A stapes prosthesis, stapes clamps, stapes prosthesis installation system and installation method

Abstract

This invention discloses a stapes prosthesis, stapes clamps, a stapes prosthesis installation system, and an installation method. The stapes prosthesis includes a rod-shaped portion and a U-shaped support portion disposed at one end of the rod-shaped portion. In use, the other end of the rod-shaped portion stands on the stapes plate, and the opening of the U-shaped support portion faces the incus, placing the incus within the U-shaped groove of the U-shaped support portion. The stapes clamp includes a housing and a push plate. The housing is fixedly mounted on a first clamp handle, and the push plate is fixedly mounted on a second clamp handle and placed inside the housing. A displacement sensor and a pressure sensor are sequentially arranged between the push plate and the inner wall of the housing along the movement direction of the push plate. A processor reads the displacement and corresponding pressure value of the stapes prosthesis in real time during the clamping process, generates a pressure-displacement curve based on the displacement and pressure value, and displays it on a display screen. The stapes prosthesis of this invention is beneficial for surgical installation of the human incus; the stapes clamp can effectively control the clamping of the stapes prosthesis without damaging the incus during the clamping process.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a stapes prosthesis, stapes clamps, a stapes prosthesis installation system, and an installation method. Background Technology

[0002] like Figure 1 As shown, commonly used artificial stapes prostheses are shaped like hooks, consisting of a cylindrical part and a hook part. In use, the cylindrical part of the artificial stapes prosthesis stands upright on the stapes plate, and the hook part hooks onto the incus. Placed on... Figure 2 After positioning as shown, the hook of the stapes prosthesis is held in place with the existing surgical forceps and force is applied to deform it, causing the hook to hook onto and fix it to the incus. The existing surgical forceps consists of a first forceps and a second forceps that are hinged together. The first forceps includes an integral first forceps head and a first forceps handle, and the second forceps consists of an integral second forceps head and a second forceps handle.

[0003] Existing artificial stapes prostheses and surgical forceps have the following defects:

[0004] 1. The opening of the hook portion of the stapes prosthesis faces the stapes plate, which is not conducive to the placement of the incus;

[0005] 2. When using existing surgical forceps to tighten the hook of the stapes prosthesis, excessive force will damage the incus, while insufficient force will affect sound transmission or cause the prosthesis to be poorly installed or even fall off. Summary of the Invention

[0006] To address the shortcomings of existing technologies, this invention provides a stapes prosthesis, stapes clamps, a stapes prosthesis installation system, and an installation method for the stapes prosthesis installation system.

[0007] This invention discloses a stapes prosthesis, comprising: a rod-shaped portion and a U-shaped support portion disposed at one end of the rod-shaped portion, wherein the U-shaped support portion has the ability to undergo elastic deformation and plastic deformation; in use, the other end of the rod-shaped portion stands on the stapes plate, and the opening of the U-shaped support portion faces the incus so that the incus is placed in the U-shaped groove of the U-shaped support portion.

[0008] As a further improvement of the present invention, the ends of the two side walls of the U-shaped support are bent outward to form symmetrical clamping holes; the clamping holes are clamped by the stapes forceps head to tighten the opening of the U-shaped support, so that the U-shaped support is clamped on the incus.

[0009] As a further improvement of the present invention, the U-shaped support portion is coaxially arranged with the rod-shaped portion, and the U-shaped support portion faces away from the rod-shaped portion.

[0010] As a further improvement of the present invention, the rod-shaped part and the U-shaped support part are integral pure titanium parts, and the rod-shaped part is preferably a cylindrical part.

[0011] As a further improvement of the present invention, the rod-shaped part and the bottom center of the U-shaped support part are connected by a neck, which has a structure that is large at both ends, small at the center, and gradually narrows towards the center from both ends.

[0012] The present invention also discloses a stapedius forceps, comprising a first forceps portion and a second forceps portion hinged together. The first forceps portion includes an integral first forceps head and a first forceps handle, and the second forceps portion is an integral second forceps head and a second forceps handle. The first forceps head and the second forceps head are used to clamp and fix the U-shaped support portion of the stapedius prosthesis to the incus. The stapedius forceps also includes a shell and a push plate.

[0013] The outer shell is fixedly installed on the first clamp handle, and the push plate is fixedly installed on the second clamp handle and placed inside the outer shell; a displacement sensor and a pressure sensor are sequentially arranged between the push plate and the inner wall of the outer shell along the movement direction of the push plate. During the relative squeezing action between the first clamp handle and the second clamp handle, the push plate drives the displacement sensor to squeeze the pressure sensor, so as to obtain the displacement amount through the displacement sensor and the pressure value through the pressure sensor.

[0014] A processor is also fixedly installed inside the housing, and a display screen is provided outside the housing; the processor is connected to the displacement sensor, pressure sensor and display screen, and the processor is used to read the displacement and corresponding pressure value in real time, form a pressure-displacement curve based on the displacement and pressure value and display it on the display screen.

[0015] As a further improvement of the present invention, a power supply and a buzzer are provided inside the housing, and the buzzer is connected to the processor; when the displacement and / or pressure value obtained by the processor is greater than the preset displacement and / or pressure value, the buzzer starts to sound.

[0016] As a further improvement of the present invention, the housing is provided with a power switch, a mode switch and a selection button. The mode switch is used to select a recording mode and a comparison mode. The recording mode is used to perform elastic deformation of the stapes prosthesis by clamping it with stapes forceps before the stapes prosthesis is implanted, so that the processor can establish and store the pressure-displacement curve of the stapes prosthesis during the elastic deformation stage. The comparison mode is used to implant the stapes prosthesis into the body after the recording mode is completed, and clamp one end of the stapes prosthesis to the incus with stapes forceps, so that the processor can compare the pressure-displacement curve established by the processor during the surgical stage with the pressure-displacement curve established in the recording mode.

[0017] As a further improvement of the present invention, the displacement sensor is a capacitive displacement sensor and the pressure sensor is a thin-film flexible FSR sensor.

[0018] The present invention also discloses a stapedius prosthesis installation system, comprising: the above-described stapedius prosthesis and the above-described stapedius clamp.

[0019] This invention also discloses a method for installing a stapes prosthesis, comprising:

[0020] Before implanting the artificial stapes prosthesis, turn on the power of the stapes forceps and select the recording mode; use the stapes forceps to grasp the stapes prosthesis, causing the stapes prosthesis to undergo elastic deformation. At this time, the processor obtains the displacement amount through the displacement sensor and the pressure value through the pressure sensor, and forms a pressure-displacement curve under elastic deformation on the display screen.

[0021] After the recording mode ends, the stapes prosthesis is implanted. The rod-shaped part of the stapes prosthesis stands on the stapes plate, and the U-shaped support part supports the incus. Then, the U-shaped support part of the stapes prosthesis is tightened with stapes forceps to clamp it onto the incus. The stapes prosthesis begins to deform elastically, and its recorded pressure-displacement curve is consistent with the pressure-displacement curve recorded in the recording mode. When the stapes prosthesis deforms and contacts the incus, the pressure-displacement curve after contact begins to change compared to the pressure-displacement curve before contact, at which point a beep sounds. The device begins to sound to alert the doctor that the stapes prosthesis has made contact with the incus. After contact with the incus, the stapes prosthesis is still in the elastic deformation stage, and the slope of its recorded pressure-displacement curve is within the preset range compared to the pressure-displacement curve before contact. When the change in the slope of the pressure-displacement curve after contact is greater than the preset value, it indicates that the stapes prosthesis has entered the plastic deformation stage from the elastic deformation stage. The doctor can then select the displacement change based on the displacement graph on the screen, thereby controlling the deformation of the stapes prosthesis.

[0022] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0023] The stapes prosthesis of the present invention is beneficial for surgical placement of the human incus;

[0024] The stapes clamp of the present invention can obtain the displacement and pressure values ​​of the stapes prosthesis during clamping, and the pressure-displacement curve plotted based on this can allow doctors to understand the clamping state of the stapes prosthesis in real time, whether plastic deformation occurs, and the amount of deformation, thereby effectively controlling the clamping of the stapes prosthesis without damaging the incus during the clamping process. Attached Figure Description

[0025] Figure 1 This is a structural diagram of an existing artificial stapedius prosthesis;

[0026] Figure 2 This is a schematic diagram of the installation of an existing artificial stapedius prosthesis;

[0027] Figure 3 This is a schematic diagram of the structure of the stapedius prosthesis disclosed in this invention;

[0028] Figure 4This is a three-dimensional schematic diagram of the staped forceps disclosed in this invention;

[0029] Figure 5 for Figure 4 Side view;

[0030] Figure 6 for Figure 5 A schematic diagram of direction AA;

[0031] Figure 7 for Figure 5 A schematic diagram of the BB direction.

[0032] In the picture:

[0033] 10. Stapedis prosthesis; 11. Rod-shaped portion; 12. U-shaped support portion; 13. Clamping hole;

[0034] 20. Staples forceps; 21. First forceps head; 22. Second forceps head; 23. First forceps handle; 24. Second forceps handle; 25. Housing; 26. Push plate; 27. Displacement sensor; 28. Pressure sensor; 29. ​​Processor; 210. Power supply; 211. Buzzer; 212. Selection button; 213. Power switch; 214. Mode switch; 215. Display screen. Detailed Implementation

[0035] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0036] The present invention will now be described in further detail with reference to the accompanying drawings:

[0037] like Figure 3As shown, the present invention provides a stapes prosthesis 10, which includes a rod-shaped portion 11 and a U-shaped support portion 12 disposed at one end of the rod-shaped portion 11. The U-shaped support portion 12 has the ability of elastic deformation and plastic deformation. The ends of the two side walls of the U-shaped support portion 12 are bent outward to form symmetrical clamping holes 13. In use, the other end of the rod-shaped portion 11 is placed on the stapes plate, and the opening of the U-shaped support portion 12 faces the incus so that the incus is placed in the U-shaped groove of the U-shaped support portion 12. Then, the clamping holes 13 are clamped by the stapes forceps head to tighten the opening of the U-shaped support portion 12, so that the U-shaped support portion 12 is clamped on the incus. Specifically: the U-shaped support portion 12 is coaxially arranged with the rod-shaped portion 11, and the U-shaped support portion 12 faces away from the rod-shaped portion 11; the rod-shaped portion 11 and the U-shaped support portion 12 are integral pure titanium parts, and the rod-shaped portion 11 is preferably a cylindrical portion; the cylindrical portion and the bottom center of the U-shaped support portion 12 are connected by a neck, and the neck has a structure that is large at both ends, small at the center, and gradually narrows towards the center from both ends.

[0038] like Figures 4-7 As shown, the present invention provides a staped forceps 20, which comprises a first clamping part and a second clamping part hinged together. The first clamping part includes an integral first clamping head 21 and a first clamping handle 23, and the second clamping part is an integral second clamping head 22 and a second clamping handle 24. The first clamping head 21 and the second clamping head 22 are used to clamp... Figure 3 The U-shaped support 12 of the stapes prosthesis 10 shown is clamped and fixed to the incus. The stapes forceps 20 also includes a housing 25 and a pusher plate 26. The housing 25 is fixedly mounted on the first handle 23, and the pusher plate 26 is fixedly mounted on the second handle 24 and placed inside the housing 25. The bottom of the housing 25 has a clearance groove to allow the pusher plate 26 to move. During the movement of the second handle 24 relative to the first handle 23, the pusher plate 26 moves synchronously within the housing 25. A displacement sensor 27 and a pressure sensor 28 are sequentially arranged between the pusher plate 26 and the inner wall of the housing 25 along the direction of movement of the pusher plate 26. The pusher plate 26 is an L-shaped plate. One end of the displacement sensor 27 abuts against the pusher plate 26, and the other end acts directly or via a spring on the pressure sensor 28. The pressure sensor 28 is mounted on the housing 25. Based on this, during the relative squeezing action between the first clamp 23 and the second clamp 24, the push plate 26 drives the displacement sensor 27 to squeeze the pressure sensor 28, so as to obtain the displacement amount through the displacement sensor 27 and the pressure value through the pressure sensor 28. Furthermore, the displacement sensor 27 is a capacitive displacement sensor, and the pressure sensor 28 is a thin-film flexible FSR sensor.

[0039] The present invention also includes a processor 29, a power supply 210, and a buzzer 211 fixedly installed inside the housing 25, and a display screen 215 outside the housing 25. The processor 29 is connected to the displacement sensor 27, the pressure sensor 28, the display screen 215, and the buzzer 211. The processor 29 is used to read the displacement and corresponding pressure value in real time, and to form a pressure-displacement curve based on the displacement and pressure value and display it on the display screen 215 so that the doctor can judge the degree of deformation of the stapes prosthesis by looking at the pressure-displacement curve on the display screen. At the same time, when the displacement and / or pressure value (in comparison mode) obtained by the processor 29 is greater than the preset displacement and / or pressure value (in recording mode) compared with the reference displacement and / or pressure value, the buzzer 211 starts to sound to remind the doctor that the plastic deformation stage is about to begin. The preset displacement and pressure values ​​can be 0.05 mm and 0.05 N, respectively.

[0040] The outer casing 25 of this invention is provided with a power switch 213, a mode switch 214, and a selection button 212. The mode switch 214 is used to select a recording mode and a comparison mode. The recording mode is used to perform elastic deformation of the stapes prosthesis 10 by clamping it with stapes forceps 20 before the stapes prosthesis is implanted, so that the processor can establish and store the pressure-displacement curve of the elastic deformation stage of the stapes prosthesis. The comparison mode is used to implant the stapes prosthesis into the body after the recording mode is completed, and clamp one end of the stapes prosthesis to the incus with stapes forceps, so that the processor can compare the pressure-displacement curve established during the surgical stage with the pressure-displacement curve established in the recording mode. If the data comparison is greater than the preset displacement and / or pressure value, it means that the pressure-displacement curve has become parallel, indicating that the stapes prosthesis has contacted the incus. At this time, the doctor can be alerted by a buzzer or the pressure-displacement curve on the display screen can be used to provide the doctor with a reference for subsequent operations.

[0041] This invention provides a stapedius prosthesis installation system, comprising: the aforementioned stapedius prosthesis 10 and the aforementioned stapedius clamp 20; and a stapedius prosthesis installation method based on the stapedius prosthesis installation system, comprising:

[0042] Before implanting the artificial stapes prosthesis, turn on the power of the stapes forceps and select the recording mode; use the stapes forceps to grasp the stapes prosthesis, causing elastic deformation of the stapes prosthesis (note that it must be elastic deformation, and not excessive force that causes it to enter the plastic deformation stage after elastic deformation). At this time, the processor obtains the displacement amount through the displacement sensor and the pressure value through the pressure sensor, and forms a pressure-displacement curve under elastic deformation on the display screen;

[0043] After the recording mode ends, the stapes prosthesis is implanted. The rod-shaped part of the stapes prosthesis stands on the stapes plate, and the U-shaped support part supports the incus. Then, the U-shaped support part of the stapes prosthesis is tightened with stapes forceps to clamp it onto the incus. The initial deformation of the stapes prosthesis is elastic deformation, and its recorded pressure-displacement curve is consistent with the pressure-displacement curve recorded in the recording mode. When the stapes prosthesis deforms and contacts the incus, the pressure-displacement curve after contact begins to change compared to the pressure-displacement curve before contact. At this time, the buzzer sounds to remind the doctor that the stapes prosthesis deformation has contacted the incus. The stapes prosthesis after contacting the incus... Still in the elastic deformation stage, the slope of the recorded pressure-displacement curve is within the preset range compared to the pressure-displacement curve before contact; that is, the slopes of the two curves are almost the same, and the curves will shift upwards in parallel. When the change in the slope of the pressure-displacement curve after contact compared to the pressure-displacement curve before contact exceeds the preset value, it indicates that the stapes prosthesis has entered the plastic deformation stage from the elastic deformation stage. The doctor can select the displacement change according to the displacement graph on the screen, thereby controlling the deformation of the stapes prosthesis to ensure that the stapes prosthesis can undergo plastic deformation without damaging the incus. In use, as long as the stapes prosthesis undergoes plastic deformation, the desired effect can be achieved.

[0044] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A stapedius clamp, comprising a first clamping part and a second clamping part hinged together, the first clamping part comprising an integral first clamping head and a first clamping handle, the second clamping part comprising an integral second clamping head and a second clamping handle, wherein the first clamping head and the second clamping head clamp and fix the U-shaped support portion of the stapedius prosthesis to the incus; characterized in that, The stapes prosthesis includes: a rod-shaped portion and a U-shaped support portion disposed at one end of the rod-shaped portion; in use, the other end of the rod-shaped portion stands on the stapes plate, and the opening of the U-shaped support portion faces the incus so that the incus is placed in the U-shaped groove of the U-shaped support portion; The staped forceps also includes: a housing and a push plate; The outer shell is fixedly installed on the first clamp handle, and the push plate is fixedly installed on the second clamp handle and placed inside the outer shell; a displacement sensor and a pressure sensor are sequentially arranged between the push plate and the inner wall of the outer shell along the movement direction of the push plate. During the relative squeezing action between the first clamp handle and the second clamp handle, the push plate drives the displacement sensor to squeeze the pressure sensor, so as to obtain the displacement amount through the displacement sensor and the pressure value through the pressure sensor. A processor is also fixedly installed inside the housing, and a display screen is provided outside the housing; the processor is connected to the displacement sensor, pressure sensor and display screen, and the processor is used to read the displacement and corresponding pressure value in real time, form a pressure-displacement curve based on the displacement and pressure value and display it on the display screen.

2. The staped forceps as described in claim 1, characterized in that, The ends of the two side walls of the U-shaped support are bent outward to form symmetrical clamping holes; the clamping holes are clamped by the head of the stapes forceps to tighten the opening of the U-shaped support and clamp the U-shaped support onto the incus.

3. The staped forceps as described in claim 1 or 2, characterized in that, The U-shaped support portion is coaxially arranged with the rod-shaped portion, and the U-shaped support portion faces away from the rod-shaped portion.

4. The staped forceps as described in claim 1 or 2, characterized in that, The rod-shaped part and the U-shaped support part are integral pure titanium parts.

5. The staped forceps as described in claim 1, characterized in that, The housing contains a power supply and a buzzer, which is connected to the processor. When the displacement and / or pressure value obtained by the processor is greater than the preset displacement and / or pressure value, the buzzer starts to sound.

6. The staped forceps as described in claim 5, characterized in that, The housing is equipped with a power switch, a mode switch, and a selection button. The mode switch is used to select a recording mode and a comparison mode. The recording mode is used to perform elastic deformation of the stapes prosthesis by clamping it with stapes forceps before implantation, allowing the processor to establish and store the pressure-displacement curve of the stapes prosthesis during the elastic deformation stage. The comparison mode is used to implant the stapes prosthesis after the recording mode is completed, and clamp one end of the stapes prosthesis to the incus with stapes forceps, allowing the processor to compare the pressure-displacement curve established during the surgical stage with the pressure-displacement curve established in the recording mode.

7. The staped forceps as described in claim 1, characterized in that, The displacement sensor is a capacitive displacement sensor, and the pressure sensor is a thin-film flexible FSR sensor.

8. A stapes prosthesis installation system, characterized in that, include: The stapedius prosthesis and the stapedius clamp as described in any one of claims 1 to 7.

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