Hinged otology suction tube and suction tube system

Abstract

An otological instrument includes a handle configured to be held by a surgeon's hand and a cannula extending outwardly from and mounted to the handle. An articulating tube is positioned at least partially within the cannula and extends at least partially outward from the distal end of the cannula. An actuator is configured to articulate the articulation tube relative to the cannula to position the distal end of the aspiration tube at a plurality of locations within the three-dimensional volume. The actuator may be configured to control extension of the articulated tube relative to the sleeve, the articulated tube assuming a curved shape when not deformed. The actuator may be configured to pull a cable within the articulated tube or push a pushrod within the articulated tube to adjust the curvature of the articulated tube.

Description

Background Technology

[0001] During middle ear surgery in otology, it is often necessary to aspirate various fluids, debris, and tissues from the middle ear cavity, including infusion fluid, blood, tissue, and bone dust. A suction cannula can be used for this purpose. Additionally, a suction cannula can be used to remove cholesteats and infected tissue. A suction cannula can be particularly helpful in reaching cholesteats that are normally difficult to access, especially deep within the ear and behind corners.

[0002] Currently, during ear surgery, whenever a curved or straight suction tube is needed, surgeons must change or exchange the instruments they hold to perform the procedure. Furthermore, the diameter of the patient's ear canal often limits the possible curvature and reach of the current suction tube, as curved suction tubes are typically introduced through the ear canal.

[0003] These limitations may make it difficult for surgeons to apply minimally invasive surgical techniques during ear surgeries, as access to the middle ear cavity for aspiration usually requires inserting a suction tube into the ear canal and through an incision near the tympanic membrane to enter the middle ear cavity. Summary of the Invention

[0004] In some embodiments, an otological instrument includes a handle configured for gripping by a surgeon's hand and a cannula extending outward from and attached to the handle. A hinge tube is at least partially located within the cannula and extends at least partially outward from a distal end of the cannula. An actuator is configured to hinge the hinge tube relative to the cannula to position the distal end of the hinge tube at multiple locations within a three-dimensional volume. Attached Figure Description

[0005] To gain a detailed understanding of the features described above, reference can be made to the embodiments for a more specific description of the briefly summarized disclosure, some of which are illustrated in the accompanying drawings. However, it should be noted that the drawings illustrate exemplary embodiments only and should not be construed as limiting the scope of the disclosure, and other equally effective embodiments are permissible.

[0006] Figure 1 The illustration shows a schematic cross-sectional view of a human ear in the prior art.

[0007] Figure 2 It is an isometric map of an otological instrument according to certain embodiments.

[0008] Figure 3A and Figure 3B This is a side view of a first embodiment of a hinge tube according to certain embodiments.

[0009] Figure 4A This is a side view of a second embodiment of the hinge tube according to certain embodiments.

[0010] Figures 4B to 4D This is a cross-sectional view of a second embodiment of the hinged tube.

[0011] Figure 5A and Figure 5B This is a side view illustrating alternative embodiments of an otological device according to certain embodiments.

[0012] Figure 6A This is a side view of a first embodiment of an instrument housing according to certain embodiments.

[0013] Figure 6B This is a cross-sectional view along section line 6B of the first embodiment of the instrument housing.

[0014] Figure 6C This is a front view of the first embodiment of the device housing.

[0015] Figure 7A This is a side view of a second embodiment of the device housing according to certain embodiments.

[0016] Figure 7B This is a cross-sectional view along section line 7B of the first embodiment of the instrument housing.

[0017] Figure 7C This is a cross-sectional view along section line 7C of the first embodiment of the instrument housing.

[0018] Figures 8A to 8K The illustrations depict different mechanisms for increasing the tension of a suture in a surgical instrument, according to certain embodiments.

[0019] For ease of understanding, the same reference numerals have been used where possible to refer to the same elements common to the figures. It is contemplated that elements and features of one embodiment can be advantageously combined in other embodiments without further description. Detailed Implementation

[0020] The human ear consists of the auricle (1) and the ear canal (2). The auricle is the fleshy part of the ear that protrudes outward from the skull, while the ear canal passes through the skull to reach the middle ear (3). In adults, the ear canal (2) extends from the auricle (1) to the tympanic cavity (4) and is approximately 2.5 cm long and 0.7 cm in diameter. The tympanic cavity (4), or tympanic membrane, separates the ear canal (2) from the middle ear (3). The tympanic cavity (4) is connected to the cochlea via ossicles (5), which contains vibration-sensitive hairs for detecting sound. The middle ear (3) is further connected to the cranial sinuses via the eustachian tubes (7).

[0021] For transauricular surgery, a cannula 10 is inserted through the ear canal 2 into the middle ear 3. Typically, the cannula 10 is inserted through a tympanic membrane flap. This flap is created by making a series of incisions in the tissue surrounding the tympanic cavity 4. The tympanic membrane flap is then lifted to allow access to the middle ear 3 behind the tympanic cavity 4, for example, by inserting the cannula 10. Surgical instruments can pass through the cavity of the cannula 10. In typical otological surgery, aspiration is applied to the middle ear 3 to remove infected tissue, pus, cholesteatoma, lavage fluid, blood, or debris (such as bone fragments and other tissue) generated by the otological procedure. Accordingly, a hinged tube 12 can be inserted through the cannula 10 into the middle ear 3 to aspirate material from within the middle ear 3. In some cases, the hinged tube 12 can also be used to grasp tissue or as an additional instrument for manipulating tissue by pushing.

[0022] Many different conditions can affect the middle ear cavity, leading to hearing loss in affected patients. Hearing loss is typically treated with middle ear surgery, which involves inserting delicate instruments, such as those through the ear canal. Diagnosis and surgical treatment present significant challenges due to the difficulty in visualization, limited accessibility, and the fragility of related anatomical structures (e.g., ossicles, tympanic cavity, oval window). These difficulties and limitations make it difficult for surgeons to apply minimally invasive techniques, and they often must utilize more invasive methods (e.g., postauricular approach or mastoidectomy) to achieve sufficient visualization and accessibility to successfully treat patients' conditions.

[0023] Accordingly, the articulated tube 12 may need to be bent to reach certain areas. The required degree of curvature and the orientation of the curvature plane will change throughout the aspiration process. The articulated tube 12 can be implemented as an articulated tube 12 according to any embodiment disclosed herein to implement varying radii of curvature and orientation. In the following description, reference is made to transauricular otology. It should be understood that the embodiments disclosed herein provide at least some benefits when used in transmastoid surgery. For example, the articulated tube can be used when performing mastoidectomy to remove a large cholesteatoma. In some cases, the same procedure may include both a transmastoid approach and a transauricular approach, each using the articulated tube 12. The surgeon may use either the transmastoid approach or the transauricular approach which is more suitable for accessing a particular cholesteatoma.

[0024] refer to Figure 2 The surgical instrument 20 includes a handle 22, which is held by the surgeon performing the ear surgery. In a typical procedure, the surgeon's other hand will manipulate a second instrument while using the surgical instrument 20 to provide suction. However, as discussed below, the surgical instrument 20 can perform functions beyond providing suction.

[0025] Instrument 20 is connected to a vacuum source 26, such as a vacuum pump, via tube 24. The supply of vacuum pressure through tube 24 can be controlled via input device 26a, such as a foot pedal operated by a surgeon, a button on handle 22, or other input devices, such as a touchscreen, voice command processing device, gesture detection device, etc. In the illustrated embodiment, tube 24 enters handle 22 through proximal end 28, wherein cannula 10 protrudes from distal end 30 of handle 22.

[0026] The cannula 10 extends from the proximal end 32, which is fixed to the handle 22, to the distal end 34. The cannula 10 may be straight between the proximal end 32 and the distal end 34, or it may be curved. For example, the cannula 10 may be curved to generally conform to the curvature of the ear canal 2. The cannula 10 may be implemented as a tube made of metal (such as nitinol, steel, or aluminum) or a rigid or flexible polymer. The cannula 10 may be configured to remain substantially undeformed during use, or to flex to conform to the ear canal 2 when positioned in the ear canal 2 such that the distal end 34 of the cannula 10 is located within the middle ear 3, or to flex in response to movement of the handle.

[0027] The hinge tube 12 protrudes from the distal end 34 of the sleeve 10 and extends to the distal end 38 of the hinge tube 12. The distal end 38 defines an opening for aspiration of material. This opening may be located at the end face of the hinge tube 12, or the end of the hinge tube 12 may be closed, and one or more openings for aspiration of material may be formed on the side of the distal portion of the hinge tube 12. During operation, the hinge tube 12 will flex, and is therefore made of a material that can flex elastically without failure. The bending capability of the hinge tube 12 may be due to the properties of the material and / or features formed in the hinge tube 12 (discussed below). Therefore, the hinge tube 12 may be made of a metal (such as nitinol, steel, or aluminum) or a rigid or flexible polymer. The hinge tube 12 is sized to fit within the lumen of the sleeve 10, and the sleeve itself is sized to fit within the ear canal 2.

[0028] In different embodiments, the total length of the sleeve 10 ranges from 4 cm to 15 cm, and the outer diameter ranges from 0.4 mm to 10.0 mm, more particularly from 0.4.0 mm to 5.0 mm, and even more particularly from 0.4 mm to 3.0 mm. The length of the hinge tube 20 can range from 0.5 cm to 2.0 cm, and the outer diameter can range from 0.4.0 mm to 10.0 mm, more particularly from 0.4 mm to 5.0 mm, and even more particularly from 0.4 mm to 3.0 mm.

[0029] The portion of the articulated tube 12 located between the distal end 34 of the sleeve 10 and the distal end 38 of the articulated tube 12 can exhibit multiple radii of curvature in multiple bending planes. For example, within a bending plane of approximately 0.5 mm, the bending plane intersects the axis 36 of the sleeve 10, which is parallel and collinear with the axis of symmetry of the inner cavity of the sleeve 10. When the sleeve 10 is bent, the axis 36 can be defined as a line extending from the distal end 34 of the sleeve and tangent to the curve defined by the centerline of the sleeve 10 at a point within 0.1 mm of the distal end 34. The length of the suction tube 12 between the distal end 34 of the sleeve 10 and the distal end 38 of the suction tube 12 can also be adjustable.

[0030] For example, section 40 of handle 22 may include a gripping portion 42 for engaging with a surgeon's finger holding handle 22. One or more control structures may be positioned on or near section 40. For example, the one or more control structures may include one or more sliders 44 mounted to handle 22 and directly or indirectly connected to cannula 10 or aspiration tube 12. Slides 44 may be engaged by the surgeon's thumb or other fingers to adjust the relative position of cannula 10 and aspiration tube 12. For example, movement of slider 44 toward distal end 30 of handle 22 may extend cannula 10 over aspiration tube 12, thereby retracting aspiration tube 12 relative to cannula 10. Movement of slider 44 toward proximal end 28 of handle 22 may retract cannula 10 into handle 22, thereby extending aspiration tube 12 relative to cannula 10. When the slider 44 is coupled to the suction tube 12, the movement is reversed: movement of the slider 44 toward the distal end 30 will extend the suction tube 12 relative to the sleeve 10, and movement of the slider 44 toward the proximal end 28 will retract the hinge tube 12 relative to the sleeve 10. Although the slider 44 is shown, other actuators, such as deformable baskets, push-buttons, or other manually actuated structures, can be used.

[0031] One or both of the sleeve 10 and the articulated tube 12 can be rotated relative to the handle 22. Therefore, the articulated tube 12 can be connected to the tube 24 via a rotary pneumatic fitting to facilitate this rotation while still maintaining a seal between the articulated tube 12 and the tube 24. For example, a control structure mounted to the handle 22 may include a knob 46 or other control structure such that actuation of the knob 46 will rotate one or both of the sleeve 10 and the articulated tube 12 relative to the handle 22. In this way, the plane of curvature of the articulated tube 12 can lie in multiple planes intersecting the axis 36. In other words, by adjusting the radius of curvature of the articulated tube 12 and its orientation about the axis 36, the distal end 38 of the articulated tube 12 can be positioned at multiple points within a three-dimensional volume surrounding the distal end 34 of the sleeve 10.

[0032] It should be noted that in some embodiments, the cannula 10 and the articulated tube 12 are not rotatable relative to the handle 22. In such embodiments, the surgeon can perform a rotational movement 48 of the handle 22 itself to achieve the same range of movement of the distal end 38 of the articulated tube 12.

[0033] refer to Figure 3A and Figure 3B In some embodiments, the hinge of the hinge tube 12 is performed in conjunction with the sleeve 10. In the illustrated embodiment, the suction tube 12 in its undeformed state is... Figure 3B The illustrated curved shape necessitates that the suction tube 12 deform to fit within the sleeve 10. However, positioning within the sleeve 10 requires only elastic deformation of the suction tube 12. The radius of the undeformed hinge tube 12 can be constant or can vary with distance from the distal end 38. For example, in the illustrated embodiment, the radius of curvature decreases with distance from the distal end 38. In other embodiments, the radius of curvature can increase with distance from the distal end 38. The radius of curvature of the distal end 38 can have a single value or include values ​​ranging from 0.1 mm to 10 mm.

[0034] By varying the length of the articulated tube 12 extending outward from the distal end 34 of the sleeve 10, the distal end 38 of the articulated tube 12 can be positioned at different locations relative to the distal end 34 of the sleeve 10. The further the articulated tube 12 extends, the greater the radial outward extension of the distal end 38 from the axis 36 of the sleeve 10. This range of motion of the articulated tube 12, coupled with the translational range of the sleeve 10 itself, allows the distal end 38 of the articulated tube 12 to be arbitrarily positioned within the middle ear 3 in three dimensions, including extending around obstacles.

[0035] In some embodiments, the hinge tube 12 is made of a formable material, allowing the surgeon to deform it into a desired shape manually or using tools. The hinge tube 12 can then extend beyond the cannula 10 to a desired point within the middle ear 3, which, as described above, can include rotation of the hinge tube 12. The deformation required to pass the hinge tube 12 through the cannula 10 can be smaller than the deformation required to completely or partially release the deformation performed by the surgeon. Using this method, the surgeon can shape the hinge tube 12 into various shapes throughout an otological procedure to approximate a desired location within the middle ear 3.

[0036] As another alternative, the surgeon can be equipped with a set of articulated suction tubes 12 with different radii of curvature, different curve shapes, or other variations in length or characteristics, and can attach a selected articulated suction tube 12 to the handle 22 at any time during the procedure to reach the desired location within the middle ear 3.

[0037] refer to Figure 4A , Figure 4B and Figure 4CIn alternative embodiments, the articulated tube 12 can be actuated by a cable, push rod, or other actuator to change the radius of curvature of the articulated tube 12 and the corresponding position of the distal end 38. In such embodiments, the undeformed shape of the articulated tube 12 can be straight or curved, with a constant or varying radius of curvature.

[0038] The articulated connector 12 may include one or more regions with different mechanical properties relative to the rest of the articulated connector 12 to facilitate bending, such as bending in a primary bending plane. In the illustrated embodiment, the primary bending plane is parallel to the page. Providing one or more regions with different mechanical properties along the length of the articulated connector 12 such that the force required to bend the articulated connector 12 in the primary bending plane is less than 50%, 25%, or 10% of the force required to bend the articulated connector 12 in a plane defined as perpendicular to the primary bending plane and intersecting the centerline of the articulated connector 12 at one, two, or more points (e.g., when the articulated connector 12 is straight). Providing one or more regions with different mechanical properties along the length of the articulated connector 12 may also make the force required to bend the articulated connector 12 in one direction (“primary direction”) in the primary bending plane less than 50%, 25%, or 10% of the force required to bend the articulated connector 12 in the opposite direction in the primary bending plane.

[0039] In the illustrated embodiment, each of one or more regions with different mechanical properties is implemented as partially extending through a notch 50 through the hinge tube 12. The notch 50 can be cut by laser cutting, co-molding with the hinge tube 12, or other cutting processes. The notch 50 can be cut perpendicular to the main bending plane from the hinge tube 12. The notch 50 can extend inwardly into the hinge tube 12 from the concave side (hereinafter referred to as the "concave side") of the hinge tube 12 when bent in the main direction in the main bending plane, from the side opposite the concave side (hereinafter referred to as the "convex side"), or both sides. When the hinge tube 12 is at its maximum extension, the notch 50 can be distributed along all or a portion (e.g., at least 50%) of the portion of the hinge tube 12 extending outward from the sleeve 10.

[0040] In the illustrated embodiment, the distal portion of the articulated tube 12 (e.g., 1 mm to 10 mm distal) includes one or more through-hole lateral slots 52. The distal portion may not have a notch 50. One or more lateral slots 52 may be cut perpendicular to the bending plane from the articulated tube 12. In the illustrated embodiment, the elongated dimension of the one or more lateral slots 52 is substantially (e.g., within 5 degrees) parallel to the centerline of the articulated tube 12 on which the one or more lateral slots 52 are formed. The slots 52 may facilitate bending and deformation of the distal portion, whether in response to an actuating force or an external force acting on the distal portion.

[0041] For details, please refer to the following: Figure 4B and Figure 4C Each slot 50 may include a portion 54 that extends through the hinged tube 12 from one side, such as extending inward from the concave side. The width of the portion 54 is parallel to the centerline of the hinged tube 12, and this width decreases as the hinged tube 12 bends in the principal direction within the principal bending plane. Figure 4C As shown in the figure. When the hinge tube 12 is not deformed, the width can be 0.01 to 0.1 times the outer diameter of the hinge tube 12.

[0042] Each groove 50 may include an arcuate portion 56 extending to both sides of portion 54, such as extending across the deepest point of portion 54. The arcuate portion 56 may be arcuate downwards toward the centerline of the hinge tube 12 and / or toward the concave side. The arcuate portion 56 may be symmetrical or asymmetrical with respect to the center of portion 54. When the hinged suction tube is not deformed, the radius of curvature of the arcuate portion 56 may be 0.5 to 1 times the outer diameter of the hinge tube 12, and when straight, its extension along the centerline of the hinge tube 12 is 0.3 to 1 times the outer diameter of the hinge tube 12. When the hinge tube 12 is not deformed, the thickness of the arcuate portion 56 may be 0.01 to 0.1 times the outer diameter of the hinge tube 12. Figure 4C As shown, when the articulated tube 12 bends in the main direction in the main bending plane, the thickness of the arc groove 56 decreases.

[0043] In some embodiments, the convex side may have an expansion groove 58 extending inwardly from the convex side. The depth of the expansion groove 58 may be smaller than the depth of the groove 50 from the concave side inward, for example, less than 50%, less than 25%, or less than 10%. When undeformed, the expansion groove 58 may have a small thickness (parallel to the centerline when the hinge tube 12 is straight), for example, not as wide as the cut width of the process used to form the expansion groove 58. For example, the thickness of the expansion groove 58 may be less than 0.1 mm, 0.01 mm, or less than one micrometer. In the illustrated embodiment, the expansion groove 58 is positioned between the grooves 50, for example, positioned at the midpoint between the grooves 50. Figure 4C As shown, when the articulated tube 12 bends in the main direction in the main bending plane, the expansion groove 58 widens.

[0044] The configuration of slots 50, 52, and 58 is merely exemplary. Other configurations may be used. For example, the configuration of U.S. Patent 10,085,883 may be used. Figure 3A Any slotted end design up to Figure 3H used to implement the articulated tube 12 is hereby incorporated herein by reference in its entirety.

[0045] Cable 60 extends within hinge tube 12 such that it extends across multiple slots 50 and is secured to hinge tube 12 near its distal end 38 (e.g., within 10 mm, 5 mm, 1 mm, or 0.1 mm). In the illustrated embodiment, cable 60 extends within hinge tube 12 and is secured to hinge tube 12 closer to the concave side than the convex side, such that cable 60 can be tensioned to bend hinge tube 12 in the main direction within the main bending plane. Cable 60 may be secured to suction tube 12 in the distal portion as defined above, or it may be secured to suction tube at some other point offset from the distal end 38 by a greater range.

[0046] refer to Figure 4D In other embodiments, cable 60 may be implemented as a push rod 66. The push rod may extend along the hinge tube 12 and may be fixed to the hinge tube closer to the convex side than the concave side.

[0047] The hinge tube 12 may be made of an elastic material such that when the tension on the cable 60 is removed or the pressure on the push rod 66 is removed, the hinge tube 12 will spring back to its undeformed shape within the range allowed by any resistance of the material in contact with the suction tube 12 in the middle ear 3.

[0048] In embodiments including cable 60 or push rod 66, slider 44 may be coupled to cable 60 or push rod 66 to bend or straighten the articulated suction cannula in response to input from a surgeon. Slider 44 may be derived from U.S. Patent 10,085,883. Figures 4A to 4D Any of the mechanisms shown are connected to cable 60 or push rod 66. Alternatively, cable 60 or push rod may be driven by an electric actuator, pneumatic actuator, hydraulic actuator, or other type of actuator that receives input from the surgeon.

[0049] In some embodiments, the articulated tube 12 is actuated by the cable 60 or the push rod 66, and can also extend and retract relative to the sleeve 10. Accordingly, a second slider 44 or other input device may be mounted to the handle 22 and coupled to the articulated tube 12 or the sleeve 10 to cause relative movement between the articulated tube 12 and the sleeve 10, as described above with respect to the slider 44.

[0050] In the illustrated embodiment, one or more sleeves 62, 64 are positioned within the cavity of the articulated tube 12. At least one sleeve 62 may be used to provide a sealed path through the articulated tube 12 and prevent fluid from flowing into the cavity of the sleeve 62 through the slots 50, 52, and 58. In some embodiments, an additional sleeve 64 may be positioned between the sleeve 62 and the articulated tube 12 such that a cable 60 or push rod 66 is positioned between the sleeves 62 and 64 to hold the cable 60 or push rod 66 and isolate the cable 60 or push rod 66 from the environment of the articulated tube 12. One or more sleeves 62, 64 may be made of the same material as the articulated tube 12 or a different material. For example, the sleeves 62, 64 may be made of a polymer that is more flexible than the polymer used to form the articulated tube 12, for example, a polymer with a hardness at least 10, 25, or 50 units lower on the Shore A scale or Shore D scale.

[0051] exist Figure 3A , Figure 3B , Figure 4A , Figure 4B , Figure 4C and Figure 4D In the embodiments described, the movement (and corresponding springback movement) of the articulated tube 12 bending in a main direction within a single main bending plane is discussed. However, the articulated tube 12 can be articulated in other ways. For example, multiple cables 60 and / or push rods 66, as configured above, can be arranged at different locations around the circumference of the articulated tube 12 to achieve bending in multiple bending planes. Similarly, slots can define different bending planes, such as a first set of slot patterns defining a first bending plane and a second set of slot patterns defining a second bending plane and oriented at 90 degrees relative to the first set of slot patterns around the circumference of the articulated tube 12. Likewise, within a single bending plane, one cable 60 and / or push rod 66 can be used for bending in one direction, and another cable and / or push rod for bending in another direction. In such embodiments, one or more regions with modified mechanical properties can be omitted or selected to facilitate bending in more than one bending plane.

[0052] refer to Figure 5A and Figure 5B The handle 20 can have different configurations. In the illustrated embodiment, the handle 20 includes a portion 20b that is offset from and angled relative to the portion 20a to which the cannula 10 is fixed. The portion 20b is configured to be grasped by a surgeon's hand, and its longest dimension can be between 10 cm and 20 cm. For example, the portion 20a can define an axis 70, which can be defined as the axis of symmetry of the portion 20a, the axis of rotation of the knob 46, or the axis of symmetry of the portion of the cannula 10 positioned within the portion 20a. Therefore, the portion 20b can be angled relative to the axis 70. Figure 5A and Figure 5B The angle of portion 20b relative to axis 70 can be defined as the angle between the orientation of the longest dimension of portion 20b (either the axis of symmetry or the longest dimension of asymmetrical portion 20b) and axis 70. The offset can be achieved by connecting portion 20a to portion 20b and extending portion 20c outward from axis 70. The amount and angle of the offset of portion 20b relative to portion 20a ensure that the surgeon's hand holding portion 20b does not obstruct the view of the ear canal 3 during otological surgery. For example, the offset can be between 1 cm and 5 cm. The angle can be between 15 degrees and 45 degrees, such as between 25 degrees and 40 degrees, so that the total length of handle 20 between the proximal end 28 and the distal end 30 is between 15 cm and 25 cm. Figure 5A and Figure 5B In some embodiments, the slider 44 can be mounted to portion 20a, portion 20b, or portion 20c. In particular, the flexibility of the cable 60 allows it to adapt to different terrains. Figure 5A and Figure 5B The offset and / or angle variation of the embodiments allows the slider 44 to be positioned at any ergonomic location on portion 20a, portion 20b, or portion 20c.

[0053] refer to Figures 6A to 7C Various modifications can be made to the device 20 described herein. For example, the articulated tube 12 can be used for additional or alternative purposes. For example, multiple medical devices that can be deployed using the articulated tube 12 may include some or all of the following: • A tube that supplies vacuum pressure. • A tube used to provide irrigation fluid (e.g., saline). • Tubes used for infusing drugs, gels, foams, viscoelastic materials or other materials. • One or more optical fibers that transmit light to the middle ear 3. • One or more optical fibers that conduct light from the middle ear 3 to a camera, endoscope, or other imaging device. • One or more optical fibers used to transmit laser light to the middle ear for ablation or other treatments. • A cable connected to an ultrasonic imaging transducer located at or near the distal end 38 of the articulated tube 12 (e.g., within 2 mm). • A tube for conducting pressurized gas for inflation or other purposes. • Waveguides used for conducting electromagnetic waves in diathermy therapy.

[0054] Any of the medical devices listed above may be statically positioned within the hinge tube 12, either alone or as a group of two or more devices.

[0055] refer to Figures 6A to 7C The device 20 according to any of the above embodiments may include a device housing 80 configured to deploy a plurality of medical devices via a hinge tube 12 to perform transauricular medical assessment, diagnosis, treatment, or surgery in the middle ear 3. Each of the plurality of medical devices may include (a) a single medical device among the medical devices listed above, or (b) two or more of the medical devices listed above combined into a single structure or otherwise deployed as a single medical device (as described below).

[0056] The device housing 80 enables each of a plurality of medical devices to be selectively deployed and guided into the articulated tube 12 one at a time from a single tiered location, in any order. Figures 6A to 7C In one embodiment, multiple medical devices are housed in an instrument housing 80, which is positioned in an external environment outside the body for use by a surgeon or other medical professional. The instrument housing 80 is operatively coupled to the articulated tube 12, for example, by attachment to its proximal end. The instrument housing 80 may be mounted to a handle 22, or it may be located away from the handle 22 and coupled to the articulated tube 12 via a tube 24 or other tubing.

[0057] For details, please refer to the following: Figure 6A The instrument housing 80 may define a longitudinal axis 82. The longitudinal axis 82 may be substantially parallel (e.g., within 5 degrees) and substantially collinear (e.g., within 0.1 mm) with the centerline of the hinge tube 12 at the attachment point between the tube 12 and the instrument housing 80. Components of the instrument housing 80 may be made of metal (such as stainless steel, aluminum, or nitinol) or rigid polymer.

[0058] The device housing 80 may include a portion 84 defining an inner cavity 86, such as a cylindrical inner cavity that is cylindrical about a longitudinal axis 82. The exterior of the portion 84 may also be cylindrical and centered on the longitudinal axis 82. The diameter of the inner cavity 86 may be substantially the same as the diameter of the inner cavity of the hinge tube 12 (e.g., within 0.1 mm). The hinge tube 12 abuts the portion 84 to receive a medical device inserted through the inner cavity 86.

[0059] The device housing 80 includes a receiving portion 88 that defines a plurality of receptacles 90. The receiving portion 88 may have a cylindrical outer surface centered on an axis 82 or some other external shape. The receptacles 90 may be implemented as cylindrical apertures whose axes are substantially (e.g., within 5 degrees) parallel to axis 82. The receptacles 90 may have any distribution within the receiving portion 88 and any number may be accommodated within the receiving portion 88, while being large enough to accommodate multiple medical devices. For example, there may be 2 to 20 or 2 to 5 receptacles 90. See, for example, [reference needed]. Figure 6B Five cavities 90 may exist, evenly distributed around axis 82. The cavities 90 extend parallel to axis 82 and completely through the receiving portion 90. Each cavity 90 receives a device 92 from multiple medical devices, which may be cylindrical or non-cylindrical in shape. The size of the cavity 90 is configured to allow the device 92 to slide freely through the cavity 90.

[0060] The receiving portion 88 is connected to the portion 84 via a tapered portion 94. The tapered portion 94 has a tapered cavity 96 that facilitates a smooth transition between the receiving portion 88 and the cavity 86. For example, the tapered cavity 96 may be truncated conical in shape. The outer surface of the tapered portion 94 may also be truncated conical in shape. The proximal opening 98 of the cavity 96 is configured to overlap with the cavity 90 and may be configured to extend outward from all cavities 90 perpendicular to axis 82, for example, extending outward by 1 mm to 3 mm. The distal opening 100 of the tapered portion 94 may be substantially the same size as the cavity 86 of the portion 84 (e.g., within 0.1 mm). The edge between the tapered cavity 96 and the cavity 84 may be beveled or chamfered to facilitate access of the medical device into the cavity 84. The length of the conical lumen 96 along the axis 82 and the corresponding cone angle of the lumen 96 can be selected to smoothly guide each medical device 92 from the cavity 90 into the lumen 84. The length and cone angle can be selected based on the flexibility of the device 92 used. For example, the length can be one to three times the diameter of the lumen 84, and the cone angle can be between 15 degrees and 45 degrees.

[0061] Each cavity may have a corresponding manipulator 102, which is coupled to the cavity or substantially (e.g., within 0.1 mm) aligned with the cavity in a plane perpendicular to axis 82. The manipulator 102 may be implemented as a manually actuated actuator or an actuator controlled by electrical signals, hydraulic pressure, or pneumatic pressure. Each manipulator engages with an instrument 92 to translate the instrument 92 out of the corresponding cavity 90, through the conical inner cavity 96, into the articulated tube 12. The manipulator 102 is also configured to retract the instrument 92 back into the cavity 90 after use. The manipulator 102 may be manually actuated by the surgeon or activated by a robot or computer system coupled to the manipulator 102 in response to input received from the surgeon.

[0062] In use, the surgeon selects instrument 92 and actuates or activates the manipulator 102 corresponding to the cavity 90 containing instrument 92. The manipulator 102 then pushes instrument 92 through the conical cavity 96, cavity 84, and into the actuation tube 12 (see...). Figure 6CIt should be noted that, when the first instrument 92 is already present in the actuation tube 12, the process of deploying the second instrument 92 includes using the operating device 102 corresponding to the cavity 90 to retract the first instrument into the cavity 90 corresponding to the second instrument 92.

[0063] refer to Figures 7A to 7C In some embodiments of the device housing 88, the receiving portion 88 is rotatable relative to the portion 84. In such embodiments, the portion 84 may be offset relative to the axis 82, for example, by the same amount as the offset of the center of the cavity 90 of the receiving portion 88 relative to the axis 82. The portion 84 may be statically mounted to the mounting portion 110. The receiving portion 88 may be rotatably mounted to the mounting portion, for example, by a journal pin 112, wherein the axis of rotation of the receiving portion 88 is substantially parallel to and substantially collinear (e.g., within 2 degrees) with the axis 82 (e.g., within 0.1 mm). The mounting portion 110 defines an inner cavity 114 that is substantially aligned with an inner cavity 86 (e.g., within 0.1 mm), and its diameter is substantially the same as the diameter of the inner cavity 86 of the portion 84 (e.g., within 0.1 mm). The mounting portion 110 and the portion 84 may be integrally formed. The diameter of the inner cavity 114 may be substantially the same as the diameter of the cavity 90 (e.g., within 0.1 mm), or it may be larger. The inner cavity 114 may taper, for example, between a diameter larger than or substantially the same as the diameter of the cavity and a diameter substantially equal to the diameter of the inner cavity 86.

[0064] The receiving portion 88 can be manually rotated relative to the mounting portion 110. A locking portion or other structure may facilitate alignment of the cavity 90 relative to the inner cavity 114. A gripping portion 116, knurling, rubber surfaces, or other structures may be provided on the outer surface of the receiving portion 88 to assist the surgeon in rotating it. Alternatively, rotation of the receiving portion 88 may be performed by an electronic, mechanical, pneumatic, or hydraulic actuator in response to input from the surgeon. For example, the positioning of the actuator on the receiving portion 88 may be controlled by a computer in response to input received from the surgeon.

[0065] exist Figures 7A to 7C In this embodiment, the actuating device 102 can function as described above. Specifically, assuming the first instrument 92 is currently positioned within the hinge tube 12, Figures 7A to 7CAn embodiment may include: activating an actuating device 102 corresponding to the first cavity 90 to retract the first instrument 92 into the first cavity 90; rotating the receiving portion 88 to align the second cavity 90 with the inner cavity 114 of the mounting portion 110; and activating an actuating device corresponding to the second cavity 90 to translate the second instrument 92 through the inner cavity 114, the inner cavity 86, and into the hinge tube 12. In an alternative method, a single actuating device 102 is used, and this single actuating device engages only with any instrument 92 currently aligned with the inner cavity 114 in the cavity 90.

[0066] Now for reference Figures 8A to 8K According to certain embodiments of surgical instruments 810 (e.g., otological instruments as described above) that utilize a drawstring 822 to actuate, for example, a hinged tube 820, different mechanisms (discussed in further detail below) can be used to increase the tension of the drawstring 822. For example, such as Figures 8A to 8K As illustrated, the surgical instrument 810 may include a channel 814 and two optical fibers 824 and 826. In some embodiments, the cable 60 described above may utilize the mechanism described below with respect to the draw cable 822.

[0067] exist Figure 8A and Figure 8B In this configuration, a pull wire 822 is wound around a pinion 840 fixed between a control button 842 and a base 844. The pinion 840 includes two surfaces: a small-diameter surface r that rolls between the control button 842 and the base 844; and a large-diameter surface R around which the pull wire 822 is wound. As the pinion 840 rotates and translates, the radial difference between the small-diameter surface r and the large-diameter surface R causes a differential displacement Δl in the pull wire. By selecting appropriate diameters for the small-diameter surface r and the large-diameter surface R, a relatively small displacement Δl of the pull wire can be achieved during relatively large translations of the control button, allowing the user to precisely control the deflection of the articulated connector 820, which may include a slotted end design. In one embodiment, the small-diameter surface r includes gear teeth, and the control button 842 and the base 844 have matching gear teeth. This reduces the likelihood of slippage.

[0068] Figure 8C and Figure 8D The diagram illustrates a lever arm 850 having a sliding actuating pin 852, which is held in place by a retaining pin 854 located at the arm's pivot. A control button can be used to advance the sliding pin 852, allowing the proximal portion of the lever arm 850 to rise, thus rotating the tether 856 at the distal end of the lever arm 850 to apply tension to the drawline 822. Figure 8E and Figure 8FA pull cable 822 is shown, which passes through a sliding pin 860 and a first retaining pin 862, and is anchored to a second retaining pin 864. Pushing a control button 866 attached to the sliding pin 860 increases the tension in the pull cable 822.

[0069] Figure 8G and Figure 8H The diagram illustrates a pull wire 822 threaded through a sliding pin 870. As the control button 874 is pushed forward, a guide rail 872 guides the sliding pin in a generally upward direction. The path of the guide rail 872 determines how the tension in the pull wire 822 changes with the advancement of the control button, thus allowing the tension to increase smoothly and in a controlled manner. Figure 8G and Figure 8H In the case of linear guidance illustrated in the diagram, the cable will tighten in the later stages of pushing the control button 874. Figure 8I In the alternative configuration shown, the guide rail 872 is reshaped to provide greater tension to the cable at the start of the push-to-push motion of the control button 874, thereby increasing the tension more evenly throughout the stroke of the control button 874. Figure 8J In the middle, the guide rail 872 is tilted even more sharply, so that most of the tension increase occurs in the early stroke of the control button 874. Figure 8K An alternative embodiment of guide rail 872 is illustrated, which has a locking portion 880, thereby allowing different “stops” along paths corresponding to different angles of the articulated tube 820. A shelf or surface with a locking portion can also be used with any of the embodiments of otological instruments using sliding pins or similar actuation mechanisms presented herein, including... Figures 8A to 8K Any of the embodiments shown.

[0070] As used herein, the phrase “at least one” in the list of items refers to any combination of these items, including a single member. For example, “at least one of a, b, or c” is intended to cover a, b, c, ab, ac, bc, and abc, as well as any combination of multiples of the same element (e.g., aa, aaa, aab, aac, abb, acc, bb, bbb, bbc, cc, and ccc, or any other order of a, b, and c).

[0071] Although some embodiments relate to transcanal methods of otological surgery, the aspects described herein can also be applied to transmastoid and similar methods.

[0072] The foregoing description is provided to enable any person skilled in the art to practice the various embodiments described herein. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein can be applied to other embodiments. Therefore, the claims are not intended to limit them to the embodiments shown herein, but are given the full scope consistent with the language of the claims.

[0073] In the claims, unless specifically stated otherwise, references to singular elements are not intended to mean "one and only one," but rather "one or more." Unless otherwise specifically stated, the term "some" means one or more. All structural and functional equivalents of elements in all aspects described throughout this disclosure that are known or will be known hereafter by one of ordinary skill in the art are expressly incorporated herein by reference and are intended to be covered by the claims. Furthermore, nothing disclosed herein is intended for public disclosure, whether or not such disclosure is expressly stated in the claims. According to 35 USC The provisions of 112(f) shall not construe any element of a claim unless it is expressly described using the phrase “means for…” or, in the case of a method claim, using the phrase “steps for…”. The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any aspect described herein as “exemplary” shall not be construed as preferred or advantageous over other aspects. Example Implementation

[0074] Example 1: A method for performing an ear surgery, the method comprising: inserting a cannula into the middle ear of a patient; and actuating a suction tube relative to the cannula such that the distal end of the suction tube is moved to a plurality of positions within a three-dimensional volume of the middle ear, the suction tube being at least partially located within the cannula and at least partially extending outward from the distal end of the cannula.

[0075] Example 2: The method as described in Example 1 further includes at least one of the following: (a) inserting the cannula through the patient's ear canal and past the tympanic membrane flap in a transauricular procedure; or (b) inserting the cannula through the mastoid opening in a transmastoid procedure.

[0076] Example 3: The method described in Example 1 further includes supplying vacuum pressure to the suction tube.

[0077] Example 4: The method as described in Example 1 further includes rotating the suction tube relative to the middle ear.

[0078] Example 5: The method as described in Example 4, wherein rotating the suction tube relative to the middle ear includes at least one of the following: rotating the handle on which the sleeve is mounted relative to the middle ear; and rotating the suction tube relative to the handle.

[0079] Example 6: The method as described in Example 1, wherein actuating the suction tube relative to the sleeve comprises at least one of the following: (a) extending the suction tube outward relative to the sleeve, the suction tube being curved in an undeformed shape; and (b) applying a force to at least one of a push rod and a cable extending within and fixed to the suction tube, the suction tube comprising one or more regions having mechanical properties such that the suction tube has a primary bending plane, such that a first force required to bend the suction tube in a primary direction in the primary bending plane is less than 50 percent of a second force required to bend the suction tube in a plane perpendicular to the primary bending plane and intersecting the centerline of the suction tube.

Claims

1. An otological instrument, comprising: A handle, configured to be held by a surgeon's hand; A sleeve that extends outward from the handle and is installed to the handle; A hinged tube, which is at least partially located within the sleeve and extends at least partially outward from the distal end of the sleeve; as well as An actuator configured to hinge the articulated tube relative to the sleeve to position the distal end of the articulated tube at multiple locations within a three-dimensional volume.

2. The otological device as described in claim 1, wherein, At least one of the hinged tube or the sleeve is rotatably mounted to the sleeve.

3. The otological instrument of claim 2, further comprising a control structure mounted to the handle and configured to rotate at least one of the articulated tube or the sleeve in response to interaction with the control structure.

4. The otological device as described in claim 1, wherein, The sleeve is installed to a first portion of the handle, the handle including a second portion that is offset relative to the first portion and at least one of being at an angle.

5. The otological instrument as described in claim 1, wherein, The hinge tube is curved when it is not deformed; and The actuator is configured to control the amount by which the articulated tube extends outward from the distal end of the sleeve.

6. The otological device as described in claim 5, wherein, The actuator is a slider mounted to the handle.

7. The otological device as described in claim 6, wherein, The actuator is configured to move the sleeve relative to the hinge tube.

8. The otological device as described in claim 6, wherein, The actuator is configured to move the articulated tube relative to the sleeve.

9. The otological device as described in claim 1, wherein, The actuator is at least one of a push rod and a cable that extends within the hinge tube and is connected to the control structure.

10. The otological device as claimed in claim 9, wherein, The articulated tube includes one or more regions with mechanical properties, such that the articulated tube has a primary bending plane, such that a first force required to bend the articulated tube in the primary direction in the primary bending plane is less than 50 percent of a second force required to bend the articulated tube in a plane perpendicular to the primary bending plane and intersecting the centerline of the articulated tube.

11. The otological device as claimed in claim 10, wherein, The one or more regions include one or more grooves distributed along the hinge tube.

12. The otological instrument of claim 1, further comprising a vacuum source coupled to the articulated tube.

13. The otological device of claim 1, further comprising one or more medical devices configured to be inserted through the hinge tube, the one or more medical devices being selected from the group consisting of: A tube used to supply vacuum pressure; Tubes used to provide irrigation fluid; A tube for infusing at least one of the following: drugs, gels, foams, or viscoelastic materials; Pipes used for transmitting pressurized gas; One or more optical fibers; The cable connected to the ultrasound imaging transducer; and Waveguides used to conduct electromagnetic waves for diathermy therapy.

14. The otological device as claimed in claim 13, wherein, The one or more medical devices include a plurality of medical devices, and the otological device further includes an instrument housing, the instrument housing including a plurality of cavities, each cavity being configured to receive one or more of the plurality of medical devices, the instrument housing being configured to selectively guide an instrument of the plurality of medical devices into the articulated tube.

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