG. [Figure 8] 3C is a cutaway side view of the coupler device and duodenoscope of FIGS. 3A and 3B in a second position. FIG. [Figure 9] FIG. 3C is a cutaway side view of the coupler device and duodenoscope of FIGS. 3A and 3B in a third position. [Figure 10] FIG. 3C is an enlarged side view of a working channel extension with a membrane of the coupler device of FIGS. 3A and 3B. [Figure 11] FIG. 3C is a top view of the coupler device of FIGS. 3A and 3B. [Figure 12] FIG. 10 is a cutaway view of another exemplary embodiment of a coupler device of the present disclosure. [Figure 13] FIG. 13 is a cutaway side view of the coupler device of FIG. 12. [Figure 14] FIG. 14 is a cutaway side view of the coupler device of FIG. 13 in use with a duodenoscope. [Figure 15] FIG. 10 is an enlarged side view of an exemplary embodiment of a working channel extension of the present disclosure. [Figure 16] FIG. 16 is another enlarged side view of the working channel extension of FIG. 15. [Figure 17A] FIG. 16 is a perspective view of the working channel extension of FIG. 15. [Figure 17B] FIG. 17B illustrates the working channel extension of FIG. 17A in use with an instrument. [Figure 18] 4 is a perspective top view of the coupler device of FIG. 3 having locking features. [Figure 19] FIG. 10 is a perspective view of another exemplary embodiment of a working channel extension of the present disclosure. [Figure 20A] 10A-10C illustrate several embodiments of an anti-reflective coating on the visualization section of a coupler device in accordance with the present disclosure. [Figure 20B] 10A-10C illustrate several embodiments of an anti-reflective coating on the visualization section of a coupler device in accordance with the present disclosure. [Figure 20C] 10A-10C illustrate several embodiments of an anti-reflective coating on the visualization section of a coupler device in accordance with the present disclosure. [Figure 21] FIG. 10 illustrates an anti-fog coating on the visualization section of a coupler device in accordance with the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0040] This description and the accompanying drawings illustrate exemplary embodiments and should not be construed as limiting, with the claims defining the scope of the present disclosure, including equivalents. Various mechanical, compositional, structural, and operational changes may be made without departing from the scope of this description and the claims, including equivalents. In some instances, well-known structures and techniques have not been shown or described in detail so as not to obscure the present disclosure. Like numbers in two or more figures represent the same or similar elements. Furthermore, elements and related aspects described in detail with respect to one embodiment may, to the extent practical, be included in other embodiments in which those elements and aspects are not specifically shown or described. For example, an element may be described in detail with respect to one embodiment but not with respect to a second embodiment, yet still be claimed to be included in the second embodiment. Furthermore, the description herein is for illustrative purposes only and does not necessarily reflect the actual shape, size, or dimensions of the system or exemplary embodiments.

[0041] It should be noted that as used in this specification and claims, the singular forms "a," "an," and "the" include plural referents unless expressly and unambiguously limited to one referent. As used herein, the term "comprises" and its grammatical variations are intended to be open-ended such that the recitation of items in a list does not exclude other similar items that may be substituted for or added to such listed items.

[0042] While the following disclosure primarily relates to optical couplers or companion devices for use with optical imaging endoscopes, it should be understood that the device features of the present description can be readily adapted for use with a variety of reusable or single-use endoscopic scopes, instruments, and devices. The optical couplers of the present invention can be used as part of a surgical kit that includes a variety of different instruments or devices for use in a procedure. Such a kit is described in a commonly assigned, currently pending U.S. patent application entitled "Medical Device Kit with Endoscope Accessory," filed December 17, 2019, the entire contents of which are incorporated herein by reference for all purposes. One example of a coupler device for use with the present invention is described in commonly-assigned, co-pending PCT patent application PCT / US2016 / 043371, filed July 21, 2016, which claims the benefit of U.S. Provisional Patent Application No. 62 / 195,291, filed July 21, 2015, the complete disclosure of which is incorporated herein by reference for all purposes.

[0043] The term "endoscope" in this disclosure generally refers to any scope used on or in a medical application involving a body (human or otherwise), including, for example, laparoscopes, duodenoscopes, arthroscopes, colonoscopes, bronchoscopes, enteroscopes, cystoscopes, laparoscopes, laryngoscopes, sigmoidoscopes, thoracoscopes, cardioscopes, and saphenous vein harvesters using a scope, whether robotic or non-robotic.

[0044] A variety of scopes are used when engaging in remote visualization within a patient. The scope used depends on the extent to which the physician needs to navigate within the body, the type of surgical instruments used for the procedure, and the level of invasiveness appropriate for the type of procedure. For example, visualization within the gastrointestinal tract may require the use of endoscopy in the form of flexible gastroscopes and colonoscopes, endoscopic ultrasound scopes (EUS), and specialized duodenoscopes with lengths that may extend many feet and diameters that may be greater than one centimeter. These scopes can be turned, articulated, or steered by the physician as they are navigated through the patient. Many of these scopes include one or more working channels for supporting instruments through them, fluid and irrigation channels for irrigating tissue and cleaning the scope, an insufflation channel for insufflation to improve navigation and visualization, and a light guide for illuminating the scope's field of view.

[0045] Smaller, less flexible or rigid scopes, or scopes with a combination of flexibility and rigidity, are also used in medical applications. For example, smaller, thinner, and shorter scopes are used to examine joints and perform arthroscopic procedures, such as surgery on the shoulder or knee. When a surgeon uses arthroscopic surgery to repair a torn meniscus in the knee, a more rigid scope is typically inserted through a small incision on one side of the knee to visualize the injury, while instruments are passed through an incision on the other side of the knee. Instruments can irrigate the scope within the knee to maintain visualization and to manipulate tissue and complete the repair.

[0046] Other scopes can be used for diagnosis and treatment using minimally invasive endoscopic procedures, including, by way of example only, scopes for examining and treating conditions within the lungs (bronchoscopes), scopes for the mouth (enteroscopes), scopes for the urethra (cystoscopes), scopes for the abdomen and peritoneal cavity (laparoscopes), scopes for the nose and sinuses (laryngoscopes), scopes for the anus (sigmoidoscopes), scopes for the chest and thoracic cavity (thoracoscopes), and scopes for the heart (cardioscopes). Additionally, robotic medical devices rely on scopes for remote visualization of the area to be evaluated and treated.

[0047] These and other scopes can be inserted through natural orifices (mouth, sinuses, ears, urethra, anus, and vagina), as well as through incisions and port-based openings in a patient's skin, cavities, skull, joints, or other medically indicated entry points. Diagnostic uses of endoscopy through visualization with these medical scopes include investigating symptoms of disease such as digestive ailments (e.g., nausea, vomiting, abdominal pain, gastrointestinal bleeding), confirming diagnoses (e.g., by performing biopsies for anemia, bleeding, inflammation, and cancer), or surgically treating disease (e.g., removing a ruptured appendix or cauterizing intragastric bleeding).

[0048] Referring now to FIG. 1 , the present disclosure can include an optical viewing endoscope of the type described above. An exemplary endoscope 100 for use with the present disclosure includes a proximal handle 112 adapted for manipulation by a surgeon or clinician, which is coupled to an elongated shaft 114 adapted for insertion through a natural orifice or for endoscopic or percutaneous penetration into a patient's body cavity. The endoscope 100 further includes a fluid delivery system 116 coupled to the handle 112 through a universal cord 115. The fluid delivery system 116 can include several different tubes coupled to an internal lumen within the shaft 114 for delivery of fluids such as water and air, suction, and other features a clinician may desire to remove fluids, blood, debris, and particulate matter from the field of view. This provides a clearer view of underlying tissue or material for evaluation and therapy. In the exemplary embodiment, the fluid delivery system 116 includes a water jet connector 118, a water bottle connector 120, a suction connector 122, and an air pipe 124. Water jet connector 118 is coupled to an internal water jet lumen 126 that extends through handle 112 and elongated shaft 114 to the distal end of endoscope 100. Similarly, water jet connector 118, water bottle connector 120, suction connector 122, and air pipe 124 are each connected to internal lumens 128, 130, 132, 134, respectively, that pass through shaft 114 to the distal end of endoscope 100.

[0049] Endoscope 100 may further include a working channel (not shown) for passing instruments therethrough. The working channel allows for the passage of instruments along shaft 114 of endoscope 100 for evaluation and treatment of tissue and other materials. Such instruments may include cannulas, catheters, stents and stent delivery systems, papillotomes, wires, other imaging devices including miniscopes, baskets, snares, and other devices for use with an intraluminal scope.

[0050] The proximal handle 112 can include various controls that allow a surgeon or clinician to operate the fluid delivery system 116. In an exemplary embodiment, the handle 112 includes a suction valve 135, an air / water valve 136, and a biopsy valve 138 for extracting tissue samples from a patient. The handle 112 will also include an eyepiece (not shown), such as a lens and light transmission system, coupled to an image capture device (not shown). As used herein, the term "image capture device" does not necessarily mean a device having only a lens or other light-guiding structure. Instead, it is contemplated that the image capture device can be any device capable of capturing and transmitting an image, including, for example, (i) a relay lens between the objective lens at the distal end of the scope and the eyepiece, (ii) an optical fiber, (iii) a charge-coupled device (CCD), or (iv) a complementary metal-oxide semiconductor (CMOS) sensor. The image capture device can simply be a chip for sensing light and generating an electrical signal for communication corresponding to the sensed light, or other technology for transmitting an image. The image capture device can have a viewing end through which light is captured. In general, an image capture device can be any device that is capable of viewing, capturing an image, and / or capturing video of an object.

[0051] In some embodiments, endoscope 100 includes some form of positioning assembly (e.g., a manual controller) attached to the proximal end of the shaft to allow the operator to steer the scope. In other embodiments, the scope is part of a robotic element that provides steerability and positioning of the scope relative to the desired point to interrogate and focus the scope.

[0052] Referring now to FIG. 2 , the distal end portion of a side-viewing endoscope 150 (e.g., a duodenoscope or EUS) will now be described. As shown, the scope 150 includes a shaft 151 having a distal end portion 152 with an observation region 154 and an instrument region 156, both of which face laterally, or lateral to the longitudinal axis of the shaft 151. The observation region 154 includes an air nozzle port 158, a camera lens 160, and a light source 162 for providing a view of a target site within a patient. The instrument region 156 includes an opening 164 coupled to a working channel (not shown) in the shaft 151 of the scope 150. The opening 164 is configured to allow passage of an instrument from the working channel of the scope 150 to the target site. Preferably, the scope 150 further includes an articulation mechanism for adjusting the angle at which the instrument passes through the opening 164. In this exemplary embodiment, the articulation mechanism includes an elevator 166, however, one skilled in the art will recognize that the articulation mechanism can include a variety of other components designed to articulate the angle of the instrument, such as a cable extending through shaft 151.

[0053] Of course, it will be appreciated that the coupler device of the present invention can be used with a viewing scope, such as a gastroscope or colonoscope, etc. A more complete description of such a device can be found in commonly assigned, co-pending U.S. patent application entitled "Endoscope Accessory and Medical Device Kit," filed December 17, 2019, the complete disclosure of which is incorporated herein by reference for all purposes.

[0054] 3A and 3B illustrate an exemplary embodiment of a coupler device 10 of the present disclosure. The coupler device 10 functions as an accessory component for an existing endoscope. The device seals and covers areas of the scope prone to infection to prevent the entry of debris, fluids, or other undesirable substances that could potentially lead to bacterial contamination and reduced performance of the scope.

[0055] In certain embodiments, coupler device 10 provides a flexible working channel for inserting instruments into the scope. The flexible working channel can be easily angled. As shown, in a preferred embodiment, coupler device 10 can be used with a duodenoscope 40 or other side-viewing scope instrument. Of course, coupler device 10 can be adapted for use with end-viewing scopes. Furthermore, coupler device 10 of the present disclosure can be used with all types of scopes for various medical applications. The duodenoscope 40 shown herein is for illustrative purposes only.

[0056] Of course, it will be appreciated that instruments passing through the scope can be articulated by a variety of different mechanisms. For example, in some embodiments, unlike current endoscope elevators that can only deflect instruments in a single axis and therefore change their path due to the limited range of motion of the endoscope elevator, which can only raise and lower and cannot move left and right or articulate into other quadrants, the device of the present invention can have multiple cables that allow the exit angle to be articulated in multiple directions, including different quadrants. In some embodiments, the cables can be attached directly to the working channel extension or to other devices that can be articulated to change the exit angle of the working channel extension, for example, including dowels encased in a device that is below the working channel extension but can be advanced back and forth to move the working channel extension as the cables are advanced and retracted. In some embodiments, the articulation capabilities of the coupler device can be generated using an elevator that is embedded in the coupler device and is disposable, and therefore discarded after the procedure.

[0057] The articulation capability of the coupler device can be created using cable-free elements, including, for example, piezoelectric materials, micromotors, organic semiconductors, and electroactive polymers. In some embodiments, the articulation capability of the coupler device can be created by the transmission of force to the working channel extension or recessed elevator through interlocking connectors that transmit force, twisting wires, slidable sheaths, and shape-memory alloys that change shape through the transmission of temperature. In some embodiments, the device includes a power connector or motor that delivers energy, including electromagnetic energy, to the device during or before passage of an instrument therethrough, resulting in the transmission of a force that changes the exit angle from the coupler device. This force transmission can include rotating the device as it exits the working channel extension. The device can be navigated and articulated directly by the user or as part of a robotic system in which user input is translated by the system through a variety of means including cables, power connectors, motors, electromagnetic energy, slidable sheaths, tactile means, computer-guided and guided inputs, and other means for pointing and guiding the device to its intended location, including a desired remote location for specific diagnostic and therapeutic purposes within a patient or for non-medical applications.

[0058] 3A and 3B , coupler device 10 can include a body 12, a proximal end 14, a distal end 16, a lower surface 18, and an upper surface 20. Proximal end 14 mounts over the working end of a duodenoscope 40 and extends over the working end portion of the scope 40. Upper surface 20 can include a lens and light guide 24 and a scope flushing opening 28 used to force fluid through the scope camera to flush debris from the camera and also used to force air through the camera to dry the camera and insufflate the patient's gastrointestinal tract. Upper surface 20 can further include open areas above lens and light guide 24 and scope flushing opening 28 to facilitate viewing of the target site and to allow for the emission of fluid from and into the target site (and / or the emission of air that can be passed over light guide 24 to dry the camera or into a portion of the target site to insufflate the site). Additionally, top surface 20 includes flexible working channel region 30, which includes flexible working channel extension 34 and is surrounded by flexible membrane 38. This flexible membrane 138 acts as a protective hood or cover for the working end of coupler device 10, allowing for flexible articulation while keeping out debris, fluids, bacteria, or other undesirable materials.

[0059] As shown in Figures 4A and 4B, duodenoscope 40 can include a light guide 44, a lens 46, and an irrigation opening 48. Coupler device 10 cooperates with each of these components of scope 40 to provide a fully functional scope. Coupler device 10 does not interfere with the scope's ability to emit a clear image, but rather reduces the risk of contamination associated with each use. This benefit is achieved by providing coupler device 10 that attaches to the working end component of scope 40 and seals around the working end.

[0060] As further shown in Figures 3A, 3B, 4A, 4B, 5, and 6, coupler device 10 provides an extension of the scope's working channel 42. Working channel extension 34 of coupler device 10 of Figure 3 is flexible and can contact the scope's working channel 42 with a sealed connection at the working channel extension's proximal end 34a, as shown in Figure 6. The distal end 34b of working channel extension 34 serves as an exit portal for instruments to pass through scope 40 to access various parts of the body.

[0061] Additionally, coupler device 10 provides an additional seal around the scope elevator 50. Because coupler device 10 seals elevator 40, the risk of debris, ingress, fluid, bacteria, and other materials building up behind the elevator and working channel is significantly reduced. Ingress of debris, bacteria, and other materials is believed to be a contributing factor to drug-resistant infections associated with current scopes. While preventing ingress, coupler device 10 advantageously maintains flexibility for movement of working channel extension 34.

[0062] In use, the scope's working channel extension 34 allows for the passage of instruments along the scope's working channel 42 and through the working channel extension 34 of the device 40 for evaluation and treatment of tissue and other materials. Such instruments may include cannulas, catheters, stents and stent delivery systems, papillotomes, wires, other imaging devices including miniscopes, baskets, snares, and other devices for use with the scope within a lumen. The working channel extension 34 is sufficiently flexible that an elevator 50 of the scope 40 can raise and lower the working channel extension 34 so that instruments can be advanced along the working channel extension of the scope 40 and exit its distal end (or exit portal) 34b at various angles, or can be raised and lowered by a cable or other means for articulating the working channel extension 34.

[0063] As shown in Figures 7-9, during use when the elevator 50 of the scope 40 is actuated, the flexible working channel extension 34 of the coupler device moves or accommodates this actuation along direction AA. In Figure 7, the elevator 50 is raised slightly, creating a hinged ramp or shoulder that pushes the working channel extension 34 a corresponding angle, shifting the exit portal or distal end 34b of the working channel extension to the left. In Figure 8, the elevator is raised higher than in Figure 7, thereby shifting the distal end 34b of the working channel extension 34 further to the left as compared to Figure 7, whereas Figure 9 illustrates the elevator 50 raised even higher and the distal end 34b of the working channel extension 34 moved further to the left as compared to Figures 7 and 8.

[0064] 10 shows, the ability of distal end 34b of working channel extension 34 to shift along the width of working channel region 30 of coupler device 10 is due in part to distal end 34b itself being attached to flexible membrane 38. This flexible membrane 38 includes a plurality of relaxed folds or creases that allow excess material to stretch and flex as elevator actuation flexes or shifts the working channel extension in response. Additionally, flexible membrane 38 acts as a protective cover or hood for working channel region 38, preventing the intrusion of fluids, debris, or other undesirable materials from entering scope 40 and resulting in bacterial contamination or the injection of other undesirable fluids, debris, or particulate matter.

[0065] It is contemplated that the coupler device 10 of the present disclosure can be configured for single-use or can be configured for reuse. The coupler device 10 can be fabricated from any biocompatible material, such as silicone or another elastomeric or polymeric material. Additionally, the material can be transparent. As shown in FIG. 11 , the coupler device 10 can be formed from a transparent material to provide a transparent cover for the scope camera and light source, thereby allowing unobstructed performance of the scope 40.

[0066] 12-14 illustrate another exemplary embodiment of the coupler device 10 of the present disclosure. In this embodiment, the coupler device 10 is adapted for use with a scope that is actuated by a cable, eliminating the need for an elevator component. As shown, the coupler device 10 maintains the same structural features as described above, but now includes an additional disposable outer sheath 60 that can accept the scope's internal actuation cable 54. This cable 54 can be disconnected from the elevator and reattached to the flexible working channel extension 34 of the coupler device 10. In this embodiment, an elevator is no longer required, and actuation of the cable accomplishes movement of the working channel extension 34. The outer sheath 60 can be configured to be attached directly to the scope 40 by wrapping around the exterior of the scope or by a friction-fit connection. In embodiments, multiple cables can be included in one or more sheaths to enable articulation in other quadrants than the single-axis articulation using an elevator in current duodenoscopes.

[0067] In other embodiments, coupler device 10 can include a closable (i.e., self-sealing) port that allows for the injection of an anti-adhesion, anti-bacterial, anti-inflammatory, or other medication or injectable substance that prevents bacterial adhesion or colonization on the scope. An applicator can be provided integrated into coupler device 10 that has a port for delivery of the injectable substance. Alternatively, the applicator can be separate from coupler device 10 and attached to the distal end of scope 40. The injectable substance can include silver, platinum, copper, other anti-adhesion, anti-bacterial, anti-inflammatory, or other medication or injectable substance in a form that includes a gel or other solution that is compatible with the materials of the scope and coupler device and is biocompatible for patient use.

[0068] In one exemplary embodiment, the device includes an anti-infective material. In another exemplary embodiment, the device includes an anti-infective coating. In yet another embodiment, the device includes a coating that is hydrophobic. In yet another embodiment, the device is superhydrophobic. In yet another embodiment, the device is anti-infective and hydrophobic. In yet another embodiment, the device is anti-infective and superhydrophobic. In yet another exemplary embodiment, an anti-inflammatory coating is incorporated into the device. The anti-inflammatory coating may be hydrophobic.

[0069] In one exemplary embodiment, device 10 can include a silver ion coating. In another embodiment, device 10 can have a hydrogel applied, injected into, or made into a portion of device 10 in the area covering or extending around the scope elevator. In addition to its antibacterial properties, silver can also conduct electricity. Thus, in yet another embodiment, device 10 can include electrical wires or other power transfer points that allow for the generation of an electric field across the silver ion coating to improve the silver ion coating's ability to prevent infection. In some embodiments, the electrical wires or other power transfer points can also be made of other antibacterial and electrically conductive materials, including platinum and copper.

[0070] 15 and 16 illustrate another embodiment of a working channel extension 234 of the present disclosure. As envisioned, the working channel extension can comprise a variety of material combinations. For example, as shown in FIG. 15, the working channel extension 234 can be formed of multiple elastic materials bonded to a biocompatible metal. In some embodiments, one of the elastic materials can be PTFE, and another elastic material can be a biocompatible elastic material covering the biocompatible metal. In the example of FIG. 15, the working channel extension 234 can comprise an inner elastic material 210 and an outer elastic material. The exterior of the working channel extension 234 can include a biocompatible metal 230, which can take the form of a coil or winding 232. In one embodiment, the biocompatible metal can be encapsulated by one or more of the elastic materials.

[0071] In FIG. 16, an outer biocompatible elastic material 220 is formed to create a gasket 222 that seals the proximal end of the working channel extension 234 against the working channel of the endoscope to create a seal and prevent the ingress of unwanted bacteria, biological matter, and other materials into the sealed area.

[0072] In Figure 17A, working channel extension 234 is shown with an adjustable exit angle Θ to lock instrument 200 in place. In this embodiment, exit angle Θ, when adjusted, creates a compressive force within working channel 234, locking instrument 200 in place as shown in Figure 17B. This can be used to secure an instrument when advancing a wire through it, or to secure a wire while exchanging a second instrument through the wire.

[0073] 18 shows an alternative embodiment for locking instrument 200 in place. In this embodiment, working channel extension 234 is raised to a point where instrument 200 therein is pressed against lock 180 on device 100, causing a change in the exit angle of working channel extension 234 and locking instrument 200 in a fixed location within working channel extension 234.

[0074] In FIG. 19, an alternative embodiment of working channel extension 234 is shown with a flange 268 for attaching the working channel extension to membrane material 38 that is part of device 10.

[0075] 20A-20C illustrate an embodiment of a portion of an optical layer positioned on or within a visualization section 300 of one of the coupler devices of the present disclosure. Alternatively, the optical layer shown in FIGS. 20A-20C can be disposed on a camera lens of an endoscope. In one embodiment, the visualization section 300 preferably extends along a portion of the top surface 20 of the body 12 of the coupler device 10 opposite the light guide 44 and lens 46. Alternatively, the visualization section 300 can be positioned directly on the light guide 44 and lens 46. The visualization section 300 can comprise any suitable material, such as an optical material such as glass, polycarbonate, acrylic, clear gel or silicone, or other material having sufficient optical clarity to transmit an image.

[0076] The visualization section may comprise a substantially transparent film, sheet, layer, coating, wall, or other substrate positioned over the coupler device to allow light to pass therethrough. Alternatively, the visualization section may comprise an area within the body of the optical coupler comprising a substantially transparent material, such as a clear gel or similar material, that will allow light to pass therethrough.

[0077] In certain embodiments, the camera lens and light guide are directed laterally from the shaft of the endoscope (i.e., a side-viewing scope), and the visualization section is located on a lateral surface of the coupler device, so that light from the light guide passes through the coupler device to reach the target site. In other embodiments, the camera lens and light guide can be directed longitudinally from the shaft of the endoscope (i.e., an end-viewing scope), and the visualization section is located on a distal surface of the coupler device. In still other embodiments, the coupler device or endoscope can include mirrors or other light-reflecting surfaces to redirect the light passing to and from the camera and light guide to "align" the visualization section with the light guide and camera lens. In this last embodiment, the visualization section may not necessarily be directly opposite the camera light guide, as long as the mirror or other redirecting surface is configured to direct the light through the visualization section to the target site.

[0078] In an alternative embodiment, the visualization section 300 includes a visualization section extending within the body of the coupler and comprising a substantially clear gel material, such as silicone, silicone elastomer, epoxy, polyurethane, and mixtures thereof. Alternatively, the visualization section can comprise a material selected from hydrogels, such as polyvinyl alcohol, poly(hydroxyethyl methacrylate), polyethylene glycol, poly(methacrylic acid), and mixtures thereof. The material for the visualization section can be selected from albumin-based gels, mineral oil-based gels, polyisoprene, or polybutadiene. A more complete description of suitable transparent gels suitable for the present invention is disclosed in U.S. Pat. No. 8,905,921, the complete disclosure of which is incorporated herein by reference for all purposes.

[0079] As shown in FIG. 20A , the visualization section 300 comprises an inner surface 302 facing the light guide 44 and lens 46 and an opposite outer surface 304 facing the target site. In one embodiment, an optical layer 306 is positioned on the inner surface 302 of the visualization section 300. Of course, the optical layer 306 could also be disposed on the outer surface 304, or on both the inner surface 302 and the outer surface 304. Alternatively, the optical layer 306 could be disposed within the visualization section 300. Preferably, the optical layer 306 comprises an anti-reflective material that reduces total internal reflection of light passing through the optical layer 306 while substantially maintaining light transmission therethrough. In a preferred embodiment, the optical layer 306 comprises a different material than the visualization section 300, particularly a material having a different refractive index.

[0080] The optical layer 306 is preferably a thin, substantially transparent film that presents a double interface to light so that it and the visualization section 300 generate two reflected waves. The optical layer 306 creates an interference effect with the visualization section 300, thereby reducing the total percentage of reflected light without substantially reducing the transparency of the visualization section. These reflected waves, when out of phase, cancel each other out partially or completely, thereby reducing the total amount of light reflected from the visualization section 300. In certain embodiments, the optical layer 306 has a thickness of less than about 100 nanometers, preferably about 50 nanometers, and a lower refractive index than the visualization section 300. This causes the two reflections to be substantially out of phase with each other so as to maximize the amount of reflected light that cancels out without substantially reducing the overall transmittance of the visualization section 300 and the optical layer 306.

[0081] In certain embodiments, the optical layer 306 comprises a material that is substantially non-reflective in the mid-range wavelengths of the visible spectrum (i.e., from 400 nanometers to 700 nanometers). Suitable materials for the optical layer 306 can include magnesium fluoride, cerium fluoride, zinc oxide, aluminum oxide, and the like. In an exemplary embodiment, the optical layer comprises magnesium fluoride.

[0082] 20B, another embodiment of the present invention includes two optical layers 308, 310 positioned on the inner surface 302 of the visualization section 300. Each of the optical layers 308, 310 comprises a different material, preferably having a different refractive index than the visualization section 300. In an exemplary embodiment, one of the optical layers 308, 310 comprises magnesium fluoride, and the other optical layer comprises a suitable material such as cerium fluoride, zinc oxide, aluminum oxide, or the like.

[0083] 20C shows yet another embodiment of the present disclosure having three optical layers 312, 314, 316 on one of the faces of visualization section 300. As in the immediately preceding embodiment, each of the optical layers 312, 314, 316 comprises a different material having a different refractive index. In an exemplary embodiment, one of the optical layers comprises magnesium fluoride, one of them comprises zinc oxide, and the third optical layer comprises either aluminum oxide or cerium fluoride.

[0084] In yet another embodiment, the optical coupler of the present disclosure can include one or more optical components for absorbing stray light reflected from tissue surfaces and / or the surfaces of the coupler. Light passing through the visualization section of the optical coupler has a tendency to be reflected back to the camera lens or light source from tissue surfaces within the patient. This phenomenon can occur, for example, when an operator advances an endoscope from a smaller volume area within the patient, such as the intestine, to a larger volume area, such as an organ (e.g., the stomach). The larger volume area results in a greater amount of reflected light being reflected back into the coupler device and onto the camera lens of the scope. This reflected light creates glare that further limits the operator's ability to view the target area.

[0085] The optical components of the present disclosure can include light-absorbing material positioned in or on one or more areas of the coupler device, such as the visualization section or body. For example, light-absorbing material can be disposed on the body 12, the lower surface 18, the upper surface 20, the open areas above the lens and light guide 24, and over the scope flushing opening 28, within the working channel region 30, such as in or on the working channel extension 34 or flexible membrane 38 (see FIGS. 3 and 4).

[0086] The light-absorbing material is positioned to absorb reflected, scattered, or stray light from the patient's tissue and / or the surfaces of the optical coupler, thereby minimizing glare that may otherwise be caused by the reflected light. The light-absorbing material may be a thin black strip, a square, a circle, a rectangle, or other suitable shape positioned to absorb reflected light so that it does not interfere with the camera lens.

[0087] Alternatively, the optical components can include a baffle, such as a camera baffle, positioned on or within the coupler device. Preferably, the baffle includes one or more channels or vanes positioned and configured to direct reflected stray light away from the camera lens on the endoscope. The baffle can be designed to block light arriving from a light source outside the field of view (FOV) of the camera lens. Light outside the system's field of view should undergo multiple reflections on the system's surfaces, minimizing the intensity of light effectively reaching the camera lens. The interior surface can include a light-absorbing material or color, such as a blackened surface.

[0088] Baffles of the present disclosure may comprise tubes with vanes in their interior walls. These vanes are used to reduce the intensity of light reflected off these walls. Baffles may be positioned, for example, on or within the body 12, or on the lower surface 18 or upper surface 20. Alternatively, baffles may be positioned in the open areas above the lens and light guide 24 and scope cleaning opening 28, or within the flexible working channel region 30, such as in or on the working channel extension 34 or flexible membrane 38.

[0089] 21 illustrates another embodiment of the present invention that includes an optical layer 320 on or within one of the surfaces of the visualization section 300. In a preferred embodiment, the optical layer 320 comprises an anti-fog agent, treatment, or material positioned on the inner surface 304 of the visualization section 300 (or within the visualization section 300) to inhibit or prevent condensation of fluids, such as water, in the form of droplets on the visualization section 300, thereby improving the view of the target site within the patient. Alternatively, the optical layer 320 can be formed on the outer surface of the visualization section 300 or placed directly on the camera lens of the endoscope. The optical layer 320 is preferably designed to minimize surface tension to provide a non-scattering film of fluids, such as water, instead of individual droplets that would otherwise obstruct the view through the visualization section 300, similar to fog.

[0090] The optical layer 320 can be applied to the visualization section 300 as a spray solution, cream, gel, or the like, or can comprise a film coupled to the visualization section 300 or a chemical or additive manufactured within the visualization section 300. In one embodiment, the optical layer 320 comprises a surfactant configured to minimize the surface tension of water. Surfactants suitable for use with the present invention can have a nonionic, anionic, cationic, or amphoteric polarity and can include detergents, fatty acid soaps, dispersants, or other suitable materials that reduce the surface tension from water molecules on the visualization section, thereby reducing the number of water droplets that form on the exterior surface.

[0091] In another embodiment, the optical layer 320 comprises a hydrophilic coating configured to maximize the surface energy of the visualization section 300. Coatings suitable for use with the present invention include demisters, defoggers, defrosters, polymers, and hydrogels, such as gelatin, colloids, and nanoparticles, such as titanium dioxide, or other suitable hydrophilic materials.

[0092] In yet another embodiment, the optical layer 320 comprises chemicals or additives added to the visualization section 300 such that they leach from the inside of the visualization section 300 to the outer surface 304. These chemicals create a surface that inhibits the formation of water droplets.

[0093] All issued patents, published patent applications, and non-patent publications referred to herein above are hereby incorporated by reference in their entirety for all purposes to the same extent as if each individual issued patent, published patent application, or non-patent publication was specifically and individually indicated to be incorporated by reference.

[0094] Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the embodiments disclosed herein. It is intended that the specification and examples be considered as exemplary only, with the scope and spirit of the embodiments being indicated by the following claims. [Explanation of symbols]

[0095] 100 Endoscope 112 Proximal Handle 116 Fluid Delivery System 120 Water Bottle Connector 124, 128, 130, 134 Air pipes

Claims

1. 1. A coupler device for an endoscope having a light and a camera lens, comprising: a body having an at least partially closed distal end and a proximal end configured to attach to a distal end portion of the endoscope; a substantially transparent visualization section having a first refractive index positioned between the light and camera lens of the endoscope and a target site within a patient to enable viewing of the target site; an optical component on an inner surface of the visualization section and having a second refractive index different from the first refractive index so as to reduce the amount of light reflected from the surface of the visualization section; Equipped with 10. A coupler device, wherein the optical component further comprises a hydrophilic coating that inhibits condensation of fluid on the visualization section.

2. 10. The coupler device of claim 1, wherein the optical component comprises an anti-reflective coating disposed on the inner surface of the visualization section.

3. 10. The coupler device of claim 1, wherein the optical component comprises an optical layer configured to reduce a substantial portion of the reflected light within the visible range of light waves.

4. 10. The coupler device of claim 1, wherein the optical component comprises a magnesium fluoride coating.

5. 10. The coupler device of claim 1, wherein the optical component comprises two or more anti-reflection coatings.

6. 10. The coupler device of claim 1, wherein the visualization section comprises a substantially transparent viewing surface between the camera lens and the light and the target site.

7. The coupler device of claim 1 , wherein the visualization section comprises a substantially transparent material disposed within the body.

8. 10. The coupler device of claim 1, further comprising a second optical component on or within the visualization section, the second optical component configured to inhibit condensation of fluid on the visualization section.

9. 10. The coupler device of claim 1, further comprising a working channel extension within the body, the working channel extension having an open distal end and a proximal end configured for attachment to a working channel of the endoscope.

10. 10. The coupler device of claim 9, further comprising a mechanism for articulating an instrument passing through a working channel on the endoscope, wherein the working channel extension is flexible and angularly adjustable.

11. 10. The coupler device of claim 1, wherein the optical component comprises a light absorbing material positioned to reduce the amount of light reflected from a face of the coupler device.

12. 10. The coupler device of claim 1, wherein the optical component comprises a light absorbing strip on or within the visualization section of the coupler device, the light absorbing strip positioned to absorb stray light from inside the patient.

13. 10. The coupler device of claim 1, wherein the optical component comprises a baffle on the coupler device, the baffle having one or more vanes on the coupler device configured to direct stray light away from the camera lens.

14. 15. The coupler device of claim 14, wherein the optical component includes an optical layer comprising one or more chemicals applied to an outer surface of or within the visualization section, the chemicals configured to inhibit condensation of water on the visualization section.

15. 15. The coupler device of claim 14, wherein the optical component includes an optical layer comprising an anti-fog film applied to a surface of the visualization section.

16. 15. The coupler device of claim 14, wherein the optical component includes an optical layer comprising a surfactant configured to minimize the surface tension of water on the visualization section.

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