OSSICULAR REPLACEMENT PROTHESIS WITH CONTROLLABLE STAPEDIAL CONFORMING FUNCTION, MANUFACTURE METHOD THEREOF AND APPLICATOR DEVICE THEREFOR

A system for partial ossicular replacement with controllable stapedial engaging function is described; a respective process of manufacturing a partial ossicular replacement prosthesis with controllable stapedial engaging function and a partial ossicular replacement prosthesis are further described; the system comprises: a partial ossicular replacement prosthesis comprising a stapedial part and a tympanic part, an applicator device comprising a handpiece, an essentially planar static face, an elongated essentially cylindrically shaped plunger; the process comprises: providing a preform of at least stapedial part, forming a plurality of elongated cuts, shaping a centrical portion, shaping a distal portion; the partial ossicular replacement prosthesis comprises a stapedial part and a tympanic part.

TECHNICAL FIELD

In general, the present invention pertains to the art of medical devices. In particular, the invention relates to partial ossicular replacement prosthesis with controllable stapedial conforming function, manufacture method thereof and applicator device.

BACKGROUND ART

Ossiculoplasty reconstructs a sound-conducting mechanism between the tympanic membrane (TM) graft and oval window. The surgery performed is dependent on the ossicular deficit. Variations include the use of a prosthesis, autologous ossicle (most commonly the incus), bone cement, cartilage, etc. In general terms, a partial ossicular replacement prosthesis (PORP) extends from the tympanic membrane (TM), malleus, or incus to an intact stapes with mobile footplate.

A total ossicular replacement prosthesis (TORP) replaces the entire ossicular chain while a partial ossicular replacement prosthesis (PORP) replaces only the incus and malleus but not the stapes. Indications for use of an ossicular replacement prosthesis include: chronic middle ear disease, otosclerosis, congenital fixation of the stapes, secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, as well as surgically correctable injury to the middle ear from trauma.

It is believed that the current state of the art is represented by the following patent literature: U.S. Pat. Nos. 6,168,625, 7,087,081, 8,192,489, 8,206,444, 8,936,637, 10,646,331, US20090149697, US2019201189, US2019192425, EP2583639 and WO1992018066.

US8206444describes a middle ear prosthesis comprising a body of deformable material capable of retaining different shapes. The body in U.S. Pat. No. 8,206,444 comprises a slotted wall defining a cavity for receiving a bone of the middle ear. The wall in U.S. Pat. No. 8,206,444 is deformable, proximate slots in the wall between an open position for receiving the bone and a closed position wherein the body is reshaped to grasp the bone.

U.S. Pat. No. 7,087,081 describes a stapedial prosthesis includes a body defining a bucket and a shaft, and a bail handle coupled to the bucket and a method of implanting a stapedial prosthesis. The bucket in U.S. Pat. No. 7,087,081 is preferably adjustable in diameter to fit the incus lenticular process. The shaft in U.S. Pat. No. 7,087,081 preferably has a varying diameter, with a central portion of a smaller diameter than a distal portion which aids in depth perception during implantation and reduces mass to permit better sound energy transmission by the prosthesis. The bail handle in U.S. Pat. No. 7,087,081 is preferably spring-loaded and preferably constructed of titanium. The bail handle in U.S. Pat. No. 7,087,081 may be coupled to the body without crimping, twisting or welding and preferably biases the incus toward the bucket.

SUMMARY OF THE INVENTION

The invention was made in view of the deficiencies of the prior art and provides systems, methods and processes for overcoming these deficiencies. According to some embodiments and aspects of the present invention, there are provided a partial ossicular replacement prostheses with controllable stapedial conforming function, methods of manufacturing the partial ossicular replacement prostheses with controllable stapedial conforming function, applicator devices for the partial ossicular replacement prostheses with controllable stapedial conforming function and methods of operating the applicator devices for the partial ossicular replacement prostheses with controllable stapedial conforming function.

In accordance with some aspects and embodiments of the present invention a system is provided for partial ossicular replacement with controllable stapedial engaging portion function includes: a partial ossicular replacement prosthesis including: a stapedial part including an essentially cylindrical shell shape with an elongated interior lumen, the stapedial part including: a distal terminal stapedial engaging portion including a plurality of structured elements configured for controllably conforming to a distal portion of a stapes; a centrical applicator operated portion, forming a continuum with the stapedial engaging portion, including a plurality of protruding elements facing inwardly into the elongated interior lumen of the stapedial part, in which the plurality of protruding elements are configured to be operated by an applicator; a proximal basal stem portion, forming a continuum with the centrical portion; a tympanic part including an essentially flattened shape, the tympanic part including: an anterior face, associated with a tympanic membrane; a posterior face, forming a continuum with the proximal basal stem portion; a throughout aperture, disposed essentially at a center of the essentially flattened shape; an applicator device for the partial ossicular replacement prosthesis including: a handpiece configured for manual grip by an operator; an essentially planar static face, configured to engage to the anterior face of the tympanic part of the partial ossicular replacement prosthesis; an elongated essentially cylindrically shaped plunger, configured to be introducible into the elongated interior lumen of the stapedial part of the partial ossicular replacement prosthesis, through the throughout aperture in the tympanic part of the partial ossicular replacement prosthesis; a tab operatively connected to the elongated essentially cylindrically shaped plunger, configured for controllably translating the essentially cylindrically shaped plunger within the elongated interior lumen of the stapedial part of the partial ossicular replacement prosthesis; in which the partial ossicular replacement prosthesis is configured to assume at least two configurations: a divergent configuration in which a distal portion of the plunger is engaged to the plurality of protruding elements of the centrical portion of the stapedial part; whereby the plurality of the structured elements of the distal terminal stapedial engaging portion of the stapedial part are essentially spread apart, and a convergent configuration in which the distal portion of the plunger is withdrawn from the plurality of protruding elements of the centrical portion of the stapedial part; whereby the plurality of the structured elements of the distal terminal stapedial engaging portion of the stapedial part essentially conform to the distal portion of the stapes.

In some embodiments, the partial ossicular replacement prosthesis is configured to assume a plurality of configurations in-between the divergent configuration and the convergent configuration.

In some embodiments, the plunger is configured to be controllably withdrawn within the elongated interior lumen of the stapedial part, whereby the partial ossicular replacement prosthesis is configured to be gradually altered between the divergent and the convergent configurations.

In some embodiments, the partial ossicular replacement prosthesis includes at least one biocompatible material selected from a group of: a pliable or pliant metal, pliable or pliant alloy, bio-ceramic material, plastic resilient and any combination thereof.

In some embodiments, a prostheses kit including a plurality of the partial ossicular replacement prostheses is provided, in which the essentially cylindrical shell shape with the elongated interior lumen of the stapedial part of each one of the plurality of the partial ossicular replacement prostheses includes at least one different parameter of: a length, diameter and shape.

In some embodiments, at least one edge of the plurality of structured elements of the stapedial engaging portion of the stapedial part of the partial ossicular replacement prosthesis includes a profile selected from a group of: a chamfered profile, filleted profile or beveled profile.

In some embodiments, the tympanic part of the partial ossicular replacement prosthesis includes at least one shape selected from a group of: a discoid shape, egg shape, oval shape, bulb shaped and horseshoe shape.

In some embodiments, the tympanic part of the partial ossicular replacement prosthesis includes at least one structural element selected from a group of: a notch, groove, recess, circular aperture, structured aperture, furrowed surface and textured surface.

In some embodiments, the proximal basal stem portion of the stapedial part of the partial ossicular replacement prosthesis includes external screw threading matching an internal screw threading of the throughout aperture of the tympanic part of the partial ossicular replacement prosthesis, in which the stapedial part of the partial ossicular replacement is configured for length adjustment.

In some embodiments, the plunger forms a perpendicular arrangement with the tab of the applicator device for the partial ossicular replacement prosthesis.

In accordance with some aspects and embodiments of the present invention a process of manufacturing a partial ossicular replacement prosthesis with controllable stapedial engaging function is provided, including the steps of: providing a preform of at least stapedial part including an essentially cylindrical shell shape with an elongated interior lumen; forming a plurality of elongated cuts from a terminal distal face of the stapedial part preform, along a substantial length of the essentially cylindrical shell shape, thereby forming a plurality of elongated biasing elements, extending from a proximal basal stem portion of the essentially cylindrical shell shape; shaping the a centrical portion of the plurality of elongated biasing elements to form a plurality of protruding elements facing inwardly into the elongated interior lumen, thereby forming a centrical applicator operated portion of the stapedial part; thereby forming at least a stapedial part of the partial ossicular replacement prosthesis.

In some embodiments, the process of manufacturing a partial ossicular replacement prosthesis further includes shaping a distal terminal portion of the plurality of the plurality of elongated biasing elements to form a plurality of structured elements configured to conform to a distal portion of a stapes, thereby forming a stapedial engaging portion of the stapedial part.

In some embodiments, the process of manufacturing a partial ossicular replacement prosthesis further includes shaping an edge of at least one distal terminal portion of the plurality of elongated biasing elements to form a profile selected from a group of: a chamfered profile, filleted profile or beveled profile.

In some embodiments, the process of manufacturing a partial ossicular replacement prosthesis further includes connecting a tympanic part to the stapedial part, thereby forming the partial ossicular replacement prosthesis.

In some embodiments, the process of manufacturing a partial ossicular replacement prosthesis further includes forming a throughout aperture, essentially at a center of the tympanic part of the partial ossicular replacement prosthesis.

In some embodiments, the process of manufacturing a partial ossicular replacement prosthesis further includes forming a plurality of marquise shaped recesses in-between the elongated biasing elements, following the step of forming a plurality of the elongated cuts from a terminal distal face of the stapedial part preform and preceding the step of shaping the a centrical portion of the plurality of the elongated biasing elements.

In accordance with some aspects and embodiments of the present invention a partial ossicular replacement prosthesis with controllable stapedial engaging function is provided, including: a stapedial part including: a distal terminal stapedial engaging portion including a plurality of structured elements configured for controllably conforming to a distal portion of a stapes and a centrical applicator operated portion, forming a continuum with the stapedial engaging portion, including a plurality of protruding elements facing inwardly into the elongated interior lumen of the stapedial part, in which the plurality of protruding elements are configured to be operated by an applicator; a proximal basal stem portion, forming a continuum with the centrical portion; a tympanic part including an essentially flattened shape, the tympanic part including: an anterior face, associated with a tympanic membrane; a posterior face, forming a continuum with the proximal basal stem portion; a throughout aperture, disposed essentially at a center of the essentially flattened shape; in which the partial ossicular replacement prosthesis is configured to assume at least two configurations: a divergent configuration in which a distal portion of a plunger of the applicator is engaged to the plurality of protruding elements of the centrical portion of the stapedial part; whereby the plurality of the structured elements of the distal terminal stapedial engaging portion of the stapedial part are essentially spread apart, and

a convergent configuration in which the distal portion of the plunger of the applicator is withdrawn from the plurality of protruding elements of the centrical portion of the stapedial part; whereby the plurality of the structured elements of the distal terminal stapedial engaging portion of the stapedial part essentially conform to the distal portion of the stapes.

In some embodiments, the partial ossicular replacement prosthesis is configured to assume a plurality of configurations in-between the divergent configuration and the convergent configuration.

In accordance with some aspects and embodiments of the present invention a method of operating an applicator device for a partial ossicular replacement prosthesis with controllable stapedial engaging function is provided including: providing a partial ossicular replacement prosthesis including: a stapedial part including an essentially cylindrical shell shape with an elongated interior lumen, the stapedial part including: a distal terminal stapedial engaging including a plurality of structured elements configured for controllably conforming to a distal portion of a stapes; a centrical applicator operated portion, forming a continuum with the stapedial engaging portion, including a plurality of protruding elements facing inwardly into the elongated interior lumen of the stapedial part; a proximal basal stem portion, forming a continuum with the centrical portion; a tympanic part including an essentially flattened shape, the tympanic part including: an anterior face, associated with a tympanic membrane; a posterior face, forming a continuum with the proximal basal stem portion; a throughout aperture, disposed essentially at a center of the essentially flattened shape; in which the partial ossicular replacement prosthesis is configured to assume at least two configurations: a divergent configuration in which a distal portion of a plunger is engaged to the plurality of protruding elements of the centrical portion of the stapedial part; whereby the plurality of the structured elements of the distal terminal stapedial engaging portion of the stapedial part are essentially spread apart, and a convergent configuration in which the distal portion of a plunger is withdrawn from the plurality of protruding elements of the centrical portion of the stapedial part; whereby the plurality of the structured elements of the distal terminal stapedial engaging portion of the stapedial part essentially conform to the distal portion of the stapes; providing an applicator device for a partial ossicular replacement prosthesis with controllable stapedial engaging function including: a handpiece configured for manual grip by an operator; an essentially planar static face, configured to engage to the anterior face of the tympanic part of the partial ossicular replacement prosthesis; an elongated essentially cylindrically shaped plunger, configured to be introducible into the elongated interior lumen of the stapedial part of the partial ossicular replacement prosthesis, through the throughout aperture in the tympanic part of the partial ossicular replacement prosthesis; a tab operatively connected to the elongated essentially cylindrically shaped plunger, configured for controllably translating the essentially cylindrically shaped plunger within the elongated interior lumen of the stapedial part of the partial ossicular replacement prosthesis; introducing the plunger of the applicator device into the elongated interior lumen of the stapedial part of the partial ossicular replacement prosthesis, through the throughout aperture on the tympanic part of the partial ossicular replacement prosthesis; engaging the anterior face of the tympanic part of the partial ossicular replacement prosthesis, to the essentially planar static face of the applicator device; advancing the plunger of the applicator device within the elongated interior lumen of the stapedial part to engage to the plurality of protruding elements of the centrical portion of the stapedial part, thereby driving the partial ossicular replacement prosthesis into the divergent configuration; withdrawing the plunger of the applicator device from the plurality of protruding elements of the centrical portion of the stapedial part, thereby driving the partial ossicular replacement prosthesis into the convergent configuration.

In some embodiments, the method of operating an applicator device further includes displacing the tab of the applicator device, thereby driving the partial ossicular replacement prosthesis to assume a plurality of configurations in-between the divergent configuration and the convergent configuration.

In some embodiments, the method of operating an applicator device further includes controllably withdrawing the plunger within the elongated interior lumen of the stapedial part, thereby gradually altering the partial ossicular replacement prosthesis between the divergent and the convergent configurations.

In some embodiments, the method of operating an applicator device further includes selecting from a prostheses kit including a plurality of the partial ossicular replacement prostheses, a partial ossicular replacement prosthesis, in which the tympanic part of the partial ossicular replacement prosthesis includes at least one shape selected from a group of: a discoid shape, egg shape, oval shape, bulb shaped and horseshoe shape.

In some embodiments, the method of operating an applicator device further includes selecting from a prostheses kit including a plurality of the partial ossicular replacement prostheses, a partial ossicular replacement prosthesis, in which the tympanic part of the partial ossicular replacement prosthesis includes at least one structural element selected from a group of: a notch, groove, recess, circular aperture, structured aperture, furrowed surface and textured surface.

Definitions

The term readily connectable, as referred to herein, should be construed as a standardized unit that may be conveniently connected to other components of the system. The term readily connectable, however, doesn't necessarily means readily disconnectable or removable. The term readily connectable is optionally satisfied by providing for ease of at least onetime connection or coupling.

The terms matching and/or matchable as referred to herein is to be construed as a cross-sectional area and/or shape of a component is equal or essentially similar to a cross-sectional area and/or shape of another component. It should be acknowledged that the component need only to be similar in the cross-sectional areas and/or shapes, to satisfy the term matching/matchable, so long as the cross-sectional areas can be mated or the combination will fit into and/or occupy essentially the same lateral space.

The term structured as referred to herein is to be construed as including any geometrical shape, exceeding in complexity a plain linear shape or a shape embodying simple cylindrical, elliptical or polygonal contour or profile. A more complex shape, a plain linear shape or a shape embodying simple cylindrical, elliptical or polygonal contour or profile, constitutes an example of structured geometry.

The terms firm rigid, or stiff, as referred to herein, are to be construed as having rigidity modulus value, otherwise referred to as the shear modulus, of 4800 MPa or more. Materials are considered to be firm rigid, or stiff but not tensile, when such materials are incapable of being efficiently elastically flexed or bent. Stiff materials, such as steel, are defined as having rigidity modulus value well exceeding 4800 MPa.

The terms pliable or pliant, as referred to herein, are to be construed as having high tensile strength and capable of being efficiently elastically flexed or bent but not being resilient and incapable of being efficiently stretched or expanded. The term tensile or tensile strength, as referred to herein, is to be construed inter alia as a shortcut of the known term ultimate tensile strength, frequently represented acronym as UTS, meaning an intensive property of a material or structure to withstand loads tending to elongate, namely to resist tension, defined as the maximum stress that a material can withstand while been stretched or pulled before sustaining breaking, substantial deformation and/or necking before fracture, such as nylon, relating to essentially non-ductile materials, having UTS value ranging between about 600 and 1000 MPa or more, but not including rigid, firm or stiff materials.

The terms elastic or resilient, as referred to herein, are to be construed as having tensile strength lower than aforesaid tensile strength of pliable or pliant material and optionally being capable of efficiently stretching or expanding, relating inter alia to essentially ductile materials, having UTS value lesser than about 600 MPa.

The term biasing means or alike, as referred to herein, should be construed as including any material, structure or mechanism, configured to accumulate mechanical energy, by changing the configuration thereof, upon a force exerted thereon, such as a compressive, tensile, shear or torsional force, and for releasing the energy accumulated therein, by returning to the normal configuration thereof and by performing a mechanical work, typically by linear or radial displacement. Examples of biasing means in a non-limiting manner include, springs, elastomers, leaf-springs, coil-springs, tension/extension spring, compression spring torsion spring, constant spring, variable spring, variable stiffness spring, flat spring, machined spring, serpentine spring, garter spring, cantilever spring, helical spring, hollow tubing springs, volute spring, V-spring, belleville washer or belleville spring, constant-force spring, gas spring, mainspring, negator spring, progressive rate coil springs, rubber band, spring washer and wave spring.

By operationally connected and operably coupled, as used herein, is meant connected in a specific way (e.g., in a manner allowing water to move and/or electric power to be transmitted) that allows the disclosed system and its various components to operate effectively in the manner described herein.

In the specification or claims herein, any term signifying an action or operation, such as: a verb, whether in base form or any tense, gerund or present/past participle, is not to be construed as necessarily to be actually performed but rather in a constructive manner, namely as to be performed merely optionally or potentially.

The term substantially as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to being largely but not necessarily entirely of that quantity or quality which is specified.

The term essentially means that the composition, method or structure may include additional ingredients, stages and or parts, but only if the additional ingredients, the stages and/or the parts do not materially alter the basic and new characteristics of the composition, method or structure claimed.

As used herein, the term essentially changes a specific meaning, meaning an interval of plus or minus ten percent (±10%). For any embodiments disclosed herein, any disclosure of a particular value, in some alternative embodiments, is to be understood as disclosing an interval approximately or about equal to that particular value (i.e., ±10%).

As used herein, the terms about or approximately modify a particular value, by referring to a range equal to the particular value, plus or minus twenty percent (+/−20%). For any of the embodiments, disclosed herein, any disclosure of a particular value, can, in various alternate embodiments, also be understood as a disclosure of a range equal to about that particular value (i.e. +/−20%).

As used herein, the term or is an inclusive or operator, equivalent to the term and/or, unless the context clearly dictates otherwise; whereas the term and as used herein is also the alternative operator equivalent to the term and/or, unless the context clearly dictates otherwise.

It should be understood, however, that neither the briefly synopsized summary nor particular definitions hereinabove are not to limit interpretation of the invention to the specific forms and examples but rather on the contrary are to cover all modifications, equivalents and alternatives falling within the scope of the invention.

While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown merely by way of example in the drawings. The drawings are not necessarily complete and components are not essentially to scale; emphasis instead being placed upon clearly illustrating the principles underlying the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Prior to elaborating any embodiment of the present invention, in order to present the background for the inventive concept more clearly, reference is firstly made toFIG.1, showing illustrative representation of anatomy of the ear, shown inFIG.4of US20190192425. Outer ear10is the external portion of the organ and is composed of pinna (auricle)12, auditory canal (external auditory meatus)14and the outward facing portion of tympanic membrane16, colloquially known as the ear drum. Pinna12, which is the fleshy part of outer ear10that is visible on the side of the head, collects sound waves and directs them toward auditory canal14. Tympanic membrane16, is a thin membrane that separates outer ear10from middle ear20. Thus, the function of outer ear10, is inter alia to collect and direct sound waves towards tympanic membrane16and middle ear20.

Middle ear20is an air-filled tympanic cavity22, behind tympanic membrane16. Middle ear20lies within the temporal bone, and includes within this space the three ear bones (auditory ossicles): malleus24, incus26and stapes28. The auditory ossicles are linked together via tiny ligaments, which form a bridge across the space of tympanic cavity22. Malleus24is attached to tympanic membrane16at one end, and is linked to incus26at its anterior end. Incus26is in turn linked to stapes28. Stapes28is attached to oval window30(elliptical window), one of two windows located within the tympanic cavity. A fibrous tissue layer, known as the annular stapedial ligament (also called the stapediovestibular joint), forms a ring of fibrous soft tissue that connects the base of the stapes to the oval window of the inner ear.

Sound waves from outer ear10, first cause tympanic membrane16to vibrate. The vibration of tympanic membrane16is then transmitted across to cochlea32through the auditory ossicles and oval window30, which transfers the motion to the fluids in auris interna40. The auditory ossicles are arranged to provide a mechanical linkage between tympanic membrane16and oval window30of fluid-filled auris interna40, where sound is transformed and transduced to auris interna40for further processing. Stiffness, rigidity or loss of movement of the auditory ossicles, tympanic membrane16or oval window30leads to hearing loss, e.g. otosclerosis, or rigidity of the stapes bone.

Tympanic cavity22also connects to the throat via eustachian tube34. Eustachian tube34provides the ability to equalize the pressure between the outside air and the middle ear cavity. Round window36(circular window) is a component of the auris interna40, which is also accessible within tympanic cavity22, opens into cochlea32of auris interna40. Round window36is covered by a round window membrane, which consists of three layers: an external or mucous layer, intermediate or fibrous layer and internal membrane, which communicates directly with the cochlear fluid. Round window36, therefore, has direct communication with auris interna40via the internal membrane.

Movements in oval30and round36windows are interconnected, i.e. as stapes28bone transmits movement from tympanic membrane16to oval window30to move inward against the auris interna40fluid, round window36(round window membrane) is correspondingly pushed out and away from the cochlear fluid. This movement of round window36allows movement of fluid within cochlea32, which leads in turn to movement of the cochlear inner hair cells, allowing hearing signals to be transduced. Stiffness and rigidity in round window36membrane leads to hearing loss because of the lack of ability of movement in the cochlear fluid. Recent studies have focused on implanting mechanical transducers onto round window36, which bypasses the normal conductive pathway through oval window30and provides amplified input into the cochlear chamber. By way of example only, some medical device implants bypass damaged portions of the ear and directly stimulate the auditory nerve46.

Auditory signal transduction takes place in auris interna40. The fluid-filled auris interna40, or inner ear, consists of two major components: the cochlear and the vestibular apparatus. Auris interna40is located in part within the osseous or bony labyrinth, an intricate series of passages in the temporal bone of the skull. The vestibular apparatus is the organ of balance and consists of the three semi-circular canals42and the vestibule. Three semi-circular canals42are arranged relative to each other such that movement of the head along the three orthogonal planes in space can be detected by the movement of the fluid and subsequent signal processing by the sensory organs of semi-circular canals42, called the crista ampullaris. The crista ampullaris contains hair cells and supporting cells, and is covered by a dome-shaped gelatinous mass called the cupula. The hairs of the hair cells are embedded in the cupula. Semi-circular canals42detect dynamic equilibrium, the equilibrium of rotational or angular movements.

The endolymph fluid pushes against the cupula, which tilts to one side. As the cupula tilts, it bends some of the hairs on the hair cells of the crista ampullaris, which triggers a sensory impulse. Because each semi-circular canal42is located in a different plane, the corresponding crista ampullaris of each semi-circular canal42responds differently to the same movement of the head. This creates a mosaic of impulses that are transmitted to the central nervous system on the vestibular branch of vestibulocochlear nerve44, which mediates the sense of balance and equilibrium.

The vestibule is the central portion of auris interna40and contains mechanoreceptors bearing hair cells that ascertain static equilibrium, or the position of the head relative to gravity. Cochlea32is the portion of the auris interna40related to hearing. Cochlea32is a tapered tube-like structure that is coiled into a shape resembling a snail. The inside of cochlea32is divided into three regions, which is further defined by the position of the vestibular membrane and the basilar membrane. The portion above the vestibular membrane is the scala vestibuli, which extends from oval window30to the apex of cochlea32and contains perilymph fluid, an aqueous liquid low in potassium and high in sodium content.

The basilar membrane defines the scala tympani region, which extends from the apex of cochlea32to round window36and also contains perilymph. The basilar membrane contains stiff fibers, which gradually increase in length from round window36to the apex of cochlea32. The fibers of the basement membrane vibrate when activated by sound. In between the scala vestibuli and the scala tympani is the cochlear duct, which ends as a closed sac at the apex of cochlea32. The cochlear duct contains endolymph fluid, which is similar to cerebrospinal fluid and is high in potassium.

The organ of Corti, the sensory organ for hearing, is located on the basilar membrane and extends upward into the cochlear duct. The organ of Corti contains hair cells, which have hairlike projections that extend from their free surface, and contacts a gelatinous surface called the tectorial membrane. Although hair cells have no axons, they are surrounded by sensory nerve fibers that form the cochlear branch of the vestibulocochlear nerve44(cranial nerve VIII).

As discussed, oval window30, also known as the elliptical window communicates with stapes28to relay sound waves that vibrate from tympanic membrane16. Vibrations transferred to oval window30increase the pressure inside fluid-filled cochlea32via the perilymph, scala vestibuli and/or scala tympani, which in turn causes round window36membrane to expand in response. The concerted inward pressing of the oval window30and outward expansion of round window36allows for the movement of fluid within cochlea32without a change of intra-cochlear pressure. However, as vibrations travel through the perilymph in the scala vestibuli, they create corresponding oscillations in the vestibular membrane.

These corresponding oscillations travel through the endolymph of the cochlear duct and transfer to the basilar membrane. When the basilar membrane oscillates, the organ of Corti moves along with it. The hair cell receptors in the Organ of Corti then move against the tectorial membrane, causing a mechanical deformation in the tectorial membrane. This mechanical deformation initiates the nerve impulse that travels via vestibulocochlear nerve44to the central nervous system, mechanically transmitting the sound wave received into signals that are subsequently processed by the central nervous system.

The fragile structures of middle ear20are sometimes prone to chronic infections, trauma, or congenital or neoplastic causes, which may damage the auditory ossicles (malleus24, incus26and stapes28). Discontinuity of bone between tympanic membrane16and oval window30can lead to a decreased in sound conduction resulting in conductive hearing loss. Conductive hearing loss can be cured by a variety of treatments. Ossiculoplasty reconstructs a sound-conducting mechanism between tympanic membrane16and oval window30. One of the most common treatment procedures is a surgical intervention to remove one or more of the auditory ossicles, when they are entirely or partially absent or damaged, and to replace them with prostheses. These prostheses are called ossicular replacement prostheses (ORP). Ossicular replacement prostheses are used for ossicular reconstruction and for improving sound transmission.

Three types of ossicular replacement prostheses frequently used are: stapes prostheses, partial prostheses (PORP) and total prostheses (TORP). Stapes prostheses are fixed to incus26and protrude by way of a piston into auris interna40. PORP is usually lies against tympanic membrane16, malleus24or incus26and establishes a connection with an intact stapes superstructure. TORP is usually used when the malleus24, incus26and stapes28are absent, but the stapes footplate is intact.

Ossiculoplasty is performed under local or general anesthesia. The ear is prepped and draped in a sterile fashion. A tympanomeatal flap is elevated to expose middle ear20cavity and access the auditory ossicles. The auditory ossicles are inspected for any defects and gently palpated to assess for mobility and continuity. Stapes footplate mobility is essential for hearing success. If the distal portion of stapes28, namrly stapes capitulum, is intact, then a PORP can be used. If the stapes footplate is intact and mobile, a TORP can be used.

The distance from the mobile stapes28superstructure or footplate to tympanic membrane16is measured, and the prothesis is then trimmed and/or adjusted accordingly. The headplate of the PORP or TORP can be positioned under the native or grafted tympanic membrane16and the other prothesis end can be connected to the intact stapes28superstructure or footplate. The placement of the prothesis should result in good stability and not prone to dislocation or displacement.

Illustrative embodiments of the invention are described below. In the interest of clarity, not all features of actual implementation are described in this specification. It should be appreciated that various features or elements described in the context of some embodiment may be interchangeable with features or elements of any other embodiment described in the specification. Moreover, it will be appreciated that for the development of any actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with technology- or business-related constraints, which may vary from one implementation to another, and the effort of such a development might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure.

In accordance with some embodiments of the present invention, reference is now made toFIG.2A and2B, showing an isometric view of system100. System100is configured for partial ossicular replacement with controllable stapedial engaging function. In some embodiments, system100comprises partial ossicular replacement prosthesis102, hereinafter abbreviated by acronym PORP. Partial ossicular replacement prosthesis (PORP)102is configured for connecting tympanic membrane16with a distal portion of stapes28. In some examples, PORP102is configured in various lengths, widths, diameters and/or shapes.

In some example, at least a portion or part of PORP102is made of at least one appropriately biocompatible material, such as Nitinol, gold, tantalum, steel, platinum, titanium and/or other resilient metals and/or composite materials and/or a combination thereof. In other example, at least a portion or part of PORP102is made of at least one bioceramic materials, such as bioglass, glass-ceramic materials, alumina, zirconia, ceramic oxide, carbon, hydroxyapatite and/or other bioceramic materials and/or a combination thereof. In another example, at least a portion or part of PORP102is made of at least one biocompatible plastic, such as silicone, polyethylene, polytetrafluorethylene and/or other biocompatible plastic and/or combination thereof.

In some embodiments of the present invention, PORP102is configured to assume at least two configurations. In accordance with some embodiments, reference is now made toFIG.3A to3C, showing respectively isometric, side and top views of PORP102, in a convergent configuration. In some embodiments, PORP102comprises stapedial part104, as well as toFIG.2A and2B. Stapedial part104is configured for connecting with a distal part of a stapes, such as stapes28shown inFIG.1. In some embodiments, stapedial part104comprises an essentially cylindrical shell shape with elongated interior lumen105. Elongated interior lumen105within the essentially cylindrical shell shape of stapedial part104is configured to accommodate plunger206that is manipulatable by tab208of applicator device200. In some embodiments, the essentially cylindrical shell shape of stapedial part104is configurable at various interior and/or exterior diameters, lengths and shapes.

In some embodiments, stapedial part104comprises distal terminal stapedial engaging portion106. Stapedial engaging portion106is configured for being readily connectable with a distal portion of stapes28. In some embodiments, stapedial engaging portion106further comprises a plurality of structured elements108. The plurality of structured elements108are configured for controllably conforming to a distal portion of stapes28. As shown inFIG.5A, complex150A of PORP102in the convergent configuration conforms to stapes emulating structure152. In some embodiments, the plurality of structured elements108comprise at least one edge with a profile, such as chamfered, filleted or beveled profile.

In some embodiments, PORP102of system100is configured to assume a plurality of configurations in-between the divergent configuration and convergent configuration. In some embodiments, plunger206of applicator device200plunger is configured to be controllably withdrawn within elongated interior lumen105of stapedial part104. In such embodiments, PORP102is configured to be gradually altered between the divergent and convergent configurations.

In some embodiments, stapedial part104comprises centrical applicator operated portion110. Centrical applicator operated portion110forms a continuum with stapedial engaging portion106. In some embodiments, centrical applicator operated portion110comprises a plurality of protruding elements112. The plurality of protruding elements112face inwardly into elongated interior lumen105of stapedial part104. The plurality of protruding inwardly facing elements112are configured to be operated by applicator200.

In some embodiments, stapedial part104comprises proximal basal stem portion114. Proximal basal stem portion114forms a continuum with centrical applicator operated portion110of stapedial part104. Proximal basal stem portion114is configured for being connected with tympanic part116of PORP102.

In some embodiments, PORP102comprises tympanic part116. Tympanic part116is configured for lying vis-a-vis tympanic membrane16. In some embodiments, tympanic part116typically embodies a flattened shape. In some embodiments, part116typically embodies a form, such as rounded, egg-shaped, oval, horseshoe-shaped, discoid and bulb shaped form. In some embodiments, tympanic part116comprises at least one notch124. At least one notch124is configured for fitting vis-a-vis tympanic membrane16. In some examples, at least one notch124comprises arcuate shape of various sizes.

In some embodiments, tympanic part116comprises anterior face118. Anterior face118of tympanic part116is often directly engaged with tympanic membrane16. In some embodiments, however, a piece of cartilage is firstly placed over anterior face118of tympanic part116, and only then anterior face118of tympanic part116is covered with tympanic membrane16.

In some embodiments, tympanic part116comprises throughout aperture122, shown inFIG.6. Throughout aperture122is disposed essentially at a center of the essentially flattened shape of tympanic part116.

In some embodiments, proximal basal stem portion114of PORP102comprises a screw. The screw threading at proximal basal stem portion114of PORP102is configured for adjusting PORP102in length. In some embodiments, proximal basal stem portion114of PORP102comprises an external screw threading. An external screw threading is configured for matching with an internal screw threading of throughout aperture122of tympanic part116of PORP102. In some embodiments, throughout aperture122comprises an internal screw threading. An internal screw threading is operatively connectable with stapedial part104of PORP102.

In some embodiments of the present invention, system100comprises applicator device200. In accordance with some embodiments, reference is now made toFIG.7A to7DandFIG.8A and8B, showing respectively isometric, side, top and bottom views of applicator device200. Applicator device200is configured for partial ossicular replacement with PORP102, characterized by controllable stapedial engaging function. In some embodiments, applicator device200comprises handpiece202. Handpiece202is configured for manual griping by the operator. In some embodiments, applicator device200comprises essentially planar static face204. Planar static face204is configured for engaging to anterior face118of tympanic part116of PORP102.

In accordance with some embodiments, of the present invention, reference is now made toFIG.4A to4C, showing respectively isometric, side and top views of PORP102, in a divergent configuration. In some embodiments, in the divergent configuration of PORP102the plurality of inwardly facing elements112of centrical portion110of stapedial part102are driven by a distal portion of plunger206. The divergent configuration of PORP102further includes essentially spreading apart the plurality of structured elements108of distal terminal stapedial engaging portion106of stapedial part104. With reference toFIG.5Bcombination150B of PORP102in the divergent configuration and stapes emulating structure152is shown.

In accordance with some embodiments of the present invention, reference is now made toFIG.9A and9Bshowing isometric views of preform302comprising at least the stapedial part during the stages of manufacture of PORP102, as well as toFIG.10showing schematic block diagram of process301of PORP102manufacturing. In some embodiments, process301of manufacturing PORP102involves processing preform302by at least one machine for producing one-part of the protheses, and/or individual parts thereof, as well as entire PORP102, such as by a molding machine.

In some embodiments, process301of manufacturing PORP102commences at step303with providing preform302of at the least stapedial part. In some embodiments, preform302of at least the stapedial part comprises an essentially cylindrical shell shape with elongated interior lumen105. In some embodiments, providing preform302comprises manufacturing a plurality of preforms, of different lengths, shapes and diameters.

In accordance with some embodiments of the present invention, process301of manufacturing PORP102comprises forming a plurality of elongated cuts304, at step305. In some embodiments, forming the plurality of elongated cuts304of step305is performed from the distal terminal face of preform302, along a substantial length of essentially cylindrical shell shape of preform302. In some embodiments, the plurality of elongated cuts304at step305forms a plurality of elongated biasing elements312extending from proximal basal stem portion114of an essentially cylindrical shell shape of preform302. In some embodiments, the forming of plurality of elongated cuts304at step305includes processing preform302by at least one machine, such as laser cutting machine, electrical discharge machine, CNC, drills or any other type of subtractive manufacturing, as well as any combination thereof.

In accordance with some embodiments of the present invention, process301of manufacturing PORP300further comprises step307of shaping the centrical portion of a of elongated biasing elements312. In some embodiments, step307of shaping of the centrical portion of plurality of elongated biasing elements312forms a plurality of protruding elements112, such as protruding elements shown in2A and3A, facing inwardly into elongated interior lumen105of preform302. In some embodiments, step307of shaping centrical portion of plurality of elongated biasing elements312forms centrical applicator operated portion110of stapedial part104of PORP102. In some embodiments, step307of shaping the centrical portion of plurality of elongated biasing elements312includes processing preform302by at least one machine, such as a press, punching or metal bending machine.

In some preferred embodiments, process301of manufacturing PORP300yet further comprises a step of forming a plurality of mariquose shaped recesses314, in-between elongated biasing elements312. The step of forming a plurality of mariquose shaped recesses314, in-between elongated biasing elements312, is typically performed following the forming of plurality of elongated cuts304at step305and prior to step307of shaping centrical portion of plurality of elongated biasing elements312.

In some embodiments, process301of manufacturing PORP300further comprises step309of shaping the distal terminal portion of plurality of elongated biasing elements308. In some embodiments, step309of shaping the distal terminal portion of plurality of elongated biasing elements312forms a plurality of structured elements configured to conform to a distal portion of stapes, such as stapes28shown inFIG.1. In some embodiments, step309of shaping the distal terminal portion of the plurality of biasing elements312forms stapedial engaging portion106of stapedial part104. In some embodiments, shaping a distal terminal portion of the plurality of biasing elements308includes processing by at least one machine such, as a chamfering and/or filleting machine.

In accordance with some aspects of the present invention, reference is now made toFIG.11, showing a high-level flowchart of method400of operating an applicator device for manipulating the PORP, such as applicator device200for manipulating PORP102shown in2A and2B. In some examples, method400of operating applicator200device for manipulating PORP102commences at step402, with providing suitable PORP102. In some examples, step402, of providing PORP102, comprises selecting PORP102with diameter, length and/or shape suitable for specific patient, from a kit comprising a plurality of PORPs with different diameters, lengths and/or shapes. In some examples, step402, of providing PORP102, comprises selecting PORP102with size, length, diameter and/or shape matching plunger206of applicator device200. In some examples, step402, of providing a PORP, comprises length adjustment of stapedial part104of PORP102. In some examples, step402, of providing a PORP, includes using disinfectants, sterilization, as well as providing of instruments and utensils for proper handling, such as tweezers, scissors and/or forceps.

In some embodiments, method400of operating an applicator device for a PORP comprises step404, of providing an applicator device. In some examples, step404of providing an applicator device, comprises using disinfectants and/or sterilization of applicator device200. In some examples, step404of providing an applicator device, comprises length adjustment of plunger206of applicator device200. In some examples, step404, of providing an applicator device, comprises selecting plunger206of applicator device200with size, length, diameter and/or shape matching PORP102.

In some embodiments, method400of operating an applicator device for a PORP comprises step406, of introducing plunger206into an elongated interior lumen of the stapedial part of a PORP. In some examples, step406, of introducing the plunger of applicator device into the elongated interior lumen of the stapedial part, is performed by manipulating PORP by sterile instruments, such as forceps.

In some embodiments, method400of operating an applicator device for a PORP comprises step408, of engaging the anterior face of the tympanic part of the PORP to the essentially planar static face of the applicator device. Step408is configured for stabilizing the engaging of PORP102by applicator device200onto the stapes.

In some embodiments, method400of operating an applicator device for a PORP comprises step410of advancing the plunger of an applicator device within an elongated interior lumen of the stapedial part of the PORP. In some examples, step410is configured for driving PORP into the divergent configuration. In some examples, step410is performed by pressing onto tab208of applicator device200.

In some embodiments, method400of operating an applicator device for a PORP comprises step412of withdrawing the plunger of an applicator device from the plurality of inwardly facing elements of a stapedial part of the PORP. In some examples, step412of withdrawing the plunger of an applicator device from the plurality of inwardly facing elements of a stapedial part of the PORP is configured for driving PORP102into the convergent configuration on a distal portion of stapes28. In some examples, step412is performed by gradually pulling tab208of applicator device200or by releasing tab208of applicator device200.