Repeated drug delivery apparatus for artificial cochlea

Abstract

The present invention relates to the field of medical device technology. Specifically, disclosed is a repeated drug delivery apparatus for an artificial cochlea, comprising a receiving module, a stimulator, a stimulation electrode, and a drug delivery system. The drug delivery system comprises at least a first drug chamber and an injection port. The first drug chamber comprises a top wall and a bottom wall that are arranged opposite to each other and connected by means of a stretchable and deformable wall. The top wall is provided with a first radiopaque marker part that can be visualized by a medical imaging device, and the bottom wall is provided with a second radiopaque marker part that can be visualized by the medical imaging device. In the described structure, the distance between the first radiopaque marker part and the second radiopaque marker part is observed or measured by the medical imaging device, and the release of liquid drug in the first drug chamber can be accurately judged, thereby achieving a more accurate drug use.

Description

Cochlear implant repeat drug delivery device Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a cochlear implant repeated drug delivery device. Background Art

[0002] Cochlear implants (CIs) are currently the primary treatment for severe sensorineural hearing loss, enabling many hearing-impaired individuals to regain their hearing and reintegrate into society. While numerous cochlear implants are currently available, there is still room for improvement.

[0003] For example, Chinese invention patent publication number CN115430026A discloses an integrated cochlear implant with a repetitive drug delivery electrode and control device. The device comprises two drug reservoirs: a first reservoir and a second reservoir. The first reservoir stores liquid medicine, while the second reservoir communicates with the first reservoir for quantitative drug release. However, in this configuration, the first reservoir is disposable and cannot be refilled, making it incapable of long-term drug therapy. Furthermore, after implantation, the release of the liquid from the first reservoir cannot be monitored.

[0004] For example, the invention patent with publication number CN115089851A discloses a cochlear implant with sustainable drug delivery, in which the drug storage capsule cannot be refilled with drug solution and is a disposable drug storage capsule, which cannot be used for long-term drug treatment; after the drug storage capsule is implanted in the body, the drug release of the internal drug solution cannot be monitored.

[0005] As another example, Chinese invention patent publication number CN116832325A discloses a cochlear implant for repeated drug delivery to the inner ear, wherein a drug reservoir can be replenished with liquid medicine for long-term treatment. However, after the reservoir is implanted in the body, it is still impossible to accurately determine the release of the liquid medicine inside.

[0006] Summary of the Invention

[0007] The technical problem to be solved by the present invention is to resolve the technical defect in the prior art that the release of the internal drug solution of the cochlear implant cannot be accurately determined after the drug reservoir is implanted in the body.

[0008] In order to solve the above technical problems, the technical solution provided by the present invention is as follows: a cochlear implant repeated drug delivery device, comprising at least a receiving module, a stimulator, a stimulation electrode and a drug delivery system, wherein the stimulation electrode is respectively connected to the stimulator and the drug delivery system, and the drug delivery system comprises at least a first drug chamber and an injection seat, the drug inlet of the first drug chamber is connected to the injection seat, the drug outlet of the first drug chamber is connected to the stimulation electrode, the first drug chamber comprises a top wall and a bottom wall arranged opposite to each other, the top wall and the bottom wall are connected by a retractable deformable wall, the top wall is provided with a first development marking portion that can be developed by medical imaging equipment, and the bottom wall is provided with a second development marking portion that can be developed by medical imaging equipment.

[0009] In a preferred embodiment, the first developing marking portion and the second developing marking portion are platinum-iridium alloy rings, platinum gold rings or tungsten steel rings.

[0010] In a preferred embodiment, an axial guide structure is provided between the top wall and the bottom wall of the first medicine bin; the axial guide structure is a positioning shell provided on the outside of the first medicine bin, and the positioning shell includes a relatively arranged positioning upper wall, a positioning bottom wall and a positioning side wall located between the positioning upper wall and the positioning bottom wall.

[0011] In a preferred embodiment, the first medicine chamber is further provided with a medicine liquid delivery power mechanism, and the medicine liquid delivery power mechanism is: an elastic body arranged between the top wall and the bottom wall; or, a deformation body arranged between the top wall and the positioning upper wall.

[0012] In a preferred embodiment, the drug delivery system also includes a second drug chamber that does not require replenishment of drug solution, and the drug outlet of the second drug chamber is connected to the stimulation electrode; the second drug chamber includes a drug bag made of elastic material, an expansion layer arranged on the outside of the drug bag, and a semipermeable membrane arranged on the outside of the expansion layer.

[0013] In a preferred embodiment, a one-way valve is provided between the injection seat and the first medicine chamber, between the first medicine chamber and the stimulation electrode, and between the second medicine chamber and the stimulation electrode; the one-way valve includes a one-way valve body provided with a medicine inlet hole, a one-way valve cap body provided with a medicine outlet hole, and a valve core provided in the valve cavity of the one-way valve body, and the valve flaps that fit together are provided on the side of the valve core facing the medicine outlet hole, and a medicine-passing gap is formed between the valve flaps.

[0014] In a preferred embodiment, the free end of the one-way valve body is provided with a rounded corner, and the free end of the one-way valve cap is provided with a tapered corner.

[0015] In a preferred embodiment, the injection seat includes an injection seat shell and an injection seat cover plate, an injection port is provided at the center of the injection seat cover plate, a silicone body covering the injection port is provided between the injection seat shell and the injection seat cover plate, an injection cavity is formed between the injection seat shell and the silicone body, and a medicine liquid outlet is provided on one side of the injection cavity; the injection seat is also provided with a positioning mechanism for positioning the injection port.

[0016] In a preferred embodiment, the silicone body is provided with a silicone ring protruding from the injection seat cover along the edge of the injection port, and the silicone ring forms the positioning mechanism.

[0017] In a preferred embodiment, the positioning mechanism includes a magnetic ring arranged on the inner side of the injection seat cover and surrounding the injection port, and a magnetic display card used in conjunction with the magnetic ring, the magnetic display card is provided with a center hole adapted to the injection port, the magnetic display card is provided with a sealed cavity surrounding the center hole, and the sealed cavity is encapsulated with powder for magnetic attraction with the magnetic ring.

[0018] In a preferred embodiment, the stimulation electrode is provided with a silicone carrier, and the stimulation electrode comprises an electrode portion, a drug releasing portion and an interface portion in sequence along the length direction; a plurality of electrode sheets are arranged on the silicone carrier of the electrode portion at intervals along the length direction; a drug rod mounting cavity is arranged inside the silicone carrier of the electrode portion, and a drug rod is mounted in the drug rod mounting cavity; the interface portion is provided with a first interface end for connecting to a stimulator and a second interface end for connecting to a drug delivery system; the stimulation electrode is provided with a drug releasing channel extending from the second interface end to the drug releasing portion, and the drug releasing portion is provided with a plurality of drug releasing ports radially penetrating to the drug releasing channel at intervals along the length direction.

[0019] In a preferred embodiment, a hard sleeve is provided on the outer side of the silica gel carrier of the drug releasing portion, and the sleeve is provided with drug releasing holes corresponding to the drug releasing ports one by one.

[0020] In a preferred embodiment, the drug release hole and the drug release port are provided with a tapered hole section whose inner diameter gradually decreases from the outside to the inside, and the drug release portion is also provided with a drug release one-way valve. The drug release one-way valve is made of silicone. The drug release one-way valve includes a tapered section adapted to the tapered hole section and a connecting section extending from the small diameter end of the tapered section. The free end of the connecting section is fixedly connected to the interior of the drug release portion, and the diameter of the connecting section is smaller than the minimum diameter of the drug release port.

[0021] In a preferred embodiment, the medicine rod includes a rod-shaped body, the diameter of which gradually decreases from the drug release portion to the free end of the electrode portion, and a plurality of annular grooves are arranged on the rod-shaped body at intervals along the length direction; or, the medicine rod includes a plurality of spherical bodies connected in series, the diameter of which gradually decreases from the drug release portion to the free end of the electrode portion.

[0022] In a preferred embodiment, the electrode sheet includes an arc-shaped body, and both end portions of the body are bent inwards to fit with the inner surface of the body to form attachment holes.

[0023] The cochlear implant repetitive drug delivery device of this embodiment, wherein the first drug chamber is connected to the injection seat, can be used to replenish the drug solution, and is suitable for long-term treatment and use of cochlear implant patients. Compared with the existing technology, it has the following advantages:

[0024] Among them, the top wall and the bottom wall of the first medicine chamber are connected by a retractable deformable wall, so that the distance between the top wall and the bottom wall is variable. Furthermore, the first development marking part and the second development marking part that can be developed by medical imaging equipment are respectively provided on the top wall and the bottom wall. By observing or measuring the distance between the first development marking part and the second development marking part by medical imaging equipment, the release status of the medicine liquid in the first medicine chamber can be accurately judged, thereby achieving more accurate medication. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] FIG1 is a schematic structural diagram of the cochlear implant repeated drug delivery device according to this embodiment;

[0026] FIG2 is a schematic diagram of the structure of the stimulation electrodes in the cochlear implant repeated drug delivery device of this embodiment;

[0027] FIG3 is a schematic cross-sectional view of the AA structure shown in FIG2 ;

[0028] FIG4 is a schematic structural diagram of the electrode sheet in this embodiment;

[0029] FIG5 is a schematic diagram of the structure of a medicine stick according to the first embodiment of the present invention;

[0030] FIG6 is a schematic structural diagram of a medicine stick according to a second embodiment of the present invention;

[0031] FIG7 is a schematic cross-sectional view BB of the drug release portion of the first embodiment of this embodiment shown in FIG2;

[0032] FIG8 is an exploded schematic diagram of the structure shown in FIG7 ;

[0033] FIG9 is a schematic cross-sectional view BB of the drug release portion of the second embodiment of this embodiment shown in FIG2 ;

[0034] FIG10 is an exploded schematic diagram of the structure shown in FIG9 ;

[0035] FIG11 is a schematic structural diagram of the sleeve in this embodiment;

[0036] FIG12 is a schematic structural diagram of the first medicine warehouse according to the first embodiment of this embodiment;

[0037] FIG13 is a schematic structural diagram of the first medicine chamber according to the second embodiment of the present invention;

[0038] FIG14 is a schematic structural diagram of the second medicine warehouse in this embodiment;

[0039] FIG15 is a schematic diagram of the external structure of the injection seat in this embodiment;

[0040] FIG16 is a schematic cross-sectional view of the injection seat according to the first embodiment of the present invention;

[0041] FIG17 is a schematic cross-sectional view of the injection seat according to the second embodiment of the present invention;

[0042] FIG18 is a schematic diagram of the external structure of the magnetic display card in this embodiment;

[0043] FIG19 is a schematic cross-sectional view of the magnetic display card shown in FIG18 ;

[0044] Figure 20 is a schematic structural diagram of the one-way valve in this embodiment;

[0045] FIG21 is a schematic structural diagram of the one-way valve shown in FIG20 in an exploded state;

[0046] FIG22 is a schematic structural diagram of a three-way connector in this embodiment;

[0047] FIG23 is a schematic structural diagram of the pagoda joint in this embodiment. DETAILED DESCRIPTION

[0048] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0049] In the description of the present invention, it should be understood that the terms "upper", "lower", "front", "back", "inside", "outside", etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0050] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected" and "connected" should be understood in a broad sense. For example, it can be a fixed connection, an integral connection, or a detachable connection; it can be the internal communication of two components; it can be a direct connection or an indirect connection through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0051] As shown in Figure 1, a cochlear implant repetitive drug delivery device according to this embodiment includes a receiving module 20, a stimulator 30, a stimulating electrode 10, and a drug delivery system. The stimulating electrode 10 is connected to the stimulator 30 and the drug delivery system, respectively. It should be noted that both the receiving module 20 and the stimulator 30 employ conventional structures of existing cochlear implants, and their specific structures are not described in detail herein.

[0052] The structure of the stimulation electrode 10 of this embodiment is shown in Figure 2. It is provided with a silicone carrier 100. The stimulation electrode 10 includes an electrode portion 11, a drug release portion 12, and an interface portion 13 in the longitudinal direction. Two booster rings 14 are provided at the connection between the drug release portion 12 and the interface portion 13. The silicone carrier 100 of the electrode portion 11 is provided with a plurality of electrode pads 111 spaced apart along the longitudinal direction. The electrode pads 111 are connected to the stimulator 30 via electrode leads 113.

[0053] In this embodiment, the silicone carrier 100 of the electrode portion 11 is provided with a drug rod mounting cavity 110, in which a drug rod 112 is mounted. To facilitate implantation of the stimulation electrode 10, the diameter of the electrode portion 11 gradually decreases from the drug release portion 12 toward the drug release portion 12.

[0054] In this embodiment, as shown in Figures 2 to 4, the electrode sheet 111 includes an arc-shaped body 1111. As a special feature of this embodiment, the end portions 1112 at both ends of the body 1111 are bent inward to fit with the inner surface of the body 1111 and form attachment holes 1113. The advantage of such a setting is that during the molding process of the stimulation electrode 10, the attachment holes 1113 are filled with the silicone carrier 100, so that the bonding force between the electrode sheet 111 and the silicone carrier 100 is stronger, which can effectively prevent the contact of the electrode sheet 111 from falling off. However, the end portions 1112 of the traditional electrode sheet 111 are only bent, such as the contact electrode disclosed in CN116832325A, which does not form an attachment hole. In actual application, there is a risk that the contact of the electrode sheet will fall off.

[0055] In this embodiment, the preferred first medicine rod 112 has a structure as shown in FIG5 , comprising a rod-shaped body 1121. The diameter of the rod-shaped body 1121 gradually decreases from the drug-releasing portion 12 toward the free end of the electrode portion 11. Specifically, the rod-shaped body 1121 is provided with a plurality of annular grooves 1122 spaced along its length. These annular grooves 1122 serve as bending stress grooves, reducing resistance to bending of the electrode portion 11 and, consequently, implant resistance of the stimulation electrode 10. This helps protect the fine structure of the cochlea during surgery, thereby preserving residual hearing.

[0056] In this embodiment, another preferred structure of the drug rod 112 is shown in Figure 6 . It comprises a plurality of spherical bodies 1123 connected in series by platinum-iridium wires 1124. The diameter of the spherical bodies 1123 gradually decreases from the drug-releasing portion 12 toward the free end of the electrode portion 11. This drug rod structure also reduces the implant resistance of the stimulation electrode 10, better protecting the fine structure of the cochlea during surgery, and thus preserving residual hearing.

[0057] In this embodiment, as shown in FIG2 , the interface portion 13 is provided with a first interface end 131 for connecting to the stimulator 30 and a second interface end 132 for connecting to the drug delivery system. The stimulation electrode 10 of this embodiment is provided with a drug release channel 15 extending from the second interface end 132 to the drug release portion 12.

[0058] As shown in FIG. 2 and FIG. 7 to FIG. 10 , in this embodiment, the drug releasing portion 12 is provided with a plurality of drug releasing openings 121 radially penetrating to the drug releasing channel 15 at intervals along the length direction.

[0059] As a special feature of this embodiment, as shown in Figures 7 to 10, a hard sleeve 122 is provided on the outer side of the silicone carrier 100 of the drug releasing portion 12. As shown in Figure 11, the sleeve 122 is provided with drug releasing holes 123 corresponding to the drug releasing ports 121. Preferably, in this embodiment, the sleeve 122 is made of a metal tube. Of course, other hard materials suitable for subcutaneous implantation can also be used. In this embodiment, the purpose of providing the hard sleeve 122 on the outer side of the silicone carrier 100 of the drug releasing portion 12 is to enhance the rigidity and strength of the stimulation electrode 10 to facilitate the implantation of the stimulation electrode; and to prevent external tissue from flattening the drug releasing portion 12 to ensure the patency of the drug releasing channel 15 and the drug releasing port 121.

[0060] As a special feature of this embodiment, in addition to the sleeve 122, the drug release portion 12 of this embodiment is also provided with a drug release check valve 125. As shown in Figures 7-10, the drug release hole 123 and the drug release port 121 are provided with a tapered hole section 124 whose inner diameter gradually decreases from the outside to the inside. The drug release check valve 125 includes a tapered section 1251 adapted to the tapered hole section 124 and a connecting section 1252 extending from the smaller diameter end of the tapered section 1251. The free end of the connecting section 1252 is fixedly connected to the interior of the drug release portion 12, and the diameter of the connecting section 1252 is smaller than the minimum diameter of the drug release port 121.

[0061] In this embodiment, Figure 7 is a BB cross-sectional view of the drug release portion shown in Figure 2 of the first embodiment, and Figure 8 is an exploded schematic diagram of the structure shown in Figure 7. In this embodiment, only one drug release port 121 is provided in the circumferential direction of the BB cross-section, and a fixing hole 126 for fixing the connecting section 1252 is provided at a position opposite to the drug release port. The fixing methods that can be used include but are not limited to gluing.

[0062] In this embodiment, Figures 9 and 10 are schematic structural diagrams of the drug release portion of the second embodiment, which differs from the structure shown in Figures 7 and 8 in that two drug release ports 121 are evenly distributed in the circumferential direction of the BB cross section, and the connecting sections 1252 of the two drug release one-way valves 125 are connected together.

[0063] In this embodiment, the drug release check valve 125 is preferably made of silicone, which has a certain degree of elasticity, and the connecting section 1252 in particular has a telescopic property. The drug solution in the drug release channel 15 can be released through the gap between the drug release check valve 125 and the tapered hole section 124. However, the drug release check valve 125 prevents blood and other substances in the tissue from flowing back into the drug release channel 15 and blocking the drug release channel and the drug release port, thereby improving drug release reliability.

[0064] As shown in Figure 1, as a special feature of this embodiment, the drug delivery system includes a first drug chamber 40 and a second drug chamber 50, each of which is independently arranged. The first drug chamber 40 and the second drug chamber 50 are both connected to the drug release channel 15 of the stimulation electrode 10. Among them, the first drug chamber 40 is connected to the injection seat 60 for liquid replenishment, while the second drug chamber is not provided with a liquid replenishment mechanism and does not require liquid replenishment. In this embodiment, the purpose of setting up two drug chambers is to meet the needs of combined treatment of multiple drugs, to achieve customized personalized precision treatment plans, and to ensure accurate and controllable drug delivery.

[0065] The first medicine chamber 40 of the first embodiment of the present embodiment is shown in Figure 12, and includes a top wall 41 and a bottom wall 42 arranged opposite to each other, and the top wall 41 and the bottom wall 42 are connected by a retractable deformable wall 43. As a special feature of this embodiment, the top wall 41 is provided with a first developing marking portion 44 that can be developed by medical imaging equipment, and the bottom wall 42 is provided with a second developing marking portion 45 that can be developed by medical imaging equipment. The purpose of providing the first developing marking portion 44 and the second developing marking portion 45 is that after implantation, the distance between the two can be observed or measured by medical imaging equipment (such as X-ray or CT, etc.), and then the release of the liquid medicine in the first medicine chamber 40 can be judged, so that more accurate medication can be achieved.

[0066] Preferably, the first developing identification portion 44 and the second developing identification portion 45 in this embodiment include but are not limited to a platinum-iridium alloy ring, a platinum ring or a tungsten steel ring.

[0067] In this embodiment, the deformable wall 43 can be an elastic wall made of elastic material or a corrugated wall as shown in Figure 12. In short, its purpose is to achieve the change of the distance between the top wall 41 and the bottom wall 42. The specific structure is not limited in this embodiment.

[0068] In this embodiment, during the relative movement of the top wall 41 and the bottom wall 42, in order to accurately determine the release of the drug solution, it is necessary to ensure the coaxiality of the top wall 41 and the bottom wall 42 during the movement. Usually, an axial guide structure can be set between the top wall 41 and the bottom wall 42. For example, a guide column can be set, and a guide hole adapted to the guide column can be set on the top wall 41 and / or the bottom wall 42.

[0069] Preferably, in this embodiment, as shown in FIG12 , the axial guide structure is a positioning shell 46 sleeved on the outside of the first medicine chamber 40, and the positioning shell 46 includes an oppositely arranged positioning upper wall 461, a positioning bottom wall 463, and a positioning side wall 462 located between the positioning upper wall 461 and the positioning bottom wall 462. As an axial guide structure, compared with a traditional axial guide structure such as a guide column-guide hole type, the positioning shell 46 is encapsulated inside the positioning shell 46. The relative movement of the top wall 41 and the bottom wall 42 is not affected by external tissues, which can achieve more accurate judgment of the release of the drug solution and more accurate medication.

[0070] In this embodiment, the drug inlet 471 of the first drug chamber 40 is connected to the injection seat 60 via a conduit 90, for replenishing the drug solution through the injection seat 60. The drug outlet 472 of the first drug chamber 40 is connected to the drug release channel 15 of the stimulation electrode 10 via a conduit 90, enabling the drug solution in the first drug chamber to be released through the drug release portion.

[0071] In this embodiment, the first drug chamber 40 is further provided with a drug delivery mechanism for delivering the drug solution to the stimulation electrode 10. A preferred drug delivery mechanism is an elastic body disposed between the top wall 41 and the bottom wall 42, as shown in FIG12 . In this embodiment, the elastic body is a silicone rubber band 48, and the number of rubber bands 48 can be one or more, without limitation. After the drug solution is replenished through the injection seat 60, the rubber band 48 is stretched, and the elastic force of the rubber band 48 serves as the driving force for drug delivery.

[0072] FIG13 is a schematic structural diagram of the first medicine chamber of the second embodiment of this embodiment, which differs from the first embodiment shown in FIG12 in that the structural form of the drug delivery power mechanism is different. Specifically, in this embodiment, the drug delivery power mechanism is a deformable body arranged between the top wall 41 and the positioning upper wall 461. The deformable body can be an elastic structure, which is compressed after replenishing the drug solution, and the elastic restoring force serves as the driving force for drug delivery. Preferably, in this embodiment, the deformable body is an airbag 49, which is a telescopic deformable structure, for example, it can be made of an elastic material, or it can be formed of a corrugated wall as shown in FIG13. The airbag 49 is provided with an inflation port 491, which can be filled with nitrogen, helium, etc. The driving force for drug delivery is provided by the deformable airbag.

[0073] In this embodiment, a preferred structure of the second drug reservoir 50 is shown in Figure 14 , comprising a drug sac 51 made of an elastic material, an expansion layer 52 disposed outside the drug sac 51, and a semipermeable membrane 53 disposed outside the expansion layer 52. The drug sac 51 is preferably made of a water-impermeable elastic silicone material, while the semipermeable membrane 53 is a semipermeable membrane that only allows water to pass through. The expansion layer 52 contains a water-swelling expansion agent, the main components of which are typically a water-absorbing resin, sodium acrylate, polyvinyl alcohol, and a hydrophilic polyurethane.

[0074] In this embodiment, the second drug reservoir 50 is used before surgery to add disposable liquid medicine to the drug capsule 51 via a puncture needle formed by a needle cap 55 and a needle tube 54. The end of the needle cap 55, away from the needle tube 54, is connected to a catheter 90 that communicates with the needle tube. Postoperatively, the needle cap 55 and needle tube 54 serve as the drug outlet for the second drug reservoir 50, connected to the stimulation electrode 10 via the catheter 90. Due to the action of the semipermeable membrane 53, water in the human tissue fluid passes through the semipermeable membrane 53 and enters the expansion layer 52. The expansion agent in the expansion layer 52 expands upon contact with water, compressing the drug capsule 51 and thus delivering the liquid medicine to the stimulation electrode 10.

[0075] The structure of the injection seat 60 of the first embodiment of this embodiment is shown in Figures 15 and 16, and includes an injection seat shell 61 and an injection seat cover 62, wherein an injection port 63 is provided at the center of the injection seat cover 62, and a silicone body 64 covering the injection port 63 is provided between the injection seat shell 61 and the injection seat cover 62, wherein an injection cavity 68 is formed between the injection seat shell 61 and the silicone body 64, and a drug liquid outlet 681 is provided on one side of the injection cavity 68, and the drug liquid outlet 681 is connected to the first drug chamber through a conduit 90.

[0076] Since the injection seat in this embodiment is implanted subcutaneously, it is impossible to visually locate the injection port 63 when replenishing the liquid medicine. To achieve the purpose of accurately locating the injection port, as a special feature of this embodiment, the injection seat in this embodiment is provided with a positioning mechanism for locating the injection port 63.

[0077] Preferably, in this embodiment, as shown in Figures 15 and 16 , the silicone body 64 is provided with a silicone ring 65 that protrudes from the injection seat cover 62 along the edge of the injection port 63. This silicone ring 65 forms the positioning mechanism. When the liquid medicine needs to be replenished, the raised silicone ring 65 can be found by touch. Based on the positioning of the silicone ring 65, the location of the injection port can be accurately found, achieving the purpose of accurately injecting the replenished liquid medicine.

[0078] The structure of the injection base 60 of the second embodiment of this embodiment is shown in Figure 17 . Compared to the first embodiment shown in Figure 16 , the second embodiment differs in that a positioning mechanism is added. Specifically, the added positioning mechanism includes a magnetic ring 66 disposed on the inner side of the injection base cover and surrounding the injection port 63, and a magnetic display card 610 used in conjunction with the magnetic ring 66.

[0079] As shown in Figures 18 and 19, the magnetic display card 610 of this embodiment is provided with a central hole 6101 adapted to the injection port 63. The magnetic display card 610 is provided with a sealed cavity 6102 surrounding the central hole. The sealed cavity 6102 encapsulates a powder 6103 for magnetic attraction with the magnetic ring 66. Among them, a common powder can be a mixture of iron powder and a coloring dispersant. The material of the magnetic display card 610 can be transparent acrylic or PET. When it is necessary to inject a supplementary liquid, the magnetic display card 610 is placed at the location of the injection seat. The powder 6103 forms a ring under the action of the magnetic ring 66, and then accurately finds the location of the injection port.

[0080] It should be noted that the embodiment shown in Figure 17 includes two positioning mechanisms, and either method can be used to position the injection port. Of course, as an equivalent embodiment, the silicone ring 65 can also be omitted, and only the magnetic ring 66 and the magnetic display card 610 can be used as the positioning mechanism.

[0081] As a preferred implementation of this embodiment, as shown in Figures 16 and 17, a sealing ring 67 is further provided between the silicone body 64 and the injection seat housing 61 to further improve the sealing performance between the silicone body 64 and the injection seat housing 61 to prevent the drug solution from flowing out.

[0082] As a preferred implementation of this embodiment, as shown in FIG15 , a plurality of sewing rings 69 are further provided along the circumferential direction on the outer edge of the injection seat housing 61 to fix the injection seat 60 in a corresponding position to prevent displacement.

[0083] In this embodiment, to prevent the backflow of the drug solution, as shown in Figure 1, a one-way valve 70 is provided between the injection seat 60 and the first drug chamber 40, between the first drug chamber 40 and the stimulation electrode 10, and between the second drug chamber 50 and the stimulation electrode 10.

[0084] A preferred structure of a one-way valve 70 is shown in Figures 20 and 21, comprising a one-way valve body 71 provided with a drug inlet hole 77, a one-way valve cap body 72 provided with a drug outlet hole 76, and a valve core 73 disposed in the valve cavity of the one-way valve body 71. The valve core 73 is provided with mutually fitting valve flaps 74 on the side facing the drug outlet hole 76, with a drug gap 75 formed between the valve flaps 74. When the drug liquid passes through the one-way valve 70, it can only enter from the drug inlet hole 77, flow through the drug gap 75 between the valve core 73 and the valve flap 74, and flow out from the drug outlet hole 76, but cannot flow in the opposite direction, thereby effectively preventing the drug liquid from flowing back.

[0085] In this embodiment, a foolproof design is preferably implemented to prevent the one-way valve from being installed in the wrong direction during assembly, thereby improving assembly efficiency. Specifically, as shown in FIG20 , the free end of the one-way valve body 71 is provided with a rounded corner 79, representing the drug inlet end, and the free end of the one-way valve cap 72 is provided with a tapered corner 78, representing the drug outlet end.

[0086] In this embodiment, since two drug chambers are provided, namely the first drug chamber and the second drug chamber, a three-way connector 80 is further included for convenient connection. As shown in FIG22 , the three-way connector 80 of this embodiment has a first interface 81 at one end and two second interfaces 82 at the other end. The first interface 81 is connected to the second interface end 132 of the stimulation electrode 10 via a catheter 90, and the two second interfaces 82 are connected to the first drug chamber and the second drug chamber, respectively.

[0087] Preferably, in this embodiment, as shown in Figure 1, the second interface end 132 of the stimulation electrode 10 is connected to the catheter 90 via a pagoda connector 83. As shown in Figure 23, the pagoda connector of this embodiment includes a first connector end 831 connected to the second interface end 132, a second connector end 832 connected to the catheter 90, and an axially extending through-hole 833. In this embodiment, the purpose of connecting via the pagoda connector is that the length of the catheter 90 can be conveniently cut according to the situation during the operation, the drug delivery system is conveniently connected to the stimulation electrode, and the replacement of the drug delivery system is also convenient.

[0088] In short, the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A cochlear implant repeated drug delivery device, comprising at least a receiving module, a stimulator, a stimulating electrode and a drug delivery system, wherein the stimulating electrode is connected to the stimulator and the drug delivery system respectively, and the drug delivery system comprises at least a first drug chamber and an injection seat, wherein the drug inlet of the first drug chamber is connected to the injection seat, and the drug outlet of the first drug chamber is connected to the stimulating electrode, characterized in that: The first medicine chamber includes a top wall and a bottom wall that are arranged opposite to each other, and the top wall and the bottom wall are connected by a retractable deformable wall. The top wall is provided with a first developing marking portion that can be developed by a medical imaging device, and the bottom wall is provided with a second developing marking portion that can be developed by a medical imaging device.

2. The cochlear implant repeated drug delivery device according to claim 1, characterized in that: The first development marking portion and the second development marking portion are platinum-iridium alloy rings, platinum rings or tungsten steel rings.

3. The cochlear implant repeated drug delivery device according to claim 1, characterized in that: An axial guide structure is arranged between the top wall and the bottom wall of the first medicine bin. The axial guide structure is a positioning shell arranged outside the first medicine bin. The positioning shell includes a relatively arranged positioning upper wall, a positioning bottom wall and a positioning side wall located between the positioning upper wall and the positioning bottom wall.

4. The cochlear implant repeated drug delivery device according to claim 3, characterized in that: The first medicine chamber is also provided with a drug liquid delivery power mechanism, and the drug liquid delivery power mechanism is: an elastic body arranged between the top wall and the bottom wall; or, a deformation body arranged between the top wall and the positioning upper wall.

5. The cochlear implant repeated drug delivery device according to any one of claims 1 to 4, characterized in that: The drug delivery system also includes a second drug chamber that does not require replenishment of drug solution, and the drug outlet of the second drug chamber is connected to the stimulation electrode; the second drug chamber includes a drug bag made of elastic material, an expansion layer arranged on the outside of the drug bag, and a semipermeable membrane arranged on the outside of the expansion layer.

6. The cochlear implant repeated drug delivery device according to claim 5, characterized in that: One-way valves are arranged between the injection seat and the first medicine chamber, between the first medicine chamber and the stimulation electrode, and between the second medicine chamber and the stimulation electrode; the one-way valve includes a one-way valve body provided with a medicine inlet hole, a one-way valve cap body provided with a medicine outlet hole, and a valve core arranged in the valve cavity of the one-way valve body, and valve flaps that fit together are arranged on the side of the valve core facing the medicine outlet hole, and a medicine passing gap is formed between the valve flaps.

7. The cochlear implant repeated drug delivery device according to claim 6, characterized in that: The free end of the one-way valve body is provided with a rounded corner, and the free end of the one-way valve cap body is provided with a cone angle.

8. The cochlear implant repeated drug delivery device according to any one of claims 1-4 or 6-7, characterized in that: The injection seat includes an injection seat shell and an injection seat cover plate, an injection port is arranged at the center of the injection seat cover plate, a silicone body covering the injection port is arranged between the injection seat shell and the injection seat cover plate, an injection cavity is formed between the injection seat shell and the silicone body, a medicine liquid outlet is arranged on one side of the injection cavity; the injection seat is also provided with a positioning mechanism for positioning the injection port.

9. The cochlear implant repeated drug delivery device according to claim 8, characterized in that: The silicone body is provided with a silicone ring protruding from the injection seat cover along the edge of the injection port, and the silicone ring forms the positioning mechanism.

10. The cochlear implant repeated drug delivery device according to claim 8, characterized in that: The positioning mechanism includes a magnetic ring arranged on the inner side of the injection seat cover and surrounding the injection port, and a magnetic display card used in conjunction with the magnetic ring, the magnetic display card is provided with a center hole adapted to the injection port, the magnetic display card is provided with a sealed cavity surrounding the center hole, and the sealed cavity is encapsulated with powder for magnetic attraction with the magnetic ring.

11. The cochlear implant repeated drug delivery device according to any one of claims 1-4 or 6-7 or 9-10, characterized in that: The stimulation electrode is provided with a silicone carrier, and the stimulation electrode includes an electrode part, a drug releasing part and an interface part in sequence along the length direction; a plurality of electrode sheets are arranged on the silicone carrier of the electrode part at intervals along the length direction; a drug rod mounting cavity is arranged inside the silicone carrier of the electrode part, and a drug rod is mounted in the drug rod mounting cavity; the interface part is provided with a first interface end for connecting to a stimulator and a second interface end for connecting to a drug delivery system; the stimulation electrode is provided with a drug releasing channel extending from the second interface end to the drug releasing part, and the drug releasing part is provided with a plurality of drug releasing ports radially penetrating to the drug releasing channel at intervals along the length direction.

12. The cochlear implant repeated drug delivery device according to claim 11, characterized in that: A hard sleeve is sleeved on the outer side of the silica gel carrier of the drug releasing part, and the sleeve is provided with drug releasing holes corresponding to the drug releasing openings one by one.

13. The cochlear implant repeated drug delivery device according to claim 12, characterized in that: The drug release hole and the drug release port are provided with a conical hole section whose inner diameter gradually decreases from the outside to the inside. The drug release part is also provided with a drug release one-way valve. The drug release one-way valve is made of silicone. The drug release one-way valve includes a conical section adapted to the conical hole section and a connecting section extending from the small diameter end of the conical section. The free end of the connecting section is fixedly connected to the interior of the drug release part, and the diameter of the connecting section is smaller than the minimum diameter of the drug release port.

14. The cochlear implant repeated drug delivery device according to claim 11, characterized in that: The medicine rod comprises a rod-shaped body, the diameter of which gradually decreases from the drug release portion to the free end of the electrode portion, and a plurality of annular grooves are arranged on the rod-shaped body at intervals along the length direction; or, the medicine rod comprises a plurality of spherical bodies connected in series, the diameter of which gradually decreases from the drug release portion to the free end of the electrode portion.

15. The cochlear implant repeated drug delivery device according to claim 11, characterized in that: The electrode sheet comprises an arc-shaped body, and both ends of the body are bent inwards to fit with the inner surface of the body to form attachment holes.

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