Endoscope speculum, system & method

Abstract

Various specula and features of specula are disclosed, including specula with soft tips, expanding bases, lumens along the specula, ways for affixing or securing specula to a patient, and methods and systems for using the improved specula. The speculum comprising a body having a first end with a first opening and a second end with a second opening with a diameter less than the first opening, and a lumen extending substantially from the first opening to the second opening.

Description

[0001]PDSD No.394.0002WO01 Endoscope Speculum, System & Method Field Embodiments herein relate to a speculum for endoscopic examination and medical procedures on a patient’s ear, as well as systems and methos for using the endoscope speculum, including in augmented reality applications. Summary The present disclosure is directed, in part, to improved specula for examination and therapeutic procedures in a patient’s ear. The improved specula can include a variety of features that allow for easier ear examinations, less discomfort for patients, and new and improved therapeutic procedures (such as saline field surgery). The improved features are such that multiple improvements can be made to specula depending upon the intended use. Thus, the subject matter relates to various specula and features of those specula, to those features combined into specific specula designs, methods and systems for using those specula, and also devices for securing the specula to a patient. These features and improvements include: speculum features / functions, ways for affixing or securing specula to a patient, and methods and systems for using the improved specula. The improvements allow for a wide range of specialized specula. Generally, these specula include features that are related to the exterior and interior of the specula, as well as features that are on the proximal (health care provider) region or distal (patient) region of the speculum. Some features are intermediate to the proximal and distal regions of the speculum. Also, it will be appreciated that specula can include a combination of these features. A brief overview of these improved features is provided below. Some of the improvements relate to the exterior of the specula. For example, this can include specula with flexible widths. In one implementation, the speculum has a slit down the side with an overlapping section so that the outer diameter can be varied to snuggly fit within the inner ear. Squeezing the speculum reduces the distal tip size allowing the doctor to use the speculum as a retractor. This design allows the speculum to be more adaptable to different ear sizes. The slit can be designed to PDSD No.394.0002WO01 extend all the way or partially to the proximal end of the speculum, and can also have an overlap or no overlap at the slit. In an example embodiment the distal (patient end) of the tip of the speculum is flexible. This flexibility can be implemented in various regards, including tips that are able to be readily bent, as well as some that are pre-bent. In some embodiments the speculum (and especially the tip) can be made of multiple materials. The speculum can include a living hinge at the distal end that readily adapts to the geometry of the patient’s inner ear. Thus, the tip can be flexible as well as have a certain bend molded into it. Also, the speculum can be made with flexible tips that can be formed using a single material for the whole speculum or using different materials. In some embodiments the tip is made of silicone, which can increase comfort for patients. The tip can optionally clip onto the base of the speculum to allow for different distal tip shapes and diameters. In some embodiments the design has a gasket seal. As noted above, in some embodiments the speculum is made of two components, such as partially of silicone, such as at the tip. A flexible silicone tip increases comfort for patients and decreases chance of injury. This can be especially true for pediatric applications. Such specula can be made, for example, in two shots on an injection mold, thus fusing the plastic and silicone pieces together. Various aspects of improved interiors for the specula are also disclosed. In some embodiments, multiple access lumens and access ports are possible. The speculum can come with a range of lumens for an endoscope. The lumens typically start on the interior of the proximal side and exits on the outside of the distal side of the speculum. Alternate opening shapes are possible, such as designs that widen the proximal end of the speculum while retaining the size of the distal tip. The specula can come multiple shapes including oval, clover, or more. Suction or irrigation specula are disclosed, including some to accommodate suction, irrigation, or endoscopes. Some such specula will include a silicone o-ring that creates a seal within the ear. The specula can include pigtail attachments for the suction and irrigation. An addition specula is on configured for stereoscopy, including with two parallel cameras that allow physicians to perform surgeries in 3D making for faster PDSD No.394.0002WO01 safter surgeries. Physicians can, for example, wear a headset (such as an OculusTMheadset) or 3D glasses to make use of the stereoscopic effect. Various ways of affixing a speculum to an ear are also disclosed, such as holding the speculum still relative to the patient's head. This can be done, for example, by using either staples, ear band, or gown clips. In an embodiment, a speculum, the speculum is included having a body having a first end with a first opening and a second end with a second opening with a diameter less than the first opening, a lumen extending substantially from the first opening to the second opening. In an embodiment, the body is formed of a polymeric material. In an embodiment, the body is substantially conical along at least a portion of its length between the first end and the second end. In an embodiment, the second opening is configured for insertion into the outer ear of a patient. In an embodiment, further can include a lumen extending substantially from the first opening to the second opening. In an embodiment, the speculum includes two lumens extending substantially from the first opening to the second opening. In an embodiment, the speculum includes three lumens extending substantially from the first opening to the second opening. In an embodiment, wherein body includes a proximal portion and a distal portion, the first and second portions joined by a flexible portion. In an embodiment, the body includes a proximal portion and a distal portion, the proximal portion and distal portion are formed of different materials. In an embodiment, wherein proximal portion of includes a more rigid material than the distal portion. In an embodiment, the distal portion of the body includes at least two finger extensions. In an embodiment, the at least two finger extensions are formed of the same material as the rest of the body. In an embodiment, a different material is provided between the at least two finger extensions. In an embodiment, the at least two finger extensions are formed of a material more rigid than the material between the at least two finger extensions. PDSD No.394.0002WO01 In an embodiment, further can include a slit along the body from the first end to the second end. In an embodiment, the slit allows for changing the diameter of the body. In an embodiment, further can include ratcheting teeth for holding the diameter of the body. In an embodiment, a speculum, the speculum is included having a body having a first end with a first opening and a second end with a second opening with a diameter less than the first opening, a flexible pivoting portion between the first end and second end of the body. In an embodiment, the body is formed of a polymeric material. In an embodiment, the body is substantially conical along at least a portion of its length between the first end and the second end. In an embodiment, the second opening is configured for insertion into the outer ear of a patient. In an embodiment, the speculum includes two lumens extending substantially from the first opening to the second opening. In an embodiment, the speculum includes three lumens extending substantially from the first opening to the second opening. In an embodiment, wherein body includes a proximal portion and a distal portion, the first and second portions joined by a flexible portion. In an embodiment, the body includes a proximal portion and a distal portion, the proximal portion and distal portion are formed of different materials. In an embodiment, wherein proximal portion of includes a more rigid material than the distal portion. In an embodiment, the distal portion of the body includes at least two finger extensions. In an embodiment, the at least two finger extensions are formed of the same material as the rest of the body. In an embodiment, a different material is provided between the at least two finger extensions. In an embodiment, the at least two finger extensions are formed of a material more rigid than the material between the at least two finger extensions. In an embodiment, further can include a slit along the body from the first end to the second end. PDSD No.394.0002WO01 In an embodiment, the slit allows for changing the diameter of the body. In an embodiment, further can include ratcheting teeth for holding the diameter of the body. In an embodiment, further can include one or more means to retain the speculum in a patient’s ear. In an embodiment, further can include a saline port. In an embodiment, further can include a suction port. In an embodiment a clip is included having a first portion for securing an endoscope, a second portion for securing to a tool for insertion of ear tubes into a patient. In some embodiments a flexible tip camera is used with a small diameter and high definition resolution. A flexible tip camera allows an angle to better view different areas of an ear canal / tympanic membrane depending on unique ear anatomy. Traditional rigid endoscopes come in 0°, 30°, 45°, and 70° models. The present application allows for 0° flexible endoscope, which can alter the flexible tip dynamically to achieve a range of 0 to 60 degree viewing angles dynamically and with one low-cost flexible camera. The design also allows for a fixed 0° 30°, 60° specialty speculums that may be required with unique ear canal anatomies and four unique ear canal procedures. The present disclosure allows for underwater surgery / ear irrigation / fogging / blood splatter. With modern rigid endoscopes in the ear, they fog up and get dirty with blood splatter or wax. With flexible endoscopes and with our the system of the present application it is possible to integrate irrigation and suction channels into the wall of the speculum. Just as a camera can been mounted on the periphery of the speculum to optimize working space in the inner diameter of the speculum, it is possible to peripherally mount irrigation and suction channels in the speculum. Irrigation and suction channels can allow for underwater visualization of the ear canal. Underwater visualization can eliminate fogging of the camera tip and also eliminate blood splatter which fogs up a camera tip slowing down surgery. Underwater surgery also allows mixing of vasoconstructive substances, like Afrin or epinephrine, or antibiotics into the saline irrigation, which further decreases bleeding, operative time, and surgeon fatigue. In surgery wasted time increases cost, complications, and surgeon fatigue. Underwater surgery can minimize rates of bleeding, infection and even deafness. PDSD No.394.0002WO01 Underwater surgery can also increase surgeries done in the clinic setting avoiding the cost of an operating room. The present disclosure includes embodiments comprising: A camera shaft that is accessed from the outside of the spectrum as opposed to the inside of the speculum. A dual lumen design such that when inserting the speculum the camera / viewing lumen collapses into a working lumen. The working lumen then opens up after insertion and the viewing lumen move to the periphery of the ear canal. This increases working space in the speculum without compromising visualization. In addition to keeping open a viewing port for deeper ear structures, part of the role of traditional rigid ear speculum are to prevent hair or wax from blocking the view through an otoscope or microscope. One hair in the ear proximal ear canal (so between the eyes and the desired deeper ear canal structures) impacts the depth of field of the eyes from the deeper ear canal structures. This need to maintain a viewing port does not require a round / rigid speculum nor is this current design ideal for ear canals that vary in shape (some more slit like, oval or oblong than uniformly round). In certain embodiments instead of using rigid plastic it is possible to use very flexible materials to achieve the function of keeping wax or ear hairs from blocking the field of view. The disclosure is also directed to a soft beveled speculum, including one with a flexible and dynamic function. In some embodiments beveled specs will not be rigid continuous plastic, but will have fingers that flex independently while maintaining rigidity. These flexible fingers in a beveled tip can both increase comfort to patients that are awake and help adapt to each patient's unique ear canal anatomy. In some embodiments the distal tip of the speculum is flared out. This flare will accommodate (with flares of various lengths, angles, rigid fingers, etc. ) the hourglass shape of the medial ear canal. Traditional tapering ear speculum designs are narrowest as the ear canal starts to open up and this minimizes both the viewing window and working window. Operating ear speculums have slightly improved upon viewing ear speculums by making the tip of their speculum beveled (top of speculum is longer than the bottom of the speculum. This bevel effectively increases the viewing and working PDSD No.394.0002WO01 inner diameter. Unfortunately, these beveled operating speculum, are rigid and thus don't increase or decrease in size like the present example speculum. Changing speculums in the operating room increases the cost of equipment needed and adds to the time of surgery. There are cases where ear canal trauma from rigid speculum actually lead the post-operative scarring of the ear canal which would require additional surgical treatment. Additionally, these beveled operating speculum do not have a flared distal tip. A flared distal tip in some situations further improves the operating view of an operating speculum. With a rigid speculum, a flared distal tip would be more prone to cutting and abrading the ear canal, leading to pain, bleeding, and potential infections / scarring. A flared out tip practically needs to be flexible to be used in an awake or sedated patient. In certain embodiments a flexible camera can be affixed centrally (or anywhere else in an ear speculum). The combination of a flexible camera or rigid camera acts to hold the rigid or flexible camera in place. The above-referenced features allow for improved examination and therapeutic treatments, along with improved systems and methods. including assisted imaging and stereoscopy. Also, as noted above, the various features described herein can be incorporated into use for saline field surgery. This summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details are found in the detailed description and appended claims. Other aspects will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which is not to be taken in a limiting sense. The scope herein is defined by the appended claims and their legal equivalents. Brief Description of the Figures Aspects may be more completely understood in connection with the following figures (FIGS.), in which: FIG.1 is a cross sectional view of the anatomy of human ear, showing a speculum inserted into the ear, as well as various internal ear elements. FIG.2 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. PDSD No.394.0002WO01 FIG.3 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.4 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.5 is a cross-sectional view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.6 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.7 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.8 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.9 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.10 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.11 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.12 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.13 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.14 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.15 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.16 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.17 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.18 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.19 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. PDSD No.394.0002WO01 FIG.20 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.21 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.22 is a photograph of two 3D-printed specula constructed and arranged in accordance with various embodiments herein. FIG.23 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.24 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.25 is a cross-sectional view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.26 is a photograph of a 3D-printed speculum constructed and arranged in accordance with various embodiments herein. FIG.27 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.28 is a perspective view of a speculum constructed and arranged in accordance with various embodiments herein. FIG.29 is a photograph of a 3D-printed speculum constructed and arranged in accordance with various embodiments herein. FIG.30 is a perspective view of a means for retaining a speculum on a patient constructed and arranged in accordance with various embodiments herein. FIG.31 is a perspective view of a speculum assembly for saline surgery, the assembly constructed and arranged in accordance with various embodiments herein. FIG.32 is a perspective view of a clip constructed and arranged in accordance with various embodiments herein. FIG.33 is a perspective view of a clip constructed and arranged in accordance with various embodiments herein. FIG.34 is a perspective view of a clip and device for inserting an ear tube into a patient’s ear, constructed and arranged in accordance with various embodiments herein. FIG.35 shows example specula with a retaining band constructed and arranged in accordance with various embodiments herein. PDSD No.394.0002WO01 FIG.36 shows example specula constructed and arranged in accordance with various embodiments herein. FIG.37 shows example specula with beveled soft tips constructed and arranged in accordance with various embodiments herein. FIG.38 shows example specula with a rigid base and flexible tip constructed and arranged in accordance with various embodiments herein. FIG.39 shows example molded specula with open lumen configurations constructed and arranged in accordance with various embodiments herein. FIG.40 show examples of a manufacturing technique for forming specula constructed and arranged in accordance with various embodiments herein. FIG.41 show examples of a manufacturing technique for forming specula constructed and arranged in accordance with various embodiments herein. FIG.42 show examples of a manufacturing technique for forming specula constructed and arranged in accordance with various embodiments herein. FIG.43 shows an example specula with lights and camera, such as used for augmented reality applications. While embodiments are susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example and drawings, and will be described in detail. It should be understood, however, that the scope herein is not limited to the particular aspects described. On the contrary, the intention is to cover modifications, equivalents, and alternatives falling within the spirit and scope herein. Detailed Description The present disclosure is directed, in part, to improved specula for examination and therapeutic procedures in a patient’s ear. The improved specula can include a variety of features that allow for easier ear examinations, less discomfort for patients, and new and improved therapeutic procedures (such as saline field surgery). The improved features are such that multiple improvements can be made to specula depending upon the intended use. Thus, the subject matter relates to various specula and features of those specula, to those features combined into specific specula designs, methods and systems for using those specula, and also devices for securing the specula to a patient. These features and improvements include: speculum features / functions, ways for PDSD No.394.0002WO01 affixing or securing specula to a patient, and methods and systems for using the improved specula. The improvements allow for a wide range of specialized specula. Generally, these specula include features that are related to the exterior and interior of the specula, as well as features that are on the proximal (health care provider) region or distal (patient) region of the speculum. Some features are intermediate to the proximal and distal regions of the speculum. Also, it will be appreciated that specula can include a combination of these features. A brief overview of these improved features is provided below. Some of the improvements relate to the exterior of the specula. For example, this can include specula with flexible widths. In one implementation, the speculum has a slit down the side with an overlapping section so that the outer diameter can be varied to snuggly fit within the inner ear. Squeezing the speculum reduces the distal tip size allowing the doctor to use the speculum as a retractor. This design allows the speculum to be more adaptable to different ear sizes. The slit can be designed to extend all the way or partially to the proximal end of the speculum, and can also have an overlap or no overlap at the slit. In an example embodiment the distal (patient end) of the tip of the speculum is flexible. This flexibility can be implemented in various regards, including tips that are able to be readily bent, as well as some that are pre-bent. In some embodiments the speculum (and especially the tip) can be made of multiple materials. The speculum can include a living hinge at the distal end that readily adapts to the geometry of the patient’s inner ear. Thus, the tip can be flexible as well as have a certain bend molded into it. Also, the speculum can be made with flexible tips that can be formed using a single material for the whole speculum or using different materials. In some embodiments the tip is made of silicone, which can increase comfort for patients. The tip can optionally clip onto the base of the speculum to allow for different distal tip shapes and diameters. In some embodiments the design has a gasket seal. As noted above, in some embodiments the speculum is made of two components, such as partially of silicone, such as at the tip. A flexible silicone tip increases comfort for patients and decreases chance of injury. This can be especially PDSD No.394.0002WO01 true for pediatric applications. Such specula can be made, for example, in two shots on an injection mold, thus fusing the plastic and silicone pieces together. Various aspects of improved interiors for the specula are also disclosed. In some embodiments, multiple access lumens and access ports are possible. The speculum can come with a range of lumens for an endoscope. The lumens typically start on the interior of the proximal side and exits on the outside of the distal side of the speculum. Alternate opening shapes are possible, such as designs that widen the proximal end of the speculum while retaining the size of the distal tip. The specula can come multiple shapes including oval, clover, or more. Suction or irrigation specula are disclosed, including some to accommodate suction, irrigation, or endoscopes. Some such specula will include a silicone o-ring that creates a seal within the ear. The specula can include pigtail attachments for the suction and irrigation. An addition specula is on configured for stereoscopy, including with two parallel cameras that allow physicians to perform surgeries in 3D making for faster safter surgeries. Physicians can, for example, wear a headset (such as an OculusTMheadset) or 3D glasses to make use of the stereoscopic effect. Various ways of affixing a speculum to an ear are also disclosed, such as holding the speculum still relative to the patient's head. This can be done, for example, by using either staples, ear band, or gown clips. The above-referenced features allow for improved examination and therapeutic treatments, along with improved systems and methods. including assisted imaging and stereoscopy. Also, as noted above, the various features described herein can be incorporated into use for saline field surgery. Reference will now be made to the figures. FIG.1 is a cross sectional view of the anatomy of human ear, showing a speculum 100 inserted into the ear 110, as well as various internal ear elements. The speculum gives access to the inner ear, with the tip of the speculum extending into the outer ear canal. Also shown in FIG.1 is the ear drum, middle ear, ear ossicles, oval window, round window, vestibule, semicircular canals, cochlea and eustachian tube. FIG.2 is a perspective view of a speculum 200 constructed and arranged in accordance with various embodiments herein, the speculum 200 including a base 210 that is the widest point in the speculum 200, along with a tip 220. The base is on the PDSD No.394.0002WO01 proximal (health care provider) end of the speculum 200 when in use, while the tip 220 is on the distal end of the speculum 200. The tip 220 is inserted into the outer ear of a patient during use. The speculum 200 in FIG.1 includes a slit 230 running along the length of the speculum from the base 210 to the tip 220. The slit 230 allows for the diameter of the speculum 200 to be changed during use, such as by compressing the speculum 200 into a smaller diameter for insertion into a patient’s ear. This allows the speculum 200 to be inserted with less discomfort to a patient, and also allows for insertion into the ear of patients with more narrow outer ear canals. FIG.3 is a perspective view of a speculum 300 constructed and arranged in accordance with various embodiments herein. The speculum 300 includes base 310, tip 320, and also hinge 330. In this embodiment the tip 320 is configured to flex along hinge 330 during insertion into the ear of a patient. Thus, the tip 320 is flexible and readily configures to a patient’s outer ear canal. Such design allows for less discomfort to patients, and accommodates variations in size and shape of a patient’s ear canal. FIGS.4 to 6 show an example of a speculum 400 with a soft tip 420. FIG.4 is a perspective view of the speculum 400 showing the exterior of the speculum 400, FIG.5 is a cross-sectional view of the speculum 400; FIG.6 is a perspective view of the speculum 400 from the base end showing the interior of the speculum 400. The speculum 400 includes a base 410 and a tip 420. In this example construction the speculum 400 is made of two materials: a flexible distal portion 424 and a more rigid proximal portion 426. The flexible distal portion 424 is generally made of a relatively flexible and soft elastomer that easily conforms and bends. FIG.7 is a perspective view of a speculum 700 constructed and arranged in accordance with various embodiments herein. Speculum 700 has a soft tip 720 made of a more flexible material than the wider proximal portion 726. The speculum 700 allows for a more comfortable placement into a patient’s ear, and also the flexible nature of the soft tip 720 allows for placement of with patients with curves to the ear canal, as well as narrow inner ear canals. FIG.8 is a perspective view of a speculum 800 constructed and arranged in accordance with various embodiments herein. The speculum 800 includes tip 820 and base 810, along with an interior lumen, such as for an endoscope camera. The interior lumen terminates at port 850 (the lumen is not shown, but in this embodiment would run along the interior of the specula 800). This embodiment allows for enhanced PDSD No.394.0002WO01 procedures, such as the ability to insert ear tubes into a patient while having an improved view by means of the endoscopic camera positioned through port 850. FIG.9 is a perspective view of a speculum 900 constructed and arranged in accordance with various embodiments herein including a base 910 and a lumen or channel 952 FIG.10 is a perspective view of a speculum 1000 constructed and arranged in accordance with various embodiments herein, including a base 1010, a lumen 1040 and a port 1050 for the lumen. An endoscope camera (not shown) can be inserted through the lumen 1040 and out through port 1050 for improved view of a patient’s ear. FIG.11 is a perspective exterior view of a speculum 1100 constructed and arranged in accordance with various embodiments herein, having a lumen down the interior of speculum 1100, and also the showing base 1110 and exit port 1150 for a lumen. FIG.12 is a perspective view of the speculum 1100 of Fig.11, showing entrance to the lumen 1140 as well as the exit port 1150 for the lumen 1140. FIGS.13 and 14 are perspective view of a speculum 1300 constructed and arranged in accordance with various embodiments herein, showing a three-lumen design, the lumens useful for providing access to an endoscope camera, as well as for providing (for example) irrigation and suction. The speculum 1300 includes three different exit ports 1352, 1354, and 1356. Port 1354 is connected by way of a lumen to access tube 1360, and port 1356 is connected to access tube 1362. Access tube 1360 and access tube 1362 can be used, for example for irrigation and suction purposes. FIG.15 and 16 are perspective views of a speculum 1500 constructed and arranged in accordance with various embodiments herein, the speculum 1500 including a base 1510 and a tip with opening 1522 at a distal end. The speculum 1500 includes lumen 1540 and 1542, through which endoscopic cameras or other devices 1560, 1562 (such as lights for illumination) can be inserted. FIGS.17, 18 and 19 are perspective views of a speculum 1700 constructed and arranged in accordance with various embodiments herein, including a base 1710, a lumen 1740 (with an open slot 1750 along its side to allow for variable diameter of inserted devices and flexibility in how insertion or removal of a device. The speculum 1700 includes an adjustable ratcheting side slot 1730 that can be closed or PDSD No.394.0002WO01 opened by engaging teeth 1732 and 1734 to narrow or widen the base 1710. Speculum 1700 also includes opening 1822 at its distal end. FIGS.20 and 21 are a perspective view of a speculum 2000 constructed and arranged in accordance with various embodiments herein. Speculum 2000 includes base 2010 and opening 2122, and a tip with two or more fingers 2044 separated by gaps 2046. The fingers 2044 allow for more flexibility in placement of the speculum 2000 because they are flexible. In some embodiments the speculum 2000 includes an adjustable ratcheting side slot that can be closed or opened by engaging teeth 2132 and 2134 to narrow or widen the base 2010. FIG.22 is a photograph of two 3D-printed specula 2220 constructed and arranged in accordance with various embodiments herein, in particular an embodiment of the specula shown in FIGS 20 and 21. FIGS.23 to 25 are perspective view of a speculum constructed and arranged in accordance with various embodiments, with similarities to the designs of FIGS.20 to 21 and 22, having somewhat rigid fingers 2334 separated by softer and more flexible portions 2332. The speculum 2300 includes a base 2310 and tip 2320. A lumen 2340 is also depicted in this embodiment. FIG.26 is a photograph of a 3D-printed speculum 2600 constructed and arranged in accordance with various embodiments herein, being an example embodiment of the designs shown in FIGS 23 to 25, with as base 2620 and flexible portions 2624 between more rigid fingers 2634. The speculum 2600 shown in FIG. 26 is a prototype design showing a functioning model, and is 3D-printed, but volume production would likely be molded, with the more rigid portions molded first and the flexible portions over molded onto the more rigid portions. FIG.27 and 28 are perspective views of a speculum 2700 constructed and arranged in accordance with various embodiments herein. The speculum 2700 includes an opening 2720, flexible (such as elastomer or rubber) portions 2732 and more rigid portions 2734. External ribs 2780 are further shown. FIG.29 is a perspective view of the a speculum constructed and arranged in accordance with various embodiments herein, showing opening 2920 and base 2910. FIG.29 is a photograph of a 3D-printed speculum 2900 constructed and arranged in accordance with various embodiments herein, in particular as an example implementation of the speculum of FIGS 27 and 28, showing base 2910, opening 2920, and ribs 2980. The speculum 2900 shown in FIG.29 is a prototype design PDSD No.394.0002WO01 showing a functioning model, and is 3D-printed, but volume production would likely be molded, with the more rigid portions molded first and the flexible portions over molded onto the more rigid portions. FIG.30 is a perspective view of a means for retaining a speculum on a patient constructed and arranged in accordance with various embodiments herein, showing straps 3012 and 3014, along with tabs 3016 and 3018 for securing to a patient (such as with hook-and-loop fasteners or otherwise. FIG.31 is a perspective view of a speculum assembly 3100 for saline surgery, the speculum assembly 31100 constructed and arranged in accordance with various embodiments herein, and includes tool ports 3102, 3104, and 3106. Example uses for these tool ports can be for an endoscope. In addition, a saline port 3180 and suction port 3182 are shown. FIG.32 is a perspective view of a clip constructed and arranged in accordance with various embodiments herein, the clip used (for example) to secure an endoscope or other camera device to a device for insertion of ear tubes into a patient. The clip 3200 includes openings 3270 and 3274 for securing the endoscope and tool, respectively (for example), while arms 3272 and 3276 surround these openings and latch onto the endoscope and tool. FIG.33 is a perspective view of a clip constructed and arranged in accordance with various embodiments herein, showing openings 3372 and 3374, along with arms 3376, 3377, 3378, and 3379 that surround openings 3372 and 3374. FIG.34 is a perspective view of a clip 3484 and the shaft ear tube insertion device for inserting an ear tube into a patient’s ear, constructed and arranged in accordance with various embodiments herein, showing an endoscope 3482 and the shaft 3486 of the ear tube insertion tool. FIG.35 shows example specula 3500 with a retaining band constructed and arranged in accordance with various embodiments herein. FIG.36 shows example specula 3600 constructed and arranged in accordance with various embodiments herein, showing a lumen 3610 for retaining an endoscopic camera. FIG.37 shows example specula 3700 with beveled soft tips 3720 constructed and arranged in accordance with various embodiments herein. PDSD No.394.0002WO01 FIG.38 shows example specula 3800, 3801, 3802, and 3803 (various embodiments), each with a rigid base 3810 and flexible tip 3820 constructed and arranged in accordance with various embodiments herein. FIG.39 shows example molded specula 3900 with open lumen 3940 configurations constructed and arranged in accordance with various embodiments herein. FIG.40 show examples of a manufacturing technique for forming specula 4000 constructed and arranged in accordance with various embodiments herein, using linked segments to form a lumen made with small segments over a cable. FIG.41 show examples of a manufacturing technique for forming specula 4100 constructed and arranged in accordance with various embodiments herein, using a separately molded lumen 4140. FIG.42 show examples of a manufacturing technique for forming specula 4200 constructed and arranged in accordance with various embodiments herein, using a curved pin 4280 that extends into the mold to form a lumen. FIG.43 shows an example specula 4300 with lights 4390 and camera 4392, such as used for augmented reality applications. This design integrates a digital camera into the speculum with lights (which are typically separate). The camera and lights can be mounted in a variety of configurations and locations around the periphery of the inner or outer diameter of the speculum tip. Separating the camera from the lights effectively increases the working distance of the inner diameter of the speculum, which effectively makes it easier to work in tighter spaces. As an example, a typical endoscopic ear camera may be 1.8 mm in diameter with the lights and camera all together. With these individual parts making up the 1.8 mm diameter deconstructed and mounted separately around the periphery of the speculum as opposed to obstructing the interlooming with 1.8 mm diameter in one spot, it is possible divide this obstruction in three separate spots and maximize the functional operating space within the inner diameter. The individual parts of endoscopic camera can be mounted on the inside or outside of the speculum through a channel on the outer or inner area of the speculum or these parts circumferentially enclosed with a cavity built within the structure of the speculum. It should be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content PDSD No.394.0002WO01 clearly dictates otherwise. It should also be noted that the term “or” is generally employed in its sense including “and / or” unless the content clearly dictates otherwise. It should also be noted that, as used in this specification and the appended claims, the phrase “configured” describes a system, apparatus, or other structure that is constructed or configured to perform a particular task or adopt a particular configuration. The phrase "configured" can be used interchangeably with other similar phrases such as arranged and configured, constructed and arranged, constructed, manufactured and arranged, and the like. All publications and patent applications in this specification are indicative of the level of ordinary skill in the art to which this invention pertains. All publications and patent applications are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated by reference. As used herein, the recitation of numerical ranges by endpoints shall include all numbers subsumed within that range (e.g., 2 to 8 includes 2.1, 2.8, 5.3, 7, etc.). The headings used herein are provided for consistency with suggestions under 37 CFR 1.77 or otherwise to provide organizational cues. These headings shall not be viewed to limit or characterize the invention(s) set out in any claims that may issue from this disclosure. As an example, although the headings refer to a “Field,” such claims should not be limited by the language chosen under this heading to describe the so-called technical field. Further, a description of a technology in the “Background” is not an admission that technology is prior art to any invention(s) in this disclosure. Neither is the “Summary” to be considered as a characterization of the invention(s) set forth in issued claims. The embodiments described herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art can appreciate and understand the principles and practices. As such, aspects have been described with reference to various specific and preferred embodiments and techniques. However, it should be understood that many variations and modifications may be made while remaining within the spirit and scope herein.

Claims

PDSD No.394.0002WO01 The Claims Are:

1. A speculum, the speculum comprising: a body having a first end with a first opening and a second end with a second opening with a diameter less than the first opening; a lumen extending substantially from the first opening to the second opening.

2. The speculum of claim 1, wherein the body is formed of a polymeric material.

3. The speculum of claim 1, wherein the body is substantially conical along at least a portion of its length between the first end and the second end.

4. The speculum of claim 1, wherein the second opening is configured for insertion into the outer ear of a patient.

5. The speculum of claim 1, further comprising a lumen extending substantially from the first opening to the second opening.

6. The speculum of claim 1, wherein the speculum comprises two lumens extending substantially from the first opening to the second opening.

7. The speculum of claim 1, wherein the speculum comprises three lumens extending substantially from the first opening to the second opening.

8. The speculum of claim 1, wherein body comprises a proximal portion and a distal portion, the first and second portions joined by a flexible portion.

9. The speculum of claim 1, wherein the body comprises a proximal portion and a distal portion, the proximal portion and distal portion are formed of different materials.PDSD No.394.0002WO01 10. The speculum of claim 9, wherein proximal portion of comprises a more rigid material than the distal portion.

11. The speculum of claim 1, wherein the distal portion of the body comprises at least two finger extensions.

12. The speculum of claim 11, wherein the at least two finger extensions are formed of the same material as the rest of the body.

13. The speculum of claim 11, wherein a different material is provided between the at least two finger extensions.

14. The speculum of claim 13, wherein the at least two finger extensions are formed of a material more rigid than the material between the at least two finger extensions.

15. The speculum of claim 1, further comprising a slit along the body from the first end to the second end.

16. The speculum of claim 15, wherein the slit allows for changing the diameter of the body.

17. The speculum of claim 15, further comprising ratcheting teeth for holding the diameter of the body.

18. A speculum, the speculum comprising: a body having a first end with a first opening and a second end with a second opening with a diameter less than the first opening; a flexible pivoting portion between the first end and second end of the body.

19. The speculum of claim 18, wherein the body is formed of a polymeric material.PDSD No.394.0002WO01 20. The speculum of claim 18, wherein the body is substantially conical along at least a portion of its length between the first end and the second end.

21. The speculum of claim 18, wherein the second opening is configured for insertion into the outer ear of a patient.

22. The speculum of claim 18, wherein the speculum comprises two lumens extending substantially from the first opening to the second opening.

23. The speculum of claim 18, wherein the speculum comprises three lumens extending substantially from the first opening to the second opening.

24. The speculum of claim 18, wherein body comprises a proximal portion and a distal portion, the first and second portions joined by a flexible portion.

25. The speculum of claim 18, wherein the body comprises a proximal portion and a distal portion, the proximal portion and distal portion are formed of different materials.

26. The speculum of claim 25, wherein proximal portion of comprises a more rigid material than the distal portion.

27. The speculum of claim 18, wherein the distal portion of the body comprises at least two finger extensions.

28. The speculum of claim 27, wherein the at least two finger extensions are formed of the same material as the rest of the body.

29. The speculum of claim 27, wherein a different material is provided between the at least two finger extensions.

30. The speculum of claim 29, wherein the at least two finger extensions are formed of a material more rigid than the material between the at least two finger extensions.PDSD No.394.0002WO01 31. The speculum of claim 18, further comprising a slit along the body from the first end to the second end.

32. The speculum of claim 31, wherein the slit allows for changing the diameter of the body.

33. The speculum of claim 31, further comprising ratcheting teeth for holding the diameter of the body.

34. The speculum of claim 18, further comprising one or more means to retain the speculum in a patient’s ear.

35. The speculum of claim 18, further comprising a saline port.

36. The speculum of claim 18, further comprising a suction port.

37. A clip, the clip comprising: a first portion for securing an endoscope; a second portion for securing to a tool for insertion of ear tubes into a patient.

38. A speculum, the speculum comprising: a body having a first end with a first opening and a second end with a second opening with a diameter less than the first opening; a means for retaining at least one light source; and a means for retaining a camera.

39. The speculum of claim 38, wherein the means for retaining at least one source comprises a lumen.

40. The speculum of claim 38, wherein the means for retaining at least one source comprises a lumen.PDSD No.394.0002WO01 41. The speculum of claim 38, wherein the light source and camera are positioned within the interior body of the speculum near its second end.

42. The speculum of claim 38, wherein the light source and camera are positioned within the exterior body of the speculum near its second end.

43. A system for augmented reality medical procedures, the system incorporating the speculum of claim 38.

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