Patent Description:
Otitis media with effusion (OME) is a very common ear disease that causes body imbalance, discomfort and may even result in irreversible damage to the middle ear structure. When medication as a treatment for OME fails, a ventilation tube (VT, or grommet) is surgically inserted on the tympanic membrane (TM) so that the accumulated fluid can be drained out. The procedure is called "myringotomy with tube insertion". It starts by performing a myringotomy, which involves making a small incision on the TM, and then inserting a VT into the incision. This surgery can be performed under local anaesthesia (LA) in adults if they can tolerate the discomfort, but the usual practice for young children is to use general anaesthesia (GA) as the pain tolerance level of young children is very low. Approximately <NUM>% of children have OME at some time before school age, and the insertion of VT is one of the most common paediatric surgeries performed, and the most common reason for a child to undergo a GA. Studies have shown that there are long term health effects from GA, including possible delay in brain development of children. Hence there is a need to research on ways to avoid GA during myringotomy and VT insertion. One possible way is to shorten the duration of the incision and VT insertion procedures such that it is over in a blink of an eye and the child only has to be still for a short while. In this case, a mild sedation or local anaesthesia may preferably be sufficient.

There have been several developments that aim to do achieve that goal, by combining the <NUM>-step procedures into a single step. This can eliminate the need to change tool sets hence shorten the duration. Two such examples are the "Insertion System for Deploying a Ventilation Device" by Perceptis Medical Inc (<CIT>) and the "Tympanic Membrane Pressure Equalization Tube Delivery System" by Acclarent Inc (<CIT>). Both systems utilise a cutting sheath or cutting member to incise the TM and a deformable VT that is preloaded within the sheath or shaft such that when the VT is inserted into the incision, and the shield or sheath that is holding the VT is released, the distal flange of the deformable VT opens up and assumes an expanded configuration. In both systems, the deformable VT is custom made by the respective companies. This means that users of the systems have to use the companies specific VTs, and would be constrained to the specific VT's shape, size and material. This is undesirable as different patients require different VTs according to their age and the severity of OME.

<CIT> describes a tympanic ventilation tube device for releasing fluid from the middle ear includes a tubular member, a first flange connected to a proximal end of the tubular member, a second flange connected to a distal end of the tubular member, and a cutting element connected to either the tubular member or the second flange. The cutting element projects in a generally distal direction and serves to facilitate the incising of the tympanic membrane during the insertion of the tubular member, wherein the first flange and the second flange seat against opposite sides of the membrane following the insertion. A spring-loaded protector is movably mounted to either the tubular member or the second flange for retracting in a proximal direction to expose the cutting element during an incising of a tympanic membrane by the cutting element in an insertion operation and for extending in a distal direction to cover the cutting element upon insertion of the cutting element and the distal flange through the tympanic membrane.

In light of the above, it would be desirable to provide an alternative device that not only provides a system that facilitates the VT insertion without requiring a <NUM>-step process or multiple tool set changes, but would also allow the use of commercially available VTs of differing sizes and shapes. Also, for neonate and infants, the TM is in an extremely oblique position, whereas for adults, the TM angles range from <NUM> degrees to <NUM> degrees. Hence, it would be desirable for the system to be able to cater to a wide-range of TM angles.

Embodiments of the present invention seek to address at least one of the above needs.

In accordance with the present invention, there is provided a device for incision and insertion of a ventilation tube into a tympanic membrane, according to claim <NUM> and the dependent claims.

Embodiments of the disclosure will be better understood and readily apparent to one of ordinary skill in the art from the following written description, by way of example only, and in conjunction with the drawings, in which:.

Embodiments of the present disclosure provide a method and device for incising the TM or any other membrane and inserting a commercially available VT or any equivalent tube into the membrane in a smooth and continuous motion without requiring a change of tool sets.

The method according to example embodiments includes to first make an incision that is around the width of the VT to be inserted. Then, the VT is placed in an upright position that is perpendicular to the incision, such that the edge of the inner flange is facing the incision. With a rotating motion, the inner flange is tilted into the incision, while the outer flange is pulled slightly outwards to facilitate the rotation. In this way, the VT will be eased into the incision by using a pushing force (at the bottom) and pulling force (at the top) that creates a torque. By using this method, the entire insertion procedure can advantageously be completed in under one second according to example embodiments, and there is minimal trauma to the TM during VT insertion. Also, the method according to example embodiments can allow surgeons to be able to cater to a larger range of TM angles such that patients with very oblique TM down to <NUM> degrees will be able to use this system, and it is especially effective for oblique TM. This is because the VT <NUM> will approach the TM <NUM> in an upright direction along an approach direction <NUM> according to example embodiments, and only a slight rotational motion <NUM> is required to insert the inner flange <NUM> of the VT <NUM> into the TM <NUM> if the TM <NUM> is oblique, as shown in <FIG>.

The design of the device according to example embodiments can include an ergonomic housing with the pivot tool set (which is a shaft assembly according to example embodiments). As shown in <FIG>, <FIG>, a mechatronic setup design <NUM> according to an example embodiment consists of the mechanical structure including pivot tool set <NUM>, the electrical actuators including solenoid <NUM> and linear motor <NUM>, a switch button <NUM>, a trigger button <NUM>, the sensors including force sensor <NUM> and the micro controller <NUM>, which can carry out the myringotomy with tube insertion automatically controlled by the micro controller <NUM>. The force sensor <NUM> is used to sense and measure the contact force between the TM and the tip of the tool set <NUM>, providing feedback to the microcontroller <NUM> which in turn synchronizes the mechanism of action of actuators controlling the tool set <NUM>. The linear motor <NUM> is used for moving the tool set <NUM> and making the incision. The solenoid <NUM> is used for pushing the VT out for insertion. The user controls the device through the trigger button <NUM> with visual (such as light indicator) and audio (such as transducer) feedback provided by the mechatronic setup with integrated force sensing system, all powered by internal power supply (such as battery <NUM>). The switch button <NUM> is a power switch, which is used to turn the device on and off. The switch button <NUM> can also be used to change between different modes (e.g., adult mode and child mode). The trigger button is used to activate the process of the device. Specifically, the procedure is as follow:.

In the mechatronic setup design <NUM> according to another example embodiment shown in <FIG>, <FIG>, the mechanical structure is slightly different in such a way that two same type of electrical linear actuators <NUM>, <NUM> can be applied for moving the tool set <NUM>, one making the incision and another pushing the VT out for insertion. The structural design and placement of components are alternatively arranged to maximize ergonomic of the device in this example embodiment, while the overall functioning and operation remains as described above with reference to the embodiments shown in <FIG>, <FIG>.

In <FIG>, two mechanical setup designs according to example embodiments are shown, respectively, for assisting the surgeon to deploy the VT manually by pushing the button <NUM>, <NUM>. These two mechanical setup designs are based on the cam mechanism concept. Once the button <NUM> is pushed, the cam <NUM> of a rotary cam mechanism will rotate around the axle <NUM> and cause a linear movement of a cam follower <NUM> connected to one end of a pusher rod <NUM> disposed inside an outer tubing <NUM> coupled to the holder/cutter <NUM>, and the pusher rod <NUM> in turn pushes out the VT (not shown). In the other example design, once the button <NUM> is pushed, the cam <NUM> of a linear cam mechanism will cause a linear movement of a cam follower <NUM> connected to one end of a guide wire coupled to a pusher rod disposed inside an outer tubing <NUM> coupled to the holder/cutter <NUM>, and the pusher rod in turn pushes out the VT (not shown). The surgeon can control the pushing distance by controlling the pushing force on the button <NUM>, <NUM>.

The pivot tool set for mechanical setup design I shown in <FIG> is a straight offset tool set <NUM> while the pivot tool set for mechanical setup design II shown in <FIG> is a curve tool set <NUM> which is driven by the guide wire <NUM> disposed inside the outer tubing <NUM> and coupled to the inner pusher <NUM>, as shown in <FIG>.

Besides the cam mechanism design, the actuation system can be also changed to an electrical actuator such as voice coil motor or solenoid, etc. in different embodiments.

The shaft assembly of the pivot tool set according to example embodiments includes an outer tube <NUM>, an attachment <NUM> with a cutter <NUM> at the bottom and a hook <NUM> at the top that is attached to the outer tube's <NUM> distal end, and an inner shaft <NUM> which is linearly moveable within the outer tube <NUM> acts as a pusher to push the VT 510a, b into the incision (see <FIG>. The VT <NUM> is loaded on the distal tip of the attachment <NUM> of the shaft assembly such that the VTs inner flange <NUM> is sitting on the cutter <NUM> and the device hook <NUM> clasps the VT's outer flange <NUM> at the top with the bent portion of the hook <NUM> inside the bore of the VT 510a, b (see <FIG>). The dimension of shaft assembly depends on the size of VT <NUM> such that the cutter <NUM> tip is extended from the loaded VT 510a, b and the height of the hook <NUM> is slight loosely fitted with the length of the VT 510a, b. An alternative arrangement can be for the hook <NUM> to be made of a flexible and bendable material that allows VTs of slightly variable height to be used, according to other example embodiments.

VT tubes are generally classified into two major categories; pediatric- and adult-sized VT. Tiny Tytan and Shah Type VT are pediatric-sized VT that shares the same lumen (inner) as well as outer diameter, which are <NUM> and <NUM> - <NUM>, respectively. They also have the same tube body length of <NUM> - <NUM>. On the other hand, there are more variety of adult-sized VT design. However, the lumen (inner) diameter of most commonly used adult-sized VT usually ranges only from <NUM> - <NUM>, with tube body length ranges from <NUM> - <NUM>.

The pivot tool set <NUM>, <NUM> is attached to an actuation system which can be a fully mechanical setup according to example embodiments, comprising of a spring system (see <FIG>) or the pivot tool set <NUM> can contain electrical components including force sensors <NUM> and actuators <NUM>, <NUM> to allow automatic detection when the cutter touches the TM, and automatic actuation after the touch (see <FIG> and <FIG>). In both setups, a hair-like structure or fiber (e.g., suture) <NUM> can be attached to the tip of the attachment <NUM> as shown in <FIG>. The hair-like structure <NUM> can provide a method of proximity sensing when bringing the device closer to the eardrum before commencing the surgical procedure. Upon touching the eardrum, the deflection or displacement of the structure <NUM> serves as a signal to inform the surgeon that the applicator is sufficiently close to the eardrum to begin with the surgical procedure. This method could potentially minimize the contact time and the amount of force to be exerted on the eardrum compared to that without using any such structure, according to example embodiments. This method of proximity sensing according to example embodiments is explained further below.

Similarly, when a curve hair-like structure or fiber 700a, 700b is placed under the cutter <NUM> with a fixed distance as shown in <FIG> according to example embodiments, it can be used for detecting the incision depth (the distance from the cutter <NUM> tip incised on the TM <NUM> to the surface of the TM). As can be seen in <FIG>, the structure 700a, 700b (e.g., suture) will become straighter while the cutter <NUM> incises deeper into the TM <NUM>. Alternatively, as shown in <FIG>, a marker e.g. <NUM> on the cutter <NUM> showing a fixed distance (e.g., <NUM>) from the cutter <NUM> tip to the marker <NUM> can be also used for the incision depth detection. In other words, when the surgeon sees that the TM is on the marker <NUM>, he/she will notice how deep the cutter <NUM> goes into the TM. Different colours of the markers e.g. <NUM> can be used to indicate different distances in an example embodiment, and different widths of the markers can be used to set different tolerances in an example embodiment.

In the following, the procedural steps while the device according to example embodiments is employed are described:.

For automatic operation, after initialization (step <NUM>, compare <FIG>), a foot pedal or a switch is activated according to an example embodiment. The motor in the device will then move the tool set <NUM> forward slowly until the force sensor registers that the tool set <NUM> has touched the eardrum <NUM>, as illustrated in <FIG>. The motor then moves the tool set <NUM> forward such that the cutter element, here in the form of cutter <NUM>, pierces the eardrum <NUM> in the designated insertion site, as illustrated in <FIG>. The pusher <NUM> then moves forward to push the lower end of the VT, here a grommet <NUM>, into the incision, as illustrated in <FIG>. Together with the hook <NUM> at the top, this creates a torque that rotates the grommet <NUM> into the incision, as illustrated in <FIG>. In other words, a holder member of the device, here in the form of the upper surface of the cutter <NUM>, is configured to dispose the grommet <NUM> in an orientation in which a longitudinal axis <NUM> of the grommet <NUM> is substantially perpendicular to the cutter <NUM>, and a pusher member of the device, here in the form pusher <NUM>, is configured to apply a pushing force to a first end <NUM> of the grommet <NUM> in a direction substantially perpendicular to the longitudinal axis <NUM>, the first end <NUM> of the grommet <NUM> being disposed closer to the cutter <NUM> than a second end <NUM> of the grommet <NUM>. Substantially perpendicular to the longitudinal axis <NUM> is intended to cover the various orientations between the pushing force applied by the pusher <NUM> and the longitudinal axis <NUM> during the pivoting for insertion of the grommet <NUM>, noting that for each orientation, there is at least a component of the pushing force that is exactly perpendicular to the longitudinal axis <NUM>, as will be appreciated by a person skilled in the art. A pivot member of the device, here in the form of hook <NUM>, is configured to releasably engage the second end <NUM> of the grommet <NUM> such that the grommet <NUM> is pivotable about the hook <NUM> under the pushing force applied to the first end <NUM> of the grommet <NUM> by the pusher <NUM>, for insertion of the first end <NUM> of the grommet T <NUM> into the incision. As shown in <FIG>, the rim of the grommet <NUM> being "anchored" in the incision can preferably resist the pullout from the incision to a good extent because the withdrawal time of the tool set (pusher <NUM> and cutter <NUM>) is generally quick with low friction between the cutter <NUM> and the grommet <NUM>. The withdrawal speed (or time) is preferably optimized to achieve this. Furthermore, the resistance against pulling out the grommet <NUM> during tool set withdrawal can be strengthened in different embodiments which will be described in more detail with reference to <FIG> and <FIG> below, where the cutter is withdrawn first while the VT is fully anchored by the ear membrane before withdrawing the tool set with the hook. The average time of operation of automatic insertion is less than two seconds, according to example embodiments.

Step <NUM> (manual operation according to an example embodiment).

For manual operation, after initialization (step <NUM>, compare <FIG>), the surgeon brings the device/tool set <NUM> towards the TM, here eardrum <NUM>. Once the device/tool set <NUM> touches the eardrum <NUM>, the surgeon can sense the touching force to his/her hand as illustrated in <FIG>, and then the surgeon can directly push the device/tool set <NUM> forward to incise the eardrum <NUM> until he/she feels an obvious force changing or is indicated by the methods descripted above with reference to <FIG>, as illustrated in <FIG>. Following that, the surgeon can activate the inner pusher <NUM> to tilt or pivot the VT, here in the form of a grommet <NUM>, into the incision, as illustrated in <FIG>. Finally, the surgeon withdraws the device/tool set after the grommet <NUM> has been inserted, as illustrated in <FIG>.

Step <NUM> (semi-automatic operation according to an example embodiment).

The semi-auto operation is realized by another fully mechanical setup design of a device <NUM> according to an example embodiment (see <FIG>) that is modified based on the mechanical setup design I embodiment shown in <FIG>. For semi-auto operation, the surgeon manually brings the tip of the tool set to touch the TM. Next, the surgeon presses the button <NUM> on the device <NUM> and the device <NUM> will make an incision on the TM and then insert the VT into the incision automatically in sequence. That is, the operation is actuated by a mechanical system instead of the operation being actuated by the mechatronic system as described above with reference to <FIG>. In the cam mechanism <NUM>, there are two separate linear cams <NUM>, <NUM> with separate cam followers <NUM>, <NUM>, one for movement the whole pivot tool set <NUM> (see <FIG>) and the other for movement of the inner pusher <NUM> (see <FIG>), to allow for two separate movements of the whole pivot tool set <NUM> and the inner pusher <NUM> individually, according to an example embodiment.

A force sensing stage with a mock membrane holder was used to simulate a mock TM and to measure the force applied on it. In this experiment, polyvinyl chloride (or commonly known as cling wrap) was chosen as mock TM material. Polyvinyl chloride's elastic modulus falls within previously published range of TM's, thus most realistic in regards to the stabbing force during VTA's myringotomy procedure, and is convenient and widely available. The mock membrane holder is sloped at different degrees ranging from <NUM> degrees to <NUM> degrees to mimic the obliqueness of the eardrum. A mechatronic setup with fully automatic operation according to an example embodiment (compare <FIG> and <FIG> described above) was used for this experiment. A Tiny Tytan ventilation tube was used for the paediatric-sized tool set and Shah Activent tube was used for the adult-sized tool set. <NUM> trials were conducted per angle, hence a total of <NUM> trials were conducted for each tool set type. The number of first attempt successful insertions as well as the insertion force were recorded and shown in the charts in <FIG>, respectively.

As shown in tables <NUM> and <NUM>, example embodiments advantageously provided high success rate and low insertion force. Additionally, while for extremely oblique angles such as those below <NUM>°, the first-attempt success rate of tube deployment decreases in these experiments, such cases can further be addressed using various modified embodiments, e.g. using cutter and pusher such as those illustrated in <FIG> or <FIG>, described below.

Incorporation of hair-like structure or fiber as proximity sensing, according to example embodiments.

The inclusion of a hair-like structure on the tool set according to example embodiments is deemed to facilitate office-based ventilation tube insertion procedure in a few aspects as follows:.

The strand of suture can be included by at least two methods, by way of example, not limitation,(<NUM>) with the suture firmly fixed on the tool set, or (<NUM>) the suture loosely adhering to the tool set by use of a lubricant.

In this method, a strand of suture is placed and fixed stably on the tool set. The method of fixing can be done by using sterile tape such as biocompatible Steri-StripTM by <NUM> or other biocompatible glues. The suture is fixed in such a way that a short segment is protruded out of the tool set at a preferred distance (<NUM> or less). When the system approaches the eardrum, the suture is deflected. The deflection can be seen under microscope or surgical eye loup and serves as a proximity feedback to surgeon that the applicator device is within a zone that it can be activated for myringotomy and grommet tube insertion.

This method requires a strand of suture to be loosely adhering to the surface of the tool set by applying a small drop of lubricant to the suture. Although the suture is not fixed to the tool set, it is held in place by the surface tension of the lubricant, yet allows the suture to move slightly when it touches the eardrum. Similar to Method <NUM>, a short segment of the suture is protruded out of the tool set at a preferred distance (<NUM> or less). The protruded segment of suture can be visualized by surgeon under the microscope or a surgical eye loupe. When surgeon brings the suture to the eardrum, the suture is either slightly deflected or displaced or both upon touch.

The methods <NUM> and <NUM> of suture inclusion according to example embodiments described above have been verified by an ENT surgeon on two volunteers, and have been shown to work well as a proximity sensing tool on the device during cadaver tests. Generally, the suture that is protruded out from the tool set provides surgeon with sufficient visualization of the suture when the tool set is brought towards the eardrum. Dyed suture with darker colours are easier to be noticed under microscope than undyed suture when the set-up are placed in the ear canal. During the testing on volunteers where the surgeon touched healthy eardrum with the suture, both volunteers were asked to rate the sensation from <NUM> to <NUM>, with <NUM> being no feeling at all and <NUM> being extreme pain (see <FIG>). No analgesic was ingested nor local anesthesia applied to the eardrum. When the suture is fixed onto the tool set with a sterile tape, the average rating is <NUM>. For the free-moving suture, the average rating is <NUM>. From the results, it can be seen that a fixed suture caused slightly more discomfort than a free-moving one upon gentle touch of the suture on the eardrum. This is likely due to a greater force exerted by suture that is fixed on the tool set. However, as both methods did not cause any significant pain to the eardrums without any analgesic or local anesthesia, the methods were verified to be a simple and feasible way to obtain a reasonable resolution of proximity sensing for surgeon, according to example embodiments.

The design of the pivot tool set is not limited to the design as described above with reference to <FIG>, but can be designed differently according to different embodiments so as to provide a device capable of facilitating the movements involved in the method according to example embodiments. Some alternative designs will now be described, by way of example, not limitation.

<FIG> show different designs of the inner pusher according to example embodiments. The main function of the inner pusher is to apply a forward force on the inner flange of the VT (i.e. the first end of the VT that is closer to the blade). There can be several designs of the inner pusher that can achieve this aim, as long as the pusher preferably exerts a force only on one side of the VT, for example, a pusher that has a sloping end and the slope can be of different gradient and curvatures, as shown for different pushers <NUM>-<NUM> in <FIG>. The different designs of inner pusher can also give different pivoting angle/effect of the VT as required, depending for example on the angle of TM that the VT needs to negotiate. Furthermore, for a VT <NUM> with a wider inner flange a pusher <NUM> with a wider head <NUM> can be used, as shown in <FIG>. The pusher <NUM> can also be a hollow member to reduce the weight of the toolset, as shown in <FIG>.

The VT pusher <NUM> can be placed at the outer core (i.e. cover the outer tube <NUM>), as shown in <FIG>. <FIG> show the working process of this design according to an example embodiment. With this design, the pusher <NUM> can be wider and in different shape so that the tool set can fit different types of VTs or grommets, according to example embodiments.

Instead of the fixed cutter on the tip, a movable cutter <NUM> can be also designed to be placed outside the outer tube <NUM> with an inner pusher <NUM>, as shown in the tool set of <FIG>. The working process is shown in Figures <NUM>(<NUM>)-(<NUM>). The movable cutter <NUM> can be driven individually or correlated with the inner pusher <NUM>. The cutter <NUM> can be retracted before the punch out of the inner pusher <NUM> to insert the VT into the TM, here the eardrum <NUM>, in such embodiments, as illustrated in <FIG>.

<FIG> show different designs of cutters, which can be used in different user cases. For example, the tilted cutter <NUM> can be used in the case that the eardrum angle is extremely close to horizontal (less than 20deg). As shown in <FIG>, the VT <NUM> would remain perpendicular to the tilted cutter <NUM> in order to negotiate the extremely horizontal TM angle. The perpendicular position of the VT <NUM> with respect to the tilted cutter <NUM> is preferred so that the flange of the VT <NUM> adjacent to the tilted cutter would be guided smoothly into the slit on the TM once the incision is made by the tilted cutter <NUM>. Again, it is noted that there is at least a component of the pushing force applied to the VT <NUM> by the pusher <NUM> in such embodiments that is exactly perpendicular to the longitudinal axis <NUM>, as will be appreciated by a person skilled in the art.

The crescentic cutter 1802a,b can be used in the case that the eardrum is thick, which can also help to make the incision larger and prevent the VT from dropping. The crescentic cutter 1802a with higher crescent on each side could be used with some VT types that have a slightly thicker flange that sits on the cutter 1802a to ease the VT insertion whilst the crescentic cutter 1802b with lower crescent could be used for VT with thinner flange. The two-step/multi-step cutter <NUM> with a steeper tip <NUM> followed by one or more sections <NUM> of slighter incline can help to reduce the incision force while the incision can be kept the same. The bevel cutter <NUM> (i.e. blade <NUM> at the side) can behave like a surgical knife, which can potentially reduce the force. The horizontal cutters 1814a, b have an off-axis blade 1816a, b, as shown in <FIG>. The working process of the horizontal cutter <NUM> during VT insertion is shown in the <FIG>. By pushing out the pusher <NUM> inside the outer tube <NUM> (and attachment/holder <NUM>), the VT <NUM> will be pivoted and rotated by the sloped and suitably oriented end <NUM> of the pusher <NUM> towards the membrane <NUM> with very low angle, for insertion into the incision made by the blade.

The cutter <NUM> can also be attached to the shaft <NUM> at different angles so as to accommodate TM angles from <NUM> - <NUM> degree, as shown in <FIG>. The shaft <NUM> can also be slightly bent or curved to achieve the same effect, as shown In <FIG>. In such embodiments, guide wire can be used to obtain "curved" pusher movement. <NUM>) Hook in different shapes, according to example embodiments.

<FIG> show the hook in different forms and shapes to fit different types of VTs according to example embodiments, e.g. <FIG> shows a hook design <NUM> specially designed for VT <NUM> with a tab. The hook <NUM> can also be a chamfered design (see <FIG>). The chamfered design of the hook 2002a, b may be suitable if the VT does not require much engagement for pivoting, and the reduced contact with the inner bore of the VT can assist in the subsequent release of the VT after the pivot. <FIG> shows the hook <NUM> with a bristly or brush-type design with curved thins strands. The flexible strands would be able to achieve the same effect as the hook design and can be used for VT that may not have a regular shape or if the inner bore of the VT is not directly in line with the central axis. The flexible strands hook <NUM> design is able to fit VT of different heights so that a tool set change is preferably not required if different type of VT is used, e.g. for the left or right ear TM.

Interface between the toolset and reusable part, according to example embodiments.

For quick mounting and removing the toolset, some designs for the interface between the toolset and reusable part are shown in <FIG>.

In <FIG>, an interface for a push-and-lock mechanism of a tool set is shown, according to an example embodiment. In this embodiment, a spring-loaded push button <NUM> is located on one side of the mounting platform <NUM>. The push button <NUM> is mechanically connected to a lock fixture <NUM> on the other side of the platform <NUM>. When the push button <NUM> is pressed, the lock fixture <NUM> is slightly displaced and opened to allow the tool set <NUM> to be inserted to the platform <NUM>. The tool set <NUM> comprises four ledges e.g. <NUM>, one on each plane surface of a base <NUM>, to allow the tool set <NUM> to be fittingly slid into the rail guide <NUM> on the mounting platform <NUM> in the desired orientation. Releasing the push button <NUM> will then lock and secure the base <NUM> and hence the tool set <NUM>. The symmetrical design of the tool set <NUM> enables cutter and pusher to be rotated to particular orientation to increase the usability of the device.

Another example embodiment of an interface for a quick mounting mechanism of a tool set is shown in <FIG>. In this plug-and-pull embodiment, the tool set <NUM> comprises two guides e.g. <NUM>, one on each side of a base <NUM>, that serve to be slid into a rail guide <NUM> on a mounting platform <NUM>. At the center of the mounting platform <NUM>, there is a spring ball plunger <NUM> that secures the tool set <NUM> by snap-fitting the notch <NUM> on the base <NUM>. The tool set <NUM> can be removed by pulling the tool set base <NUM> out of the rail guide <NUM>.

In one embodiment of the present invention described herein, a device for incision and insertion of a ventilation tube is provided, the device comprising a cutter member configured to make an incision; a holder member configured to dispose the ventilation tube in an orientation in which a longitudinal axis of the ventilation tube is substantially perpendicular to the cutter element; and a pusher member configured to apply a pushing force to a first end of the ventilation tube in a direction substantially perpendicular to the longitudinal axis, the first end of the ventilation tube being disposed closer to the blade than a second end of the ventilation tube; wherein the holder member comprises a pivot element configured to releasably engage the second end of the ventilation tube such that the ventilation tube is pivotable about the pivot element under the pushing force applied to the first end of the ventilation tube by the pusher member, for insertion of the first end of the ventilation tube into the incision.

The device may further comprise a shaft assembly comprising a first shaft member coupled to the holder member, and a second shaft member coupled to the pusher member, wherein the first and second shaft members are moveable relative to each other. The first shaft member may be further coupled to the cutter member. The first shaft member may be coupled to the cutter member such that the first shaft member is disposed in a plane of the cutter member. The first shaft member may be coupled to the cutter member such that the first shaft member is disposed at a non-zero angle relative to a plane of the cutter member. The first shaft member may comprise a curved tip element coupled to the cutter member.

The shaft assembly may further comprise a third shaft member coupled to the cutter member moveable relative to the first and second shaft members. The third shaft member may be configured to be retractable in a direction away from the incision prior to the pusher member applying the pushing force to the first end of the ventilation tube.

The cutter member may comprise one of a group consisting of a straight cutter, a tilted cutter, a crescentic cutter, a two-step/multi-step cutter, a horizontal cutter, and a bevel cutter.

The pivot element may comprise a hook. The hook may comprise a chamfered tip or curved thin strands.

The pusher member may comprise one of a group consisting of a solid pusher with a tip having desired curvature, a pusher rod with a head element having a width larger than the pusher rod, a hollow pusher rod, a pusher rod with a long slope tip element, and a pusher rod with curved tip element.

The device may further comprise a sensor member for sensing a proximity of the cutter member to a membrane on which the incision is to be made. The sensor member may comprise a pressure sensor coupled to the cutter member. The sensor member may comprise a first deflection element configured to protrude the cutter member in a direction towards the membrane and to deflect upon contact with the membrane. The first deflection element may comprise a hair-like structure or fiber.

The device may further comprise a detector member for detecting a depth of the incision. The detector member may comprise one or more markers on the cutter member. The detector member may comprise a second deflection element configured to protrude the cutter member in a sideways direction and to deflect upon contact with the membrane. The second deflection element may comprise a hair-like structure or fiber or a pair of hair-like structures or fibers configured to protrude the cutter member in opposing sideways directions.

The device may further comprise an activation structure configured for activating movement of the pusher member for applying the pushing force to the first end of the ventilation tube. The activation structure may be further configured for activating movement of the cutter member for making the incision. The activation structure may be configured as an automatic operation structure, semi-automatic operation structure, or manual operation structure. The activation structure may be configured as a re-usable part of the device configured to cooperate with a disposable part of the device, the disposable part comprising at least the cutter member, the holder member and the pusher member.

In another embodiment of the present invention described herein, there is provided use of the device of the above embodiments in making an incision and inserting a ventilation tube in a membrane.

<FIG> shows a flowchart <NUM> illustrating a method for making and incision and inserting a ventilation tube in a membrane, according to an example embodiment. At step <NUM>, an incision is made using a cutter member. At step <NUM>, the ventilation tube is disposed in an orientation in which a longitudinal axis of the ventilation tube is substantially perpendicular to the cutter element using a holder member coupled to the cutter member. At step <NUM>, a pushing force is applied to a first end of the ventilation tube in a direction substantially perpendicular to the longitudinal axis, the first end of the ventilation tube being disposed closer to the blade than a second end of the ventilation tube, using a pusher element coupled to the cutter member and the holder member. At step <NUM>, the second end of the ventilation tube is releasably engaged using a pivot element of the holder element. At step <NUM>, the ventilation tube is pivoted about the pivot element using the pushing force applied to the first end of the ventilation tube by the pusher member, for inserting the first end of the ventilation tube into the incision.

The above description of illustrated embodiments of the systems and methods is not intended to be exhaustive or to limit the systems and methods to the precise forms disclosed. While specific embodiments of, and examples for, the systems components and methods are described herein for illustrative purposes, various equivalent modifications are possible within the scope of the systems, components and methods, as those skilled in the relevant art will recognize.

The teachings of the systems and methods provided herein can be applied to other processing systems and methods, not only for the systems and methods described above.

The elements and acts of the various embodiments described above can be combined to provide further embodiments. These and other changes can be made to the systems and methods in light of the above detailed description.

Claim 1:
A device (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) for incision and insertion of a ventilation tube into a tympanic membrane, the device comprising:
a cutter member (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, 1802a,b, <NUM>, <NUM>, 1814a,b, <NUM>) configured to make an incision;
a holder member (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) configured to dispose the ventilation tube in an orientation in which a longitudinal axis of the ventilation tube is substantially perpendicular to the cutter member (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, 1802a,b, <NUM>, <NUM>, 1814a,b, <NUM>); and
a pusher member (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) configured to apply a pushing force to a first end of the ventilation tube in a direction substantially perpendicular to the longitudinal axis, the first end of the ventilation tube being disposed closer to the cutter member than a second end of the ventilation tube;
wherein the holder member (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) comprises a pivot element (<NUM>,<NUM>,2002a,2002b,<NUM>) configured to releasably engage the second end of the ventilation tube such that the ventilation tube is pivotable about the pivot element under the pushing force applied to the first end of the ventilation tube by the pusher member (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>), for insertion of the first end of the ventilation tube into the incision.