Devices, systems, and methods for otology

Abstract

Systems and methods can be employed to facilitate access and surgery in the external, middle, and inner ear for the diagnosis or treatment of ear conditions including, but not limited to, hearing loss and excess earwax. In some examples, the systems and methods include instruments and techniques that facilitate trans-tympanic or trans-fibroannular access to the middle ear. The systems and methods can also be used to improve the accessibility of various otologic procedures, such as, but not limited to, cholesteatoma removal, tympanic membrane repair, and ossicular chain repair.

Description

[0001] Cross-references to 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 is incorporated herein by reference in its entirety); U.S. Provisional Application No. 63 / 040,495, filed June 17, 2020 (which is incorporated herein by reference in its entirety); U.S. Provisional Application No. 63 / 051,568, filed July 14, 2020 (which is incorporated herein by reference in its entirety); and U.S. Provisional Application No. 63 / 077,481, filed September 11, 2020. Priority interests in 48 (which are fully incorporated herein by reference), U.S. Provisional Application No. 63 / 078,141 filed September 14, 2020 (which are fully incorporated herein by reference), U.S. Provisional Application No. 63 / 080,510 filed September 18, 2020 (which are fully incorporated herein by reference), U.S. Provisional Application No. 63 / 081,015 filed September 21, 2020 (which are fully incorporated herein by reference), and U.S. Provisional Application No. 63 / 082,996 filed September 24, 2020 (which are fully incorporated herein by reference). Technical Field

[0003] This document relates to systems, methods, and materials for facilitating access and surgery to the outer, middle, and inner ear for the diagnosis or treatment of conditions, including but not limited to hearing loss, excessive earwax buildup, and other ear conditions. In some examples, systems and methods include instruments and techniques for facilitating access to the middle ear via the tympanic membrane or the annulus fibrosus. Background Technology

[0004] The human ear suffers from a variety of conditions, including but not limited to excessive earwax buildup, 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, schwannoma, and tympanic membrane perforation, to provide a few examples.

[0005] Access to the tympanic membrane, middle ear, and inner ear through the ear canal has historically been challenging due to the angle of the ear canal, the sensitivity of the ear canal walls, the small cumulative cross-section of the ear canal due to the angle, the large size of the shaft and functional tips of available instruments, the structures that create angles and obstruct spaces in the middle ear, and the lack of methods or systems to allow access to the middle or inner ear. Furthermore, there is a lack of instruments specifically designed for various otological procedures. Summary of the Invention

[0006] This document describes systems and methods for otologic surgery, such as but not limited to removal of excess earwax buildup in the external ear. This document also describes systems and methods for minimally invasive access to the middle ear for the purpose of providing surgical or pharmaceutical treatment for inner ear and middle ear disorders. For example, this document describes systems and methods for trans-tympanic access and trans-fibro-annular access for minimally invasive delivery of various treatments. The devices, systems, materials, compounds, compositions, articles, and methods described herein can be used to treat various disorders of the middle ear and / or inner ear, including but not limited to hearing loss, tinnitus, balance disorders including vertigo, Meniere’s disease, vestibular neuronitis, vestibular hemangioma, labyrinthitis, otosclerosis, ossicular chain dislocation, cholesteatoma, external ear infection, middle ear infection, hemangioma, and tympanic membrane perforation, to provide a few examples. In some embodiments, the treatment facilitated by the systems and methods described herein includes delivery of a therapeutic agent into the round window niche and proximate to the round window membrane of the cochlea under direct visualization. In particular implementations, the active agent of the therapeutic agent can then passively transfer into the perilymph (within the cochlea) through the round window membrane according to a concentration gradient by diffusion. In some embodiments, devices and methods are also described herein that support intracochlear delivery of therapeutic drugs or implants.

[0007] In one aspect, the present document relates to a surgical instrument configured for otologic surgery. The instrument includes a handle defining a longitudinal handle axis, an actuation mechanism coupled to the handle, and an instrument shaft extending from the handle and defining a longitudinal shaft axis. The longitudinal shaft axis extends at a non-zero angle relative to the longitudinal handle axis.

[0008] Such a surgical instrument configured for otologic surgery can optionally include one or more features. In some embodiments, the instrument is an injection instrument configured to deliver a therapeutic agent within the middle ear. The instrument can be an injection instrument configured to deliver a therapeutic agent to a round window niche location within the middle ear. The instrument can be a forceps instrument, a diathermy instrument, a suction tissue cutter instrument, and / or an ultrasonic instrument.

[0009] In another aspect, the present document relates to another surgical instrument configured for otologic surgery. The instrument includes a handle, an actuation mechanism coupled to the handle, and an instrument shaft extending from the handle. The instrument shaft is curved.

[0010] In another aspect, the present disclosure relates to a method of treating a middle ear or inner ear disorder in a patient. The method includes accessing the middle ear of the patient by advancing a distal portion of an otologic instrument through or proximate to a tympanic membrane of the patient.

[0011] Such a method of treating a middle ear or inner ear condition in a patient can optionally include one or more of the following features. The method can also include implanting a port device in the tympanic membrane annulus. Advancing a distal portion of an otologic instrument through the tympanic membrane annulus or adjacent the tympanic membrane annulus can be performed by passing the distal portion of the otologic instrument through a channel defined by the port device. In some embodiments, the channel is curved and causes the distal portion of the otologic instrument to bend as the distal portion of the otologic instrument is passed through the channel. The method can also include making a puncture or incision within or adjacent the tympanic membrane annulus. Advancing a distal portion of an otologic instrument through the tympanic membrane annulus or adjacent the tympanic membrane annulus can be performed by passing the distal portion of the otologic instrument through the puncture or incision. In some embodiments, the otologic instrument is a first otologic instrument, and the method can also include accessing the middle ear of the patient by advancing a distal portion of a second otologic instrument through or adjacent the tympanic membrane annulus of the patient. The distal portions of the first and second otologic instruments can be in the middle ear at the same time. In some embodiments, the first otologic instrument is an endoscope, and the second otologic instrument is an injection instrument configured to deliver a therapeutic agent within the middle ear. In particular embodiments, the first otologic instrument is an endoscope, and the second otologic instrument is a diathermy instrument or an ultrasonic instrument. In certain embodiments, the first otologic instrument is an endoscope and the second otologic instrument is a suction tissue cutter instrument. The method can also include using a liquid to flood the middle ear, and treating the middle ear or inner ear condition using the otologic instrument when the middle ear is flooded with the liquid.

[0012] In another aspect, the present disclosure relates to another method of treating an ear condition in a patient. The method includes flooding a middle ear with a liquid. The method also includes treating the ear condition using one or more otologic instruments when the middle ear is flooded with the liquid.

[0013] Such a method of treating an ear condition in a patient can optionally include one or more of the following features. In some embodiments, the one or more otologic instruments include a suction tissue cutter instrument, and treating the ear condition includes removing a membrane or fibrous tissue in the middle ear using the suction tissue cutter instrument. In particular embodiments, the one or more otologic instruments include a suction tissue cutter instrument, and treating the ear condition includes removing tissue along an edge of a tympanic membrane perforation.

[0014] Some or all of the embodiments described herein can provide one or more of the following advantages. First, the systems and methods for treating hearing loss and all other ear conditions as described herein can include specialized instruments and techniques that can be used to access the outer, middle, and / or inner ear regions, including, for example, the round window niche of the cochlea. New types of otologic instruments are described herein, such as instruments for micro-thermolysis, pneumatically driven cutters, suction cutters, micro-suction devices, ultrasonic cutters / debriders, and the like, as well as combinations of these instruments. The specialized instruments and techniques described herein facilitate new types of treatment for inner ear and middle ear conditions. In addition, current treatments can be performed with enhanced efficacy and efficiency using the specialized instruments and techniques described herein.

[0015] Second, the systems and methods for treating hearing loss and other ear conditions as described herein facilitate treatment in a minimally invasive manner. Such minimally invasive techniques can advantageously reduce recovery time, patient discomfort, and treatment costs. In addition, the methods described herein can be performed using local anesthetics without the need for general anesthesia. Thus, treatment costs, patient risk, recovery time, and recurrence rates are further advantageously reduced.

[0016] Third, the systems and methods for treating hearing loss and other ear conditions as described herein allow for direct access to the middle ear cavity through or adjacent to the hard fibrous ring (tympanic ring) that surrounds the tympanic membrane in a seamless, low-impact manner. In some embodiments, such trans-tympanic ring access through the tympanic ring can be safer (e.g., with a lower risk of intraoperative laceration or damage to the tympanic membrane), less invasive, and achievable without the need for sealing or repair after surgery.

[0017] Fourth, console systems for otologic surgery are described herein that advantageously incorporate and integrate multiple treatment modalities for enhanced synchronous functionality. This integration also provides convenience and efficiency improvements by eliminating the need for the clinician to move back and forth between the control of separate systems throughout the course of treatment, thereby improving surgical precision.

[0018] Fifth, methods for temporarily filling the middle ear and / or outer ear cavities are described herein so that treatment procedures can be performed “underwater.” Such methods have a number of advantages, such as, but not limited to, maintaining fluid balance in the cochlea during surgery, packing against bleeding, enabling suction procedures that allow for constant irrigation or washing of middle ear structures, improving visualization, and enabling precise use of suction cutters to trim or remove tissue during surgery, as described herein, and the like.

[0019] Sixth, described herein are devices that can deliver ultrasound energy to cause fragmentation, emulsification, or resurfacing of materials such as, but not limited to, cerumen, membranes, tumors, cholesteatomas, skin, bone, etc. As described herein, some such ultrasonic devices are specifically designed for use in air, and are thus cooled by internal fluid circulation, irrigation / suction, or other means.

[0020] Seventh, described herein are devices that combine illumination and / or suction with diathermy therapy in a single instrument. Such a combination can advantageously provide a single-handed instrument with multiple useful functions.

[0021] The details of one or more embodiments of the application are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the application will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF DRAWINGS

[0022] Figure 1 A patient is shown in position for a medical procedure to treat hearing loss and other ear conditions, in accordance with some embodiments described herein.

[0023] Figure 2 An instrument is shown for obtaining a minimally invasive passageway through the tympanic membrane into the middle ear, in accordance with some embodiments.

[0024] Figure 3 An instrument is shown for obtaining a minimally invasive passageway through the tympanic membrane ring (a hard fibrous ring that surrounds the tympanic membrane) into the middle ear, in accordance with some embodiments.

[0025] Figure 4 A right tympanic membrane is shown with superimposed lines and markings that indicate coordinates of locations around the tympanic membrane ring.

[0026] Figure 5 An example is shown schematically of how an instrument is designed to allow visualization within the external ear canal when the instrument is in use.

[0027] Figure 6 An example otologic instrument is shown, in accordance with some embodiments.

[0028] Figure 7 Another example otologic instrument is shown, in accordance with some embodiments.

[0029] Figure 8 Two example otologic instruments are shown, in accordance with some embodiments. Figure 6 Two example otologic instruments are shown, in accordance with some embodiments.

[0030] Figure 11 and Figure 12 Two example otologic instruments are shown, in accordance with some embodiments. Figure 7two of the exemplary otologic instruments used during a medical procedure for treating an ear condition.

[0031] Figure 13 Another exemplary otologic instrument is shown in accordance with some embodiments.

[0032] Figure 14 An enlarged view of a distal portion of the exemplary otologic instrument of Figure 13

[0033] Figure 15 The otologic instrument of Figure 13 is shown in a first exemplary configuration.

[0034] Figure 16 The otologic instrument of Figure 13 is shown in a second exemplary configuration.

[0035] Figure 17 An exemplary end effector that can be incorporated into the otologic instruments described herein is shown.

[0036] Figure 18 Another exemplary end effector that can be incorporated into the otologic instruments described herein is shown.

[0037] Figure 19 Another exemplary end effector that can be incorporated into the otologic instruments described herein is shown.

[0038] Figure 20 Another exemplary end effector that can be incorporated into the otologic instruments described herein is shown.

[0039] Figure 21 Another exemplary end effector that can be incorporated into the otologic instruments described herein is shown.

[0040] Figure 22 Another exemplary end effector that can be incorporated into the otologic instruments described herein is shown.

[0041] Figure 22A An alternative design for the instrument of Figure 22 is shown.

[0042] Figure 23 Another exemplary end effector that can be incorporated into the otologic instruments described herein is shown.

[0043] Figure 24a-24c is a series of illustrations showing how the end effector of Figure 23 functions to cut and aspirate tissue.

[0044] Figure 25 Another exemplary end effector that can be incorporated into the otologic instruments described herein is shown. ​

[0045] Figure 26 Another example end effector that can be incorporated into an otologic instrument described herein is shown.

[0046] Figure 27 Another example end effector that can be incorporated into an otologic instrument described herein is shown.

[0047] Figure 28 Another example end effector that can be incorporated into an otologic instrument described herein is shown.

[0048] Figure 29 Another example end effector that can be incorporated into an otologic instrument described herein is shown.

[0049] Figure 30 Another example end effector that can be incorporated into an otologic instrument described herein is shown.

[0050] Figure 31 An example console system that can be used in otologic surgery is depicted in accordance with some embodiments.

[0051] Figure 32 is a longitudinal cross-sectional view of another example end effector that can be incorporated into an otologic instrument described herein.

[0052] Figure 33 is an end view of the instrument of Figure 32

[0053] Figure 34A is a transverse cross-sectional view of the instrument of Figure 32

[0054] Figure 34B is an alternative cross-sectional view of the instrument of Figure 32

[0055] Another type of example instrument is shown that can be incorporated as part of an otologic instrument described herein. Figure 35

[0056] Figure 36A various examples of alternative transverse cross-sections of the shaft of the instrument of Figure 35

[0057] Figure 37A and 37B depict the instrument of Figure 35 in use.

[0058] The same reference numbers in the various drawings indicate the same elements. DETAILED DESCRIPTION

[0059] Reference is made to Figure 1 ​​​​In some cases, the patient 10 may be positioned in the exemplary suitable location shown to undergo various procedures to treat ear conditions, including but not limited to earwax removal, sensorineural hearing loss (including latent hearing loss, noise-induced hearing loss, age-related hearing loss, drug-induced hearing loss (e.g., chemotherapy-induced hearing loss or aminoglycoside-induced hearing loss), sudden sensorineural hearing loss (SNHL), autoimmune inner ear diseases, etc.), tinnitus, balance disorders (including vertigo), Meniere's disease, vestibular neuritis, vestibular neuritis, synovitis, labyrinthitis, otosclerosis, ossicular chain dislocation, cholesteatoma, external ear infection, middle ear infection, synovial and tympanic membrane perforation.

[0060] In some cases, the procedure can be performed with the patient 10 fully supine (as shown) or reclining in a chair. For example, the patient 10's head can be rotated approximately 30 to 45 degrees away from the clinician 1 (facing the patient 10's opposite ear). The patient 10's jaw can be slightly raised, and / or the external portion of the patient 10's ear can be pulled upwards and backwards to adjust the diameter and angle of the ear canal opening. In this way, the round window of the patient 10's inner ear will be oriented generally upwards (e.g., away from the ground).

[0061] In some implementations, patient 10 remains conscious during surgery to treat an ear condition. That is, a local anesthetic can be used instead of a general anesthetic to perform the surgery. For example, in some cases, agents such as phenol or lidocaine can be applied as a local anesthetic to the tympanic membrane (“TM”) to facilitate the surgery. In some cases, patient 10 may be given general anesthesia for the surgery.

[0062] This disclosure describes treatment methods and apparatus for treating patient 10 using minimally invasive methods. As further described below, specific embodiments of the systems and methods for treating patient 10 may include a set of improved otological medical instruments and improved treatment techniques.

[0063] Also refer to Figure 2 After preparing patient 10 for surgery, clinician 1 used various otological instruments (as further described below) Figure 2 The patient 10 is treated with a general instrument 110 (at least one of the instruments). For example, as described herein, the instrument 110 may be advanced toward the TM30 into the external auditory canal 20, and subsequently advanced through the TM30 such that the distal portion of the instrument 110 is located in the middle ear 40. In some cases, an endoscope (not shown) is used in the external auditory canal 20 to provide direct visualization during the advancement of the instrument 110. In some cases, a microscope or other magnifying instrument is used to provide direct visualization during the advancement of the instrument 110.

[0064] Although Figure 2While a single instrument 110 is depicted, in some cases, two or more instruments 110 are used simultaneously within the middle ear 40. For example, in some embodiments, a first instrument 110 can be an endoscope, and a second instrument 110 can include an end effector for grasping, cutting, tearing, cauterizing, injecting, suctioning, irrigating, etc., and combinations thereof. The endoscope can be used to provide visualization within the middle ear 40, while the second instrument 110 is used to provide treatment.

[0065] The exemplary method of access to the middle ear 40 that is depicted is trans-tympanic. That is, the instrument is passed through the TM 30. In some cases, the instrument 110 is advanced through the TM 30 via one or more temporarily implanted tympanic membrane port devices, such as those described in U.S. Patent Application 63 / 024,183, filed May 13, 2020, which is incorporated by reference herein for all purposes. In some cases, the instrument 110 is advanced directly through an opening made in the TM 30 (e.g., by making an incision or puncture in the TM 30, without a tympanic membrane port device within the opening of the TM 30).

[0066] Reference is made to Figure 3 , in addition to or as an alternative to the trans-tympanic method of access to the middle ear 40 as described above, in some cases, the middle ear 40 can be accessed by passing through the tympanic annulus 32 (a hard fibrous ring that surrounds the TM 30). This method can also be referred to as trans-fibrous annulus access or annular access to the middle ear 40. In this case, the distal portion of the instrument(s) 110 can pass through the tympanic annulus 32 using a port device, or through a puncture / incision in the tympanic annulus 32 without the need for a port device.

[0067] While access to the middle ear 40 through the TM 30 (trans-tympanic method) is a viable technique, due to the fragility of the TM 30, care must be taken to prevent damage to the TM 30. However, the TM 30 has a hard fibrous ring that extends around the outer periphery or circumference of the TM 30, the tympanic annulus 32. As one example, the anterior portion of the tympanic annulus 32 (the most directly accessible portion via the ear canal 20) is covered by a thin layer of skin and sits on top of bone. In some embodiments, access to the middle ear 40 can be achieved through or adjacent to the tympanic annulus 32, for example, using a subannular, transannular, or perannular method. This method would be advantageous in mitigating the concern of tearing or damaging the TM 30 intraoperatively.

[0068] While Figure 3While the middle ear 40 is depicted with a single instrument 110, in some cases, two or more instruments 110 are used simultaneously within the middle ear 40 using the depicted trans-tympanic access. For example, in some embodiments, a first instrument 110 can be an endoscope, and a second instrument 110 can include an end effector for grasping, cutting, cauterizing, injecting, suctioning, viewing, irrigating, etc., and combinations thereof. The endoscope can be used to provide visualization within the middle ear 40, while the second instrument 110 is used to provide treatment.

[0069] The tympanic membrane ring 32 does tend to rest against the tympanic membrane and / or near the facial nerve in some cases, and in some embodiments, an access port device or other auxiliary device can temporarily anchor through the tympanic membrane ring 32 for subsequent insertion of an instrument therethrough, while reducing blood loss, total tissue damage, and preventing accidental puncture or damage to nearby nerves.

[0070] Also with reference to Figure 4 , the TM 30 is shown with its outer peripheral tympanic membrane ring 32. Positions on the tympanic membrane ring 32 can be identified using a clock face analogy, with the malleus at the 12 o’clock position, as shown. Some advantageous positions for passing an instrument 110 through the tympanic membrane ring 32 would be between the 3-5 o’clock position (best at 4-5 o’clock) for the left ear and the 7-9 o’clock position (best at 7-8 o’clock) for the right ear. Additional advantageous positions for passing an instrument 110 through the tympanic membrane ring 32 would be between the 4-5 o’clock position for the left ear and the 7-8 o’clock position for the right ear.

[0071] In some embodiments, one or more port devices with a pass-through channel to facilitate sliding instrument access can be temporarily implanted in the tympanic membrane ring 32. In some embodiments, the channel defined by the port device would have a curve or angle to it. Such a curve or angle can be advantageous for use with externally deflectable instruments 110. Such instruments 110 can have one or more sections, such as a helical cutting portion or otherwise flexible portion, that allow for deflection of the tip or shaft of the instrument 110 such that the instrument 110 is correspondingly reoriented as it passes through the curved channel defined by the port device. As described herein, this can be advantageous for reorienting the instrument 110 to be more towards the central portion of the middle ear 40 or other desired target area without requiring actuation of the instrument 110.

[0072] In some embodiments, various procedures for treating ear conditions as described herein can be performed partially or entirely with the middle ear 40 and / or outer ear 20 filled with liquid. The cavity of the middle ear 40 is generally filled with air. A liquid (e.g., saline, water, etc.) can be used to temporarily fill the cavity of the middle ear 40 such that the treatment procedures described herein can be performed “underwater.” Such an approach would have several advantages.

[0073] When placing a cochlear implant electrode, the fluid compartments of the cochlea are ruptured. This can result in loss of perilymph fluid, effusion or exudation of perilymph into the air-filled middle ear 40, resulting in dizziness and / or irreversible damage to the delicate cellular structures of the cochlea. Filling the cavity of the middle ear 40 with an artificial perilymph analog (e.g., artificial cerebrospinal fluid with a higher protein concentration) can maintain fluid balance in the cochlea during surgery.

[0074] When performing middle ear or inner ear surgery (e.g., cholesteatoma surgery or a stapedectomy), the round window membrane or oval window can be damaged, resulting in loss of perilymph fluid, effusion or exudation of perilymph into the air-filled middle ear 40, resulting in dizziness and irreversible damage to the delicate cellular structures of the cochlea. Filling the cavity of the middle ear 40 with an artificial perilymph analog (e.g., artificial cerebrospinal fluid with a higher protein concentration) can maintain fluid balance in the cochlea during surgery.

[0075] Intraoperative bleeding in the middle ear space 40 must be continuously managed during surgery. Maintaining a fluid-filled chamber in the middle ear 40 can aid in tamponading the bleeding, particularly when using heavy liquids such as hyaluronic acid sodium-based viscoelastic materials (e.g., Healon, DuoVisc, ProVisc, or Viscoat) or silicone oil.

[0076] Maintaining a constant infusion of simple saline solution or artificial perilymph analog in the middle ear 40 can allow aspiration surgery to be performed that will allow constant flushing or washing of the ear structures. This can facilitate control of bleeding and allow the use of aspiration ultrasonic instruments and aspiration pneumatic cutters that resect tissue. These instruments can provide both infusion and aspiration simultaneously. Alternatively, a central console as further described below can control the infusion line into the ear and the aspiration of separate instruments to maintain a constant fluid volume and pressure. In either case, simultaneous infusion and aspiration will minimize the need for frequent exchange of instruments and allow more efficient clearing of blood and other debris.

[0077] An endoscope can be used to enable visualization of the fluid-filled ear 40. The use of an endoscope in a fluid-filled space eliminates the concern or difficulty of fogging or blood obscuring the lens, and the associated need to subsequently clean the endoscope lens. Optionally, a lens can be placed at the air / liquid interface to allow visualization through a microscope (similar to a swimmer's mask). The lens can have ports through or around the lens to allow instruments to pass through. In some embodiments, such a lens can be made to provide a wide viewing angle.

[0078] In the case of tympanoplasty, it can be advantageous to fill all or part of the ear canal with fluid in addition to the middle ear cavity. This will provide additional mechanical support to the tympanic membrane and allow an aspiration cutter to be used to trim the edges of the perforation.

[0079] With reference toFigure 5 Figure 1 illustrates an instrument 200 extending toward TM30 into the external ear 20 of a patient 10. The symbol of the eye 12 is also shown as a representation that the clinician 1 needs to use an endoscope, microscope, or other optical instrument to obtain direct visualization within the external ear 20 as the instrument 200 is advanced. Because the ear canal of the external ear 20 is relatively small in cross-section, and can be curved or angled, the actual space for the instrument 200 and the visualization device is quite limited. As described further below, the instruments described herein are designed to mitigate some of the competing demands for space between the instrument 200 and the visualization device used by the clinician 1. In addition, the instruments described herein are designed to facilitate the simultaneous use of two or more instruments 200.

[0080] Current instruments used for otologic surgery have generally remained essentially unchanged in design or use compared to many years ago. While there have been some advances in endoscopes used for otologic surgery, such endoscopes still have a relatively large diameter shaft (e.g., about 2 mm) that is straight and rigid. Even ear canal-based approaches still use instruments with a relatively large diameter shaft (e.g., 1.5 mm to 7 mm) and a straight handle. For the few otologic instruments that are actuatable (e.g., scissors), actuation requires large hand and finger movements that interfere with holding the functional distal tip in place. In addition, such handles often obstruct the microscope view.

[0081] The variable anatomical width and curvature of the ear canal 20 (from patient to patient) also limits the possible range of instrument motion, and can limit the simultaneous use of more than one instrument without the handles or shafts of the instruments interfering with each other. In addition, once TM30 under the ear canal 20 is reached, TM30 is angled from the line of sight, increasing the difficulty of interaction through TM30.

[0082] Reference Figure 6 The example otologic instrument 200 is angled to facilitate its use, in a manner that facilitates direct visualization and / or the simultaneous use of two otologic instruments 200, as described further below. The otologic instrument 200 includes a handle 210, an actuation mechanism 220, an angled portion 230, and an instrument shaft 240. The actuation mechanism 220 is coupled to the handle 210, or includes a portion of the handle 210. The angled portion 230 is coupled to the handle 210 and / or the actuation mechanism 220 and extends distally from the handle 210 and / or the actuation mechanism 220. The instrument shaft 240 is coupled to the angled portion 230 and extends distally from the angled portion 230. The otologic instrument 200 can be reusable or disposable.

[0083] In the illustrated embodiment, the instrument shaft 240 includes a proximal end portion 242, a distal end portion 244, and a distal tip 246. While the instrument shaft 240 is linear in this example, in some embodiments one or more portions of the instrument shaft 240, or the entire instrument shaft 240, can be curved. In some such embodiments, the curved portion of the instrument shaft 240 is permanently curved. In some such embodiments, the curved portion of the instrument shaft 240 is actuable such that a clinical user of the instrument shaft 240 can control the shape of the portion to transition it between curved or linear.

[0084] In some embodiments, the instrument shaft 240 (or portions thereof) is constructed from a semi-flexible or plastically material. Such materials can be metal or polymer, such as Pebax or Nylon, such that the instrument shaft 240 and its internal geometry will readily be bent by external forces. This will allow the clinician to self-determine the curvature of the instrument shaft 240 (manually or otherwise) without requiring specific manufacturing. Additionally, this will allow the curvature of the instrument shaft 240 to fit the angles of the patient’s ear canal anatomy, or reduce the likelihood of damaging distal anatomy (e.g., the tympanic membrane). A polymer tube can be used to construct a steerable mechanism to utilize a relatively short distance (e.g., compared to a similar diameter neurovascular catheter that is typically > 120 cm long), while also allowing for a small bend radius. Other polymers for constructing the instrument shaft 240 can include, but are not limited to, HDPE, PEEK, PET, silicone, polyurethane, etc.

[0085] The proximal end portion 242 is optional. In some embodiments, the proximal end portion 242 is configured to add stiffness, column strength, and / or stability to the instrument shaft 240.

[0086] In some embodiments, the length of the instrument shaft 240 is in a range of about 30 mm to 90 mm, about 40 mm to 80 mm, about 50 mm to 80 mm, about 60 mm to 80 mm, or about 70 mm. In some embodiments, the diameter of the distal end portion 244 is in a range of about 0.02 mm to 1.1 mm, about 0.06 mm to 0.8 mm, about 0.1 mm to 0.7 mm, or about 0.4 mm to 0.6 mm. Thus, the ratio of the length of the instrument shaft 240 to the diameter of the distal end portion 244 can be in a range of about 400: 1 to 50: 1, about 300: 1 to 100: 1, about 200: 1 to 100: 1, or about 130: 1 to 170: 1.

[0087] In some embodiments, the proximal portion 242 has a larger diameter than the distal portion 244. For example, in some embodiments, the proximal portion 242 has a diameter in the range of about 1 mm to 3 mm or about 1.5 mm to 2.5 mm. The proximal portion 242 can have a length in the range of about 5 mm to 80 mm, about 10 mm to 70 mm, about 20 mm to 60 mm, or about 30 mm to 50 mm.

[0088] The otologic instrument 200 can include an end effector attached at the distal tip 246. Any type of end effector can be included. For example, Figure 14 -30 depicts various types of non-limiting end effectors that can be included as part of the otologic instrument 200. Thus, the otologic instrument 200 can be configured for multiple purposes, such as but not limited to grasping, cutting, tearing, cauterizing, infusing, suctioning, irrigating, as an endoscope, etc., and combinations thereof. Such end effectors can include angled blades or inner ear knives, grasping forceps with varying angles or extendable forceps, microtrauma suction, side cutting scissors, round knives, middle ear knives (e.g., sickle knives), injection cannulas, and any other instrument that can be used in otologic surgery.

[0089] In some embodiments, the distal portion 244 (or a portion thereof) is actuable, steerable, and / or deflectable. In some cases, it is advantageous to controllably move the functionality of the steerable or deflectable distal portion 244 off-axis from the adjacent proximal portion 242, particularly in the middle ear 40 where the bony features of the middle ear block a straight axis and create a blind angle. In some embodiments, the steerability or deflection of the distal portion 244 allows the angle of the handle or the curvature of the shaft to be moved relative to the angle or curvature of the handle 210 anywhere between 90° to 270°, 120° to 240°, 150° to 210°, or 170° to 190°.

[0090] In some embodiments, the distal portion 244 is deflectable and can have a minimum bend radius of between about 2 mm to 8 mm. It is contemplated that having a bend radius of between about 2 mm to 8 mm for the distal portion 244 is advantageous in the relatively “tight” space of the middle ear 40. This is a smaller bend radius than can typically be achieved using various laser-cut metal hypotube. In some embodiments, having a concentric series of polymer tubes, with the inner tube having large cutouts (larger than would be required for a steel or other metal hypotube), can allow the distal portion 244 to preferentially bend to such a small bend radius that it is essentially a kink in the inner tube (e.g., PEEK or PET material). The outer tube would be a flexible material and still allow fluid flow to or from the distal tip portion 244 (e.g., PEBAX or polyurethane), and most of the polymer would substantially return to its shape once the force is removed, facilitating removal of the distal tip. Other polymers can be HDPE, PEEK, PET, silicone, polyurethane, etc.

[0091] Some embodiments thereof will advantageously allow radial rotation of the angle of the distal portion 244 relative to the handle 210 or the curvature of the proximal portion 242. Otolaryngologists are typically “left-handed” or “right-handed,” meaning that there is a preference for using a particular tool with a given hand, and that the left ear requires a different path angle than the right ear. The ability to rotate the actuation of the distal portion 244 and the angle of curvature will advantageously allow the otolaryngologist to use the instrument with their preferred hand. Furthermore, this will allow navigation or steering around bends or corners according to the target, without needing to change the entry point.

[0092] The otologic instrument 200 includes an angle portion 230. The angle portion 230 is disposed between the handle 210 and the instrument shaft 240. Thus, the longitudinal axis of the handle 210 and the longitudinal axis of the instrument shaft 240 can be non-linear relative to one another, or arranged at a non-zero angle relative to one another. In some embodiments, the angle defined between the longitudinal axis of the handle 210 and the longitudinal axis of the instrument shaft 240 is in the range of about 0° to 90°, about 10° to 70°, about 20° to 50°, or about 30° to 40°.

[0093] In some embodiments, the angle portion 230 is configured such that the angle defined between the longitudinal axis of the handle 210 and the longitudinal axis of the instrument shaft 240 is a fixed or constant angle. In particular embodiments, the angle portion 230 is configured to be adjustable, such that the angle defined between the longitudinal axis of the handle 210 and the longitudinal axis of the instrument shaft 240 is selectively adjustable by a clinical user of the otologic instrument 200.

[0094] The angle between the longitudinal axis of the handle 210 provided by the angular portion 230 and the longitudinal axis of the instrument shaft 240 helps improve access under the ear canal 20, as well as improve external or microscope-based visualization (the most common visualization currently used by otologists). It also allows for the simultaneous use of two or more instruments 200 in the ear canal 20.

[0095] The otologic instrument 200 also includes an actuation mechanism 220. In the illustrated embodiment, the otologic instrument 200 includes a single actuation mechanism 220. In some embodiments, the otologic instrument 200 includes two or more actuation mechanisms (which can be the same type of mechanism or different types of mechanisms). The depicted actuation mechanism 220 is configured to be actuated by compressing the actuation mechanism 220. In some embodiments, other types of actuation mechanisms 220 can be included as part of the otologic instrument 200. For example, the actuation mechanism 220 can be one or more of a button, a trigger, a slider, a knob, a foot pedal, a valve, and the like, as well as combinations thereof.

[0096] The otologic instrument 200 also includes a handle 210. In some embodiments, the diameter of the handle 210 and any actuation mechanism 220 can be reduced to about 4 mm to 8 mm to improve access and visualization.

[0097] The otologic instrument 200 can include markings along the handle 210 to indicate to the clinician 1 the direction of steerability of the distal portion 244, the direction of actuation of the distal portion 244 or the end effector, and / or the direction of deflectability of the distal portion 244 or other portions of the otologic instrument 200. Some embodiments can have additional or combined markings on the proximal portion 242 and / or the distal portion 244 to aid in depth perception, which is advantageous when using an endoscope as one of the visualization instruments, which does not have binocular vision or depth perception.

[0098] Reference is also made to Figure 8 -10, various exemplary configurations of the simultaneous use of two of the otologic instruments 200 are depicted. As can be apparent from these views, the angle between the longitudinal axis of the handle 210 and the longitudinal axis of the instrument shaft 240 facilitates spacing apart the handles 210 so that the instruments 200 can be individually manipulated without interfering with each other.

[0099] Reference is made to Figure 7Another example otologic instrument 300 is configured to facilitate its use in a manner that facilitates direct visualization and / or simultaneous use of two otologic instruments 300, as further described below. The otologic instrument 300 includes a handle 310, an actuation mechanism 320, and an instrument shaft 340. The actuation mechanism 320 is coupled to the handle 310, or includes a portion of the handle 310. The instrument shaft 340 is coupled to the actuation mechanism 320 or the handle 310 and extends distally from the actuation mechanism 320 or the handle 310. The otologic instrument 300 can be reusable or disposable.

[0100] Any of the features of the otologic instrument 200 described above can be incorporated into the design of the otologic instrument 300. Further, any of the features of the otologic instrument 300 can be incorporated into the design of the otologic instrument 200. Accordingly, such hybrid otologic instruments are contemplated and encompassed within the scope of the present disclosure. The construction materials of the otologic instrument 300 can be the same as those described above with reference to the otologic instrument 200. The dimensions of the components of the otologic instrument 300 can be the same as those of the components of the otologic instrument 200 as described above.

[0101] In some embodiments, the longitudinal axis of the handle 310 and the longitudinal axis of the proximal-most portion of the instrument shaft 340 are collinear. As the instrument shaft 340 extends distally, the axis of the instrument shaft 340 is curved, or angled relative to the axis of the handle 310. This arrangement displaces the handle 310 off axis from the distal portion of the instrument shaft 340. This can create the potential to move the handle 310 further out of the field of view, thereby significantly improving the ability to visualize outside the ear canal 20, and so as to simultaneously use two instruments 300 without the handles 310 of the two instruments 300 interacting with each other. Additionally, the smooth curvature of the instrument shaft 340 can enable an actuation mechanism that requires tight tolerances or a significant coaxial structure within the shaft 340. In some embodiments, this longitudinal curvature of the instrument shaft 340 can result in the distal tip 346 being displaced from the longitudinal axis of the handle 310 by about 0.0 cm to 5.0 cm, about 1.0 cm to 5.0 cm, or about 2.0 cm to 5.0 cm.

[0102] Any type of end effector can be incorporated by the otologic instrument 300 at the distal tip 346. For example, Figure 14 -30 depicts various types of non-limiting end effectors that can be included as part of the otologic instrument 300. Accordingly, the otologic instrument 300 can be configured for multiple purposes, such as but not limited to grasping, cutting, tearing, cauterizing, infusing, suctioning, irrigating, as an endoscope, etc., and combinations thereof. Such end effectors can include angled blades or inner ear knives, forceps with varying angles or extendable forceps, microtrauma suction, side cutting scissors, round knives, middle ear knives (e.g., sickle knives), injection cannulas, and any other instrument that can be used in otologic surgery.

[0103] In some embodiments, the instrument shaft 340 (or a portion thereof) is actuable, steerable, and / or deflectable. In some cases, it is advantageous to make the steerable or deflectable instrument shaft 340 controllably move functionality away from the axis of the handle 310, particularly in the middle ear 40 where bony middle ear structures block a straight axis and create a blind angle. In some embodiments, the curvature, steerability, or deflection of the instrument shaft 340 allows the distal end of the instrument shaft 340 to extend at an angle of between 10° to 50°, 20° to 40°, 20° to 30°, or 10° to 30° relative to the longitudinal axis of the handle 210.

[0104] The otologic instrument 300 also includes an actuation mechanism 320. In the illustrated embodiment, the otologic instrument 300 includes a single actuation mechanism 320. In some embodiments, the otologic instrument 300 includes two or more actuation mechanisms (which can be the same type of mechanism or different types of mechanisms). The depicted actuation mechanism 320 is configured to be actuated by compressing the actuation mechanism 320. In some embodiments, other types of actuation mechanisms 320 can be included as part of the otologic instrument 300. For example, the actuation mechanism 320 can be one or more of a button, a trigger, a slider, a knob, a foot pedal, a valve, and the like, as well as combinations thereof.

[0105] The otologic instrument 300 also includes a handle 310. In some embodiments, the diameter of the handle 310 and any actuation mechanisms 320 can be reduced to about 4 mm to 8 mm to improve access and visualization.

[0106] The otologic instrument 300 can include markings along the handle 310 to indicate to the clinician 1 the direction of curvature of the instrument shaft 340, the direction of actuation of the instrument shaft 340 or end effector, and / or the direction of deflectability of the instrument shaft 340 or other portions of the otologic instrument 300. Some embodiments can have additional or combined markings on the instrument shaft 340 to aid in depth perception, which is advantageous when using an endoscope as one of the visualization instruments that does not have binocular vision or depth perception.

[0107] Reference is also made to Figure 11 and 12 various exemplary configurations of using two of the otologic instruments 300 at the same time are depicted. As is apparent from these views, the curvature of the instrument shaft 340 facilitates spacing apart the handles 310 so that the instruments 300 can be individually manipulated without interfering with each other.

[0108] Reference is made to Figure 13 and 14Another example otologic instrument 400 is configured to facilitate its use in a manner that facilitates direct visualization and / or simultaneous use of two otologic instruments 400, as further described below. The otologic instrument 400 includes a handle 410, an actuation mechanism 420, and an instrument shaft 440. The actuation mechanism 420 is coupled to the handle 410, or includes a portion of the handle 410. The instrument shaft 440 is coupled to the actuation mechanism 420 and / or the handle 410 and extends distally from the actuation mechanism 420 and / or the handle 410. The otologic instrument 400 can be reusable or disposable.

[0109] Any of the features of the otologic instruments 200 and 300 described above can be incorporated into the design of the otologic instrument 400. Moreover, any of the features of the otologic instrument 400 can be incorporated into the design of the otologic instruments 200 and 300. Accordingly, such hybrid otologic instruments are contemplated and encompassed within the scope of the present disclosure. The construction materials of the otologic instrument 400 can be the same as those described above with reference to the otologic instruments 200 and 300. The dimensions of the components of the otologic instrument 400 can be the same as those of the instruments 200 and 300 as described above.

[0110] The instrument shaft 440 includes an outer sleeve member 442 and an inner deflectable member 444. The outer sleeve member 442 can be curved (similar to the instrument shaft 340 described above). In some embodiments, the inner deflectable member 444 is slidably disposed within the outer sleeve member 442. The inner deflectable member 444 includes a distal tip 446.

[0111] The inner deflectable member 444 can be controllably deflected by the clinician 1. In some embodiments, the inner deflectable member 444 is selectively deflectable and can be deflected to achieve a minimum bend radius of between about 2 mm to 8 mm. It is contemplated that having a bend radius of the inner deflectable member 444 of between about 2 mm to 8 mm is advantageous in the relatively “tight” space of the middle ear 40. This is a smaller bend radius than can typically be achieved with various laser-cut metal hypotubes. In some embodiments, having a concentric series of polymer tubes, with the inner tube having large cutouts (larger than would be required for a steel or other metal hypotube), can allow the inner deflectable member 444 to preferentially bend to such a small bend radius that it is essentially a kink in the inner tube (e.g., of PEEK or PET material).

[0112] The otologic instrument 400 can include an end effector attached at the distal tip 446. Based on the disclosure herein, it will be clear that various types of end effectors can be included, particularly those sized and structured for use in the middle ear. For example, Figure 15-30 depicts various types of non-limiting end effectors that can be included as part of an otologic instrument 400. Thus, the otologic instrument 400 can be configured for multiple purposes, such as but not limited to grasping, cutting, tearing, cauterizing, infusing, suctioning, irrigating, as an endoscope, etc., and combinations thereof. Such end effectors can include angled blades or inner ear knives, forceps with varying angles or extendable forceps, microtrauma suction, side cutting scissors, round knives, middle ear knives (e.g., sickle knives), injection cannulas, and any other instrument that can be used in otologic surgery.

[0113] Also with reference to Figure 15 and 16 In some embodiments, the inner deflectable member 444 is controllably rotatable relative to the outer sleeve member 442 and the handle 410. Thus, the clinician 1 can rotate the inner deflectable member 444 to adjust the radial extension direction of the inner deflectable member 444 over a wide range of angles (e.g., 90°, 180°, 270°, 360°, or any position therebetween) relative to the longitudinal axis of the handle 410.

[0114] In the configuration of Figure 15 , the curvatures of the outer sleeve member 442 and the inner deflectable member 444 are in the same direction and thus are additive. In some embodiments, the steerable or deflectable nature of the distal portion 244 allows for alignment of the angle or curvature of the shaft with the angle or curvature of the handle 210 at any position between 60° and 300° from the angle or curvature of the handle 210. In contrast, in the configuration of Figure 16 , the curvatures of the outer sleeve member 442 and the inner deflectable member 444 are in opposite directions. Thus, it is contemplated that a wide range of configurations of the instrument shaft 440 are possible by rotating the inner deflectable member 444 relative to the longitudinal axis of the handle 410, and by deflecting the inner deflectable member 444.

[0115] In some embodiments, the otologic instrument 400 includes markings along the handle 410 that indicate to the clinician 1 the direction of rotation of the radial extension direction of the inner deflectable member 444 and / or the bend radius of the inner deflectable member 444. Some embodiments can have additional or combined markings on the instrument shaft 440 to aid in depth perception, which is advantageous when using an endoscope as one of the visualization instruments, which does not have binocular vision or depth perception.

[0116] Figure 17 -30 shows various types of end effectors that can be incorporated into any of the otologic instruments described herein. It should be understood that these end effectors are merely examples, and other types of end effectors can also be incorporated with any of the otologic instruments described above.

[0117] Figure 17An exemplary grasping device 500 that can be incorporated into any of the otologic instruments described herein is shown. One or both of the jaws of the grasping device 500 are moveably actuable by the clinician 1 to grasp tissue between the jaws.

[0118] Figure 18 An exemplary cutting device 600 that can be incorporated into any of the otologic instruments described herein is shown. The cutting device 600 includes a curved blade that is actuable by the clinician 1 to shear tissue. The tips of the blade can also be used to pierce and / or manipulate tissue.

[0119] Figure 19 An exemplary side-cutting scissors 700 that can be incorporated into any of the otologic instruments described herein is shown. The side-cutting scissors 700 includes laterally extending blades that are actuable by the clinician 1 to shear tissue. The tips of the blades can also be used to pierce and / or manipulate tissue.

[0120] Figure 20 An exemplary pick-up forceps 800 that can be incorporated into any of the otologic instruments described herein is shown. One or both of the jaws of the pick-up forceps 800 are moveably actuable by the clinician 1 to grasp tissue between the jaws. The tips of the jaws can also be used to pierce and / or manipulate tissue.

[0121] Figure 21 Another exemplary pick-up forceps 900 that can be incorporated into any of the otologic instruments described herein is shown. One or both of the jaws of the pick-up forceps 900 are moveably actuable by the clinician 1 to grasp tissue between the jaws. The tips of the jaws can also be used to pierce and / or manipulate tissue.

[0122] Figure 22 An exemplary coaxial bipolar diathermy instrument 1000 that can be incorporated into any of the otologic instruments described herein is shown. The coaxial diathermy instrument 1000 includes a probe 1010 and a distal tip 1020 that includes an electrode for delivering heat. Using the coaxial principle, the current flows only at the end face of the probe. It allows a function that is essentially a strong heat to be positioned at the very distal tip 1020 of the probe 1010. It is small in volume, has a terminal coagulation effect, and when used in conjunction with a low frequency diathermy device, allows such a probe to be used safely close to delicate tissue. Bipolar diathermy instruments have been used in the ear canal and outside the ear, but have in the past been too large and imprecise for middle ear surgery. Existing diathermy instruments in the field of otology have not been used in middle ear surgery for a variety of reasons, including the difficulty of accessing the middle ear or inner ear region, and because the bony structure of the middle ear blocks the straight-line approach angle to the desired target.

[0123] In some embodiments, the probe 1010 can be deflectable or steerable (as described above) for the purpose of deviating from the function of the adjacent shaft 1030. In other embodiments, an aspiration feature can be included in the same instrument to remove loose blood or thin clots from actively bleeding vessels and then immediately coagulate them. This same shaft bipolar diathermy instrument 1000 is highly advantageous and enables entirely new otologic surgical functions.

[0124] Figure 22A Optional modifications to the same shaft bipolar diathermy instrument 1000 are depicted. Diathermy therapy is a useful modality in surgery in general, and is not currently used in otology; neither in mastoid / open access procedures, in the external ear canal, in the middle ear, or in the inner ear applications. Adding other functions to diathermy therapy will further increase its utility beyond what is expected.

[0125] Adding illumination (as depicted by light 1022) is another useful function that can be optionally added to the same shaft bipolar diathermy instrument 1000. The diathermy instrument 1000 can have a light source mounted at the distal tip, or a fiber that carries light to the distal tip. In otologic surgery, adequate illumination can be problematic, especially in cases where the handle of the instrument being used blocks the light source. The middle ear and surrounding anatomy is composed of many small, complex structures that create corners that also block visualization and illumination, and on-board illumination for the diathermy probe instrument 1000 will greatly enhance its range of use as well as ease of use. The ability to control the light source close to the target tissue can also minimize the possibility of glare created by reflections off other surfaces, such as the tympanic membrane. Movement of the light source during operation can also cast shadows, allowing for more accurate identification of anatomical structures.

[0126] Aspiration (as depicted by arrow 1024) is another useful function that can be optionally added to the same shaft bipolar diathermy instrument 1000. Diathermy can be used primarily to control bleeding, as a way to cauterize small blood vessels in the middle ear cavity or ear canal. Adding an aspiration function will enable "one-handed" cauterization of blood vessels, while simultaneously clearing the surgical field of blood and other cauterized tissue. This two-part ability to manage bleeding will greatly ease the clinician's ability to quickly control bleeding, minimizing surgical time, minimizing the related opportunities for instrument switching and attendant tissue damage, reducing the number of personnel and hands in the surgical field, and generally easing the tedious tasks encountered in most surgical procedures.

[0127] Using the same shaft bipolar diathermy instrument 1000 in combination with built-in illumination 1022 and / or aspiration 1024 will result in a one-handed instrument 1000 that is highly suitable for use in otologic surgery, with a value greater than the sum of the individual functionalities expected.

[0128] Figure 23 and 24a- 24c shows an exemplary pneumatic suction cutter 1100 that can be incorporated into any of the otologic instruments described herein. 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 an internal lumen defined by the outer shaft 1110. Thus, as Figure 24a - As shown in 24c, tissue can be cut between the outer shaft 1110 and the inner reciprocating shaft 1120 (e.g., like a "guillotine" blade cutter). As portions of tissue are cut, they can be suctioned through the pneumatic suction cutter 1100, as shown.

[0129] The pneumatic suction cutter 1100 can be used, for example, to remove middle ear tissue and to refresh the edges of a tympanic membrane perforation during tympanoplasty (repair of the tympanic membrane). During tympanoplasty, the edges of an existing tympanic membrane perforation are first "refreshed" by removing tissue at the outer edge of the perforation. There is currently no precise instrument for performing this procedure, and typically more tissue than desired is removed, resulting in a larger perforation than desired, further complicating the subsequent repair procedure. A small pneumatic "guillotine" blade cutter with suction, provided by the pneumatic suction cutter 1100, can ensure a more precise cut of the outer edge. This can also be combined with liquid infusion or immersion of the middle ear and / or external ear canal. The pneumatic suction cutter 1100 can also be used to remove membrane and fibrous tissue in the middle ear.

[0130] In the case of an axially reciprocating blade of the inner reciprocating shaft 1120, the port defined by the outer shaft 1110 is most desirably positioned on the side of the outer shaft 1110 so that the target tissue is approached by the side of the instrument tip ("side-cut"). This orientation can be preferred, for example, when debriding the outer edge of a tympanic membrane perforation in preparation for graft placement or repair. A side-cut port can also be the ideal choice for removal of earwax from the ear canal wall.

[0131] Figure 25 An exemplary endoscope 1200 or light source 1200 is shown that can be incorporated into any of the otologic instruments described herein.

[0132] Figure 26 Another exemplary grasping device 1300 is shown that can be incorporated into any of the otologic instruments described herein.

[0133] Figure 27 An exemplary injection instrument 1400 is shown that can be incorporated into any of the otologic instruments described herein. The distal portion of the injection instrument 1400 can be steerable / deflectable or can have a natural curved shape that emerges as the distal portion is extended out of a proximal sleeve in which the distal portion is slidably disposed.

[0134] Figure 28An exemplary suction instrument 1500 that can be incorporated into any of the otologic instruments described herein is shown. In some embodiments, a distal portion 1510 of the suction device 1500 can include a tip member 1512 and a suction port 1514. The tip member 1512 can be used by the clinician 1 for various purposes such as, but not limited to, piercing tissue, lacerating tissue, dissecting tissue, retracting tissue, etc. The suction port 1514 can be used by the clinician 1 to apply suction to perform various tasks such as, but not limited to, removing fluid, removing particulate, clearing attachments on tissue for dissecting tissue, retracting tissue, stretching / lacerating tissue, etc.

[0135] Figure 29 An exemplary dilator device 1600 that can be incorporated into any of the otologic instruments described herein is shown. In some embodiments, a distal portion 1610 of the dilator device 1600 includes a first diverging member 1612a and an opposing second diverging member 1612b. The diverging members 1612a-1612b can be actuated by the clinician 1 to open / separate (as shown) as well as close. Thus, the dilating members 1612a-1612b can be used by the clinician 1 for various purposes such as, but not limited to, separating tissue, lacerating tissue, dissecting tissue, stretching tissue, retracting tissue, etc. In some embodiments, as depicted, the distal tips of the dilating members 1612a-1612b can be blunt, atraumatic tips. Figure 29

[0136] Figure 30 Another exemplary dilator device 1700 that can be incorporated into any of the otologic instruments described herein is shown. The dilator device 1700 can be used to dilate and tear open an open tissue such as a pseudomembrane in a manner very similar to that of the dilator device 1600 described above. However, in contrast to the blunt, atraumatic tips of the dilating members 1612a-1612b, the dilating members 1712a and 1712b of the dilator device 1700 include tip members 1714a and 1714b, respectively. As shown, the tip members 1714a-1714b can extend laterally at an angle from the axis of the dilator device 1700, the tip members 1714a-1714b can be used to pierce tissue such as a pseudomembrane. Thereafter, the dilating members 1712a and 1712b can be advanced distally and subsequently actuated open (as shown) by the clinician 1 to unroll the pseudomembrane so that access to the round window (e.g., into the round window niche and into the round window membrane) can be achieved. Figure 30

[0137] ​​While the dilator device 1700 includes dilating members 1712a and 1712b with tip members 1714a and 1714b extending laterally at an angle, in some embodiments, a side-cutting scissors can additionally or alternatively be used for the procedures described herein. Such a side-cutting scissors can include two blades that can be pivoted relative to one another to cut tissue therebetween. In some embodiments, a pair of blades (or end portions thereof) can extend laterally at an angle (e.g., 30° to 60° or 20° to 80°, but not limited thereto) from an axis of the scissors.

[0138] Other types of instruments, end effectors, and devices for delivering various other otologic treatment modalities are also contemplated and within the scope of the present disclosure. For example, an ultrasonic instrument for bone or tissue resection (e.g., cholesteatoma) can be incorporated into any of the otologic instruments described herein. That is, a small gauge ultrasonic instrument equipped with aspiration and infusion to clear debris can be used to clear small areas of bone adjacent to the facial nerve and other delicate structures. Such an instrument can be used to help debride bone of soft tissue, as in the case of cholesteatoma resection. The ability of the instrument to be “tuned” to remove specific tissue densities is highly advantageous to improve selectivity of tissue removal in cholesteatoma removal.

[0139] Further, a laser instrument can be incorporated into any of the otologic instruments described herein. Laser-based methods are a useful modality for surgical treatment that is currently only limited use in otology. A green laser can be particularly useful as it generally only applies heat in the presence of broken / exposed blood (due to the color of blood), which allows it to heat and cauterize blood without damaging underlying or adjacent tissue. These instruments have limited use in otology for a variety of reasons, including difficulty accessing the middle or inner ear regions, and due to the bony middle ear structure blocking a straight-line angle of attack to the desired target. In some embodiments, a functional tip laser probe has a tip that can be actuated to create off-axis maneuverability or functionality from an adjacent axis that would be highly advantageous and enable a whole new functionality for otologic surgery.

[0140] In all of the above instrument embodiments, any of the functional end effectors, handle angling, shaft bending or angling, markers, actuation mechanisms, maneuverability mechanisms, deflection mechanisms, and any other features described above can be combined in any sort of arrangement and embodiment.

[0141] References Figure 31In some cases, various otologic procedures described herein can be performed using the example otologic console system 1800. In current otologic surgical suites, there are multiple devices each with a separate operating console, e.g., lasers, cauterizers, drills, endoscopes, operating microscopes, etc. In addition, room suction is also used. In many cases, all of these devices are needed, and the surgeon and OR staff must move back and forth between consoles throughout the surgical case. In addition, there are some technologies that can be used in otologic surgery that are not currently supported in the OR, including microdiathermy as described above, pneumatic cutters, microsuction, and ultrasonic cutters / debriders.

[0142] The otologic console system 1800 is a single station or console that can support multiple modalities, allowing for synchronized functions of multiple instruments (e.g., infusion / aspiration, illumination / visualization, laser, etc.) and / or control of other therapeutic devices as described herein (e.g., pneumatic suction cutters, lasers, ultrasound, diathermy, middle ear immersion, etc.). The otologic console system 1800 generally includes one or more user displays 1810, one or more user input devices 1820, one or more control devices (e.g., the depicted footswitch 1830), and a control system 1840 having one or more processors, computer memory, and other control devices and systems.

[0143] In some embodiments, the otologic console system 1800 can include an adjustable room suction controller / restrictor. In particular embodiments, the otologic console system 1800 can include an integrated suction pump (e.g., a peristaltic pump) to allow for removal of microvolumes of fluid with finer control (including, e.g., volumetric control) and less trauma than simple room suction.

[0144] Room suction is often used in otologic surgery. Depending on the level of suction required and anatomical size constraints, various tip diameters are exchanged throughout the case. Suction tips are typically blunt metal, which can cause local trauma. While some suction instruments allow for on / off suction control by finger actuation, there is typically a lack of fine control of suction force. For example, in the case of cochlear electrode implantation, microliter volumes need to be removed from the delicate round window membrane. The otologic console system 1800 or a standalone control unit can be configured with a peristaltic or venturi pump to allow the clinician 1 to remove fluid with this precision.

[0145] A soft, flexible tip on the suction instrument would be advantageous to limit trauma. The design can also include a feature to prevent "sealing" against tissue, limiting the amount of direct suction that can be applied to structures such as the round window membrane or structures near the facial nerve. This can be achieved by a side slit, hole, or other feature that allows air to enter the instrument via an auxiliary route.

[0146] In some embodiments, aspiration from the console 1800 or controlled by the console 1800 can be controlled by actuation of the foot pedal 1830 to allow the clinician 1 to increase the amount of aspiration applied without the need for instrument exchange. The ability to adjust the amount of aspiration from continuous to a "on-demand" bolus microliter volume will allow the clinician 1 to fine tune the instrument according to the surgical situation, reducing potential trauma.

[0147] One or more foot pedals 1830 can provide hands-free control and actuation of the various instruments described herein. In some cases, even small translational movement of the instruments resulting from manual actuation can be detrimental in the middle ear space. Furthermore, many mechanical actuation mechanisms require the clinician 1 to move the instrument to conform to the movement at the distal tip (e.g., extendable forceps). Combining foot pedal 1830 actuation with an otologic instrument that remains stationary at the distal tip during actuation will greatly improve surgical precision.

[0148] Furthermore, the console 1800 can include plug-in support for one or more of the following: diathermy, laser probe, pneumatic handpiece, infusion, aspiration / suction, ultrasonic handpiece, drill bit, endoscope, and microscope control with footswitch control.

[0149] In some embodiments, the console 1800 is configured to control the infusion line into the middle ear 40 and the suction of the individual instruments to maintain a constant fluid volume and pressure. In either case, simultaneous infusion and suction will minimize the need for frequent instrument exchange and allow for more efficient clearing of blood and other debris.

[0150] Figure 32 -34B depicts an exemplary high-speed rotary suction tip cutter 1900 that can be incorporated into any of the otologic instruments described herein. The high-speed rotary suction tip cutter 1900 includes an outer shaft 1910 and an inner rotary shaft 1920. The inner rotary shaft 1920 rotates within a lumen defined by the outer shaft 1910. The end of the outer shaft 1910 defines an opening 1912 that can receive tissue therethrough. In the depicted embodiment, the opening 1912 is a circular segment (e.g., a quarter circle, a half circle, etc.). Thus, as shown, when tissue is captured in the opening 1912, the tissue can be cut between the outer shaft 1910 and the inner rotary shaft 1920 (e.g., like a "rotary shear" knife cutter). As portions of the tissue are cut, as shown, the portions of the tissue can be aspirated by the high-speed rotary suction cutter 1900. Figure 32

[0151] ​The high-speed rotating suction tip cutter 1900 can be used, for example, to remove middle ear tissue, to rework the edge surface of a tympanic membrane perforation, etc. in tympanoplasty (repair of the tympanic membrane). During tympanoplasty, the edges of an existing tympanic membrane perforation are first "refreshed" by removing tissue at the outer edge of the perforation. There is currently no precise instrument for performing this procedure, and typically more tissue than desired is removed, resulting in a larger perforation than desired, further complicating the subsequent repair procedure. A small rotating tip cutter, with suction as provided by the high-speed rotating suction tip cutter 1900, can ensure more precise cutting of the tissue. This can also be combined with liquid infusion or immersion of the middle ear and / or external ear canal. The high-speed rotating suction tip cutter 1900 can also be used to remove membrane and fibrous tissue in the middle ear.

[0152] While the tip of the depicted high-speed rotating suction tip cutter 1900 is blunt, in some embodiments the tip can be beveled, tapered, rounded, etc.

[0153] Removal of material (e.g., tissue, bone, etc.) can be performed using the high-speed rotating suction tip cutter 1900. Cutting is achieved at the interface of the inner wall at the location of the inner rotating shaft 1920 and the opening 1912 of the outer shaft 1910. The shape and location of the opening 1912 can be configured for optimal contact with the target tissue or material. Since the cutting action occurs just inside the outer surface of the instrument 1900 (on the order of 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 tissue while maximizing removal of the target material. In some embodiments, a suction channel down the center of the instrument 1900 can help pull target material into the opening 1912 to facilitate cutting. In some embodiments, the level of suction force and cutting speed of the instrument 1900 can be adjusted by a central console (e.g., the console 1800 of FIG. 1) based on the mechanical properties of the target and surrounding tissue. Suction can also immediately remove cut or shredded material from within the surgical field. Figure 31

[0154] In some cases, such as removal of material from the bony surface of the middle ear, it can be advantageous to position the cutting action at the end of the instrument ("end cutting"), as provided by the high-speed rotating suction tip cutter 1900. In this case, a rotating blade is preferred. In this case, the instrument tip can be blunt, rounded, beveled, or conical, with the cutting blade shape and orientation reflecting the shape and orientation of the opening 1912 to achieve an effective shearing or scissor-like cut.

[0155] Figure 34B ​An alternative inner rotation axis 1920a is depicted. In this example, the inner rotation axis 1920a has two end openings. The two end openings provide two tissue cuts per revolution (compared to a single tissue cut per revolution provided by the inner rotation axis 1920).

[0156] The dimensions of the high-speed rotary suction tip cutter 1900 are suitable for the application. In the case of cerumen removal, in some embodiments the outer diameter of the high-speed rotary suction tip cutter 1900 will be in the range of 0.4 mm to 4 mm in outer diameter, and preferably less than 2 mm in diameter. The distal shaft portion that is inserted into the ear canal will be 25-70 mm long, preferably about 50 mm long. The diameter of the handle portion will preferably be smaller so as not to obstruct visualization of the target area. The handle portion can be at an angle or curve relative to the distal shaft, or the distal shaft itself can have a curve.

[0157] Figure 35 - 37B shows another example instrument according to some embodiments. This is an ultrasonic instrument 2000 that can be used for the fragmentation or emulsification of cerumen and / or target tissues (e.g., cholesteatoma, pseudomembrane, and bone). The ultrasonic instrument 2000 generally includes a handle 2010 and a distally extending shaft 2020. Ultrasonic energy is delivered at least from the distal tip portion of the shaft 2020.

[0158] During many otologic procedures, material is encountered that is adjacent to tissue or bone that needs to be maintained or protected, while still desiring removal of the target material. For example, cholesteatoma is an abnormal skin growth in the middle ear that is well suited for targeted material removal. Pseudomembranes, such as those that cover the round window niche, are common growths that will need to be removed to facilitate access to the round window niche and membrane. Highly specific bone resection is useful for many procedures in the external ear, middle ear, and inner ear.

[0159] Cerumen is a material that is produced in the cartilaginous portion of the external ear, and is generally beneficial, but can become harmful if produced in excess or not balanced by the natural removal processes (epithelial migration and jaw movement). Excess cerumen or cerumen plugs can impede sound transmission, causing mild conductive hearing loss, pain, itching, and even a tympanic membrane perforation if the cerumen is pushed further into the ear. A variety of factors, including genetics and hearing aid use, can cause excess cerumen. Genetics, in particular, determine whether a given individual has wet cerumen or dry cerumen.

[0160] Cerumen removal by an otolaryngologist, neurologist, or other specialist is often performed by curettage, either for the patient's benefit or in preparation for other otic procedures. While curettage is the primary method, it is not without risk, as the edges of a typical metal curette are sharp and can easily damage the ear canal wall or cause intense pain to the highly sensitive ear canal wall.

[0161] Impacted earwax can also be performed by a primary care clinician or even as a home procedure. The use of ear swabs is not recommended as these often push the earwax further into the ear and risk eardrum perforation. Typical procedures to remove earwax often include the use of a softening agent (earwax dissolver) as a preparatory step followed by irrigation. Often, the earwax dissolver needs to be used multiple times a day for 3-5 days prior to irrigation, which can be a cumbersome step that presents challenges to compliance. These earwax removal procedures are surprisingly common, with up to 150,000 ears irrigated per week in the United States. Unfortunately, irrigation is often performed poorly and complications such as infection (otitis), dizziness, pain, vertigo, tinnitus, and especially eardrum injury or perforation can occur. Major complications occur in one in a thousand ears.

[0162] The ultrasonic instrument 2000 advantageously provides a method and apparatus for removing earwax that can selectively remove earwax without damaging the tube wall or eardrum. The ultrasonic instrument 2000 is easy to use and is otherwise advantageous as it can expand the care setting (e.g., moving the method from a specialist clinic to primary care, or from primary care to home use).

[0163] The use of ultrasonic emulsification (e.g., as provided by the ultrasonic instrument 2000) or the use of cutting (e.g., as provided by the high-speed rotating suction tip cutter 1900 above) is highly advantageous for removing earwax among other uses. The energy frequency, tip geometry, or other properties of the ultrasonic instrument 2000 can be modulated to be selective to the material (e.g., earwax) while still limiting damage to adjacent tissue or skin (e.g., ear canal skin). The ultrasonic instrument 2000 can degrade or emulsify the target material. If the ultrasonic instrument 2000 already has built-in suction, it can suction the earwax while emulsifying the earwax to effectively remove the earwax in a precise and easily visualized manner. The precision and ease of visualization are other methods that can limit damage to adjacent tissue. Thus, the use of such an ultrasonic emulsifier to remove earwax would be superior to existing earwax removal in many ways for an otolaryngologist, but also accessible and usable by a primary clinician in a way that can reduce common complications associated with existing methods.

[0164] Ultrasonic instruments are often used with a liquid medium surrounding the target tissue to conduct the ultrasonic energy. However, in otolaryngology, procedures are often performed without the target area being submerged or liquid-encapsulated, and the surgical space encountered is often air-filled. For example, the middle ear is one of the rare air-filled cavities in the body, as opposed to being liquid-filled. Thus, it can be envisioned that ultrasonic cutting or emulsification is challenging without the need for higher energy delivery, which can rapidly damage the instrument due to excessive heat generation. It has been observed that the use of existing ultrasonic cutters or morcellators in air at room temperature rapidly leads to instrument failure and breakage.

[0165] It is contemplated that for use in an inflated cavity or space that is easily accessible and capable of being filled with a liquid medium (e.g., filling the external ear canal with saline), this method of filling the space with a liquid medium would be advantageous to enable the use of instruments that are typically problematic to use in air.

[0166] Ultrasound instrument 2000 addresses the problem of using an ultrasonic cutter / debrider in air. In some embodiments, ultrasound instrument 2000 has an additional cooling mechanism inside the distal shaft 2020. Referring to Figure 36A The various exemplary cross-sectional views shown in E, in some embodiments, the shaft 2020 defines one or more channels that can serve as internal cooling mechanisms to deliver a liquid. For example, the shaft 2020 can define an outflow channel (toward the distal tip portion) and an inflow channel (toward the proximal handle 2010) that allow fluid flow to transfer heat away from the distal tip of the shaft 2020.

[0167] It is contemplated that the inflow and outflow channels (which are connected) can extend along the shaft 2020 in various configurations, such as to allow straight (linear), helical, oscillating (sawtoothed), or other paths / shapes of fluid and air flow and associated movement of thermal energy. The channels can be cut from or embedded into the shaft 2020 of the device 2000, or free-floating within the shaft 2020 and made of metal (e.g., stainless steel, titanium, or other metals) or polymer (e.g., silicone, polyurethane, PDMS, nylon, or other) materials. The channels can be located primarily in the center of the shaft 2020, or primarily in the outer region of the shaft 2020 (as shown in Figs. Figure 36B The channels can have a cross-section that is circular (e.g., Figs. Figure 36A , 36D and 36E), arcuate annular (e.g., Figs. Figure 36B ), hemispherical, semicircular (e.g., Figs. Figure 36C ), or other shapes. Channels primarily on the outer portion of the shaft 2020 can be advantageous to allow increased contact area and protection of the patient from heat generated by the internal elements.

[0168] The fluid used for liquid cooling (e.g., heat transfer fluid) can be water, saline, deionized water, ethylene glycol / water solution (ethylene or propylene glycol), ethanol, alcohol, high viscosity oil, dielectric fluid (e.g., fluorocarbon and PAO), silicone oil, viscoelastic material (e.g., sodium hyaluronate based), or other fluid suitable for heat transfer. The fluid can even be a pressurized gas medium, which is typically a gas at ambient pressure. Fluids with better biocompatibility (e.g., water-based) will be preferred to reduce the risk associated with device breakage and to facilitate the manufacture, sterilization, and packaging of the device. Ideally, the heat transfer fluid has high thermal conductivity. Cavitation and convection associated with the ultrasonic delivery of energy can result in additional cooling. The fluid can be supplied to the ultrasonic instrument 2000 when cooling below room temperature or at room temperature.

[0169] It is contemplated that in some embodiments there can be a single outflow (towards the distal tip) fluid flow, e.g., by irrigation. This would allow cooling of the shaft 2020 while also supplying a limited amount of liquid in the target region at the distal tip, which would add the points of acting as a conductive medium and increasing the efficacy of the energy delivery / reducing the energy required to degrade or emulsify the target material.

[0170] It is also contemplated that a single suction or aspiration passageway / channel would serve as another heat transport mechanism to help with cooling. Thus, for either the outcoming channel or the incoming channel, they can have multiple configurations (as described above) to help increase the contact area or heat transfer efficiency.

[0171] It is contemplated that having both an irrigation channel and an aspiration channel within the shaft 2020 would obtain the respective benefits while effectively acting as a cooling mechanism for the ultrasonic instrument 2000. The irrigation and aspiration through the ultrasonic instrument 200 can be controlled by a central console (e.g., the console 1800 described with reference to Figure 31 The temperature within the ultrasonic instrument 2000 can be monitored by the console 1800, which can trigger an increase in the irrigation and / or aspiration rate as needed to maintain cooling.

[0172] Figure 36A -E shows various types of shafts 2020 in cross-section. Each has a first channel 2022a and a second channel 2022b. In some embodiments, the shaft 2020 has only a single channel 2022a or 2022b. The channels 2022a-2022b can be used to transport cooling fluid or for aspiration and / or irrigation. Figure 36A Embodiments of shafts 2020 that are solid except for the channels 2022a-2022b having circular cross-sections are depicted. Figure 36B Embodiments of shafts 2020 that are solid except for the channels 2022a-2022b having arcuate annular cross-sections are depicted. Figure 36CAn embodiment of a hollow shaft 2020 is depicted, and the shaft 2020 defines a channel 2022a-2022b having a semi-circular cross-section. Figure 36D An embodiment of a hollow shaft 2020 is depicted, and the shaft 2020 includes two parallel tubular channels 2022a-2022b having circular cross-sections. Figure 36E An embodiment of a hollow shaft 2020 is depicted, and the shaft 2020 defines / includes two concentric channels 2022a-2022b having circular cross-sections (although channel 2022a is actually an annular / circular or toroidal cross-section).

[0173] In another embodiment, the ultrasound instrument 2000 has one or more heat sinks (e.g., with fins) along the shaft 2020 that define channels to circulate air outward (toward the distal tip) and inward (toward the proximal handle). This configuration can utilize conduction and convection (as applicable) to transfer heat.

[0174] It is contemplated that other methods or mechanisms for local cooling of the shaft 2020 (e.g., thermoelectric cooling) would be advantageous due to efficacy, size, efficiency, or manufacturing cost. Thermoelectric cooling utilizes the application of an electric current to create a heat exchange between a heat source and a heat sink, and thus functions as a solid-state heat pump. It is contemplated that the heat sink can be placed in the handle 2010 of the ultrasound instrument 2000 or more proximally to allow heat to be transferred away from the heat source at the distal tip and shaft 2020. An additional advantage of thermoelectric cooling is that no moving parts are required, which potentially improves the reliability and ease of manufacturing of the device, while also eliminating concerns about a heat transfer medium with potential leaks.

[0175] As another method of being able to use the ultrasound instrument 2000 in an air environment, piezoelectric elements suitable for higher temperatures can be used. There are many ferroelectric / piezoelectric materials available, such as zirconium-titanate lead PZT, modified PZT, aluminum titanate Bi4Ti30i2, modified aluminum titanate, lithium titanate LiNb03, LNN based on LiNb03, lead metatitanate PbNb206, modified lead titanate, modified lead metatitanate, orthophosphoric acid hydrogen galileo GaP04, aluminum nitride AIN, BMT-PT, BS-PT, sol-gel spray-on films, and other materials can be considered for such use.

[0176] In all of the above instrument embodiments, any of the functional end effector, handle angulation, shaft bending or angulation, marker, actuation mechanism, steerable mechanism, deflection mechanism, irrigation or aspiration channel, and any other feature described above can be combined in any sort of arrangement and embodiment.

[0177] The devices, systems, materials, compounds, compositions, articles, and methods described herein can be understood by reference to the foregoing detailed description of specific aspects of the disclosed subject matter. However, it should be understood that the foregoing aspects are not limited to particular devices, systems, methods, or particular reagents, and thus can vary. It should also be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.

[0178] While the instruments disclosed herein are primarily described in the context of otologic surgery, either in the external ear or using a transcanal trans-tympanic approach to access the middle ear, it should be understood that these instruments are not limited to these uses. For example, in some embodiments, the instruments described herein can be used in combination with other access approaches and techniques, including but not limited to trans-mastoid access, trans-tympanic access through a tympanic membrane flap, intra-aural access, post-aural access, post-aural point access, nasopharyngeal access, any of the previously described approaches to achieve access to the Eustachian tube, and other approaches.

[0179] A number of embodiments have been described. Nevertheless, it will be understood that various modifications can be made without departing from the scope of the claims presented herein. Accordingly, other embodiments are within the scope of the following claims.

Claims

1. A surgical instrument configured to perform an otological procedure within the middle ear of a patient, the instrument comprising: The handle, which defines the longitudinal axis of the handle; An actuating mechanism, which is connected to the handle; as well as An instrument shaft extending distally from the handle along a longitudinal axis, wherein the distal end of the instrument shaft is configured to enter the middle ear. A non-zero angle is defined between the longitudinal axis and the longitudinal handle axis. The instrument axis includes a proximal portion, a distal portion, and a distal tip, wherein the proximal portion and the distal portion are defined along a longitudinal axis, and the distal portion is deflectable relative to the proximal portion.

2. The instrument according to claim 1, wherein, The instrument is an injection device configured to deliver a therapeutic agent into the middle ear.

3. The instrument according to claim 1, wherein, The instrument is an injection device configured to deliver a therapeutic agent into a circular niche within the middle ear.

4. The instrument according to claim 1, wherein, The instrument in question is a pair of tweezers.

5. The instrument according to claim 1, wherein, The instrument in question is a heat transfer instrument.

6. The instrument according to claim 1, wherein, The instrument in question is a tissue aspiration and cutting instrument.

7. The instrument according to claim 1, wherein, The instrument in question is an ultrasonic instrument.

8. The instrument according to claim 1, wherein, The instrument includes an angled portion that is connected to and extends distally from the handle and the actuation mechanism.

9. The instrument according to claim 8, wherein, The instrument shaft is connected to the angled portion and extends distally from the angled portion.

10. The instrument according to claim 8, wherein, The angle between the longitudinal handle axis and the longitudinal shaft axis is limited to the range of 10° to 70°.

11. The instrument according to claim 8, wherein, The angle between the longitudinal handle axis and the longitudinal shaft axis can be selectively adjusted.

12. The instrument according to claim 1, wherein, The instrument provides radial rotation of the distal portion of the instrument shaft relative to the handle.

13. The instrument according to claim 1, wherein, The diameter of the proximal portion of the instrument shaft is larger than the diameter of the distal portion.

14. The instrument according to claim 1, wherein, The diameter of the distal portion is in the range of 0.02 mm to 1.1 mm.

15. The instrument according to claim 1, wherein, The instrument includes an end effector attached to the distal tip of the instrument shaft.

16. The instrument according to claim 15, wherein, The end effector includes at least one of the following: an angled blade or inner ear knife, a forceps with adjustable angle or an extendable forceps, a microtrauma suction device, a side-biting scissor, a circular knife, a middle ear knife, and an injection cannula.

17. The instrument according to claim 1, wherein, The actuation mechanism is attached to the handle and is actuated by compressing the actuation mechanism.

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