Cochlear implantable catheter and cell transmission device

Abstract

To provide a catheter to be embedded in a cochlea and a cell transmission device.SOLUTION: A catheter to be embedded in a cochlea includes an embedded catheter body. Both ends of the embedded catheter body facing each other define a proximal end and a guide distal end. A central lumen is provided in the center of the embedded catheter body. An outer surface of the embedded catheter body is provided with at least one guide groove extending along a longitudinal direction of the embedded catheter body, and a plurality of horizontally oriented through holes penetrating the central lumen from the outer surface of the embedded catheter body. The embedded catheter body is configured to enter a cochlea of an internal ear of a patient and is bent along rotation of the cochlea of the patient, and a cell or a medicine as a treatment medicine passes the central lumen and the plurality of horizontally oriented through holes and enters the inside of the cochlea of the patient.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a cochlear implant catheter and a cell delivery device, and particularly to a cochlear implant catheter and a cell delivery device for delivering cells or drugs into the inner ear of a human.

Background Art

[0002] The auditory receptor (cochlea of the inner ear) and the auditory nerve are important structures for a person to receive external voice signals, but they are likely to lose their functions due to factors such as drugs, environment, aging, or gene mutations. Once the auditory function of humans is damaged, it is very likely to become permanent damage and cannot be recovered, so it is an obstacle to treat hearing impairment at present. With the development of gene medicine and regenerative medicine, gene cloning therapy for hearing impairment and regeneration of cochlear auditory organ cells have been recognized, and it is expected to treat hearing impairment by cell therapy.

[0003] Cell therapy for treating hearing impairment mainly injects cells or drugs as therapeutic agents into the inner ear, and uses the cells injected into the inner ear to replace or regenerate the necessary auditory cells. Alternatively, the original cells in the inner ear are differentiated or transformed into the necessary auditory cells by the implanted cells or drugs to restore the patient's hearing. In cell therapy, when classified by cell source, the injected cells may be autologous cells or allogeneic cells. When classified by cell type, the cells may be progenitor cells or stem cells. The drugs used may be cell growth factors that promote cell growth or cell transformation, or small molecule therapeutic drugs.

[0004] Effectively injecting cells or therapeutic agents into the cochlea is a crucial element of cell therapy for auditory impairment. The surrounding structures of the cochlear rotation consist of a bony labyrinth. The cochlea, from the basal rotation to the apical rotation, consists of a spiral of narrow tubes, including the central scala, vestibular scala, and tympanic scala. The interior of the cochlear rotation is a sealed structure filled with lymphatic fluid, and the volume of a human cochlea is only about 10 μl. The pressure of the lymphatic fluid and the barrier effect of the round window membrane make it easy for some drugs or cells to leak out of the blood vessels, reducing the effectiveness of drug or cell delivery to the cochlea.

[0005] Current technology proposes implantable catheters that work by embedding electrodes in the cochlear implant. These implantable catheters have an additional lumen for carrying therapeutic drugs into the patient's cochlea, in addition to the original implantable electrode array and conductive wires. Because these catheters are equipped with electrodes and conductive wires to stimulate the auditory nerve, and also have an additional lumen for carrying or delivering drugs, their diameter must be increased. Furthermore, since these implantable catheters must be implanted along with the electrodes and are permanently implanted, they differ from the designs of the present invention, which are applied to deliver drugs or cells to the cochlea in a single treatment.

[0006] Therefore, currently, there are still many difficulties in the technology to directly or partially deliver cells or drugs to the cochlea, and how to improve the structural design of the device to overcome the above shortcomings is an important challenge in solving the problems present in cochlear cell therapy. [Overview of the project] [Problems that the invention aims to solve]

[0007] The problem that this invention aims to solve is to provide a cochlear implantable catheter and a cell transmission device that address the shortcomings of conventional techniques for partially delivering cells or drugs to the cochlea. [Means for solving the problem]

[0008] To solve the above problems, the present invention provides a cochlear implantable catheter for delivering a drug, such as cells or therapeutic agents, to a patient's cochlea, comprising a flexible implantable catheter body, wherein the opposing ends of the implantable catheter body define a proximal end and a guide tip, the portion of the implantable catheter body implanted in the patient's cochlea is defined as the implanted portion, and the implanted portion has a connection terminal on the side facing the proximal end, the interior of the implantable catheter body has a central lumen that penetrates from the center of the proximal end to the center of the guide tip, the implanted portion has at least one guide groove provided on its outer surface and a plurality of transverse through holes that penetrate from the outer surface of the implanted portion to the central lumen, and the implantable catheter body is positioned with the guide tip facing the direction of the patient's cochlea and in front of the patient The implantable catheter is configured to enter the cochlea, and advances while curving along the helical structure of the patient's cochlea, entering between the basal and apical rotations of the patient's cochlea, introducing the cells or therapeutic agent into the central lumen from the proximal end, and entering the interior of the cochlea by passing through the central lumen and the plurality of transverse through-holes, and at least one of the guide grooves is a helical groove provided on the outer surface of the implanted portion of the implantable catheter body along a helical path extending in the longitudinal direction of the implantable catheter body, or a groove that extends along the path of the central axis of the implantable catheter body and in the longitudinal direction of the implantable catheter body, so as to reduce overflow of lymphatic fluid from the cochlea by making it easier to bend the implantable catheter body when it is inserted into the interior of the patient's cochlea.

[0009] To solve the above problems, another means employed in the present invention is a cell transmission device for transmitting cells or a drug as a therapeutic agent to the cochlea of ​​a patient, comprising: one cochlear implantable catheter; and a transmission module connected to the cochlear implantable catheter for transmitting the cells or the drug to the cochlea of ​​the patient, wherein the transmission module has a pressure generator and a connecting tube connected to the outlet of the pressure generator, the pressure generator storing a fluid containing the cells or the drug and driving the fluid containing the cells or the drug to send the fluid containing the cells or the drug from the outlet to the connecting tube, one end of the connecting tube relative to the pressure generator being connected to the proximal end of the implantable catheter body, the cells or the drug entering the central lumen of the implantable catheter, passing through the central lumen and the plurality of transverse through-holes into the cochlea of ​​the patient. [Effects of the Invention]

[0010] The present invention has the following beneficial effects. According to the cochlear implantation catheter and cell transmission device provided by the present invention, when the guide tip of the cochlear implantation catheter is implanted in the basal rotation of the patient's cochlea, the good flexibility of the cochlear implantation catheter allows it to bend and rotate in the apical rotational direction along the spiral ligament of the outer wall of the cochlear ventricle, allowing it to penetrate deeply into the cochlea. The design of the guide groove reduces resistance between the outer wall of the implantation catheter body and the lymphatic fluid inside the cochlea. This increases the success rate of cochlear implantation catheter implantation and reduces implantation damage to the cochlear body.

[0011] Furthermore, the cochlear implantation catheter of the present invention is designed with guide grooves and features uniformly distributed transverse through-holes in the catheter body. This allows for the uniform distribution of cells or drugs to different locations within the cochlea, thereby preventing overflow of lymphatic fluid inside the cochlea.

[0012] To further understand the features and technical content of the present invention, the following detailed description of the invention and the drawings are provided, but the drawings provided are for reference and illustrative purposes only and are not intended to limit the present invention. [Brief explanation of the drawing]

[0013] [Figure 1] This is a schematic diagram of a first embodiment of the cochlear implantable catheter of the present invention. [Figure 2] This is a schematic cross-sectional view of the cochlear implantable catheter of the present invention. [Figure 3] This is a partially enlarged schematic diagram of part III of Figure 1 of the cochlear implantation catheter of the present invention. [Figure 4] This is a partially enlarged schematic diagram of another embodiment of the cochlear implantation catheter of the present invention. [Figure 5] This is a schematic diagram of one embodiment of the cell transmission device of the present invention. [Figure 6] This is a schematic diagram of another embodiment of the cell transmission device of the present invention. [Figure 7] This is a schematic diagram of a procedure for implanting the cochlear implantation catheter of the present invention into a patient's cochlea to deliver cells or drugs for treating hearing impairment. [Figure 8] This is an enlarged schematic diagram illustrating how the cochlear implantable catheter of the present invention delivers cells or drugs to the patient's cochlea. [Figure 9] This is a schematic diagram of a second embodiment of the cochlear implantable catheter of the present invention. [Figure 10] This is a schematic cross-sectional view of a second embodiment of the cochlear implantable catheter of the present invention. [Modes for carrying out the invention]

[0014] The following is an embodiment describing the “cochlear implantable catheter and cell transmission device” disclosed by the present invention through specific embodiments, and those skilled in the art will be able to understand the advantages and effects of the present invention from the content disclosed herein. The present invention may be implemented or applied by other specific embodiments, and each detail herein may be modified and changed in various ways without departing from the concept of the present invention, based on different viewpoints and applications. It should also be noted in advance that the drawings of the present invention are for simple and schematic purposes only and do not represent actual sizes. The following embodiments will describe the relevant technical content of the present invention in more detail, but the disclosed content will not limit the scope of protection of the present invention. Also, the term “or” as used herein may include any one or more of the relevant enumerated items in any combination, depending on the actual situation.

[0015] [First Embodiment] As shown in Figures 1 to 8, the cochlear implantable catheter and cell delivery device of the embodiment of the present invention can deliver cells or drugs into the cochlea of ​​a patient to treat the patient's hearing impairment by cell or drug or gene therapy. In particular, this specification describes the following: Cells or drugs for treating hearing impairment include cells of the type such as autologous cells, stem cells, progenitor cells and carriers that carry cells, or genes that promote the growth of auditory cells or genes that promote the conversion of cells into auditory cells. Genes include drugs or compositions thereof of the type such as deoxyribonucleic acid (DNA), plasmid DNA, small interfering RNA, oligonucleotides and their transport carriers, cell growth factors, regenerative medicine preparations for hearing impairment, and exosomes.

[0016] As shown in FIGS. 1, 2, and 7, the snail-implanted catheter 1 of the present invention guides cells for treating hearing impairment or a drug as a therapeutic agent into the interior of the patient's snail 700. In this embodiment, the snail-implanted catheter 1 has an implanted catheter body 100. In a preferred embodiment, the implanted catheter body 100 is formed from a suitable biocompatible material. In one embodiment, the material of the implanted catheter body 100 may be silicone resin, for example, Silastic MDX 4-4210. In another embodiment, the implanted catheter body 100 may be formed from fluororesin, polyurethane, polyvinyl chloride or similar materials.

[0017] The structure of the implanted catheter body 100 is mainly an elongated tubular body having flexibility, and the implanted catheter body 100 can define an opposing proximal end 110 and a guide tip 120. The implanted catheter body 100 can be implanted into the interior of the patient's snail 700 in the direction of the patient's snail 700 by the guide tip 120. The portion of the implanted catheter body 100 implanted into the patient's snail 700 is defined as the implanted portion. The implanted catheter body 100 has a connection terminal 160 on the side facing the proximal end 110. The connection terminal 160 is arranged for connecting to a conduit for sending cells or drugs. The implanted catheter body 100 is provided with a protruding ring 170 at the boundary between the connection terminal 160 and the implanted portion. The protruding ring 170 is for the operator to distinguish the range of the implanted portion of the implanted catheter body 100. The diameter of the protruding ring 170 is configured to be larger than the diameters of the implanted portion and the connection terminal 160, so that the operator can clearly identify the position of the protruding ring 170 and ensure that the implanted length of the implanted catheter body 100 into the patient's snail 700 does not exceed the length L of the implanted portion.

[0018] The implanted portion of the implanted catheter body 100 has a central lumen 130, at least one spiral guide groove 140, and a plurality of lateral through holes 150. The central lumen 130 penetrates from the center of the connection terminal 160 and the proximal end 110 along the central axis of the implanted catheter body 100 to the center of the guide tip 120. The guide groove 140 surrounds the outer surface of the implanted catheter body 100 for 360 degrees. The lateral through holes 150 penetrate from the outer surface of the implanted portion of the implanted catheter body 100 into the central lumen 130.

[0019] The shape and size of the implanted catheter body 100 are designed according to the structure of the human cochlea 700. Generally, the length of the adult cochlea 700 is 30 mm. Therefore, in a preferred embodiment of the present invention, by configuring the length L of the implanted portion of the implanted catheter body 100 to be 8 mm to 30 mm, after the implanted catheter body 100 is implanted into the cochlea 700 of the patient, the depth that the guide tip 120 can enter into the cochlea 700 is close to the range of 8 mm to 30 mm, and the implanted portion can be implanted at different positions from the basal turn to the apical turn of the cochlea 700 of the patient.

[0020] Also, in order to reduce the squeezing pressure of the lymph fluid on the cochlea 700 when the implanted catheter body 100 is implanted into the cochlea 700 of the patient, the diameter of the implanted portion of the implanted catheter body 100 is configured to be 0.3 mm to 1.0 mm. In a preferred embodiment, the diameter of the implanted portion may be configured to be 0.5 mm to 0.8 mm.

[0021] As shown in FIG. 8, the cells for treating hearing impairment or the drug as a therapeutic agent enter from the central lumen 130 located at the connection terminal 160 into the internal central lumen 130 of the implanted portion, flow to the end of the central lumen 130 located at the guide tip 120, and flow out from the plurality of lateral through holes 150.

[0022] As the diameter of the central lumen 130 increases, the cross-sectional area of ​​the central lumen 130 increases, while the wall thickness of the implanted catheter body 100 decreases. Therefore, the diameter of the central lumen 130 is adjusted between the flow rate and viscosity of the fluid delivered by the implanted catheter body 100 and other factors such as the required strength of the implanted catheter body 100.

[0023] More specifically, the diameters of the central lumen 130 and the multiple transverse through-holes 150 of the cochlear implantation catheter 1 can both be changed depending on the type of cells or drug that the cochlear implantation catheter 1 is intended to deliver. For example, in one embodiment of the present invention, the cochlear implantation catheter 1 is for carrying a regenerative medicine agent for hearing impairment containing spheroids. The spheroids contained in the regenerative medicine agent for hearing impairment mainly consist of progenitor cells and stem cells with a cell count of 2 to 10. The average diameter of each spheroid is distributed in the range of 30 μm to 100 μm. In this embodiment, the diameter of the central lumen 130 is configured to be 300 μm to 500 μm, and the diameters of the multiple transverse through-holes 150 are configured to be 50 μm to 300 μm.

[0024] With the above configuration, the diameter of the central lumen 130 and the diameters of the multiple transverse through-holes 150 can be matched to the size of the spheroid contained in the hearing impairment regenerative medicine agent delivered by the implanted catheter body 100. This allows the therapeutic agent and spheroid to smoothly pass through the central lumen 130 and the multiple transverse through-holes 150 and enter the patient's cochlea 700.

[0025] In another embodiment of the present invention, the cochlear implantable catheter 1 is for carrying a regenerative medicine formulation for hearing impairment containing a single stem cell or inner hair cell, or a regenerative medicine formulation for hearing impairment containing a cell growth factor. The average diameter of the stem cell or inner hair cell is distributed in the range of 5 μm to 10 μm. The types of cell growth factors include various small molecule polypeptides and proteins, and the average diameter of the cell growth factors is 1 μm to 5 μm.

[0026] In this embodiment, the diameter of the central lumen 130 is configured to be 100 μm to 200 μm, to match the size of a single cell or cell growth factor. The diameters of the multiple transverse through-holes 150 are configured to be 10 μm to 50 μm. With the above configuration, the diameter of the central lumen 130 and the diameters of the multiple transverse through-holes 150 can be matched to the size of the cells or cell growth factors contained in the therapeutic drug delivered by the implanted catheter body 100, so that the therapeutic drug or cells can smoothly pass through the central lumen 130 and the multiple transverse through-holes 150 and enter the patient's cochlea 700.

[0027] In this embodiment, at least one guide groove 140 provided on the outer surface of the implanted catheter body 100 is provided on the outer surface of the implanted catheter body 100 along a helical path extending in the longitudinal direction of the implanted catheter body 100. The function of the guide groove 140 is to improve the flexural elasticity of the implanted catheter body 100, so that when the implanted catheter body 100 enters the patient's cochlear duct, the implanted catheter body 100 becomes more flexible and can enter the apex rotation of cochlear rotation along the helical ligament of the outer wall of the cochlear ventricle.

[0028] On the other hand, at least one guide groove 140 provides a guiding effect to reduce the resistance caused by contact between the outer surface of the implanted catheter body 100 and the lymphatic fluid inside the cochlear duct when the implanted catheter body 100 is inserted into the patient's cochlear duct, thereby reducing the degree of pressure increase in the lymphatic fluid in the cochlear ventricle. This reduces the phenomenon of lymphatic fluid overflow in the cochlear ventricle due to excessive pressure inside the cochlea.

[0029] To achieve the above objective, in this embodiment, the helical angle of at least one guide groove 140 is configured to be between 15 and 60 degrees. Furthermore, the width of at least one guide groove 140 is configured to be between 10 μm and 200 μm. In particular, if the helical angle of the helical guide groove 140 is 45 degrees, the shear stress generated by contact between the outer surface of the implanted catheter body 100 and the lymphatic fluid can be minimized, thereby providing a desirable effect of reducing lymphatic fluid overflow.

[0030] As shown in Figure 3, in one embodiment of the present invention, the multiple transverse through-holes 150 are extension paths along at least one guide groove 140 and are provided at the same intervals inside at least one guide groove 140. The distance between two adjacent transverse through-holes 150 is configured not to be less than 50 μm. In this embodiment, since the multiple transverse through-holes 150 are located inside the guide groove 140, cells or drugs flowing out from the multiple transverse through-holes 150 enter the inside of the guide groove 140 and flow according to the guidance of the guide groove 140, thereby enabling a more uniform distribution of cells or drugs inside the cochlea 700.

[0031] As shown in Figure 4, in another embodiment of the present invention, the multiple lateral through-holes 150 are provided in positions that do not overlap with the guide grooves 140 in the implanted catheter body 100. That is, in this embodiment, the multiple lateral through-holes 150 are provided in areas of the implanted catheter body 100 where the guide grooves 140 are not provided.

[0032] In particular, regarding the design of the cochlear implantable catheter 1 of the present invention, the implantable catheter body 100 can be a transmission catheter that delivers fluid containing cells for treating hearing impairment or a regenerative medicine agent for hearing impairment. Therefore, it is not necessary to provide electrodes or wiring for a cochlear implant on the implantable catheter body 100, thus avoiding an increase in the diameter of the implantable catheter body 100 due to electrodes and wiring. Assuming that the implantable catheter body 100 maintains sufficient strength and can withstand the resistance it receives when implanted into the cochlea 700, the wall thickness of the implantable catheter body 100 can be reduced as much as possible. As a result, by reducing the diameter and volume of the implantable catheter body 100, it is possible to reduce the overflow of lymphatic fluid caused by lymphatic fluid being squeezed out into the cochlea 700 when the implantable catheter body 100 is implanted into the patient's cochlea 700.

[0033] Figure 5 shows an embodiment of the cell transmission device 2 combined with the cochlear implantation catheter 1 of the present invention. The cell transmission device 2 includes the cochlear implantation catheter 1 and a transmission module 200 connected to the cochlear implantation catheter 1. The transmission module 200 includes a pressure generator 210, a connecting pipe 400 connected to the outlet of the pressure generator 210, and a control device 500 connected to the pressure generator 210.

[0034] In this embodiment, the pressure generator 210 may be selected from a micropump, peristaltic pump, compressor, or other type of pressure generating device. The control device 500 is connected to the pressure generator 210 and controls the operation of the pressure generator 210, and controls the flow velocity and pressure at which the pressure generator 210 delivers fluid.

[0035] The operator pre-fills the central lumen 130 of the cochlear implantation catheter 1 with a transport carrier containing cells or a drug as a therapeutic agent, connects the connection terminal 160 of the cochlear implantation catheter 1 to the connecting tube 400, and implants the implanted portion of the implantation catheter body 100 of the cochlear implantation catheter 1 into the patient's cochlea 700. Then, the pressure generator 210 generates pressure, which in turn delivers the cells or drug as a therapeutic agent inside the cochlear implantation catheter 1 into the patient's cochlea 700.

[0036] Figure 6 shows another embodiment of the cell transmission device 2 combined with the cochlear implantable catheter 1 of the present invention. It should be noted that this embodiment is similar to the embodiment in Figure 5, and therefore, similar technical details will not be repeated.

[0037] In this embodiment, the cell transmission device 2 includes a cochlear implantation catheter 1 and a transmission module 300 connected to the cochlear implantation catheter 1. The transmission module 300 includes a pressure generator 310, which is a syringe. The pressure generator 310 has a plunger (not shown) inside. One end of the pressure generator 310 has an outlet 320 connected to a connecting tube 400. An interlocking mechanism 340 is connected to the other end of the pressure generator 310 opposite the outlet 320. The interlocking mechanism 340 is connected to the plunger inside the pressure generator 310 and is driven by a single drive module 330 to push the plunger inside the pressure generator 310 and generate pressure. Since the drive module 330 is a drive device controlled by a stepping motor, the operation of the interlocking mechanism 340 can be precisely controlled, achieving the objective of precisely controlling the flow rate and velocity of the cells or drug as a therapeutic agent.

[0038] Figures 7 and 8 show schematic diagrams of a method for implanting a cochlear implantation catheter 1 inside the patient's cochlea 700 to deliver a fluid containing cells or drugs to treat hearing impairment into the patient's cochlea 700. As shown in Figure 7, the cochlear implantation catheter 1 enters the interior of the cochlea 700 through the round window membrane 710 of the cochlea 700, with its guide tip 120 facing the cochlea 700. The guide tip 120 of the cochlear implantation catheter 1 enters at least the innermost scala of the tympanic cavity inside the cochlea 700.

[0039] The proximal end 110 of the implanted catheter body 100 of the cochlear implanted catheter 1 is connected to the transmission module 200 of the cell transmission device 2 by a connecting tube 400. The transmission module 200 delivers a fluid containing cells or drugs to treat hearing impairment into the implanted catheter body 100 of the cochlear implanted catheter 1, which flows from the central lumen 130 through multiple transverse through-holes 150, passes through the multiple transverse through-holes 150, and enters the patient's cochlea 700.

[0040] Since the multiple transverse through-holes 150 of the cochlear implantation catheter 1 are distributed within the length of the implanted portion of the implantation catheter body 100, it is possible to avoid the concentration of fluid pressure in a single location inside the cochlea 700, and to uniformly distribute cells or drugs that treat hearing impairment to different locations inside the cochlea 700, thereby improving the therapeutic effect.

[0041] It is important to explain that in the embodiment shown in Figure 8, the cells 800 contained in the fluid delivered by the cochlear implantation catheter 1 are formed when multiple cells combine to form a spheroid. However, the present invention is not limited to this, and for example, the cells 800 contained in the fluid may be single cells or cell growth factors.

[0042] Furthermore, in the process by which the cell transmission device 2 delivers fluid into the patient's cochlea 700, it is necessary to control the fluid's velocity and flow rate to avoid overflow of the fluid containing cells 800 or drugs into the cochlea 700. Additionally, it is necessary to control the fluid's pressure to prevent excessive pressure from causing death or damage to the cells 800 within the fluid.

[0043] In a preferred embodiment of the present invention, the cell transmission device 2 is configured to deliver a fluid with a viscosity of 2 Pas to 5 Pas to the cochlear implantation catheter 1 at a flow rate of 0.1 sccm to 0.5 sccm, and the fluid pressure is configured to be within the range of 1000 MPa to 1500 MPa.

[0044] It should be explained that the cochlear implantation catheter 1 of the present invention is designed to deliver a fluid containing cells or drugs to treat hearing impairment into the cochlea 700, and then be removed from the patient's cochlea 700, rather than remaining implanted inside the patient's cochlea 700. Therefore, depending on the need for treatment, the operator can choose to deliver the cells or drugs into the patient's cochlea 700, remove the cochlear implantation catheter 1, and then close the round window membrane 710 of the cochlea 700 to retain the cells or drugs inside the cochlea 700, or implant electrodes for an artificial electronic ear and then close the cochlea 700.

[0045] [Second Example] Figures 9 and 10 show a second embodiment of the cochlear implantable catheter of the present invention. It should be noted that the technical features of this embodiment are similar to those of the first embodiment, and therefore, the same technical features will not be repeated.

[0046] As shown in Figure 9, in this embodiment, the cochlear implantable catheter 1a has a plurality of guide grooves 140a provided on the outer surface of the implanted portion of the implantable catheter body 100a. The plurality of guide grooves 140a are linear grooves provided on the outer surface of the implanted portion of the implantable catheter body 100a, extending along a path parallel to the central axis of the implantable catheter body 100a and along the longitudinal direction of the implantable catheter body 100a.

[0047] As shown in Figure 10, cross-sectional observation of the implanted portion of the implanted catheter body 100a reveals that multiple guide grooves 140a are provided around the outside of the implanted catheter body 100a at equal angular intervals and are recessed from the outer surface of the implanted catheter body 100a toward the center of the implanted catheter body 100a. The multiple guide grooves 140a can improve the bending elasticity of the implanted catheter body 100a. When the implanted catheter body 100a enters the cochlea 700, the multiple guide grooves 140a provide a guiding effect, reducing resistance between the implanted catheter body 100a and the lymphatic fluid inside the cochlea 700, thereby reducing lymphatic fluid overflow.

[0048] [Beneficial effects of the examples] The present invention has the following beneficial effects. The cochlear implantation catheter and cell transmission device provided by the present invention have good flexibility, making them easy to implant into the patient's cochlea. This allows them to bend easily and penetrate deeply into the cochlear duct along the spiral ligament of the outer wall of the cochlear duct. The design of the guide groove reduces resistance between the outer wall of the implantation catheter body and the lymphatic fluid inside the cochlea. This increases the success rate of cochlear implantation catheter implantation and prevents damage to the cochlea.

[0049] Furthermore, the cochlear implantation catheter of the present invention is designed with guide grooves and features uniformly distributed transverse through-holes in the catheter body. This allows for the uniform distribution of cells or drugs to different locations within the cochlea, thereby preventing overflow of lymphatic fluid inside the cochlea.

[0050] The information disclosed above is merely a preferred and implementable embodiment of the present invention and does not limit the scope of the claims of the present invention. Therefore, all equivalent technical modifications made using the contents of the specification and drawings of the present invention are included within the scope of the claims of the present invention. [Explanation of Symbols]

[0051] 1, 1a: Cochlear implantable catheter 2: Cell transmission device 100, 100a: Implantable catheter body 110, 110a: Proximal end 120, 120a: Guide tip 130, 130a: central lumen 140, 140a: Guide groove 150, 150a: Lateral through hole 160, 160a: Connection terminals 170: Protruding ring 200, 300: Transmission module 210, 310: Pressure generator 220, 320: Exit 330: Drive Module 340: Interlocking mechanism 400: Connecting pipe 500: Control device 700: Cochlea 710: Round window membrane 800: Cell L: Length

Claims

1. A cochlear implantable catheter for delivering a drug, either as a cell or therapeutic agent, to the patient's cochlea, Includes a flexible implantable catheter body, The implantable catheter body has a proximal end and a guide tip defined at opposite ends in the longitudinal direction. The portion of the implanted catheter body that is implanted in the patient's cochlea is defined as the implanted portion. The embedded portion has a connection terminal on the side facing the proximal end, The interior of the implanted catheter body has a central lumen that penetrates from the center of the proximal end to the center of the guide tip, The embedded portion has at least one guide groove provided on its outer surface and a plurality of transverse through holes that penetrate from the outer surface of the embedded portion into the central lumen. The implantable catheter body is configured to insert into the patient's cochlea with its guide tip facing the direction of the patient's cochlea, to advance while curving along the spiral structure of the patient's cochlea, to enter between the basal and apical turns of the patient's cochlea, to introduce the cells or therapeutic agent into the central lumen from the proximal end, to enter the interior of the cochlea by passing through the central lumen and the plurality of transverse through-holes. A cochlear implantable catheter, wherein at least one of the guide grooves is a spiral groove provided on the outer surface of the implanted portion of the implantable catheter body along a spiral path extending in the longitudinal direction of the implantable catheter body, so as to facilitate bending and provide a guiding effect when inserting the implantable catheter body into the cochlea of ​​the patient, thereby reducing the overflow of lymphatic fluid from the cochlea, or a groove that extends along the path of the central axis of the implantable catheter body and in the longitudinal direction of the implantable catheter body.

2. The cochlear implantable catheter according to claim 1, wherein the length of the implanted portion of the implantable catheter body is configured to be 8 mm to 30 mm, and the diameter of the implanted portion is configured to be 0.3 mm to 1.0 mm.

3. The cochlear implantable catheter according to claim 2, wherein the diameter of the central lumen is configured to be 300 μm to 500 μm, and the diameters of the plurality of transverse through-holes are configured to be 50 μm to 300 μm.

4. The cochlear implantable catheter according to claim 2, wherein the diameter of the central lumen is configured to be 100 μm to 200 μm, and the diameters of the plurality of transverse through-holes are configured to be 10 μm to 50 μm.

5. The cochlear implantable catheter according to claim 2, wherein the implantable catheter body is provided with a protruding ring at the boundary between the connection terminal and the implanted portion, and the diameter of the protruding ring is larger than the diameter of the implanted portion and the connection terminal of the implantable catheter body.

6. The cochlear implantable catheter according to claim 1, wherein at least one of the guide grooves is a helical groove, and the helical angle of at least one of the guide grooves is configured to be between 15 and 60 degrees.

7. The cochlear implantable catheter according to claim 1, wherein at least one of the guide grooves is a straight groove and is provided on the outside of the implantable catheter body at equal angular intervals.

8. The cochlear implantable catheter according to claim 1, wherein the groove depth of at least one of the guide grooves is configured to be 10 μm to 200 μm.

9. A cell transmission device for delivering cells or drugs as therapeutic agents to the cochlea of ​​a patient, A cochlear implantation catheter according to any one of claims 1 to 8, Includes a transmission module connected to the cochlear implantation catheter for transmitting the cells or the drug to the patient's cochlea, The transmission module comprises a pressure generator and a connecting pipe connected to the outlet of the pressure generator. The pressure generator stores the fluid containing the cells or the drug, and drives the fluid containing the cells or the drug to send the fluid containing the cells or the drug from the outlet to the connecting pipe. A cell transmission device in which one end of the connecting tube is connected to the pressure generator, the proximal end of the implanted catheter body, and the cells or drug enter the central lumen of the implanted catheter, pass through the central lumen and the plurality of transverse through-holes, and enter the cochlea of ​​the patient.

10. The cell transmission device according to claim 9, wherein the transmission module is configured to deliver a fluid with a viscosity of 2 Pas to 5 Pas to the cochlear implantation catheter at a flow rate of 0.1 sccm to 0.5 sccm, and the pressure of the fluid is configured to be in the range of 1000 MPa to 1500 MPa.

Images