A monitoring type pre-bent cochlear implant electrode

Abstract

The application provides a monitoring type pre-bending cochlear implant electrode, which internally embeds a withdrawable optical fiber pressure guide wire (4); a slot (2) is formed in the front end of the cochlear implant electrode; the front end of the optical fiber pressure guide wire (4) is provided with a pressure sensor (5); the pressure sensor (5) is exposed in the slot (2); the front end of the cochlear implant electrode is provided with a plurality of color marks (3). The application has the advantages that precise detection and feedback of cochlear pressure are realized, real-time mechanical information is provided for surgical operation, compared with traditional pressure monitoring at the round window 5mm, the device can more directly reflect the action of cochlear pressure on the basilar membrane, and the precise control of the surgical process is improved, visual and pressure feedback monitoring is realized during the cochlear implantation surgery, and the minimally invasive implantation of the surgery is laid a foundation.

Description

Technical Field

[0001] This application belongs to the field of medical devices, specifically relating to a monitoring type pre-bent cochlear implant electrode. Background Technology

[0002] Cochlear implant surgery establishes an artificial auditory pathway, allowing patients with severe / profound sensorineural hearing loss to hear external sounds again. With the increasing maturity and refinement of cochlear implant technology, current clinical treatment goals have expanded from simply restoring hearing to precisely protecting the patient's original physiological structure. Optimizing minimally invasive surgical techniques has become the mainstream direction of this technology's development. Related research indicates that maintaining a stable cochlear microenvironment (e.g., controlling perilymph loss to less than 0.5 μL and limiting fenestration exposure time to less than 10 minutes) helps reduce postoperative cochlear fibrosis, thereby effectively preserving the function of residual hair cells. This protection of the auditory microenvironment not only enhances the auditory nerve's ability to process complex acoustic signals but also improves the patient's speech induction (SIN) and musical pitch recognition in noisy environments. Current technology cannot yet solve the problem of providing real-time visual and pressure feedback during cochlear implant surgery; currently, it relies solely on the surgeon's experience for judgment. Utility Model Content

[0003] The purpose of this application is to overcome the shortcomings of existing technologies that cannot provide real-time visual and cochlear pressure information feedback during surgery.

[0004] To achieve the above objectives, this application proposes a monitoring-type pre-bent cochlear implant electrode, wherein a removable optical fiber pressure guidewire is inserted inside the cochlear electrode.

[0005] The cochlear electrode has a groove at its front end;

[0006] The front end of the optical fiber pressure guide wire has a pressure sensor; the pressure sensor is exposed in the groove;

[0007] The front end of the cochlear electrode has multiple color markings.

[0008] As an improvement to the aforementioned cochlear electrode, the length of the groove is 30-40 mm.

[0009] As an improvement to the aforementioned cochlear electrode, the plurality of color markings are: starting from the end of the groove near the front end of the cochlear electrode and moving away from the front end of the cochlear electrode, there is a color marking point at predetermined intervals.

[0010] As an improvement to the aforementioned cochlear electrode, the set distance is 5mm, and the number of color markers is 7.

[0011] As an improvement to the aforementioned cochlear electrodes, adjacent color markers are of different colors.

[0012] As an improvement to the aforementioned cochlear electrodes, the color markers are encapsulated in medical-grade silicone.

[0013] As an improvement to the aforementioned cochlear electrodes, the material used for color marking is an inert pigment, including titanium dioxide, iron oxide, or silver oxide.

[0014] As an improvement to the aforementioned cochlear electrode, the outer diameter of the optical fiber pressure guidewire is 0.125-0.155 mm, and the length is 50-70 mm.

[0015] As an improvement to the aforementioned cochlear electrodes, it further includes: a signal demodulation system for demodulating the optical signal of the optical fiber pressure guidewire to obtain the cochlear pressure value.

[0016] Compared with existing technologies, the advantages of this application are:

[0017] 1. The fiber optic pressure guidewire works closely with the signal demodulation system and the pressure velocity feedback system to achieve accurate detection and information feedback of cochlear pressure, providing real-time mechanical data support for surgical procedures;

[0018] 2. This device combines a pressure guidewire with an artificial cochlear electrode. Compared with the traditional method of monitoring pressure at 5mm in the circular window, this device more directly reflects the effect of cochlear pressure on the basilar membrane, which can greatly improve the precision control of the surgical process.

[0019] 3. This device enables simultaneous signal demodulation, micro-pressure monitoring, and cochlear implantation. Combined with visual color markings, it provides visual and pressure information feedback and monitoring during cochlear implantation surgery.

[0020] 4. The pressure guide wire is made of optical fiber material, which ensures the efficiency of signal acquisition and transmission;

[0021] 5. The main component of the color markings is inert pigment, which has higher stability and ensures that the implant has high biocompatibility and stability. Attached Figure Description

[0022] Figure 1 The diagram shown is of the structure of a monitoring-type pre-bent cochlear implant electrode when it is not in use.

[0023] Figure 2 The image shown is a longitudinal cross-sectional view of a monitoring-type pre-bent cochlear implant electrode.

[0024] Figure 3 The diagram shown is of the fiber pressure guide wire structure.

[0025] Figure 4The diagram shown is a schematic of the structure after a monitoring-type pre-bent cochlear implant electrode is implanted into the cochlea. Detailed Implementation

[0026] The technical solution of this application will be described in detail below with reference to the accompanying drawings.

[0027] This application proposes a monitoring-type pre-bent cochlear implant electrode. Using this cochlear electrode, an optical fiber pressure guide wire can be implanted into the patient's cochlea along with the cochlear electrode, allowing for more direct acquisition and feedback of real-time pressure within the cochlea. Combined with color-coding, it provides visual and pressure information feedback during cochlear implantation surgery.

[0028] like Figure 1 , Figure 2 and Figure 3 As shown, the monitoring-type pre-bent cochlear implant electrode proposed in this application may include a cochlear electrode 1, an optical fiber pressure guide wire 4, and a signal demodulation system.

[0029] The cochlear electrode 1 can be a cylindrical, pre-bent cochlear electrode, with its silicone tip pre-bent approximately 270°–280° to bring the electrode as close as possible to the spiral ganglion. A removable fiber optic pressure guidewire 4 can be inserted inside the cochlear electrode 1. A groove 2 can be formed in the silicone tip of the cochlear electrode 1 to expose the fiber optic pressure guidewire 4. The length of the groove 2 at the silicone tip of the cochlear electrode 1 is 30-40 mm, preferably 35 mm. Starting from the top of the groove 2 at the silicone tip of the cochlear electrode 1 and moving away from the silicone tip, a color marker 3 is set every 5 mm, for a total of 7 markers, with adjacent markers 3 being different colors. The color markers 3 can be used for surgical implantation guidance. The color markers 3 can be composed of inert pigments such as titanium dioxide (white), iron oxide (red or yellow), or silver oxide (black) to distinguish electrode depth, and are encapsulated in medical-grade silicone to ensure high biocompatibility and stability.

[0030] The fiber optic pressure guidewire 4 serves as a support wire for the cochlear electrode 1 and also acquires pressure signals. The end of the fiber optic pressure guidewire 4 can have a pressure sensor 5 for detecting cochlear pressure. After the cochlear electrode 1 is inserted, the pressure sensor 5 can be located at the end of the groove 2 near the end of the cochlear electrode 1 and exposed. The outer diameter of the fiber optic pressure guidewire 4 can be 0.125-0.155 mm, preferably 0.145 mm, and the length is 50-70 mm, preferably 61.8 mm. The measurement range of the fiber optic pressure guidewire 4 can be 0-50 mmHg, and the measurement accuracy can be 0.5 mmHg, which fully meets the needs of clinical use. The outer surface of the fiber pressure guidewire 4 should be free of foreign matter and surface defects; tensile strength, tip pull, and bending resistance should meet the requirements of ISO 11070 standard; torsional strength and kink resistance should be no less than those of similar products already on the market; measurement accuracy should meet the requirements of AAMI BP22 standard; zero drift / zero thermal effect / sensitivity thermal effect should meet the requirements of AAMI BP22 standard.

[0031] The signal demodulation system is used to demodulate the signal from the fiber optic pressure guidewire 4 via an accompanying connector. The demodulation system may include a light source, a fiber optic coupler, a fiber optic Fabry-Perot sensor, and a demodulation module. The emitted light from the light source is transmitted to the fiber optic Fabry-Perot sensor via the fiber optic coupler, where two-beam interference occurs. The returned light, carrying cavity length information, is then transmitted to the demodulation module via the fiber optic coupler. The sensor detects the pressure on the pressure guidewire and converts it into an electrical signal. After processing by the demodulation system, the current pressure value can be displayed. A digital model of cochlear pressure is then established based on the current pressure value.

[0032] During use, the cochlear electrode 1, with the fiber optic pressure guidewire 4 inserted, is slowly implanted into the cochlea. Simultaneously, the fiber optic pressure guidewire 4 detects pressure information in the surgical cochlea and transmits the pressure signal to the signal demodulation system via a signal transmission line. After demodulation processing, the pressure data is displayed on an imaging monitor, providing doctors with real-time pressure information. Color-coded indicators 3 help the operator clearly understand the implantation depth of the cochlear electrode 1. While the cochlear electrode 1 is implanted, the fiber optic pressure guidewire 4 is slowly withdrawn. The pre-bent cochlear electrode 1 deforms into a spiral columnar structure as the fiber optic pressure guidewire 4 is withdrawn to adapt to the shape of the cochlea. Once the cochlear electrode 1 is in place, the fiber optic pressure guidewire 4 is completely withdrawn. Because the fiber optic pressure guidewire 4 is completely placed inside the cochlear electrode 1, withdrawing it outwards will not cause secondary damage to the cochlea (i.e., it will not cause further damage to the cochlear basilar membrane), effectively preserving residual hearing and improving postoperative hearing restoration.

[0033] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application and are not intended to limit it. Although this application has been described in detail with reference to the embodiments, those skilled in the art should understand that modifications or equivalent substitutions to the technical solutions of this application do not depart from the spirit and scope of the technical solutions of this application, and should all be covered within the scope of the claims of this application.

Claims

1. A monitoring-type pre-bent cochlear implant electrode, characterized in that, A removable optical fiber pressure guidewire (4) is inserted inside the cochlear electrode; The cochlear electrode has a groove (2) at its front end; The front end of the optical fiber pressure guide wire (4) has a pressure sensor (5); the pressure sensor (5) is exposed in the groove (2); The front end of the cochlear electrode has multiple color markings (3).

2. The monitoring-type pre-bent cochlear implant electrode according to claim 1, characterized in that, The length of the groove (2) is 30-40mm.

3. The monitoring-type pre-bent cochlear implant electrode according to claim 1, characterized in that, The plurality of color markings (3) are: starting from the end of the groove (2) near the front end of the cochlear electrode and moving away from the front end of the cochlear electrode, there is a color marking (3) at a predetermined distance.

4. The monitoring-type pre-bent cochlear implant electrode according to claim 3, characterized in that, The set distance is 5mm, and the number of color marks (3) is 7.

5. The monitoring-type pre-bent cochlear implant electrode according to claim 1, characterized in that, The adjacent color markers (3) have different colors.

6. The monitoring-type pre-bent cochlear implant electrode according to claim 1, characterized in that, The color markings (3) are encapsulated in medical-grade silicone.

7. The monitoring-type pre-bent cochlear implant electrode according to claim 1, characterized in that, The material of the color mark (3) is an inert pigment, including titanium dioxide, iron oxide or silver oxide.

8. The monitoring-type pre-bent cochlear implant electrode according to claim 1, characterized in that, The outer diameter of the optical fiber pressure guide wire (4) is 0.125-0.155 mm, and the length is 50-70 mm.

9. The monitoring-type pre-bent cochlear implant electrode according to claim 1, characterized in that, Also includes: The signal demodulation system is used to demodulate the optical signal of the optical fiber pressure guidewire (4) to obtain the cochlear pressure value.

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