Devices, systems, and methods of otology

Abstract

Devices, systems, and methods can be used to facilitate performing procedures in the outer, middle, and / or inner ear in order to diagnose and / or treat diseases, including but not limited to hearing loss and other ear diseases. For example, devices, systems, and methods are described herein that include instruments and techniques to minimize invasiveness and / or enhance the efficacy of procedures performed in the outer, middle, and / or inner ear space, such as, for example, mastoidectomy, tympanoplasty, cholesteatoma treatment, otosclerosis treatment, and Eustachian tube treatment.

Description

[0001] Cross-reference of related applications

[0002] This application claims U.S. Provisional Application No. 62 / 965,481, filed January 24, 2020; U.S. Provisional Application No. 63 / 024,183, filed May 13, 2020 (which are incorporated herein by reference in their entirety); U.S. Provisional Application No. 63 / 040,495, filed June 17, 2020 (which are incorporated herein by reference in their entirety); U.S. Provisional Application No. 63 / 051,568, filed July 14, 2020 (which are incorporated herein by reference in their entirety); and U.S. Provisional Application No. 63 / 077,440, filed September 11, 2020. Priority claims to U.S. Provisional Application No. 63 / 078,141, filed September 14, 2020 (which is incorporated herein by reference in its entirety), U.S. Provisional Application No. 63 / 080,510, filed September 18, 2020 (which is incorporated herein by reference in its entirety), U.S. Provisional Application No. 63 / 081,015, filed September 21, 2020 (which is incorporated herein by reference in its entirety), and U.S. Provisional Application No. 63 / 082,996, filed September 24, 2020 (which is incorporated herein by reference in its entirety). Technical Field

[0003] This document relates to devices, systems, and methods for facilitating surgery in the outer, middle, and inner ear to diagnose and / or treat diseases, including but not limited to hearing loss and other ear conditions. In some examples, the systems and methods include instruments and techniques that can be used to minimize the invasiveness of surgery performed in the outer, middle, and / or inner ear spaces. Background Technology

[0004] The human ear is susceptible to a variety of diseases, including but not limited to hearing loss, tinnitus, balance disorders including vertigo, Meniere's disease, vestibular neuritis, vestibular schwannoma, labyrinthitis, otosclerosis, ossicular chain dislocation, cholesteatoma, external ear infection, middle ear infection, and tympanic membrane perforation, to name just a few.

[0005] In one example, conductive hearing loss (CHL) involves the loss of the normal mechanical pathway for sound to reach the hair cells in the cochlea, such as due to malformations, middle ear effusion, ruptured tympanic membrane, the presence of tumors, and / or ossicular disorders. Sensorineural hearing loss (SNHL) is due to the absence or damage of hair cells in the cochlea, or impaired downstream nerve signal transmission. SNHL is commonly associated with exposure to loud noise, head trauma, aging, infection, Meniere's disease, tumors, ototoxicity, and genetic disorders such as Usher syndrome. Summary of the Invention

[0006] This document describes devices, systems, and methods for performing surgery in, but not limited to, the outer ear, middle ear, and / or inner ear to diagnose and / or treat diseases, including but not limited to hearing loss and other ear diseases. For example, this document describes devices, systems, and methods including instruments and techniques to minimize invasiveness and / or enhance the effectiveness of surgeries performed in the outer ear, middle ear, and / or inner ear spaces.

[0007] In some embodiments, the devices, systems, and methods used to facilitate the surgeries described herein can be used for middle ear and / or inner ear surgeries involving surgical access via methods including (but not limited to) transmastoid, transcanal, intraauricular, postauricular, and postural approaches. For example, techniques and instruments for performing transmastoid access to the middle ear space with a reduced level of invasiveness are described herein. In another example, this disclosure describes instruments and techniques for minimally invasive debulking of cholesteatomas. Furthermore, enhanced instruments and techniques for surgeries such as tympanoplasty and myringotomy are described herein. In addition to visualization of the middle ear and / or inner ear, the devices, systems, and methods described herein are well-suited for use in other cavities or spaces within the body and other pathways. For example, the devices, systems, and methods are well-suited for visualization and surgery related to the Eustachian tube, mastoid sinus space, and external tympanic cavity.

[0008] The devices, systems, and methods described herein can be used in conjunction with other therapeutic techniques. For example, the devices, systems, and methods described herein can be used in conjunction with therapeutic techniques such as, but not limited to, therapeutic agent delivery (which may be in the form of a gel, liquid, or solid), antibiotic delivery, gene delivery, device or implant delivery, diagnostic procedures, and surgical procedures.

[0009] In one aspect, this disclosure relates to a method for treating cholesteatoma or soft tissue lesions in the middle ear. The method includes advancing the shaft of an instrument via the external auditory canal such that the distal end of the instrument contacts the cholesteatoma or soft tissue lesion in the middle ear. The method also includes delivering a therapeutic treatment from the instrument to the cholesteatoma or soft tissue lesion to reduce its volume.

[0010] This method for treating cholesteatoma or soft tissue lesions in the middle ear may optionally include one or more of the following features: Advancement may include passing the axis of the instrument through a perforation in the tympanic membrane located between the external auditory canal and the middle ear. The method may also include placing a port device in the perforation. Advancement may include passing the axis of the instrument through the lumen of the port device while the port device is in the perforation. The instrument may be a syringe device. Delivery of the treatment may include injecting an agent from the syringe device into the cholesteatoma or soft tissue lesion. The instrument may be an ultrasonic device. Delivery of the treatment may include applying ultrasonic energy from the ultrasonic device to the cholesteatoma or soft tissue lesion to emulsify at least a portion of the cholesteatoma or soft tissue lesion. The instrument may be a laser device. Delivery of the treatment may include applying laser energy to the cholesteatoma or soft tissue lesion.

[0011] In another aspect, this disclosure relates to a method for removing ossified deposits around the stapes footplate in the middle ear. The method includes advancing the axis of an instrument via the external auditory canal such that the distal end of the instrument approaches the ossified deposits surrounding the stapes footplate. The method further includes delivering a therapeutic treatment from the instrument to the ossified deposits around the stapes footplate to remove at least some of the deposits.

[0012] This method for removing ossified deposits around the footplate of the stapes in the middle ear may optionally include one or more of the following features: Advancement may include passing the axis of an instrument through a perforation in the tympanic membrane located between the external auditory canal and the middle ear. The method may also include placing a port device in the perforation. Advancement may include passing the axis of the instrument through the cavity of the port device while the port device is in the perforation. The instrument may be a cutting and aspiration instrument. Delivery treatment may include cutting and aspirating portions of the deposit using the cutting and aspiration instrument. The instrument may be an ultrasonic instrument. Delivery treatment may include applying ultrasonic energy from the ultrasonic instrument to the deposit to emulsify at least a portion of the deposit. The instrument may be a laser instrument. Delivery treatment may include applying laser energy from the laser instrument to the deposit to remove at least a portion of the deposit. The instrument may be a diathermy instrument. Delivery treatment may include applying thermal energy from the diathermy instrument to the deposit to remove at least a portion of the deposit.

[0013] In another aspect, this disclosure relates to a method for treating otosclerosis in the middle ear. The method includes advancing an axis of an instrument via the external auditory canal such that the distal end of the instrument is within the middle ear. The method also includes delivering a therapeutic treatment from the instrument. The instrument may be: (i) a cutting and aspiration instrument, (ii) an ultrasonic instrument, (iii) a laser instrument, or (iv) a diathermy instrument.

[0014] In another aspect, this disclosure relates to a method for surface resurfacing the periphery of a tympanic membrane perforation. The method includes advancing the axis of a reciprocating cutting instrument toward the perforation via the external auditory canal. The method also includes engaging the reciprocating cutting instrument to remove tissue from the periphery of the tympanic membrane perforation.

[0015] This method for surface resurfacing around a tympanic membrane perforation may also include aspirating at least some tissue from the periphery of the tympanic membrane perforation using a reciprocating cutting instrument.

[0016] In another aspect, this disclosure relates to an additional method for surface resurfacing the periphery of a tympanic membrane perforation. The method includes advancing an ultrasonic instrument's axis toward the perforation via the external auditory canal. The method also includes activating the ultrasonic instrument to remove tissue from the periphery of the tympanic membrane perforation.

[0017] In another aspect, this disclosure relates to a method for treating eustachian tube dysfunction. The method includes: (i) advancing an axis of an instrument toward the eustachian tube via the external auditory canal, wherein the instrument includes a balloon on a distal portion of the axis, wherein the balloon is deflated during advancement; (ii) positioning the balloon in the eustachian tube; and (iii) inflating the balloon while it is in the eustachian tube.

[0018] This method of treating Eustachian tube dysfunction may optionally include one or more of the following features. Advancement may include passing the axis of an instrument through a perforation in the tympanic membrane located between the external auditory canal and the Eustachian tube. The method may also include placing a port device in the perforation. Advancement may include passing the axis of the instrument through the lumen of the port device while the port device is in the perforation. Advancement may include passing the axis of the instrument through an opening of an ear drainage tube in the tympanic membrane located in the tympanic membrane. In some embodiments, a stent device is positioned on a balloon during advancement. In some such embodiments, when the balloon is in the Eustachian tube, inflation of the balloon expands the stent device such that the expanded stent device keeps the Eustachian tube open after the balloon is removed from the Eustachian tube. The stent device may be a drug-eluting stent device.

[0019] In another aspect, this disclosure relates to a different method for treating cholesteatoma or soft tissue lesions in the middle ear. The method includes advancing an instrument via a shaft through an opening in the mastoid process, such that the distal end of the instrument contacts the cholesteatoma or soft tissue lesion in the middle ear. The method also includes delivering a therapeutic treatment from the instrument to the cholesteatoma or soft tissue lesion to reduce its volume.

[0020] This method for treating cholesteatoma or soft tissue lesions in the middle ear may include one or more of the following optional features: The device may be a syringe device. Delivery of the treatment may include injecting an agent from the syringe device into the cholesteatoma or soft tissue lesion. The device may be an ultrasound device. Delivery of the treatment may include applying ultrasound energy from the ultrasound device to the cholesteatoma or soft tissue lesion to emulsify at least a portion of the cholesteatoma or soft tissue lesion. The device may be a laser device. Delivery of the treatment may include applying laser energy to the cholesteatoma or soft tissue lesion.

[0021] Some or all of the embodiments described herein may provide one or more of the following advantages. First, some embodiments of the instruments and related techniques described herein for treating or diagnosing ear diseases reduce the invasiveness of the procedure compared to conventional methods. For example, instruments and techniques for reducing invasiveness through the mastoid process into the middle ear and / or inner ear are disclosed. Therefore, less mastoid bone resection (mastoidectomy) is required. In turn, recovery time, treatment costs, and the likelihood of complications may all be reduced. In another example, debulking of cholesteatoma can be performed minimally invasively using the instruments and techniques described herein.

[0022] Secondly, the use of the instruments and techniques described herein can enhance the efficacy of various ear surgeries. For example, this article describes improved tools and methods for minimally invasive cholesteatoma decomposition. Such tools include, but are not limited to, ultrasonic instruments, high-speed cutting instruments, syringe instruments, diathermy instruments, and laser instruments, to provide some examples. In another example, the instruments and techniques described herein can be used to perform surgery for otosclerosis with enhanced efficacy. This is because, for example, the instruments and techniques described herein can be used precisely to remove the buildup while preserving the stapes. In yet another example, instruments and techniques for reducing operative time and complication risk in standard stapes resection and stapesotomy are described. In yet another example, this article describes instruments and techniques for improved tympanoplasty, which can be performed with enhanced efficacy.

[0023] Third, this article describes novel otological instruments, such as instruments for microthermotherapy, pneumatic or electric cutters, aspiration cutters, micro-aspiration, ultrasonic cutters / debridements, and combinations thereof. The specialized instruments and techniques described herein facilitate novel treatments for inner and middle ear diseases. Furthermore, the specialized instruments and techniques described herein can be used to perform current treatment procedures with enhanced efficacy and efficiency.

[0024] Fourth, the devices, systems, and methods described herein advantageously allow instruments to be delivered to the surgical area and to operate in a fluid-filled space in addition to an inflatable space.

[0025] Fifth, this article describes a method for temporarily filling the middle and / or external auditory cavities to allow the treatment procedure to be performed “underwater.” This method has many advantages, such as, but not limited to, maintaining fluid balance in the cochlea during surgery, tamping bleeding, allowing for continuous flushing or aspiration of the middle ear structures, improved visibility, and allowing for precise use of aspiration cutters to trim or remove tissue during surgery, as described herein.

[0026] Sixth, the system described in this article can also be used for diagnostic purposes. This use can help with surgical planning, changing the location of care, and may improve patient outcomes.

[0027] Details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will become apparent from the specification, drawings, and claims. Attached Figure Description

[0028] Figure 1 This is a diagram illustrating the traditional transmammary access medical procedure.

[0029] Figure 2 This is a diagram comparing the extent of mastoidectomy with that of a traditional transmastoid medical procedure and the extent of a transmastoid medical procedure using the instruments and techniques described herein.

[0030] Figure 3 The illustration schematically depicts a transmammary access medical procedure using the described instruments and techniques.

[0031] Figure 4 Example techniques for reducing cholesteatoma are shown according to some embodiments.

[0032] Figure 4A This is a perspective view of the tympanic membrane port device, which can be used for... Figure 4 The technology shown.

[0033] Figure 4B It shows the location within the tympanic membrane. Figure 4A Tympanic membrane port device.

[0034] Figure 5 The illustration depicts another technique for reducing cholesteatoma according to some embodiments.

[0035] Figure 6 An exemplary stapediotomy procedure is illustrated, which can be performed with enhanced efficacy using the instruments and techniques described herein.

[0036] Figure 7 and Figure 8 An exemplary tympanotomy procedure is illustrated, which can be performed with enhanced efficacy using the instruments and techniques described herein.

[0037] Figure 9 The illustration depicts another exemplary tympanotomy procedure according to some embodiments.

[0038] Figure 10 Another exemplary technique for performing ear surgery with a fluid-filled space is shown.

[0039] Figure 11 An exemplary heat-transfer device according to some embodiments is shown.

[0040] Figure 12 It shows Figure 11 The optional distal end portion of the heat-transmitting device.

[0041] Figure 13 An exemplary tympanoplasty procedure according to some embodiments is shown.

[0042] Figure 14 This is a perspective view of an exemplary reciprocating cutting instrument that can be used to perform the various surgical procedures described herein.

[0043] Figure 14A -C shows Figure 14 The use of reciprocating cutting instruments.

[0044] Figure 15 This is an end view of another exemplary cutting instrument that can be used to perform the various surgical procedures described herein.

[0045] Figure 16 It shows Figure 15 The use of cutting instruments.

[0046] Figure 16A It shows Figure 15 An exemplary cross-sectional view of the cutting instrument.

[0047] Figure 16B It shows Figure 15 Another exemplary cross-sectional view of the cutting instrument.

[0048] The same reference symbols in each figure represent the same element. Detailed Implementation

[0049] Now for reference Figure 1 The diagram illustrates the traditional transmastoid passage leading to the middle ear 40. The transmastoid approach to the middle ear 40 is used in various ear treatment surgeries, such as, but not limited to, cholesteatoma removal, labyrinthectomy, cochlear implant placement, and repair of superior ear canal split syndrome, to provide some examples.

[0050] To access the middle ear 40 using the conventional transmastoid approach shown, a relatively large number of cells are removed from the hollow, air-filled space within the mastoid bone 10 in the skull behind the ear. Following this simple mastoidectomy, a small opening to the middle ear 40 is formed. The amount of bone removed in the initial simple mastoidectomy is at least partly driven by the limited range, maneuverability, and size of conventional instruments. Typically, even a small-diameter opening into the middle ear space 40 requires a large tapered resection of the bone 10 surrounding the opening to allow the instruments sufficient angle of attack to enter the middle ear space 40. As indicated by arrows 20a and 20b, during the procedure, the instruments 20 are manually manipulated along a basic path to avoid delicate and important anatomical structures such as nerves and / or blood vessels.

[0051] Depending on the required surgical scope, additional bone removal is often required beyond a simple mastoidectomy. First, it may be necessary to create a facial depression. Second, in some cases, it may be necessary to remove the wall separating the ear canal and the mastoid cavity. Finally, in some cases, it may be necessary to remove the middle ear bones or ossicles. The need for additional bone removal beyond a simple mastoidectomy is driven at least in part by the limited range, operability, and size of the conventional instruments used in ear surgery (represented herein by instrument 20).

[0052] Figure 2 A comparison is shown between a conventional simple mastoidectomy 60 associated with conventional surgery (as shown and described above) and a minimal mastoidectomy 100 associated with a transmastoid approach using the instruments and techniques described herein. As shown, the minimal mastoidectomy 100 is much smaller. Therefore, using the instruments and techniques described herein, much less mastoid bone 10 needs to be removed for the transmastoid approach; this is because the diameter of the opening to the middle ear 40 is reduced and / or the predominantly conical volume surrounding the opening to the middle ear 40 is reduced.

[0053] The instruments and techniques described herein can be combined with preoperative or intraoperative imaging techniques to further reduce the degree of bone removal required. For example, CT imaging can be used to identify axial access paths for safe drilling into the middle ear cavity 40, bypassing key structures including the semicircular canals, sigmoid sinus, chorda tympani, and facial nerve. Small-size steerable instruments and / or endoscopes can then be delivered into the middle ear cavity 40 through the drilling channels along these access paths using one or more drilling paths.

[0054] As another potential benefit, the instruments and techniques described herein can help eliminate the need for further bone removal beyond a simple mastoidectomy. In particular, in many cases, the need for a subcanal mastoidectomy can be avoided. With the traditional, more invasive subcanal mastoidectomy, the posterosuperior wall of the external auditory canal is removed to increase access to the middle ear and mastoid during the procedure. Transforming the typical subcanal mastoidectomy into a supracanal mastoidectomy preserves the posterosuperior wall of the external auditory canal, retains an important part of the patient's anatomy, and also eliminates the additional surgical steps associated with transplantation and reconstruction of the canal wall. In turn, recovery time, treatment costs, and the likelihood of complications can all be reduced. In some cases, the instruments and techniques described herein enable certain procedures to be performed entirely through the ear canal, thus eliminating the need for transmastoid access. Instead, access can be achieved through a variety of transcanal methods, even the most invasive of which (which require elevating the tympanic membrane flap) require minimal or no bone removal compared to transmastoid methods.

[0055] Figure 3 An example instrument 120 is shown for performing a simple minimal mastoidectomy 100 via the mastoid method as described herein. Example instrument 120 broadly represents all the various types of instruments described herein.

[0056] As further described below, some features of the instrument 120 facilitating minimal mastoidectomy 100 via the mastoid approach include small-size shafts, flexible shafts, steerable / deflectable shafts, angled shafts, curved shafts, and combinations thereof. Furthermore, as further described below, the instrument 120 includes various types of specialized instruments for high-speed cutting, suction, irrigation, diathermy, ultrasonic delivery, laser delivery, formulation injection, emulsification, etc.

[0057] Figure 4 An example surgical procedure for treating cholesteatoma or soft tissue lesions 50, according to some embodiments, is described. That is, minimally invasive reduction of cholesteatoma or soft tissue lesions can be performed using the instruments and techniques described herein.

[0058] In the depicted example, an exemplary syringe device 300 is used to inject a therapeutic agent into the cholesteatoma 50. In some embodiments, the injected therapeutic agent may be a keratolytic agent (e.g., for breaking down epithelial tissue), an immune response modulator, a cryotherapy agent, etc., and is not limited thereto. Such agents can be administered in combination with surgical methods to help facilitate tissue removal. Such agents may also be administered after surgical resection to reduce the risk of lesion regrowth. In some cases, these agents may be administered via a sustained-release middle ear implant or formulation. Combinations of these methods can be uniquely effective by combining the benefits of both without significantly increasing the patient's risk.

[0059] In some cases, such as debulking surgery for cholesteatoma50 (or other soft tissue lesions), the described procedure can be performed periodically, for example, every few years. This can be surprisingly beneficial for several reasons. The ability to use minimally invasive visualization allows for the identification of cholesteatomas or other lesions earlier in the course of the disease (before the patient reports symptoms), which often means smaller and less severe lesions. Cholesteatomas originate from the epithelium of the tympanic membrane or ear canal25. As it proliferates, it typically progresses to involve the ossicles and eventually invades the mastoid bone, inner ear, facial nerve, or intracranial septum. The extent of the cholesteatoma determines the level of invasiveness required for successful resection. Therefore, early detection and management can minimize the need for more invasive surgery and minimize more serious consequences of the disease, such as ossicular erosion requiring reconstructive repair. Furthermore, typical existing surgeries must be invasive because there is a high concern about missing any cholesteatomas, which can regenerate and require repeated invasive procedures. The ability to minimally invasively debulking cholesteatoma alters the risk / benefit ratio, allowing for earlier and more frequent interventions that surprisingly pose less overall risk to patients than a single invasive surgery.

[0060] While an injectable therapeutic agent for treating cholesteatoma 50 has been described, other techniques and related instruments for treating cholesteatoma 50 may be used and are within the scope of this disclosure. For example, in some embodiments, instrument 300 may be an ultrasound instrument that can be used to emulsify cholesteatoma 50. In another example, in some embodiments, instrument 300 may be a high-speed cutting instrument that can physically dissect portions of cholesteatoma 50. In another example, in some embodiments, instrument 300 may be a diathermy instrument, which is particularly advantageous in managing hypervascular glomus malformations to sever the feeding vessels and manage intraoperative bleeding. In another example, in some embodiments, instrument 300 may be a laser instrument.

[0061] Instrument 300 may include small-size shafts, flexible shafts, steerable / deflectable shafts, angled shafts, curved shafts, and combinations thereof. These instruments provide improved range and visualization through canal-based access to the middle ear, allowing for greater extent of cholesteatoma resection without requiring more invasive access methods. Furthermore, in some embodiments, instrument 300 may serve multiple purposes, such as combinations of functions, including but not limited to aspiration, illumination, irrigation, endoscopy, diathermy, laser energy delivery, injection, phacoemulsification, etc.

[0062] The described minimally invasive procedure for treating cholesteatoma 50 uses a transtympanic approach (e.g., through the tympanic membrane region 30). In some embodiments, the transtympanic approach includes extending the axis of an instrument through an opening (e.g., perforation, slit, or perforation) in the tympanic membrane (TM) 30. In a particular embodiment, the described minimally invasive procedure for treating cholesteatoma 50 uses a tympanic membrane flap procedure, whereby the axis of an instrument extends through the ear canal 25 to the cholesteatoma 50 without passing through the TM 30.

[0063] In some implementations, such as Figure 4A and 4B As shown, a transtympanic approach for minimally invasive surgery to treat cholesteatoma 50 includes extending the axis of an instrument through a tympanic port device 200 (TM port device 200). An example TM port device 200 includes three conjoined, continuous portions: (i) a distal portion 204, (ii) a middle portion 206, and (iii) a proximal portion 208. A lumen 202 centrally passes through each of portions 204 / 206 / 208. In some embodiments, the diameter of the lumen 202 is in the range of 0.4 mm to 0.6 mm, 0.5 mm to 0.75 mm, or 0.5 mm to 1.0 mm, but is not limited thereto.

[0064] The inner diameter or cavity of the proximal portion 208 may be gradually tapered to have a larger diameter at the proximal end, thereby forming a funnel shape to facilitate instrument alignment when the instrument enters the port device.

[0065] The distal portion 204 may be truncated conical in shape. That is, the farthest end of the distal portion 204 has a smaller outer diameter than the nearest end of the distal portion 204. The intermediate portion 206 and the proximal portion 208 are each cylindrical. The outer diameter of the intermediate portion 206 is smaller than the outer diameter of each of the following: (i) the nearest end of the distal portion 204 and (ii) the proximal portion 208. Therefore, in this embodiment, the intermediate portion 206 can be considered as the “waist region” of the TM port device 200. The cavity 202 may be conical, cylindrical, elliptical, pyramidal, or other shapes, and the distal portion 204 may also be of this shape.

[0066] As further described below, the intermediate portion 206 is the location (at least primarily) where the tissue of the TM30 will reside when the TM port device 200 is implanted into the TM30. The relatively small outer diameter of the intermediate portion 206 (compared to the outer diameters of adjacent portions of the distal portion 204 and the proximal portion 208) will help to hold the TM port device 200 in the TM30. In some embodiments, the outer diameter of the intermediate portion 206 is in the range of 0.25 mm to 0.75 mm, 0.25 mm to 1.0 mm, or 0.5 mm to 1.25 mm, and is not limited thereto. The longitudinal length of the intermediate portion 206 may be in the range of 0.1 mm to 0.3 mm, 0.1 mm to 0.5 mm, or 0.2 mm to 0.6 mm, and is not limited thereto. The outer diameter and length of the intermediate portion 206 are sufficient to accommodate the thickness of the TM30 while preventing unintentional bending, tearing, or other forces from being applied to the TM30 during insertion of the TM port device 200. In some embodiments, the lumbar region is excluded, and the frictional engagement between the distal portion and the TM is sufficient to hold the port device in the TM during surgery while reducing the force exerted on the TM during port insertion or removal.

[0067] In some embodiments, the TM port device 200 can be implanted into the TM 30 without using a needle. Instead, an incision can be made in the TM 30 first using a blade, needle, or laser. The TM port device 200 can then be implanted into the TM 30 by advancing it into the incision.

[0068] When the TM port device 200 is implanted (or attached, connected, joined, etc.) to the TM 30, the TM port device 200 serves as a grommets, a stress-relieving component to prevent the TM 30 from tearing, a middle ear inlet port, an instrument insertion channel, a working channel, etc.

[0069] The configuration and dimensions of the TM port device 200 allow for removal from the TM 30 without the need for sutures to seal any incisions or windows formed in the TM 30 during insertion. Typically, the length of a self-sealing window through the TM 30 is no greater than about 2.5 mm, preferably between about 0.5 mm and 1.5 mm. While the tools and methods described herein offer the advantage of eliminating the need for sutures to access the middle and / or inner ear, this does not preclude the surgeon from applying one or more closure techniques during removal of the TM port device 200. That is, one or more techniques for closing windows in the TM 30 may be performed if the clinician so requires.

[0070] The TM port device 200 may be formed of a material with rigidity and strength for insertion into and removal from the TM 30, while also withstanding stresses that may occur during operation of surgical instruments inserted through it. In some embodiments, at least a portion of the TM port device 200 is formed of surgical metals such as stainless steel, titanium, platinum, nitinol, and / or plastics such as polyimide, PEEK, fluoropolymers, silicone, etc. In some embodiments, the insertion portion of the TM port device 200 may be formed of polyimide (or other rigid or semi-rigid polymers) and have a maximum outer diameter not exceeding about 20 gauges (0.8 mm). One or more portions of the TM port device 200 may be coated with or formed of an elastic conformal material.

[0071] Figure 5 Another example procedure for treating cholesteatoma 50 according to some embodiments is described. That is, a minimally invasive cholesteatoma debulking procedure can be performed using instrument 400 and the techniques described herein.

[0072] For example, in some embodiments, the example device 400 may be an ultrasound device that can be used to emulsify the cholesteatoma 50. In another example, in some embodiments, the device 400 may be a high-speed cutting device that can physically remove portions of the cholesteatoma 50. In yet another example, in some embodiments, the device 400 may be a diathermy device or a laser device that can ablate portions of the cholesteatoma 50.

[0073] The device 400 may include small-size shafts, flexible shafts, steerable / deflectable shafts, angled shafts, bending shafts, and combinations thereof. Furthermore, in some embodiments, the device 400 may serve multiple purposes, such as combinations of functions, including but not limited to aspiration, illumination, irrigation, endoscopy, diathermy, laser energy delivery, injection, and phacoemulsification.

[0074] In some embodiments, an example device 400 for minimally invasive treatment of cholesteatoma 50 may be, for example, an ultrasound device. This ultrasound device 400 can be used to deliver ultrasound energy to cause tissue disruption, emulsification, or surface remodeling, said tissue including, but not limited to, membranes, tumors, cholesteats, skin, bone, etc. This technique can facilitate control of bleeding, and in some embodiments, allows the use of aspiration ultrasound devices to remove tissue (or aspiration high-speed cutters or diathermy devices).

[0075] In some embodiments, example device 400 may be an ultrasound device that can be used to treat cholesteatoma 50. Ultrasound devices for bone or tissue removal (e.g., cholesteatoma 50) can be combined / incorporated into any otological device described herein. That is, small-sized ultrasound devices equipped with aspiration and infusion capabilities to remove debris can be used to remove small bone fragments near the facial nerve and other delicate structures. Such devices can be used to assist in the removal of bone from soft tissue, as in the case of cholesteatoma 50 removal. The ability of an ultrasound device to be “tuned” to remove specific tissue densities is highly advantageous for improving the selectivity of tissue removal in cholesteatoma 50 removal.

[0076] In some embodiments, example device 400 may be a laser device that can be used to treat cholesteatoma 50. Laser devices can be combined / incorporated into any otological device described herein. Laser-based methods are a useful surgical intervention, currently used only in limited settings in otology. Green lasers may be particularly useful because they typically heat only where blood is scattered / exposed (due to blood pigmentation), allowing them to heat and cauterize blood without damaging underlying or adjacent tissue. The use of these devices in otology is limited for various reasons, including difficulty accessing the middle or inner ear region, and because bony middle ear structures impede a straight angle of attack towards the desired target. In some embodiments, a functional tip laser probe with a steerable or functional tip that can be actuated to produce off-axis deviations from adjacent axes can be highly advantageous and enable entirely new functionalities in otological surgery.

[0077] Figure 6 Exemplary minimally invasive surgical procedures, according to some embodiments, are described for addressing otosclerosis, thus replacing current surgeries such as stapes resection and stapesotomy. The instruments and techniques used to perform this surgery facilitate the precise removal of ossified deposits around the stapes footplate, a condition known as otosclerosis. Such a procedure restores the mobility of the stapes footplate without removing the superstructure of the stapes and drilling holes in the stapes footplate (stapesotomy) or completely removing the footplate (stapes resection). The described instruments will allow precise visualization and access to the stapes footplate, minimizing accessory bone removal and eliminating the need for ossicular chain prosthesis reconstruction, which is required in current stapes resection and stapesotomy procedures.

[0078] In some embodiments, the operative time and outcomes of standard stapediotomy and stapedectomy procedures can be improved using the instruments and techniques described herein. In one example, a side-biting disposable scissor can be used to cut the stapedius tendon. Typically, in stapediotomy and stapedectomy procedures, bone removal from the scutum is required to enable visualization and instrument access. In another example, steerable, small-gauge instruments and a wide-field visualization system can be used to minimize or avoid bone removal, which will shorten operative time and reduce the risk of collateral tissue damage. Scutum removal is typically performed using a curette, which is difficult to control precisely and poses a risk to adjacent tissues. In yet another example, ultrasound instruments can be used to achieve more precise bone removal, thereby reducing the risk of injury to adjacent nerves.

[0079] Again, the procedure is described as being performed by example instrument 400 (which represents a variety of different types of instruments and combinations thereof, as described herein).

[0080] In some cases, the instruments and techniques described herein enable minimally invasive procedures via transcanal (25°) and transtympanic membrane approaches, thanks to the smaller diameter instruments and the elimination of the need for implant and ossicle removal (existing implants and ossicles may not be suitable for minimally invasive access or incision). This eliminates the need for transcanal (25°) approaches, such as those requiring tympanic flap elevation, thereby reducing patient risk and operative time.

[0081] For example, in some embodiments, the example instrument 400 for performing minimally invasive stapesectomy is a green laser with a steerable tip, suction, and illumination. In some embodiments, the example instrument 400 for performing minimally invasive stapesectomy is an ultrasonic emulsifier as described above.

[0082] The device 400 may include small-size shafts, flexible shafts, steerable / deflectable shafts, angled shafts, bending shafts, and combinations thereof. Furthermore, in some embodiments, the device 400 may serve multiple purposes, such as combinations of functions, including but not limited to aspiration, illumination, irrigation, endoscopy, diathermy, laser energy delivery, injection, and phacoemulsification.

[0083] In some embodiments, it is used to perform actions for resolving otosclerosis ( Figure 6 Example instrument 400 for minimally invasive surgery is a high-speed cutting device, such as... Figure 14 The example pneumatic suction cutter 1100 is shown. In some embodiments, the pneumatic suction cutter 1100 may be electrically driven (rather than pneumatically driven). The pneumatic suction cutter 1100 includes an outer shaft 1110 and an inner reciprocating shaft 1120. The inner reciprocating shaft 1120 reciprocates proximally and distally within a cavity defined by the outer shaft 1110. Thus, as Figures 14A-14CAs shown, the tissue can be cut between the outer shaft 1110 and the inner reciprocating shaft 1120 (e.g., like a "guillotine" blade cutter). When the tissue portion is cut, the tissue portion can be aspirated by the pneumatic suction cutter 1100, as shown.

[0084] The pneumatic suction cutter 1100 can be used for various purposes, such as stapes incision, removal of middle ear tissue, and resurfacing or cleaning of the edge surface of a tympanic membrane perforation in tympanoplasty procedures (e.g., tympanic membrane repair surgery, as further described below).

[0085] Still refer to Figure 6 The use of the pneumatic suction cutter 1100 for minimally invasive surgery (and other procedures) to address otosclerosis can also be combined with fluid injection or irrigation into the middle ear and / or external auditory canal 25. The pneumatic suction cutter 1100 can also be used to remove membranes and fibrous tissue from the middle ear.

[0086] In the case of an axially reciprocating blade with an inner reciprocating shaft 1120, the port defined by the outer shaft 1110 is ideally located on the side of the outer shaft 1110, such that the target tissue is close to the side of the instrument tip (“lateral cut”). For example, this orientation may be preferred when debridement of the periphery of a tympanic membrane perforation in preparation for graft placement or repair. The lateral cut port can also be ideal for removing cerumen from the wall of the ear canal 25.

[0087] Figure 15-16B Another example of a high-speed cutter is depicted, which can be used to solve... Figure 6 The minimally invasive surgical procedure for treating otosclerosis is described in the text, along with other ear surgeries described herein. The rotary aspiration end cutter 1900 is functional and can be combined with or incorporated into any of the otological instruments described herein.

[0088] The high-speed rotating suction end cutter 1900 includes an outer shaft 1910 and an inner rotating shaft 1920. The inner rotating shaft 1920 rotates within a cavity defined by the outer shaft 1910. The end of the outer shaft 1910 defines an opening 1912 through which tissue can be received. In the depicted embodiment, the opening 1912 is a circular segment (e.g., a quarter circle, a semicircle, etc.). Thus, as... Figure 16 As shown, when tissue is captured in opening 1912, it can be cut between outer axis 1910 and inner rotation axis 1920 (e.g., like a "rotary shear" blade cutter). While the tissue portion is being cut, it can be aspirated by high-speed rotating suction cutter 1900, as shown.

[0089] The high-speed rotary suction end cutter 1900 can be used for example Figure 6The described minimally invasive surgical procedure for treating otosclerosis includes the removal of soft tissue from the middle ear, trimming the epithelial margins around the perforation edge of the tympanic membrane in tympanoplasty procedures (e.g., tympanic membrane repair surgery described below), and more. The high-speed rotating suction end cutter 1900 can also be used to remove membranes and fibrous tissue from the middle ear.

[0090] Although the tip of the high-speed rotating suction end cutter 1900 depicted is blunt, in some embodiments the tip may be beveled, tapered, rounded, etc.

[0091] Material removal (e.g., tissue, bone, etc.) can be performed using a high-speed rotating suction end cutter 1900. Cutting is achieved at the interface between the inner walls of the inner rotating shaft 1920 and the outer shaft 1910 at the location of the opening 1912. The shape and position of the opening 1912 can be configured for optimal contact with the target tissue or material. Because the cutting action occurs precisely within the outer surface of the instrument 1900 (approximately the wall thickness of the outer shaft 1910), the size of the opening 1912 and the suction force can be selected to limit damage to adjacent tissues while maximizing the removal of target material. In some embodiments, a suction channel extending downwards along the center of the instrument 1900 can help draw the target material into the opening 1912 to facilitate cutting. In some embodiments, the suction force level and cutting speed of the instrument 1900 can be adjusted based on the mechanical properties of the target and surrounding tissues. Suction also enables the immediate removal of cut or shredded material from the surgical area.

[0092] In some cases, such as when removing material from the bone surface of the middle ear for stapestomy, it is advantageous to position the cutting action at the end of the instrument (“end-cutting”), as provided by the high-speed rotary aspiration end-cutter 1900. In this case, a rotating blade is preferred. In this case, the instrument end can be blunt, rounded, beveled, or tapered, wherein the shape and orientation of the cutting blade reflects the shape and orientation of the opening 1912 to achieve effective shearing or scissor-like cutting.

[0093] Figure 16B An alternative inner rotation axis 1920a is depicted. In this example, the inner rotation axis 1920a has two end openings or cutting edges. The two end openings provide two tissue cuts per revolution (compared to the single tissue cut per revolution provided by the inner rotation axis 1920).

[0094] The high-speed rotary suction end cutter 1900 is sized to suit the application. In some embodiments, the outer diameter of the high-speed rotary suction end cutter 1900 will be in the range of 0.4 mm to 4 mm, and preferably less than 2 mm. The length of the distal shaft portion inserted into the ear canal 25 is 25-70 mm, preferably about 50 mm. To avoid obstructing visualization of the target area, the diameter of the handle will preferably be small. The handle may be angled or bent relative to the distal shaft, or the distal shaft itself may be curved.

[0095] In some embodiments, it is used to perform minimally invasive stapediotomy (SAP) surgery. Figure 6 ) and / or other exemplary instruments 400 for ear surgery described herein are as follows Figure 11 An exemplary coaxial bipolar diathermy device 1000 is shown. The coaxial diathermy device 1000 includes a probe 1010 and a distal end 1020, the distal end 1020 including electrodes for transferring heat. Using the coaxial principle, current flows only on the distal surface of the probe. This allows the inherently intense heat to be directed at the most distal end 1020 of the probe 1010. It is small in size, has terminal clotting effects, and when used with a low-frequency diathermy unit, this probe can be safely used near delicate tissue. Bipolar diathermy devices are used in the ear canal 25 and externally, but for middle ear surgery, they have historically been too large and imprecise. Existing diathermy devices in the field of otology have not been used for middle ear surgery for various reasons, including difficulty in accessing the middle or inner ear region, and because the bony structures of the middle ear impede a straight angle of attack towards the desired target.

[0096] In some embodiments, the probe 1010 may be deflectable or steerable (as described above) to enable off-axis functionality. In other embodiments, aspiration features may be included in the same instrument to remove loose blood or thin clots from actively bleeding vessels and then immediately coagulate them. This coaxial diathermy device 1000 is highly advantageous and provides entirely new functionality for otological surgery.

[0097] Figure 12 Optional modifications to the coaxial bipolar diathermy device 1000 are described. Diathermy itself is a useful surgical intervention, currently not used in otology; whether for mastoid / open access surgery, external auditory canal 25, middle ear, or inner ear applications. Adding additional functionality to diathermy would further increase its usefulness than anticipated.

[0098] Another useful feature that can optionally be added to the coaxial bipolar diathermy device 1000 is the addition of illumination (as shown in light 1022). The diathermy device 1000 can have a light source mounted at the distal end, or an optical fiber that transmits light to the distal end. In otological surgery, adequate illumination can be problematic, especially when the instrument handle in use obstructs the light source. The anatomy of the middle ear and surrounding areas consists of many small and complex structures that create corners that also hinder visualization and illumination, and the onboard illumination of the diathermy probe device 1000 will greatly enhance its usability and ease of use. The ability to control the light source close to the target tissue also minimizes the possibility of glare from reflections from other surfaces, such as the tympanic membrane. Movement of the light source during operation can also cast shadows, making anatomical structures easier to identify.

[0099] Another useful additional feature that can be optionally added to the coaxial bipolar diathermy device 1000 is aspiration (as indicated by arrow 1024). Diathermy may primarily be used to control bleeding as a way to cauterize the microvessels in the middle ear cavity or ear canal25. Adding aspiration functionality would allow for “one-handed” cauterization of blood vessels while simultaneously clearing the surgical space of blood and other cauterized tissue. This two-part ability to manage bleeding would greatly reduce the burden on clinicians in rapidly controlling bleeding, thereby minimizing surgical time, minimizing the associated risks of instrument changes and collateral tissue damage, reducing the number of personnel and hands required in the surgical space, and overall alleviating the heavy workload encountered in most surgical procedures.

[0100] The coaxial bipolar thermotherapy device 1000, when used in conjunction with the built-in illumination device 1022 and / or the suction device 1024, produces a single-handed device 1000 that is well-suited for use in otological surgeries, such as minimally invasive stapesotomy and other surgeries described herein, with a value greater than the sum of the expected individual functions.

[0101] Figure 7-8Exemplary minimally invasive Eustachian tube treatment techniques according to some embodiments are depicted. The Eustachian tube 42 is located near the carotid artery and other sensitive structures, making it potentially dangerous for surgery. Ear infections are a particularly common problem, and conventional treatments using a tympanic incision tube 80 to create an opening for the tympanic membrane 30 are an imperfect solution for fluid buildup ultimately caused by Eustachian tube obstruction. Therefore, the depicted minimally invasive Eustachian tube 42 treatment is an advantageous technique that can address the root cause of most ear infections. Furthermore, the use of transcanal access 25, tympanic incision ear drainage tube access, port access, or any minimally invasive access method facilitates surgery that can be performed in an office setting without general anesthesia, an advantage that opens up potential for the described method. As another advantage, the access path is potentially shorter and less tortuous compared to catheters that must be manipulated along a tortuous and long nasopharyngeal route, which significantly reduces the difficulty of constructing a delivery system capable of reaching the target area. It may be advantageous to be able to access the Eustachian tube 42 minimally invasively via the transauricular canal 25, as it eliminates or reduces many of the problems associated with the delivery of traction force that hinder the obstruction or dysfunction of the Eustachian tube 42, and enables a new method of direct directional delivery to the Eustachian tube 42 and adjacent areas.

[0102] Here, the tympanic membrane incision ear drainage tube 80 (or the temporary positioning TM port device 200, for example) Figure 4A (As shown in -B) provides a pathway through TM30 to the middle ear 40 (which is filled with fluid in this example). That is, the distal portion of the balloon catheter device 500 can extend into the middle ear 40, such that the balloon 520 of the balloon catheter device 500 is positioned in the Eustachian tube 42. During the advancement of the balloon catheter device 500, the balloon 520 is in a contracted state. Specifically, the deflated balloon 520 is located in the non-bone portion of the Eustachian tube 42 (e.g., the elastic cartilaginous portion of the Eustachian tube 42, i.e., the lower two-thirds where it meets the nasopharynx).

[0103] In some embodiments, the distal end portion of the balloon catheter device 500 is steerable to facilitate placement of the deflated balloon 520 into the Eustachian tube 42. As the deflated balloon 520 is positioned within the Eustachian tube 42, it can inflate to radially expand. The expansion of the Eustachian tube 42 caused by the inflation of the balloon 520 stretches the endothelium of the Eustachian tube 42, promoting healing and forming a thin layer of fibrous scar tissue. This helps support the opening of the Eustachian tube 42 and increases the luminal size of the Eustachian tube 42, which facilitates drainage. In some embodiments, the balloon 520 may be coated with medication. In some embodiments, the balloon 520 may deliver a stent to keep the Eustachian tube 42 open. In some such embodiments, the stent may be a drug-eluting stent. In some such embodiments, the stent may be a bioresorbable stent. For Eustachian tube obstruction, a stent may be a more durable solution than a tympanostomy tube 80.

[0104] Tympanotomy with ear drainage tube 80 (or as) Figure 4A The temporary positioning TM port device 200 shown in -B can be made wholly or partially of a reabsorbable material, which will allow the tube or port to dissolve and / or detach over time, thereby minimizing the risk of tissue damage during physical removal. Examples of reabsorbable materials include polylactic acid and collagen scaffolds.

[0105] refer to Figure 9 With a similar access method (e.g., via the external auditory canal 25), the tympanotomy ear drainage tube 80 (or TM port device 200) provides an off-the-shelf access point for delivering sprays, gels, therapeutic agents, gene delivery, antibiotics, anti-mucosal agents, surfactants, dilators or adrenaline, devices, etc., to the middle ear 40 and / or eustachian tube 42. A cannula or needle 600 can be used to deliver gels or liquids, which may be loaded with antibiotics, antihistamines, decongestants, mucolytics / expectorants, dilators or adrenaline, surfactants, etc. This needle or cannula 600 can integrate any / all features of the instruments described herein (e.g., small-size shafts, flexible shafts, steerable / deflectable shafts, angular shafts, bending shafts, and / or combinations of functions, including but not limited to aspiration, illumination, irrigation, endoscopy, diathermy, laser energy delivery, injection, phacoemulsification, etc.). For example, a tympanotomy ear drainage tube 80 (or TM port device 200) allows for precise direct delivery of therapeutic agents into the tympanic cavity to the tympanic end of the Eustachian tube 42 to treat Eustachian tube dysfunction. Precise delivery of therapeutic agents for Eustachian tube dysfunction into the middle ear can be achieved through, but is not limited to, surfactants such as dipalmitoylphosphatidylcholine [DPPC], beractant, calfactant, poractant, simethicone, betahistine, or other formulations. In contrast to the described intranasal approach for treating Eustachian tube dysfunction, the middle ear 40 pathway provides access to a natural reservoir in the hypotympanic cavity and is closer to the isthmus or osteochondral junction of the Eustachian tube, potentially allowing for a longer, sustained release of the therapeutic agent to alter the surface tension of the Eustachian tube 42 and enhance its opening function, thereby restoring ventilation of the middle ear.

[0106] refer to Figure 10 In some embodiments, the procedures described herein and other ear surgeries can advantageously be performed by flooding the middle ear 40 and / or the outer ear 25. The cavity of the middle ear 40 is typically filled with air. Liquids (e.g., saline, water, etc.) can be used to temporarily fill the cavity of the middle ear 40, allowing the treatment procedures described herein to be performed “underwater.” This approach offers numerous advantages.

[0107] When cochlear implant electrodes are placed, the scala tympani (one of the fluid-filled compartments of the cochlea) is intentionally disrupted. This can lead to perilymph leakage into the air-filled middle ear 40, potentially causing dizziness and / or permanent damage to the delicate cellular structures of the cochlea. Filling the cavity of the middle ear 40 with an artificial perilymph-like fluid (such as artificial cerebrospinal fluid with a higher protein concentration) or a viscoelastic material based on sodium hyaluronate (such as sodium hyaluronate (Healon), DuoVisc, ProVisc, or Viscoat) can maintain fluid balance in the cochlea during surgery.

[0108] During middle or inner ear surgery (e.g., cholesteatoma surgery or stapes resection), the round window membrane or oval window may be unintentionally damaged, leading to perilymph loss. This perilymph may leak into the air-filled middle ear cavity 40, causing vertigo and permanent damage to the delicate cellular structures of the cochlea. Filling the cavity of the middle ear 40 with an artificial perilymph-like fluid (e.g., artificial cerebrospinal fluid with a higher protein concentration) or a viscoelastic material based on sodium hyaluronate (e.g., sodium hyaluronate (Healon), DuoVisc, ProVisc, or Viscoat) can maintain fluid balance in the cochlea during surgery.

[0109] Cochlear insufflation for placement of cochlear implant electrodes, or entry into the inner ear cavity for treatment of neuromas, schwannomas, or any other reason, can lead to loss of perilymph, resulting in vertigo and permanent damage to the delicate cellular structures of the cochlea. Filling the middle ear cavity 40 with an artificial perilymph-like fluid (such as artificial cerebrospinal fluid with a higher protein concentration) or a viscoelastic material based on sodium hyaluronate (such as sodium hyaluronate (Healon), DuoVisc, ProVisc, or Viscoat) can maintain fluid balance in the cochlea during surgery. Intraoperative bleeding in the middle ear space 40 must be constantly controlled during the surgical procedure. Maintaining a fluid-filled chamber in the middle ear 40 can help tamponade the bleeding, especially if heavy fluids such as sodium hyaluronate-based viscoelastic materials (such as sodium hyaluronate (Healon), DuoVisc, ProVisc, or Viscoat) or silicone oil are used. Alternatively, the fluid can contain hemostatic agents to further reduce bleeding.

[0110] Maintaining a constant infusion of a simple saline solution or artificial perilymph-like fluid within the middle ear 40 allows for the execution of aspiration procedures that enable constant flushing or cleaning of the ear structures. Antioxidants (such as glutathione) can also be added to the flushing solution to minimize intraoperative and postoperative inflammation. This facilitates bleeding control and allows for tissue removal using aspiration-type ultrasonic instruments and aspiration-type pneumatic cutters. In some embodiments, these instruments can provide both infusion and aspiration simultaneously. Simultaneous infusion and aspiration minimizes the need for frequent instrument changes and allows for more efficient removal of blood and other debris. This replacement is particularly beneficial in cholesteatoma resection, where complete removal of the infiltrated epithelial tissue is crucial for minimizing the risk of recurrence.

[0111] An endoscope can be used to visualize the fluid-filled middle ear 40. Using an endoscope in a fluid-filled space eliminates concerns or difficulties regarding lens fogging or blood obscuring the lens, and the subsequent need to clean the lens of the endoscope. Alternatively, a lens can be placed at the air / liquid interface to allow observation through a microscope (similar to a swimmer's mask). The lens may have ports through or around it to allow instruments to pass through. In some embodiments, such a lens can be made to provide a wide field of view.

[0112] In the case of tympanoplasty, it may be advantageous to fill all or part of the ear canal 25 with fluid, in addition to the middle ear cavity 40. This will provide additional mechanical support for the tympanic membrane 30 and allow for the use of a suction cutter to trim the edges of the perforation.

[0113] Still referencing Figure 10 In the depicted example, the TM port or lens assembly 210 is temporarily positioned within the TM 30. In some embodiments, the TM port or lens assembly 210 is the TM port 210. Alternatively, in some embodiments, the TM port or lens assembly 210 is the TM lens assembly 210 (for observation within the middle ear 40).

[0114] The TM lens assembly 210 includes a truncated conical proximal portion extending into the outer ear 25. In this example, the truncated conical proximal portion of the TM lens assembly 210 acts as a dam to allow partial flooding of the outer ear 25 (e.g., to the horizontal plane 26) while ensuring that the proximal surface of the TM lens assembly 210 remains dry. An open passage between the middle and outer ear (via an incision, an open or valved TM port 210, or other device) allows any excess fluid in the middle ear to drain without creating high pressure in the middle ear 40, and partially fills the ear canal 25 or tubular structure when overflowing or excessive, facilitating the regulation of fluid volume / pressure in the middle ear 40 without requiring additional potentially complex instruments. By controlling the fluid level in the ear canal 25 in conjunction with this truncated conical feature, the lens / water interface on the distal surface of the lens and the lens / air interface on the proximal surface are maintained, allowing optimal optical transmission to an externally located surgical microscope.

[0115] In some embodiments, the TM port or lens assembly 210 is a TM port for access to the middle ear 40. A “wall” or “funnel” around the TM port can be used in conjunction with a valved port to keep the proximal port surface dry. This has the advantage of preventing potential middle ear irrigation fluid contamination during instrument insertion through the port. Another advantage of keeping the TM port surface dry is maintaining the port’s visibility for easy instrument positioning.

[0116] In some embodiments, a suction device 220 (or a endoscopic endoscope with suction features) is used in the outer ear 25 to control the liquid level 26 in the outer ear 25 (or to completely remove the liquid from the outer ear 25). The suction device 220 may be a wicking device or a typical suction-driven suction device.

[0117] In a particular embodiment, TM port 210 includes one or more valves to restrict fluid outflow into the ear 25. TM port 210 may also include various valves / openings for instruments, observation, suction, flushing, etc.

[0118] Conversely, the valve can be one-way to restrict fluid from entering the middle ear 40, thus allowing fluid to leave the middle ear 40 without returning through the valve. As an example, this directs the flow of infused fluid from the middle ear 40 to the ear canal 25, thereby minimizing potential contamination of the fluid in the middle ear 40 by the fluid that has already come into contact with the skin of the ear canal 25.

[0119] In another example embodiment, the TM port or lens assembly 210 may have one or more side channels to allow bidirectional flow and “drain” excess fluid from the middle ear 40.

[0120] In another exemplary embodiment, the TM port 210 may be connected to a predominantly tubular member extending proximally outward from that port, and this tubular member may serve as an overflow reservoir for any excess fluid draining from the middle ear 40 without generating high pressure within the middle ear 40, thereby facilitating the regulation of fluid volume / pressure within the middle ear 40 and eliminating the need for valves or walls on other lenses or ports used in the same procedure. This tubular member may be connected to a lateral flow or suction device at a given height above the port location, thereby maintaining a given pressure determined by the head height of the lateral flow.

[0121] Although the isthmus of the Eustachian tube may contract during fluid filling procedures (the Eustachian tube is typically closed except during chewing, swallowing, or yawning), thus enabling fluid filling of the middle ear, it is foreseeable that the devices described herein (e.g., small-size shafts, flexible shafts, steerable / deflectable shafts, angular shafts, curved shafts, and / or including but not limited to aspiration, illumination, irrigation, endoscopy, diathermy, laser energy delivery, injection, phacoemulsification, etc.) can enable the local delivery of agents (e.g., vasoconstrictors or prokinetic agents) to stimulate contraction of the isthmus of the Eustachian tube, thereby allowing fluid to fill the middle ear space. In other embodiments, the isthmus may be mechanically sealed, for example via a temporarily deployed balloon catheter, or via a short-term absorbable gel (e.g., formulated to dissolve over a timescale of several hours).

[0122] Conversely, it is foreseeable that in certain circumstances, ensuring the Eustachian tube isthmus remains unrestricted or open to provide drainage of the middle ear space after surgery using fluid-filled methods is advantageous. It is foreseeable that the instruments described herein (e.g., small-size shafts, flexible shafts, steerable / deflectable shafts, angular shafts, curved shafts, and / or combinations thereof, including but not limited to aspiration, illumination, irrigation, endoscopy, diathermy, laser energy delivery, injection, phacoemulsification, etc.) will enable the local delivery of agents such as antibiotics, antihistamines, decongestants, mucolytics / expectorants, dilators, or adrenaline, surfactants, to achieve dilation or opening of the Eustachian tube isthmus, thereby facilitating fluid drainage of the middle ear space.

[0123] Figure 13 An example tympanoplasty procedure using example instrument 400 is depicted. In some embodiments, the tympanoplasty procedure can be performed underwater.

[0124] In tympanoplasty, the edges of the existing tympanic membrane perforation 31 are first "renewed" by removing tissue surrounding the perforation 31. Currently, there are no precise instruments to perform this procedure, and more tissue is often removed than needed, further enlarging the perforation, complicating subsequent repair surgery, and reducing the chances of successful closure of the perforation 31.

[0125] In some cases, the exemplary instrument 400 used to perform tympanoplasty may be a small pneumatic "guillotine" blade cutter with suction provided by a pneumatic suction cutter 1100. Figure 14 The pneumatic suction cutter 1100 ensures more precise cutting of the periphery of the perforation 31 because the TM30 maintains tension through suction during cutting. Furthermore, the cutting action does not require manual operation like scissors, thus precise cutting can be controlled simply by guiding the instrument's cutting port to the target tissue. Therefore, the small pneumatic "guillotine" blade cutter with suction provided by the pneumatic suction cutter 1100 ensures more precise cutting of the periphery of the perforation 31. In some embodiments, this cutting can also be combined with fluid infusion or instillation into the middle ear 40 and / or the external auditory canal 25. The pneumatic suction cutter 1100 can also be used to remove membranes and fibrous tissue from the middle ear 40.

[0126] Various other types of instruments 400 can be used in tympanoplasty. For example, in some embodiments, ultrasonic instruments, curettes, or end-cutters ( Figure 15-16B It can be used to remove the epithelial surface tissue around the perforation 31.

[0127] While the instruments disclosed herein are primarily described in the context of otological surgery, either in the external ear or using methods that access the middle or inner ear via the ear canal, tympanic membrane, etc., it should be understood that the instruments are not limited to these uses and can be used in other cavities or spaces within the body and by other methods. For example, in some embodiments, the instruments described herein can be used for other methods and techniques for accessing the middle ear, inner ear, Eustachian tube, mastoid sinus cavity, including but not limited to mastoid access, transcanal access via the tympanic-external flap, via the tympanic membrane ring, intraauricular, postauricular, postauricular point, etc. Such systems and methods can be used for drug delivery, gel delivery, antibiotic delivery, gene delivery, graft placement, device or implant delivery, tissue removal, diagnostic procedures, sampling procedures, surgical procedures, etc.

[0128] It should be noted that any embodiment or feature of an embodiment described herein may be combined in any combination and any arrangement, and all are within the scope of this disclosure.

[0129] The devices, systems, and methods described herein can be used to treat any disease of the middle and / or inner ear, including but not limited to hearing loss, tinnitus, balance disorders including vertigo, Meniere's disease, vestibular neuronitis, vestibular schwannoma, labyrinthitis, otosclerosis, ossicular chain dislocation, cholesteatoma, otitis media, middle ear infection, and tympanic membrane perforation, to provide some examples. In some embodiments, the devices, systems, and methods described herein can be used in the precise delivery of therapeutic agents to the round window niche and / or other target sites (e.g., the oval window or other parts of the middle ear cavity) and to provide access to other features or areas of the middle ear. For example, the systems and methods described herein can be used for minimally invasive surgical reconstruction of the ossicular chain, removal of cholesteatoma, diagnostic evaluation, and other procedures. Any and all such techniques used in the use of the systems and methods described herein are included within the scope of this disclosure.

[0130] The devices and systems described herein can be made of metals, such as, but not limited to, aluminum, titanium, stainless steel, etc., or of polymers, such as, but not limited to, ABS, PEEK, PET, HDPE, injection-molded parts, etc. Components such as flexible rings can be made of elastic materials, gels, etc.

[0131] The apparatuses, systems, materials, compounds, compositions, articles, and methods described herein can be understood by referring to the above detailed description of specific aspects of the disclosed subject matter. However, it should be understood that the foregoing aspects are not limited to specific apparatuses, systems, methods, or reagents, as they may vary. It should also be understood that the terminology used herein is for descriptive purposes only and is not intended to be limiting.

[0132] Many embodiments have been described. However, it should be understood that various modifications can be made without departing from the scope of the claims herein. Therefore, other embodiments are within the scope of the appended claims.

Claims

1. A system for treating cholesteatoma or soft tissue lesions (50) in the middle ear, said system comprising instruments (300, 400) configured to: The axis of the instrument is advanced through the external auditory canal (25) such that the distal end of the instrument comes into contact with a cholesteatoma or soft tissue lesion in the middle ear; and The device delivers therapeutic treatment to the cholesteatoma or soft tissue lesion to reduce its volume. in, The system also includes a lens assembly (210) for viewing the middle ear (40), which is configured to be temporarily positioned in the tympanic membrane (30) located between the external auditory canal (25) and the middle ear. The lens assembly includes a proximal portion of a truncated cone extending into the external ear, the proximal portion of the truncated cone gradually opening in the direction toward the external ear.

2. The system according to claim 1, wherein, The device is an injection device (300), and the delivery treatment includes injecting a drug from the injection device into a cholesteatoma or soft tissue lesion; and / or Wherein, the instrument is an ultrasound instrument (400), and wherein the delivery treatment comprises applying ultrasound energy from the ultrasound instrument to the cholesteatoma or soft tissue lesion to emulsify at least a portion of the cholesteatoma or soft tissue lesion; and / or The device is a laser device, and the delivery treatment includes applying laser energy to a cholesteatoma or soft tissue lesion.

3. A system for removing ossified deposits around the footplate of the stapes in the middle ear, the system comprising an instrument configured to: The axis of the instrument is advanced through the external auditory canal, causing the distal end of the instrument to approach the ossified deposits surrounding the stapes footplate; and The instrument delivers a therapeutic treatment to the ossified deposits around the stapes footplate to remove at least some of the deposits. in, The system also includes a lens assembly (210) for viewing the middle ear (40), which is configured to be temporarily positioned in the tympanic membrane (30) located between the external auditory canal (25) and the middle ear. The lens assembly includes a proximal portion of a truncated cone extending into the external ear, the proximal portion of the truncated cone gradually opening in the direction toward the external ear.

4. The system according to claim 3, wherein, The instrument is a cutting and aspiration instrument, and the delivery treatment includes cutting and aspirating portions of the buildup using the cutting and aspiration instrument; and / or Wherein, the device is an ultrasound device, and wherein the delivery treatment process includes applying ultrasound energy from the ultrasound device to the deposit to emulsify at least a portion of the deposit; and / or Wherein, the device is a laser device, and wherein the delivery treatment process includes applying laser energy from the laser device to the deposit to remove at least a portion of the deposit; and / or The device is a diathermy device, and the delivery treatment process includes applying heat energy from the diathermy device to the pile to remove at least a portion of the pile.

5. A system for treating otosclerosis in the middle ear, the system comprising an instrument configured to: The axis of the instrument is advanced through the external auditory canal, so that the distal end of the instrument is inside the middle ear; and The treatment is delivered from the device. in, The instruments are: (i) cutting and suction instruments, (ii) ultrasonic instruments, (iii) laser instruments, or (iv) diathermy instruments, and The system further includes a lens assembly (210) for viewing the middle ear (40), which is configured to be temporarily positioned in the tympanic membrane (30) located between the external auditory canal (25) and the middle ear. The lens assembly includes a proximal portion of a truncated cone extending into the external ear, the proximal portion of the truncated cone gradually opening in the direction toward the external ear.

6. A system for treating eustachian tube dysfunction, the system comprising an instrument (500) configured to: The axis of the instrument is advanced through the external auditory canal toward the Eustachian tube (42), wherein, The device includes a balloon (520) on the distal portion of the shaft, wherein the balloon is deflated during propulsion; Position the balloon in the Eustachian tube; and Inflate the balloon while it is in the Eustachian tube. The system further includes a lens assembly (210) for viewing the middle ear (40), which is configured to be temporarily positioned in the tympanic membrane (30) located between the external auditory canal (25) and the middle ear. The lens assembly includes a proximal portion of a truncated cone extending into the external ear, the proximal portion of the truncated cone gradually opening in the direction toward the external ear.

7. The system according to claim 6, wherein, The shaft of the instrument, which advances the device through the external auditory canal toward the Eustachian tube (42), includes an opening in the tympanic membrane incision tube (80) through which the shaft of the instrument passes; and / or During the process of advancing the device toward the Eustachian tube (42) via the external auditory canal, the support device is positioned on the balloon, and wherein the support device is inflated when the balloon is in the Eustachian tube, such that the Eustachian tube remains open therein by the inflated support device after the balloon is removed from the Eustachian tube.

8. The system according to claim 7, wherein, The stent device is a drug-eluting stent device.

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