Memory alloy cervical dilator

Abstract

The invention relates to the technical field of medical gynecological instruments, in particular to a memory alloy cervical dilator. A memory alloy cervical dilator is composed of a handle and a dilating rod, the dilating rod is divided into an end, a connecting section and a dilating section, the dilating section is located between the end and the connecting section, and the connecting section is connected with the handle; the expansion section is formed by splicing a plurality of expansion spokes, and the plurality of expansion spokes are arranged in parallel to form a supporting expansion cage frame; an expansion spoke of the expansion rod is made of TiNi memory alloy, the expansion spoke is in a straight rod shape in a non-deformation state, and the expansion spoke is in an arched bent shape in a deformation state; and the plurality of expansion spokes deform to form an ellipsoid supporting expansion cage frame. Compared with a traditional cervix dilating rod, the memory alloy cervix dilator is simpler and more convenient to use, the dilating spoke is in a straight state before being used, the memory alloy cervix dilator can be easily placed into an undilated cervix canal, and in the uterus dilating process, the memory alloy cervix dilator can be used for dilating the cervix. The expansion spoke gradually and slowly expands and deforms along the radial outer side of the expansion rod under the action of the human body temperature of about 37 DEG C.

Description

Technical Field

[0001] The invention relates to the technical field of medical gynecological instruments, in particular to a memory alloy cervical dilator. Background Art

[0002] In recent years, with the increase in artificial abortion, spontaneous abortion and intrauterine surgery, uterine dilator instruments have become the leading instruments for intrauterine surgical instruments. At present, uterine dilator instruments are mostly supported by inflation or water. A cervical dilator is disclosed in the prior art, application number: CN202280055906.6, application date: 2022.08.18, publication (announcement) number: CN117858739A. As an outpatient surgery, a cervical dilator is positioned in the cervix of the patient. The cervical dilator is then inflated by adding water so that the expandable material located in the patient's cervix begins to expand. Typically, before starting induction of labor or other surgery requiring cervical dilation, the expandable material expands the cervical dilator balloon at a rate of 1-3 mm / hour while the patient is at home overnight until the cervix is ​​dilated to 3 cm. However, the above-mentioned prior art equipment needs additional auxiliary equipment for inflation or water filling. Not only does it require the connection and layout of a large number of supporting equipment before the equipment is used, which takes up space, but the auxiliary equipment configured after the equipment is used also needs to be cleaned and disinfected. The cleaning and disinfection of the auxiliary equipment is complicated and the overall equipment utilization efficiency is low. At present, improving the existing equipment to simplify the process of uterine dilation operation and reduce patient discomfort has become a major development trend of such equipment. Summary of the invention

[0003] The present invention solves the deficiencies of the prior art and provides a memory alloy cervical dilator which is simple to operate and can expand gently and continuously.

[0004] The technical solution adopted by the present invention to solve the technical problem is: The memory alloy cervical dilator consists of an expansion rod and a handle. It can be divided into various specifications according to the effective use length and expansion diameter of the product. The expansion rod is made of TiNi memory alloy material, with a hollow head end and composed of multiple expansion spokes, which are an integral structure with the expansion rod; the expansion spokes maintain a straight shape at room temperature. When the phase change temperature of 34±3℃ is reached, multiple independent expansion spokes will expand and deform along the radial outside of the expansion rod until the set expansion diameter is reached. The handle is made of ABS / PP material and has anti-slip protrusions on the surface.

[0005] Compared with the traditional cervical dilator, the memory alloy cervical dilator of the present invention is simpler in use steps. Its expansion radii are in a straight state before use and can be easily placed in the unexpanded cervical canal. During the dilation process, the expansion radii gradually expand and deform along the radial outer side of the dilation rod under the action of human body temperature (about 37°C). The dilation rod of the same diameter can be provided with expansion radii of different diameters. The effect of multiple dilations of ordinary dilator can be achieved in one operation, and the dilation process is gentle and continuous, which greatly reduces the discomfort of patients during the operation.

[0006] A memory alloy cervical dilator consists of a handle and an expansion rod. The expansion rod is divided into an end, a connecting section and an expansion section. The expansion section is located between the end and the connecting section, and the connecting section is connected to the handle. The expansion section is spliced ​​by a plurality of expansion spokes, and the plurality of expansion spokes are arranged in parallel to form a supporting expansion cage. The expansion spokes of the expansion rod are made of TiNi memory alloy, and are straight rod-shaped when not deformed, and arched and curved when deformed. The plurality of expansion spokes are deformed to form an ellipsoidal supporting expansion cage.

[0007] The temperature at which the expansion spokes are deformed is 34±3°C, and multiple expansion spokes are deformed along the radial outer side of the expansion rod. After the expansion spokes enter the human body, the temperature rises and the deformation begins to be activated. When the temperature reaches 37°C, the expansion spokes are deformed to the maximum range. The integrated structure of the device is deformed automatically by the human body temperature, and there is no supporting equipment, which greatly simplifies the device structure and operation difficulty. The integrated structure of the device is convenient for subsequent overall cleaning and disinfection, and can be restored to its original state by cooling, and can be reused.

[0008] The expanded diameter of the expanded spokes ranges from 6mm to 20mm; the length S of the expanded spokes after being stretched out is ≥35mm; and the arched height of the expanded spokes ranges from 3mm to 10mm.

[0009] The expansion section is formed by splicing at least 4 expansion spokes, which are radially arranged outward from the center of the expansion rod. The expansion spokes are used for multi-point support, and the expansion section is processed and plasticized to facilitate complete fit with the human body.

[0010] The expansion section is formed by splicing 4 or 6 expansion spokes, and can be supported as a whole at multiple points, thereby increasing the support points to reduce local forces and protect local tissues.

[0011] The expansion spoke is hingedly connected with the expansion rod through a pin, and the end and the connecting section are provided with a connecting hole and a plug hole, which are interconnected, and the pin is composed of a pin shaft, a pin housing and a spring, and the expansion spoke is connected with the end or the connecting section through the plug hole, and the pin is inserted into the connecting hole, and the pin is clamped with the expansion spoke; the pin shaft can be retracted into the pin housing under the action of the spring to facilitate the installation of the pin, and is convenient for quick disassembly and assembly.

[0012] The handle is provided with an anti-skid protrusion made of rubber or nylon, which is convenient for grasping the handle and performing surgical operations, and accurately inserting the expansion rod into the uterus.

[0013] The beneficial effects of the present invention are: 1. The uterine dilation process is gentle and continuous, which can greatly reduce the patient's discomfort during the operation.

[0014] 2. One operation can achieve the effect of multiple uterine dilations, simplifying the operation steps and reducing the operator's labor intensity.

[0015] 3. The expansion tube is made of TiNi memory alloy, which has good biocompatibility.

[0016] 4. Various specifications can be set according to the length and expanded diameter of the expanded spokes to meet the diverse needs of users.

[0017] The cervical dilator is composed of a dilator rod and a handle. The dilator rod is made of TiNi memory alloy material, the head end of which is hollowed out and composed of multiple dilator spokes, which are an integral structure with the dilator rod; the dilator spokes maintain a straight shape at room temperature, and when the phase change temperature reaches 34±3°C, multiple independent dilator spokes will expand and deform along the radial outer side of the dilator rod until the set dilator diameter is reached. The dilator diameter is set between 6mm and 20mm. The length of the dilator spokes after being stretched is the effective use length of the product. According to literature retrieval, the length of the cervical canal of adult women is about 25 to 35mm. To ensure that the product can fully dilate the cervical canal, the length of the dilator spokes after being stretched is S≥35mm. The dilator handle is made of ABS / PP material, and the surface is provided with anti-slip protrusions.

[0018] In traditional uterine dilation surgery, common cervical dilator rods are mostly made of stainless steel. During the operation, multiple different specifications of thickness need to be prepared, and the operation is cumbersome. For example, if the doctor needs to dilate the patient's cervical opening to 6mm, the common cervical dilator rods need to be used step by step from small to large according to the specifications of the dilator rods. The four specifications of 3.5mm, 4mm, 5mm, and 6mm dilator rods are used in sequence and removed after a period of time. Not only is the operation process cumbersome, but the discontinuous dilation process can easily cause discomfort to the patient. The memory alloy cervical dilator described in the present invention is simpler in use steps than the traditional cervical dilator rod. Its expansion spokes are in a straight state before use and can be easily placed in the unexpanded cervical canal. During the dilation process, the expansion spokes gradually expand and deform along the radial outer side of the dilation rod under the action of human body temperature of about 37°C. The dilation rod of the same diameter can be provided with expansion spokes of different diameters. The effect of multiple dilations of ordinary dilator rods can be achieved in one operation, and the dilation process is gentle and continuous, which greatly reduces the discomfort of patients during the operation. The present invention can simplify the doctor's operation when dilating the uterus and reduce the discomfort of patients during the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This is the axonometric diagram of the memory alloy cervical dilator before phase transformation; Figure 2 This is the axonometric diagram of the memory alloy cervical dilator after phase transformation; Figure 3 It is a schematic diagram of the structure of the memory alloy cervical dilator after phase transformation; Figure 4 It is a schematic diagram of an integrated expansion spoke structure; Figure 5 It is a schematic diagram of the hinged expansion spoke structure; Figure 6 for Figure 5 BB section view; Figure 7 This is a schematic diagram of the pin connection.

[0020] In the figure: handle 1, expansion rod 2, expansion spoke 21, pin 22, pin shaft 221, spring 222, pin housing 223, anti-slip protrusion 3. DETAILED DESCRIPTION

[0021] A memory alloy cervical dilator is composed of a handle 1 and a dilating rod 2. The dilating rod 2 is divided into an end, a connecting section and a dilating section. The dilating section is located between the end and the connecting section, and the connecting section is connected to the handle 1. The dilating section is spliced ​​by a plurality of dilating spokes 21, and the plurality of dilating spokes 21 are arranged in parallel to form a supporting dilating cage. The dilating spokes 21 of the dilating rod 2 are made of TiNi memory alloy. The dilating spokes 21 are straight rod-shaped when not deformed, and are arched and curved when deformed. The plurality of dilating spokes 21 are deformed to form an ellipsoidal supporting dilating cage.

[0022] The temperature at which the expansion spokes 21 are deformed is 34±3°C, and the expansion spokes 21 are deformed along the radial outer side of the expansion rod. The expansion diameter of the expansion spokes 21 is in the range of 6mm to 20mm; the length S of the expansion spokes 21 after expansion is ≥35mm; the height of the expansion spokes 21 is in the range of 3mm to 10mm.

[0023] The expansion section is composed of at least 4 expansion spokes 21; the expansion spokes 21 are arranged radially outward from the center of the expansion rod 2. The diameter of the expansion rod 2 can be selected from any of φ3.5mm, φ4mm, φ5mm, φ6mm, φ7mm, φ8mm, φ9mm, φ10mm, φ11mm, φ12mm, φ13mm, φ14mm, φ15mm, φ16mm, φ17mm, and φ18mm. During the operation, the appropriate expansion rod 2 can be selected according to the patient, so that the expansion rod 2 can be inserted into the uterus and fit the inner wall of the uterus. At the same time, the expansion spoke 21 is individually controlled and adjusted by the expansion diameter, the length after expansion, and the arch height during the shaping stage of the expansion spoke 21; so that the expansion spoke 21 can be arched and expanded. The expansion spoke 21 and the expansion rod 2 can be combined with different models to meet the use needs of diverse patients. For example, different expansion spokes can be set for an expansion rod of the same diameter to achieve different expansion needs.

[0024] The expansion section is composed of 4 or 6 expansion spokes 21. The expansion spokes 21 are hingedly connected to the expansion rod 2 through the pin 22. The end and the connecting section are provided with a connecting hole and a plug hole, and the connecting hole and the plug hole are connected to each other. The pin 22 is composed of a pin shaft 221, a pin shell 223 and a spring 222. The expansion spoke 21 is connected to the end or the connecting section through the plug hole, and the pin 22 is inserted into the connecting hole, and the pin 22 is clamped with the expansion spoke 21; the pin shaft 221 can be retracted into the pin shell 223 under the action of the spring 222 to facilitate the installation of the pin. The handle 1 is provided with an anti-slip protrusion 3, and the material of the anti-slip protrusion 3 is rubber or nylon. The four expansion spokes 21 realize 4-point synchronous expansion, which greatly reduces the difficulty of operation compared with the traditional uterine expansion rod multiple expansion methods. In particular, the traditional uterine expansion rod is prone to excessive local force when applying force, and cervical tearing and injury pain in patients are common phenomena. The expansion section of the present invention realizes synchronous force expansion at an excitation temperature of 34±3°C, and no local excessive force is generated, which greatly reduces the occurrence of cervical tearing and injury pain. Compared with the four expansion spokes 21, the six expansion spokes 21 have more supporting points, which further reduces the local pain during uterine dilation.

[0025] When in use, a memory alloy cervical dilator is an expansion rod made of TiNi memory alloy material. The memory alloy cervical dilator consists of an expansion rod and a handle. According to the effective use length and expansion diameter of the product, a variety of specifications can be set. The expansion rod is made of TiNi memory alloy material, and its head end is hollowed out. It is composed of multiple expansion spokes and is an integral structure with the expansion rod; the expansion spokes maintain a straight shape at room temperature. When the phase change temperature reaches 34±3℃, multiple independent expansion spokes will expand and deform along the radial outside of the expansion rod until the set expansion diameter is reached. The handle is made of ABS / PP material, and the surface is provided with anti-slip protrusions. During the operation, the doctor uses a vaginal speculum to fully expose the cervical opening, takes out the cervical dilator, gently inserts the head end into the cervical canal, and pushes the cervical dilator forward until the expansion spokes of the expansion rod completely enter the cervix; after the product is inserted, it is necessary to wait for a period of time until the cervical dilator is completely deformed and the cervical canal is expanded to the required expansion diameter; when the product is taken out, gently pull it back outward to take out the product.

[0026] In addition to the traditional technology of using a dilator to dilate the cervical canal in order of diameter, the more commonly used technologies in the background art are to use a balloon filled with sterile water to dilate the cervix or to set up a corresponding expansion mechanical structure to achieve cervical dilation through external input power. The advantages of this technology over the traditional technology are: 1. No additional energy input is required during cervical dilation, which can simplify the operation and reduce the labor intensity of the user; 2. The deformation of the expansion radii 21 of the memory alloy product at the phase change temperature is continuous and gentle, and the expansion radii are made of metal and have strong support. That is, the product has both continuous and gentle deformation during balloon expansion and support strength after mechanical expansion of the structure. This technology integrates the advantages of the two technologies.

[0027] There are two different ways to connect multiple expansion spokes and expansion rods. Figure 3 As shown and hinged as Figure 4As shown, the integrated expansion spoke 21 and the expansion rod 2 are a whole piece of material. At the phase change temperature, only the expansion spoke part of the product is deformed to achieve the effect of expanding the cervix. The hinged expansion spoke 21 is hingedly connected to the expansion rod 2 through a pin 22. The pin 22 is composed of a pin shaft 221, a pin housing 223 and a spring 222. When the pin 22 is installed, the pin shaft 221 can be retracted into the pin housing 223 under the action of the spring 222 to facilitate the installation of the pin. The integrated expansion spoke 21 and the expansion rod are a whole, and the product has better material strength, but the price of the memory alloy material is relatively high, which may lead to too high production cost of the product, and it does not have a price advantage in market competition, which is not conducive to the wide promotion and use of the product. Only the expansion spoke part of the hinged expansion spoke 21 is made of memory alloy, and the other parts can be made of other metal materials such as medical stainless steel, so as to reduce the material cost and production cost of the product while ensuring the function of the product, which can facilitate the promotion of the product in the market and have more economic benefits.

Claims

1. A memory alloy cervical dilator, characterized in that The expansion rod (2) is composed of a handle (1) and an expansion rod (2). The expansion rod (2) is divided into an end, a connecting section and an expansion section. The expansion section is located between the end and the connecting section, and the connecting section is connected to the handle (1). The expansion section is formed by splicing a plurality of expansion spokes (21). The plurality of expansion spokes (21) are arranged in parallel to form a support expansion cage. The expansion spokes (21) of the expansion rod (2) are made of a TiNi memory alloy. The expansion spokes (21) are straight rod-shaped when not deformed, and are arched and bent when deformed. The plurality of expansion spokes (21) are deformed to form an ellipsoidal support expansion cage.

2. A memory alloy cervical dilator according to claim 1, characterized in that The temperature at which the expansion spokes (21) are in a deformed state is 34±3° C., and the plurality of expansion spokes (21) are deformed along the radial outer side of the expansion rod.

3. A memory alloy cervical dilator according to claim 1, characterized in that The expanded diameter of the expanded spoke (21) ranges from 6 mm to 20 mm; the length S of the expanded spoke (21) after being stretched out is ≥35 mm; and the arched height of the expanded spoke (21) ranges from 3 mm to 10 mm.

4. A memory alloy cervical dilator according to claim 2, characterized in that The expansion section is formed by splicing at least four expansion spokes (21); the expansion spokes (21) are radially arranged outward from the center of the expansion rod (2).

5. A memory alloy cervical dilator according to claim 4, characterized in that The expansion section is formed by splicing four or six expansion spokes (21).

6. A memory alloy cervical dilator according to claim 5, characterized in that The expansion spoke (21) is hingedly connected to the expansion rod (2) via a pin (22); a connection hole and a plug hole are provided on the end and the connection section; the connection hole and the plug hole are communicated with each other; the pin (22) is composed of a pin shaft (221), a pin housing (223) and a spring (222); the expansion spoke (21) is connected to the end or the connection section via the plug hole; the pin (22) is inserted into the connection hole; the pin (22) is clamped to the expansion spoke (21); the pin shaft (221) can be retracted into the pin housing (223) under the action of the spring (222).

7. A memory alloy cervical dilator according to claim 6, characterized in that The handle (1) is provided with an anti-slip protrusion (3), and the material of the anti-slip protrusion (3) is rubber or nylon.

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