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JP-7857032-B2 - Cochlear implantable catheter and cell transmission device

JP7857032B2JP 7857032 B2JP7857032 B2JP 7857032B2JP-7857032-B2

Inventors

  • 王智弘

Assignees

  • 國防醫學大學

Dates

Publication Date
20260512
Application Date
20240925
Priority Date
20231220

Claims (10)

  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 within the range of 1000 MPa to 1500 MPa.

Description

This invention relates to a cochlear implantable catheter and a cell delivery device, and more particularly to a cochlear implantable catheter and a cell delivery device for delivering cells or drugs to the inner ear of a person. The auditory receptors (cochlea in the inner ear) and auditory nerve are crucial structures for receiving external sound signals, but they are susceptible to loss of function due to factors such as medication, environmental factors, aging, or genetic mutations. Once human hearing function is damaged, the damage is highly likely to be permanent and irreversible, making it a significant obstacle to treating hearing impairment at present. With advances in genetic medicine and regenerative medicine, gene cloning therapy for hearing impairment and cochlear auditory organ cell regeneration have been recognized, and there is hope that cell therapy can treat hearing impairment. Cell therapy for treating hearing impairment primarily involves injecting cells or therapeutic drugs into the inner ear. These injected cells are then used to replace or regenerate necessary auditory cells. Alternatively, the implanted cells or drugs differentiate or convert the patient's original inner ear cells into the required auditory cells, thereby restoring hearing. In cell therapy, the injected cells may be autologous or allogeneic. 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 agents. 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 extravasate, reducing the effectiveness of drug or cell delivery to the cochlea. Current technology proposes implantable catheters that work by embedding electrodes in the cochlear implant. These implantable catheters, in addition to the original implantable electrode array and conductive wires, have an accompanying lumen for carrying therapeutic drugs and transmitting them into the patient's cochlea. Because these implantable 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 devices, they differ from the design of the present invention, which is applied to deliver drugs or cells to the cochlea in a single treatment. Therefore, currently, there are still many difficulties in the technology of directly and partially delivering cells or drugs to the cochlea. Improving the structural design of the devices to overcome these shortcomings is a crucial challenge in resolving the problems inherent in cochlear cell therapy. This is a schematic diagram of a first embodiment of the cochlear implantable catheter of the present invention.This is a schematic cross-sectional view of the cochlear implantable catheter of the present invention.This is a partially enlarged schematic diagram of part III of Figure 1 of the cochlear implantation catheter of the present invention.This is a partially enlarged schematic diagram of another embodiment of the cochlear implantation catheter of the present invention.This is a schematic diagram of one embodiment of the cell transmission device of the present invention.This is a schematic diagram of another embodiment of the cell transmission device of the present invention.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.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.This is a schematic diagram of a second embodiment of the cochlear implantable catheter of the present invention.This is a schematic cross-sectional view of a second embodiment of the cochlear implantable catheter of the present invention. 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 presen