Eustatian tube venting element with deployment system and method for its use

Abstract

A venting device and a method and system for its use for deployment of in the Eustachian tube (ET) of a human or other mammal is disclosed. The venting device includes a support element, which comprises a hollow, generally tubular body having an inner tubular surface defining a continuous bore extending therethrough, and may also include a flexible extension, such as a pull wire for facilitating removal of the support elements from the ET when desired. The support element includes, for example, tubular body, which has a length, inner diameter and outer diameter, dimensioned such that when the venting device is positioned in the ET, the support element extends in a cartilaginous portion of the ET.

Description

[0001] Docket 602667

[0002] EUSTATIAN TUBE VENTING ELEMENT WITH DEPLOYMENT SYSTEM AND METHOD FOR ITS USE

[0003] CROSS-REFERENCES TO RELATED APPLICATIONS

[0004] This application is related to and claims priority from commonly owned US Provisional Patent Application Serial Number 63 / 762,699, entitled: Stent, Stenting System and Method, filed on 25 February 2025, the disclosure of which is incorporated by reference in its entirety herein.

[0005] TECHNOLOGICAL FIELD

[0006] This disclosure is directed to venting element for the Eustachian tube (ET), as well as a systems and methods for ET venting.

[0007] BACKGROUND ART

[0008] References considered to be relevant as background to the presently disclosed subject matter are listed below:

[0009] - Bluestone, CD. Eustachian Tube Structure, Function, Role in Otitis Media.

[0010] BC Decker Inc; Hamilton, Ontario: 2005

[0011] - Bluestone, CD.; Klein, JO. Otitis Media in Infants and Children. BC Decker;

[0012] Hamilton, Ontario: 2007

[0013] Stephen Chad Kanick and William J. Doyle, Barotrauma during air travel: predictions of a mathematical

[0014] - F.J. Sheer, J.D. Swarts, and S.N. Ghadiali, Three-dimensional Finite Element Analysis of Eustachian Tube Function under Normal and Pathological Conditions. Med Eng. Phys. 2012, 34(5): 605-616

[0015] - Poe DS, et al. Analysis of Eustachian tube function by video endoscopy.

[0016] Am. J. Otol. 2000; 21:602-607

[0017] - WO 2009 / 001358

[0018] - US 9,510,976

[0019] - US 6,589,286

[0020] - WO 2018 / 055630Docket 602667

[0021] Acknowledgement of the above references herein is not to be inferred as meaning that these are in any way relevant to the patentability of the presently disclosed subject matter.

[0022] BACKGROUND

[0023] Adequate ventilation and drainage are essential for normal middle ear function, and it is the Eustachian tube (ET) that normally provides for that. Chronic Eustachian tube dysfunction has been implicated in the pathogenesis of many otologic disorders and is thought to be a principal cause of a variety of otologic surgical failures. Patients with chronic middle ear disease have often been shown to have a mechanical narrowing of the ET, usually at the isthmus junction of the bony and cartilaginous portions. ET dysfunction has also been associated with functional disorders of the cartilaginous part.

[0024] The Eustachian tube is ordinarily closed in the resting position and dilates to the open position typically with swallowing, yawning, and with other voluntary or involuntary efforts. Tubal opening typically lasts less than one-half of a second. Closure of the Eustachian tube is maintained by a valve-like structure and valve-like function of the opposing mucosal surfaces, submucosal tissue, fat, muscle, and cartilage, proximate to the opening to the nasopharynx (that may be referred to herein as the "ET valve"). This valve-like structure typically measures approximately 5 mm in length and lies within the cartilaginous portion of the ET located about 10 mm distal into the tube from the nasopharyngeal orifice's posterior cushion or torus tubarius.

[0025] A common problem resulting from Eustachian tube dysfunction is Otitis Media with Effusion (OME) or the presence of fluid in the middle ear with no signs or symptoms of acute ear infection. Persistent middle ear fluid from OME results in decreased mobility of the tympanic membrane and serves as a barrier to sound conduction. OME may occur spontaneously because of poor Eustachian tube function or as a response following Acute Otitis Media. This may occur in infants and children ages 1-6 years due to anatomical differences and physiological changes of the Eustachian tube. At birth, the tube is horizontal and approx. 17-18 mm long. It grows to be at an incline of approx. 45 degrees and reaches a length of approx. 35 mm in adulthood. Due to its relatively horizontalDocket 602667

[0026] position in infants and young children and the relatively short length, these subjects are more likely to suffer from Eustachian tube dysfunction.

[0027] There are also treatments that use ballooning to open the ET, but these often suffer from complications such as patulous ET (~2% of cases) and difficulty treating irregular ET anatomies.

[0028] SUMMARY

[0029] The present disclosure is directed at a venting device and a method for its use, for example, when deployed in the Eustachian tube (ET) of a human or other mammal. The venting device comprises a support element that can be temporarily deployed in the ET to restore the ET function, for example in the event of an OME while preserving its natural physiology. The present disclosure also concerns a venting device delivery system as well as a method of delivery of the device.

[0030] By embodiments of this disclosure, the support element is configured to prevent negative pressure-induced collapse and vacuum effects within the ET canal, while avoiding interference with the proximal physiologic valve region. The venting device is configured not to interfere with the normal function of the ET. The support element maintains ventilation and secretion clearance, without interfering with the physiological opening and closing of the ET during swallowing or pressure equalization. It also permits the ET valve to remain closed at rest in a manner that closely respects normal ET function. The proper placement of the support element may be verified by a variety of means such as, but not limited to, by an endoscopic camera visualization and / or by other guidance measures.

[0031] The support element may, for example, be a hollow, generally tubular body having an inner, generally tubular surface defining a continuous bore extending therethrough. Such support element may have the following characteristics:

[0032] (i) A length such that when positioned in a midportion of the ET, it escapes the physiologic valve of the ET close to the nasopharynx (few mm from the nasopharynx) and extends towards the distal part of the cartilaginous portion of the ET. Thus, the support element extends between an inner portion (typically a few millimeters away from the nasopharynx) of a cartilaginous of the ET towards a bony portion of the ET (proximateDocket 602667

[0033] to the inner ear). In this manner it leaves a proximal region of the cartilaginous portion adjacent to a nasopharyngeal orifice, e.g. of at least 2 mm, 3 mm or even at least 4 mm, free of the support device to thereby preserve (and not disrupt) natural ET valve function, (ii) An outer diameter that is the same or less than the ET diameter at said midportion; and

[0034] (iii) A rigidity in a transverse direction sufficient to support walls of said midportion from fully collapsing (which, if happens, can occlude the ET) while maintaining an inner diameter that is dimensioned to permit air to pass therethrough for equalizing pressure between the nasopharynx and the middle ear space and permitting drainage of liquid therethrough.

[0035] The support element, by embodiments of this disclosure, may be formed with features that increase flexibility and allow the support element to flex along its transverse cross section in response to pressure from the ET. Such features may comprise or include elongated slots, which may be cuts, grooves or indentations. The term "slot" as used herein refers to at least one cut, slit, groove, indentation and the like; the slots being typically elongated.

[0036] The venting device may also comprise, by embodiments of this disclosure, a flexible extension, such as a pull wire attached to the support device and extending proximally therefrom, and is dimensioned so it can extend out from the ET into the nasopharynx when the support device is deployed in the ET. The flexible extension facilitates retrieval of the support device from the ET. The support element forms a passage that facilitates drainage of fluids from a middle ear to a nasopharynx cavity and pressure equalization in the middle ear, while permitting normal closure (and opening) of a natural ET valve.

[0037] BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Some embodiments of the present disclosure are herein described, by way of example only, with reference to the accompanying schematic drawings. With specific reference to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the disclosure andDocket 602667

[0039] are not necessarily to scale. In this regard, the description taken with the drawings makes it apparent to those skilled in the art how embodiments of the disclosure may be practiced.

[0040] Attention is now directed to the drawings, where like reference numerals or characters indicate corresponding or like components. In the drawings:

[0041] FIG. l is a side view of a venting device deployment assembly in accordance with embodiments of the present disclosure;

[0042] FIGs. 2A and 2C are side views of the venting device deployment assembly in an exemplary operation of deploying the venting device in the Eustachian tube of a human;

[0043] FIG. 2B is a cross-sectional view of the human ear;

[0044] FIG. 3A-1 is a perspective view of the venting device, in accordance with embodiments of the present disclosure;

[0045] FIG. 3 A-2 is a perspective view of the venting device of FIG. 3 A-l showing axial orientations for a longitudinal axis LA and a transverse axis TA;

[0046] FIG. 3A-3 is a perspective view of an alternative venting device, in accordance with an embodiment of the present disclosure; and

[0047] FIG. 3B is the cross-sectional view of FIG. 2B showing the venting device deployed in the Eustachian tube with respect to the ear and nasopharynx.

[0048] DETAILED DESCRIPTION OF EMBODIMENTS

[0049] GENERAL DESCRIPTION-OVERVIEW

[0050] Throughout this document, the terms "proximal" and "distal" and their derivatives are used to reference orientation relative to the practitioner or the direction of insertion of the device into position in the ET; where "proximal" indicates the direction toward the nasopharynx and "distal" indicates the direction toward the middle ear. These terms represent example orientations for various structures disclosed herein, used to explain the present disclosure. The use of these terms is not in any way limiting.

[0051] Throughout this document, certain terms are used interchangeably to refer to the same components of the venting device deployment assembly. Specifically, the terms "inner sheath" and "holder sheath" both refer to the component designated by reference numeral 116 in the drawings, and which may be utilized in some embodiments of thisDocket 602667

[0052] disclosure, which functions to hold the venting device during delivery and is configured to engage the venting device. Similarly, the terms "outer sheath" and "stopper sheath" both refer to the component designated by reference numeral 118 in the drawings, and which may be utilized in some embodiments of this disclosure, which functions as a stop surface for the venting device during deployment. The use of either terminology in the specification or claims refers to the same structural component and carries the same functional meaning.

[0053] Provided by this disclosure are a venting device for deployment in the ET, a deployment assembly for such a venting element (comprising a venting device, a venting device delivery system and optionally a venting device removal device), a venting device deployment method and a method of venting the ET.

[0054] The present disclosure provides a venting device and a method and system for its use for deployment of in the Eustachian tube (ET) of a human or other mammal. The venting device includes a support element, which comprises a hollow, generally tubular body having an inner tubular surface defining a continuous bore extending therethrough, and may also include a flexible extension, such as a pull wire for facilitating removal of the support elements from the ET when desired. The support element includes, for example, tubular body, which has a length, inner diameter and outer diameter, dimensioned such that when the venting device is positioned in the ET, the support element extends in a cartilaginous portion of the ET.

[0055] It has been realized, in accordance with this disclosure that contrary to common wisdom, effective ET venting may be achieved through the use of undersized support elements, including (i) support element length is undersized relative to the ET length, and (ii) the support element diameter is undersized relative to the width of the ET (the ET is not cylindrical).

[0056] The support element surface may, by some embodiments, be made to be smooth and free of openings (not meshed), although it may, by some other embodiments, have features that increase transverse flexibility. For example, it may be slotted with slots (which may be cuts or grooves). In the case of cuts, these are typically blind cuts, namely cuts that do not reach an edge of the support element. In some embodiments, the cuts may have an open end, namely extend to the edge, e.g., alternating between a cut that opens atDocket 602667

[0057] one end and another that opens at the opposite end. The slots may extend along the support element, e.g., may be axially extending (namely that extend substantially parallel to a longitudinal axis of said element), may extend along an undulated or helical path defined the external surface of the support device, etc. The slots may be blind slots (that do not reach the end of the support device) or may be slots open at one of their ends, namely reaching to one of terminal edges of the support element. Non-limiting examples of such support element is a blind-slotted sleeve or a castellated sleeve. The cuts are typically dimensioned to prevent tissue from growing therethrough into the interior (e.g., bore) of the support device.

[0058] Such a support element defines a passage that facilitates drainage of fluids from the middle ear to the nasopharynx cavity and pressure equalization in the middle ear, while permitting normal closure of the natural ET valve.

[0059] The disclosed support element maintains the function of the ET (or canal), as its presence in the ET prevents the ET (canal) walls from creating negative pressure, which creates a vacuum and prevents the ET from opening. The location of the support element in the ET, toward the nasopharynx, leaves the valve formed by opposing mucosal surfaces, submucosal tissue, fat, muscle, and cartilage, proximate to the nasopharynx opening, such that the ET valve opens and closes free of interference and / or obstruction. This combination of features allows the ET to operate normally and allows for fluid drainage through the support element.

[0060] Additionally, the support element includes a flexible extension, such as a pull wire or retrieval wire, attached to the tubular body of the support element. This flexible extension allows the venting element to be pulled and removed from the ET, for example, through the nasopharynx. As a result, the venting element may remain in the body temporarily, and not for the patient’s lifetime, and once the clinician determines that the support element is no longer needed it can be removed.

[0061] By an embodiment of this disclosure the support element is designed to be positioned at the distal area of the cartilaginous length of the ET, leaving the proximal area of the cartilaginous length (closer to the nasopharynx), which is ET valve further away from the bony area (proximate to the inner ear) of the Eustachian tube, free to function, to close and open normally.Docket 602667

[0062] In accordance with embodiments of this disclosure, the venting device comprises a support element, for example, of a hollow tubular body having a smooth, solid-walled surface defining a continuous bore extending therethrough. The solidwalled surface, as opposed to mesh or perforated designs, provides a continuous passage for fluid flow while maintaining structural integrity within the Eustachian tube (ET).

[0063] By an embodiment of this disclosure the length of the area at the proximal area of the cartilaginous length that is left free from support element is typically at least 4 mm, at times at least 5 mm and may be longer up to 10 or 12 mm

[0064] By an embodiment of this disclosure the support element has a tubular body made typically (but not exclusively) from elastic material, e.g., an elastic polymer such as PEBAX® Thermoplastic Elastomer from Arkema Global of France, or Polyamide or other implant suitable polymer.

[0065] The selection of elastic materials for the support element construction serves multiple functions in the effective treatment of ET dysfunction. The elasticity of these materials contributes to the support element's ability to conform to individual anatomical variations without exerting excessive pressure on the ET walls and even reach its designated location in the ET while being bent on its way through the guiding catheter.

[0066] The elasticity of materials such as PEBAX® or Polyamide allows the support element to maintain its tubular shape and provide the necessary bore patency for fluid drainage and pressure equalization, while simultaneously permitting the flexibility required to accommodate the natural movements of the ET during physiological functions such as swallowing or yawning. This balance of rigidity and flexibility is essential for long-term placement in the dynamic environment of the ET. The elastic properties also contribute to the support element's ability to conform to individual anatomical variations without exerting excessive pressure on the ET walls, which could lead to tissue trauma or complications such as patulous ET. Additionally, the material elasticity facilitates the deployment and retrieval processes, allowing the support element to be compressed during delivery and to resume its intended shape upon deployment, and later to be elongated slightly during retrieval to reduce its profile for atraumatic removal through the ET.Docket 602667

[0067] By an embodiment of this disclosure the support element diameter may be between 2 to 3 mm, but it may also be between 1 to 5 mm. These dimensions are adjustable for Eustachian tube dimensions, based on the patient age, e.g., being an adult / child, man / woman, tall / short and other human characteristics.

[0068] By an embodiment of this disclosure the support element length may be about 10 mm, but it may also be between 5 to 15 mm, also depending on the Eustachian tube dimensions and the patient age, man / woman, tall / short and other human characteristics.

[0069] The precise positioning of the support element relative to specific anatomical landmarks within the ET contributes to its proper function and therapeutic efficacy. When correctly deployed, the distal end of the support element extends toward, but preferably does not enter, the bony portion of the ET (proximate to the inner ear). The proximal end of the support element is positioned to maintain a specific minimum distance — at least 4 mm, and preferably 5 mm or more — from the nasopharyngeal orifice of the ET. This distance ensures that the natural (native) ET valve, which is located in the proximal cartilaginous portion and measures approximately 5 mm in length, remains completely free from venting element interference. This valve-like structure, comprising opposing mucosal surfaces, submucosal tissue, fat, muscle, and cartilage, is responsible for the normal opening and closing functions of the ET.

[0070] By preserving the functional integrity of this valve through precise support element positioning, the natural physiological mechanisms of ET opening during swallowing, yawning, and other actions are maintained, while the support element simultaneously provides the structural support needed in the distal region to address the underlying condition. This anatomical precision distinguishes the present support element design from prior approaches and is fundamental to achieving the therapeutic objectives without introducing complications such as patulous ET.

[0071] By an embodiment of this disclosure the support element is coupled to a flexible extension, such as a pull wire, which is attached to the support element. When the support element is delivered and released inside the Eustachian tube, the pull wire is released and stretched back along the delivery system such that it protrudes fromDocket 602667

[0072] the Eustachian tube into the nasopharynx. The flexible extension can be used to retrieve the support element after some time once the support element is no longer needed. The flexible extension can be made from a polymer, elastomer, metal, silk, or the like, and it can be a single wire tied to the support element or a loop shape.

[0073] When retrieval of the support element is desired, typically after the treatment objectives have been achieved, the flexible extension provides a simple and non-invasive means for removal. The retrieval procedure involves accessing the exposed portion of the flexible extension that extends into the nasopharynx, typically using endoscopic visualization, including use of a camera, imager, or the like, for guidance. By applying controlled proximal tension to the flexible extension, in a direction away from the ET opening, the support element can be gently dislodged from its position and drawn back through the ET into the nasopharynx for complete removal. The proximal tension is applied, for example, in a steady, gradual manner to avoid any trauma to the ET tissue. The flexible extension’s design ensures that the force applied is distributed appropriately to initiate support element movement without damaging the surrounding tissues. This retrieval method eliminates the need for additional surgical procedures to remove the support element after it has served its therapeutic purpose.

[0074] By an embodiment of this disclosure the support element is delivered with a delivery system that comprises a marker, or other visual indicator, which indicates the depth to which the support element is inserted from the nasopharynx into the Eustachian tube, for example, the delivery system can be viewed using an optic system, including a cameras, for example, and a marker can be positioned on the delivery system about 5 mm proximal to the support element. The support element can then be released from the delivery system leaving the support element about 5 mm deep inside the Eustachian tube.

[0075] The visual indicia system provides precise guidance for proper support element positioning and may comprise multiple markers on the holder sheath and / or the stopper sheath. These markers are designed to align with anatomical reference points visible through an endoscopic visualization system during the procedure. For example, a primary marker positioned about 5 mm proximally to the support elementDocket 602667

[0076] on the holder sheath can be aligned with the torus tubarius or other visible nasopharyngeal landmark to ensure that the support element is positioned at the optimal depth, leaving the proximal area of the cartilaginous portion (proximate to the nasopharynx opening) free. Additional markers may be included to indicate insertion boundaries or to accommodate different patient anatomies. The markers may be radiopaque to allow visualization under fluoroscopy if required or may be distinct visual indicators such as colored bands or patterns that are easily distinguishable through endoscopic visualization.

[0077] By an embodiment of this disclosure the delivery system comprises means to support insertion through the nasopharynx into the Eustachian tube which requires bending the distal end of the delivery system into the Eustachian tube. For example, the delivery catheter may be made of an inner, holder sheath, with the support element mounted on its distal end and an outer, stopper sheath that supports the support element proximally, such that when the inner, holder sheath is pulled back (proximally) the support element is free from the delivery system. It may further comprise a flexible bend to the inner, holder sheath, having the support element positioned thereon, and the outer, stopper sheath. A stiff mandrel placed inside the inner, holder sheath holds the delivery catheter straight for insertion (distally) into the nasopharynx and is pulled back (proximally) to allow the delivery catheter to bend (according to a prevent or precurved bias of the delivery catheter) and then to be inserted into the Eustachian tube up until the marker marks the support element depth.

[0078] The delivery system for deploying the support element comprises several integral components designed to work in synchronization for precise support element placement.

[0079] A guiding catheter is provided that has a distal end biased to a precurved position, preferably at approximately 45 degrees to correspond to the natural angle between the nasopharynx and the ET. The guiding catheter is dimensioned to extend from the nasopharynx into the ET and provides the initial pathway for support element delivery. A removable mandrel is disposable within the guiding catheter and serves to maintain the guiding catheter in a straight configuration during initial insertion through the nasopharynx. The mandrel is designed to be partially withdrawable to allow the distal endDocket 602667

[0080] of the guiding catheter to assume its precurved orientation when approaching the ET opening, facilitating entry into the ET at the proper angle. The delivery system further includes a holder sheath dimensioned to extend through the guiding catheter. The holder sheath has an outer portion specifically configured to frictionally engage the inner surface of the tubular support element, maintaining the support element in position during advancement through the delivery path while allowing for controlled release during deployment.

[0081] The frictional engagement between the holder sheath and the support element is precisely engineered to provide secure attachment during delivery while allowing for controlled release during deployment. A stopper sheath extends partially over the holder sheath within the delivery system. The stopper sheath has a distal end precisely positioned to serve as a stop surface for the proximal end of the support element during deployment. This mechanical stop function prevents proximal migration of the support element during the withdrawal of the holder sheath, ensuring that the support element remains at the intended deployment location. The stopper sheath is dimensioned with an inner diameter slightly larger than the outer diameter of the holder sheath to allow smooth relative movement between the two components while maintaining proper alignment. The distal end of the stopper sheath may be configured with a slightly flared or tapered profile to create an optimal contact surface with the proximal end of the support element during deployment, distributing contact forces evenly to avoid damage to the support element structure. The stopper sheath also provides structural support to the delivery system during navigation through the anatomical pathway to the ET, contributing to the overall stability and maneuverability of the system.

[0082] This engagement may be achieved through several means, including a slight expansion of the holder sheath's outer diameter in the region that contacts the support element's inner surface, or through the use of surface textures or materials with specific frictional properties. The engagement force is carefully calibrated to be sufficient to prevent premature support element movement during navigation through the delivery path, yet low enough to allow smooth disengagement when the holder sheath is withdrawn proximally against the stopper sheath. This balance is for precise support element placement without causing trauma to the delicate ET tissues. During deployment,Docket 602667

[0083] as the holder sheath is withdrawn proximally, the frictional forces are gradually overcome, allowing the support element to remain in place while the holder sheath slides out from within it. This controlled release mechanism ensures that the support element remains at the intended deployment location without proximal migration during the deployment process.

[0084] The handle component of the delivery system provides the practitioner with precise control over the deployment procedure. The handle is ergonomically designed and coupled to both the holder sheath and the stopper sheath, housing the retraction mechanism that enables the controlled proximal retraction of the holder sheath relative to the stopper sheath during support element deployment. This mechanism may comprise a sliding element, trigger, or wheel that translates the practitioner's hand movements into precise, controlled movements of the delivery components. The handle may also incorporate features to prevent accidental deployment, such as safety locks or two-stage activation requirements. Additionally, the handle may include ports for endoscopic instrumentation, allowing for simultaneous visualization during the deployment process. The design of the handle takes into account the anatomical constraints of working through the nasal passage and the need for stable, one-handed operation during the critical phases of support element positioning and deployment.

[0085] The undersized support element of this disclosure maintains ET function and enables ET ventilation without the need for ballooning. Furthermore, such a support element does not cause patulous ET, and therefore, can be used in treatment of irregular ET anatomies. The flexible extension of some embodiments permits removal of the support element through pulling thereof.

[0086] The method for deploying the support element in the ET begins with providing the support element deployment assembly as described above, comprising the support element, holder sheath, and stopper sheath, with the support element mounted on the holder sheath and the stopper sheath extending partially over the holder sheath with its distal end positioned proximally to the support element.

[0087] A guiding catheter is advanced through the nasopharynx of the patient. Prior to insertion, a mandrel is inserted within the guiding catheter to maintain it in a straight configuration for smooth passage through the nasopharynx. Once the distal end of theDocket 602667

[0088] guiding catheter is positioned near the ET opening, the mandrel is partially withdrawn to allow the distal end of the guiding catheter to assume its precurved orientation, facilitating entry into the ET. The support element deployment assembly is then advanced through the guiding catheter until the support element is positioned at the distal area of the cartilaginous length of the ET. This positioning is precisely controlled through the use of visual markers on the holder sheath or stopper sheath, which align with a reference point when the support element has reached the proper deployment location.

[0089] The function of the support element is influenced by its position such that the proximal area of the cartilaginous length of the ET remains free of the support element, preserving the natural valve function. Once properly positioned, the holder sheath is withdrawn proximally to disengage the support element from the holder sheath while the distal end of the stopper sheath maintains the support element in the intended position. The stopper sheath and guiding catheter are then withdrawn proximally from the patient, leaving the support element deployed in the ET with the pull wire extending proximally from the support element into the nasopharynx for potential future retrieval.

[0090] The undersized support element of this disclosure provides several important functional benefits in the treatment of ET dysfunction. The support element defines a passage that facilitates drainage of fluids from the middle ear to the nasopharynx cavity and pressure equalization in the middle ear, addressing the primary symptoms associated with ET dysfunction.

[0091] The strategic design of the support element's dimensions and its precise positioning are fundamental to its therapeutic effectiveness while avoiding complications common to alternative treatment approaches. By leaving the proximal area of the cartilaginous portion free, the support element allows the natural valve of the ET to open and close normally during physiological functions such as swallowing, yawning, and other movements. This preservation of natural valve function maintains the protective barrier function of the ET that prevents reflux of nasopharyngeal secretions and pathogens into the middle ear while still allowing for pressure equalization when needed.

[0092] The undersized diameter of the support element relative to the ET width ensures that it does not exert excessive radial force on the ET walls, which could otherwise lead to tissue trauma, inflammation, or patulous ET (abnormal patency of the ET).Docket 602667

[0093] Additionally, the support element's design accommodates the natural anatomical variations found in different patients, making it suitable for treatment of irregular ET anatomies that may be challenging to address with other interventions. The combination of these features results in a support element that maintains the delicate balance between providing sufficient structural support to address the underlying ET dysfunction while respecting and preserving the natural physiological mechanisms of the ET.

[0094] DETAILED DESCRIPTION OF EXAMPLARY NON-LIMITING EMBODIMENTS FIG. 1 illustrates the distal portion of a deployment assembly 100 of a venting device 110 fitted on the distal portion ready for deployment. The venting device (ventilator) 110, which includes, for example, a support element (support) 111, dimensioned to fit comfortably in the Eustachian tube (ET), and a flexible extension 120, extending from the support element 111 and extending from the proximal end 11 Ip under the stopper sheath 118 (to be referred to below).

[0095] The support element 111 may be, for example, a hollow tubular member or body, with a bore 112 extending therethrough. For example, the support element 111 may also be a stent or other open pathway maintaining device. The support elementl 11 may be, for example, cylindrical, and of a circular (transverse) cross-section, and open at its ends (proximal 11 Ip and distal 11 Id ends), and has an internal bore (lumen) that when in situ in the ET (namely after deployment) permits ventilation and allows for the passage of fluid therethrough. The support element 111 is, for example, a solid-walled (e.g., closed walled) tube of an implant-suitable polymeric material, such as PEB AX® or Polyamide, or an elastic metal such as Nitinol or stainless steel.

[0096] The flexible extension 120, such as a pull wire or retrieval wire, is attached to and extends from the support element 111. The flexible extension 120 is typically attached to the support element 111 by adhesives, mechanical fasteners, welds and the like or may be integrally formed with the support element 111 and, hence, made of the same material. The flexible extension 120 may be fabricated from a polymer material, elastomeric material, metal, metal alloys, silk, or the like, and may be configured either as a single wire tied to the support element 111 or formed in a loop shape for improved gripping during retrieval.Docket 602667

[0097] While the flexible extension 120 is typically part of the venting device 110, some embodiments of the venting device 110 do not require the flexible extension 120. The flexible extension 120 facilitates removal of the support element 111, but in embodiments where the flexible extension is absent, the removal may be achieved by forceps and other griping surgical tools.

[0098] The support element 111 has a length, indicated as L (longitudinal) in FIG. 3A-1, which is specifically dimensioned to be shorter than the full length of the cartilaginous portion of the ET; for example, between 5 mm and 15 mm, possibly about 10 mm. The support element 111 has a diameter D, as shown in FIG. 3A-1, which is undersized relative to the width of the non-cylindrical ET at the deployment location; for example, between 1 or 2 mm, and 3, 4 or 5 mm.

[0099] This intentional undersizing of both the length and diameter of the support element 111 represents a significant departure from conventional venting element approaches. Contrary to common wisdom in ET venting device 110, which typically employs support elements 111 sized to match or slightly exceed the ET dimensions, this undersized design enables the support element 111 to provide the necessary structural support while allowing the ET to maintain its natural physiological functions. The zone Z in FIG. 2B illustrates the specific deployment location suitable for this undersized approach. FIG. 2B shows the ear, outer ear, middle ear and inner ear, as well as the ET and the nasopharynx NP.

[0100] When properly positioned in the ET, as illustrated in FIG. 3B, the support element 111 extends from a distal area of the cartilaginous portion of the ET toward the bony portion BP (FIG. 2B), proximate to the inner ear, while leaving at least 4 or 5 mm of the proximal area of the cartilaginous portion adjacent to the nasopharyngeal orifice free of the support element 111. This position is indicated in FIG. 2B as zone Z, is the one accommodating the support element 111 (Fig. 3B), such that the natural ET valve NV (FIG. 2B), located in the proximal cartilaginous region, remains free to function normally.

[0101] Specifically, zone Z represents the optimal deployment location that balances the need for structural support in the cartilaginous portion while preserving the natural ET valve function.Docket 602667

[0102] The inner, holder, sheath 116 is dimensioned to fit within the inner diameter of the support element 111. The inner, holder sheath 116 is, for example, a cylindrical tube of a circular cross-section, having an outer diameter to allow the inner, holder sheath 116 to be frictionally engaged within the support element 111 by frictional forces. The frictional forces are also such that the inner, holder sheath 116 may be easily moved out of the support element 111 during deployment. For example, the inner, holder sheath 116 is of an outer diameter, typically equal to the diameter of the bore 112 to achieve the aforementioned frictional forces.

[0103] The frictional engagement between the holder sheath 116 and the support element 111 is engineered to provide secure attachment during delivery while allowing for controlled release during deployment. As shown in FIG. 1, the outer diameter of the holder sheath 116 is calibrated to create sufficient frictional forces with the inner surface of the support element 111 to prevent premature movement during navigation through the delivery path, yet low enough to allow smooth disengagement when the holder sheath 116 is withdrawn proximally against the stopper sheath 118. During deployment, as illustrated in the sequence of FIGs. 2A and 2C, as the holder sheath 116 is withdrawn proximally, these frictional forces are gradually overcome, allowing the venting device 110 to remain in place while the holder sheath 116 slides out from within it.

[0104] The stopper, outer sheath 118, extends partially over the holder, inner sheath 116. The outer, stopper sheath 118, is, for example, of a cylindrical tube of a circular cross section, of an inner diameter, typically slightly greater or equal to the outer diameter of the inner, holder sheath 116, to allow for the inner, holder sheath 116 to be moved proximally through the outer, stopper sheath 118 upon venting device 110 deployment.

[0105] The flexible extension 120, such as the pull or retrieval wire, extends from the support element 111 between the inner, holder sheath 116, and the outer, stopper sheath 118. This flexible extension wire 120 is used to extract the deployed venting device 110, when the venting device support element 110 is to be removed from the ET.

[0106] The flexible extension 120, as shown in FIG. 1, FIG. 3A-1, 3A-2, 3A-3, and FIG.

[0107] 3B, is attached to the support element 111 (e.g., support element 111) and extends proximally therefrom. When the venting device 110, which includes the support element 111, is deployed in the ET, as illustrated in FIG. 3B, the flexible extension 120 extendsDocket 602667

[0108] from the support element 111 into the nasopharynx, providing a means for retrieval of the support element 111 after the treatment period. When retrieval is desired, controlled proximal tension can be applied to the exposed portion of the flexible element 120 in the nasopharynx to gently dislodge the support element 111 from its position and draw it back through the ET for complete removal.

[0109] In alternative embodiments the support element 111, e.g., the support element body, as shown in FIG. 3A-3, may include slots, such as longitudinal slots 160 or cuts (e.g., extending along the longitudinal axis LA, shown in FIG. 3A-2), openings, holes or the like, in the support element 111 wall (body all). In the case of the longitudinal slots 160, the slots 160 are small enough to allow for the support element 111 to flex and change transverse cross sectional shape (along the transverse axis TA of FIG. 3A-2), but small enough to prevent tissue from growing inside of the support element 111 (in the bore 112). The slots 160 may be continuous, for example, blind slots, which terminate before the ends of the support element 111) or intermittent (e.g., longitudinally oriented smaller non-continuous slots). Still other embodiments may include the ends 11 Ip, 11 Id of the support element 111 to flare outward and / or inward.

[0110] A kit may be formed of one or more of the venting devices 110, a delivery system therefor, and optionally, a support element removal device. The venting device delivery system may include, for example, a guiding catheter 200, mandrel 202 and handle 230. These components in the kit may be packaged in a sterile manner in a container capable of providing a sterile barrier, for one time on demand use. The support element removal device may be, for example, a catheter provided device capable of gripping the flexible extension 120 and / or the support element 111, and pulling it out of the ET and into the nasopharynx, such that the venting device 110, via the support element 111, is removed (and subsequently removed from the patient’s body). The retrieval procedure may be performed after the support element 111 has served its therapeutic purpose, typically following improvement in ET function and resolution of middle ear symptoms.

[0111] The procedure involves accessing the exposed portion of the flexible extension 120 in the nasopharynx, preferably using endoscopic visualization for guidance. A retrieval tool (not shown) may be used to grasp the flexible extension 120 and apply controlled proximal tension in a direction away from the ET opening. The tension isDocket 602667

[0112] applied in a steady, gradual manner to avoid trauma to the ET tissue, causing the support element 111 to first disengage from the ET walls and then be drawn back through the ET into the nasopharynx. The elastic properties of the support element material allow it to deform slightly during retrieval, reducing its effective diameter and facilitating atraumatic removal through the ET. While not illustrated in the figures, the retrieval tool may comprise a grasping instrument specifically designed to securely engage the pull wire 120 through an endoscopic approach via the nasopharynx NP (FIGs. 2B and 3B)

[0113] The outer, stopper sheath 118 includes a distal end 118d, that serves as a stop surface for the support element 111, for example, by the proximal end 11 Ip of the support element 111 coming into abutment with the outer, stopper sheath 118, when the inner, holder sheath 116 is pulled proximally during support element 112 deployment.

[0114] The distal end 118d of the stopper sheath 118 is precisely positioned, as shown in FIG. 1, to serve as a mechanical stop for the proximal end 11 Ip of the support element 111 during deployment of the venting device 110. This stop function, illustrated in the deployment sequence of FIGs. 2A to 2C, prevents proximal migration of the support element 111 during the withdrawal of the holder sheath 116, ensuring that the support element 111 remains at the intended deployment location in zone Z of the ET. The distal end 118d may be configured with a slightly flared or tapered profile to create an optimal contact surface with the proximal end 11 Ip of the support element 111 during deployment, distributing contact forces evenly to avoid damage to the support element 111 structure.

[0115] FIGs. 2A, 2C, and 3B illustrate an example method for placement of support element 110 in the ET. FIG. 2 A shows a guiding catheter 200 with a mandrel 202 therein. The guiding catheter 200 has a distal end 200d biased to a precurved position, preferably at approximately 45 degrees to correspond to the natural angle between the nasopharynx NP and the ET. The guiding catheter 200 is dimensioned to extend from the nasopharynx into the ET and provides the initial pathway for support element 111 delivery. The removable mandrel 202, shown in FIG. 2A, is disposable within the guiding catheter 200 and serves to maintain the guiding catheter 200 in a straight configuration during initial insertion through the nasopharynx.Docket 602667

[0116] The guiding catheter 200 enters the body straight, and once the mandrel 202 is moved proximally to be partially withdrawn from the guiding catheter 200, the distal end 200d of the guiding catheter 200 assumes its precurved orientation. This precurved orientation facilitates entry into the ET at the proper angle for accessing zone Z, as illustrated in FIG. 2B, and allows for the precise deployment of the support element 111 in the ET.

[0117] The guiding catheter 200, shown in FIG. 2A, has a distal end 200d biased to a precurved position, preferably at approximately 45 degrees to correspond to the natural angle between the nasopharynx and the ET. The guiding catheter 200 is dimensioned to extend from the nasopharynx NP into the ET and provides the initial pathway for venting device 110 delivery. The removable mandrel 202, also shown in FIG. 2A, is disposable within the guiding catheter 200 and serves to maintain the guiding catheter 200 in a straight configuration during initial insertion through the nasopharynx NP. The mandrel 202 is designed to be partially withdrawable to allow the distal end 200d of the guiding catheter 200 to assume its precurved orientation when approaching the ET opening, facilitating entry into the ET at the proper angle for accessing zone Z, as illustrated in FIG. 2B.

[0118] FIG. 2C shows an example support element delivery system 220, where the support element 111 of the venting device 110 is positioned over the inner, holder sheath 116. Both the inner, holder sheath 116 and the outer, stopper sheath 118 extend into a handle 230, from which the inner sheath 116 and the outer, stopper sheath 118 are controlled, for proximal and distal movement.

[0119] The handle 230, as shown in FIG. 2C, is ergonomically designed and coupled to both the holder sheath 116 and the stopper sheath 118, housing a retraction mechanism 234 that enables the controlled proximal retraction of the holder sheath 116 relative to the stopper sheath 118 during venting device 110 deployment. This mechanism 234 may comprise a sliding element, trigger, or wheel that translates the practitioner's hand movements into precise, controlled movements of the delivery components. The handle 230 may also incorporate features to prevent accidental deployment, such as safety locks or two-stage activation requirements, and may include ports for endoscopic instrumentation, allowing for simultaneous visualization during the deployment process.Docket 602667

[0120] In the aforementioned example operation, the outer, stopper sheath 118, along with the inner, holder sheath 116 and support element 111 are moved distally through guiding catheter 200 (the mandrel 202 having been removed previously). For example, indicia in the outer, stopper sheath or the handle 230 indicate the depth of the outer, stopper sheath 118, the inner, holder sheath 116 and the support element 111. When the support element 110 has moved through the guiding catheter 200 and is in a position in the zone Z (FIG. 2B), the deployment of venting device 110 begins.

[0121] As shown in FIG. 2C, visual indicia or markers 232 may be positioned on the stopper sheath 118 and / or the handle 230 to indicate the proper insertion depth of the support element 110 into the ET. For example, a primary marker 232 positioned about 5 mm proximally to the support element 111 can be aligned with visible nasopharyngeal landmarks to ensure that the support element 110 is positioned at the optimal depth in zone Z, leaving the proximal area of the cartilaginous portion free as illustrated in FIG.

[0122] 2B. These markers 232 may be radiopaque to allow visualization under fluoroscopy if required or may be distinct visual indicators such as colored bands or patterns that are easily distinguishable through endoscopic visualization used during the procedure. Cameras may also be used for visualization.

[0123] The inner holder sheath 116 is pulled proximally by the handle 230, the pulling moving the inner, holder sheath 116 proximally beyond the support element 111 and ultimately through the outer, stopper sheath 118. The support element 111 is now completely disengaged from the inner, holder sheath 116. Should the support element 111 have been pulled proximally with the inner, holder sheath 116, the travel of the support element 110 proximally is limited by the distal surface 118d of the outer, stopper sheath 118, which serves as a stop surface for the support element 111. The forces of the ET hold the support element 111 in place upon the disengagement of the inner, holder sheath 116. The flexible extension 120 extends proximally from the support element 111 as part of the deployment and remains attached to the support element 111.

[0124] With the support element 111 (and flexible extension 120) now deployed, as shown in FIG. 3B, and in place in the zone Z in the ET, the outer, stopper sheath 118 is moved proximally, and along with the inner, holder sheath 116, out of the mammalian body. The guiding catheter 200 is then removed from the body.Docket 602667

[0125] When deployed in the ET, as shown in FIG. 3B, the support element 111 defines a passage through its bore 112 that facilitates drainage of fluids from the middle ear to the nasopharynx cavity and pressure equalization in the middle ear, addressing the primary symptoms associated with ET dysfunction. The strategic positioning of the support element 111 in zone Z, as illustrated in FIG. 2B, leaves the proximal area of the cartilaginous portion free, allowing the natural valve NV of the ET to open and close normally during physiological functions such as swallowing and yawning. This preservation of natural valve function maintains the protective barrier function of the ET while still allowing for pressure equalization when needed.

[0126] The undersized diameter D of the support element 111 relative to the ET width ensures that it does not exert excessive radial force on the ET walls, which could otherwise lead to tissue trauma or complications such as patulous ET. This design accommodates the natural anatomical variations found in different patients, making it suitable for treatment of irregular ET anatomies that may be challenging to address with other interventions.

[0127] The prevention of patulous ET, a condition characterized by an abnormally patent Eustachian tube that remains permanently open, is a significant advantage of this support element 111 design. The undersized support element 111 avoids this complication by providing targeted support without over-distending the tube. Additionally, the venting device 110 (with its support element 111) is particularly well-suited for treating patients with irregular ET anatomies, such as those with naturally narrow lumens, tortuous pathways, or unusual angles between the nasopharynx and ET. The support element 110 can be precisely positioned in zone Z to accommodate these individual differences while maintaining its therapeutic benefits. This adaptability makes the support element 111 appropriate for a wider range of patients, including those who may not be good candidates for alternative treatment approaches.

[0128] ASPECTS OF THE DISCLOSURE

[0129] Embodiments of the present disclosure are directed to a device for ventilating an Eustachian tube (ET), comprising a tubular-shaped support element, having (i) a length such that when positioned in a midportion of the ET, it extends from an inner cartilaginousDocket 602667

[0130] portion of the ET toward a bony portion of the ET, while leaving a proximal area of the cartilaginous portion adjacent to a nasopharyngeal orifice free of the support element; (ii) an outer diameter that is the same or less than the ET diameter at said midportion, and (iii) a rigidity that permits it to support walls of said midportion from fully collapsing while maintaining an inner diameter that is dimensioned to permit air to pass therethrough.

[0131] Optionally, the device (venting device) is such that, the support element is circular in transverse cross section.

[0132] Optionally, the device (venting device) is such that, the support element includes a plurality of slots.

[0133] Optionally, the device (venting device) is such that, the slots are cuts or grooves that extend along the support element.

[0134] Optionally, the device (venting device) is such that, the cuts are blind cuts. Optionally, the device (venting device) is such that, the slots are castellated slots, with adjacent slots being open at opposite ends of said element.

[0135] Optionally, the device (venting device) is such that it additionally comprises: a flexible extension in communication with the support element, and wherein the device is deployable such that said flexible extension extends into a nasopharynx.

[0136] Optionally, the device (venting device) is such that, said flexible extension is a pull wire.

[0137] Embodiments of the present disclosure are directed to a method of venting the Eustachian tube (ET). The method comprises: introducing a venting device into the ET, the venting device comprising: an overall tubular-shaped support element, wherein the tubular-shaped support element has: a length such that when positioned in a midportion of the ET, it extends from a distal area of a cartilaginous portion of the ET toward a bony portion of the ET, while leaving a proximal area of the cartilaginous portion adjacent to a nasopharyngeal orifice free of the support element; an outer diameter that is the same or less than the ET diameter at said midportion; and a rigidity in a transverse direction sufficient to support walls of said midportion from collapsing while maintaining an inner diameter that is dimensioned to permit drainage of fluids from a middle ear to a nasopharynx cavity and pressure equalization in the middle ear.Docket 602667

[0138] Optionally, the method is such that the support element is circular in transverse cross section.

[0139] Optionally, the method is such that the support element is slotted with longitudinally extending slots.

[0140] Optionally, the method is such that the slots are blind slots.

[0141] Optionally, the method is such that the slots are castellated slots, with adjacent slots being open at opposite ends of said support element.

[0142] Optionally, the method is such that the venting device comprises a flexible extension, and wherein, the venting device is deployed such that said flexible extension extends into a nasopharynx.

[0143] Optionally, the method is such that the flexible extension is a pull wire.

[0144] Embodiments of the present disclosure are directed to a method for deploying a venting device in a Eustachian tube (ET) of a mammal. The method comprises: providing a venting device deployment assembly comprising a support element, a holder sheath and a stopper sheath, wherein the support element is mounted on the holder sheath, and the stopper sheath extends partially over the holder sheath with a distal end of the stopper sheath positioned proximally to the support element; advancing a guiding catheter through a nasopharynx of the mammal; advancing the venting device deployment assembly through the guiding catheter until the support element is positioned at a distal area of a cartilaginous length of the ET, such that a proximal area of the cartilaginous length of the ET remains free of the support element; proximally withdrawing the holder sheath to disengage the support element from the holder sheath while maintaining the support element position with the distal end of the stopper sheath; and proximally withdrawing the stopper sheath and the guiding catheter from the mammal while leaving the support element deployed.

[0145] Optionally, the method is such that it further comprises: inserting a mandrel within the guiding catheter to maintain the guiding catheter in a straight configuration during advancement through the nasopharynx; and partially withdrawing the mandrel from the guiding catheter to allow a distal end of the guiding catheter to assume a precurved orientation for entry into the ET.Docket 602667

[0146] Optionally, the method is such that the step of advancing the venting device deployment assembly comprises: advancing the venting device deployment assembly through the guiding catheter until a visual marker on the holder sheath or stopper sheath aligns with a reference point, thereby indicating that the support element is positioned at the distal area of the cartilaginous length of the ET.

[0147] Optionally, the method is such that the venting element is deployed with a flexible extension attached to the support element, the flexible extension extending proximally from the support element into the nasopharynx after the support element is deployed in the ET.

[0148] Optionally, the method is such that it additionally comprises: retrieving the support element from the ET by applying proximal tension to the pull wire after a treatment period.

[0149] Embodiments of the present disclosure are directed to a delivery system for deploying a venting device in a Eustachian tube (ET) through a guiding catheter. The delivery system comprises: a holder sheath dimensioned to extend through the guiding catheter, the holder sheath having an outer portion configured to frictionally engage an inner surface of a tubular support element; a stopper sheath extendable partially over the holder sheath, the stopper sheath having a distal end positionable to serve as a stop surface for a proximal end of the support element during deployment; and a retraction mechanism for proximally retracting the holder sheath relative to the stopper sheath to deploy the support element.

[0150] Optionally, the delivery system is such that it further comprises: a guiding catheter having a distal end biased to a precurved position, the guiding catheter dimensioned to extend from a nasopharynx into the ET.

[0151] Optionally, the delivery system ids such that it further comprises: a removable mandrel disposable within the guiding catheter, the mandrel configured to maintain the guiding catheter in a straight configuration during initial insertion and being partially withdrawable to allow the distal end of the guiding catheter to assume the precurved position.Docket 602667

[0152] Optionally, the delivery system is such that it further comprises: visual indicia disposed on at least one of the holder sheath and the stopper sheath, the visual indicia configured to indicate a proper insertion depth of the venting element into the ET.

[0153] Optionally, the delivery system is such that it further comprises: a handle coupled to the holder sheath and the stopper sheath, the handle housing the retraction mechanism for proximally retracting the holder sheath relative to the stopper sheath.

[0154] Embodiments of the present disclosure are directed to a venting device for deployment in a Eustachian tube (ET) of a mammal. The venting device comprises: a hollow tubular body having a smooth, solid-walled surface defining a continuous bore extending therethrough; the tubular body has a length between about 5 mm and about 15 mm dimensioned such that when the tubular body is positioned in the ET it extends from a inner area of a cartilaginous portion of the ET toward a bony portion of the ET while being clear of a proximal area of the cartilaginous portion adjacent to a nasopharyngeal orifice; the hollow tubular body having a diameter between about 1 mm and about 5 mm and being configured to define a passage that facilitates drainage of fluids from a middle ear to a nasopharynx cavity and pressure equalization in the middle ear; and a flexible extension attached to the tubular body and extending proximally therefrom, the flexible extension configured to facilitate retrieval of the tubular body from the ET.

[0155] In this specification, any given number should be construed as defining a value which is about that given, namely ±10%, ±15%, or even ±20%.

[0156] Although the disclosure has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

Claims

Docket 602667CLAIMS:

1. A device for ventilating an Eustachian tube (ET), comprising a tubular-shaped support element, havinga length such that when positioned in a midportion of the ET, it extends from an inner cartilaginous portion of the ET toward a bony portion of the ET, while leaving a proximal area of the cartilaginous portion adjacent to a nasopharyngeal orifice free of the support element,an outer diameter that is the same or less than the ET diameter at said midportion, anda rigidity that permits it to support walls of said midportion from collapsing while maintaining an inner diameter that is dimensioned to permit air to pass therethrough.

2. The device of claim 1, wherein the support element is circular in transverse cross section.

3. The device of claim 1 or 2, wherein the support element includes a plurality of slots.

4. The device of any one of claims 1 to 3, wherein the slots are cuts or grooves that extend along the support element.

5. The device of claim 4, wherein the cuts are blind cuts.

6. The device of claim 3, wherein slots are castellated slots, with adjacent slots being open at opposite ends of said element.

7. The device of any one of claims 1 to 6, additionally comprising:a flexible extension in communication with the support element, and wherein the device is deployable such that said flexible extension extends into a nasopharynx.

8. The device of claim 7, wherein said flexible extension is a pull wire.

9. A method of venting the Eustachian tube (ET), comprising introducing a venting device into the ET, the venting device comprising an overall tubular-shaped support element, wherein the tubular-shaped support element has:a length such that when positioned in a midportion of the ET, it extends from a distal area of a cartilaginous portion of the ET toward a bony portion of the ET, whileDocket 602667leaving a proximal area of the cartilaginous portion adjacent to a nasopharyngeal orifice free of the support element;an outer diameter that is the same or less than the ET diameter at said midportion; anda rigidity in a transverse direction sufficient to support walls of said midportion from collapsing while maintaining an inner diameter that is dimensioned to permit drainage of fluids from a middle ear to a nasopharynx cavity and pressure equalization in the middle ear.

10. The method of claim 9, wherein the support element is circular in transverse cross section.

11. The method of claim 9 or 10, wherein the support element is slotted with longitudinally extending slots.

12. The method of claim 11, wherein the slots are blind slots.

13. The method of claim 11, wherein the slots are castellated slots, with adjacent slots being open at opposite ends of said support element.

14. The method of any one of claims 9-13, whereinthe venting device comprises a flexible extension, andwherein, the venting device is deployed such that said flexible extension extends into a nasopharynx.

15. The method of claim 14, wherein said flexible extension is a pull wire.

16. A method for deploying a venting device in a Eustachian tube (ET) of a mammal, the method comprising:providing a venting device deployment assembly comprising a support element, a holder sheath and a stopper sheath, wherein the support element is mounted on the holder sheath, and the stopper sheath extends partially over the holder sheath with a distal end of the stopper sheath positioned proximally to the support element;advancing a guiding catheter through a nasopharynx of the mammal; advancing the venting device deployment assembly through the guiding catheter until the support element is positioned at a distal area of a cartilaginous length of the ET, such that a proximal area of the cartilaginous length of the ET remains free of the support element;Docket 602667proximally withdrawing the holder sheath to disengage the support element from the holder sheath while maintaining the support element position with the distal end of the stopper sheath; andproximally withdrawing the stopper sheath and the guiding catheter from the mammal while leaving the support element deployed.

17. The method of claim 16, further comprising:inserting a mandrel within the guiding catheter to maintain the guiding catheter in a straight configuration during advancement through the nasopharynx; and partially withdrawing the mandrel from the guiding catheter to allow a distal end of the guiding catheter to assume a precurved orientation for entry into the ET.

18. The method of claim 16 or 17, wherein the step of advancing the venting device deployment assembly comprises:advancing the venting device deployment assembly through the guiding catheter until a visual marker on the holder sheath or stopper sheath aligns with a reference point, thereby indicating that the support element is positioned at the distal area of the cartilaginous length of the ET.

19. The method of any one of claims 16-18, wherein the venting element is deployed with a flexible extension attached to the support element, the flexible extension extending proximally from the support element into the nasopharynx after the support element is deployed in the ET.

20. The method of claim 19, further comprising: retrieving the support element from the ET by applying proximal tension to the pull wire after a treatment period.

21. The method of any one of claims 16-20, wherein the venting device is that of any one of claims 1-7.

22. A delivery system for deploying a venting device in a Eustachian tube (ET) through a guiding catheter, the delivery system comprising:a holder sheath dimensioned to extend through the guiding catheter, the holder sheath having an outer portion configured to frictionally engage an inner surface of a tubular support element;Docket 602667a stopper sheath extendable partially over the holder sheath, the stopper sheath having a distal end positionable to serve as a stop surface for a proximal end of the support element during deployment; anda retraction mechanism for proximally retracting the holder sheath relative to the stopper sheath to deploy the support element.

23. The delivery system of claim 22, further comprising: a guiding catheter having a distal end biased to a precurved position, the guiding catheter dimensioned to extend from a nasopharynx into the ET.

24. The delivery system of claim 22 or 23, further comprising: a removable mandrel disposable within the guiding catheter, the mandrel configured to maintain the guiding catheter in a straight configuration during initial insertion and being partially withdrawable to allow the distal end of the guiding catheter to assume the precurved position.

25. The delivery system of any one of claims 22 to 24, further comprising: visual indicia disposed on at least one of the holder sheath and the stopper sheath, the visual indicia configured to indicate a proper insertion depth of the venting element into the ET.

26. The delivery system of any one of claims 22 to 25, further comprising: a handle coupled to the holder sheath and the stopper sheath, the handle housing the retraction mechanism for proximally retracting the holder sheath relative to the stopper sheath.

27. A venting device for deployment in a Eustachian tube (ET) of a mammal, the venting device comprising:a hollow tubular body having a smooth, solid-walled surface defining a continuous bore extending therethrough; the tubular body has a length between about 5 mm and about 15 mm dimensioned such that when the tubular body is positioned in the ET it extends from a distal area of a cartilaginous portion of the ET toward a bony portion of the ET while being clear of a proximal area of the cartilaginous portion adjacent to a nasopharyngeal orifice; the hollow tubular body having a diameter between about 1 mm and about 5 mm and being configured to define a passage that facilitates drainage of fluids from a middle ear to a nasopharynx cavity and pressure equalization in the middle ear; andDocket 602667a flexible extension attached to the tubular body and extending proximally therefrom, the flexible extension configured to facilitate retrieval of the tubular body from the ET.

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