Occluder shaping device

Abstract

The embodiment of the utility model discloses an occluder shaping device, and relates to the technical field of medical instruments. The plugging device shaping device comprises a mold body, a first electrode, a second electrode and a power supply assembly, the mold body is used for placing a plugging device, and the mold body is a conductor; the first electrode and the second electrode are respectively arranged on the mold body; the positive electrode and the negative electrode of the power source assembly are electrically connected with the first electrode and the second electrode respectively, during shaping, current passes through the mold body and can heat the mold body, meanwhile, the current can be transmitted to the plugging device, the plugging device can be shaped through the current, heating of the mold body also acts on shaping at the same time, and therefore the shaping efficiency is improved. The plugging device is shaped by adopting the current heating mold body, so that the energy consumption is low, accurate shaping can be realized, the shaping time is short, and the plugging device is easier to adapt to smaller sheathing canals.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a closure device shaping device. Background Technology

[0002] With the continuous development of interventional materials and devices and interventional cardiology, minimally invasive treatment of congenital heart diseases such as atrial septal defect, ventricular septal defect, patent ductus arteriosus, and patent foramen ovale using transcatheter occluders, as well as endovascular occlusion, has become an important treatment method and is increasingly being adopted by doctors and patients.

[0003] An occluder is an implantable medical device used to treat defects in the heart or blood vessels. It typically consists of a metal mesh framework, a flow-blocking membrane, and sutures. The metal mesh framework is woven from metal wires into a two-disc, one-waist structure. A flow-blocking membrane made of polymer material is sewn into the middle of each disc and the waist using sutures. The flow-blocking membrane seals the defect and prevents blood shunting. The occluder is implanted into the defect site in the patient's heart or blood vessel via catheter intervention. After a period of time, the surface of the occluder undergoes endothelialization, integrating with the surrounding tissue, while the metal mesh framework remains permanently in place at the defect site.

[0004] The occluder needs to be sufficiently flexible, so that it can smoothly return to its preset expanded shape after being released from the delivery sheath, thereby effectively sealing the defect in the heart or blood vessel; on the other hand, if the occluder is improperly placed or the size is not suitable during the operation, the occluder can be retrieved back into the sheath for adjustment or pulled out of the body for replacement.

[0005] In existing technologies, the fabrication of occluders typically involves laser-cutting thin-walled nickel-titanium alloy tubes to obtain the desired initial structure, or using an automatic braiding machine or hand-weaving to weave nickel-titanium alloy wires into long, thin cylindrical nickel-titanium mesh tubes, forming the initial structure of the occluder. This initial structure is then placed in a shaping mold and, together with the mold, placed in a heat treatment apparatus. Depending on the actual needs, heat treatment is used to shape the occluder mesh skeleton with different preset expansion shapes. The heat-setting temperature is 400℃~800℃, and the heat-setting time is 5min~120min.

[0006] Existing technologies employ heat treatment equipment that is energy-intensive and has an excessively long setting time. When the heat treatment setting time of the occluder is too long, its superelasticity decreases, leading to an increase in the force required for the occluder to deform. This increases the resistance to the occluder's insertion and retraction from the sheath, making it more difficult to adapt to smaller sheaths and increasing the difficulty and risk of the surgery. Utility Model Content

[0007] Therefore, it is necessary to provide a sizing device for the plugging device, which uses electric current heating for sizing. This not only has low energy consumption, but also enables precise sizing, has a short sizing time, and is more adaptable to smaller sheaths.

[0008] This utility model provides a sealing device for shaping, comprising:

[0009] A mold body, which is used to hold the plug, and the mold body is a conductor;

[0010] First electrode and second electrode; the first electrode and second electrode are respectively disposed on the mold body; and

[0011] A power supply assembly, wherein the positive and negative terminals of the power supply assembly are electrically connected to the first electrode and the second electrode, respectively.

[0012] In one embodiment, the mold body is made of steel, aluminum, or copper.

[0013] In one embodiment, the mold body includes an upper mold, a middle mold, and a lower mold, the upper mold, the middle mold, and the lower mold forming a cavity of a pre-defined extended shape of a plug.

[0014] In one embodiment, the upper mold, the middle mold, and the lower mold are structural components made of conductive materials.

[0015] In one embodiment, the upper mold, the middle mold, and the lower mold are structural components made of steel, aluminum, or copper, respectively.

[0016] In one embodiment, the upper mold, the middle mold, and the lower mold are electrically connected to the first electrode and the second electrode, respectively. The power supply assembly includes a power source, a first conductive element, and a second conductive element. The positive and negative terminals of the power source are electrically connected to the first conductive element and the second conductive element, respectively. The first conductive element and the second conductive element are electrically connected to the first electrode and the second electrode, respectively.

[0017] In one embodiment, the power supply assembly further includes a first conductive clip and a second conductive clip, the first conductive element and the second conductive element being electrically connected to the first conductive clip and the second conductive clip respectively, and the first conductive clip and the second conductive clip respectively clamping the first electrode and the second electrode.

[0018] In one embodiment, the first conductive element and the second conductive element are wires, respectively.

[0019] In one embodiment, the power source is a constant DC power source.

[0020] Implementing the embodiments of this utility model will have the following beneficial effects:

[0021] The occluder shaping device of this utility model has a mold body used to hold the occluder. The mold body is a conductor, and the first electrode and the second electrode are respectively set on the mold body. The positive and negative terminals of the power supply component are electrically connected to the first electrode and the second electrode, respectively. During shaping, current flows through the mold body, which can heat the mold body. At the same time, the current can also be transmitted to the occluder. Not only can the current shape the occluder, but the heating of the mold body also acts on the shaping at the same time. Therefore, by using current to heat the mold body to shape the occluder, not only is the energy consumption low, but the shaping is also accurate, the shaping time is short, and it is easier to adapt to smaller sheaths. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0023] in:

[0024] Figure 1 This is a schematic diagram of the initial structure of the plug in one embodiment.

[0025] Figure 2 This is a schematic diagram of a sealing device shaping apparatus in one embodiment.

[0026] Figure 3 This is a schematic diagram of a plug with a preset extended shape in one embodiment.

[0027] Figure label:

[0028] 1. Plugging device;

[0029] 2. Mold body; 21. Upper mold; 22. Middle mold; 23. Lower mold; 24. First electrode; 25. Second electrode. Detailed Implementation

[0030] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0031] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0032] In the description of this utility model, it should be noted that if terms such as "upper," "lower," "inner," or "outer" are used to indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the utility model product is usually placed during use, they are only for the convenience of describing this utility model and simplifying the description, and do not 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 utility model.

[0033] Furthermore, the terms "first" and "second" are used only to distinguish descriptions and should not be interpreted as indicating or implying relative importance.

[0034] It should be noted that, where there is no conflict, the features in the embodiments of this utility model can be combined with each other.

[0035] Please combine them together Figures 1 to 3 The sealing device provided by this utility model will now be described.

[0036] The occluder shaping device includes: a mold body 2, a first electrode 24, a second electrode 25, and a power supply assembly. The mold body 2 is used to place the occluder 1 and is a conductor. The first electrode 24 and the second electrode 25 are respectively disposed on the mold body 2. The positive and negative terminals of the power supply assembly are electrically connected to the first electrode and the second electrode, respectively.

[0037] It is understandable that the mold body 2 of the occluder shaping device is used to place the occluder 1. The mold body 2 is a conductor, and the first electrode 24 and the second electrode 25 are respectively set on the mold body 2. The positive and negative terminals of the power supply component are electrically connected to the first electrode 24 and the second electrode 25, respectively. During shaping, current flows through the mold body 2, which can heat the mold body 2. At the same time, the current can also be transmitted to the occluder 1. Not only can the current shape the occluder 1, but the heating of the mold body 2 also acts on the shaping at the same time. Therefore, by using current to heat the mold body 2 to shape the occluder 1, not only is the energy consumption low, but the shaping is also accurate, the shaping time is short, and it is easier to adapt to smaller sheaths.

[0038] Specifically, the material of mold body 2 can be steel, aluminum, or copper. A conductive material can be chosen for mold body 2.

[0039] It should be noted that the superelastic shape memory alloy tube is laser-cut, and the superelastic shape memory alloy wire is braided into a thin cylindrical mesh tube using an automatic braiding machine or by hand to form the initial structure of the plug 1.

[0040] It is worth noting that the occluder 1 is preferably made of a superelastic shape memory alloy material, such as nickel-titanium alloy. Nickel-titanium alloy has excellent shape memory properties, superelasticity, and biocompatibility, and its martensitic inverse transformation completion temperature is 20℃-35℃. Before implantation, the nickel-titanium alloy occluder 1 can be compressed into the sheath. After implantation, it undergoes a martensitic inverse transformation under the body's temperature environment. After being released from the delivery sheath, which is smaller than its own diameter, it automatically returns to its original preset expanded shape and is in a superelastic state, sealing the cardiac septal defect or blocked blood vessel, and maintaining sufficient radial support to prevent displacement of the occluder 1.

[0041] In this embodiment, the mold body 2 includes an upper mold 21, a middle mold 22, and a lower mold 23. The upper mold 21, the middle mold 22, and the lower mold 23 form the cavity of the occluder 1 with a preset extended shape. The shape of the cavity of the occluder 1 formed by the upper mold 21, the middle mold 22, and the lower mold 23 can be designed according to the needs of the implantation site to be sealed, so as to obtain the desired preset extended shape of the occluder 1.

[0042] Furthermore, the upper mold 21, middle mold 22, and lower mold 23 are electrically connected to the first electrode 24 and the second electrode 25, respectively. The first electrode 24 can be a positive electrode, and the second electrode 25 can be a negative electrode. Since the plugger 1 is woven from superelastic shape memory alloy wire, the first electrode 24 and the second electrode 25 are provided on the mold body 2, so that a current is formed on the mold body 2 to heat the mold body 2. Since the mold body 2 is a conductor, the first electrode 24 and the second electrode 25 can be electrically connected to the upper mold 21, middle mold 22, and lower mold 23 simultaneously.

[0043] Furthermore, the upper mold 21, middle mold 22, and lower mold 23 are structural components made of conductive materials. This allows current to flow through the upper mold 21, middle mold 22, and lower mold 23, thereby performing both thermal shaping and current-driven shaping on the initial structure of the plug 1.

[0044] Specifically, the upper mold 21, the middle mold 22, and the lower mold 23 are structural components made of steel, aluminum, or copper, respectively.

[0045] Furthermore, the power supply assembly includes a power supply, a first conductive element, and a second conductive element. The positive and negative terminals of the power supply are electrically connected to the first conductive element and the second conductive element, respectively. The first conductive element and the second conductive element are electrically connected to the first electrode 24 and the second electrode 25, respectively.

[0046] Specifically, the first and second conductive components can be wires. By providing the first and second conductive components, the positive and negative terminals of the power supply can be electrically connected to the first electrode 24 and the second electrode 25, respectively.

[0047] Furthermore, the power supply assembly also includes a first conductive clip and a second conductive clip. The first conductive element and the second conductive element are electrically connected to the first conductive clip and the second conductive clip, respectively. The first conductive clip and the second conductive clip clamp the first electrode 24 and the second electrode 25, respectively. By providing the first conductive clip and the second conductive clip, the first conductive element and the second conductive element of the power supply can be quickly connected to and disconnected from the first electrode 24 and the second electrode 25, making it convenient to use.

[0048] In one embodiment, the power supply is a constant DC power supply with a voltage of 1V-50V, and the heat setting time is 1s-30s. The heat setting time and heat setting temperature are not limited to the above numerical range and can be adjusted according to the size of the cross-sectional area of ​​the initial structure of the plug 1. The heat setting time of the initial structure of the plug 1 with a larger cross-sectional area is shorter, and the heat setting time of the initial structure of the plug 1 with a smaller cross-sectional area is longer.

[0049] In existing technologies, the plugging device is placed in a shaping mold, and then placed together with the mold in a heat treatment apparatus. Depending on the actual needs, the plugging device is heat-treated to obtain a mesh skeleton with different preset expansion shapes. The heat-setting time ranges from 5 minutes to 120 minutes. When the heat-setting time of the plugging device is too long, its hyperelasticity decreases. In existing technologies, the recoverable strain of plugging devices manufactured using heat treatment equipment is 7% to 8%.

[0050] In one embodiment, elongated cylindrical mesh tubes are woven from hyperelastic shape memory alloy wires of different diameters according to the initial structure of the plug 1. The voltage and current parameters can be varied while the heat setting time remains constant, thereby ensuring its hyperelasticity. The following implementation method is provided:

[0051] In one specific embodiment, the initial structure of the occluder 1 is a slender cylindrical mesh made of 0.09mm superelastic shape memory alloy wire. The voltage of the constant DC power supply is set to 2V, the heat setting time is set to 10s, and the current is set to 9A. The recoverable strain of the occluder is 8.6%.

[0052] In another specific embodiment, the initial structure of the occluder 1 is made of a long and thin cylindrical mesh woven from 0.05mm ultra-elastic shape memory alloy wire. The voltage of the constant DC power supply is set to 2V, the heat setting time is set to 10s, and the current is set to 5A. The recoverable strain of the occluder is 8.9%.

[0053] In another specific embodiment, the initial structure of the occluder 1 is made of a slender cylindrical mesh woven from 0.03mm superelastic shape memory alloy wire. The voltage of the constant DC power supply is set to 4V, the heat setting time is set to 10s, and the current is set to 2A. The recoverable strain of the occluder is 9.3%.

[0054] Of course, in other embodiments, the power supply can also be a pulsed DC power supply, an AC power supply, a pulsed AC power supply, etc.

[0055] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0056] The above-disclosed embodiments are merely preferred embodiments of the present utility model and should not be construed as limiting the scope of the present utility model. Therefore, any equivalent variations made in accordance with the claims of the present utility model shall still fall within the scope of the present utility model.

Claims

1. A sealing device for shaping, characterized in that, include: A mold body, which is used to hold the plug, and the mold body is a conductor; First electrode and second electrode; the first electrode and second electrode are respectively disposed on the mold body; as well as A power supply assembly, wherein the positive and negative terminals of the power supply assembly are electrically connected to the first electrode and the second electrode, respectively.

2. The sealing device according to claim 1, characterized in that, The mold body is made of steel, aluminum, or copper.

3. The sealing device according to claim 1, characterized in that, The mold body includes an upper mold, a middle mold, and a lower mold, which together form the cavity of a stopper with a preset extended shape.

4. The sealing device shaping apparatus according to claim 3, characterized in that, The upper mold, the middle mold, and the lower mold are structural components made of conductive materials.

5. The sealing device according to claim 4, characterized in that, The upper mold, the middle mold, and the lower mold are structural components made of steel, aluminum, or copper, respectively.

6. The sealing device shaping apparatus according to claim 4, characterized in that, The upper mold, the middle mold, and the lower mold are electrically connected to the first electrode and the second electrode, respectively.

7. The sealing device according to claim 1, characterized in that, The power supply assembly includes a power source, a first conductive element, and a second conductive element. The positive and negative terminals of the power source are electrically connected to the first conductive element and the second conductive element, respectively. The first conductive element and the second conductive element are electrically connected to the first electrode and the second electrode, respectively.

8. The sealing device shaping apparatus according to claim 7, characterized in that, The power supply assembly further includes a first conductive clip and a second conductive clip, the first conductive element and the second conductive element being electrically connected to the first conductive clip and the second conductive clip respectively, and the first conductive clip and the second conductive clip respectively clamping the first electrode and the second electrode.

9. The sealing device according to claim 7 or 8, characterized in that, The first conductive element and the second conductive element are wires, respectively.

10. The sealing device shaping apparatus according to claim 7, characterized in that, The power source is a constant DC power source.

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