WO2006119512A2

WO2006119512A2 - Surgical tool and insertion device for tube placement

Info

Publication number: WO2006119512A2
Application number: PCT/US2006/017906
Authority: WO
Inventors: Michael Pannunzio; Kornelis Poelstra; Shayn Peirce-Cottler; Bradley Kesser; Danielle Gause; Anuradha Roy; Lisa S. Kelly
Original assignee: University Of Virginia Patent Foundation
Priority date: 2005-05-05
Filing date: 2006-05-05
Publication date: 2006-11-09
Also published as: WO2006119512A3

Abstract

According to some embodiments, a medical device for treatment of Otitis Media includes a housing or body, a hollow tube protruding therefrom, a suction tube extending from the hollow tube and an ear tube located between the distal end of the suction tube and the hollow tube. A vacuum can be provided so as to suction fluid contained in an ear canal and/or middle ear into the suction tube. The ear tube is slideably moveable relative to the suction tube so that it can be disengaged from the device by pushing it beyond the distal end of the suction tube. In some embodiments, a scalpel is also integrated into the medical device. In preferred embodiments, a trigger communicates with a slider assembly which moves the hollow tube when the trigger is actuated, thereby disengaging the ear tube.

Description

SURGICAL TOOL AND INSERTION DEVICE FOR TUBE PLACEMENT

BACKGROUND OF THE INVENTION

The present application claims priority to U.S. Provisional Application Serial No. 60/677,902, filed on May 5, 2005, entitled "Surgical Tool and Inserter Device for Tube-Placement Solution During, the entire disclosure of which is incorporated herein by reference.

1. Field of the Invention

The present invention generally relates to surgical devices and the insertion of surgical tubes and, some preferred embodiments relate to insertion of otitis media related tubes, and in particular, to a medical device for conducting myringotomy and placement of a ventilation tube in the tympanic membrane for the effective treatment of chronic otitis media.

2. Background Discussion

Middle ear infection, known in the medical field as Otitis Media, is a condition that occurs commonly in children, and is in fact the most frequently diagnosed childhood disease in the United States. By age seven (7), more than 90% of children in the United States have experienced Otitis Media. The infection is usually caused by bacteria or virus present in the middle ear. As a result of the infection, fluid accumulates in the middle ear behind the ear drum, also known as the tympanic membrane. This accumulation of fluid can cause pressure in the ear resulting in significant ear pain, stretching of the ear drum, and loss of hearing. If left untreated, the condition can cause rupture of the tympanic membrane which may result in permanent hearing damage. Among other things, hearing loss can be of serious concern in children because normal hearing is critical in developing basic speech and language skills. A common treatment for chronic otitis media (the presence of fluid in the middle ear greater than three months) is myringotomy with insertion of a ventilation tube into the tympanic membrane. Typically, myringotomy involves a small incision made in the tympanic membrane. A tube can then be placed in the incision in order to facilitate drainage of the effusion from the middle ear space. The placement of the tube promotes ventilation of the middle ear and equalizes air pressure between the atmosphere (in the ear canal) and the middle ear. The procedure decreases pressure and pain in the ear and also restores hearing loss due to fluid accumulation. The placement of the tubes also prevents further accumulation of fluids and reduces recurrence of ear infections while they remain in place.

The federal Agency for Healthcare Research and Quality recommends that children who have fluid behind the eardrum in both ears for three (3) months and have hearing loss be referred to a specialist (Otolaryngologist- Head and Neck surgeon) for possible tube placement. Children who have hearing loss and middle ear effusion in only one ear may also be considered for tube placement. For children having repeated middle ear infections, surgery for introduction of the tubes is more contentious. As many as 30% of children who have tubes inserted need to have tubes inserted more than once. Stool SE, et al. (1994) Otitis Media with Effusion in Young Children- Clinical Practice Guideline No. 12 (AHCPR Publication No. 94-0622) Rockville MD: Agency Health Care Policy and Research.).

In the past, surgical instruments used for placement of ventilation tubes have not been conveniently designed, so that physicians are unable to hold and precisely manipulate the small ear tubes, which are mere millimeters in length and diameter. Furthermore, due to the instrumentation, the procedure has been designed such that after incision, the physician must remove the scalpel and then separately with other instruments and suction fit the tube into the incision. There is an inherent "fiddle-factor" (e.g., involving extra movement or play) which occurs in the patient's ear in order to seat the tube in the small opening created by the incision, which increases difficulty and risk for potential damage to the ear-drum and delicate ear canal. Additionally, infiltration of fluids into the ear canal from the middle ear space makes visualization during insertion difficult. Multiple passages into the ear are usually needed in order to suction fluids or blood from the external ear canal and middle ear. This extends the time of the procedure and risks further injury to the eardrum and ear canal. Also, because of the length, difficulty and effect of the procedure, the patient is usually placed under general anesthesia as the procedure is carried out.

Systems and methods are therefore needed that can overcome the above issues and/or other problems in the existing art.

SUMMARY OF THE INVENTION

The present invention addresses the above issues and improves upon the current technology and/or other background technologies and/or problems therein.

According to some embodiments, a medical device for treatment of a subject's ear (e.g., for chronic otitis media with effusion) is provided that includes: a body portion; a pusher element movably supported on said body portion; a suction tube supported on said body portion for suctioning fluid from within the subject's ear canal or middle era proximate an incision within the patient's ear drum; an ear tube moveable via the pusher element relative to said suction tube such as to place said ear tube within the patient's ear drum upon application of a force causing said pusher element to move said ear tube.. In some examples, the body portion is substantially gun-shaped and includes a depending handle portion and a forward protruding portion. In some embodiments, the ear tube coaxially surrounds the suction tube and is moved over the suction tube via the pusher element. In some examples, the pusher element includes a hollow tube. In some examples, the pusher element includes a pushing extension member extending from the body portion. In some examples, the device further comprises: a slider contained within the body portion; a trigger extending from the body portion that actuates the slider; the trigger being adapted to move the slider to in turn move the pusher element upon the application of a manual force to the trigger.

In some of the preferred embodiments, the device further includes a scalpel supported on the body portion. In some examples, a vacuum source is located external to the body portion and a suction tube extends from the body portion to the vacuum source. In some examples, the device further includes a manually operated relief aperture arranged to allow air to pass into the suction tube when opened. In some cases, the device can include a finger hole on the body portion for manual opening or closing of the relief aperture, while in some cases the device can include an actuator element on the body portion for opening or closing of the relief aperture.

According to some other embodiments, an assembly for inserting an ear tube in a subject's ear, comprises: 1 ) a body portion having: a pusher element extending from said body portion; a suction tube extending from said body portion and configured to suction fluid from proximate an incision within a subject's ear drum; an ear tube supported upon said body portion and located between a distal end of said suction tube and said pusher element; said ear tube being moveable relative to said suction tube via said pusher element such that it disengages from said assembly when moved beyond said distal end of said suction tube; and 2) a vacuum source external to said body portion in communication with said suction tube for suctioning fluid from the subject's ear canal via said suction tube. In some examples, the pusher element includes a hollow tube. In some examples, the pusher element includes a pushing extension member extending from the housing, the pushing extension member being configured to push the ear tube from the assembly.

According to some examples, the assembly or device includes: a slider contained within the body portion; a trigger extending from the body portion that actuates the slider; the trigger being adapted to move the slider to in turn move the pusher element upon the application of a manual force to the trigger. According to some other embodiments, a method for conducting a myringotomy and inserting an ear tube in a subject's ear is performed that includes: a) providing a hand-held device containing a suction tube for suctioning fluid proximate an incision, an ear tube supported on the hand-held device and a pusher element for pushing said ear tube off of said hand-held device; b) using the hand-held device to suction fluid from proximate an incision in a subject's ear drum with the hand-held device located in a use position adjacent the patient's ear; and c) using the hand-held device to insert the ear tube into the incision with the hand-held device located in said use position. In some examples, the method can further include providing the hand-held device with a scalpel for making said incision, and using the handheld device to make said incision in a subject's ear drum with the hand-held device located in the use position adjacent the patient's ear In some embodiments, the method further includes locating the hand-held device into the use position using a stop guard that contacts the patient's head and/or a speculum on the patient's head. In some embodiments, the method includes limiting the time period between the making of the incision and the inserting of the ear tube to less than 30 seconds, or, in some embodiments, to less than 15 seconds, or, in some embodiments, to less than 12 seconds.

According to some other embodiments, a method is performed comprising: inserting a surgical tool within a patient's ear and using said tool to both suction fluid from proximate an incision within a patient's ear drum and to place an ear tube within the patient's ear drum in a single step. In some examples, the method further includes making the incision within said ear drum with a scalpel supported onf said surgical tool during said single step.

Embodiments of the present invention can enable a surgeon to use one single tool inside the ear, slide the tube inside the myringotomy in a controlled fashion, and thereafter remove the tool. Such a medical device can enable a simplified procedure, reduces "fiddle-factor", lessens the need for prolonged anesthesia, and reduces complications from exiting and entering the ear with multiple instruments. Use of embodiments of the device aid in avoidance of damage to the external ear-canal due to multiple insertions/retractions of surgical tools; utilization of multiple instruments that need to be maintained, cleaned and sterilized; multiple attempts to place the ear-tube that needs to be levered into the myringotomy using a sharp, traditional 'Rosen-needle' and risk for uncontrolled pushing of the tube into the middle ear and lengthy insertion procedures with poor visualization and prolonged anesthesia time.

The above and/or other aspects, features and/or advantages of various embodiments will be further appreciated in view of the following description in conjunction with the accompanying figures. Various embodiments can include and/or exclude different aspects, features and/or advantages where applicable. In addition, various embodiments can combine one or more aspect or feature of other embodiments where applicable. The descriptions of aspects, features and/or advantages of particular embodiments should not be construed as limiting other embodiments or the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The preferred embodiments of the present invention are shown by a way of example, and not limitation, in the accompanying figures, in which:

Fig. 1 is a side view of one embodiment of a medical device for treatment of Otitis Media;

Fig. 2 is a side view of one embodiment of the front portion of the medical device for treatment of Otitis Media shown in Fig. 1, including a special ear-tube to facilitate straight forward pushing insertion.

Fig. 3 is a broken-away side view of another embodiment of a medical device for treatment of Otitis Media; Fig. 4 is a broken-away side view of an embodiment of a medical device for treatment of Otitis Media similar to that shown in Fig. 3;

Fig. 5 is a broke-away side view of the device shown in Fig. 3 in an insertion state;

Fig. 6 is a perspective view of two halves of a body for a device similar to that shown in Figs. 3 to 5 according to some illustrative embodiments;

Fig. 7 is a side view of another embodiment of a medical device according to the present invention;

Fig. 8 is a perspective view of an illustrative trigger and slider mechanism that can be employed within, e.g., the embodiment shown in Fig. 7; and

Fig. 9 is a perspective view of two halves of a body for a device similar to that shown in Fig. 7 according to some illustrative embodiments;

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

While the present invention may be embodied in many different forms, there is described here detailed illustrative embodiments with the understanding that the present disclosure is to be considered as an example of the principles of the invention and is not intended to limit the invention to the illustrated embodiments.

According to the preferred embodiments of the invention, a device is provided that operates both as a surgical tool and as an inserter device for a surgical tube, preferably an ear tube. In the preferred embodiments, the surgical tool enables both suctioning of fluids from within a patient's ear and insertion of an ear tube in a single step. Here, single step means during the use of a single tool with the single tool in substantially a single operating position. In some preferred embodiments, the surgical tool enables an operation to be conducted in which only one step is required to perform a myringotomy, along with the suctioning and inserting of the tube.

According to the preferred embodiments of the device, a variety of advantages can be achieved, such as, e.g., a guided approach to inserting a tube can be achieved, and/or continuous suction control can be achieved, and/or all components can be integrated into a safe, user friendly device to reduce the 'fiddle-factor' of ear-tube insertion.

According to the preferred embodiments, a novel ear tube insertion gun can be provided that includes one or more of the following advantageous features:

1 ) The device enables a convenient and ergonomic one-handed operation of the device;

2) The device is configured to readily fit into a patient's ear canal, such as, e.g., including an ear tube having a distal end that is contoured to fit into the ear canal and the tympanic membrane;

3) The device includes features that enable the suctioning of infiltrating fluids;

4) The device permits a controlled, reliable insertion of an ear tube;

5) The design allows for a uncomplicated, easy to manufacture and/or inexpensive to manufacture device.

Referring now to the figures, Figures 1 and 2 show a first illustrative embodiment of an otitis media surgical device 1. To facilitate reference, Figure 2 shows an enlarged view of the end portion encircled in dashed lines in Figure 1. As shown, the device 1 can include a suction tube 10 (discussed below) as well as an inserter portion for inserting an ear tube 7 into an ear drum. In some embodiments, the suction tube 10 can be formed adjacent or along with a scalpel 6, as shown. However, in some preferred embodiments, the scalpel is not employed. In instances in which a scalpel is employed, as discussed below, the scalpel can be fixed in position relative to the suction tube. In some instances in which the scalpel is employed, the scalpel can be integrally formed with the suction tube. In some instances in which a scalpel is employed, it can be made so as to be retractable.

In the preferred embodiments, the tool can have a body or housing 2. In some preferred embodiments, the body or housing 2 is configured in the shape of a gun, with a handle 3 and a forward protruding portion 4. As illustrated, the handle can include, e.g., a grip portion adapted to be grasped with one's thumb and fingers in a manner similar to a pistol grip of a common handgun. Nevertheless, in other embodiments, the body can have any other desired configuration, as long as it can be, most preferably, conveniently held within one's hand or hands.

In some preferred embodiments, as shown in Figure 1 , a forward projecting member, or tube 5, extends from the forward protruding portion of the housing. In some illustrative embodiments, the housing 2 can be composed of ABS-plastic or another suitable plastic or other suitable material. As with the embodiment shown in Figure 6, discussed below, in some implementations, the body or housing 2 can include two half shells that are attached together to form a unitary body or housing. Although a substantially hollow housing is depicted in Figure 6, in some embodiments, the housing can be either hollow or solid. On the other hand, in some preferred embodiments, the tube 5 is preferably made of a metal, such as, e.g., stainless steel or another suitable material.

As discussed above, in some optional embodiments, a scalpel 6 extends from the tube 5. In some embodiments, the scalpel 6 can be attached to the end of the tube 5. In yet other embodiments, the scalpel can be attached so as to extend from inside the hollow tube 5. In yet some other embodiments, the scalpel can be integrally formed at the end of the tube 5. Preferably, the scalpel 6 has a sharpened distal end for making incisions within a subject's ear drum. As indicated above, however, in the preferred embodiments, the scalpel could be omitted and a rounded tip at the end of a hollow suction tube 10 can be provided to reduce injury. As depicted in Figures 1 and 2, an ear tube 7 is preferably supported proximate a front end of the tube 5, such as, e.g., surrounding a portion of the tube 5 and/or the suction tube 10 (and/or scalpel 6) adjacent the tube 5.

As shown in Figure 1, the device 1 preferably includes a pusher element in the form of a pushing extension 32 that extends from the housing 2. In this embodiment, upon actuation of trigger 17 (e.g., via an operator's fingers), the pushing extension 32 preferably is laterally moved in a forward direction (e.g., rightward in Figure 1) so as to contact a rear end of the ear tube 7 and so as to push the ear tube forward over and off the distal end of the suction tube 10 (and/or scalpel 6).

In some embodiments, the tube 5 can have an outer diameter that is smaller than an inside passage or through-hole within the ear tube 7 such that the tube 5 is received within the ear tube with the ear tube slideably supported on tube 5. On the other hand, in some embodiments, the tube 5 is dimensioned wide enough so as to abut a rear end of the ear tube 7, while the ear tube 7 surrounds the rear or proximal portion of the suction tube 10 (and/or scalpel 6).

In some embodiments, in order to facilitate an operator's use of the device (e.g., for increased visibility into a patient's ear canal), the tube 5 can be curved so as to turn downward to facilitate view. However, such a curvature could render working with the device more difficult in some contexts (such as, e.g., when working along with a straight speculum). In some preferred embodiments, the facilitation of use can involve having the tube 5 formed as thin as possible, such as, e.g., narrower than an inner diameter of the ear tube 7 to facilitate use and enhance a physician's line of sight around the device.

In some embodiments, the structure tube 5 and/or tube 10 can be made interchangeable such a tube can be replaced with like parts (e.g., for reuse between patients, for replacing contaminated parts, etc.) and/or with parts of different sizes and/or shapes. By way of example, in some embodiments, the tube 5 and/or 10 can have a mechanism to change its size to accommodate different ear tube sizes, such as, e.g., having a peel off layer or the like to enable modification to accommodate different size ear tubes.

In some embodiments, it can be less expensive (e.g., for manufacturing purposes) to keep the dimensions of the tubes 5 and/or 10 substantially constant (even though there are different sized ear tubes). In some embodiments, tubes are selected that are suitable for all or substantially all sized ear tubes. This will keep the total cost of the device down (e.g., avoiding the requirement of extra, substitute parts.). Nevertheless, in some embodiments, a device 1 is sold pre-packaged with a set of tubes (such as, e.g., two, three or even four tubes (e.g., 5 and/or 10), such as, e.g., including two tubes of the two most common sizes of ear tubes. In some cases, replaceable tubes can also help in operation procedures. For example, a physician can start with a smaller size tube and if the surgeon makes the myringotomy too long, drops one tube on the floor and/or the like, the physician can then turn to the back-up tube in the package having a next larger size.

Moreover, many surgeons have their own tube that he/she generally familiar with and uses. There are dozens of different kinds of ventilation tubes on the market, made of different materials, different diameters, different shapes to fit a particular need or to ease insertion. Accordingly, in some embodiments, the tubes 5 and/or 10 and/or other components of the device 1 can be replaceable to accommodate the interest of the physician, so as to enable flexibility in having many ear tubes fit the device. By way of example, inner diameters of tubes typically range from about 0.9 mm to 1.3 mm. While most surgeons use a tube that has a 1.14 mm inner diameter, adding flexibility can be advantageous in some instances.

In the illustrated embodiment, the ear tube is preferably located, in an initial state or a loaded state, at a location between proximate an end of the tube 5 and a distal end of the suction tube 10 (and/or scalpel 6). In the illustrated embodiment, the ear tube 7 rests against the pushing extension 32 and/or an end of the tube 5 in said initial or loaded state. In some embodiments, the suction tube 10 (and/or scalpel 6), the ear tube 7 and the tube 5 are positioned along substantially the same longitudinal axis. In the preferred embodiments, the length of the tube 5 extending from the housing 2 is sufficient to enable the tube to enter the ear canal (such as, e.g., for the insertion of the ear tube, for suctioning and/or for the performance of a myringotomy). In some embodiments, the length should be, e.g., between about 50.0 and 100.0 mm long, or, more preferably, about 76.0 mm long. In various embodiments, the hollow tube 5 can be shorter or longer depending on the needs of the procedure or the preference of the physician.

As best seen in Figure 2, in some preferred embodiments, the ear tube 7 is substantially spool-shaped with a hollow center passage through which the tube 5, suction tube 10 and/or scalpel 6 are received, a cylindrical midsection and rear and front end flanges. In the embodiment shown in Figure 2, the ear tube 7 has a rear or proximal flange 9 and a front or distal flange 8 to facilitate retention of the ear tube within a patient's ear drum (e.g., with the proximal flange located over-lapping a front side of a patient's ear drum and with the distal flange located over-lapping a rear side of the patient's ear drum when inserted into the patient's ear drum). In some referred embodiments, the front or distal flange is configured or contoured to facilitate insertion into the patient's ear drum. By way of example, in some embodiments, the front flange 8 which enters the incision can be contoured so as to facilitate insertion (such as, e.g., having a tapered contour as shown in Figure 2), can be collapsible or flexible, and/or can configured similar to an umbrella, to facilitate insertion. In some embodiments, an "Umbrella" model ear tube by Micromedics, Inc. can be employed in which an inner flange collapses during insertion through the incision and inverts for convenient removal from the incision. Preferably, as shown, the rear flange 9 is substantially flat and wide enough to inhibit the tube from being pushed through the incision.

In some embodiments, the ear tube can be made of a plastic material, such as, e.g., a biocompatible plastic material. In some embodiments, the flanges can be integrally molded or formed with the plastic material of the ear tube. In other embodiments, the ear tube can be made with any appropriate materials now or later known in the art. In some embodiments, the flanges can be made with a rubber material, such as, e.g., a silastic rubber. In the preferred embodiments, the ear tube is contoured or otherwise adapted to facilitate insertion.

As best seen in Figure 2, as discussed above, in the preferred embodiments, the device includes a suction tube 10 that includes a suction opening proximate an end thereof. In some embodiments, the distal end of the tube includes a central opening into the suction tube. In some embodiments including a scalpel, the suction tube opening is adjacent and end of the scalpel as shown. In the illustrated and non-limiting example that includes a scalpel, the suction tube 10 extends along the scalpel and passes through the center of the ear tube 7 to the tube 5.

In the preferred embodiments, the tube 5 is a hollow tube that receives the suction tube 10 therein. Alternatively, in some implementations, the suction tube 10 can be supported alongside the tube 5. In the preferred embodiments, the suction tube 10 extends to an external vacuum source (e.g., such as, e.g., an air pump that draws air rearward through the suction tube 10). As shown, the suction tube 10 can extend from the device 1 to the vacuum source itself or to another suction tube ST. In some embodiments, the suction tube ST leading to the vacuum source is flexible to facilitate manipulation of the device 1 , while the suction tube 10 is substantially rigid, such as, e.g., being made of stainless steel or another metal.

Thus, with the foregoing structure, the operator (e.g., physician) can readily use the device to concurrently withdraw fluids discharged into the ear canal during incision through the ear drum membrane while attending to insertion of the ear tube. Moreover, in some embodiments employing a scalpel, the device can be conveniently used to make an incision in the tympanic membrane and then to subsequently insert the ear tube into the resulting incision. Reference is now made to Figures 3 to 6 which show a second illustrative embodiment of an otitis media surgical device. The embodiment shown in these figures is generally similar to the above-described embodiments. However, among other things, the embodiment shown in Figures 3 to 6 includes a modified pusher element structure.

Referring now to Figure 3, the tube 5 is arranged such that if moved forward in the longitudinal direction it can push the ear tube 7 over the suction tube 10 . In some embodiments, the suction tube 10 can be a hollow and blunt-tipped inner tube used for suctioning of fluids. Although not illustrated, in some embodiments, the device can also include a scalpel 6, such as, e.g., described above in relation to the foregoing embodiments. The ear tube is slideably moveable, so that with effective application of force the ear tube 7 can be released from the medical device as it is pushed past the distal end of the suction tube 10 and/or scalpel 6 so that the ear tube moves off the suction tube 10 and/or scalpel 6. As discussed above, this enables an operator to use the suction tube 10 to remove fluids while attending to insertion of the ear tube 7 and/or to use a scalpel 6 to make an incision in the tympanic membrane and then subsequently insert the ear tube into the resulting incision.

To facilitate reference, Figure 3 includes an enlargement of the end portion of the device 1 depicted within dashed lines. In this regard, as shown, the tube 5 is preferably dimensioned wide enough so as to abut a rear end of the ear tube 7, while the ear tube 7 surrounds the rear or proximal portion of the suction tube 10 and/or scalpel 6. While in the illustrated embodiment shown in Figure 1 , the tube 5 is formed wide enough to abut the rear end of the ear tube, in some embodiments, the tube 5 can include a portion that fits within the center of the ear tube and the tube 5 can include a projection, flange or the like on a periphery thereof to abut the rear of the ear tube.

As discussed above, the device 1 shown in Figure 3 also preferably includes a suction tube 10 similar to that discussed in the above-discussed embodiments. As discussed above, in some preferred embodiments, the tube 5 is a hollow tube and the suction tube 10 is preferably received within the center of the hollow tube 5.

The diameter of ear tube 7 is such that it can fit around the suction tube 10 and/or scalpel 6 as it is being pushed forward. In some illustrative and non-limiting embodiments, the inner diameter of the ear tube can be from about 0.4 mm to 4 mm, depending on circumstances. As in the foregoing embodiments, when the ear tube 7 is moved relative to the suction tube 10 and/or scalpel 6 so that it can be disengaged, it preferably circumferentially surrounds the suction tube 10 and/or scalpel 6 as it moves off the end of the device. In some alternative embodiments, although omitting benefits of the foregoing generally co-axial embodiments the ear tube 7 can also be adapted to move adjacent to the suction tube 10 and/or scalpel 6. In some illustrative and non-limiting embodiments, the length of the ear tube can be about 2.5 mm. However, in various embodiments this length can be varied. For example, in some embodiments, this length can be as much as 3 millimeters, or, in some embodiments, as much as 5 millimeters or even more. Among other things, this length can be varied based on requirements for fitting the ear tube in the incision made in the ear drum for drainage of the fluid in the middle ear. In addition, in some illustrative and non-limiting examples, when the ear tube 7 is positioned between the tube 5 and the distal end of the suction tube 10 and/or scalpel 6, the suction tube 10 and/or scalpel 6 may protrude out about 1 to 2 mm, or, in some embodiments, about 1.5 mm.

As discussed above, Figure 3 also shows an inner hollow tube or suction tube 10 that can also be provided which extends inside the outer hollow tube 5 and is enclosed by the outer hollow tube 5. The outer diameter of the inner hollow 10 tube is preferably sufficiently less than the inner diameter of the outer hollow tube 5 so as to facilitate relative movement of the hollow tube 5 thereover. Thus, there is preferably a sufficient amount of free space between a portion of the inner hollow tube 10 and the outer hollow tube 5. In some illustrative and non-limiting embodiments, the inner hollow tube 10 can have an inner diameter of about 0.02 to 0.025 inches and an outer diameter of about 0.03 to 0.04 inches, while the outer hollow tube 5 can have an inner diameter of about 0.04 to 0.045 inches and an outer diameter of about 0.05 to 0.06 inches. In some preferred embodiments, a small tip is fabricated at the location where the ear-tube-implant 7 is located to allow for gentle attachment of the tube to the 'pusher' 5. This would allow also to withdraw the ear-tube after it has been pushed ahead inadvertently over the inner tube 10/6 prior to final insertion.

Moreover, in some embodiments, the device can include a retaining mechanism to retain the ear tube thereon until the ear tube is forced off the end of the device, such as, e.g., by pulling a trigger. By way of example, in some embodiments, a latch mechanism can be provided on the tube 5 or the member 32 that retains the rear flange 9 of the ear tube, but which releases therefrom upon actuation of the trigger. Alternatively, the device can include a resilient tab extending from, e.g., the suction tube 10 in front of the ear tube 7, such as, e.g., to retain the ear tube 7 during operation, until said ear tube 7 is forced over said resilient tab during insertion (such as, e.g., by applying a pushing force via the trigger).

As described above, the inner hollow tube 10 preferably extends out from the end of the outer hollow tube 5. In addition, the ear tube 7 is preferably supported around the inner hollow tube 10, encircling it, or positioned adjacent or proximate to it. Moreover, as discussed above, in embodiments employing a scalpel 6, the scalpel 6 can be attached to the end of the inner hollow tube 10, or can be attached or positioned adjacent to the inner hollow tube 10, or can be located proximate to the inner hollow tube. In some illustrative and non-limiting embodiments, the inner hollow tube 10 can extend about 1.0 to 2.0 mm beyond the ear tube 7, and about 3.0 to 5.0 mm beyond the end of the outer hollow tube 5.

In some illustrative embodiments, the housing 2 can have a tip portion, such as, e.g., a rubber tip RT at the end of the protruding portion having a through passage via which the tube 5 is snugly, but slideably received and configured so to stabilize the outer tube 5 such that it moves substantially only in a direction along the center axis of the tube 5. In some preferred embodiments, a stop guard 11 can be provided which extends a predetermined distance from the housing 2 to contact the exterior portion of a patient's head (e.g., either above the patient's ear or within the patient's ear) to limit or block further entry of the hollow tube into an ear canal. Among other things, the stop guard 11 can be used to facilitate placement within the ear canal and/or to inhibit over insertion of the device into the ear canal. In some embodiments, the stop guard 11 can be adjustable so as to enable the device to be adapted to different patients or the like. In some illustrative and non-limiting embodiments, the stop guard 11 can be about 20 mm, or 30 mm, or even 40 mm in length.

With reference to Figure 4, in some embodiments, an ear speculum 12 can be located within a patient's ear canal during use of the device. In some embodiments, the stop guard can be caused to abut the speculum during placement of the device (such as shown) within a patient's ear. In some embodiments, the speculum can be placed within a patient's ear prior to insertion of the device and the tube 5, etc., can be later inserted through a central bore of the speculum. In some embodiments, the speculum 12 can be located on the device 1 so as to be located within the patient's ear canal 13 during manipulation of the device 1 so as to insert the suction tube 10 and/or scalpel 6 into the ear canal 13 for suctioning of fluid in the ear canal or the middle ear and/or making an incision in the ear drum 14 through to the region of the middle ear 15.

As further shown in Figure 3 to 5, a slider assembly 17 is preferably provided which is linked so as to move via a manually operated trigger 18. As shown, the trigger 18 is preferably supported so as to rotate around a pivot P and to extend outside the housing 2 for actuation by an operator. The trigger 18 preferably has a first portion extending inside the housing and a second portion extending outside of the housing. The trigger 18 is preferably provided with a bias mechanism 19, such as, e.g., a spring, so that it is biased in a manner to return to its first position after actuation. Furthermore, the trigger 18 can have a spring hook 21 which can connect to a spring for biasing action. As discussed above, the slider assembly 17 is preferably connected so as to move the tube 5 forward against the ear tube 7, thereby pushing the ear tube 7 past or over the suction tube 10 and/or scalpel 6. By way of example, in some embodiments, the slider assembly 17 can include a through-hole within which the tube 5 can be fixedly retained, such as, e.g., by being press-fit, attached via adhesives, and/or the like.

In some embodiments, the slider assembly 17 includes a slider 22 which articulates the tube 5 such that when the slider 22 moves, the tube 5 simultaneously moves therewith. In some preferred embodiments, the slider includes a glide track (such as, e.g., similar to the track 23 shown in Figure 7), to guide the movement of the slider 22. As illustrated in Figures 3 to 5, a coupling arm 24 is preferably provided which couples the trigger 18 to the slider 22.

Figures 7 to 9 illustrate a third embodiment of the invention, which includes a modified housing configuration. Among other things, in this illustrative embodiment, the projecting portion of the housing 2 tapers toward a tip end TE and has a through hole through which the tube 5 can be received. Although not shown, the embodiments shown in Figures 7 to 9 can include various components from the foregoing embodiments.

Among other things, Figures 7 and 8 show an illustrative slider 22 and related structure that can be employed within any of the foregoing embodiments. As shown in Figures 7 and 8, in such an embodiment the slider 22 can have a main body 25 and an extension portion 26. As discussed above, in some embodiments, the main body of the slider 22 can include a through-hole or aperture which can receive the tube 5. In such an embodiment, the tube 5 will preferably extend from the aperture in the slider 22 and extend outside the housing 2. Furthermore, as shown in Figure 7, the glide track 23 preferably receives a portion of the extension portion of the slider 22. While one side of the track 23 is shown in Figure 7, it should be appreciated that the other side of the housing or body 2 will include a second similar half of the track 23 so as to retain the slider 22 thereon in the preferred embodiments. Thus, in the preferred embodiments, the halves 2A and 2B of the body 2 preferably include such track portions in the preferred embodiments. When the slider 22 is moved, it will cause the outer hollow tube 5 to move along with it.

Referring back to the second embodiment shown in Figures 3 to 6, it is noted that using such a trigger and slider assembly, the ear tube 7 can be readily pushed over the suction tube 10 and/or scalpel 6. In this regard, Figure 5 illustrates a state of the trigger and slider assembly with the slider in a forward position such that the ear tube 7 is pushed off the device. Referring back to Figure 3, it can be observed that the trigger 18 is in a stored position, the tube 5 is in a stored position, and the ear tube 7 is positioned in front of the end of the tube 5 but within the distal end of the suction tube 10 and/or scalpel 6. However, when the trigger is actuated, the slider 22 moves along the glide track 23. This movement, in turn, causes the tube 5 to move simultaneously therewith. By way of example, in some instances, the slider may move forward a distance of about 3.0 to 5.0 millimeters. As a result, the tube will move forward this same distance. Therefore, if at the same time the inner hollow tube 10 extends from the outer hollow tube 5 by a distance less than or equal to about the distance that the slider is moved, the tube 5 can push the ear tube 7 past the end of the inner hollow tube 10 and/or scalpel 6 as illustrated in Figure 5. As a result, the ear tube 7 can be readily pushed past the scalpel 6 and/or the inner hollow tube 10 and can thereby be readily inserted into an incision. However, in some embodiments, the outer hollow tube 5 may not need to be moved to the distal end of the scalpel 6 and/or the inner hollow tube 10 in order to disengage the ear tube 7. Furthermore, in other embodiments, the glide track may allow for movement of the slider less than or greater than 3.0 to 5.0 millimeters depending on the circumstances.

As described above, in the preferred embodiments, such as, e.g., shown in Figure 3, a vacuum can be applied via an inner hollow tube or suction tube 10 so as to suction fluid out of the ear canal. The vacuum enables the inner hollow tube 10 to suction fluid in the ear canal or middle ear during the procedure. By way of example, fluid may exist in the ear canal initially and/or may infiltrate the ear canal during making of the incision in the ear drum with the device. The vacuum can be provided by a wall vacuum source, such as, e.g., an air pump or other vacuum source, which is coupled to a vacuum hose connector 28 attached to the housing of the device. As depicted in Figure 3, in some embodiments the suction tube 10 can extend to a suction tube 27 (which can be either a separately attached tube or a continuation of the same tube) that is contained in the housing 2 and that extends so as to couple to the vacuum hose connector. In some embodiments, the suction tube 27 can be flexible or can be rigid. In some embodiments, the suction tube 27 can extend from the vacuum hose connector 28 and can connect to the tube 10 which extends through the slider 22, or otherwise past the slider 22 so as to be appropriately positioned proximate the tip end of the device (e.g., scalpel 6 and/or tube 10). In this manner, a vacuum source can, thus, apply a suction via the flexible suction tube 27 and the tube 10.

In some preferred embodiments, any of the foregoing embodiments can be adapted so as to provide a mechanism for controlling the suctioning via the device. In particular, in some embodiments, a simple on/off switch of the vacuum source can be utilized. However, in other embodiments, the vacuum source can remain on, and a mechanism is employed so as to release the vacuum applied by the vacuum source via the tube 10. In the preferred embodiments, in order to control the application of the vacuum, a vacuum aperture or pore 29 is provided which passes through the housing 2 and communicates with the interior of the flexible suction tube 27 or the tube 10. As a result, by blocking the vacuum aperture 29, a vacuum can be applied to the inner hollow tube 5 so as to allow the application of suction via the tube 10. In some embodiments, the aperture can be blocked simply and easily with a thumb of an operator. In some embodiments, a suction control piece 30 can be placed on the housing for more convenient access by a thumb for covering the aperture running through the control piece 30, the housing 2 and into the flexible suction tube 27. When a user releases his thumb or the like, air can, thus, freely pass via the vacuum aperture or pore 21 through the suction control piece. Thus, by releasing one's thumb or other finger, the suction can be readily released. Among other things, it can be advantageous to employ such a method for applying a suction because a suction is, thus, only applied when an operator actively covers the aperture, which can help to avoid undesired application of suction forces during operation. In some illustrative and non-limiting examples, the vacuum aperture or pore 21 can have a diameter of about 1 mm-5 mm. This aperture size can be varied based on the circumstances. In some illustrative and non-limiting examples, the suction control piece 30 can have a length and/or width of about 15 to 25 mm. This can be varied based on the circumstances. In some alternative embodiments, the aperture 29 can be blocked by an actuator, such as, e.g., a switch 31 as shown in Figure 1 and can be used to, e.g., mechanically or automatically open or close such an aperture using a valve or the like. In other embodiments, a switch 31 can be an electrical switch that communicates with the vacuum source or with an electronically controlled valve within the suction line (e.g., within tubes 10, 27, ST) so as to otherwise release the vacuum applied to the end of the tube 10 during operation.

According to some of the preferred embodiments, a substantial increase in the efficiency and speed of the myringotomy, incision and insertion procedures can be achieved. By way of example, using some of the preferred embodiments, a physician is able to perform a myringotomy, to suction the haematoma from the tympanic membrane, to remove fluid from the middle ear with the suction tube, and to place the ear tube in the myringotomy all within less than about one minute, or, in some embodiments, less than about 30 seconds, or, in some embodiments, less than about 15 seconds, or, in some embodiments, even less than about 12 seconds. Moreover, in some embodiments, this can all be achieved with reduced risk and damage to the ■ ear canal.

Among other things, various embodiments of the invention can greatly facilitate cutting of the correct size, etc., during myringotomy. Moreover, various embodiments of the invention can allow for instant suction at a tip of a scalpel to evacuate fluid from the middle ear. Moreover, some embodiments enable this regulation in an efficient and advantageous manner with the thumb of the operator applied at the handle of the device.

Among other things, the preferred embodiments of the invention can also advantageously avoid unnecessary steps and/or reduce the steps of: removal of an original scalpel; introduction of a new device (e.g., a grasper holding the tube); attempting to push the ear tube through the myringotomy with limited control along with potential risk of damage to an outer ear canal and/or ear drum during the procedure.

As set forth above, in the most preferred embodiments, a one-hand operated device is provided that facilitates easy insertion of an ear tube into tympanic membrane incision while suctioning infiltrating fluids. Among other advantages, the preferred embodiments: allow for one-handed operation; suctions infiltrating fluids; enables visualization of an ear drum; provides contouring to readily fit an ear canal; and/or permits controlled and reliable insertion of an ear tube into a patient's ear.

Broad Scope of the Invention:

While illustrative embodiments of the invention have been described herein, the present invention is not limited to the various preferred embodiments described herein, but includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations and/or alterations as would be appreciated by those in the art based on the present disclosure. The limitations in the claims are to be interpreted broadly based on the language employed in the claims and not limited to examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive. For example, in the present disclosure, the term "preferably" is non-exclusive and means "preferably, but not limited to." In this disclosure and during the prosecution of this application, means-plus- function or step-plus-function limitations will only be employed where for a specific claim limitation all of the following conditions are present in that limitation: a) "means for" or "step for" is expressly recited; b) a corresponding function is expressly recited; and c) structure, material or acts that support that structure are not recited. In this disclosure and during the prosecution of this application, the terminology "present invention" or "invention" may be used as a reference to one or more aspect within the present disclosure. The language present invention or invention should not be improperly interpreted as an identification of criticality, should not be improperly interpreted as applying across all aspects or embodiments (i.e., it should be understood that the present invention has a number of aspects and embodiments), and should not be improperly interpreted as limiting the scope of the application or claims. In this disclosure and during the prosecution of this application, the terminology "embodiment" can be used to describe any aspect, feature, process or step, any combination thereof, and/or any portion thereof, etc. In some examples, various embodiments may include overlapping features. In this disclosure, the following abbreviated terminology may be employed: "e.g." which means "for example."

Claims

CLAIMSWhat is claimed is:

1. A medical device for treatment of a subject's ear, comprising: a body portion; a pusher element movably supported on said body portion; a suction tube supported on said body portion for suctioning fluid from within the subject's ear canal or middle era proximate an incision within the patient's ear drum; an ear tube moveable via the pusher element relative to said suction tube such as to place said ear tube within the patient's ear drum upon application of a force causing said pusher element to move said ear tube.

2. The medical device of claim 1 , further including a scalpel supported on said body portion for creating an incision within the patient's ear drum.

3. The medical device of claim 1 , wherein said body portion is substantially gun-shaped and includes a depending handle portion and a forward protruding portion.

3. The medical device of claim 1 , wherein said pusher element includes a hollow tube.

4. The medical device of claim 1 , said ear tube coaxially surrounds said suction tube and is moved over said suction tube via the pusher element.

5. The medical device of claim 1 , wherein said pusher element includes a pushing extension member extending from said body portion.

6. The medical device of claim 5, wherein said pusher element is adapted to provide forward and reverse sliding motion over the suction tube while pushing or pulling the ear tube in a similar direction.

7. The medical device of claim 6, further including a mechanism to releasably retain the ear tube upon said medical device.

8. The medical device of claim 3, further comprising: a slider contained within the body portion; a trigger extending from the body portion that actuates the slider; said trigger being adapted to move said slider to in turn move said pusher element upon the application of a manual force to said trigger.

9. The medical device of claim 8, further including: a track for guiding the movement of the slider.

10. The medical device of claim 9, further including a coupling arm coupling the trigger to the slider.

11. The medical device of claim 10, wherein said trigger has a first position in a loaded state in which the device is not actuated, and further including a biasing mechanism that biases said trigger into said first position.

12. The medical device of claim 1 , further including a suction tube supported on said body portion and a vacuum source for suctioning fluid in an ear canal via said suction tube.

13. The medical device of claim 1 , wherein said vacuum source is located external to said body portion and further including a suction tube extending from said body portion to said vacuum source.

14. The medical device of claim 13, further including a manually operated relief aperture arranged to allow air to pass into said suction tube when opened.

15. The medical device of claim 14, further including a finger hole on said body portion for manual opening or closing of the relief aperture.

16. The medical device of claim 14, further including an actuator element on said body portion for opening or closing of the relief aperture.

17. The medical device of claim 16, wherein said actuator element operates a valve that opens or closes said relief, aperture.

18. The medical device of claim 1 , further including a stop guard extending from said body portion and arranged to abut a subject's head to facilitate placement of the ear tube within the subject's ear.

19. The medical device of claim 1 , further including an ear speculum inserted within the subject's ear to facilitate operating within the ear canal.

20. The medical device of claim 1 , wherein said ear tube includes a proximal flange and a distal flange.

21. The medical device of claim 20, wherein said distal flange of said ear tube is contoured to facilitate insertion in the subject's ear.

22. A method of using the medical device of claim 1 , comprising: using said medical device to suction fluid from proximate an incision within a subject's ear and to place an ear tube within the incision within the subject's ear.

23. An assembly for inserting an ear tube in a subject's ear, comprising:

1 ) a body portion having: a pusher element extending from said body portion; a suction tube extending from said body portion and configured to suction fluid from proximate an incision within a subject's ear drum; an ear tube supported upon said body portion and located between a distal end of said suction tube and said pusher element; said ear tube being moveable relative to said suction tube via said pusher element such that it disengages from said assembly when moved beyond said distal end of said suction tube; and

2) a vacuum source external to said body portion in communication with said suction tube for suctioning fluid from the subject's ear canal via said suction tube.

24. The assembly of claim 24, further including a scalpel extending from said body portion and having a distal end configured to create an incision within the subject's ear drum.

25. The assembly of claim 23, wherein said pusher element includes a hollow tube.

26. The assembly of claim 23, wherein said ear tube surrounds said suction tube when moved past said suction tube.

27. The assembly of claim 24, further including said suction tube extending from said body portion to a position proximate said scalpel.

28. The assembly of claim 23, wherein said pusher element includes a pushing extension member extending from said housing, said pushing extension member being configured to push said ear tube from said assembly.

29. The assembly of claim 23, further comprising: a slider contained within the body portion; a trigger extending from the body portion that actuates the slider; said trigger being adapted to move said slider to in turn move said pusher element upon the application of a manual force to said trigger.

30. The assembly of claim 23, further including: a track for guiding the movement of the slider.

31. The assembly of claim 23, further including a coupling arm coupling the trigger to the slider.

32. The assembly of claim 23, wherein said trigger has a first position in a loaded state in which the device is not actuated, and further including a biasing mechanism that biases said trigger into said first position.

33. The assembly of claim 23, further including a flexible suction tube extending from said body portion to said vacuum source.

34. The assembly of claim 23, further including a manually operated relief aperture arranged to allow air to pass into said suction tube when opened.

35. The assembly of claim 23, further including a finger hole on said body portion for manual opening or closing of the relief aperture.

36. The assembly of claim 23, further including an actuator element on said body portion for opening or closing of the relief aperture.

37. The assembly of claim 36, wherein said actuator element operates a valve that opens or closes said relief aperture.

38. The assembly of claim 23, further including a stop guard extending from said body portion and arranged to abut a subject's head to facilitate placement of the ear tube within the subject's ear.

39. The assembly of claim 23, further including an ear speculum inserted within the patient's ear to facilitate operating within the ear canal.

40. A method of using the assembly of claim 23 for, comprising: using said medical device to place an ear tube within an incision within a patient's ear and to suction fluid from proximate the incision within the subject's ear.

41. A method for inserting an ear tube in a subject's ear, comprising: a) providing a hand-held device containing a suction tube for suctioning fluid proximate an incision, an ear tube supported on the hand-held device and a pusher element for pushing said ear tube off of said hand-held device; b) using the hand-held device to suction fluid from proximate an incision in a subject's ear drum with the hand-held device located in a use position adjacent the patient's ear; and c) using the hand-held device to insert the ear tube into the incision with the hand-held device located in said use position.

42. The method of claim 41 , further including providing the hand-held device with a scalpel for making said incision, and using the hand-held device to make said incision in a subject's ear drum with the hand-held device located in the use position adjacent the patient's ear.

43. The method of claim 42, further including locating said hand-held device into said use position using a stop guard that contacts the patient's head and/or a speculum on the patient's head.

44. The method of claim 42, further including limiting the time period between making of said incision and said inserting of said ear tube to less than 30 seconds.

45. The method of claim 42, further including limiting the time period between making of said incision and said inserting of said ear tube less than 15 seconds.

46. The method of claim 42, further including limiting the time period between making of said incision and said inserting of said ear tube to less than 12 seconds.

47. A method, comprising: inserting a surgical tool within a patient's ear and using said tool to both suction fluid from proximate an incision within a patient's ear drum and to place an ear tube within the patient's ear drum in a single step.

48. The method of claim 47, further including making the incision within said ear drum with a scalpel supported onf said surgical tool during said single step.