WO2013113022A1

WO2013113022A1 - Device and method for the insertion and removal of tympanostomy tubes

Info

Publication number: WO2013113022A1
Application number: PCT/US2013/023487
Authority: WO
Inventors: George B. Kenney; Christian Pfeffer; Lev Rosenblum
Original assignee: Entra Tympanic, Llc
Priority date: 2012-01-29
Filing date: 2013-01-28
Publication date: 2013-08-01

Abstract

Embodiments of the present invention relate to systems, methods, and apparatus for inserting and/or removing tympanostomy tubes in an office setting. For example, a tube insertion device can allow a user to insert the tympanostomy tube into the patient's tympanic membrane by isolating movement of moving elements of the tube insertion device within the patient's ear canal from external movements. As such, the tube insertion device can include one or more moving elements, which can create a puncture and insert the tympanostomy tube into the patient's tympanic membrane.

Description

DEVICE AND METHOD FOR THE INSERTION AND REMOVAL OF TYMPANOSTOMY TUBES CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of priority to U.S. Provisional Patent Application No. 61/591,970, filed January 29, 2012, entitled "Device and Method for the Insertion and Removal of Ventilation Drainage Tubes in the Tympanic Membrane," the entire content of which is incorporated herein by this reference.

BACKGROUND OF THE INVENTION

Background of the invention

The Field of the Invention

This invention relates to systems, methods, and apparatus for inserting and removing tympanostomy tubes.

Background and Relevant Art

Middle ear infections (also known as acute otitis media) occur most commonly in patients under three years of age. Treatment of such infections can include watchful waiting for 2-3 days, systemic antibiotics, or tympanostomy tubes if the patient requires three rounds of systemic antibiotics in 6 months or four rounds of systemic antibiotics in 12 months for middle ear infections. If the infection persists beyond the initial 2-3 day watchful waiting period, the patient can receive systemic antibiotics that can reduce the otopathogenic bacteria in the patient's middle ear. However, overuse of systemic antibiotics can lead to expanding drug resistance in bacteria. If the ear infection persists, then a tympanostomy tube can be inserted into the patient's tympanic membrane. The tympanostomy tube can expose the middle ear as well as the anaerobic bacteria located therein to air, which can suppress bacterial growth. Furthermore, the tympanostomy tube can allow fluid, if any, located in the middle ear to flow out. Also, the tympanostomy tube can allow the patient to receive localized treatment of the infection and/or inflammation in the middle ear (e.g., the patient can receive antibiotic and/or steroid drops through the tube).

Usually, the patient is sedated before the tympanostomy tube insertion procedure. For example, to avoid patient's movements that can disrupt or jeopardize the safety of the procedure, the patient can be placed under general anesthesia. As such, the tympanostomy tube insertion procedures can be costly. BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention provide systems, methods, and apparatus for inserting a tympanostomy tube into a patient's tympanic membrane as well as removing the tympanostomy tube therefrom. One embodiment includes a tube insertion device that allows a user to insert the tympanostomy tube into the patient's tympanic membrane by isolating movement of moving elements of the tube insertion device within the patient's ear canal from external movements (e.g., patient's head movements). As such, the tube insertion device can include one or more moving elements, which can create a puncture and insert the tympanostomy tube into the patient's tympanic membrane.

One embodiment includes a tube insertion device for inserting a tympanostomy tube into a patient's tympanic membrane. Such device has a stationary body configured to remain in a substantially fixed position within the patient's ear canal. The stationary body is also configured to create a sufficient seal with the patient's ear canal to allow reduction of pressure therein. Additionally, the device includes a sliding body slidably coupled to the stationary body. The sliding body is free to move into the patient's ear canal in response to reduced pressure within the patient's ear canal. Moreover, the device includes a penetrator having a penetrating tip, and the penetrator is movable in a lateral direction relative to the sliding body. The device also includes a vacuum mechanism that is configured to reduce pressure within the patient's ear canal sufficiently to force the sliding body to slide toward the patient's tympanic membrane.

One or more embodiments include another tube insertion device for inserting a tympanostomy tube into a patient's tympanic membrane. Such device has a stationary body configured to remain in a substantially fixed position within the patient's ear canal and to create a sufficient seal with the patient's ear canal to allow reduction of pressure therein. Furthermore, the device has a sliding body slidably coupled to the stationary body. The sliding body is free to move into the patient's ear canal in response to reduced pressure within the patient's ear canal. The device also includes a penetrator coupled to or integrated with the sliding body and a tympanostomy tube removably secured to the sliding body. Additionally, the device has a vacuum mechanism configured to reduce pressure within the patient's ear canal sufficiently to induce the sliding body to slide toward the patient's tympanic membrane.

At least one embodiment of the present invention includes yet another tube insertion device for inserting a tympanostomy tube into a patient's tympanic membrane. Such device has a stationary body and a sliding body coupled to the stationary body. The sliding body is movable into the patient's ear canal and toward the patient's tympanic membrane. The device also includes a piercing tip configured to create a perforation in the patient's tympanic membrane. The piercing tip is movable toward the patient's tympanic membrane. Moreover, the device includes a source of a focused light configured to provide a lighted targeting point on the patient's tympanic membrane, the lighted point approximately corresponding with an intended point of contact of the piercing tip with the patient's tympanic membrane.

Additional or alternative embodiments include a method in inserting a tympanostomy tube into a patient's tympanic membrane. The method includes sealing the patient's ear canal sufficiently to allow reduction of pressure therein and positioning a sliding body of a tube insertion device inside the patient's ear canal. Furthermore, the method includes forcing the sliding body of the tube insertion device to move toward the patient's tympanic membrane by reducing the pressure in the patient's ear canal and creating a puncture in the patient's tympanic membrane. The method also includes inserting a tympanostomy tube into the puncture in the tympanic membrane.

Embodiments of the present invention also include a tympanostomy tube configured for insertion into a tympanic membrane of a patient and further configured for removal therefrom. The tympanostomy tube can have a tubular shaft and a back flange coupled to or integrated with a proximal end of the tubular shaft. Additionally, the tympanostomy tube can have a front flange coupled to or integrated with a distal end of the tubular shaft, the front flange having an angled front face and an opening passing through the back flange, through the tubular shaft, and through the front flange.

Additional features and advantages of exemplary embodiments of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of such exemplary embodiments. The features and advantages of such embodiments may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features will become more fully apparent from the following description and appended claims, or may be learned by the practice of such exemplary embodiments as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the above-recited and other advantages and features of the invention can be obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. For better understanding, the like elements have been designated by like reference numbers throughout the various accompanying figures. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

Figure 1A illustrates a cross-sectional view of a tube insertion device in accordance with one embodiment of the present invention;

Figure IB illustrates a cross-sectional view of the tube insertion device of Figure 1A;

Figure 2A illustrates a cross-sectional view of the tube insertion device of Figure 1A inserted into an ear canal in accordance with one embodiment of the present invention;

Figure 2B illustrates a cross-sectional view of the tube insertion device of Figure 1A inserted into an ear canal and coupled to a tympanic membrane in accordance with one embodiment of the present invention;

Figure 2C illustrates a cross-sectional view of the tube insertion device of Figure 1A inserted into an ear canal with a tympanostomy tube partially inserted into the tympanic membrane in accordance with one embodiment of the present invention;

Figure 2D illustrates a cross-sectional view of the tube insertion device of Figure 1A inserted into an ear canal with a tympanostomy tube fully inserted into the tympanic membrane in accordance with one embodiment of the present invention;

Figure 2E illustrates a cross-sectional view of the tube insertion device of Figure 1A inserted into an ear canal with a partially retracted penetrator in accordance with one embodiment of the present invention;

Figure 2F illustrates a cross-sectional view of a tube insertion device of Figure 1A inserted into an ear canal with a retracted sliding body and penetrator in accordance with one embodiment of the present invention;

Figure 3 illustrates a cross-sectional view of a tube insertion device in accordance with another embodiment of the present invention;

Figure 4A illustrates a cross-sectional view of a tube insertion device of Figure 3 inserted into an ear canal in accordance with one embodiment of the present invention;

Figure 4B illustrates a cross-sectional view of the tube insertion device of Figure 3 coupled to a tympanic membrane in accordance with one embodiment of the present invention;

Figure 4C illustrates a cross-sectional view of the tube insertion device of Figure 3 with a tympanostomy tube inserted into the tympanic membrane in accordance with one embodiment of the present invention;

Figure 5A illustrates a cross-sectional view of a clamping device secured to a tympanostomy tube in accordance with one embodiment of the present invention;

Figure 5B illustrates a cross-sectional view of a clamping device removing a tympanostomy tube from the tympanic membrane in accordance with one embodiment of the present invention;

Figure 6A illustrates a cross-sectional view of a tympanostomy tube in accordance with one embodiment of the present invention;

Figure 6B illustrates a top view of the tympanostomy tube of Figure 6A; and

Figure 7 illustrates a chart of acts for inserting a tympanostomy tube into a tympanic membrane in accordance with one embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Embodiments of the present invention provide systems, methods, and apparatus for inserting a tympanostomy tube into a patient's tympanic membrane as well as removing the tympanostomy tube therefrom. For example, a tube insertion device can allow a user to insert the tympanostomy tube into the patient's tympanic membrane by isolating movement of moving elements of the tube insertion device within the patient's ear canal from external movements (e.g., patient's head movements). As such, the tube insertion device can include one or more moving elements, which can create a puncture and insert the tympanostomy tube into the patient's tympanic membrane.

Additionally, the tube insertion device can have a stationary body that can be secured inside or near the patient's ear canal. Thus, the stationary body can have a substantially fixed position relative to the ear canal and various structures contained therein. Particularly, the stationary body can have substantially fixed position relative to the patient's tympanic membrane, which is located inwardly, at the end of the patient's ear canal. Consequently, the stationary body can isolate movement of one or more moving elements, which can move in a predetermined path or trajectory relative to the stationary body. For example, the stationary body can have a locating channel or an aperture that can guide one or more moving elements in a predetermined trajectory. Hence, the stationary body can isolate movement of such moving elements relative to the patient's ear canal from movements external to the ear canal (e.g., patient's head movements).

In any event, a moving element of the tube insertion device can penetrate the tympanic membrane, thereby creating a puncture therein. Furthermore, a moving element of the tube insertion device can insert the tympanostomy tube into the patient's tympanic membrane. In one or more embodiments, the tympanostomy tube can be inserted into the tympanic membrane by the same moving element that creates a puncture in the tympanic membrane. For example, such moving element of the tube insertion device can puncture the tympanic membrane and insert the tympanostomy tube into the tympanic membrane in a single motion. Subsequently, the moving element can be withdrawn from the patient's tympanic membrane as well as from the ear canal, leaving the tympanostomy tube secured within the puncture in the tympanic membrane.

In one exemplary embodiment, one of the moving elements can be a sliding body that can move inward (into the patient's ear canal) and outward (out of the patient's ear canal) relative to the stationary body. Particularly, the sliding body can be slidably coupled to the stationary body. For instance, the sliding body can be located within the aperture of the stationary body, which can guide the sliding body in a predetermined trajectory as the sliding body moves inward and/or outward. Accordingly, the sliding body can slide inward and contact the patient's tympanic membrane. Moreover, the sliding body can have a sufficiently large distal end or a stopping portion thereof that can act as a stop, such that after the distal end of the sliding body contacts the tympanic membrane, the sliding body is precluded from further movement inward.

In some embodiments, another moving element, such as a penetrator, can carry and insert the tympanostomy tube into the tympanic membrane. As such, the penetrator can be slidably disposed within the sliding body. The penetrator also can have a piercing tip on a distal end thereof. Furthermore, the penetrator can have the tympanostomy tube removably secured near the piercing tip. Thus, the penetrator can penetrate the tympanic membrane and create a puncture therein and can insert the tympanostomy tube into the puncture in a single motion. For example, the sliding body can slide inward, into the ear canal and contact the tympanic membrane. Subsequently, the penetrator can move (e.g., within the sliding body) toward the tympanic membrane, create a puncture in the tympanic membrane, and secure the tympanostomy tube within the puncture in the tympanic membrane.

Alternatively, the sliding body can carry and insert the tympanostomy tube into the tympanic membrane. For instance, the sliding body can incorporate a piercing tip as well as can be configured to carry the tympanostomy tube, which can be secured near the piercing tip of the sliding body. Hence, the sliding body can move inward relative to the stationary body and can penetrate the tympanic membrane, thereby creating a puncture therein. Additionally, the sliding body can insert and secure the tympanostomy tube within the puncture in the tympanic membrane. The sliding body can create the puncture and secure the tympanostomy tube in the puncture in a single motion.

In any event, the tube insertion device can safely insert a tympanostomy tube into the patient's tympanic membrane in an office setting (e.g., without sedating the patient with general anesthesia). An exemplary embodiment of a tube insertion device 100 is illustrated in Figures 1A-1B. Referring now to Figure 1A, the tube insertion device 100 includes a stationary body 1 10 and a first moving element, such as a sliding body 120, which can move relative to the stationary body 110. Additionally, the tube insertion device 100 includes a second moving element, such as a penetrator 130 that also can move relative to the stationary body 110, and can penetrate the patient's tympanic membrane.

Furthermore, the penetrator 130 can carry a tympanostomy tube 140 near a distal end thereof and can insert the tympanostomy tube 140 into the patient's tympanic membrane, as described below in more detail. In some embodiments, the tube insertion device 100 includes a vacuum mechanism 150 that can remove air from the patient's ear canal, thereby reducing pressure therein. It should be appreciated that the vacuum mechanism can be integrated into a handheld version of the tube insertion device 100 or can be separate therefrom and in fluid communication therewith.

The stationary body 110 of the tube insertion device 100 is configured to fit into the patient's ear canal and can establish a point of reference for the sliding body 120 relative to the patient's ear canal. Particularly, the stationary body 110 can be substantially fixed relative to the patient's ear canal and can provide a predetermined pathway or trajectory for the sliding body 120 relative to the ear canal. Accordingly, the user can move the sliding body 120 into the patient's ear canal and toward a predetermined location on the patient's tympanic membrane.

In one embodiment, the stationary body 110 has a compressible outer layer 111 that comprises compressible or deformable material, such as silicone, neoprene, rubber, foam, etc. Thus, the outer layer 111 can deform and conform to the ear canal of the patient, thereby providing a comfortable and secure fit therein. Additionally, as described in further detail below, the outer layer 111 can provide at least a partial pressure seal between the stationary body 110 and walls of the ear canal, which can facilitate reduction of air pressure within the ear canal. In other words, the stationary body 110 can create a sufficient seal with the ear canal, in a manner that can allow the vacuum mechanism to reduce pressure in the ear canal.

In one embodiment, the stationary body 110 has a substantially circular cross-sectional shape, which can fit into the patient's ear canal. Also, the outer layer 111 can deform and conform to a particular shape of the patient's ear canal. Alternatively, the stationary body 110 can have a non-circular cross-sectional shape (e.g., elliptical), which can approximate the cross-sectional shape of the patient's ear canal. Although in some embodiments the stationary body 110 can include the outer layer 111, it should be appreciated that embodiments of the present invention also may have the stationary body 110 without additional layers (i.e., a monolithic stationary body 110). The stationary body 110 also can have any number of layers, which can have various configurations and shapes. For example, the stationary body 110 may have multiple layers, each of which can have various thicknesses and physical properties such as stiffness or flexibility. In any case, however, the stationary body 110 can fit into the patient's ear canal to guide the sliding body 120 along a predetermined trajectory therein.

Also, a particular configuration of the stationary body 110 can vary from one embodiment to the next. Nevertheless, the stationary body 110 can have a configuration that facilitates insertion of the stationary body 110 into the ear canal of a patient. Furthermore, the stationary body 110 can be configured to seal the ear canal in a manner that allows the vacuum mechanism 150 to sufficiently reduce pressure in the ear canal, as further described below.

Additionally, in at least one embodiment, the stationary body 110 includes an aperture 112 that accommodates a shaft 121 of the sliding body 120. In one embodiment, the shaft 121 has a slip fit within the aperture 112, such that the sliding body 120 can slide in a lateral direction substantially freely or with minimal frictional resistance along the aperture 112 and relative to the stationary body 110. In any case, the clearance between the aperture 112 and the shaft 121 can be sufficient to allow the sliding body 120 to move inward in response to reduced pressure inside the ear canal.

Also, the clearance between the inside dimension of the aperture 112 and the outside dimension of the shaft 121 can be sufficiently small to facilitate reduction of pressure inside the ear canal. In other words, although some air may enter the ear canal through the clearance between the aperture 112 and the shaft 121, the rate of entry can be sufficiently small (e.g., smaller than the rate of air removal from the ear canal, as produced by the vacuum mechanism 150). Hence, the clearance between the aperture 112 and the shaft 121 can allow the air pressure within the ear canal to be reduced to a desired level. Moreover, the clearance between the aperture 112 and the shaft 121 can act as a valve, preventing a rapid decrease of pressure in the ear canal as well as limiting the pressure differential produced between the ear canal and ambient air pressure (e.g., atmospheric pressure).

In some embodiments, the sliding body 120 and/or the shaft 121 thereof have a cylindrical shape, as illustrated in Figure IB. Accordingly, the aperture 112 has a substantially round cross-section. An appropriate clearance therebetween can vary from one embodiment to the next and may depend on particular dimensions of the sliding body 120 and aperture 112. For example, the stationary body 110 can have about between 0.001" and 0.005" clearance between the inside dimension of the aperture 112 and the outside dimension of the sliding body 120 (e.g., sliding body 120 can have a slip fit inside the aperture 112). In some embodiments, however, the clearance may be greater or less than 0.005".

The sliding body 120 that has a cylindrical shape can rotate relative to or within the aperture 112 of the stationary body 110. This invention, however, is not so limited. In additional or alternative embodiments, the sliding body 120 and the aperture 112 of the stationary body 110 can have any number of cross -sectional shapes and sizes, which can vary from one embodiment to the next. For instance, the sliding body 120 and the aperture 112 can have corresponding elliptical cross- sectional shapes. Consequently, embodiments of the present invention include the sliding body 120 that may have a substantially fixed axial orientation relative to the aperture 112 (and to the stationary body 110).

Moreover, the aperture 112 is located off-center relative to the stationary body 110 (as illustrated in Figure IB). In other words, the sliding body 120 is not concentric with the stationary body 110. Accordingly, the sliding body 120 can move in an off-centered position relative to the center axis of the stationary body 110. Nevertheless, the sliding body 120 moves along a pathway that is parallel to the axial center axis of the stationary body 110 (i.e., the aperture 112 is parallel to the axial center axis of the stationary body 110). Hence, the sliding body 120 can contact the patient's tympanic membrane at a desired quadrant (e.g., at a posterior inferior quadrant). Alternative embodiments can incorporate the aperture 112 that is substantially aligned with the center of the stationary body 110 (i.e., the sliding body 120 can move concentrically relative to the stationary body 110). Furthermore, the aperture 112 also can be misaligned or non-parallel with the axial center axis of the stationary body 110. The sliding body 120 and/or the stationary body 110 (or the aperture 112 thereof) can comprise any number of suitable materials. Specifically, the materials at the interface between the sliding body 120 and the aperture 112 can provide lubrication and/or reduced friction between the sliding body 120 and the aperture 112. Thus, only slighted force may be required to move the sliding body 120 in the inward direction (e.g., 1 lbf). For instance, the sliding body 120 and/or the aperture 112 can comprise or can be coated with Teflon (Polytetrafluoroethylene). Consequently, as further described below, reducing the air pressure within the ear canal and, thereby, creating a pressure differential about opposing portions of the sliding body 120, can push the sliding body 120 inward and into contact with the patient's tympanic membrane.

In some embodiments, the sliding body 120 incorporates multiple vacuum channels 122 (illustrated in Figures 1A-1B) that can facilitate withdrawal of air from the patient's ear canal, as further described below. As such, the vacuum channels 122 are in fluid communication with the vacuum mechanism 150, which can withdraw the air from the patient's ear canal, to reduce pressure therein. In one example, the sliding body 120 has four vacuum channels 122, which can be connected to the vacuum mechanism 150. Additionally, the vacuum channels 122 pass through the distal end of the sliding body 120, thereby forming openings in a face of the sliding body that define the distal end thereof. Hence, the sliding body 120 can couple (e.g., suction couple ) to the tympanic membrane, as further described below, by contacting the tympanic membrane in a manner that the tympanic membrane closes or covers the openings of the vacuum channels 122.

It should be appreciated that this disclosure is not so limited. In other embodiments, the sliding body 120 can incorporate a single vacuum channel or any number of vacuum channels. Moreover, the sliding body 120 can comprise a dual- lumen tube (i.e., a tube within another tube), which can have a vacuum channel formed between the inner and outer lumens of the dual-lumen tube. In any case, the sliding body 120 can have a single vacuum channel or multiple vacuum channels that may have any number of shapes and configurations, and which can remove air from the ear canal at a desired rate.

In additional or alternative embodiments, the tube insertion device 100 can withdraw air from the ear canal through vacuum channels located in other components or elements thereof. For instance, the tube insertion device 100 can incorporate vacuum channels in the stationary body 110 and/or in the penetrator 130. In any event, the vacuum mechanism 150 can be in fluid communication with the vacuum channels, in a manner that allows the vacuum mechanism 150 to remove air from the patient's ear canal through the vacuum channels of the tube insertion device 100.

In light of this disclosure, those skilled in the art should appreciate that the vacuum mechanism can be any suitable mechanism for sufficiently reducing pressure within the patient's ear canal to advance the sliding body 120 inward and/or to flex the tympanic membrane outward. Examples of suitable vacuum mechanisms include but are not limited to vacuum pumps, vacuum containers (i.e., containers seals at reduced pressure), cylinder-piston assemblies, etc. In any event, a suitable vacuum mechanism 150 can withdraw air from the ear canal through the vacuum channels in the tube insertion device 100, thereby reducing the pressure in the ear canal.

In one or more embodiments, the sliding body 120 has a flange 123 located on a proximal end thereof. The flange 123 has a greater cross-sectional area than the shaft 121 of the sliding body 120. The pushing force on the sliding body 120 produced by the ambient air pressure can be equal to the pressure difference between the atmospheric pressure and the reduced pressure of the ear canal multiplied by the cross-sectional area of the shaft 121. Accordingly, the amount of pushing force applied onto the sliding body 120 can be adjusted by changing the cross-sectional area of the shaft 121 to a desired size.

As described above, reduced pressure in the ear canal can induce inward movement of the sliding body 120. The size of the flange 123 of the sliding body 120 can determine the rate of such movement (i.e., the greater the size of the flange 123 the greater can be the speed and/or acceleration of advancement of the sliding body 120). Additionally, the cross-sectional size of the portion of the sliding body 120 that is at least partially sealed by the aperture 112 (e.g., the shaft 121) can determine the amount of pressure applied by the sliding body 120 onto the tympanic membrane, when the sliding body 120 comes into contact therewith. Hence, in some embodiments, the aperture 112 and the sliding body 120 can be sized such that the sliding body 120 can remain in equilibrium after contacting the tympanic membrane, as further discussed below. Additionally or alternatively, in some embodiments, the aperture 112 can be sized and configured to seal about the flange 123. As such, the size of the flange 123 also can determine the amount of pressure applied by the sliding body 120 onto the tympanic membrane when the sliding body 120 comes into contact therewith.

As described above, the tube insertion device 100 also includes the penetrator 130, which can be free (i.e., with minimal frictional resistance) to move relative to the stationary body 110. For instance, the penetrator can be free to move in a lateral direction relative to the sliding body 120 and/or relative to the stationary body 110 (i.e., inward and outward in the ear canal). Accordingly, the penetrator 130 can be moved toward and can pierce the patient's tympanic membrane.

In one embodiment, the penetrator 130 has a piercing tip 131 on a distal end thereof. The piercing tip 131 can be coupled to or integrated into the penetrator 130. Specifically, the piercing tip 131 is configured to pierce the patient's tympanic membrane, as further described below. In one example, the piercing tip 131 has angled faces that meet at a point, which forms the piercing tip 131 of the penetrator 130. Additionally or alternatively, the piercing tip 131 can have faces that have one or more cutting edges thereon, similar to a typical syringe needle. In any event, the piercing tip 131 is configured to penetrate the tympanic membrane and to form a perforation therein.

The penetrator 130 also has a main shaft 132, which fits within the sliding body 120. Specifically, the sliding body 120 has an opening or a channel 124 that can accommodate the main shaft 132 therein. Furthermore, the channel 124 is sufficiently large to allow the main shaft 132 (and consequently, the penetrator 130) to move therein. In one example, the main shaft 132 can be moved axially and/or laterally relative to the sliding body 120. It should be noted that the penetrator 130 also can move or slide relative to the stationary body 110. Hence, the penetrator 130 and the sliding body 120 can move independently of one another as well as independently of the stationary body 110.

In some embodiments, however, the penetrator 130 can move together with the sliding body 120, as the sliding body 120 slides relative to the stationary body 110. Accordingly, the penetrator 130 can advance inward, toward the tympanic membrane together with the sliding body 120. Particularly, as the pressure within the patient's ear canal is reduced, and the sliding body 120 is forced to advance inward, the penetrator 130 can move inward together with the sliding body 120.

Alternatively, as noted above, the penetrator 130 can move inward independently of the sliding body 120. For example, the sliding body 120 can slide or move inward relative to the stationary body 110, while the penetrator 130 can remain stationary relative to the stationary body 110 and/or relative to the patient's ear canal. Moreover, the penetrator 130 can move only partially inward, as the sliding body 120 moves inward, toward the patient's tympanic membrane (e.g., the sliding body 120 can move inward farther than the penetrator 130). Also, the sliding body 120 can move inward at the same or at a different speed than the penetrator 130. It should be also noted that the penetrator 130 can be moved outward (away from the patient's tympanic membrane) as the sliding body 120 moves inward.

As described above, the penetrator 130 can carry the tympanostomy tube 140 thereon and can insert the tympanostomy tube 140 into the patient's tympanic membrane. Specifically, in at least one embodiment, the penetrator 130 has a reduced cross-section at a distal portion 133 thereof. Also, the distal portion 133 of the penetrator 130 is sized to accept the tympanostomy tube 140. In other words, the inside size or diameter of an opening in the tympanostomy tube 140 fits about the distal portion 133 of the penetrator 130.

Additionally, the opening of the tympanostomy tube 140 can have a slip fit about the distal portion 133 of the penetrator 130. Particularly, the tympanostomy tube 140 can be substantially free (i.e., with minimal frictional resistance) to move relative to the penetrator 130 in a lateral direction. Consequently, as further described below, the distal portion 133 of the penetrator 130 can perforate the tympanic membrane together with the tympanostomy tube 140, and the distal portion 133 can slide out of the tympanostomy tube 140, leaving the tympanostomy tube 140 secured in the tympanic membrane.

Furthermore, the tympanostomy tube 140 has a sloping front face 141, which can match the angle of the piercing tip 131. Accordingly, the piercing tip 131 and the front face 141 can create a perforation in the tympanic membrane and can dilate the perforation in a single movement. For instance, the piercing tip 131 can penetrate the tympanic membrane, thereby forming the perforation therein, and the front face 141 can dilate the perforation in the tympanic membrane in a manner that allows the tympanostomy tube 140 to be inserted into the perforation.

As described above, the penetrator 130 can move together with the sliding body 120. For instance, the clearance between the channel 124 and the main shaft 132 can be sufficiently small as to allow the friction force therebetween to maintain the sliding body 120 and the penetrator 130 as a single unit. Additionally or alternatively, a flange of the tympanostomy tube 140 can have a frictional slip fit within the channel 124. Thus, the tympanostomy tube 140 can frictionally hold the sliding body 120 and the penetrator 130 together as a single unit, which can move inward, into the patient's ear canal. In other embodiments, however, the clearance between the channel 124 and the main shaft 132 can be such as to prevent any friction force from maintaining the sliding body 120 and the penetrator 130 together.

In some instances, first, the sliding body 120 can advance inward and engage the tympanic membrane. Subsequently, the penetrator 130 together with the tympanostomy tube 140 can form a perforation and dilate the perforation in the tympanic membrane as well as insert the tympanostomy tube 140 into the perforation. Additionally, the penetrator 130 can move to a predetermined position relative to the sliding body 120 as well as relative to the tympanic membrane, thereby limiting the depth of penetration of the penetrator 130 and the tympanostomy tube 140.

For example, the distance between the proximal end (e.g., the flange 123) and the distal end of the sliding body 120 can be a known value. Likewise, the tube insertion device 100 can have the penetrator 130 with the known distance between the piercing tip 131 and a stopping point on the penetrator 130 as well as between the piercing tip 131 and the distal end of the sliding body 120. In one embodiment, the stopping point on the penetrator 130 can be a flange 134 (or a distal face of the flange 134). Specifically, the flange 134 can allow the penetrator 130 to slide to a predetermined position relative to the flange 123 that defines the proximal end of the sliding body 120. Hence, the flange 134 can allow the penetrator 130 to move inward to a predetermined position relative to the distal end of the sliding body 120, where the flange 134 can stop the penetrator 130 from further advancement.

For example, when the flange 134 abuts the flange 123, the piercing tip 131 of the penetrator 130 can be at a predetermined position relative to the distal end of the sliding body 120, which can be coupled to the tympanic membrane. Thus, the piercing tip 131 as well as the tympanostomy tube 140 can be positioned just past the tympanic membrane (i.e., at a position sufficient to penetrate the tympanic membrane and insert the tympanostomy tube 140). As such, the piercing tip 131 can avoid making contact and/or damaging any internal structures within the patient's middle ear.

It should also be appreciated that the penetrator 130 can have multiple stops that can allow positioning the penetrator 130 at various locations relative to the patient's tympanic membrane. For instance, the penetrator 130 can have a first stop just short of the tympanic membrane before making a perforation therein, and a second stop at a position when the tympanostomy tube 140 is inserted into the perforation in the patient's tympanic membrane. Thus, the user of the tube insertion device 100 can quickly advance the penetrator 130 to the first stop and can subsequently slowly advance the penetrator 130 from the first stop to the second stop.

In one or more embodiments, the penetrator 130 can be manually actuated. In other words, the user of the tube insertion device 100 can push the penetrator 130 inward until the penetrator 130 reaches a stop. For instance, the user can push the penetrator 130 until the flange 134 abuts the flange 123 and the tympanostomy tube 140 is inserted into a perforation in the patient's tympanic membrane. Subsequently, the user can manually move the penetrator 130 outward.

In some embodiments, the tube insertion device 100 includes a mechanism for illuminating and/or viewing the patient's ear canal and/or tympanic membrane during the procedure. For example, the penetrator 130 can include at least one waveguide 160 that can allow the user to view the tympanic membrane during the procedure. Particularly, the waveguide 160 can couple to a video imaging device/equipment, which can provide an image of the tympanic membrane. Furthermore, the tube insertion device 100 can include an illumination device (e.g., a lamp, a waveguide connected to a light source, etc.), which can illuminate the patient's ear canal as well as the tympanic membrane during the procedure. As such, the user can receive a color image of the ear canal and/or of the tympanic membrane on the video imaging equipment. Additionally or alternatively, the waveguide 160 can couple to a light source and can project a concentrated or focused light beam onto the patient's tympanic membrane. For instance, the waveguide 160 can transmit the laser point of a particular distinctive color (eg., red) onto the patient's tympanic membrane, which can assist the user in targeting and locating the penetrator 130 relative to the tympanic membrane. Accordingly, the user can have more control over the particular placement and movement of the penetrator 130 relative to the patient's tympanic membrane. Moreover, such targeting can provide a visual confirmation that the piercing tip 131 of the penetrator 130 will penetrate the tympanic membrane at a desired location.

It should be also appreciated that, whether a laser point or generally a focused light beam, a particular light emitting source and/or point of transmission can be located on or in any one of the components or elements of the tube insertion device 100. For instance, the waveguide 160 can pass through and/or can be located on the sliding body 120 and/or on the stationary body 110 and/or on the penetrator 130. In any event, the tube insertion device 100 can provide a lighted point on the tympanic membrane, and such lighted point can at least approximately correspond with an intended location where the piercing tip 131 will contact and penetrate the tympanic membrane.

Also, in some embodiments, one or more of the components and/or elements of the tube insertion device 100 can be transparent, which can facilitate direct viewing of the ear canal as well as the tympanic membrane during the procedure. In additional or alternative embodiments, one or more of the components and/or elements of the tube insertion device 100 can have a viewing port or a transparent portion thereof that can allow direct viewing of the ear canal and/or of the tympanic membrane. For example, the stationary body 1 10 can at least partially comprise transparent material. Similarly any one of the sliding body 120 and/or penetrator 130 (and their respective portions) can comprise transparent material. In any case, in some examples, the combination of the transparent material used in the components or elements of the tube insertion device 100 as well as the waveguide 160 and/or other viewing mechanisms incorporated into and/or connected to the tube insertion device 100 can allow the user to view, whether directly or through video imaging equipment, the ear canal and/or the tympanic membrane during and after the procedure.

Accordingly, to insert the tympanostomy tube 140 into the patient's tympanic membrane, the tube insertion device 100 can be inserted into a patient's ear canal 200, as illustrated in Figures 2A-2F. Specifically, as illustrated in Figure 2A, the stationary body 110 of the tube insertion device 100 can be located or fitted between ear canal walls 210. As noted above, in some embodiments, the stationary body 110 can fit between the ear canal walls 210 in a manner that sufficiently seals the ear canal 200 to allow the tube insertion device 100 to reduce pressure therein by a desired amount.

Thereafter, the tube insertion device 100 can remove air from the ear canal 200. For instance, the tube insertion device 100 can remove air from the ear canal 200 through the vacuum channels 122, as illustrated in Figure 2B. Thus, pressure in the ear canal 200 can be reduced from Pi (Figure 2A) to a reduced pressure Pi', which is less than Pi. In some instances, the tube insertion device 100 and/or the sliding body 120 can be exposed to atmospheric pressure P2.

Accordingly, the atmospheric pressure P2 can generate and apply first force Fi onto the sliding body 120. Specifically, the first force Fi can be approximately equal to the pressure difference between the reduced pressure Pi' and the atmospheric pressure P₂ (i.e., Δι) multiplied by the cross-sectional area of the portion of the sliding body 120 that is sealed within the aperture 1 12 of the stationary body 110 (e.g., the shaft 121 of the sliding body 120). Consequently, as noted above, the first force Fi can be adjusted to a desired or preferred amount by adjusting the pressure difference Δι and/or by adjusting the cross-sectional area portion of the sliding body 120 that is sealed within the aperture 1 12 of the stationary body 110. It should be appreciated that the first force Fi can press the sliding body 120 against a tympanic membrane 220. Adjusting the first force Fi also adjusts the amount of pressure applied by the distal end of the sliding body 120 onto the tympanic membrane 220.

Furthermore, the reduced pressure Pi' can be less than the pressure P3, inside the patient's middle ear. Accordingly, the tympanic membrane 220 can experience a second force F₂, which can deflect the tympanic membrane 220 outward. Similar to the first force Fi, the second force F₂ can be approximately the difference between the reduced pressure Pi' and the pressure in the middle ear P₃ (Δ₂) multiplied by the area of the tympanic membrane 220.

In some embodiments, the tympanic membrane 220 can close or cover the vacuum channels 122 in the sliding body 120, which can prevent further reduction of pressure in the ear canal 200 and/or inward movement of the sliding body 120. Particularly, as the tympanic membrane 220 contacts the distal end of the sliding body 120, the tympanic membrane 220 can close the vacuum channel 122, thereby preventing removal of air from the ear canal 200. Moreover, the vacuum or suction within the vacuum channels 122 can couple the tympanic membrane 220 to the distal end of the sliding body 120. As the tympanic membrane 220 couples to the sliding body 120, relative motion of the sliding body 120 and the tympanic membrane 220 can be reduced or eliminated. Hence, such coupling can facilitate safe insertion of the tympanostomy tube 140 into the tympanic membrane 220.

Additionally or alternatively, in at least one embodiment, the cross-sectional area (or size) of the shaft 121 or of the flange 123 (as applicable) can be adjusted such that the first force Fi is substantially the same as the second force F₂. In other words, the force applied by the sliding body 120 onto the tympanic membrane 220 can be substantially the same as the force applied by the tympanic membrane 220 onto the sliding body 120. Consequently, the sliding body 120 and the tympanic membrane 220 can remain in equilibrium, such that the sliding body 120 remains stationary within the ear canal 200 after coming into contact with the tympanic membrane 220.

Also, as illustrated in Figure 2C, the penetrator 130 can advance inward in a manner that the piercing tip 131 of the penetrator 130 penetrates the tympanic membrane 220. Moreover, advancement of the penetrator 130 can proceed until the flange 134 of the penetrator 130 abuts the flange 123 of the sliding body 120 (Figure 2D). Particularly, as described above, the distance between the proximal end (or face) of the flange 123 and the distal end of the shaft 121 of the sliding body 120 can be known. Accordingly, when the tympanic membrane 220 couples with the distal end of the shaft 121, the distance from the proximal end of the flange 123 (or from the proximal end of the sliding body 120) to the tympanic membrane 220 also can be known. As such, the penetrator 130 can travel to a stop that can position the piercing tip 131 and the tympanostomy tube 140 at a predetermined distance inside the tympanic membrane 220.

In other words, the penetrator 130 can advance inward to a precise location, such that the distal end or the piercing tip 131 does not contact structures inside of the middle ear. Hence, the penetrator 130 can insert the tympanostomy tube 140 into the tympanic membrane 220 without touching and/or damaging any internal structures in the middle ear. Moreover, advancing the penetrator 130 to a precise and/or predetermined location relative to the tympanic membrane 220 can eliminate or reduce the risk of over-penetrating the tympanic membrane 220 (e.g., of pushing the tympanostomy tube 140 past the tympanic membrane 220 into the middle ear).

As mentioned above, the penetrator 130 can move independently of the sliding body 120 and/or of the stationary body 110. More specifically, the penetrator 130 can be manually or automatically actuated and advanced inward in the ear canal 200 and into the tympanic membrane 220. If the penetrator 130 is advanced manually, the user can feel or experience the pressure or resistance to further movement of the penetrator 130, as the piercing tip 131 contacts the tympanic membrane 220. Hence, the user can have control over the speed and manner in which the piercing tip 131 penetrates the tympanic membrane 220. Likewise, the user can control the speed and manner (i.e., by receiving tactile feedback from resistance to further advancement) while the perforation in the tympanic membrane 220 is dilated and as the tympanostomy tube 140 is inserted into the tympanic membrane 220.

In other words, the user can receive tactile feedback provided by the resistance of the penetrator 130 to further movement, through various stages of the insertion of the tympanostomy tube 140 into the ear canal 200 (i.e., making a perforation in the tympanic membrane 220, dilating the perforation, and inserting the tympanostomy tube 140 into the tympanic membrane 220). Such feedback can assure the user that the various stages of the insertion of the tympanostomy tube 140 into the tympanic membrane 220 are conducted and completed safely. For example, if the user experiences greater than normal or expected resistance to further advancement of the penetrator 130, the user can stop or pause the procedure and verify that the penetrator 130 is positioned at a proper location (e.g., at the posterior inferior quadrant). As mentioned above, the penetrator 130 can be advanced (or moved inward) together with the sliding body 120 or independently thereof. Also, the penetrator 130 can be partially advanced together with the sliding body 120 and partially independently thereof. For example, the piercing tip 131 of the penetrator 130 can be recessed from the distal end of the sliding body 120. Thus, the sliding body 120 can advance inward together with the penetrator 130 and can couple to the tympanic membrane 220. Thereafter, the penetrator 130 can be manually advanced through the tympanic membrane 220.

As noted above, in some embodiments, the penetrator 130 can be advanced automatically or semi-automatically. For instance, the penetrator 130 can be advanced by various mechanisms, such as pneumatic mechanism (e.g., using air pressure to move the penetrator), electromechanical mechanism (e.g., a series of alternatively activated coils), mechanical mechanism (e.g., a spring, a preloaded piston, etc.), or can be advanced in a manner that combines any number of such mechanisms. Furthermore, in some instances, initiation of advancement can be selected by the user. Alternatively, initiation of advancement can occur automatically after a predetermined event or series of events. For example, the penetrator 130 can be automatically advanced after the sliding body 120 couples to the tympanic membrane.

In at least one embodiment, the sliding body 120 can remain coupled to the tympanic membrane 220, while being able to float within the ear canal 200. Particularly, when coupled to the tympanic membrane, the sliding body 120 may be substantially unrestrained from movement relative to the stationary body 110. As such, the sliding body 120 can, at least slightly, move inward in outward in the ear canal 200, while being coupled to and together with the tympanic membrane 220 (i.e., flexing the tympanic membrane 220 inward and outward).

Accordingly, such configuration can minimize the effect of external movements (e.g., patient's head movements) on the procedure, as such movements, at least in part can be absorbed by the floating of the sliding body 120. Likewise, the penetrator 130 can float together with the sliding body 120. Hence, the penetrator 130 can be advanced to a predetermined position relative to the sliding body 120 as well as to the tympanic membrane 220 at any position of the sliding body 120 within the ear canal 200, when the sliding body 120 is coupled to the tympanic membrane 220. For instance, the penetrator 130 can be automatically actuated or advanced, as described above.

In one or more other embodiments, after coupling to the tympanic membrane 220, the sliding body 120 can be fixed relative to the stationary body 110. Accordingly, in some instances, the user may have more control if or when manually advancing the penetrator 130 into the tympanic membrane 220. That is, the relative movement of the penetrator 130 and the sliding body 120 can be reduced or eliminated, which can provide additional control for manual advancement of the penetrator 130.

Moreover, in some instances, the penetrator 130 can penetrate the tympanic membrane 220 and insert the tympanostomy tube 140 therein while the tympanic membrane 220 remains flexed outward and/or attached to the distal end of the sliding body 120. As such, the piercing tip 131 of the penetrator 130 can make a perforation in the tympanic membrane 220 without pushing the tympanic membrane 220 inward, into the middle ear space. Likewise, the penetrator 130 can dilate the perforation in the tympanic membrane 220 and can insert the tympanostomy tube 140 into the tympanic membrane 220 without pushing the tympanic membrane 220 into the middle ear space. Furthermore, as the tympanic membrane 220 is flexed outward, the piercing tip 131 of the penetrator 130 can have additional space for entering the middle ear without contacting and/or damaging any structures located therein.

As described below in further detail, the tympanostomy tube 140 can have a folding front flange 142, which can at least in part form the front face 141 (described above) of the tympanostomy tube 140. As the penetrator 130 pushes the tympanostomy tube 140 through the perforation in the tympanic membrane 220, the front face 141 of the tympanostomy tube 140 can dilate the perforation. Additionally, as the tympanostomy tube 140 is pushed through the perforation in the tympanic membrane 220, the front flange 142 can fold inward, thereby reducing the outside dimension of the front flange 142 as it passes through the perforation. Specifically, in some embodiments, the front flange 142 comprises multiple sections that can collapse together, when the front flange 142 passes through the perforation in the tympanic membrane 220. Consequently, the front flange 142 can be reduced in size, thereby reducing the amount of dilation necessary for inserting the front flange 142 through the perforation in the tympanic membrane 220.

After the tympanostomy tube 140 passes through the perforation in the tympanic membrane 220, the front flange 142 can expand to its pre-collapsed configuration, as illustrated in Figure 2D. Accordingly, the front flange 142 of the tympanostomy tube 140 can provide resistance to outward movement of the tympanostomy tube 140. In other words, the front flange 142 can help to maintain the tympanostomy tube 140 in the perforation in the tympanic membrane 220.

Subsequently, as illustrated in Figure 2E, the penetrator 130 and the sliding body 120 can move in the outward direction from the ear canal 200. As the penetrator 130 moves outward, the distal portion 133 slides out of an opening 143 of the tympanostomy tube 140. When the distal portion 133 slides out of the opening 143, the tympanostomy tube 140 may be pulled in the outward direction. To the extent that the tympanostomy tube 140 moves in the outward direction, the front flange 142 can spread and flatten out in a manner that the tympanostomy tube 140 is retained in the perforation in the tympanic membrane 220. Hence, as the sliding body 120 and the penetrator 130 are removed from the ear canal 200, the tympanostomy tube 140 can remain secured in the perforation in the tympanic membrane 220, as illustrated in Figure 2F. Likewise, the stationary body 110 of the tube insertion device 100 also can be removed from the ear canal 200.

In light of this disclosure it should be appreciated that the tube insertion device may have other configurations, which are within the scope of this invention. For example, as illustrated in Figure 3, a tube insertion device 100a includes a stationary body 110a and a sliding body 120a that can move laterally within and relative to the stationary body 110a. The tube insertion device 100a and components or elements thereof can be similar to or the same as the tube insertion device 100 (Figures 1A-2F) and its respective components or elements (and vice versa), except as otherwise described herein.

In some embodiments, the tube insertion device 100a includes the sliding body 120a that has a piercing tip 125a located on a distal end of a shaft 121a. The piercing tip 125a can be coupled to or integrated with the sliding body 120a. Similar to the sliding body 120 (Figure 1A), the sliding body 120a can include the flange 123a on a proximal end thereof. As noted above, the cross-sectional area of the flange 123a can determine the amount of force applied onto the sliding body 120a, which can push and/or advance the sliding body 120a inward into the patient's ear canal.

Particularly, the tube insertion device 100a can reduce pressure inside the patient's ear canal, which can be at least partially sealed by the stationary body 110a. Thus, the pressure acting on the flange 123 a can be greater than the pressure inside the patient's ear canal. Consequently, the pressure difference across the sliding body 120a can apply force onto the sliding body 120a, which can move the sliding body 120a inward, as described above in connection with the sliding body 120 (Figures 1A-2F).

To withdraw air from the ear canal the sliding body 120a has one or more vacuum channels 122a, which can be in fluid communication with the vacuum mechanism. Additionally or alternatively, the stationary body 110a can incorporate one or more vacuum channels that can provide fluid communication between the vacuum mechanism and the patient's ear canal. In any event, the vacuum mechanism can reduce pressure in the patient's ear canal in a manner that can advance the sliding body 120a inward.

As the sliding body 120a moves inward, the piercing tip 125 a can pierce the tympanic membrane. Additionally, the sliding body 120a can insert a tympanostomy tube 140a into the perforation formed by the piercing tip 125 a in the patient's tympanic membrane. More specifically, the sliding body 120a can carry the tympanostomy tube 140a that can be secured to a distal portion 126a of the sliding body 120a. The distal portion 126a of the sliding body 120a can be similar to the distal portion 133 of the penetrator 130 (Figures 1A-2F). Also, in one embodiment, the sliding body 120a has a recess 127a near the piercing tip 125 a thereof, which can accept a back flange 144a of the tympanostomy tube 140a. Moreover, the back flange 144a can be flush with a distal face 128a of the shaft 121a. Thus, as the distal face 128a contacts the tympanic membrane, the back flange 144a may not interfere with such contact.

A particular configuration for securing the tympanostomy tube 140a to the sliding body 120a can vary from one embodiment to another. For instance, in some embodiments, the back flange 144a may protrude past the distal end of the shaft 121a. In any case, however, the sliding body 120a can carry the tympanostomy tube 140a toward and can insert the tympanostomy tube 140a into the tympanic membrane.

To insert the tympanostomy tube 140a into the patient's tympanic membrane, the stationary body 110a can be placed inside the patient's ear canal 200, as illustrated in Figure 4A. Thereafter, the vacuum mechanism can withdraw air from the ear canal 200, thereby reducing the pressure in the ear canal 200 to the reduced pressure Pi'. As mentioned above, in some instances, the flange 123a can be exposed to ambient or atmospheric pressure P₂, which can be greater than the reduced pressure Pi'. Accordingly, the pressure difference between the ambient pressure P₂ and the reduced pressure Pi' can result in a first force Fi, which can advance the sliding body 120a inward, into the ear canal 200.

Moreover, as illustrated in Figure 4B, the sliding body 120a can advance inward, into the ear canal 200, and can penetrate the tympanic membrane 220, thereby making a perforation therein. Also, the sliding body 120a can insert the tympanostomy tube 140a into the perforation in the tympanic membrane 220. Additionally, similar to the sliding body 120 (Figures 1A-2F), the sliding body 120a can couple to the tympanic membrane 220. Specifically, the tympanic membrane 220 can close the vacuum channels 122a, when the tympanic membrane 220 contacts the distal face 128a of the shaft 121a.

In other words, the sliding body 120a can penetrate the tympanic membrane 220, insert the tympanostomy tube 140a into the perforation formed in the tympanic membrane 220, and can couple to the tympanic membrane 220. It should be appreciated that, in some embodiments, coupling the sliding body 120a to the tympanic membrane 220 can stop the sliding body 120a from advancing further into the ear canal 200. Accordingly, such coupling can minimize the risk of over- penetrating the tympanic membrane 220 and/or contacting or damaging structures within the patient's middle ear.

After the tympanostomy tube 140a is inserted into the tympanic membrane 220, the sliding body 120a can move outward (e.g., the sliding body 120a can be manually or pneumatically withdrawn from the ear canal 200), as illustrated in Figure 4C by releasing the vacuum created via the vacuum channel(s) 122a. As the sliding body 120a is withdrawn from the ear canal 200, the tympanostomy tube 140a can remain secured in the perforation in the tympanic membrane 220. Likewise the stationary body 110a (or the entire tube insertion device 100a) can be removed from the ear canal 200. In some instances, removal of the stationary body 110 also can remove the sliding body 120 from the patient's ear canal 200.

If or when the tympanostomy tube has to be extracted from the tympanic membrane, the tympanostomy tube can be simply pulled in the outward direction, as illustrated in Figures 5A-5B. Specifically, as shown in Figure 5A, a clamping device 300 can grab a portion of the tympanostomy tube 140. For instance, the clamping device 300 can grab a tab 145, which protrudes from a back flange 144 of the tympanostomy tube 140. It should be appreciated that the clamping device 300 can grab any other accessible portion of the tympanostomy tube 140 (e.g., the back flange 144, a wall that forms the opening 143, etc.).

Once the clamping device 300 is secured to the tympanostomy tube 140, the clamping device 300 can be moved in the outward direction thereby pulling the tympanostomy tube 140 out of the tympanic membrane 220. Particularly, as illustrated in Figure 5B, as the front flange 142 of the tympanostomy tube 140 moves through the perforation in the tympanic membrane 220, the front flange 142 can collapse inward and away from the back flange 144. Thus, the front flange 142 can be reconfigured into a reduced profile, which can facilitate extraction of the tympanostomy tube 140 through the perforation in the tympanic membrane 220, while reducing risk of tearing and/or discomfort to the patient that may be associated with the removal of the tympanostomy tube 140.

Figures 6A-6B illustrate an exemplary embodiment of the tympanostomy tube 140, which can be inserted into and removed from the tympanic membrane 220 in a manner described above. Specifically, the tympanostomy tube 140 has the front flange 142 and back flange 144 coupled on opposing ends of a tubular shaft 146. It should be appreciated that the tympanostomy tube can be substantially monolithic. Consequently, the front and back flanges 142, 144 can be integrated within the tubular shaft 146.

The tubular shaft 146 can have any number of cross-sectional shapes and sizes. It is to be appreciated that the thickness of the tympanic membrane can vary, for instance, from about 50 μιτι to about 200 μιη. Accordingly, in some embodiments, the distance between the front flange 142 and the back flange 144 (i.e., the open space along the tubular shaft 146) is about 200 μιη. Alternatively, however, the open space along the tubular shaft 146 can be greater or less than 200 μη .

In one exemplary embodiment, the front flange 142 forms an acute angle with the tubular shaft 146. As such, the front face 141 of the front flange 142 can at least partially dilate the perforation in the tympanic membrane made by the piercing tip. Additionally, the angled front flange 142 can facilitate insertion of the tympanostomy tube 140 into the perforation in the tympanic membrane.

Furthermore, at least a portion of the front flange 142 can be flexible relative to the tubular shaft 146. Accordingly, as the tympanostomy tube 140 is pushed into the perforation in the tympanic membrane, the front flange 142 can collapse toward the tubular shaft 146, thereby reducing the resistance to insertion into the perforation in the tympanic membrane. For instance, in one embodiment, the front flange 142 comprises multiple segments (as shown in Figure 6B). As the front flange 142 is pressed against or into the perforation in the tympanic membrane, the segments of the front flange 142 can collapse together and toward the tubular shaft 146, thereby reducing the effective size of the front flange 142, and reducing the resistance thereof to insertion into the perforation in the tympanic membrane.

It should be appreciated that the front flange 142 also can be unitary or disklike (i.e., without multiple segments). Embodiments also can include the front flange 142 that comprises soft and/or flexible material. Additionally, such material can be biocompatible. For example, the tympanostomy tube 140 and/or the front flange 142 can comprise silicone, which can flex and/or bend in response to the tympanostomy tube 140 entering the perforation in the tympanic membrane.

As noted above, in some embodiments, the tympanostomy tube 140 also includes the back flange 144. The back flange 144 can prevent the tympanostomy tube 140 from being pushed into and/or from falling into the middle ear (i.e. passing through the perforation in the tympanic membrane). As such, the back flange 144 can have sufficiently large cross-sectional area, as compared with the cross-section of the perforation in the tympanic membrane and/or with the tubular shaft 146, such as to prevent the tympanostomy tube 140 from passing through the perforation in the tympanic membrane. Furthermore, in some embodiments, the back flange 144 comprises a substantially rigid material which can resist flexing in response to being pressed against the tympanic membrane. In other words, the tympanostomy tube 140 can comprise multiple materials and can incorporate a softer or more flexible front flange 142 and a more rigid back flange 144.

It should be appreciated, however, that the tympanostomy tube 140 can comprise a single material which can be sufficiently rigid and/or flexible. For instance, the tympanostomy tube 140 can comprise polypropylene which can allow the front flange 142 to flex. Moreover, the back flange 144 can have sufficient thickness, such that the polypropylene (or other suitable material) provides sufficient rigidity for the back flange 144.

Also, the tympanostomy tube 140 can include the front flange 142 that is not flexible (or which has limited flexibility). For instance, the front flange 142 may be entirely connected to the tubular shaft 146 (e.g., similar to or the same as the front flange of the tympanostomy tube 140a, illustrated in Figure 3). Thus, the tympanostomy tube 140 can dilate the perforation in the tympanic membrane sufficiently to allow the front flange 142 to pass therethrough. After the front flange 142 passes through the perforation in the tympanic membrane, the tissue surrounding the perforation can at least partially recover to its un-deformed state, thereby constricting the tympanostomy tube 140 therein. Additionally, the back flange 144 can have a larger diameter than the front flange 142, such that the back flange 144 may restrict movement of the tympanostomy tube 140 through the perforation in the tympanic membrane (even when the perforation is fully dilated by the front flange 142).

In one or more embodiments, the tympanostomy tube 140 may not have the front flange 142. Thus, the tympanostomy tube 140 may slide or fall out of the perforation in the tympanic membrane. It should be appreciated, however, that the back flange 144 may continue preventing the tympanostomy tube 140 from falling into the middle ear. Additionally, the falling of the tympanostomy tube 140 out of the tympanic membrane may not be dangerous to the patient's health. Also, irrespective of whether the front flange 142 is incorporated into a particular embodiment of the tympanostomy tube 140, the distal end of the tubular shaft 146 can have a taper. Such taper can but does not have to match the taper of the piercing tip of the penetrator and/or of the sliding body. Additionally, such taper also can form at least a portion of the front face 141 of the tympanostomy tube 140. In at least one embodiment, the tympanostomy tube 140 includes the opening 143, which passes from a proximal end to a distal end thereof (i.e., the opening 143 passes through the front and back flanges 142, 144). The opening 143 can be sufficiently large to provide ventilation to the middle ear and/or to allow fluid (if any) to drain out of the middle ear. Moreover, the opening 143 can allow medication (e.g., drops, gel, pellets, etc.) to be channeled into the middle ear.

As noted above, in some instances, the tympanostomy tube 140 can be removed from the tympanic membrane. In one example, as the tympanostomy tube 140 is pulled outward from the tympanic membrane, the front flange 142 can fold up and inward (as shown in Figure 5B), thereby facilitating the removal of the tympanostomy tube 140 from the perforation. Accordingly, less force may be required to remove the tympanostomy tube 140 from the perforation.

As described above, in one or more embodiments, the tympanostomy tube 140 includes a tab 145 located on the back flange 144 (i.e., the tab 145 can be coupled to or integrated with the back flange 144). The tab 145 can be used for securing a clamping device to the tympanostomy tube 140. The clamping device, subsequently, can be used to remove the tympanostomy tube 140 from the perforation in the tympanic membrane. The tab 145 can have any number of shapes and sizes, which can be suitable for clamping onto by a clamping device, for removal of the tympanostomy tube 140 from the tympanic membrane.

Accordingly, Figures 1 A-6B and the corresponding text, provide a number of different components and mechanisms for inserting a tympanostomy tube into a tympanic membrane. In addition to the foregoing, embodiments also can be described in terms of one or more acts in a method for accomplishing a particular result. Particularly, Figure 7 illustrates a method of inserting a tympanostomy tube into a tympanic membrane. The acts of Figure 7 are described below with reference to the components and illustrations of Figures 1A through 6B.

For example, Figure 7 shows that the method of inserting a tympanostomy tube into a tympanic membrane can include an act 400 of inserting a tube insertion device 100, 100a into an ear canal of a patient. The tube insertion device 100, 100a can have any number of suitable configurations, which can vary from one embodiment to the next. For instance, the tube insertion device 100, 100a can include a stationary body 110, 110a that can at least partially seal the patient's ear canal. Additionally, the tube insertion device 100, 100a can include moving elements that can move toward and/or couple to the patient's tympanic membrane. Specifically, at least one such moving element can be advanced into the patient's ear canal by reducing pressure therein.

Accordingly, one or more embodiments include an act 410 of reducing pressure in the patient's ear canal. As the pressure inside the patient's ear canal is reduced, the difference in pressure between the ambient pressure (e.g., atmospheric pressure) and the reduced pressure in the ear canal can force a sliding body 120, 120a of the tube insertion device 100, 100a toward the tympanic membrane. Moreover, the sliding body 120, 120a can couple to the tympanic membrane.

The method also can include an act 420 of inserting the tympanostomy tube 140, 140a into the tympanic membrane. For instance, in some embodiments, the sliding body can have a penetrating tip 125 a. Additionally, the sliding body 120a can carry a tympanostomy tube 140, 140a near the distal end thereof. Accordingly, in one or more embodiments, the sliding body also can create a perforation in the tympanic membrane, dilate the perforation, and insert the tympanostomy tube 140, 140a therein.

Alternatively, the tube insertion device can include a penetrator 130, which can move relative to the sliding body 120. The penetrator 130 can include a penetrating tip 131, which can create a perforation in the tympanic membrane. Moreover, the penetrator 130 can carry a tympanostomy tube 140, 140a near a distal end thereof. Consequently, the penetrator 130 can create a perforation in the tympanic membrane, dilate the perforation, and insert the tympanostomy tube 140, 140a into the perforation.

In one embodiment, the penetrator 130 can be moved independently of the sliding body 120. Furthermore, such movement of the penetrator 130 can be manually or pneumatically actuated. Hence, the user can have tactile feedback related to the advancement of the penetrator 130 through the tympanic membrane. Also, the penetrator 130 can have a stop, which can locate the penetrator 130 at a predetermined lateral position relative to the sliding body 120. As the distal end of the sliding body 120 can be coupled to the tympanic membrane, after such coupling, the penetrator 130 can be manually positioned at a predetermined location relative to and inside of the tympanic membrane, which can facilitate safe insertion of the tympanostomy tube 140, 140a.

The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

CLAIMS We claim:

1. A tube insertion device for inserting a tympanostomy tube into a patient's tympanic membrane, the device comprising:

a stationary body configured to remain in a substantially fixed position within the patient's ear canal and to create a sufficient seal with the patient's ear canal to allow reduction of pressure therein;

a sliding body slidably coupled to the stationary body, the sliding body being free to move into the patient's ear canal in response to reduced pressure within the patient's ear canal;

a penetrator having a penetrating tip, the penetrator being movable in a lateral direction relative to the sliding body; and

a vacuum mechanism configured to reduce pressure within the patient's ear canal sufficiently to force the sliding body to slide toward the patient's tympanic membrane.

2. The device as recited in claim 1, wherein the penetrator is configured to move independently of the sliding body.

3. The device as recited in claim 1 , wherein the penetrator further comprises a stop configured to stop lateral movement of the penetrator relative to the sliding body at a predetermined position.

4. The device as recited in claim 3, wherein the stop comprises a flange coupled to or integrated with a proximal end of the penetrator.

5. The device as recited in claim 1, wherein the penetrator is configured to carry a tympanostomy tube near a distal end thereof.

6. The device as recited in claim 1, further comprising one or more vacuum channels in fluid communication with the vacuum mechanism.

7. The device as recited in claim 6, wherein the one or more vacuum channels are located in the sliding body.

8. The device as recited in claim 7, wherein at least one vacuum channel of the one or more vacuum channels passes through a distal end of the sliding body.

9. The device as recited in claim 8, wherein the sliding body is configured to couple to the patient's tympanic membrane.

10. The device as recited in claim 6, wherein the one or more vacuum channels are located in the stationary body.

11. The device as recited in claim 1 , wherein the stationary body includes an aperture and the sliding body is slidably disposed within the aperture of the stationary body.

12. The device as recited in claim 11, wherein the sliding body has a slip fit inside the aperture of the stationary body.

13. The device as recited in claim 1, wherein the sliding body includes a channel and the penetrator is slidably disposed within the channel of the sliding body.

14. The device as recited in claim 1, further comprising a tympanostomy tube removably secured to the penetrator.

15. The device as recited in claim 14, wherein the tympanostomy tube has a flexible front flange.

16. The device as recited in claim 14, wherein the tympanostomy tube has an angled front face.

17. The device as recited in claim 16, wherein the penetrating tip has an angle that approximately corresponds with the angled front face of the tympanostomy tube.

18. A tube insertion device for inserting a tympanostomy tube into a patient's tympanic membrane, the device comprising:

a penetrator coupled to or integrated with the sliding body;

a tympanostomy tube removably secured to the sliding body; and

a vacuum mechanism configured to reduce pressure within the patient's ear canal sufficiently to induce the sliding body to slide toward the patient's tympanic membrane.

19. The device as recited in claim 18, wherein the sliding body is configured to carry a tympanostomy tube near a distal end thereof.

20. The device as recited in claim 19, further comprising a tympanostomy tube removably coupled to the sliding body near the distal end thereof.

21. A tube insertion device for inserting a tympanostomy tube into a patient's tympanic membrane, the device comprising:

a stationary body;

a sliding body coupled to the stationary body, the sliding body being movable into the patient's ear canal and toward the patient's tympanic membrane; a piercing tip configured to create a perforation in the patient's tympanic membrane, the piercing tip being movable toward the patient's tympanic membrane; and

a source of a focused light configured to provide a lighted point on the patient's tympanic membrane, the lighted point approximately corresponding with an intended point of contact of the piercing tip with the patient's tympanic membrane.

22. The device as recited in claim 21, wherein the piercing tip is coupled to or integrated into a penetrator, and the penetrator is movable toward the patient's tympanic membrane.

23. The device as recited in claim 21, wherein the piercing tip is couple to or integrated into the sliding body.

24. The device as recited in claim 21, further comprising a waveguide disposed inside of the sliding body, the waveguide being coupled to the source of focused light and configured to transmit the focused light from the focused light source and to provide the lighted point on the patient's tympanic membrane.

25. A method of inserting a tympanostomy tube into a patient's tympanic membrane, the method comprising:

sealing the patient's ear canal sufficiently to allow reduction of pressure therein;

positioning a sliding body of a tube insertion device inside the patient's ear canal;

forcing the sliding body of the tube insertion device to move toward the patient's tympanic membrane by reducing the pressure in the patient's ear canal; creating a puncture in the patient's tympanic membrane; and

inserting a tympanostomy tube into the puncture in the tympanic membrane.

26. The method as recited in claim 25, wherein penetrating the patient's tympanic membrane comprises manually moving a penetrator through the patient's tympanic membrane.

27. The method as recited in claim 26, wherein manually moving a penetrator through the patient's tympanic membrane comprises moving the penetrator inside the sliding body.

28. The method as recited in claim 25, wherein:

the sliding body comprises a penetrating tip;

the tympanostomy tube is removably secured to the sliding body; and inserting the tympanostomy tube into the puncture in the tympanic membrane comprises creating a puncture in the tympanic membrane with the penetrating tip of the sliding body.

29. The method as recited in claim 25, further comprising coupling the sliding body to the patient's tympanic membrane.

30. The method as recited in claim 29, wherein the sliding body can remain coupled to the patient's tympanic membrane and can remain substantially unrestrained from movement within the patient's ear canal.

31. A tympanostomy tube configured for insertion into a tympanic membrane of a patient and further configured for removal therefrom, the tympanostomy tube comprising:

a tubular shaft;

a back flange coupled to or integrated with a proximal end of the tubular shaft;

a front flange coupled to or integrated with a distal end of the tubular shaft, the front flange having an angled front face; and

an opening passing through the back flange, through the tubular shaft, and through the front flange.

32. The tympanostomy tube as recited in claim 31, wherein the front flange comprises a plurality of segments.

33. The tympanostomy tube as recited in claim 31, wherein the front flange is configured to fold inward and toward the tubular shaft in response to the tympanostomy tube being pressed into a perforation in the tympanic membrane.

34. The tympanostomy tube as recited in claim 31, wherein the front flange comprises a flexible material.

35. The tympanostomy tube as recited in claim 31, wherein the front flange, the back flange, and the tubular shaft comprise a substantially monolithic material.

36. The tympanostomy tube as recited in claim 31, further comprising a tab coupled to or integrated with the back flange.