WO2021209809A1

WO2021209809A1 - Office endoscope

Info

Publication number: WO2021209809A1
Application number: PCT/IB2021/000222
Authority: WO
Inventors: Eran Bendory; Ehud Bendory; Tal Shchory; Gil Hefer
Original assignee: 3Nt Medical Ltd.
Priority date: 2020-04-17
Filing date: 2021-04-06
Publication date: 2021-10-21

Abstract

An endoscope (10, 40) for visualizing an ear, nose or throat of a patient may include a handle (12, 42), a shaft (30) slidably coupled with the handle (12, 42), and a connector (18) at or near a proximal end of the handle for connecting with a cable (20). In some embodiments, the endoscope (10, 40) may also include a contact tip (14, 44) removably attached to a distal end of the handle (12, 42) and including a lumen (45) with an opening (47) at a distal end (43) of the contact tip (14), where the shaft (30) translates in and out of the opening (47). The handle (12, 42) may also include an actuator (16, 46) for moving the shaft (30) through the lumen (45) of the contact tip (14, 44) and in and out of the opening (47) on the contact tip (14, 44).

Description

OFFICE ENDOSCOPE

TECHNICAL FIELD

[0001] This disclosure is related to medical devices and methods. More specifically, the disclosure is related to an endoscope for use in physician offices for ear, nose and throat visualization.

BACKGROUND

[0002] Many different types of ear, nose and throat procedures are performed in a physician’s office, rather than in a hospital or surgery center. Most of such procedures are performed while the patient is awake, and many require the use of some type of visualization device, typically an endoscope. For example, procedures performed in the nasal cavity or the paranasal sinuses usually require the physician to use an endoscope, inserted into the nostril, to view the procedure. Procedures performed in the ear also typically require the use of a microscope, but an endoscope can also be used.

[0003] The traditional endoscopes typically used by otolaryngologists (ear, nose and throat (or “ENT”) doctors) in their offices have several shortcomings. They are relatively large and unwieldy. They can be heavy in the physician’s hand, and they typically have a relatively long shaft, thus forcing the physician to hold the handle of the endoscope in mid-air, above the patient’s face or head. Due to their size, endoscopes may also be intimidating to a patient, who sees a large metal rod (the endoscope shaft) as something that will hurt if it is advanced into his/her nose or ear, for example. Another issue is that endoscopes are typically uni-directional, with a straight, non-adjustable shaft that provides only one view in the forward direction. The straight, rigid shaft can be difficult or impossible to navigate around tight comers in a small passageway like the ear canal or a nasal cavity. And if the physician wants to look toward one side or around a comer, this typically requires using a different, angled endoscope or a more complicated swing prism endoscope, neither of which is commonly part of an otolaryngologist’s office.

Additionally, endoscopes are expensive, reusable equipment, which must be sterilized between uses. The sterilization process may delay procedures and can be inconvenient for physicians.

[0004] For all these reasons, it would be desirable to have endoscopes for in-office ear, nose and throat medical procedures. In some cases, such endoscopes might also be used by other physicians for procedures in other parts of the body. Ideally, the endoscopes would be versatile, easy to use, low profile and not intimidating for patients. At least some of these objectives are addressed in this application.

BRIEF SUMMARY

[0005] This disclosure describes various embodiments of a device, system and method for visualizing structures in the ear, nose and throat. The device, system and method, and variations thereof, may also be used in other locations in the body. Therefore, although the following descriptions and examples focus primarily on ear, nose and throat applications, this focus should not be interpreted as limiting the scope of this disclosure. Furthermore, the devices and method described herein may be used as part of any suitable diagnostic or therapeutic otolaryngology procedure. For ease of description, otolaryngology procedures will be generally referred to as “ENT procedures,” and this term encompasses any and all such procedures.

[0006] Generally, the device described herein includes a low profile, single-use endoscope, including a handle and a shaft, connected to a reusable cord. In some embodiments, the system includes simply the endoscope (handle and shaft with camera in shaft) and the reusable cord. In other embodiments, an optional contact tip is disposed over the endoscope shaft. The shaft advances out of a hole in the end of the contact tip or can alternatively be used without the contact tip. Due to the small size, ease of use and other features of the endoscope, it is often referred to herein as an “office endoscope,” meaning that it is configured for use in a physician’s office to perform office-based diagnostic and/or therapeutic procedures. The endoscope may also be used, however, in an operating room or emergency room of a hospital, in ambulatory surgery center, or in any other suitable patient care setting. Thus, the term “office endoscope” is used for convenience and should not be interpreted as limiting the scope of this disclosure.

[0007] These and other aspects and embodiments are described in further detail below, in relation to the attached drawing figures.

BRIEF DESCRIPTION OF THE DRAWINGS [0008] Fig. 1 is a perspective view of an office endoscope with cable, according to one embodiment;

[0009] Fig. 2 is a top view of the endoscope of Fig. 1, illustrating the connector for connecting with a cable; [0010] Fig. 3 is a perspective view of an office endoscope, according to an alternative embodiment;

[0011] Figs. 4A and 4B are perspective and side views, respectively, of the endoscope of Fig. 3, with the contact tip removed;

[0012] Fig. 4C is a perspective view of the same endoscope, with the contact tip removed and the endoscope shaft fully advanced;

[0013] Figs. 5A and 5B are side cross-sectional and perspective cross-sectional views, respectively, of an office endoscope having a connector inside the handle for connecting with a cable, according to an alternative embodiment;

[0014] Fig. 5C is a close-up, cross-sectional view of the proximal end of the handle of the device of Figs. 5 A and 5B, showing the internal connector;

[0015] Figs. 6A-6C are side views of the office endoscope, illustrating a method for advancing the endoscope shaft out of the contact tip, using the slider, according to one embodiment;

[0016] Fig. 7 is a perspective view of a patient with a physician positioning an office endoscope in the patient’s ear, according to one embodiment;

[0017] Fig. 8 is a close-up perspective view of a portion of the handle of the office endoscope;

[0018] Fig. 9 is a side view of the office endoscope, illustrating a distal bend in the malleable endoscope shaft, according to one embodiment;

[0019] Figs. 10A and 10B are perspective and top views, respectively, of the endoscope, illustrating a proximal bend in the malleable endoscope shaft, according to one embodiment;

[0020] Figs. 11 A-l 1C are three different perspective views of the endoscope, illustrating proximal and distal bends in the malleable endoscope shaft, according to one embodiment;

[0021] Figs. 12A and 12B are perspective views of a proximal end of a handle of an office endoscope and a battery /wireless module, according to one embodiment;

[0022] Fig. 13 is a perspective view of the endoscope handle of Figs. 12A and 12B, along with multiple battery/wireless modules and a docking station, according to one embodiment;

[0023] Figs. 14A and 14B are side views of an alternative embodiment of an office endoscope, shown with the shaft in a retracted/non-extended configuration (Fig. 14A) and an extended configuration (Fig. 14B); [0024] Fig. 14C is a perspective, partial cross-sectional view of a dial and shaft of the office endoscope of Figs. 14A and 14B;

[0025] Fig. 15A is a side view of a distal portion of an office endoscope in a straight configuration, according to one embodiment; and

[0026] Fig. 15B is a side view of the distal portion of the endoscope of Fig. 15 A, illustrated in a curved configuration.

DETAILED DESCRIPTION

[0027] This disclosure describes a low-profile endoscope designed primarily but not exclusively for use by otolaryngologists to visualize structures in the ear, nose and throat for diagnostic purposes and/or for visualization while performing medical or surgical procedures in the office (or other settings, as appropriate). In its various embodiments, the endoscope described herein has many advantages over the large, traditional endoscopes used by otolaryngologists in the office. For example, the endoscope is disposable (or “single-use”), which eliminates the need for cleaning and sterilization, as well as the risk of cross-patient contamination associated with a reusable endoscope. Since an ENT physician may perform as many as 20-40 endoscopies in one day, repeated cleaning and sterilization of an endoscope may be cumbersome, time consuming, costly, and unreliable in terms of consistently ensuring sterility and lack of contamination. Although disposable, the endoscope described herein minimizes waste by being connectable to a reusable cable (for power, video monitor and/or the like). This is less wasteful than having a cable that is also disposable. The cable can also be provided sterile, so that a user decides if it is going to be single-use or multi-use.

[0028] The endoscope described herein is also easy to connect and set up for use, leading to an efficient, short endoscopy session. Furthermore, in some embodiments, the endoscope shaft can be concealed within a cover (or “contact tip”), thus reducing the likelihood that patients (both children and adults) will be scared or intimidated by the endoscope. The endoscope shaft is also malleable, thus allowing it to be bent by the physician before use. This may allow for more ergonomic hand positions during the procedure and/or eliminate the need for angled scopes when viewing sinuses or other anatomies. The contact tip on some embodiments of the endoscope can be pushed against, and thus used for support on, the patient’s nose or nasal cavity, ear canal, etc. This may allow the physician to rest his or her hand on the patient’s face or head and thus help reduce or eliminate movement of the physician’s hand relative to the awake patient’s head and allow the physician to easily stabilize his or her hand. The endoscope may also help with desensitizing the patient during the diagnostic or therapeutic procedure, because the larger contact tip may be used to contact the patient first, and then the smaller diameter endoscope shaft is advanced and touches the patient second. Finally, the endoscope is more versatile than currently available scopes, in that it may be used with or without the contact tip, with or without a bent/angled shaft, for diagnostic procedures or therapeutic procedures, etc. Additionally, in some embodiments, the contact tip may include other functionality, such as but not limited to one or more working channels for irrigation, suction, passage of tools, and/or the like.

[0029] Referring now to Figs. 1 and 2, a low-profile, office-based endoscope 10 according to one embodiment is illustrated in perspective view and top view, respectively. The endoscope 10 generally includes two main parts: the endoscope itself and a cable 20, which is used to connect the endoscope to a power source, video monitor, laptop or desktop computer, tablet computer and/or the like. In this disclosure, the term “the endoscope” may be used either to mean an endoscope by itself, without a cable, or the combination of an endoscope and a cable. The manner in which the term is used should be apparent by referring to the corresponding drawing figure.

[0030] In this embodiment, the endoscope 10 includes a handle 12, a contact tip 14, an endoscope advancement slider 16, and a cable connector 18. The cable 20 includes an endoscope attachment end 22 and a box/ video console/laptop attachment end 24, which for simplicity will be referred to herein as a video attachment end 24. In use, the physician places or advances the contact tip 14 on or in a patient’s ear, nose or throat. The physician then slides the advancement slider 16 distally along the handle 12 to advance the endoscope shaft (not visible in Fig. 1) out of a hole in the distal end of the contact tip 14 and into the area the physician wants to visualize. When the physician is done, she slides the advancement slider 16 proximally, to retract the endoscope shaft back into the contact tip 14, and then removes the endoscope 10 from the patient. She can also simply remove the endoscope 10 without retracting the endoscope shaft back into the contact tip. In this embodiment, the endoscope 10 is a single-use, disposable device, and the cable 20 is a multi-use, reusable device, thus reducing waste versus devices that have disposable cables. In some embodiments, the cable 20 may be provided sterile, so that a user (physician, hospital, etc.) may choose whether to use it as a singe-use component or a multi-use component that can be disinfected or sterilized between uses. In the illustrated embodiment, the endoscope 10 includes an LED and an image sensor (distal chip) at the distal tip for providing light. In alternative embodiments, where LED is not used, the cable 20 may additionally attach to a light source.

[0031] Fig. 2 illustrates one embodiment of the cable connector 18, which extends off of the proximal end of the handle 12 of the endoscope. As described further below, in one alternative embodiment, a cable connector may be located inside the proximal end of the handle 12. In another alternative embodiment, the endoscope may be wireless and cordless and may be powered by battery, for example.

[0032] Fig. 3 is a perspective view of an alternative embodiment of an office endoscope 40. Many of the features of the endoscope 40 are the same as, or similar to, those of the endoscope 10 of Figs. 1 and 2, the main difference being the way the cable connects to the endoscope 40. In the embodiment of Fig. 3, the endoscope 40 includes a handle 42 with a proximal end 49, a contact tip 44 with a bulbous distal end 43, an endoscope shaft slider 46 that slides along a slot 50 and locks into place via a notch 52, and other internal features that will be described in relation to subsequent figures. In this embodiment, the cable connects to a connector located inside of the proximal end 49 of the handle 42, as described further below.

[0033] Figs 4A and 4B are perspective and side views, respectively, of the same embodiment of the endoscope 40, with the contact tip 44 removed. Fig. 4C is a perspective view of the endoscope 40, with the contact tip 44 removed and the endoscope shaft 30 and slider 46 advanced. (The LED and image sensor referred to above are located in the distal end of the endoscope 30 and is not visible in Figs. 4A-4C ) In some embodiments, the endoscope shaft 30 has an outer diameter of about 3 mm or less, or more ideally about 2.7 mm or less, and in one embodiment about 2.2 mm. In some embodiments, the endoscope shaft 30 has a length of about 50 mm to about 150 mm, or more ideally about 80 mm to about 130 mm. The shaft 30 may be made of stainless steel or any other suitable metal or polymer, according to various embodiments. In some embodiments, the endoscope shaft 30 is rigid, while in other embodiments the shaft 30 is malleable. The contact tip 44 may have any suitable size and shape, according to various embodiments. In the illustrated embodiment, for example, the contact tip 44 has a wide proximal end, tapers along its length, and then widens to form the bulbous distal end 43. This is only one exemplary shape, however, and the shape may be altered in other embodiments.

[0034] In one method of use, the endoscope shaft 30 is not advanced out of the distal end of the contact tip 44 until the distal end 43 is placed in contact with the patient, for example resting against an ear canal opening or a nostril. The endoscope shaft 30 is then advanced out of the distal end 43, to visualize the target area. When the endoscope 40 is used this way, the patient never sees the endoscope shaft 30, thus helping alleviate potential fear or concern. Additionally, since the distal end 43 of the contact tip 44 is large, relative to the anatomical opening (nostril or ear), once it touches the anatomical opening, it desensitizes the tissue from feeling the advancement of the smaller diameter endoscope shaft 30.

[0035] In some embodiments, the endoscope shaft 30 is malleable, so the physician can bend the shaft 30 to a desired angle for a procedure. To take advantage of the malleable feature, the contact tip 44 is removed (as in Figs. 4A-4C), and the physician bends the shaft 30 to a desired angle before inserting into the patient. To take advantage of this malleable feature, the endoscope 40 will be used without the contact tip 44 for that particular procedure. Thus, the endoscope shaft 30 will be more visible, but the ability to bend/angle the malleable shaft may be more important than keeping the shaft 30 hidden, especially in more interventional procedures. The shaft advancement slider 46 may be replaced with any other suitable actuator, in alternative embodiments. For example, the slider 46 may be replaced with a button, a rotation dial or the like. With a rotational dial, the rotational motion of the dial may be converted into linear translation of the endoscope shaft 30.

[0036] Figs. 5A and 5B are side cross-sectional and perspective cross-sectional views, respectively, of the office endoscope 40. Fig. 5C is a close-up cross-sectional view of the proximal end 49 of the handle 42, illustrating various features thereof. In addition to the features described above, Figs. 5A-5C show an internal lumen 45 extending through the handle 42 and the contact tip 44 and ending in a distal hole 47 on the contact tip 44. The endoscope shaft 30 slides back and forth through the lumen 45 and is attached proximally to the slider 46. Also illustrated is an internal connector 48 located inside the proximal end of the handle 42 for connecting with a cable (not shown). In this embodiment, the internal connector 48 is located inside the handle 42, rather than extending off the back of the handle 42. Thus, the connecting end of the cable (or “cord”) extends into the proximal end 49 of the handle 42 to connect to the internal connector 48. This configuration may help preserve a sterile field during a procedure, because the reusable cable extends into the handle 42 and is therefore less likely to be touched by the physician. Fig. 5C shows the proximal end 49 of the handle 42 and the connector 48 in greater detail.

[0037] Referring now to Figs. 6A-6C, a method for using the endoscope 40 is illustrated, according to one embodiment. Fig. 6A shows the endoscope 40 with the shaft 30 retracted inside the contact tip 44 and thus not visible. In this position, the slider 46 is in a most proximal position along the handle 42. The physician may insert the distal end 43 of the contact tip 44 into the patient’s ear, nose or throat with the endoscope 40 in this configuration and may use the contact tip 44 to support the endoscope 40 against tissue in the area that will be visualized and/or to desensitize an opening in the nose, ear or throat to the advancement of the endoscope shaft 30 into the anatomy that will follow immediately after.

[0038] Fig. 6B shows the endoscope shaft 30 partially advanced (hollow-tipped arrow) out of the hole in the distal end 43 of the contact tip 44. The slider 46 is moving forward (or distally), as indicated by the solid-tipped arrow. Fig. 6C shows the shaft 30 completely extended. In various embodiments, the endoscope shaft 30 may extend approximately 50 mm or less out of the distal end 43 of the contact tip 44. The endoscope shaft 30 may be used for visualization in either a partially extended configuration or a completely extended configuration. After a procedure is complete and the endoscope 40 is no longer needed, the endoscope shaft 30 may be retracted back into the contact tip 44, and the endoscope 40 may be removed from the patient. Alternatively, the endoscope 40 may simply be removed from the patient while the endoscope shaft 30 is still extended (in other words, without first retracting the endoscope shaft 30 into the contact tip 44). The embodiment of the method just described in relation to Figs. 6A-6C may be employed, for example, when the endoscope 40 is used for diagnosis.

[0039] In any of the embodiments described herein, the low-profile, single-use endoscope 40 may include a mechanism to ensure that the device is only used once and thus to prevent re-use and eliminate potential cross-contamination risk. In one embodiment, for example, once the user connects anew endoscope 40 to the video console for the first time (via a cable in some embodiments or wirelessly in others), a timer in the video console or in the endoscope 40 will trigger and enable operation of the endoscope 40 for a pre-set duration of time, for example no more than three hours. Alternatively, the mechanism may allow the endoscope 40 to operate only when it is connected to the video monitor for the first time. Once the endoscope 40 is disconnected from the video console, it will stop working and will not operate if reconnected to the console. In some embodiments, the mechanism may be a combination of both of the methods just described. In some embodiments, the safety /single-use mechanism may be based on a memory chip embedded within the single-use endoscope 40, without a battery in the endoscope 40, so that it is powered and kicks into action only once it is connected to the video console. In order to avoid inadvertent shutdown of the endoscope 40 in case it is inadvertently disconnected, the timer may be built into the memory chip embedded in the endoscope 40, so that when re-connected to the video console, the endoscope 40 will go back into operation with a remaining time as logged in the internal timer. The algorithm controlling the turning on/off of the endoscope 40 may alternatively be software based and part of the software of the video console.

[0040] In alternative embodiments, the contact tip 44 of the endoscope 40 may include one or more additional features, other than the lumen through which the endoscope shaft 30 slides. For example, the contact tip 44 may include one or more working channels, such as but not limited to channel(s) for suction, irrigation and/or passage of a tool for performing a procedure. In some embodiments, the light source for the endoscope 40 may be located on the contact tip 44 rather than on the endoscope shaft 30.

[0041] Fig. 7 shows a patient and a physician’s hand holding the endoscope 10 (of Figs.

1 and 2) in a position with the contact tip 14 in the patient’s ear. With the contact tip 14 stabilized relative to the patient’s head, if the patient moves, the contact tip 14 will move with the head. In various embodiments, the physician may move the slider 16 (or alternatively another type of actuator) with his thumb or index finger. The physician may also rest one or more fingers of the same hand on the patient’s head, for further stabilization.

[0042] Fig. 8 is a perspective view of a portion of the handle 42 of the endoscope 40, showing in greater detail the slider 46, the slot 50 and the locking notch 52. In this embodiment, when the slider 46 is advanced to its most distal/forward position in the slot 50, the slider 46 locks into place in front of the notch 52. This locking mechanism may help retain the endoscope shaft in the most-advanced position. Alternative embodiments may include multiple notches 52 along the slot 50, to facilitate incremental advancement and locking of the slider 46 along the length of the slot 50. Other alternative embodiments might not have any notches.

[0043] Referring to Fig. 9, as mentioned above, an alternative method for using the endoscope 40 involves removing the contact tip 44 before use, bending the endoscope shaft 30 to a desired angle (or multiple angles), and inserting the endoscope shaft 30 into the patient without using the contact tip 44. This method might be advantageous for use in longer procedures, such as therapeutic procedures involving the use of other devices in the ear, nose or throat. In such procedures, the endoscope shaft 30 and the other tool(s) may be used in the anatomy at the same time. In this embodiment of the method, the slider 46 may be fully advanced and locked in position to fully advance the endoscope shaft 30. The physician then bends the endoscope shaft 30 to a desired angle, for example to form a distal bend 32. The physician then inserts the angled endoscope shaft 30 and uses the endoscope 40 for visualization of anatomy as desired. The bending point can be located at any suitable position along the endoscope shaft 30, according to different embodiments. In some embodiments, the entire endoscope shaft 30 may be malleable. In other embodiments, only one or more portions of the shaft 30 may be malleable, thus dictating where the shaft 30 may be bent. The ability to form the distal bend 32 in the shaft 30 may eliminate the need for a physician to have multiple, rigid, angled endoscopes (e.g., 30, 45 and 70 degrees).

[0044] Figs. 10A and 10B illustrate another example of bending (or “angling”) the endoscope shaft 30. In this embodiment, a proximal bend 34 is made by the physician. When formed proximally as in Figs. 10A and 10B, the bend 34 allows more space to insert additional tools alongside the endoscope 40, since the handle 42 and therefore the user’s hand are at an angle and out of the way.

[0045] According to various embodiments, the malleable endoscope shaft 30 may be shaped into any other shape the user might prefer, to better fit the shape of the target anatomy. For example, the shaft 30 may be bent into an arch-like shape to help the physician better access a frontal sinus of a patient with the endoscope 40. The physician may bend the shaft 30 to any desired angle, as long as the bend is not so severe that it compromises the structure of the shaft 30. For example, the shaft 30 may be bent to approximately a 45-degree angle to visualize a frontal paranasal sinus. Bending the malleable shaft 30 may help allow the physician to see a structure or area around a comer within the patient’s anatomy and may also allow the physician to have a better view into the patient’s anatomy, without having her hand block the view. Furthermore, the bend or bends may be made at any suitable locations in the endoscope shaft 30. It may be disadvantageous and risk damaging the shaft 30 if it is bent too close to the distal end or too close to the proximal end, but otherwise any suitable locations may be used for bending.

[0046] Figs. 11 A-l 1C illustrate another embodiment of a method for bending the endoscope shaft 30, in which both a distal bend 32 and a proximal bend 34 are formed. In one embodiment, the endoscope shaft 30 may be partially advanced, and the user may form the distal bend 32 in the partially advanced configuration by using the distal end of handle 42 as a torqueing point to easily bend the partially advanced endoscope shaft 30 at a location immediately adjacent to distal end of handle 42. The shaft 30 may then be fully advanced, and the proximal bend 34 may then be formed. Alternatively, both bends 32, 34 may be formed after the endoscope shaft 30 is fully advanced. In any of the shaft bending methods described above, the physician may bend the shaft 30 by simply using his or her hands, or alternatively or additionally a bending tool may be used. The bending tool may be any suitable tool for bending an endoscope shaft, including any currently available tool or a custom bending tool.

[0047] Referring now to Figs. 12A and 12B, a proximal end 63 of another alternative embodiment of an office endoscope 60 with an internal connection 68 is illustrated. In this embodiment, instead of connecting to a multi-use cable, the handle 62 of the endoscope 60 attaches to a multi-use battery/wireless module 70, which includes a battery and a wireless communication module for transmitting the video stream captured by the endoscope 60 to a video console, personal computer, video box, smart tablet, or whatever viewing device is being used. Fig. 12A shows the battery/wireless module 70 disconnected from the handle 62, and Fig. 12B shows the battery /wireless module 70 inserted into the proximal end 63 of the handle 62 and connected to the connector 68. The reusable (“multi-use”) battery/wireless module 70 allows the endoscope 60 to be wireless while also reducing the amount of waste and cost that would occur if the battery and/or wireless transmission components were disposable. The battery /wireless module 70 rests completely within the proximal end 63 of the handle 62 when inserted, so the physician will not contact it during use, thus helping preserve the sterile surgical field

[0048] Fig. 13 is a perspective view of the distal end 63 of the endoscope handle 62 and multiple rechargeable battery/wireless modules 70 docking in a docking station 80. This simply illustrates one possible embodiment of a docking station 80 for storage and recharging of the battery/wireless modules 70. In alternative embodiments, any other suitable device(s) may be used for docking and/or recharging.

[0049] Referring now to Figs. 14A and 14B, an alternative embodiment of an endoscope 100 is illustrated. The endoscope 100 includes a handle 102 with a locking dial 110, a sliding shaft 104 with a camera (not visible) at its distal end 106, and a reusable cable 108 attached to a proximal end of the handle 102. In some embodiments, the cable 108 is provided separately and thus not part of the endoscope 100. Optionally, the endoscope may include a contact tip. Fig. 14A illustrates the shaft 104 in a retracted or non-extended position. Fig. 14B shows the shaft 104 in an extended position. To extend the shaft 104, the user turns the locking dial 110, which releases a locking mechanism from around the shaft 104 and allows it to slide out of the handle 102. One type of locking mechanism, for example, involves the locking dial 110 compressing a conformable material down onto the shaft 104 to lock it in place. Tuohy Borst adapters are one example of the type of locking mechanism that may be used. In alternative embodiments, the locking dial 110 may include any other suitable locking mechanism for locking the shaft 104 longitudinally, relative to the handle 102. When the locking dial 110 is turned to a loose position, the user may simply use two fingers (thumb and index finger, for example) to slide the shaft 104 out of the handle 102 to achieve a desired length. The user may push the shaft 104 out and pull the shaft 104 back as necessary. The user then turns the locking dial 110 in the opposite direction to lock the shaft 104 in place longitudinally for use. If the user later wishes to adjust the length of the shaft 104 again, she may repeat this process and make the shaft 104 longer or shorter, as desired. With this simple mechanism, the handle 102 and the overall endoscope 100 may be made small, lightweight and thin, for easy handling and good ergonomics.

[0050] Referring now to Fig. 14C, in some embodiments, in addition to locking the shaft 104 in place longitudinally, the shaft 104 may also locked rotationally, relative to the handle 102, to prevent the shaft 104 from rotating relative to the handle 102. To prevent shaft rotation, the handle 102 may include an anti-rotation member 112. As shown in Fig. 14C, the anti-rotation member 112 may have a shape, such as the square with rounded comers in this embodiment, which fits within a similarly shaped inner cavity of the handle 102. The anti-rotation member 112 is attached to the shaft 104 (or to a piece attached to the shaft 104) and cannot rotate within the handle 102, thus preventing the shaft 104 from rotating within the handle 102. Preventing rotation of the shaft 104 is important, because the user may easily lose his sense of orientation of the camera of the endoscope if the shaft 104 could rotate. The user will also often bend the shaft 104 to help reach a desired location in the patient’s anatomy, so maintaining orientation of the bend (or bends) in the shaft 104 is critical to the function of the endoscope 100. Whether the locking dial 110 is in its locked or unlocked position, the anti -rotation member 112 will still prevent rotation of the shaft 104 relative to the handle 102. In alternative embodiments, the anti-rotation member 112 and the corresponding inner portion of the handle 102 may have any suitable alternative shapes.

[0051] Referring now to Figs. 15A and 15B, a distal portion of one embodiment of an endoscope shaft 120 is illustrated in side view. Fig. 15A shows the endoscope shaft 120 in a straight configuration, and Fig. 15B shows the endoscope shaft 120 in a curved or bent configuration. This embodiment of the endoscope shaft 120 may be included in any of the endoscope embodiments described in this application. The endoscope shaft 120 includes a shaft body 124 that ends in a distal end 122, multiple cuts 126 in the shaft body 124, and a cover material 128 over the shaft body 124. The shaft body 124 is hollow and may have a number of cross-sectional shapes in various embodiments, such as round, tubular, ovoid, and rectangular. In some embodiments, the shaft body 124 may have a first cross-sectional shape along a first part of its length and a second cross-sectional shape along a second part of its length (and optionally one or more additional shapes). For example, the shaft body 124 may be round along most of its length and have a rectangular portion at the distal end 122, to accommodate the camera located inside the distal end 122. Such a rectangular distal end 122 may facilitate a one-piece shaft body 124, where the camera head is part of the distal end 122 of the shaft body 124. The camera/LED may pass through the lumen of the shaft body 124, from the camera at the distal end 122 proximally to the handle (not shown) at the proximal end of the shaft 120.

[0052] In many embodiments, the shaft body 124 is malleable, at least along a portion of its length, so that a user can bend it in one or more locations to better access a given anatomical structure or area with a patient’s body. For example, the shaft body 124 may be malleable along its entire length (or a majority of its length) proximal of the cut portion. Shaft malleability is described in further detail above, and any of the malleability features and functions described above may be applied to this embodiment of the endoscope shaft 120. In one example, the shaft body 124 may be a one-piece structure, for example made of a hollow metal tube such as a hypotube, and the material and size of the shaft body 124 may make it malleable. In various embodiments, all or a portion of the shaft body 124 may be heat treated, to make it more easily bendable. In other embodiments, the shaft body 124 may be made of a rigid plastic, such as poly ether ether ketone (PEEK) or polyetherimide (such as Ultem®). Other embodiments may use a composite structure for shaft body 124, such as but not limited to a metal spiral embedded in plastic.

[0053] The cuts 126 in the portion of the shaft body 124 near the distal end 122 allow that portion of the shaft 120 to be bent by the user up to, but not beyond, a certain angle.

As illustrated in Fig. 15B, when the user bends the shaft at the cuts 126, the solid portions of the shaft body 124 between the cuts 126 will eventually contact one another and prevent further bending. The cuts 126 thus allow for bending of the shaft 120 very close to its distal end 122, while preventing over-bending that might compromise the structural integrity of the shaft body 124. In various embodiments, the shaft body 124 may include any suitable number, shape and pattern of cuts 126.

[0054] The cover 128 over the shaft body 124 may be made of any suitable plastic or polymeric material. In some embodiments, the cover 128 may be made of a non-compliant material to prevent accidental bending of the shaft body 124 in the cut portion in the direction away from the openings of the cuts — in other words, in the opposite direction from the intended bending direction shown in Fig. 15B. The material of the cover 128 may be, for example, PEEK or polyethylene terephthalate (PET). The cover 128 may be disposed over the entire length of the shaft body 124 in some embodiments, or alternatively it may be placed over just the cut portion or may extend over the cut portion and slightly farther on either side beyond the cut portion. Since the bend axis of the cut portion of the shaft body 124 located at the bottom of the shaft body 124 (per the orientation of Fig. 15A), the non-compliant material of the cover 128 experiences very slight elongation and mostly compression that peaks at the upper side of the shaft body 124. This compression of the non-compliant material of the cover 128 causes it to collapse inward into the cuts 126 or outward away from the cuts 126. If the user were to try to bend the endoscope shaft 120 downwards (i.e., in the opposite direction from that shown in Fig. 15B), instead of compression, most of the non-compliant material of the cover 128 will experience elongation. Since the material cannot elongate, bending in the opposite/undesired direction is inhibited.

[0055] The above description is believed to be complete and accurate. The invention is not limited, however, to what has been particularly shown and described above in terms of various embodiments. Rather, the description of embodiments is provided primarily for exemplary purposes, and the scope of the invention is defined only by the claims, which follow.

Claims

CLAIMS We claim:

1. An endoscope for visualizing an ear, nose or throat of a patient, the endoscope comprising: a handle; a shaft slidably coupled with, and at least partially retractable into, the handle; a connector at or near a second end of the handle for connecting with a cable; and an actuator on the handle for moving the shaft from a retracted position, in which the shaft is at least partially retracted into the handle, and an extended position, in which at least a majority of the shaft is located outside of the handle.

2. The endoscope of claim 1, further comprising a contact tip removably attached to a first end of the handle and comprising a lumen with an opening at a distal end of the contact tip, wherein the actuator moves the shaft through the lumen of the contact tip and in and out of the opening on the contact tip.

3. The endoscope of claim 1, further comprising a locking mechanism on the handle for locking the shaft in the extended position to prevent the shaft from translating longitudinally or rotating relative to the handle.

4. The endoscope of claim 1, wherein the endoscope is disposable after a single use.

5. The endoscope of claim 1, wherein the shaft is malleable.

6. The endoscope of claim 1, wherein the shaft further comprises multiple cuts along one side of the shaft, closer to a distal end than to a proximal end of the shaft, to prevent over-bending of the shaft.

7. The endoscope of claim 1, wherein the shaft has an outer diameter of 2.7 mm or less.

8. The endoscope of claim 1, wherein the shaft has a length of between 80 mm and 130 mm.

9. The endoscope of claim 1, wherein the actuator is selected from the group consisting of a slider, a dial and a button.

10. The endoscope of claim 1, wherein the connector is located inside the handle.

11. The endoscope of claim 1 , further comprising a mechanism in the handle for deactivating the endoscope after one use to prevent reuse.

12. A system for visualizing an ear, nose or throat of a patient, the system comprising: an endoscope, comprising: a handle; a shaft slidably coupled with the handle, and at least partially retractable into, the handle; a connector at or near a second end of the handle; and an actuator on the handle for advancing the shaft from a retracted position, in which the shaft is at least partially retracted into the handle, and an extended position, in which at least a majority of the shaft is located outside of the handle; and a reusable cable connectable with the connector of the endoscope, for connecting the endoscope to at least one of a power source, a light source or a video monitor.

13. The system of claim 12, wherein the endoscope further comprises a contact tip removably attached to a first end of the handle and comprising a lumen with an opening at a distal end of the contact tip, wherein the actuator moves the shaft through the lumen of the contact tip and in and out of the opening on the contact tip.

14. The system of claim 12, wherein the endoscope further comprises a locking mechanism on the handle for locking the shaft in the extended position to prevent the shaft from translating longitudinally or rotating relative to the handle.

15. The system of claim 12, wherein the connector extends off of the second end of the handle, and wherein the reusable cable connects to the second end of the handle.

16. The system of claim 12, wherein the connector is located inside the handle, and wherein the reusable cable connects to the connector inside the handle.

17. The system of claim 12, further comprising a mechanism located in at least one of the endoscope, the cable or a device attached to the endoscope via the cable, for deactivating the endoscope after one use to prevent reuse.

18. A method for visualizing an ear, nose or throat of a patient, the method comprising: advancing a shaft of an endoscope out of a handle of the endoscope; bending a shaft of an endoscope at a location along the shaft that is closer to a distal end than to a proximal end of the shaft; advancing the distal end of the shaft into the ear, nose or throat of the patient; visualizing an area in the ear, nose or throat; and removing the endoscope from the patient.

19. The method of claim 18, further comprising positioning a contact tip of the endoscope into contact with tissue of the patient, at or near the area in the ear, nose or throat to be visualized.

20. The method of claim 18, further comprising retracting the shaft at least partway back into the handle before removing the endoscope from the patient.

21. The method of claim 18, further comprising resting a portion of a hand of a user of the endoscope on the patient’s head.

22. The method of claim 18, further comprising locking the shaft relative to the handle to prevent the shaft from translating longitudinally or rotating relative to the shaft.

23. The method of claim 18, wherein advancing the shaft comprises actuating an actuator on a handle of the endoscope, and wherein the actuator is selected from the group consisting of a slider, a dial and a button.

24. The method of claim 18, further comprising deactivating the endoscope after one use, using a mechanism located in at least one of the endoscope, the cable or a device attached to the endoscope via the cable.

25. A method for visualizing an ear, nose or throat of a patient, the method comprising: bending a shaft of an endoscope; inserting the bent shaft of the endoscope into the patient; visualizing an area in the ear, nose or throat; and removing the endoscope from the patient.

26. The method of claim 25, further comprising removing a contact tip from a handle of the endoscope before bending the shaft.

27. The method of claim 25, wherein bending the shaft comprises forming an angle of less than 90 degrees in the shaft.

28. The method of claim 25, further comprising resting a portion of a hand of a user of the endoscope on the patient’s head.

29. The method of claim 25, further performing a procedure on the ear, nose or throat while visualizing the procedure with the endoscope.

30. A system for visualizing an ear, nose or throat of a patient, the system comprising: a single-use endoscope, comprising: a handle; a shaft slidably coupled with the handle; a contact tip removably attached to a first end of the handle and comprising a hole; a connector at or near a second end of the handle; and an actuator on the handle for advancing the shaft out of and back into the hole on the contact tip; and a reusable battery /wireless module connectable with the connector of the endoscope, for providing power to the endoscope and transmitting images from the endoscope to a video monitor.

31. The system of claim 30, further comprising a recharging station for recharging the battery/wireless module.

32. An endoscope for visualizing an ear, nose or throat of a patient, the endoscope comprising: a handle with a proximal end and a distal end; a malleable shaft coupled with the handle and slidable longitudinally out of the distal end of the handle; a locking member on the handle for locking the shaft longitudinally relative to the handle; an anti-rotation member in the handle for preventing the shaft from rotating relative to the handle; and a connector at or near the proximal end of the handle for connecting with a power cable.

33. The endoscope of claim 32, wherein the locking member comprises a dial at or near the distal end of the handle.

34. The endoscope of claim 32, wherein the anti-rotation member comprises a shaped piece coupled with the shaft and located inside a corresponding shaped cavity inside the handle.

35. The endoscope of claim 32, wherein the shaft comprises a distal portion near a distal end of the shaft that includes multiple cuts to provide for bending of the distal portion in a direction of openings of the cuts.