Ear visualization system

An ear endoscope device for use in a surgical procedure in an ear includes a handle, a visualization shaft extending from the handle, a tool guide extending from the handle parallel to the visualization shaft and configured to guide a tool into the ear with the visualization shaft, an imaging sensor at a distal end of the visualization shaft, and a light source. In some embodiments, the ear endoscope is combined with a suction device. In other embodiments, it may be combined with another tool.

BACKGROUND

Middle ear surgery is performed on patients for a number of different reasons, most commonly for chronic recurring ear infections. When performing middle ear surgery, the ear, nose and throat (ENT) surgeon (or “otolaryngologist”) typically visualizes the middle ear and the surgical procedure in one of two ways. In some cases, the surgeon uses a microscope, positioned in front of the surgeon's eyes, and she typically uses her non-dominant hand to hold a suction device and her dominant hand to hold a surgical tool. In other cases, the surgeon uses a handheld endoscope to visualize the middle ear. The use of a handheld endoscope is problematic in several different ways.

First, standard endoscopes have long shafts and are not made for use in the ear. When the ENT surgeon uses an endoscope in the ear, he has to hold the handle of the scope up in the air, over the patient's head, with the surgeon's hand suspended in the air, unsupported. This factor alone is problematic, because if the surgeon accidentally moves his unsupported hand during surgery, he could very easily move the distal end of the endoscope in a way that could damage the tympanic membrane or one or more of the delicate structures of the middle ear.

Second, compounding on the first issue, endoscopes are generally much heavier than the small, thin surgical tools used in middle ear procedures. The surgeon thus has an ergonomic imbalance between a relatively heavy endoscope in her non-dominant hand and a relatively light surgical device in her dominant hand. This imbalance adds to the difficulty in stabilizing the endoscope. Additionally, holding a heavy endoscope suspended over the patient's head during a surgical procedure may quickly lead to arm and hand fatigue for the surgeon.

Third, since the surgeon is holding the endoscope in one hand, that hand is no longer free to hold a suction device or a surgical tool. Thus, when an endoscope is used for visualization, the surgeon cannot use a suction device and visualize the inside of the ear at the same time.

Fourth, standard endoscopes have straight shafts, so the surgeon must hold the endoscope in a direct line straight back from the patient's ear. This straight-line position makes it impossible, or at least incredibly challenging, to use an endoscope and a microscope in the same surgical procedure, since the position of the endoscope is directly in the path of vision of the microscope. This is a drawback, because in some procedures an ENT surgeon would like to be able to switch back and forth quickly and easily between viewing with a microscope and viewing with an endoscope. It is also challenging for a surgeon to manipulate multiple tools with straight shafts held in two hands during an ear surgery procedure, because the hands must be held very close together (due to the small diameter of the ear canal), and the tools tend to bump into one another as the surgeon manipulates them to perform the procedure.

For at least these reasons, it would be advantageous to have an improved system and method for ear visualization. Ideally such a system and method would be easy to use, allow for good visualization of the ear, and be compatible with use of other ear surgery devices. At least some of these objectives will be addressed in this disclosure.

BRIEF SUMMARY

This disclosure describes various embodiments of a device and method for visualizing an ear surgery procedure. In general, the device combines a visualization component (e.g., a camera) with a surgical tool component via a sheath that holds the two components together. In some embodiments, the surgical tool is a suction device, and thus the combined device in those embodiments is used for visualization and suction. The device is held in one hand and is short enough and thin enough to be advanced easily into the ear and to allow the surgeon to rest her hand on the patient's head during the procedure while holding the device, which surgeons often do in ear surgery procedures for hand stability. In some embodiments, the camera is free to roll (or “spin”) about its own axis within the sheath and/or the camera is free to rotate around the longitudinal axis of the suction device within the sheath.

In one aspect of the disclosure, a device for visualizing a surgical procedure on an ear may include a suction tube, a camera coupled with the suction tube in a side-by-side arrangement, and a sheath disposed around an outside of the suction tube and an outside of the camera to couple the suction tube and the camera together. In some embodiments, the sheath holds the camera and the suction tube in such a way that the camera is free to roll or spin about its own axis within the sheath, and the camera is also free to rotate about a longitudinal axis of the suction tube within the sheath. In some embodiments, the suction tube may have an outer diameter of no more than about 1.1 millimeters, and the camera may have an outer diameter of no more than about 2.5 millimeters. In some embodiments, for example, the sheath is disposed around the camera and the suction tube but is not fixedly attached to either one, so they are free to roll and rotate within the sheath. For example, the surgeon may want to roll the camera for image orientation and/or may want to rotate the camera around the suction tube for ergonomic reasons, such when moving the device from one hand to the other.

In some embodiments, the suction tube is rigid and includes a tubular portion with a distal suction end, a suction device attachment end opposite the distal suction end, and a bend in the tubular portion. In some embodiments, for example, the tubular portion is located about 40-100 millimeters from the distal suction end. In one embodiment, the bend in the tubular portion forms an angle of about 45 degrees, although other angles are possible in alternative embodiments. In some embodiments, the sheath is shorter than a distance from the distal suction end to the bend in the tubular portion, and the camera and the sheath are configured to slide along the tubular portion of the suction tube from a first position, in which a distal end of the camera is adjacent the distal suction end of the tubular portion, and a second position, in which the distal end of the camera is proximal to the distal suction end. In some embodiments the suction tube is made of metal. In some embodiments, at least a portion of the camera may be flexible. In some embodiments, the sheath is made of a heat-shrink polymer.

In another aspect of the disclosure, a method for performing a surgical procedure on an ear of a patient involves holding a combined visualization and suction device in one hand and advancing a distal end of the combined visualization and suction device into the ear. The combined visualization and suction device may be the same as or similar to the one described immediately above, and it may have any or all of the features described above. The method also involves viewing using the camera to view inside of the ear, activating the suction tube inside of the ear, and performing the surgical procedure on the ear, using a surgical tool held in the hand that is not holding the combined visualization and suction device. The method may also involve using the activated suction tube of the device to hold and move one or more structures within the ear. The activated suction tube may alternatively or additionally be used to suction fluid from the ear.

In some embodiments, the method may further involve rolling the camera about its own longitudinal axis within the sheath. The method may also involve rotating the camera around a longitudinal axis of the suction tube within the sheath. In some embodiments, the method may involve additionally viewing the ear using a microscope. Optionally, the suction tube may include a bend, and the method may further involve holding the combined visualization and suction device outside of a direct line of sight between a surgeon's eyes and the ear. The method may also involve supporting the hand that is holding the combined visualization and suction device on the patient's head during the surgical procedure. Optionally, the method may involve supporting the hand that is holding the surgical tool on the patient's head during the surgical procedure.

In another aspect of the present disclosure, a device for visualizing a surgical procedure in an ear may include an ear endoscope and a coupler. The ear endoscope includes a handle, a shaft extending from the handle and having a bend with an angle of 90-155 degrees, an outer diameter of no more than 2.5 millimeters, and a length of 30-80 millimeters, an imaging sensor at a distal end of the shaft, and a light source. The coupler is attached to a side of the ear endoscope shaft for attaching a tool to the endoscope. In various embodiments, the surgical tool and the overall device may include any of the features described above. The surgical tool may be a suction device, as previously described, or alternatively it may be any other suitable tool, such as but not limited to a cutting device, a piercing device, an ear tube placement device, a seeker, tweezers or forceps.

In another aspect of the disclosure, a method for performing a surgical procedure in an ear of a patient may first involve attaching a tool to an ear endoscope in a side-by-side arrangement, using a coupler, where the ear endoscope includes a shaft with a bend and an outer diameter of no more than 2.5 millimeters. The method may further involve holding a handle of the ear endoscope in one hand, advancing a distal end of the ear endoscope into the ear with the tool attached, viewing an inside of the ear, using the ear endoscope, and using the tool attached to the ear endoscope to facilitate or perform at least part of the surgical procedure. The combined visualization and surgical tool device may be the same as, or similar to, the embodiment described above, and it may include any of the features described above.

In another aspect of the present disclosure, an ear endoscope device for use in a surgical procedure in an ear may include a handle, a visualization shaft extending from the handle, a tool guide extending from the handle parallel to the visualization shaft and configured to guide a tool into the ear with the visualization shaft, an imaging sensor at a distal end of the visualization shaft, and a light source. In one embodiment, the ear endoscope device may include at least one tool coupler on a side of the shaft, at least one suction shaft insertion port at or near a distal end of the handle, two side suction tube connection ports at or near the distal end of the handle, a rear suction tube connection port at or near a proximal end of the handle, and a suction lumen connecting the rear suction tube connection port to the two side suction tube connection ports. In various embodiments, the shaft and the handle may form an angle of between about 90 degrees and about 155 degrees. In some embodiments, the shaft may have an outer diameter of no more than about 2.5 millimeters and a length of between about 30 millimeters and about 80 millimeters.

In some embodiments, the ear endoscope further includes a suction device. The suction device may include a suction shaft for passing through the at least one suction shaft insertion port and the at least one tool coupler, a thumb depress member coupled with the suction shaft for allowing a user to advance the suction shaft, a side suction tube for attaching the suction shaft, via the thumb depress portion, to one of the two side suction tube connection ports, and a rear suction tube for connecting the rear suction tube connection port to a suction source. The suction device may further include a spring disposed over a proximal portion of the suction shaft, between the thumb depress member and the handle of the ear endoscope. The spring may be configured to automatically retract the suction shaft relative to the shaft when the thumb depress portion is released. In some embodiments, an open one of the two side suction tube connection ports that is not attached to the side suction tube is configured to act as a finger operated suction control for controlling the application of suction force with a user's finger.

In some embodiments, the handle includes two suction shaft insertion ports and two tool couplers disposed on opposite sides of the shaft, where each of the two suction shaft insertion ports feeds into a corresponding one of the two tool couplers. In some embodiments, the handle includes a finger loop for facilitating holding the device with a user's finger under the handle. Alternatively, the handle may include any other finger hold shape or other ergonomic shape to facilitate gripping the device with one hand.

In another aspect of the present disclosure, a method for performing a surgical procedure in an ear canal of a patient may involve holding in one hand an ear endoscope with an attached suction device, advancing a distal end of the ear endoscope with the attached suction device into the patient's ear canal, depressing a thumb depress member of the suction device with a thumb of the hand, to advance a suction shaft of the suction device relative to a visualization shaft of the ear endoscope, applying suction in the ear canal with the suction device, and viewing an inside of the ear canal, using the ear endoscope. In one embodiment, applying suction in the ear canal involves applying a finger of the hand to an open suction control opening on the handle.

In some embodiments, the method also involves releasing the thumb depress portion to allow a spring on the suction shaft to expand to cause the suction shaft to retract relative to the shaft of the ear endoscope. In some embodiments, depressing the thumb depress member causes the suction shaft to advance through a suction shaft insertion port on a handle of the ear endoscope and through a tool coupler attached to the shaft of the ear endoscope. The spring may be disposed over the suction shaft, between the thumb depress member and the handle. The method may optionally also involve supporting the hand that is holding the ear endoscope on the patient's head during the surgical procedure.

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

DETAILED DESCRIPTION

In general, the embodiments described herein are directed to a device, system and method for visualizing an ear surgery procedure. The ear visualization device generally includes an ear endoscope (or “camera”), with an attachment mechanism for attaching an additional tool to the endoscope. Oftentimes, the additional tool is a suction device, but this is not a requirement, and in alternative embodiments, any of a number of different tools may be attached to the endoscope. In some embodiments, the attachment mechanism is built into the endoscope. Alternatively, the attachment mechanism may be a separate coupler or sheath, which attaches to the shaft of the ear endoscope and allows any of a number of different types of surgical tools to be attached to the endoscope in a side-by-side arrangement. The ear visualization system may include the ear endoscope along with a separate attachment mechanism, a light source for the endoscope, a video monitor for displaying images captured by the endoscope and/or any other suitable components. In some embodiments, the system may also include a suction device or other surgical tool. In other embodiments, the ear endoscope device or system may be provided by itself, and may be used with one or more optional, stand-alone tools.

As mentioned immediately above, in some embodiments, the attachment mechanism is a separate piece, which may be removed from the endoscope shaft. In such embodiments, the endoscope and the coupler may be referred to as a “system,” due to the combination of two different devices. In alternative embodiments, the coupler may be integral with, or permanently attached to, the endoscope shaft, in which case the endoscope with coupler may be referred to as a “device.” In any case, use of the terms “system” and “device” herein should not be interpreted as limiting the scope of the invention.

The shaft of the ear endoscope and whatever surgical tool it is used with may have very small diameters, so the distal end of the combined device fits easily into an ear canal, for helping visualize and perform an ear surgery procedure. In some embodiments, the coupler surrounds part of the endoscope shaft and part of the surgical tool in such a way that the shaft can rotate about a longitudinal axis of the tool and can also roll (or “spin”) about its own longitudinal axis.

In one embodiment, described in detail below, the surgical tool is a suction tube device. In alternative embodiments, however, the tool may be any suitable, small-diameter tool, such as but not limited to a cutting device, a piercing device, an ear tube placement device, a seeker, tweezers, forceps, a speculum, a grasper, or a curette. In the description below of the suction embodiment, the fact that any other suitably sized surgical tool may be substituted for the suction device will not be repeated with the description of every embodiment. Similarly, the devices and methods described below for use in an ear surgery procedure may be used or adapted for use in any other suitable surgical procedure. This, too, will not be repeated with the description of every embodiment.

Although the following description is focused on use of the devices, systems and methods for visualizing and facilitating ear surgery procedures, the same embodiments may be used, or adapted for use, in any other suitable procedures and parts of a human or animal body. Therefore, the invention is not limited to use in the ear.

Referring now toFIG. 1, a prior art method for performing an ear surgery using a standard endoscope10is illustrated. The figure shows a surgical field, with the patient's ear E exposed for the procedure. The surgeon is holding the endoscope10in his left hand L and a surgical tool12in his right hand. Due to the length of the endoscope10, the surgeon has to hold his left hand L up in the air, suspended over the patient, in order to hold the handle of the endoscope10. As mentioned previously, this can be very awkward and potentially dangerous to the tympanic membrane and/or structures of the middle ear, especially in longer procedures where the surgeon's left arm and left hand L get fatigued. Additionally, the surgeon does not have a free hand to hold a suction device or other surgical tool, since both of the surgeon's hands are occupied. To have suction in this scenario, a nurse or other assistant would have to hold the suction device in the patient's ear.

Referring toFIG. 2, an ear surgery visualization system100, according to one embodiment, may include an ear endoscope102and a coupler112. Also pictured inFIG. 2is a suction device128, which is not necessarily part of the system100, but which is shown in the figure for illustrative purposes. In alternative embodiments, the suction device128may be replaced by any other suitable surgical tool, such as the ones listed previously.

The ear endoscope102includes a handle104, a shaft106and a processor122, which may also act as a light source. The shaft106includes a proximal portion107, a bend108and a distal portion110, ending in a distal tip111. The endoscope102also includes a light source120in the handle104, and light fibers118that carry the light from the light source120, through the shaft106, to the distal tip111. A camera on a chip (described more fully below) may be positioned at the distal tip111, to acquire images of the ear. The system100may also include a video monitor126, although optionally the video monitor126may be a separate component that is not part of the system100. In another embodiment, the processor122and video monitor126may be combined in one unit.

The shaft106of the endoscope102may have a total length of about 30 millimeters to about 80 millimeters and an outer diameter of less than about 2.5 millimeters. In some embodiments, the outer diameter of the shaft106may be continuous along its length. Alternatively, the outer diameter of the distal portion110may be smaller than the outer diameter of the proximal portion107. The bend108may form an angle between the proximal portion107and the distal portion110of between about 90 degrees and about 155 degrees. The handle104may be very small and lightweight, compared to typical endoscope handles. In fact, the handle104may be shaped to have a comfortable pencil grip, so the surgeon may hold and manipulate the ear endoscope102like a pencil. Ear endoscope102may also include a cable124, attaching the handle104to the processor122.

The coupler112includes an endoscope attachment portion114and a tool attachment portion116. In some embodiments, each of the two portions114,116is shaped as a tube or a semicircular tube. In some embodiments, the endoscope attachment portion114and the tool attachment portion116may have the same diameter. Alternatively, they may have different diameters. For example, in some embodiments the endoscope attachment portion114has a larger diameter than that of the tool attachment portion116. The coupler112may be permanently attached to the shaft106, or it may be removable, according to different alternative embodiments. The coupler112may be attached to the distal portion110of the shaft106, as shown. Alternatively, the coupler112may be attached to the proximal portion107, for example if the shaft106is straight, or of the coupler112follows the bend108in the shaft106.

The weight, size and feel of the ear endoscope102may be similar to that of other ear surgery tools. This makes it more comfortable for the surgeon to hold and prevents an imbalance between the ear endoscope102and other tools. The surgeon may hold the handle104with a pencil grip and may rest her hand and/or the handle104on the patient's head during the procedure. In order to achieve this desired weight, size and feel, any suitable materials may be used for the various parts of the ear visualization system100. For example, in one embodiment, the handle104may be made of any suitable lightweight plastic, and the shaft106may be made of any suitable metal, such as stainless steel. Alternatively, the handle104may be made of a lightweight metal. The coupler112may be made of plastic or metal, for example. Any suitable, medically safe materials may be used.

As mentioned above, a suction device128is illustrated inFIG. 2, attached to the shaft106of the endoscope102via the coupler112, in a side-by-side arrangement. Any other tool may be substituted for the suction device128, in alternative embodiments. The suction device128is also shown with a source of suction130, which may be a separate component, wall suction, or any suitable suction source. The suction tube portion of the suction device128is flexible, at least along part of its length, and has a distal portion with an outer diameter that fits within the tool attachment portion116of the coupler. Various embodiments and features of a suction device128are described in further detail below.

Referring now toFIG. 3, the distal portion110of the endoscope shaft106is illustrated in greater detail. At the distal end111of the shaft106are positioned an imaging sensor140and two light sources142. The imaging sensor140may be any type of suitable sensor, such as a complementary metal-oxide semiconductor (CMOS) camera or any other “camera on a chip” type of device. The two light sources142(or alternatively any other number of light sources) may be light emitting diode (LED) lights, for example. These may be in addition to, or as an alternative to, the light source120shown in the handle104inFIG. 2. In other words, according to various embodiments, one or more light sources for the endoscope device102may be located in the handle104, at the distal end111of the shaft106, or both.

FIG. 4is a magnified view of an alternative embodiment of a coupler212for use with the ear endoscope102. The coupler212includes an endoscope attachment portion214, a tool attachment portion216, a longitudinal top opening250in the tool attachment portion216, and a longitudinal middle opening252between the endoscope attachment portion214and the tool attachment portion216. In this embodiment the endoscope attachment portion214has a larger diameter than that of the tool attachment portion216. The tool (not shown) may be inserted into the tool attachment portion216by pushing it down through the top opening250or by sliding it into the proximal end of the tool attachment portion216and advancing it distally. In the case where the tool is pushed through the top opening250, the coupler212may flex outward slightly, by expanding at the two openings250,252, to accommodate the tool. In alternative embodiments, the endoscope attachment portion214and/or the tool attachment portion216may be formed as complete tubes, with circular cross-sections rather than semi-circular cross-sections. As mentioned above, the coupler may be made of any suitable material.

Referring toFIGS. 5A-5D, one embodiment of an ear surgery visualization device20is illustrated. In this embodiment, the visualization device20, which may also be called “a combined visualization and suction device,” includes a suction tube22, a camera30and a coupler38(or “sheath”) disposed around the suction tube22and the camera30. The suction tube22has a distal end24, a proximal end26for connecting with suction tubing connected to a suction source, and a bend28along its length. The camera30includes a distal portion32, a proximal portion36and a distal end34.

The suction tube22may be any standard or customized suction tube device. In various embodiments, the suction tube22may be rigid and may be made out of any suitable material, such as stainless steel or other biocompatible metal or plastic. The suction tube22will have an overall diameter and length to allow it to be advanced easily into the ear and to allow a surgeon to hold the visualization device20with one hand, resting on the patient's head, during the procedure. In some embodiments, for example, the suction tube22has an outer diameter, at least along the portion between the bend28and the distal end24, of about 0.6 millimeter to about 1.1 millimeters. The bend28in the suction tube22is optional, and alternative embodiments may be straight. The bend28may be advantageous, however, because it allows the visualization device20to be held at an angle from the ear, so the hand holding the device20is not in the direct line of sight of the surgeon. This is especially advantageous in cases where the surgeon wants to use a microscope and the visualization device20in the same procedure, but it is also advantageous in keeping the suction tube22and the camera30out of the way of any surgical tools held in the surgeon's other hand. In various embodiments, for example, the bend28may be located about 40 millimeters to about 100 millimeters from the distal end24of the suction tube22. In one embodiment, the bend may be about 60 millimeters from the distal end24. In alternative embodiments of the device20, where the camera30is combined with a different type of surgical tool rather than the suction tube22, that surgical tool may also include the same or a similar bend.

The camera30may be any suitable, small-diameter camera for viewing an ear during an ear surgery procedure. In some embodiments, for example, the camera30may be a fiber optic camera or a complementary metal—oxide—semiconductor (CMOS) camera. As small-diameter cameras are well known, they will not be described in detail here. In some embodiments, at least the distal portion32of the camera30may be relatively rigid, so that the surgeon can easily roll it about its longitudinal axis and/or rotate it relative to the suction tube22. In some embodiments, the camera30may include a bend, which may coincide with the bend28in the suction tube. The camera30may include CMOS sensors with a lens array. The sensors may be arrayed in a cube of between 0.6 mm by 0.6 mm and 1.0 mm by 1.0 mm, with overall length of up to 3 mm, in some examples. Alternative embodiments may include a fiber optic bundle for image capture, rather than CMOS. The light source for illumination may be LED at the distal tip34or fiber infused with light from a remote LED.

The cross-sectional shape of the camera30may vary in different embodiments (round, oval, square, rectangular, etc.), but in the embodiment shown the camera30has a round cross-sectional shape. This is advantageous for rolling and rotating the camera30within the coupler38and relative to the suction tube22. The body of the camera30is made from a relatively rigid or at least semi-rigid material, such as stainless steel or plastic (e.g., thermoplastic). The length of the distal portion32may be, for example, about 5 mm to about 100 mm. In some embodiments, the distal portion32may be as long as the length of the suction tube22from its distal end24to the bend28, which in one embodiment is about 60 mm. In various embodiments, the camera30and a light source may be integrated into a metal tube, over-molded with plastic, encapsulated in a polymer, or the like.

The coupler38may be any suitable material and have any suitable length, thickness and size, according to various embodiments. In one embodiment, the coupler38is formed as a tube of heat-shrink polymer wrap that surrounds distal portions of the suction tube22and the camera30. The heat-shrink polymer may be polyethylene terephthalate (PET) in some embodiments, or may alternatively be any other suitable polymer, such as but not limited to a polyolefin, a polyimide or nylon. As illustrated inFIGS. 5A and 5B, in one embodiment, the coupler38is disposed about the suction tube and the camera30such that the suction tube22can advance (FIG. 5B) and retract (FIG. 5A), relative to the coupler38and the camera30. For example, in some embodiments, the suction tube22can advance from a position where its distal end24is at or near the distal end34of the camera30(FIG. 5A) to a position where its distal end24is ahead of that of the camera30(FIG. 5B). In this embodiment, the camera30may also be able to slide forward and backward. In alternative embodiments, camera30, suction tube22or both may be fixed to the inner surface of the coupler38, such as by adhesive, thus reducing the amount of mobility of one or both components relative to the coupler38.

FIG. 5Cis an exploded view of the ear surgery visualization device20, showing the suction tube22, the camera30and the coupler38separate from one another. For assembly, the coupler38may be wrapped or slid over the suction tube22and the camera30in some embodiments.

FIG. 5Dillustrates possible directions of movement of the camera30, the suction tube22and the coupler38, relative to one another. In some embodiments, the coupler38may be positioned around but not fixedly attached to the camera30and the suction tube22, as described above. In addition to allowing the suction tube22and/or the camera30to advance longitudinally through the coupler38, this configuration also allows the suction tube22and the camera30to roll about their own axes within the coupler38(two small hollow arrows around perimeter of coupler38). Additionally, the camera30may be rotated around a longitudinal axis of the suction tube22(larger hollow arrow). The suction tube22may also be rotated around a longitudinal axis of the camera30. This freedom of movement—rotation and rolling—allow the surgeon to adjust the orientation of the camera30and/or the suction tube22easily and quickly, without necessarily changing the orientation of both components. Again, however, in alternative embodiments the coupler38may be adhered or otherwise fixedly attached to either or both of the camera30and the suction tube22.

FIG. 6shows a surgical field, including a patient's ear E, and the left hand L and the right hand R of a surgeon, performing a procedure on the ear E. The surgeon's left hand L is holding the ear surgery visualization device20, as described above, which includes the suction tube22and the camera30. The suction tube22is attached proximally to a suction hose40, which in turn is attached to a source of suction (not shown). The surgeon's right hand R holds a surgical tool12. As indicated by the large arrows on the figure, the surgeon's hands are approaching the ear E from two different angles, leaving a line of direct vision open from the surgeon's eyes to the patient's ear E (depicted by the middle/upper-right hollow arrow). This arrangement will allow a surgeon to visualize the surgical field using both a microscope and the camera30, if desired. As also illustrated inFIG. 6, the ear visualization device20is sized and shaped such that the surgeon can rest her hand on the patient's head during the procedure. In performing the procedure, the surgeon may advance the device20into the ear E, suction out the ear E using the suction tube22, visualize the ear E using the camera30, and perform the procedure. Alternatively or additionally, the suction tube22may be used to hold onto and move one or more small anatomical structures of the ear, such as but not limited to the bones of the middle ear. Suction may also be used to hold different devices, such as an ear tube or ossicular prostheses. The device20is generally small enough that the camera30can be used to visualize the middle ear through a natural hole or incision in the tympanic membrane. These actions may be performed in any sequence and in any combination. In some embodiments, it may be possible for the surgeon to separate the camera30from the suction tube22during the ear surgery procedure, so they can be used separately.

In some embodiments, the ear surgery visualization device20may be used with another, different ear surgery visualization device (not shown). For example, the combined camera/suction tube device20may be held in the surgeon's non-dominant hand, and a combined camera/surgical tool device may be held in the surgeon's dominant hand. These two devices20may be used at the same time, thus acquiring two images of the ear. The views from the two cameras may be displayed on a single, split video screen, for example, with the right half marked ‘R’ and the left half marked ‘L’. In all embodiments, the video screen may be separate and located above the patient's head and within the field of view of a microscope, so that the surgeon can view the surgical field through the microscope and look at the endoscopic view through the microscope as well, or simply switch from looking through the microscope to looking at the video screen. In another embodiment, it may be possible to digitally feed the endoscopic image into the microscope, so that the surgeon can view both of them through the microscope, or toggle between them by pressing a button, for example.

Referring now toFIG. 7, an alternative embodiment of an ear surgery visualization/suction device50is illustrated. As mentioned above, in some embodiments, the suction tube22may be advanced, relative to the camera30, as shown inFIG. 5B, such that the distal end24of the suction tube22is ahead of the distal end34of the camera30. In embodiments where the distal portions of the suction tube22and the camera30are both straight and are connected in parallel with one another, the suction tube22may interfere with the field of view of the camera30in this configuration. The embodiment of the device50shown inFIG. 7is configured to address that issue. In this embodiment, the distal portion32of the camera30includes a bend52. This bend52orients the field of view54of the camera30at an angle, relative to the longitudinal axes of the suction tube22and the camera30, so the suction tube22does not interfere with or limit the field of view54. In various embodiments, the bend52may be located anywhere along the length of the camera30, although in many embodiments it will be located near the distal end34, so that it is distal to the distal end of the coupler38.

Referring now toFIG. 8, another alternative embodiment of an ear surgery visualization/suction device60is illustrated. This embodiment is alternative way of addressing the issue of the suction tube22cutting off part of the field of view54of the camera. In this embodiment, the sheath68has a wider distal end64and a narrower proximal end66. Thus, the sheath68couples the camera30and the suction tube22together such that they are oriented at an angle relative to one another. In other words, they are not parallel with one another. As with the previous embodiment, this helps prevent the field of view54of the camera30from being limited by the suction tube22.

Referring now toFIGS. 9A-9C, one embodiment of an ear visualization system300is illustrated. The ear visualization system300includes an ear endoscope302and an optional suction device310. The ear endoscope302includes a handle304, a shaft306extending from one end of the handle304, two tool couplers307a,307b(seeFIG. 9B) on either side of the shaft306, and a cable308extending from the opposite end of the handle304. Imaging components pass through the handle304, the shaft306and the cable308, which components may be any of those described above and which are not shown in these figures. The handle304includes two suction shaft apertures305a,305b(not visible in these drawings, because they are on the top surface of the handle304), through which the shaft316of the suction component310is advanced. The shaft316of the suction component310advances through one of the two tool couplers307a,307b, after exiting the distal end of the corresponding aperture305a,305b. The handle304may have any of a number of suitable sizes, shapes and weights, but in this embodiment it is configured to be held easily in a pencil grip by the physician. The handle304may be made of lightweight plastic, in some embodiments.

The suction component310includes a suction tube312, a thumb depress portion314, a suction control aperture320, a suction shaft316with a distal end317, and a spring318disposed over the suction shaft316, between the thumb depress portion314and the handle304. The suction shaft316extends through the suction shaft aperture305ain the handle304, through the tool coupler307a, and alongside the visualization component shaft306. As will be described further below, the user physician may depress the thumb depress portion314to advance the distal end317of the suction shaft316out of the distal end of the visualization shaft306and thus farther into the ear. When the user releases the thumb depress portion314, the spring318automatically retracts the suction shaft316back along the visualization shaft306, through the tool coupler307aand the aperture305a. The physician may use an index finger (or other finger) to cover the suction control aperture320to apply suction, and she may remove the finger from the hole to remove or reduce suction at the distal end317of the suction shaft316.

FIG. 9Bis a front view of the ear visualization system300, which illustrates that this embodiment includes two suction tool couplers307a,307b, one on either side of the visualization component shaft306. This embodiment thus also includes two suction shaft apertures305a,305b, each feeding into one of the two suction tool couplers307a,307b. The two tool couplers307a,307bfacilitate holding and manipulation of the device300by either a right hand or a left hand, and placement of the suction tube/other tool either below or above the camera sensor. The visualization component shaft306, the tool couplers307a,307band the suction shaft316, in some embodiments, may be made of metal, such as stainless steel or other biocompatible metal. In some embodiments, the visualization component shaft306has an outer diameter of about 2.5 millimeters or less. Similarly, each of the tool couplers307a,307bmay have an outer diameter of about 2.5 millimeters or less. The suction shaft316has an outer diameter sized to fit through the inner diameter of the tool couplers307a,307b. In some embodiments, the suction shaft316may have an outer diameter of about 1.1 millimeters or less.

FIG. 9Cis a side view of the ear visualization system300, with ear endoscope302separated from the suction device310. In this embodiment, the ergonomic design of the handle304may be important for facilitating handling of the system300by the physician. For example, the handle304includes a finger grip feature322, which may allow for easy gripping of the handle304with a middle finger (or other finger). The user's index finger may be used to control the suction control aperture320, and the user's thumb may be used to control the thumb depress portion314of the suction component310. In other embodiments, one of which is described below, the finger grip feature322may include a loop, an elastic ring or any other suitable shape.

In various alternative embodiments, one or more variations may be made to the ear endoscope device300. For example, in some embodiments, the couplers307a,307bmay extend the entire length (or along a longer portion but not the entire length) of the endoscope main shaft306. In some embodiments, there may be only one coupler and one aperture, rather than two couplers307a,307band two apertures305a,305b.

Referring toFIG. 15, in yet another alternative embodiment, an ear endoscope shaft500may include an outer shaft body502, a tool guide504forming a tool lumen506, two light sources508a,508band an imaging sensor. The tool guide504and tool lumen506, in this embodiment, are located inside the outer shaft body502, unlike the previously described embodiments that place the suction tube through a coupler on the outside of the main endoscope shaft. In some embodiments, the tool guide504may be used for applying suction or advancing a suction device through the shaft500. Alternatively, the tool guide504may be used for advancing any other suitable tool through the ear endoscope shaft500, such as any tool listed in this application. This embodiment ofFIG. 15may be applied to any of endoscope embodiments described above or below to generate alternative embodiments.

FIGS. 10A and 10Billustrate a method for advancing and retracting the suction shaft316in the ear visualization system300, according to one embodiment. InFIG. 10A, the physician is depressing the thumb depress portion314of the suction component310with her thumb T. This advances the suction shaft316through the handle304and the tool coupler307a, thus advancing the suction shaft316along the side of the visualization shaft306. Thus, the distal end317of the suction shaft316would be advanced farther down into the patient's ear. In this configuration, the spring318is compressed. InFIG. 10B, the physician has released her thumb T from the thumb depress portion314, allowing the spring318to expand and causing the suction shaft316to retract proximally through the tool coupler307aand the handle304. Thus, the physician can easily adjust the position of the distal end317of the suction shaft316relative to the visualization shaft306.

In various embodiments, the distal end317of the suction shaft316may be positioned in a number of different locations relative to the distal end of the visualization shaft306. When the suction shaft316is fully advanced, its distal end317may be located at, proximal to or distal to the distal end of the visualization shaft306. Similarly, when the suction shaft316is fully retracted, its distal end317may be located at, proximal to or distal to the distal end of the visualization shaft306. For example, in one embodiment, the distal end317of the suction shaft316may be disposed even with the distal end of the visualization shaft306in the fully retracted position and then may be advanced to a position distally beyond the distal end of the visualization shaft306. In another embodiment, the distal end317of the suction shaft316may be disposed more proximally than the distal end of the visualization shaft306in the fully retracted position and then may be advanced to a position even with the distal end of the visualization shaft306. Any combination of locations is possible, according to various alternative embodiments.

Referring toFIG. 11, a physician's hand H is shown holding the combination device300over an anatomical model. As shown, the handle304fits comfortably in the hand H, with the middle finger on the bottom and the index finger on the top. The thumb is positioned on the thumb depress portion314, and the visualization component shaft306and the suction shaft316are extended into the model. During an ear procedure, the physician might rest his or her hand on the patient's head, for support and stability and to prevent arm fatigue. The very light weight of the handle304and the device300in general make it easy to manipulate and hold.

Referring now toFIG. 12, in some embodiments, the ear visualization system300may include the ear endoscope302and a viewing system330. The viewing system may include a video monitor336, a console332and a cable334connecting the two. The console332may include a connector338, into which a connector337on the visualization component302inserts. The various parts of the viewing system330may be any suitable off-the-shelf or custom components, according to various embodiments. In an alternative embodiment, the console332may include a built-in screen, rather than having a separate video monitor336, and the endoscope300would connect to the console332. In various embodiments, the ear endoscope302may be provided with the viewing system330, with the suction device310or as a stand-alone device.

Referring now toFIGS. 13A-13C, another embodiment of an ear endoscope400is illustrated. In this embodiment the ear endoscope400includes a handle402with a finger loop404, a shaft406, two tool coupling shafts408a,408b, two side suction tube connection ports410a,410b, two suction tube insertion ports412a,412b, a rear suction tube connection port414and a sensor interface cable416. In this embodiment, the ear endoscope400may be provided as a separate unit and may be used with an add-on suction device, or it may be provided with the suction device. In either case, a suction supply may be connected to the rear suction tube connection port414, which is in fluid communication with a suction lumen running through the handle402and exiting at the two side suction tube connection ports410a,410b. One of the two side suction tube connection ports410a,410bmay in turn be connected to a short suction tube, which is connected to a suction shaft that passes through one of the suction tube insertion ports412a,412band one of the tool coupling shafts408a,408b, as will be described further below. Whichever of the two suction tube connection ports410a,410bthat is left open may be used by the physician as a suction control, by placing a finger over, or releasing the finger from, the port410a,410b. The finger loop404on the handle402may be flexible in some embodiments and rigid in others. In alternative embodiments, it may have any other suitable shape or size for facilitating gripping the endoscope400. As is evident fromFIGS. 13A-13C, the shaft406is straight in this embodiment, but it is angled relative to the handle402, so that the overall endoscope device400is angled, to allow the physician to place the shaft406in the ear canal without obstructing a direct viewing path into the ear canal.

Referring now toFIGS. 14A-14C, the ear endoscope ofFIGS. 13A-13Cis now shown with an optional suction device420.FIG. 14Ashows the suction device420detached from the ear endoscope400. The suction device420includes a suction shaft422, connected to a thumb depress member424, connected to a side suction tube426, and it also includes a rear suction tube428. The suction shaft422is passed through either of the two suction tube insertion ports412a,412band thus through the corresponding tool coupling shaft408a,408b. Side suction tube426may be connected to either of the two side suction tube connection ports410a,410b, leaving the opposite side port410a,410bopen for finger control of suction. Additionally, the rear suction tube428is attached to the rear suction tube connection port414, to supply suction force from a suction supply (not shown) to the suction device420. As explained above, a suction lumen in the handle402of the endoscope400(not visible in the figures) connects the rear suction tube connection port414with the two side suction tube connection ports410a,410b.

FIG. 14Bshows all the components of the suction device420attached to the ear endoscope.FIG. 14Cshows a physician's left hand H holding the combined ear endoscope400and suction device. As illustrated here, the physician's thumb is positioned on the thumb depress member424and is used to advance the suction shaft422. The physician's middle or ring finger may be placed through the finger loop404of the handle402. And the physician's index finger may be placed over or removed from the open side suction tube connection port410b, to control the application of suction through the suction shaft422. If the physician prefers to hold the ear endoscope400in his right hand, the side suction tube426and suction shaft422may simply be shifted to the opposite side of the ear endoscope400.

FIG. 15is a cross-sectional view of a distal/shaft portion of an ear visualization device500, according to one embodiment. The portion of the device500illustrated inFIG. 15may be used with any of the embodiments described above or below. The illustrated portion of the device500includes an outer shaft502, inside of which there is a suction shaft504forming a suction lumen506. Also located inside the outer shaft502are a camera510and two sets of light fibers508a,508b, which are illustrated as rectangular but may be bundled in circular, ovoid or any other suitable shapes. In some embodiments, the inside of the outer shaft502may be solid or filled with a material, and the camera510and light fibers508a,508bmay reside in lumens formed within the material in the outer shaft502. Again, this is only one exemplary embodiment of the shaft portion of a device500.

The above description of embodiments and features of various devices and methods is believed to be complete. The embodiments are meant to exemplary in nature, however, and not exhaustive. Thus, their description should not be interpreted as limiting the scope of the invention.