SUMMERY OF THE UTILITY MODEL
An object of the utility model is to provide a cochlear implant device and cochlear implant to solve present cochlear implant device and can not adapt to different cochlea, the signal portion after the implantation is inseparable with the cochlea laminating, leads to signal portion and the inside unable direct contact of cochlea, signal stimulation effect is poor, signal position precision is poor and the not good problem of result of use.
In order to solve the above technical problem, the utility model provides a cochlear implant device, include: a tubular structure formed by coiling a stent monofilament, and a signal part; the tubular structure has an implanted state and a released state, and in the implanted state, the tubular structure is used for being arranged on an implantation guide device and is used for being implanted into a cochlea along with the implantation guide device; during the transition of the tubular structure from the implanted state to the released state, the tubular structure is radially diameter-variable expanded; the signal part is arranged on the bracket monofilament and used for sending or receiving signals.
Optionally, the tubular structure is formed by at least two of the stent filaments spiraling along different trajectories.
Optionally, at least one signal part is arranged on at least one stent monofilament.
Optionally, each of the stent monofilaments is provided with one signal portion, each of the stent monofilaments has the same length, and each of the signal portions is arranged along the axial direction of the stent monofilament at equal intervals.
Optionally, the signal portion is disposed at an intersection of the two stent filaments, and the signal portion is located closer to an outer side of the tubular structure.
Optionally, the tubular structure is formed by braiding at least two stent monofilaments, and the number of signal parts arranged on each stent monofilament is different.
Optionally, each stent monofilament is provided with at least one signal part.
Optionally, the cochlear implant device further comprises a lead connected with the signal part; the support monofilament comprises a support monofilament body and a wire guide groove, wherein the wire guide groove extends along the axial direction of the support monofilament body, and the wire is arranged in the wire guide groove.
Optionally, the signal part is disposed on the stent monofilament body and located outside the wire guide groove.
Optionally, the signal part comprises an electrical signal component and/or an optical signal component; the electrical signal component comprises an electrode and the optical signal component comprises an LED and/or a light intensity sensor.
Optionally, the stent monofilament further comprises a drug groove for accommodating drugs.
Optionally, the stent monofilament includes an optical fiber, and the signal portion includes an optical fiber light-transmitting opening for transmitting light.
Optionally, the stent monofilament further includes a stent monofilament body and an optical fiber groove, the optical fiber groove is disposed along an axial direction of the stent monofilament body, and the optical fiber is disposed in the optical fiber groove.
In order to solve the above technical problem, the utility model also provides a cochlear implant, include: the cochlear implant device and the cochlear implant external device are in signal connection with the cochlear implant device.
In the cochlear implant device and the cochlear implant provided by the utility model, the cochlear implant device comprises a tubular structure formed by winding a single wire of a bracket and a signal part; the tubular structure has an implanted state and a released state, and in the implanted state, the tubular structure is used for being arranged on an implantation guide device and is used for being implanted into a cochlea along with the implantation guide device; during the transition of the tubular structure from the implanted state to the released state, the tubular structure is radially diameter-variable expanded; the signal part is arranged on the bracket monofilament and used for sending or receiving signals. So set up for artifical cochlear implant device can adapt to the individual difference of different cochlea, and the signal portion after guaranteeing to implant is inseparable with the cochlea laminating, guarantees excellent signal stimulation effect, improves the accurate nature of signal position, promotes patient's result of use.
Detailed Description
To make the objects, advantages and features of the present invention clearer, the present invention will be described in further detail with reference to the accompanying drawings and specific embodiments. It is to be noted that the drawings are in simplified form and are not to scale, but rather are provided for the purpose of facilitating and distinctly claiming the embodiments of the present invention. Further, the structures illustrated in the drawings are often part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently.
As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. Furthermore, in the following description, numerous specific details are set forth in order to provide a more thorough understanding of the present invention. It will be apparent, however, to one skilled in the art, that the present invention may be practiced without one or more of these specific details. In other instances, well-known features have not been described in order to avoid obscuring the present invention.
In the cochlear implant device and the cochlear implant provided by the utility model, the cochlear implant device comprises a tubular structure formed by winding a single wire of a bracket and a signal part; the tubular structure has an implanted state and a released state, and in the implanted state, the tubular structure is used for being arranged on an implantation guide device and is used for being implanted into a cochlea along with the implantation guide device; during the transition of the tubular structure from the implanted state to the released state, the tubular structure is radially diameter-variable expanded; the signal part is arranged on the bracket monofilament and used for sending or receiving signals. So set up for artifical cochlear implant device can adapt to the individual difference of different cochlea, and the signal portion after guaranteeing to implant is inseparable with the cochlea laminating, guarantees excellent signal stimulation effect, improves the accurate nature of signal position, promotes patient's result of use.
The following description refers to the accompanying drawings.
[ EXAMPLES one ]
Referring to fig. 1 to 5, fig. 1 is a schematic view of a cochlear implant device according to a first embodiment and a second embodiment; fig. 2 is a schematic view of the cochlear implant device according to the first embodiment after being implanted into a cochlea; fig. 3 is an expanded schematic view of a cochlear implant device according to a first embodiment of the present invention; FIG. 4 is a schematic view of a plurality of stent filaments according to one embodiment of the present invention; fig. 5 is a schematic diagram of a cross section of a stent monofilament provided in the first embodiment.
Referring to fig. 1, a cochlear implant device includes: a stent monofilament 100 and a signal section 200.
As shown in fig. 1, the stent monofilament 100 is coiled into a tubular configuration a. The stent monofilament 100 is preferably a sheet of wire, for example. Of course, the stent monofilament 100 is not limited to be sheet-shaped, and is not limited to be made of metal, for example, the cross section of the stent monofilament 100 is a circular or elliptical structure, and the stent monofilament 100 may be made of polymer material, such as fiber or optical fiber material. When the stent monofilament 100 is coiled to form the tubular structure a, the stent monofilament 100 may be coiled or braided around a mandrel (not shown), for example, a mandrel with a diameter of 8 mm is selected, and the stent monofilament 100 is wound and braided on the mandrel by a braiding machine, thereby finally forming a stent with a tubular structure a with a diameter of 8 mm. Wherein the mandrel may be a metal mandrel. Certainly, in practice, a worker can select a core rod with a proper diameter and shape according to the size requirement of the actual cochlea 10 of the patient, and further control the radial mechanical extrusion characteristics and the like of the support monofilament 100 at different positions by controlling the sizes of the different positions of the core rod, so as to further meet the actual condition in the cochlea 10 of the patient.
It is understood that the tubular structure a formed by the stent monofilament 100 may be radially compressed or radially expanded, with the tubular structure a being radially expanded with varying diameters, so that the tubular structure a can match the radial dimensions of the cochlea. At the same time, the tubular structure a can be lengthened or shortened along its axial length. As shown in fig. 2, the tubular structure a can also be bent along its axial direction to match the spiral structure of the cochlea 10, thereby giving the tubular structure a an implanted state and a released state. In the implanted state, the tubular structure a is for placement on an implant guide (not shown) and for implantation with the implant guide into a cochlea 10. The implantation guide is, for example, a flexible rod-like structure, and the stent monofilament 100 can be arranged coiled around the implantation guide. During the transition of the tubular structure a from the implanted state to the released state, the axis of the tubular structure a expands helically to match the helical structure of the cochlea 10. The expansion shows that the tubular structure A is expanded along the radial direction of the tubular structure A, after the tubular structure A enters a release state, the tubular structure A can be tightly attached to the cochlea 10, the arrangement is such that the radial size of the tubular structure A can be adjusted in real time when the tubular structure A is unfolded according to the internal size of the cochlea of a patient, the unfolded tubular structure A is tightly attached to the inner wall of the cochlea, each part of the support monofilament 100 can be tightly attached to the inner wall of the natural orifice of the cochlea 10 of the patient, and the problem that the fitting of the cochlear electrode and the inner wall of the cochlea is not tight is solved.
As shown in fig. 1 and 3, the signal part 200 is disposed on the stent monofilament 100 for transmitting or receiving a signal. The signal section 200 preferably includes, for example, an electrical signal component and/or an optical signal component. Preferably, the electrical signal component can be used to send electrical signals, or receive signals within the cochlea. The optical signal component can be used to emit an optical signal. The electric signal and the optical signal can stimulate the nervous system in the cochlea and directly excite the auditory nerve to recover or rebuild the auditory function of the deaf people. The position of the signal part 200 on the stent monofilament 100 is matched according to the position (such as the position of a neuron) of the signal stimulation required by the cochlea 10, for example, after a worker determines the cochlea live condition of a patient, the structure of the stent monofilament 100 after being in a release state is simulated in vitro, and then the signal part 200 is arranged according to the position of the signal stimulation required. By the arrangement, the signal part 200 on the support monofilament 100 can be accurately positioned to the position where the signal is required to stimulate, so that the artificial cochlea implant device can adapt to the individual difference of different cochlea, can adapt to the unique rugged shape of the inner walls of the cochlea of different patients, and ensures the excellent signal stimulation effect; and, the tension effect of support monofilament 100 under the release state, signal portion 200 is fixed stable with cochlea inner wall relative position for signal portion 200 can with the inside direct contact of cochlea 10 and closely laminate, difficult emergence is become flexible and the displacement after the postoperative, thereby avoids the problem that the cochlea postoperative easily takes place the displacement, improves the accurate nature of stimulation signal position, promotes patient's result of use. In this embodiment, the signal portion 200 includes an electrode, so that the electrode array carried on the stent monofilament 100 is closely attached to the inner wall of the cochlea, and the electrode array can better stimulate auditory nerves.
The cochlear implant device may include one stent monofilament 100, or may include two stent monofilaments 100. Preferably, as shown in fig. 1, the cochlear implant device comprises at least two stent monofilaments 100, the tubular structure a is formed by spiraling the at least two stent monofilaments 100 along different tracks, and the stent monofilaments 100 play a supporting role in the whole tubular structure a, and compared with a single stent monofilament 100, the tubular structure a has better radial supporting force and ensures the stability of the tubular structure a inside the cochlea 10. It will be appreciated that the different trajectories indicate that the trajectories of each stent monofilament 100 spiral are at least partially non-overlapping. That is, the angle at which each stent monofilament 100 spirals is different, so that the signal sections 200 on the stent monofilaments 100 can be disposed at more positions, thereby improving the accuracy of signal stimulation. Preferably, the tubular structure a is braided from at least two stent monofilaments 100. More preferably, each stent monofilament 100 has a different number of signal portions 200, for example, one stent monofilament 100 has one signal portion 200 and the other stent monofilament 100 has two signal portions 200. Of course, the length of one stent monofilament 100 may also be different from the length of another stent monofilament 100 in the state where the stent monofilaments 100 are straightened. The worker calculates the position of each signal part 200 integrated on the stent monofilament 100 according to the diameter change of the cochlea at the actual implanted intracochlear site in the cochlea of the patient and parameters such as the weaving combination process, the diameter of the target cochlea, the signal size and the like. In the first embodiment, as shown in fig. 1, the tubular structure a is formed by braiding three stent monofilaments 100, for example, wherein two stent monofilaments 100 are respectively provided with one signal part 200, and one signal part 200 is not provided. The three stent monofilaments 100 are arranged in a staggered manner, so that the signal part 200 can be tightly attached to a target position of a cochlea. Preferably, the signal part 200 is disposed at the intersection point of the two stent monofilaments 100, and the signal part 200 is located at the outer side closer to the tubular structure a, so that the signal part 200 can be more closely attached to the target position of the cochlea. In fact, the signal portion 200 needs to be closely attached to the inner wall of the cochlea, and if the signal portion 200 is arranged at the intersection point of two stent monofilaments 100, the signal portion 200 needs to be arranged on the stent monofilament 100 closest to the cochlea to avoid being shielded by other stent monofilaments 100. Of course, in other embodiments, the number of stent filaments 100 and signal portions 200 is not limited. The stent monofilaments 100 can be five, six, eight, or the like. The number of the signal parts 200 on each stent monofilament 100 can also be two, three or four, and the distance between each signal part 200 on a single stent monofilament 100 is not limited and can be calculated according to the actual condition of the cochlea 10. Preferably, each stent monofilament 100 is provided with at least one signal part 200, so that each stent monofilament 100 can play a role in supporting and also has a role in bearing the signal part 200.
Preferably, as shown in fig. 4, at least one signal part 200 is disposed on at least one stent monofilament 100, and the position where the signal part 200 is disposed may be set according to actual requirements, so that the signal part 200 can provide a stimulation signal. Preferably, as shown in fig. 4, each stent monofilament 100 is provided with one signal part 200, when the stent monofilament 100 is in a straightened state, the length of each stent monofilament 100 is equal, and each signal part 200 is arranged at equal intervals along the axial direction of the stent monofilament 100, so that when each stent monofilament 100 is combined by weaving, the position of the signal part 200 on each stent monofilament 100 is conveniently confirmed, and the weaving efficiency and the weaving quality are improved. In the first embodiment, each of the signal portions 200 is disposed at a distance of six millimeters along the axial direction of the stent monofilament 100.
Preferably, as shown in fig. 5, the signal part includes an electrical signal part and/or an optical signal part; the electrical signal component comprises an electrode and the optical signal component comprises an LED and/or a light intensity sensor. In the first embodiment, the signal portion 200 includes an electrical signal component, which includes an electrode. The electrode is, for example, a thin platinum-iridium alloy electrode with a length and a width of 1 mm, and is connected to a lead 300 by welding. In another embodiment, the signal section 200 includes an optical signal component including an LED and/or a light intensity sensor. Preferably, the optical signal component is connected with the lead 300 and used for receiving signals, and further stimulating the nerve of the cochlea by means of optical stimulation, and restoring or reconstructing the auditory function of the deaf person. The optical signal component can be an LED, an optical intensity sensor, an LED and an optical intensity sensor. Also, the arrangement position, the number, and the like of the optical signal components can be calculated according to the actual condition of the cochlea of the patient. In other embodiments, the signal portion includes both electrical and optical signal components.
As shown in fig. 4 and 5, the cochlear implant device further includes a lead 300, the lead 300 is connected to the signal portion 200, the lead 300 is, for example, a gold wire with an insulating layer and a diameter of thirty microns, of course, the material of the lead 300 is not limited to the gold wire, and may be other conductive materials, which can be selected by those skilled in the art according to actual needs, and will not be described herein again. The wire 300 is used for transmitting an electrical signal or the like, for example. The stent monofilament 100 comprises a stent monofilament body 110 and a wire groove 120, wherein the wire groove 120 extends along the axial direction of the stent monofilament body 110, and the wire 300 is disposed in the wire groove 120. The guide grooves 120 are not limited to a straight line along the axial direction of the stent monofilament body 110, but are arranged to follow the shape of the stent monofilament body 110, and are not limited to the strictly defined axial direction of the stent monofilament body 110, but represent the strip-shaped longitudinal direction of the strip-shaped stent monofilament body 110. For example, the stent monofilament body 110 is a nitinol wire with a width and a thickness of one hundred microns, the depth of the wire groove 120 is fifty microns, and the electrode is integrated with the stent monofilament body 110 by adhesion through an insulating material. The signal part 200, the lead 300 and the stent monofilament 100 are integrally arranged, so that the external structural size of the stent monofilament 100 is not increased when the lead 300 is connected with the signal part 200, the implantation position of the cochlear implant device is prevented from being influenced by the dislocation or displacement of the lead 300, and the stability of the cochlear implant device is ensured. The depth, length, width and other dimensions of the wire groove 120 can be set by those skilled in the art according to actual requirements, and are not described herein again. Optionally, the length of the wire groove 120 is set according to the length of the actual wire, so as to avoid setting too many structures on the stent monofilament 100, and further avoid influencing the mechanical properties of the stent monofilament 100 due to too many structures.
Preferably, the signal portion 200 is, for example, disposed on the stent monofilament body 110 and outside the wire groove 110, for example, the notch of the wire groove 110 faces a certain direction, and the signal portion 200 is disposed at the position facing the notch, so that the signal portion 200 can be disposed on the stent monofilament body 110 to be attached to the cochlea, and the signal portion 200 can cover the notch of the wire groove 110 to prevent the wire 300 in the groove from slipping out, thereby optimizing the structure of the stent monofilament 100 and ensuring the quality of the stent monofilament 100.
Preferably, the stent monofilament 100 further comprises a drug reservoir (not shown) for containing a drug. The medicine groove is preferably arranged to extend along the axial direction of the stent monofilament 100, and more preferably, the medicine groove is arranged to penetrate through the wire groove 110, it can be understood that the wire groove 110 is arranged to overlap with the medicine groove, and when a worker processes the wire groove 110 and the medicine groove, only one groove portion needs to be processed. Preferably, in the first embodiment, the slot portion on one side of the signal portion 200 is set as the wire guide 120, and the slot portion on the other side of the signal portion 200 is set as the medicine slot. Of course, the worker may further form a chemical tank on the stent monofilament 100, and the structure, size, and position of the chemical tank may be set according to actual requirements. When the medicine is put in, workers adopt a fixed-point spraying mode to put in some anti-inflammatory medicines or antibiotics and the like. In actual use, the worker can cover the surface of the stent monofilament 100 with a coating for slow release of drugs or a hydrophilic coating according to actual requirements.
The following will specifically describe the processing procedure of the cochlear implant device according to the present embodiment with reference to fig. 1 to 5:
firstly, a nickel-titanium alloy plate with the thickness of one hundred micrometers is used for laser engraving grooves (wire grooves and medicine grooves) with the width of fifty micrometers, then the grooves are cut into the support monofilament 100 with the width of one hundred micrometers, and then the signal part 200 and the support monofilament 100 are adhered and integrated through an insulating material.
Then, the wire 300 is placed in the wire groove 120.
Finally, as shown in fig. 4, the integrated stent monofilament 100, signal part 200 and conducting wire 300 are woven on a weaving machine to be integrated into a stent, so that the signal parts 200 on the stent monofilament 100 are located at the same circumferential position of the tubular structure a, and are arranged in a linear manner and are equally spaced; the wires 300 are led out from one end of the monofilament support 100 and converged and connected out.
The utility model also provides a cochlear implant, cochlear implant include as above cochlear implant and cochlear implant external device, cochlear implant external device with cochlear implant signal connection. The cochlear implant has the beneficial effects of the cochlear implant device, and the description is omitted here. The structure and principle of other components of the cochlear implant can be referred to in the prior art and will not be described herein.
[ example two ]
Referring to fig. 1, fig. 1 is a schematic view of a cochlear implant device according to a first embodiment and a second embodiment.
The same parts of the cochlear implant device of the second embodiment as those of the first embodiment will not be described, and only the differences will be described below.
In the second embodiment, as shown in fig. 1, the support monofilament 100 of the cochlear implant device includes an optical fiber, and the signal part 200 includes an optical fiber light-transmitting opening for transmitting light. The optical fiber can be directly arranged into a tubular structure A, and optical signals of the optical fiber are subjected to optical stimulation through the optical fiber light-transmitting opening. The optical fiber has both a supporting function and a light stimulation function. When the cochlea support device is in actual use, the worker can firstly enhance the strength of the optical fiber, and the worker can be ensured to reach the standard of supporting the cochlea.
Further, the stent monofilament 100 further comprises a stent monofilament body 110 and an optical fiber groove, wherein the optical fiber groove extends along the axial direction of the stent monofilament body 110, the optical fiber is arranged in the optical fiber groove, and the optical fiber with lower strength can be accommodated in the stent monofilament 100, so that the stent monofilament 100 has a supporting function, and the tubular structure a is guaranteed to have a supporting function.
It should be noted that the emphasis in each embodiment is on the difference from the other embodiments, and the same and similar parts between the embodiments may be referred to each other. In addition, different parts in the first and second embodiments may be combined with each other for use, for example, the structure in which the signal part 200, the stent monofilament 100 and the conducting wire 300 are integrated in the first embodiment is combined with the optical fiber in the second embodiment to form a same tubular structure, so that the cochlear implant device can stimulate the cochlear nerve by using an electrical signal, and can stimulate the cochlear nerve by using an optical signal, thereby laying a foundation stone for improving the use effect of the patient.
In summary, in the cochlear implant device and the cochlear implant provided by the present invention, the cochlear implant device comprises a tubular structure formed by spiraling a stent monofilament, and a signal part; the tubular structure has an implanted state and a released state, and in the implanted state, the tubular structure is used for being arranged on an implantation guide device and is used for being implanted into a cochlea along with the implantation guide device; during the transition of the tubular structure from the implanted state to the released state, the tubular structure is radially diameter-variable expanded; the signal part is arranged on the bracket monofilament and used for sending or receiving signals. So set up for artifical cochlear implant device can adapt to the individual difference of different cochlea, and the signal portion after guaranteeing to implant is inseparable with the cochlea laminating, guarantees excellent signal stimulation effect, improves the accurate nature of signal position, promotes patient's result of use.
The above description is only for the preferred embodiment of the present invention and is not intended to limit the scope of the present invention, and any modification and modification made by those skilled in the art according to the above disclosure are all within the scope of the claims.