Prosthesis for ossicular chain reconstruction

Abstract

The application discloses a prosthesis for ossicular chain reconstruction, which is used for replacing or bridging at least one element of an ossicular chain of a human being and comprises a first coupling unit arranged at a proximal end and used for matching with a tympanic membrane and receiving vibration brought by sound, a second coupling unit arranged at a distal end and mechanically connected with a stapes, and a connecting piece connected between the first coupling unit and the second coupling unit and used for transmitting vibration energy; the connecting piece is made of a material with deformation ability, so that the connecting piece can be reciprocally bent to adjust an angle; and the first coupling unit is a spiral coil disc. The application has the advantages that the spiral coil disc is used as the first coupling unit, the spiral structure of the spiral coil disc is easy to adjust in shape according to requirements during an operation, and the application is reduced in displacement and out of position; in addition, the connecting piece is made of a material with deformation ability, so that the connecting piece is easy to adjust during the operation, the prosthesis does not need to be additionally replaced or cut, the operation time is reduced, and the prosthesis can keep a continuous tension, so that the risk of displacement and out of position of the prosthesis is reduced.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to a prosthesis for ossicular chain reconstruction. Background Technology

[0002] Human hearing is primarily achieved by sound waves traveling from the external auditory canal to the middle ear and then to the inner ear. The middle ear contains the smallest bones in the human body—the ossicles, composed of the malleus, incus, and stapes, which are linked together to form the ossicular chain. The ossicular chain transmits sound wave vibrations and amplifies the sound by 22 times before transmitting it to the inner ear. Sound waves vibrate at the oval window via the stapes; the cochlea, filled with lymph fluid, acts as a transducer, converting sound energy into electrical impulses. These impulses are then transmitted to the brain via the cochlear nerve. Pathological damage to the ossicular chain, such as in chronic suppurative otitis media (a common middle ear disease), can lead to destruction or fixation of the ossicular chain, resulting in incomplete or absent sound signal transmission to the inner ear and conductive hearing loss. Clinically, treatment involves removing the middle ear lesions and reconstructing the ossicular chain using artificial ossicle prostheses. Due to individual differences in the structure and size of the middle ear in real-world environments, the middle ear structure is deep, small, and complex. Determining the implant length of the ossicular prosthesis largely depends on the surgeon's personal experience. Currently, most ossicular prostheses have fixed shapes and angles that are often fixed and unadjustable, making it difficult to make appropriate adjustments during surgery to perfectly adapt to individual patient differences. CN213250050U discloses an ossicular prosthesis, although it describes the prosthesis body (20) as a reciprocating bending structure; however, using a rod-like structure, it is prone to material fatigue and breakage during repeated bending. Furthermore, the rod-like structure requires considerable effort from the surgeon during bending. In addition, the tightness of the connection between the existing ossicular prosthesis and the stapes head is difficult to control. If it is too tight, it can lead to stapes head necrosis; if it is too loose, the ossicular prosthesis is prone to falling off. Surgery requires cartilage to be placed between the ossicles and the tympanic membrane for tympanic membrane repair. Due to individual patient differences and varying angles, the cartilage often cannot fit well against the ossicular prosthesis, affecting sound wave transmission. Reconstruction requires maintaining appropriate tension between the tympanic membrane and the stapes, meaning the length of the ossicular prosthesis must be compatible with the height of the patient's middle ear structure. Additionally, the prosthesis tray position needs to be easily adjustable to allow for a full fit between the cartilage pad and the ossicular prosthesis. Summary of the Invention

[0003] The purpose of this invention is to provide a prosthesis for ossicular chain reconstruction, which has the characteristics of easy intraoperative structural adjustment and low postoperative displacement.

[0004] The object of this invention is achieved by providing a prosthesis for ossicular chain reconstruction, used for the replacement or bridging of at least one element of the human ossicular chain, comprising...

[0005] The first coupling unit 1 is located at the proximal end and is used to cooperate with the tympanic membrane and receive the vibrations caused by sound.

[0006] The second coupling unit 2, located distally, is mechanically connected to the stapes; and

[0007] Connector 3 is connected between the first coupling unit 1 and the second coupling unit 2 and is used to transmit vibration energy;

[0008] The connector 3 is made of a material with deformation capability, which allows the connector 3 to be bent back and forth to adjust the angle;

[0009] The first coupling unit 1 is a spiral coil disk.

[0010] The connector 3 is a spiral coil 31 extending from the near end to the far end. The outer diameter of the spiral coil 31 decreases from the middle to both ends.

[0011] The second coupling unit 2 consists of multiple arc-shaped rods 24 arranged in a ring array, which together form a structure with a cover-like outline and an opening facing the far end.

[0012] The second coupling unit 2 consists of multiple connecting strips 25 arranged in a ring array. Each connecting strip 25 has a gripping piece 26 extending distally at its end. The multiple sets of connecting strips 25 and gripping pieces 26 together form a structure with a dome-shaped outline and an opening facing distally. Furthermore, the inner wall of the gripping piece 26 is provided with anti-slip textures.

[0013] Compared with previous technologies, the beneficial effects of the present invention are as follows:

[0014] 1. The first coupling unit is a spiral coil disk, whose spiral structure is easy to adjust the shape according to needs during the operation, reducing the displacement and dislodgement of the present invention.

[0015] 2. The connector is made of a deformable material, which is easy to adjust during surgery without the need for additional replacement or cutting of the prosthesis, reducing surgical time and maintaining continuous tension to reduce the risk of prosthesis displacement and dislodgement. In particular, the spiral coil structure, with the outer diameter of the spiral coil 31 decreasing from the middle to both ends, not only increases the magnitude of the force, but also increases the range of bending angles, and prevents excessive stress from causing the connector to break. In addition, it is less prone to material fatigue after repeated bending, increasing the number of bends. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the structure of Embodiment 1 of the present invention;

[0017] Figure 2 for Figure 1 The front view;

[0018] Figure 3 This is a diagram showing the state of a spiral coil after deformation.

[0019] Figure 4 This is a reference diagram for the first usage state of Example 1;

[0020] Figure 5 This is a reference diagram for the first usage state of Example 1;

[0021] Figure 6 This is a schematic diagram of the structure of Embodiment 2 of the present invention.

[0022] Labeling explanation: 1 First coupling unit, 2 Second coupling unit, 23 Anti-slip texture, 24 Arc rod, 25 Connecting strip, 26 Grip plate, 3 Connector, 31 Spiral coil. Detailed Implementation

[0023] The present invention will now be described in detail with reference to the accompanying drawings:

[0024] In the description of this invention, it should be understood that the orientation or positional relationship indicated by terms such as "far end" and "proximal end" is based on the orientation or positional relationship shown in the accompanying drawings, and is only for the purpose of facilitating the description of this invention and simplifying the description, and is not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention.

[0025] Example 1

[0026] like Figure 1-3 As shown: A prosthesis for ossicular chain reconstruction, used for replacement or bridging of at least one element of the human ossicular chain, including...

[0027] The first coupling unit 1 is located at the proximal end and is used to cooperate with the tympanic membrane and receive the vibrations caused by sound.

[0028] The second coupling unit 2, located distally, is mechanically connected to the stapes; and

[0029] Connector 3 is connected between the first coupling unit 1 and the second coupling unit 2 and is used to transmit vibration energy;

[0030] The connector 3 is made of a material with deformation capability, which allows the connector 3 to be bent back and forth to adjust the angle;

[0031] The first coupling unit 1 is a spiral coil disk.

[0032] The connector 3 is a spiral coil 31 extending from the proximal to the distal end. The outer diameter of the spiral coil 31 decreases from the middle to both ends. Because the connector 3 is made of a deformable material, it can be folded at a certain angle during actual use, such as... Figure 3 As shown, X° is the angle at which connector 3 can be folded, ranging from 105° to 180°. A spiral coil 31 is used here, which can be adjusted in length and angle to fit the anatomical structure.

[0033] The second coupling unit 2 consists of multiple connecting strips 25 arranged in a ring array. Each connecting strip 25 has a gripping piece 26 extending towards the distal end. The multiple sets of connecting strips 25 and gripping pieces 26 together form a structure with a cover-like outline and an opening facing the distal end. The inner sidewall of the gripping piece 26 is provided with anti-slip texture 23.

[0034] In this embodiment, the first coupling unit 1 can contact the malleus, which is closely attached to the tympanic membrane (e.g., Figure 4 (As shown). Alternatively, the first coupling unit 1 can be removed and fitted onto the incus by bending the spiral coil 31 (as shown). Figure 5 (As shown).

[0035] Example 2

[0036] like Figure 6 As shown: A prosthesis for ossicular chain reconstruction, used for replacement or bridging of at least one element of the human ossicular chain, including...

[0037] The first coupling unit 1 is located at the proximal end and is used to cooperate with the tympanic membrane and receive the vibrations caused by sound.

[0038] The second coupling unit 2, located distally, is mechanically connected to the stapes; and

[0039] Connector 3 is connected between the first coupling unit 1 and the second coupling unit 2 and is used to transmit vibration energy;

[0040] The connector 3 is made of a material with deformation capability, which allows the connector 3 to be bent back and forth to adjust the angle;

[0041] The first coupling unit 1 is a spiral coil disk.

[0042] The connector 3 is a spiral coil 31 extending from the proximal end to the distal end. The outer diameter of the spiral coil 31 decreases from the middle to both ends.

[0043] The second coupling unit 2 consists of multiple arc-shaped rods 24 arranged in a ring array. The multiple arc-shaped rods 24 together form a structure with a cover-like outline and an opening facing the far end.

[0044] Finally, it should be noted that the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A prosthesis for ossicular chain reconstruction, used for replacement or bridging of at least one element of the human ossicular chain, comprising: The first coupling unit (1) is located at the proximal end and is used to cooperate with the tympanic membrane and receive the vibrations caused by sound. The second coupling unit (2) is located distally and is mechanically connected to the stapes; and The connector (3) is connected between the first coupling unit (1) and the second coupling unit (2) and is used to transmit vibration energy; Its features The connector (3) is made of a material with deformation capability, which allows the connector (3) to bend back and forth to adjust the angle; The first coupling unit (1) is a spiral coil disk; The connector (3) is a spiral coil (31) extending in the near and far directions; the outer diameter of the spiral coil (31) decreases from the middle to both ends.

2. The prosthesis for ossicular chain reconstruction according to claim 1, characterized in that: The second coupling unit (2) consists of multiple arc-shaped rods (24) arranged in a ring array. The multiple arc-shaped rods (24) together form a structure with a cover-like outline and an opening facing the far end.

3. The prosthesis for ossicular chain reconstruction according to claim 1, characterized in that: The second coupling unit (2) consists of multiple connecting strips (25) arranged in a ring array. The ends of the connecting strips (25) are provided with gripping pieces (26) extending to the far end. Multiple sets of connecting strips (25) and gripping pieces (26) together form a structure with a cover-shaped outline and an opening facing the far end.

4. A prosthesis for ossicular chain reconstruction according to claim 3, characterized in that: The inner wall of the gripping piece (26) is provided with anti-slip texture (23).

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