Intracochlear administration device
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- SENSORION
- Filing Date
- 2024-07-12
- Publication Date
- 2026-07-30
Smart Images
Figure 2026525421000001_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to an administration device for administration inside the inner ear of a patient.
Background Art
[0002] Today, to address hearing impairments, especially genetic diseases, a wide range of treatment approaches are sometimes required, including the administration of liquids inside the inner ear of a patient.
[0003] It is well known that the human ear comprises an outer ear 101 (visible part), a middle ear 102, and an inner ear 103 (see FIG. 1). One of the challenges of administering liquids to the inner ear 103 relates to delivering an appropriate amount of liquid directly to the inner ear 103, such as the cochlea 104. This type of administration is difficult because the inner ear 103 is well known to be surrounded by very hard bone (called the otic capsule), except for two semi-permeable membranes 105, 106 that are exposed to the middle ear 102. - The round window 105 closed by the round window membrane (RWM), and - The oval window 106 closed by the oval window bone plate (OW).
[0004] In summary, the outer ear 101 captures sound, which is then transmitted to the eardrum M for amplification and adjustment by the ossicles of the middle ear 102. Thereby, sound waves 200 can be carried through the oval window 106 into the inner ear 103, which then causes movement of the liquid within the cochlea 104. T It is well known that there are two types of liquids present within the inner ear 103.
[0005] - Endolymph (within the cochlear duct), as well as - Perilymph (within the vestibule and tympanic canaliculi of the facial nerve). -(in the vestibule and tympanic canaliculi of the facial nerve) Both fluids are separated by a membrane, and therefore the structure of this inner ear 103 looks somewhat like a "balloon within a balloon" arrangement. The fluid compartments containing the perilymph and endolymph are isolated from the systemic circulation by a blood-inner ear barrier called the blood labyrinth barrier, which consists of tight junctions and other intercellular structures that restrict access of molecules to inner ear objects.
[0006] Therefore, any system for delivering medication to address disorders of the inner ear 103 should allow for the direct administration of fluid to the inner ear 103 (particularly directly to the cochlea 104), and the most accessible and surgically validated route is through the round window membrane 105.
[0007] The literature, U.S. Patent Application Publication No. 2021 / 154452A1 and International Publication No. 2021 / 242926A1, exemplifies the latest technology.
[0008] Furthermore, the amount of fluid to be administered must take into account the need to maintain at least the amount of perilymph (which is known to be fundamental in the physiology of the inner ear) if homeostasis is not maintained, and therefore should be kept relatively small, in the range of 40-90 μL, depending on the patient's biostructure. To optimize the dosage and thus the accuracy of the dose, the flow rate should also be controlled very precisely. This prevents high pressure that could damage internal structures, especially hair cells.
[0009] In this regard, the present invention intends to propose a catheter specifically designed for use in an ENT setting to access a patient's inner ear and perform discrete and / or puncture-type small doses, regardless of the biostructure, while limiting the risks associated with the procedure. "ENT" stands for "ear, nose, and throat" specialist, and it is a common designation for an otolaryngologist. Furthermore, the design of the present invention proposes a device that can be connected to an active device, in relation to ensuring increased and optimized control over key administration parameters, which are dose and flow rate. [Prior art documents] [Patent Documents]
[0010] [Patent Document 1] U.S. Patent Application Publication No. 2021 / 154452A1 [Patent Document 2] International Publication No. 2021 / 242926A1 [Overview of the Initiative]
[0011] Accordingly, the present invention relates to an elongated passive administration device configured to be introduced into the cochlea of a patient's ear, the administration device comprising a liquid conduit having three sections that extend along a liquid administration axis X and are arranged along the liquid administration axis X, each section having an inner diameter and an outer diameter, - Upward flow section having a first inner diameter and a first outer diameter - Intermediate section having a second inner diameter and a second outer diameter - A descending flow section having a third inner diameter and a third outer diameter, configured to be introduced into the inside of the patient's ear. The first inner diameter is smaller than the third inner diameter, and the first outer diameter is larger than or equal to the third outer diameter.
[0012] Thus, this solution achieves the above objectives. In particular, it makes it possible to obtain a device that presents a variable inner diameter / outer diameter ratio, which allows for improved control of flexibility and administration pressure, and thus improves the safety of administration.
[0013] The apparatus according to the present invention may include one or more of the following features, either separately or in combination with each other. - The third inner diameter of the downflow section is the same as the second inner diameter. - The first outer diameter is larger than the third outer diameter. - An elongated dispensing device may include a transition section having an upward flow end connected to an upward flow section and a downward flow end connected to an intermediate section, wherein the transition section presents an increasing inner diameter, the inner diameter being equal to a first inner diameter at the upward flow end of the transition section and equal to a second inner diameter at the downward flow end. - The outer diameter of the transition section may be equal to the outer diameter of the first section. - An elongated dispensing device may include a sealing section or sealing portion having an upward flow end connected to an intermediate section and a downward flow end connected to a downward flow section, the sealing section or sealing portion having a decreasing outer diameter, the outer diameter being equal to a first outer diameter at least at the upward flow end of the sealing section or sealing portion and equal to a third outer diameter at the downward flow end. - An elongated dispensing device may include a sealing section or sealing portion having an upward flow end connected to an intermediate section and a downward flow end connected to a downward flow section, the sealing section or sealing portion presenting a decreasing outer diameter, the outer diameter being equal to a first outer diameter at least at the upward flow end of the sealing section or sealing portion and slightly larger than a third outer diameter at the downward flow end - The outer diameter of the upward flow end of the sealing section or sealing portion may be larger than the first outer diameter. - The inner diameter of the sealing section or sealing portion may be equal to the second inner diameter. - The sealing section or portion may exhibit a roughly conical shape. - The descending end may present a tip with a flat edge. - Downstream sections may present at least one depth marker. - The updraft section may exhibit less flexibility than the downdraft section. - The first outer diameter is 0.6 to 2 mm, and the first inner diameter may be in the range of 0.1 mm to 0.2 mm. - The second outer diameter may be in the range of 0.5 to 2 mm. - The second inner diameter may be in the range of 0.25 mm to 0.35 mm. - The third outer diameter is in the range of 0.5 to 0.7 mm. - The upward flow section may include a connection portion at the upward flow end that presents an external thread configured to connect the administration device to an active administration device.
[0014] The present invention further aims to provide an administration kit comprising an elongated passive administration device exhibiting at least one of the technical features presented above, and an active administration device configured to be connected to the elongated passive administration device.
[0015] The present invention also aims to provide a method of administration. This is carried out by the administration kit described above, and follows - A step of connecting the connection portion of the rising flow section to an active dispensing device, wherein the active dispensing device contains the liquid to be administered, - A step of priming the device, - A step of performing visual control to ensure that no air or bubbles are present in the liquid conduit after priming has been performed, - A step to remove residual air / bubbles, - The steps include positioning the descending flow section of the administration device at the administration site in the patient's ear, - The steps of activating the active administration device and administering the liquid to be administered via the passive administration device towards the patient's inner ear, and Includes.
[0016] The present invention will be better understood, and other purposes, details, features, and advantages will become clearer, by referring to the accompanying drawings and reading the following detailed description of embodiments of the invention, where purely illustrative and non-limiting examples are given as illustrations. [Brief explanation of the drawing]
[0017] [Figure 1] This is a schematic diagram of a human ear. [Figure 2] This is a schematic diagram of the administration device according to the present invention, which is inserted into the inside of a patient's ear. [Figure 3] This is a perspective view of one embodiment of the apparatus according to the first embodiment of the present invention. [Figure 4a] This is a cross-sectional view of an upward flow section according to a first embodiment of the present invention. [Figure 4b]This is a cross-sectional view of an intermediate section according to the first embodiment of the present invention. [Figure 4c] This is a cross-sectional view of a sealing section according to a first embodiment of the present invention. [Figure 4d] This is a cross-sectional view of a downflow section according to a first embodiment of the present invention. [Figure 5] This is a perspective view of one embodiment of the apparatus according to a second embodiment of the present invention. [Figure 6a] This is a cross-sectional view of an upward flow section according to a second embodiment of the present invention. [Figure 6b] This is a cross-sectional view of an intermediate section according to a second embodiment of the present invention. [Figure 6c] This is a cross-sectional view of a sealing section according to a second embodiment of the present invention. [Figure 6d] This is a cross-sectional view of a downflow section according to a second embodiment of the present invention. [Figure 6e] This is a cross-sectional view of a downflow section according to a second embodiment of the present invention. [Figure 7a] This is a cross-sectional view of the transition section 18 according to the second embodiment. [Figure 7b] This is a cross-sectional view of the transition section 18 according to the second embodiment. [Figure 7c] This is a cross-sectional view of the transition section 18 according to the second embodiment. [Figure 8a] Figure 7a is a schematic vertical transparency view of the transition section. [Figure 8b] Figure 7b is a schematic vertical transparency diagram of the transition section. [Figure 8c] Figure 7c is a schematic vertical transparency diagram of the transition section. [Figure 9a] This is a schematic diagram of a sealing section according to an embodiment of the present invention shown in Figure 5. [Figure 9b] This is a schematic diagram of a sealing section according to an embodiment of the present invention shown in Figure 5. [Figure 9c] This is a schematic diagram of a sealing section according to an embodiment of the present invention shown in Figure 5. [Figure 10] This is a schematic longitudinal cross-sectional view of a transition section according to an embodiment of the present invention different from those shown in Figures 3 and 5. [Figure 11] This is a diagram of the administration kit according to the present invention. [Modes for carrying out the invention]
[0018] As shown in Figures 2, 3, and 11, the present invention relates to an elongated passive administration device 10 configured to be introduced into the cochlea 104 of a patient's ear 100.
[0019] As shown in Figure 1, the cochlea 104 is a bony, hollow, conical cavity through which sound waves propagate from the base (near the middle ear 102 and oval window 106) to the apex 200. In humans, the spiral tube of the cochlea 104 is approximately 30 mm long and has a diameter of 2 mm around its axis. 3 / 4 It rotates. The cochlea 104 is the part of the inner ear 103 that is involved in hearing. The core component of the cochlea 104 is the organ of Corti 107, which is the auditory organ and is distributed along the septum that separates the fluid chambers within its spiral tube. The cochlea 104 was found to be fully developed at birth and to have reached adult size.
[0020] As shown in Figure 3, the administration device 10 according to the present invention comprises a liquid conduit 12 that extends along the liquid administration axis X and has three sections 12a, 12b, and 12c arranged along the liquid administration axis X.
[0021] Preferably, the duct 12 is a single technical functional element. More preferably, the duct 12 is a single tube. The single tube can be made from several parts exhibiting different physical properties, such as flexibility.
[0022] Each section 12a, 12b, and 12c has an inner diameter D I1 , D I2 , D I3 and outer diameter D O1 , D O2 , D O3 Present.
[0023] The liquid conduit 12 thus presents an upward flow section 12a, an intermediate section 12b, and a downward flow section 12c.
[0024] Considering the difficulty of accessing the target administration site and the variability in its shape, the descending flow section 12c is configured to be flexible, and ideally more flexible than the thin cochlear implant electrode array. Considering the usefulness of the device 10 and especially the conduit 12, the portion of the ascending flow section 12a is configured to be less flexible than the descending flow section 12c. However, flexibility is a critical technical issue relating to the comfort and ease of operation for the surgeon and therefore to patient safety. In other words, with respect to the flexibility of the duct 12, a balance must be struck between the desire for sufficient flexibility for operation and the risk of the duct 12 becoming too loose, and therefore retracting.
[0025] The overall tubular flexibility of the duct 12 is influenced by the different inner-to-outer diameter ratio and the material used. This ratio is also called the pipe wall thickness. A thinner wall thickness results in a more flexible duct 12, while a thicker wall thickness results in a more rigid duct 12. [Table 1]
[0026] Taking into consideration the importance of the target administration site, the duct 12 is configured to ensure biocompatibility with the tissues of the patient's ear 100 (all inner, middle, and outer ear 101, 103) while delivering any type of liquid to the cochlea 104. In the particular case of the liquid being an adeno-associated virus (AAV) gene therapy vector-based solution, the material selected for the duct 12 is preferably inert to or compatible with the AAV solution. In this regard, the expression “inert” refers to stability in use while using the AAV solution and does not necessarily refer to overall chemical nonreactivity.
[0027] In the prior art, AAV gene therapy is generally known to refer to the use of AAV vectors to deliver defective or damaged genetic material to target human cells. Since AAV is known to be a small virus that does not cause disease in humans by itself, it is considered an ideal vector for gene therapy, particularly for addressing hereditary hearing impairments.
[0028] As seen in FIGS. 3, 4a, 5, and 6a, the ascending section 12a of the conduit 12 presents a first inner diameter D I1 and a first outer diameter D O1 Preferably, the first outer diameter D O1 of the ascending section 12a is in the range of 0.6 to 2 mm. It is preferably constant. This range is compatible with the usual instruments used in ear surgery. Preferably, the first inner diameter D I1 of the ascending section 12a is in the range of 0.1 mm to 0.2 mm. It is preferably constant. Considering the details of the administration procedure (further detailed below), the ascending section 12a presents a length in the range of 800 to 1000 mm. This length allows the surgeon to be positioned outside the surgical field, - the dead volume is limited, - the descending section 12c becomes effective within the sterile area of the operating room.
[0029] As further seen in Figures 3 and 5, the upward flow section 12a may include a connecting portion 14 at the upward flow end, configured to connect the administration device 10 to an active administration device 300 (as further described below). This connecting portion 14 should allow for a secure connection that returns the passive administration device 10 from the active administration device 300 in case of undesirable or accidental withdrawal. In the embodiments of Figures 3 and 5, the connecting portion 14 presents an external thread that can be screwed into a corresponding screw hole in the active administration device 300. This active administration device 300 may be, for example, a standard 1 mL syringe. Therefore, to connect the duct 12 to a standard 1 mL syringe, the connecting portion 14 of the upward flow section 12a of the duct 12 may be configured to allow for a secure and compatible connection to a standard commercially available connector. In an alternative embodiment, the active administration device 300 may be an automatic or electrically driven administration pump. Therefore, a robust and secure connection to such an active administration device is required.
[0030] As already mentioned, the liquid conduit 12 has a second inner diameter D I2 and the second outer diameter D O2 Further present is an intermediate section 12b having the first, second, and third outer diameters D O1 , D O2 Regardless of the size, the first inner diameter D I1 The third inner diameter D I3 It is preferable that the first and second outer diameters D O1 , D O2 Regardless of the size, the first inner diameter D I1 The second inner diameter D I2 It is preferable that it be smaller than the first inner diameter D. In some embodiments, the first inner diameter D I1 The second inner diameter D I2 Equivalent to the second inner diameter D of the intermediate section 12b. I2 The diameter is in the range of 0.25 mm to 0.35 mm. It is preferably constant. Preferably, the first and second outer diameters D O1 , D O2 The same. Preferably, the second outer diameter D of the intermediate section 12b.O2 It is in the range of 0.6 mm to 2 mm. It is preferable that it be constant.
[0031] The technical advantage of the intermediate section 12b, as described in paragraph
[0022] , lies in its high flexibility compared to the upward flow section 12a.
[0032] Considering the small amount of liquid available (approximately 250 μL), the inner diameter D I1 , D I2 This should allow for the minimization of dead volume. [Table 2]
[0033] Increasing the diameter allows for a decrease in the fluid pressure inside the duct 12, leading to safer fluid delivery inside the patient's ear 100. In other words, by increasing the diameter between the ascending section 12a and the descending section 12c of the duct 12, it becomes possible to mimic the overpressure effect. More specifically, it is important to consider the fluid pressure in the descending section 12c of the duct 12 in order to prevent the risk of cell damage. Therefore, the pressure in the descending section 12c of the duct 12 must be limited. The pressure inside the duct 12 is related to Hagen-Poisiye's equation, where the pressure decreases slowly along the axis X of the duct 12. This equation represents the laminar flow of an incompressible fluid through a cylindrical tube or tubular section.
[0034] The formula is as follows: ΔP = 8μLQ / πr 4 Here, ΔP is the pressure drop across the tubular section, μ is the dynamic viscosity of the liquid, L is the length of the tubular section, Q is the volumetric flow rate, and r is the radius of the tubular section. Therefore, for constant flow rate and constant viscosity, a longer length or a thinner radius increases the pressure drop.
[0035] The total pressure drop across both pipes is the sum of the pressure drops across each pipe. a.ΔP total =ΔP1+ΔP2 b.ΔP1=8×0.001Pa·s×0.9m×0.5E -10 m 3 / s / π(0.000075m) 4 ≈1.8 Pa c.ΔP2=8×0.001Pa·s×0.1m×0.5E -10 m 3 / s / π(0.00015m) 4 ≈0.066 Pa d.ΔP total ≈1.8Pa + 0.066Pa ≈1.87Pa Therefore, the total pressure drop across both pipes is approximately 1.87 Pa.
[0036] The pressure drop is reduced by doubling the radius of the distal section while maintaining a constant flow rate of liquid. By doubling the radius, the cross-sectional area of the tubular section is given by equation A = πr 2 The fluid velocity is quadrupled according to the equation Q=A1V1=A2V2, where Q is the volumetric flow rate, A1 and V1 represent the initial cross-sectional area and fluid velocity of the tubular section, and A2 and V2 represent the cross-sectional area and fluid velocity of the tubular section doubled.
[0037] Furthermore, Bernoulli's principle states that for an incompressible liquid flowing through a tubular section, the total energy of the liquid remains constant along the streamlines. At the ends of the tubular section, the pressure is equal to the force divided by the area. By doubling the radius, the cross-sectional area of the tubular section is given by equation A = πr². 2 It becomes four times greater according to the following principle, where A represents the cross-sectional area and r represents the radius. Therefore, the pressure at the end of the tubular section decreases fourfold due to the decrease in liquid velocity, and it is proportional to the square of the pressure according to Bernoulli's principle.
[0038] Therefore, two or three inner diameters D I1 , D I2 , D I3The present invention provides means for adjusting the fluid velocity and pressure of a tubular section, leading to a significant increase in administration safety.
[0039] The descending section 12c of the fluid conduit 12 is configured to be introduced into the inside of the patient's ear 100. More specifically, as shown in Figure 2, the descending section 12c is configured to enter the cochlea 104 of the patient's ear 100 through the round window membrane 105. Preferably, the descending section 12c has a third outer diameter D O3 And the second inner diameter D is the same as the intermediate section 12b. I2 This is presented. In an alternative embodiment, the downflow section 12c has a third outer diameter D O3 And the second inner diameter D I2 A third inner diameter D that is different from the above. I3 The following is presented: The length of the downflow section 12c is sufficient to reduce the liquid velocity at the outlet of the liquid conduit 12. First outer diameter D O1 The third outer diameter D O3 Larger than. Preferably, the third outer diameter D O3 The diameter is in the range of 0.5–0.7 mm. The descending section 12c presents a tip that can be flat or oblique. The flat shape is currently the most reliable shape in terms of safety and visibility. However, the oblique shape may be an interesting option for some specific surgical approaches and may help improve better access and / or visibility for the surgeon when the angle is dramatically different from the norm. The oblique shape also appears preferable if any instruments need to be added to the descending section 12c, as it may be better suited for connecting instruments.
[0040] As described above, in some embodiments, the tip 13 may be adapted to the addition (or attachment) of any suitable surgical instrument (e.g., needle, blade) for the purpose of tissue separation, puncture, or cutting. The shape of the tip 13 and the final placement of the tip 13 should preferably be adapted to a canalostomy (referring to the procedure in between, after administration through the posterior and / or lateral semicircular root canals, more precisely, after a posterior auricular incision from the left posterior auricular groove and an incision of the muscles covering the temporal bone, as well as after perforation of the mastoid bone that allows exposure of the posterior and lateral semicircular root canals (PSC and LSC), a small hole is made in the central portion of the root canal where the administration will be performed). Regardless of the shape of the tip 13, and considering the variability in the shape and size of the average circular window 105 in a human ear 100, the cross-section of the tip 13 is in the range of 0.5 mm to 2 mm to allow administration in both pediatric and adult populations.
[0041] Preferably, the descending section 12c further offers a length in the range of 4 to 15 mm. To control the insertion depth of the descending section 12c inside the patient's ear 100, the descending section 12c is provided with at least one depth marker 16. The depth marker 16 may be, for example, a blue or black line (ink marking) drawn on the outer wall of the descending section 12c. It may also be some groove (physical marking) recessed on the inside of the outer wall of the descending section 12c. Preferably, the descending section 12c is provided with two depth markers 16. The depth markers 16 are preferably 5 mm apart from each other.
[0042] To prevent damage to the inner ear structure, the insertion depth of the duct 12, and therefore the length of the descending section 12c, is limited to a range of 4 to 15 mm.
[0043] The elongated dispensing device 10 according to the present invention may further include a transition section 18 having an upward flow end 18a connected to an upward flow section 12a of the duct 12 and a downward flow end 18b connected to an intermediate section 12b. This transition section may present different designs depending on the embodiment.
[0044] In the first embodiment depicted in Figure 3, the transition section 18 presents a variable bore diameter, more specifically an increasing bore diameter. This variable bore diameter is preferably continuously from the first bore diameter D I1 From the second inner diameter D I2 It changes up to this point. In this way, the variable inner diameter changes from the first inner diameter D at the upward flow end 18a of the transition section 18. I1 Equal to the second inner diameter D at the descending flow end 18b I2 Equivalent to. In the alternative embodiments depicted in Figures 5, 7b, 7c, 8a, 8b, and 8c, the transition section 18 presents a constant diameter. In one embodiment, the transition section 18 has an inner diameter D for most of its length downward from its upward flow end 18a. I1 A certain inner diameter corresponding to (see Figures 7a, 8a, 7b, and 8b) is presented. However, at its downflow end 18b, its inner diameter is the second inner diameter D I2 It suddenly increases to equal to (see Figures 7c and 8c). In this embodiment, the transition section 18 preferably corresponds to the fitting of the intermediate section 12b on the rising section 12a (see Figures 7b and 8b). In this way, all the inner diameters along the transition section 18 are equal to the first inner diameter D from its rising end 18a to its descending end 18b. I1 Equal to the second inner diameter D at its descending end 18b I2This is equivalent to the above. In an alternative embodiment (see Figure 10), the inner diameter of the transition section 18 increases and decreases in different stages. The inner diameter thus increases abruptly at first and then gradually decreases. For example, the inner diameter initially increases abruptly from 0.15 mm to 0.8 mm, and then gradually decreases from 0.8 mm to 0.3 mm (due to the deformed silicone tube). However, regardless of the embodiment, the inner diameter of the transition section 18 increases overall from its upward flow end 18a to its downward flow end 18b.
[0045] Regardless of the embodiment, preferably, the outer diameter of the transition section 18 is the first outer diameter D in order to exhibit the same flexibility as the upward flow section 12a. O1 It is equal to. The length of the transition section 18 is preferably between 5 and 15 mm to ensure the integrity of the connection.
[0046] As shown in Figure 3, the duct 12 preferably comprises a sealing section 20 having an upward flow end 20a connected to the intermediate section 12b of the duct 12 and a downward flow end 20b connected to the downward flow section 12c. The section 20 is preferably a silicone overmolding that allows the connection of the two sections 12b and 12c of the duct 12, as depicted in Figures 9a, 9b, and 9c.
[0047] In the embodiment depicted in Figure 3, the sealing section 20 presents a conical shape. In some alternative embodiments, it may present a conical shape that can secure the instrument / retainer. In alternative embodiments, it may present a cylindrical shape. The sealing section 20 also functions as an insertion stopper, preventing the descending flow section 12c from being inserted excessively deep into the patient's ear 100. The sealing section 20 also ensures airtightness of the fluid conduit 12 and avoids leakage in the circular window membrane 105 of the patient's ear 100.
[0048] The sealing section 20 presents a decreasing outer diameter, and the decreasing outer diameter is at least at the upward flow end 20a of the sealing section 20 compared to the first outer diameter DO1 Equal to the third outer diameter D at the downward flow end 20b of the sealing section 20. O3 It is equal to. In an alternative embodiment, the decreasing outer diameter is the first outer diameter D at least at the upward flow end 20a of the sealing section 20. O1 Equal to the third outer diameter D at the downward flow end 20b of the sealing section 20. O3 It is slightly larger than (preferably less than 1.4 mm) (see Figure 9c). It must be smaller than the hole made in the circular window membrane 105. Preferably, the outer diameter D of the upward flow end 20a of the sealing section 20. 20a The first outer diameter D O1 It is larger than the second inner diameter D. I2 It is equal to. In some alternative embodiments (see Figure 9c), the inner diameter of the sealing section 20 is equal to the second inner diameter D I2 From the third inner diameter D I3 It can change gradually or abruptly toward. To be used between the transcraniofacial recess approach and the standard transmastoidofacial recess approach (which will be further described below), considering the diameter of the classic endoscopic middle ear surgical instruments (usually up to 3 mm), the maximum outer diameter of the ascending end 20a of the sealing section 20 should be 2.5 mm.
[0049] In some embodiments, the sealing section 20 may also be a handling section, as depicted in Figure 5, for example. In those embodiments, the sealing section 20 comprises a sealing portion 21 and a handling portion 22.
[0050] Similar to the first embodiment, the sealing portion 21 is configured to function as a sealing ring, preventing leakage when the circular window membrane 105 of the patient's ear 100 is opened.
[0051] The sealing portion 21 also presents a conical shape. In some alternative embodiments, it may also present a conical shape that can secure the instrument / retainer. In alternative embodiments, it may present a cylindrical shape. The sealing portion 21 also functions as an insertion stopper, preventing the descending flow section 12c from being inserted excessively deep into the patient's ear 100.
[0052] Logically, the sealing portion 21 presents a decreasing outer diameter, and the decreasing outer diameter is at least the first outer diameter D at the upward flow end 21a of the sealing portion 21. O1 Equal to the third outer diameter D at the downward flow end 21b of the sealing portion 21. O3 Equivalent to. Preferably, the outer diameter D of the upward flow end 21a of the sealing portion 21. 21a The first outer diameter D O1 Larger than the second inner diameter D. The inner diameter of the sealing and handling section 20 is the second inner diameter D. I2 It is equal to.
[0053] The handling portion 22 has at least a first outer diameter D O1 Equal to, outer diameter D 21a It presents a constant outer diameter equal to D. Preferably, the outer diameter D of the upward flow end 22a of the handling portion 22. 22 The first outer diameter D O1 This is greater than. This ensures that the ratio between the two sections 12a and 12b (and thus the difference in flexibility and stiffness) is consistent with the Specified in Section
[0019] and provides optimal utility characteristics. This makes it possible to slightly increase the stiffness with changes in material (i.e., different silicones) and increases in ratio.
[0054] To be used between both the transcraniofacial recess approach and the standard transmastoidofacial recess approach, and considering the diameter of classic endoscopic middle ear surgical instruments (typically up to 3 mm), the maximum outer diameter of the ascending flow end 20a of the sealing and handling section 20 should be 2.5 mm.
[0055] The transmastoid approach is a minimally invasive surgical technique that allows access to the middle ear through the external auditory canal without an external incision. T This involves lifting the mastoid bone (lifting a small external auditory canal flap). On the other hand, the standard transmastoid-facial recess approach is a surgical technique used to access the middle ear 102 by creating an opening in the mastoid bone and perforating a portion of the bone to create a pathway to the middle ear 102. This procedure is exposed to the risk of facial nerve lesion.
[0056] While the surgery is performed and the middle ear 102 is made accessible to the fluid conduit 12 of the administration device 10 according to the present invention, preparations for fluid administration are made. Catheter priming and connection between the syringe, catheter, and syringe pump are performed during the surgery. The objective is to enable administration as soon as the round window membrane 105 is opened. To do so, the administration device 10 according to the present invention is configured to be connected to and cooperate with an active administration device 300. Such an active administration device 300 is, - An elongated container having a piston configured to include a liquid to be administered and a connection system that allows connection to the connection portion 14 of the administration device 10, - An actuation system configured to operate a piston, allowing the fluid to be discharged toward the administration device 10, and therefore toward the patient's ear 100. It may be equipped with this feature.
[0057] The present invention and the active administration device 300 are as follows: - A step of connecting the connection portion 14 of the upward flow section 12a to an active dispensing device 300, wherein the active dispensing device 300 comprises, for example, a 1 mL syringe containing the liquid to be administered. - A step of priming the present invention, - A step of performing visual control to ensure that no air or bubbles are present in the liquid conduit 12 after priming has been performed (manually or mechanically via the active dispensing device 300), - A step to remove residual air / bubbles, - The step of positioning the descending flow section 12c of the administration device 10 at the administration site of the patient's ear 100, - The steps of activating the active administration device 300 and injecting the liquid into the patient's inner ear 103 via the passive administration device 10 according to the present invention, This forms a dosing kit that enables the execution of a dosing method, including the following.
[0058] Preferably, two final steps of the surgery are performed immediately before introducing the device 10 into the patient's inner ear 100: first, the oval window 106 (OW) is opened using a laser fiber, a procedure called stapes surgery. This opening makes it possible to maintain the volume and pressure of the inner ear 103 in equilibrium. Once the stapes surgery is performed, the round window membrane 105 (RWM) is opened with a posterior ocular needle, or another sharp surgical instrument such as a tapered surgical point or microsurgical hook, and the small vertical opening is sealed with hyaluronic acid gel. Canalostomy, which allows administration through the posterior and / or lateral semicircular root canals, or cochlear anastomosis, which allows administration through a separate opening to the cochlea rather than dilation of the RWM, can also be performed instead of opening the RWM. The device is then ready to administer, and the active administration device 300 can be activated.
[0059] The administration is divided into three different stages. Stage 1: Pre-administration stage. The middle ear 102 must be accessible to perform the administration. To do so, either a transcraniofacial recess approach or a standard transmastoidofacial recess approach is performed. The surgeon may decide to do both to obtain better access to the middle ear. The transmastoid approach is a minimally invasive surgical technique that allows access to the middle ear 102 through the external auditory canal without an external incision. It allows access to the middle ear structure through the tympanic membrane M TThis involves lifting the bone. On the other hand, the standard transmastoid-facial recess approach is a surgical technique used to access the middle ear 102 by creating an opening in the mastoid bone and perforating a portion of the bone to create a pathway to the middle ear 102. This procedure can lead to lesions of the facial nerve, as already mentioned above. Step 2: Administration of the fluid by activating the active device 300. First, the descending flow section 12c of the administration device 10 is placed at the administration site in the patient's inner ear 100, and then the active administration device 300 is activated to administer the fluid towards the patient's inner ear 103 via the passive administration device 10. This step preferably requires the use of hyaluronic acid to prevent fluid loss and to further facilitate the insertion of the administration device 10. Stage 3: Post-administration. At the end of administration, the fluid conduit 12 is carefully removed, and the oval window 105 is immediately sealed using gel or with a small piece of soft tissue or fat, the same procedure is followed for the oval window. Then, depending on the surgical approach, surgical adhesive can be placed in the mastoid process, and absorbable sutures are set up at the posterior auricular incision site, or, in the case of a transmastoid approach, the repositioning of the tympanic membrane and skin flap is set up.
[0060] In conclusion, the small diameter of the duct 12 of the present invention allows for dead volume limitation and optimization of operability and dosing, but two or three different inner diameters D I1 , D I2 , D I3 This ensures the limitation of the overpressure effect. More specifically, one of the main technical advantages of the present invention is to avoid overpressure occurring within the cochlea 104 during the procedure because it is already filled with perilymph despite the addition of the auxiliary fluid, thus avoiding the risk of damaging the endohair cells, which would deprive the patient of the (remaining) ability to transmit auditory information to the brain.
Claims
1. An elongated passive administration device (10) configured to be introduced into the cochlea (104) of a patient's ear (100), wherein the administration device (10) comprises a liquid conduit (12) having three sections (12a, 12b, 12c) arranged along the liquid administration axis X, and each section (12a, 12b, 12c) having an inner diameter (D Ｉ１ , D Ｉ２ ) and outer diameter (D Ｏ１ , D Ｏ２ , D Ｏ３ ) present, First inner diameter (D Ｉ１ ) and the first outer diameter (D Ｏ１ Upward flow section (12a) having ) Second inner diameter (D Ｉ２ ), and a second outer diameter (D Ｏ２ ), having an intermediate section (12b) Third inner diameter (D Ｉ３ ) and the third outer diameter (D Ｏ３ A descending section (12c) having a descending section (12c) configured to be introduced inside the patient's ear (100). The first inner diameter (D Ｉ１ ) is the third inner diameter (D Ｉ３ ) is smaller than the first outer diameter (D Ｏ１ ) is the third outer diameter (D Ｏ３ ) is greater than or equal to A long, slender passive administration device (10).
2. The third inner diameter (D) of the downward flow section (12c) Ｉ３ ) is the second inner diameter (D Ｉ２ The elongated administration device (10) according to claim 1, which is the same as the one described in claim 1.
3. The first outer diameter (D Ｏ１ ) is the third outer diameter (D Ｏ３ An elongated administration device (10) according to any one of claims 1 or 2, which is larger than ).
4. The transition section (18) has an upward flow end (18a) connected to the upward flow section (12a) and a downward flow end (18b) connected to the intermediate section (12b), and the transition section (18) presents an increasing inner diameter, wherein the inner diameter is the first inner diameter (D) at the upward flow end (18a) of the transition section (18). Ｉ１ ) is equal to the second inner diameter (D) at the downward flow end (18b). Ｉ２ An elongated dispensing device (10) according to any one of claims 1 to 3, which is equivalent to the one described in claim 1 to 3.
5. The outer diameter of the transition section (18) is the first outer diameter (D Ｏ１ An elongated passive dispensing device (10) according to claim 4, which is equal to ).
6. The present invention provides a sealing section or sealing portion (20;21) having an upward flow end (20a;21a) connected to the intermediate section (12b) and a downward flow end (20b;21b) connected to the downward flow section (12c), wherein the outer diameter of the sealing section or sealing portion (20, 21) decreases, and the outer diameter is such that the first outer diameter (D Ｏ１ ) is equal to the third outer diameter (D) at the downward flow end (20b; 21b). Ｏ３ An elongated passive dispensing device (10) according to any one of claims 1 to 5, which is equivalent to ).
7. The outer diameter (D) of the upward flow end (20a; 21a) of the sealing section or sealing portion (20; 21) ２０ａ ;D ２１ａ ) is the first outer diameter (D Ｏ１ An elongated passive dispensing device according to claim 6, which is larger than ).
8. The inner diameter of the sealing section or sealing portion (20; 21) is the second inner diameter (D Ｉ２ An elongated passive dispensing device (10) according to any one of claims 4 to 5, which is equivalent to the one described above.
9. The elongated passive dispensing device (10) according to any one of claims 4 to 6, wherein the sealing section or sealing portion (20; 21) presents a substantially conical shape.
10. The elongated passive dispensing device (10) according to any one of claims 1 to 9, wherein the upward flow section (12a) exhibits less flexibility than the downward flow section (12c).
11. The first outer diameter (D Ｏ１ The first inner diameter (D) is in the range of 0.6 to 2 mm. Ｉ１ An elongated passive dispensing device (10) according to any one of claims 1 to 10, wherein the diameter is in the range of 0.1 mm to 0.2 mm.
12. The third outer diameter (D Ｏ３ The third inner diameter (D) is in the range of 0.5 to 0.7 mm. Ｏ３ An elongated passive dispensing device (10) according to any one of claims 1 to 11, wherein the diameter is in the range of 0.25 mm to 0.35 mm.
13. The elongated passive administration device (10) according to any one of claims 1 to 12, wherein the upward flow section (12a) comprises a connection portion (14) at the upward flow end that presents an external thread configured to connect the administration device to an active administration device (300).
14. An administration kit comprising an elongated passive administration device (10) according to any one of claims 1 to 13, and an active administration device (300) configured to be connected to the elongated passive administration device (300).
15. A method of administration characterized by being performed by the administration kit described in claim 14, the following: A step of connecting the connection portion (14) of the upward flow section (12a) to an active dispensing device (300), wherein the active dispensing device (300) contains the liquid to be dispensed, The steps include priming the device (10), The steps include performing visual control to ensure that no air or bubbles are present in the liquid conduit (12) after the priming has been performed, Steps to remove residual air / bubbles, The steps include positioning the descending flow section (12c) of the administration device (10) at the administration site of the patient's ear (100), The steps include: activating the active administration device (300) and administering the liquid to be administered via the passive administration device (10) toward the patient's inner ear (103); A method of administration including the following.