Tympanic membrane repair device

A method for repairing a perforation in a tympanic membrane comprising attaching a single patch to an undersurface of the tympanic membrane covering the perforation.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to the field of Tympanoplasty and, more particularly, but not exclusively, to a device and a method for repairing a perforation in a Tympanic membrane.

Tympanoplasty is a surgical treatment for repairing a perforation in the tympanic membrane (commonly known as “eardrum”) and defects in one or more of the ossicular bones. Perforations in the eardrum may be the result of a birth defect, or may be attributed to ear/nose/throat infections, physical ear injury, exposure to high noise levels, aging, among other contributing factors.

Methods for repairing eardrum perforations and devices used in tympanoplastic surgery are known in the art.

U.S. Pat. Nos. 5,501,700 and 5,643,300 to Hirata relates to “an eardrum perforation patch and an eardrum undersurface scraper for application of the patch. The eardrum perforation patch comprises double plates connected together with a coupler and these elements are made of artificial material. The plates comprise a supporting piece and a closure piece. After being inserted into the tympanic perforation the closure piece pinches the perforation margin and it stays steadily in place until it changes to a new part of the tympanic membrane. The eardrum undersurface scraper comprises a shaft, a neck and a head with a blade edge. The neck is curved at an angle of more than 90 degrees, twisted and rotated, so that the blade edge gains access to target points behind the tympanic membrane and scrapes and entirely rakes out the mucosal barrier on the undersurface grafting bed of the tympanic membrane through the tympanic perforation. The combination of the eardrum perforation patch and the eardrum undersurface scraper is useful in repairing the tympanic perforation”.

U.S. Pat. No. 5,236,455 to Wilk et al. relate to “a device for repairing a tympanic membrane comprises a patch provided on one side with an adhesive layer, and an elongate tubular applicator member having a proximal end and a distal end. The patch is removably attached via suction to the distal end of the tubular applicator member so that the adhesive layer faces away from the elongate applicator member. The proximal end of the tubular applicator member is temporarily closed or sealed to maintain the suction force, thereby holding the tympanic patch to the distal end of the applicator tube while the tube is being inserted through the auditory canal. Upon a pressing of the patch against the ear drum so that the patch covers the perforation, the proximal end of the tube is released to pressurize the tube channel with ambient air. This pressurization releases the patch and allows it to adhere to the tympanic membrane”.

U.S. Pat. No. 4,641,651 to Card discloses “an ossicular replacement prosthesis is configured to have its tympanic membrane-facing end self-attached to a cartilage plug forced there against. Self-attachment is achieved either by a prosthesis projection penetrating the plug, a prosthesis portion enclosing at least part of the plug, or adhesive attachment between the plug and prosthesis. A cartilage punch is provided which removes a cartilage plug of uniform thickness from a patient's tragus, retains the plug after removal and then forcefully urges the plug against the prosthesis to effect self-attachment. The punch includes a reciprocatable annular cutting member and a stage surface. Tragal cartilage is inserted between the cutting member and the stage, and the cartilage plug is cut and retained in the cutting member by forcing the cutting member toward the stage to pierce the tragel cartilage. The prosthesis is then placed on the stage so that the retained cartilage plug can be forced thereagainst by again translating the cutting member toward the stage”.

U.S. Pat. No. 6,309,419 to de Juan, Jr. et al. discloses “a tympanic membrane prosthesis is provided that includes, in combination, a generally flat, planar membrane sized to overlay a tear or perforation in the tympanic membrane and having at least one preformed perforation, and at least one mechanical fixation device for fixing the membrane to the tympanic membrane of a patient. Each mechanical fixation device is a tack component including a sharp, piercing distal end, an enlarged proximal end and a shaft extending therebetween. A tack insertion device is provided to guide the tack to and through the tear covering membrane”.

SUMMARY OF THE INVENTION

According to one aspect of the present invention, there is provided a method for repairing a perforation in a tympanic membrane comprising attaching a single patch to an undersurface of the tympanic membrane covering the perforation.

In some exemplary embodiments, the method includes inserting the patch through the perforation.

In some exemplary embodiments, the method includes pulling the patch in a proximal direction against the undersurface.

In some exemplary embodiments, the method includes attaching the patch with a biocompatible adhesive.

In some exemplary embodiments, the method includes debriding peripheral tissue surrounding the perforation.

In some exemplary embodiments, the method includes rotating a cutting edge against the peripheral tissue.

In some exemplary embodiments, the method includes punching a cutting edge through the peripheral tissue.

In some exemplary embodiments, the method includes extracting the peripheral tissue.

In some exemplary embodiments, the method includes monitoring the repair of the perforation with a micro-otoscope.

According to one aspect of the present invention, there is provided a device for attaching a patch to an undersurface of a tympanic membrane, comprising a patch guiding mechanism including a rod for inserting the patch through a perforation in the tympanic membrane, and a debridement mechanism including a cutting edge for cutting tissue surrounding the perforation.

In some exemplary embodiments, the rod includes a distal end adapted to accommodate mechanical coupling of the patch.

In some exemplary embodiments, the distal end includes a spring-loaded clamp for grasping the patch.

In some exemplary embodiments, the cutting edge is a circular cutting edge.

In some exemplary embodiments, the cutting edge is rotatable.

In some exemplary embodiments, the device includes a patch release mechanism for reversely releasing the patch following attachment to the undersurface.

In some exemplary embodiments, the patch release mechanism includes a hollow tube slidably fitting over the distal end.

In some exemplary embodiments, the hollow tube is adapted to exert a radial force on the distal end of the rod.

In some exemplary embodiments, the patch release mechanism includes a release lever for proximally pulling the hollow tube.

In some exemplary embodiments, the device includes a device alignment mechanism for substantially axially aligning the device when inserted in the auditory canal.

In some exemplary embodiments, the device alignment mechanism includes an alignment receptacle for aligning the patch guiding mechanism with the perforation.

In some exemplary embodiments, the device alignment mechanism includes a speculum.

In some exemplary embodiments, the device includes an adhesive application mechanism for administering an adhesive through the device to the patch.

In some exemplary embodiments, the adhesive application mechanism includes an adhesive insertion adapter through which the adhesive is poured into the device.

In some exemplary embodiments, the adhesive insertion adapter is attached to a hollow rod in the patch guiding mechanism having a conduit fluidly connecting the adhesive insertion adapter with the patch.

In some exemplary embodiments, the patch includes a surface texture conducive to epithelial cell growth.

In some exemplary embodiments, the patch includes hyaluronic acid.

In some exemplary embodiments, a diameter of the patch is in a range from 2 mm-10 mm.

In some exemplary embodiments, the patch includes a flexible material.

In some exemplary embodiments, the patch includes a biodegradable material.

In some exemplary embodiments, the device is configured for disposing following a single use.

According to one aspect of the present invention, there is provided a kit for repairing a perforation in a tympanic membrane comprising a device for attaching a patch to an undersurface of the tympanic membrane, and a patch.

In some exemplary embodiments, the kit includes an adhesive for attaching the patch to the undersurface.

In some exemplary embodiments, the kit includes an adhesive applicator for applying the adhesive to the device.

In some exemplary embodiments, the kit includes a micro-otoscope.

In some exemplary embodiments, the kit includes a single-use, disposable device.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates to the field of Tympanoplasty and, more particularly, but not exclusively, to a device and a method for repairing a perforation in a Tympanic membrane.

An aspect of some embodiments of the present invention relates to a method for relatively rapidly repairing a perforation in a tympanic membrane including debriding peripheral membrane tissue surrounding the perforation and adhering a flexible patch to the membrane's undersurface covering the perforation. An undersurface of the tympanic membrane is the surface of the membrane bounding on the middle ear. The method can allow, in some exemplary embodiments, for repairing the perforation in an estimated period of time ranging from 5 to 20 minutes, from the time the device is introduced by the physician into an auditory canal of a patient. The method can further allow, in some exemplary embodiments, for repairing all types of tympanic membrane perforations excluding large marginal perforations (where the perforation includes a border/margin of the tympanic membrane).

In some exemplary embodiments, the patch is guided down the auditory canal of the patient and inserted through the perforation. Optionally, debridement increases a distance from a center of the perforation to a border of the perforation by at least, 1 mm. Debridement removes the injured or infected tissue surrounding the perforation, resulting in faster epithelial tissue growth across the patch and natural tissue sealing of the perforation. Optionally, debridement of the peripheral tissue is performed following inserting the patch through the perforation. Alternatively, debridement is performed prior to inserting the patch through the perforation.

In some exemplary embodiments, the method includes using a same device for introducing the patch through the perforation, attaching the patch to the undersurface, and performing the debridement. Optionally, the device is inserted into the auditory canal only once during the whole procedure. Alternatively, a separate cutting device is used for performing debridement. Optionally, the cutting device is introduced together with the single device. Optionally, the method does not require administering a painkiller and/or other medication to the patient. Alternatively, the painkiller and/or other medication are locally administered. Optionally, the device is also used for applying the painkiller and/or medication.

In some exemplary embodiments, the method includes using a micro-otoscope or other suitable instrument known in the art for monitoring the procedure. Optionally, the micro-otoscope is mechanically coupled to the device. Alternatively, the micro-otoscope is separate from the device. Alternatively, the method includes using a guidewire for guiding the device with the patch through the auditory canal and through the perforation into the middle ear, obviating a use of monitoring equipment.

In some exemplary embodiments, the patch is of a biocompatible material and is attached to the undersurface of the membrane with a biocompatible adhesive. Optionally, the adhesive is applied to the patch following inserting the patch through the perforation. Optionally, the adhesive is “instant” adhering type glue such as, for example, Dermabond by Ethicon™. Optionally, an amount of glue applied to the patch is between, 20-150 microliters. Alternatively, the adhesive is applied prior to inserting the patch through the perforation. Alternatively, the adhesive is applied prior to guiding the patch down the auditory canal. Alternatively, the adhesive is applied during production of the patch. Alternatively, the patch is self-adhering.

In some exemplary embodiments, the patch includes a surface texture for promoting epithelial tissue growth for closing the perforation. Optionally, the patch is biodegradable. Optionally, the patch includes Alloderm® and/or hyaluronic acid. Alternatively, the patch is not biodegradable and remains implanted in the patient's ear. The patch may be of a diameter in a range from 2 mm-10 mm, for example 3 mm, 4 mm, 5 mm, 6 mm, 8 mm, 9 mm. Optionally, the diameter of the patch is greater than a size of the perforation by 1 mm or more, for example, 2 mm, 3 mm, 4 mm, 6 mm, or greater. Alternatively, the patch includes a non-circular shape. Optionally, the non-circular patch includes an area similar to that of the previously mentioned circular patch. Optionally, the patch covers an area of the undersurface not less than 110% of the size of the perforation, for example, 112%, 115%, 125%, 150%, 200%, or more. Optionally, the patch overlays the borders of the perforation by at least, 1 mm, 1.2 mm, 1.5 mm, 2 mm, or greater. Alternatively, the patch is single-sized and is cut by the physician according to a size of the perforation. Optionally, the single-sized patch is of a large size for allowing several patches to be cut from the single-sized patch. Optionally, the single-sized patch may have a diameter ranging from 3 mm-20 mm, for example, 4 mm, 6 mm, 8 mm, 10 mm, 12 mm, 15 mm, 18 mm, 19 mm. Alternatively, the single-sized patch includes an area the same as that of the circular single-sized patch.

An aspect of some embodiments of the present invention relates to a tympanic membrane repair device insertable through an auditory canal of a patient for adhering a flexible patch to the membrane's undersurface covering a perforation, and for performing debridement of peripheral membrane tissue surrounding the perforation. Optionally, the device is adapted to flatly attach the patch to the undersurface. Optionally, the diameter of the perforation is increased by the debridement. Optionally, the device is used for guiding the flexible patch through the perforation into the middle ear. A single device for performing these actions is potentially advantageous over techniques known in the art as only one device is inserted a single time into the patient's auditory canal. This allows for the repair to be performed quickly, substantially saving on physician time and possible associated medical costs, and potentially reduces patient discomfort.

In some exemplary embodiments, the device includes a patch guiding mechanism which secures the patch to the device while being guided down the auditory canal and through the perforation. Optionally, the patch guiding mechanism secures the patch while being adhered to the undersurface of the tympanic membrane. Optionally, the patch is supported by a gel while being adhered to the undersurface. In some exemplary embodiments, the patch guiding mechanism includes a spring-loaded arrangement for clasping the patch. Alternatively, the patch guiding mechanism includes a male/female type fastening mechanism for securing the patch. Alternatively, the patch guiding mechanism includes a hook-and-fastener type of fastening mechanism. Alternatively, the patch guiding mechanism is connected to a vacuum device adapted to apply a sucking force to the patch for securing the patch. Optionally, the patch is secured to the device prior to insertion into the auditory canal. Alternatively, the patch is pre-attached to the patch guiding mechanism at the device manufacturer. Optionally, the patch guiding mechanism comes as a kit with the patch, the patch guiding mechanism being replaceable following one-time use.

In some exemplary embodiments, the device includes a patch release mechanism for releasing the patch once attached to the undersurface of the tympanic membrane. Optionally, the patch is released by the physician activating a patch release lever included in the patch release mechanism. Optionally, the patch is released by releasing the clamping action of the spring-loading clamping mechanism. Alternatively, the patch is released by a pulling action exerted on the patch while being attached, or already attached, to the undersurface.

In some exemplary embodiments, the device includes a debridement mechanism for cutting away tympanic membrane tissue surrounding the perforation prior to adhering the patch. Optionally, the debridement mechanism includes a circular cutting edge (blade) for performing the cutting. Optionally, cutting is performed rotating the circular cutting edge so that the surrounding membrane is progressively cut along a circumference of the enlarged perforation. Alternatively, cutting is performed by punching] through the tissue, cutting the surrounding membrane at once. Optionally, the circular cutting edge is of a diameter ranging from 2 mm-19 mm, for example, 3 mm, 5 mm, 8 mm, 12 mm, 15 mm, 18 mm. Optionally, an anvil-like arrangement is included for supporting the membrane while being punched through by the blade. Optionally, the cut tissue is fitted within the periphery of the circular cutting edge and is removed from the auditory canal together with the device. Alternatively, the cutting edge is non-circular. Additionally, the device includes a cover for maintaining the cutting edge unexposed until the debridement is to be performed. Alternatively, the blade is introduced through the device and is remotely operated by the physician for cutting the tissue. Alternatively, the blade includes a scissor-like arrangement for effecting the cutting of the surrounding membrane. Alternatively, heating may be used for cutting the surrounding membrane. Alternatively, the debridement mechanism includes an arrangement for extracting the cut tissue from the auditory canal, such as, for example, a grasping mechanism. Alternatively, the cut tissue is not removed, and is left inside the middle ear.

In some exemplary embodiments, the device includes a device alignment mechanism for allowing the physician to properly align the device inside the patient's ear and for anchoring the device while operated by the physician. Optionally, the alignment mechanism includes a speculum fitted over the device and insertable into the ear. Optionally, the speculum provides radial alignment of the device within the auditory canal. Optionally, the speculum are axially positioned within the auditory canal. Alternatively, the device does not include an alignment mechanism and is aligned by the physician while holding the device. Optionally, the physician uses a second hand to align the device.

In some exemplary embodiments, the device includes an adhesive application mechanism for introducing the adhesive into the device from outside the ear and for conducting the adhesive to the patch. Optionally, the device includes an adhesive insertion adaptor for attaching a container with the adhesive for administering the adhesive to the patch. Optionally, the container includes a premeasured amount of the adhesive required for applying to the patch. Alternatively, the device includes a container which is filled with the premeasured amount of adhesive. Optionally, the container in the device is replaceable. In some exemplary embodiments, the device includes a conduit for adhesive flow to the patch. Alternatively, the patch is self-adhering and the adhesive insertion adapter, the container, the conduit, or the adhesive are not required.

In some exemplary embodiments, the device may be used for treating a condition where a retraction pocket has been created in the tympanic membrane. Optionally, the debridement mechanism is used to cut the retraction pocket and surrounding tissue leaving an opening through which the patch is inserted and attached to the undersurface.

An aspect of some embodiments of the present invention relates to a tympanic membrane repair device which is made for a one-time (single) use. Optionally, the device is disposable following the one-time use. Optionally, the device is manufactured using relative inexpensive components and materials, for example, using plastic components and mass-production plastic molding techniques. Optionally, the device is pre-sterilized during manufacture so that in-situ sterilization is not required. Optionally, the device does not require cleaning or removal of traces of adhesive possibly remaining in the device from the application of the adhesive to the patch.

An aspect of some embodiments of the present invention relates to a tympanic membrane repair kit including a single use tympanic membrane repair device. Alternatively, the repair kit includes a multiple use device. Optionally, the repair kit includes one or more patches. Optionally, the repair kit includes the adhesive. Optionally, the repair kit includes an adhesive applicator. Alternatively, the patches are self-adhering and the adhesive and the adhesive applicator are not required. Optionally, the repair kit includes an otoscope separately insertable into the auditory canal from the tympanic membrane repair device. Additionally or alternatively, the separate otoscope is attachable to the device for insertion into the auditory canal together with the device.

Referring now to the drawings,FIG. 1schematically illustrates an exemplary tympanic membrane repair device100, according to an embodiment of the present invention. Optionally, tympanic membrane repair device100is used by a physician for guiding a flexible patch down an auditory canal and through a perforation in the tympanic membrane into the middle ear of a patient. Optionally, device100is used by the physician for attaching the patch to an undersurface of the tympanic membrane. Additionally or alternatively, device100is used by the physician for performing debridement of tissue peripherally surrounding the perforation.

In some exemplary embodiments of the invention, tympanic membrane repair device100includes a patch guiding mechanism102which secures the patch as it is guided down the auditory canal and through the perforation in the tympanic membrane. Optionally, patch guiding mechanism102secures the patch while being adhered to the undersurface.

In some exemplary embodiments, tympanic membrane repair device100includes a debridement mechanism104for cutting away membrane tissue peripherally surrounding the perforation. Alternatively, debridement mechanism104is a separate cutting device which is introduced together with device100for accessing the debridement area. Alternatively, debridement mechanism104is a separate cutting device which is introduced separately from device100for accessing the debridement area. Optionally, debridement mechanism104is introduced through device100.

In some exemplary embodiments, tympanic membrane repair device100includes a patch release mechanism106for releasing the patch from patch guiding mechanism102following attachment to the undersurface of the tympanic membrane.

In some exemplary embodiments, tympanic membrane repair device100includes a device alignment mechanism108for assisting the physician to properly align and anchor device100when inserted in the auditory canal. Optionally, device alignment mechanism108includes alignment/anchoring components known in the art and suitable to be fitted onto device100.

In some exemplary embodiments, tympanic repair device100includes an adhesive application mechanism110which serves for applying the adhesive to the patch prior to adhering to the undersurface. Optionally, adhesive application mechanism110includes a receptacle for receiving an adhesive applied exteriorly to the ear and a conduit for conducting the adhesive through device100to the patch. Alternatively, adhesive application mechanism110includes a pre-filled container with adhesive and a conduit leading to the patch. Optionally, the patch is self-adhering and adhesive application mechanism110is not included in device100.

Reference is also made toFIG. 2which schematically illustrates tympanic membrane repair device100positioned in an ear10, inside the auditory canal12, according to some exemplary embodiments of the present invention. Device100is used to repair a perforation14in a tympanic membrane16. Repair is done by using device100to introduce a patch112through perforation14for adhering the patch to an undersurface18of tympanic membrane16. In some exemplary embodiments, device100is used to perform debridement on perforation14prior to adhering patch112to undersurface18. In some exemplary embodiments, the adhesive is introduced from outside ear10and flows through device100onto patch112. Alternatively, patch112is self-adhering.

Reference is now made toFIG. 3which schematically illustrates an exemplary tympanic membrane repair device200for applying a patch212to a perforation on a tympanic membrane, according to some embodiments of the present invention. In some exemplary embodiments, tympanic membrane repair device200includes a patch guiding mechanism202, a debridement mechanism204, a patch release mechanism206, a device alignment mechanism208, and an adhesive application mechanism210. In some exemplary embodiments, device200including device mechanisms202-210, are similar to device100including device mechanisms102-110.

In some exemplary embodiments, device200includes an elongated, substantially cylindrical shape for facilitating partial insertion of the device into the patient's auditory canal while a portion of the device remains external to the auditory canal. Optionally, the portion of device200external to the auditory canal includes components of the various device mechanisms202,204,206, and210which are acted upon by the physician for operating the device. Optionally, the physician operates device200using only one hand.

In some exemplary embodiments, device200is configured with device mechanisms202-210distributed along a longitudinal axis201of the device allowing the mechanisms to be independently operated by the physician. Optionally, device200includes a telescopic configuration with the device mechanisms202,206and204concentrically overlaid one on the other (in the same order), allowing the physician to independently displace debridement mechanism204and patch release mechanism206along longitudinal axis201relative to patch guiding mechanism202.

Reference is now also made toFIGS. 4A and 4Bwhich schematically illustrate perspective views of the various mechanisms in the device; and toFIG. 4Cwhich schematically illustrates a perspective, sectional view of tympanic membrane repair device200; according to some exemplary embodiments of the present invention.

In some exemplary embodiments, patch guiding mechanism202includes a hollow rod214concentrically extending along longitudinal axis201, and having a distal end216, a proximal end218, and a throughbore220interconnecting the proximal end and the distal end. Alternatively, rod214may be a solid rod when patch212is a self-adhering patch. Optionally, rod214is of a diameter ranging from 1 mm-10 mm, for example, 2 mm, 3 mm, 4 mm, 5 mm, 7 mm, 8 mm, 9 mm. Optionally, distal end212is configured for attaching patch212to the distal end. For example, distal end216may include a spring-loaded clamping mechanism which forcedly clamps onto a projecting button224on patch212when a radial force is applied to the distal end, and which releases the projecting button when the radial force is removed.

In some exemplary embodiments, an adhesive insertion adaptor226included in adhesive application mechanism210is attached to proximal end218. Optionally, adhesive insertion adaptor226includes an opening228and a conduit230extending through the adaptor. Optionally, the adhesive for adhering patch212is introduced into device200through opening228, and flows through conduit230into throughbore220and out the distal end onto patch212.

In some exemplary embodiments, debridement mechanism204includes a proximal rotary knob242, a distal cutting blade244, and a cylindrical tube246interconnecting the knob and the blade. Optionally, cylindrical tube246slidably fits over tube232in patch release mechanism206for moving debridement mechanism in the proximal and distal direction. Reference is now also made toFIG. 5which schematically illustrates a perspective view of tympanic membrane repair device200in a debridement configuration, according to some exemplary embodiments of the present invention. Optionally, slidingly pushing rotary knob242towards patch212nears blade244to the tympanic membrane. Optionally, rotating rotary knob242rotates blade244cutting the peripheral tissue surrounding the perforation. Optionally, the cut tissue remains inside a periphery of blade244. Optionally, pulling rotary knob242in a proximal direction retrieves blade244following debridement. Optionally, the cut tissue is retrieved with blade244.

In some exemplary embodiments, patch release mechanism206includes a hollow tube232which slidably fits over rod214. Optionally, hollow tube232is of a diameter ranging from 1.5 mm-11 mm, for example, 2.5 mm, 3.5 mm, 4.5 mm, 6.5 mm, 7.5 mm, 9.5 mm. Optionally, hollow tube232includes a proximal release lever234, and a blade protector236distally positioned near a distal end222. Optionally, release lever234includes a cylindrical shape and has a spring cavity238for accommodating a coil spring240proximally located on rod214. Optionally, a cavity opening235is adapted to receive a distal portion227of adhesive insertion adaptor226for slidingly fitting into spring cavity238when release lever234is pulled in a proximal direction. Optionally, coil spring240is a compression spring and compresses inside spring cavity238as release lever234is pulled in the proximal direction and distal portion227slides into spring cavity238.

In some exemplary embodiments, when release lever234is not pulled in the proximal direction, coil spring240exerts a pushing force on hollow tube232in a direction towards distal end216. Optionally, distal end222overlays distal216applying a radial force on distal end216. Optionally, distal end216closes clasping button224on patch212. Reference is now also made toFIG. 6which schematically illustrates a perspective view of tympanic membrane repair device200in a patch release configuration, according to some exemplary embodiments of the present invention. Optionally, pulling release lever234in the proximal direction retrieves hollow tube232in the proximal direction, and distal end222from over distal end216. Optionally, the radial force applied on distal end216for clasping button224is removed, releasing patch212.

In some exemplary embodiments, device alignment mechanism208serves to maintain device200aligned and anchored in the auditory canal. Optionally, device alignment mechanism208is funnel shaped and includes an alignment receptacle209for slidingly accommodating cylindrical tube246and thereby maintaining device200aligned with the perforation. Optionally, a minimum diameter of alignment mechanism208ranges from 2 mm-15 mm, for example, 3 mm, 5 mm, 7 mm, 9 mm, 11 mm, 13 mm. Optionally, device alignment mechanism208includes a speculum or similar type of device known in the art. Optionally, device alignment mechanism208is fitted into the opening to the auditory canal. Optionally, a distance between a distal end of alignment mechanism208and patch212ranges from 10 mm-35 mm, for example, 15 mm, 20 mm, 25 mm, 30 mm.

Reference is now made toFIGS. 7A-7Cwhich schematically illustrate partial perspective views of device200in a patch guiding configuration, in a debridement configuration, and in a patch release configuration, respectively, according to some exemplary embodiments of the invention.

In some exemplary embodiments, as shown inFIG. 7A, patch212is secured in position by the clamping action of distal end216due to the spring-loaded clamping mechanism, with distal end222applying the radial force (pressing) on distal end216. Blade244is retrieved. Optionally, in this configuration, device200is guided down the auditory canal and patch212inserted through the perforation in the tympanic membrane.

In some exemplary embodiments, as shown inFIG. 7B, cylindrical tube246is moved in the distal direction for nearing blade244to the debridement area in the tympanic membrane.

In some exemplary embodiments, as shown inFIG. 7C, distal end222has been slidingly moved in the proximal direction, uncovering distal end216. The radial force applied by distal end222on distal end216is removed. Distal end216opens due to the spring-loaded clamping mechanism releasing button224on patch212. Optionally, patch212has been adhered to the tympanic membrane. An annular recess225is formed between patch212and button224where a button224diameter is greater than a diameter of the annular recess.

Reference is now made toFIG. 8which illustrates a flow chart of a non-limiting method of repairing a perforation in a tympanic membrane by adhering a flexible patch to an undersurface of the membrane, according to some exemplary embodiments of the present invention. Reference is also made toFIGS. 9A-11which schematically illustrate the operation of tympanic membrane repair device200while performing the method, according to some exemplary embodiments of the present invention.

At800, a physician optionally performs an otoscopy to locate the perforation and determines its size, and selects a patch212of a suitable dimension and attaches it to distal end216. Alternatively, the physician performs the otoscopy for making a perforation. Optionally, the patch is selected so that it is at least 1 mm larger than the largest radius of the perforation. Optionally, attachment is done by pulling on release lever234so that distal end222moves in a proximal direction away from distal end216. Distal end216opens and button224in patch212is inserted into the distal end. Optionally, release lever234is returned to its original “closed” position, distal end222moving distally over216pressing distal end216closed over button222, securing patch212. Optionally, patch212is pre-attached to distal end216. The physician then inserts device200into the patient's ear first introducing the end of the device to which patch212is attached.

At801, the physician guides patch212down the auditory canal and through the perforation in the tympanic membrane. Optionally, the physician utilizes a micro-otoscope to monitor the medical procedure. Optionally, the micro-otoscope is mechanically attached to device200. Alternatively, the micro-otoscope is separately inserted into the auditory canal. Optionally, a position of device200is adjusted by the physician and is maintained aligned/anchored by device alignment mechanism208which is fitted into the opening of the auditory canal.

At802, the physician performs debridement of the tissue surrounding the perforation. In some exemplary embodiments, as shown inFIGS. 9A and 9B, once device200has been inserted down the auditory canal and patch212inserted through the perforation in the tympanic membrane, debridement of the tissue surrounding the perforation is done. A first step in debridement includes moving rotary knob in a distal direction A for nearing blade244to the membrane. In some exemplary embodiments, as shown inFIGS. 10A and 10B, once blade244has been neared to the tympanic membrane, rotary knob242is rotated in a clockwise direction B for cutting away the peripheral tissue. In some exemplary embodiments, cutting of the tissue may be done by rotating rotary knob242in a counterclockwise direction. Optionally, cutting is done by a reciprocating motion both in a clockwise direction and a counterclockwise direction. In some exemplary embodiments, cutting of the tissue may not require rotating rotary knob242. Optionally, pushing rotary knob242in the distal direction also results in cutting of the tissue. Optionally, the cut tissue is fitted within the periphery of the cutting edge of blade244. Alternatively, the physician inserts a cutting instrument for debriding, for example, a blade, scissors, or other instrument known in the art suitable for performing debridement of the perforation.

At803, the physician aligns device200so that patch212is proximal to the area of the perforation, on the undersurface of the tympanic membrane.

At804, the physician applies adhesive to patch212. In some exemplary embodiments, as shown inFIGS. 11A and 11B, following debridement and for adhering patch212to the undersurface of the tympanic membrane, the physician attaches an adhesive container248with an adhesive250to adhesive insertion adapter226. Optionally, adhesive container248includes a capsular container. Optionally, adhesive container248includes a syringe and a plunger which is pushed in the distal direction, as shown by arrow C, for administering adhesive250. Optionally, the capsular container is fittedly accommodated in the syringe. Optionally, the adhesive is an “instant” glue. Optionally, adhesive250is introduced into device200and flows through the device and out distal end216, spreading over the surface of patch212, as shown by arrows D. Optionally, steps1203and1204are interchangeable. Alternatively, patch212is self-adhering and there is no need for the adhesive insertion adapter226or for the administering of the adhesive into device200.

At805, patch212is attached to the undersurface of the tympanic membrane sealing the perforation. Optionally, device200is pulled in a proximal direction for attaching patch212to the undersurface. Optionally, patch212adheres “instantly” to the undersurface by the instant glue. In some exemplary embodiments, as shown inFIG. 12, following adhering of patch212and for releasing the patch, patch release lever234is pulled in a proximal direction E. Optionally, distal end222is pulled in the proximal direction E uncovering distal end216, which opens as the radial force is removed from the spring-loaded clamping mechanism. Optionally, opening of distal end216releases button224on patch212, releasing the patch. Alternatively, device200is pulled in the proximal direction after waiting a predetermined amount of time for adhering of patch212to the undersurface, the patch detaching due to the resistance of the undersurface to the pulling.

At806, the physician retrieves device200from the auditory canal. In some exemplary embodiments, device200is retrieved only after waiting a predetermined amount of time following attachment of patch212to the undersurface for complete adhesion. Alternatively, biodegradable foam is introduced into the middle ear for supporting patch212as it adheres to the tympanic membrane.

Reference is now made toFIG. 13which schematically illustrates a tympanic membrane repair kit1300, according to some exemplary embodiments of the invention. In some exemplary embodiments, kit1300is a single use kit which is disposed of following one-time usage. Kit1300includes a tympanic membrane repair device1301, which may be similar to that shown inFIG. 1at100, or inFIG. 3at200. Optionally, kit1300includes one or more patch1302, for example, 2, 3, 4, 5 patches. Optionally, patch1302includes patches of different sizes, for example, having a diameter in a range from 2 mm-10 mm, for example 3 mm, 4 mm, 5 mm, 6 mm, 8 mm, 9 mm. Alternatively, the patch is a single-sized patch. Optionally, kit1300includes an adhesive and an adhesive applicator1303.

The term “consisting of” means “including and limited to”.