Pediatric surgical intervention closure device

Abstract

We provide interventional closure devices for pediatric surgery. [Solution] The system comprises a closing plate 1, a fixed plate 2, and a reinforcing device 5. The fixed plate is installed on one side of the closing plate, and the closing plate is connected to the fixed plate via a first connecting intermediate part 3. An annular locking wheel 4 for connecting to a transfer device is provided at the tail end of the closing plate. The reinforcing device has a position limiting plate 501 and a second connecting intermediate part 502. The position limiting plate is U-shaped and is positioned on one side closer to the fixed plate, and the position limiting plate is connected to the fixed plate using the second connecting intermediate part. After the closing device is released, the elastic recovery force generated by the spring restoring its shape is transmitted to the position limiting plate via the distal end connection part and the cushioning pad, pushing the position limiting plate and moving it toward the fixed plate. This sustained elastic compression force is further transmitted to the fixed plate, pushing it toward the closing plate indefinitely, thereby maintaining a tight seal between the closing plate and the fixed plate and effectively enhancing the closing effect.

Description

Technical Field

[0001] The present invention relates to the technical field of medical instruments, and particularly to an interventional occluder for pediatric surgery.

Background Art

[0002] An occluder is a device that closes a lesion defect site in the body using a transfer device. For the interventional occlusion treatment of congenital heart diseases, which has advantages such as minor injury, safe and rapid surgery, and reliable effects in the short and medium term, the occluder, as an implanted medical device for interventional treatment, is used for the treatment of atrial septal defect, ventricular septal defect, and patent ductus arteriosus of congenital heart diseases and is widely applied clinically. In the interventional occlusion treatment of congenital heart diseases, it is generally necessary to implant a biodegradable occluder at the site to be occluded.

[0003] Currently, the occluders frequently used clinically usually have a double-disk structure including a closing disk located on the side with the defect and a fixing disk located on the opposite side of the defect, and the two disks are connected at the middle part. During the operation, after compressing the occluder and loading it into the transfer catheter sheath and delivering it to the target position in the body with a pushing rod and releasing it, the closing disk and the fixing disk expand on both sides of the site to be occluded respectively, and the edge tissue of the defect is clamped by using the radial supporting force generated by their self-expanding characteristics to achieve the closing effect.

[0004] Most of the existing occluders perform positioning only with a single fixed structure and lack a dedicated strengthening mechanism. Therefore, it is difficult to ensure that the occlusion disk and the fixing disk closely adhere to both sides of the site to be occluded after implantation, and displacement is likely to occur due to factors such as the heartbeat of the heart and the activities of the child.

Summary of the Invention

Problems to be Solved by the Invention

[0005] An object of the present invention is to provide an interventional occluder for pediatric surgery to solve the problems raised in the above background art.

Means for Solving the Problems

[0006] To achieve the above objective, this invention provides the following technical means.

[0007] Pediatric surgical intervention closure devices are, The system comprises a closing plate and a fixed plate, the fixed plate being installed on one side of the closing plate, the closing plate being connected to the fixed plate via a first connecting intermediate section, and an annular tethering wheel for connection to a transfer device being provided at the tail end of the closing plate; The device further comprises a reinforcement device having a position limiting plate, a second connecting intermediate section, and a compression assembly; The position limiting plate is U-shaped and positioned on one side closer to the fixing plate; The position limiting plate is connected to the fixed plate using the second connecting intermediate portion; The compression assembly is positioned between the position limiting plate, the fixing plate, and the closing plate; The compression assembly has a proximal end connection and a distal end connection, and a cushioning pad is fixedly connected to both the proximal end connection and the distal end connection, and the proximal end connection is fixedly connected to the fixing plate via the cushioning pad, The distal end connection portion is fixedly connected to the position limiting plate via the cushioning pad; A first movable member and a second movable member are provided between the distal end connection and the proximal end connection, the first movable member fits with the second movable member, and a spring is provided between the first movable member and the second movable member.

[0008] Preferably, a fixing structure for fixing is provided on the outer wall of the side surface of the fixing plate.

[0009] Preferably, the bottom of the position limiting plate abuts against the outer wall of the fixing plate.

[0010] Preferably, the cushioning pad is made of a medical-grade polymer material.

[0011] Preferably, the first movable member is tubular, the second movable member is rod-shaped, and one end of the second movable member is inserted into the internal cavity of the first movable member.

[0012] Preferably, the position limiting plate, the fixing plate, and the closing plate are all made of nitinol memory alloy. [Effects of the Invention]

[0013] The pediatric surgical intervention closure device according to this invention has the following beneficial effects compared to existing technology.

[0014] 1. In the pediatric surgical intervention closure device according to this invention, after the closure device is compressed and loaded into the transport catheter sheath, delivered to the target location in the body, and released, the closure plate and fixing plate instantly restore to their predetermined disc-shaped structures due to the self-expansion properties of the nitinol memory alloy, and each adheres tightly to both sides of the defect, achieving initial clamping and closure of the defect site, thereby blocking abnormal blood flow.

[0015] 2. In the pediatric surgical intervention closure device according to the present invention, after the closure device is released, the elastic recovery force generated by the spring restoring its shape is transmitted to the position limiting plate via the distal end connection and the cushioning pad, pushing the position limiting plate and moving it toward the fixing plate. This sustained elastic compressive force is further transmitted to the fixing plate, continuously pushing toward the closure plate, thereby maintaining a tight seal between the closure plate and the fixing plate, effectively enhancing the closure effect, preventing loosening and movement of the closure device, and ensuring the reliability of the closure. [Brief explanation of the drawing]

[0016] [Figure 1] Figure 1 is a schematic diagram showing the structure of the present invention. [Figure 2] Figure 2 is a schematic diagram showing a partial structure of the present invention. [Figure 3] Figure 3 is a schematic diagram showing an enlarged view of the structure of portion A in Figure 1 of the present invention. [Modes for carrying out the invention]

[0017] Next, we will clearly and completely describe the technical means in the embodiments of the present invention with reference to the drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative labor are included in the protection scope of the present invention. Embodiment

[0018] The pediatric surgical intervention occluder comprises a closing disk 1 and a fixing disk 2. The fixing disk 2 is installed on one side of the closing disk 1. The closing disk 1 is connected to the fixing disk 2 through a first connection intermediate part 3. An annular engaging ring 4 for connecting to a transfer device is provided at the tail of the closing disk 1.

[0019] In this embodiment, before transfer, the occluder is compressed and loaded into the transfer catheter sheath. During the operation, the doctor connects the occluder to the annular engaging ring 4 at the tail of the closing disk 1 with a propulsion rod and pushes the occluder along the transfer catheter sheath to the cardiac defect site. After the transfer system reaches the target position, first, a part of the transfer catheter sheath is pulled back to release the fixing disk 2. The fixing disk 2 is woven with nitinol memory alloy and has self-expanding properties. It breaks free from the restraint of the transfer catheter sheath and automatically restores to a preset disk-shaped structure. The fixing structure provided on the outer wall of the side surface of the fixing disk 2 abuts against the distal tissue wall of the defect site after deployment to achieve initial fixation and prevent the occluder from moving to the operating side. By continuously pulling back a part of the transfer catheter sheath or pushing the propulsion rod forward, the closing disk 1 is released. The closing disk 1 also self-expands and spreads to cover the proximal side of the defect site. At this time, the closing disk 1 and the fixing disk 2 are connected through the first connection intermediate part 3 and are respectively located on both sides of the defect opening to perform initial mechanical closure on the defect opening and block the blood flow.

[0020] The pediatric surgical intervention occluder further comprises a strengthening device 5. The strengthening device 5 has a position limiting disk 501, a second connection intermediate part 502, and a compression combination body 503.

[0021] The position limiting disk 501 is U-shaped and is arranged on the side approaching the fixing disk 2.

[0022] The position limiting plate 501 is connected to the fixed plate 2 using the second connection intermediate part 502.

[0023] The compression assembly 503 is arranged between the position limiting plate 501, the fixed plate 2, and the closing plate 1.

[0024] The compression assembly 503 has a proximal end connection part 5031 and a distal end connection part 5032. Buffer pads 5033 are fixedly connected to both the proximal end connection part 5031 and the distal end connection part 5032. The proximal end connection part 5031 is fixedly connected to the fixed plate 2 through the buffer pad 5033, and the distal end connection part 5032 is fixedly connected to the position limiting plate 501 through the buffer pad 5033.

[0025] A first movable member 5034 and a second movable member 5035 are provided between the distal end connection part 5032 and the proximal end connection part 5031. The first movable member 5034 is fitted with the second movable member 5035, and a spring is provided between the first movable member 5034 and the second movable member 5035.

[0026] In this embodiment, within the transfer catheter sheath, the structures such as the closing plate 1 and the fixed plate 2 are compressed and deformed, and the spring is in an extended state. When the structures such as the closing plate 1 and the fixed plate 2 are released from the transfer catheter sheath, the spring returns to its original shape, thereby moving the position limiting plate 501 in the direction closer to the fixed plate, enabling the defect opening to be better closed together with the closing plate 1 on the fixed plate 2.

[0027] Under the continuous elastic compression action of the spring, the fixed plate 2 is pushed in the direction of the closing plate 1, causing the two to adhere closely to both sides of the part to be closed, further enhancing the closing effect. As the child grows, even if the tissue at the defect site thickens or the heart structure changes, the spring in the compression assembly 503 is passively compressed or extended, always maintaining a certain initial tension, achieving automatic adjustment, and preventing loosening or detachment of the occluder due to tissue growth.

[0028] A fixing structure for fixing is provided on the outer wall of the side surface of the fixed plate 2.

[0029] In this embodiment, after the fixing structure (e.g., a fixing ring) provided on the outer wall of the side of the fixing plate 2 expands, it contacts the distal tissue wall of the defective area, achieving initial fixation and preventing the closure device from moving towards the operating side.

[0030] The bottom of the position restriction plate 501 abuts against the outer wall of the fixed plate 2.

[0031] In this embodiment, when the position limiting plate 501 receives thrust from the pressure assembly 503, it is ensured that the force is always stably transmitted to the entire fixed plate 2 with the fixed plate 2 as the fulcrum.

[0032] The cushioning pad 5033 is made from medical-grade polymer material.

[0033] In this embodiment, the cushioning pad 5033 is made of a medical polymer material, providing both cushioning and fixation, and effectively mitigating the impact force on the fixing plate and position limiting plate during the compression process.

[0034] The first movable member 5034 is tubular, and the second movable member 5035 is rod-shaped, with one end of the second movable member 5035 being inserted into the internal cavity of the first movable member 5034.

[0035] The position restriction plate 1, the fixed plate 2, and the closing plate 501 are all made of nitinol memory alloy.

[0036] In this embodiment, the position limiting plate 1, the fixing plate 2, and the closing plate 501 are all made of nitinol memory alloy. By utilizing the excellent superelasticity and shape memory properties of this material, each plate can be compressed to a small volume within the transport catheter sheath, and the preset plate structure is automatically restored quickly after release.

[0037] The operating principle of this invention is as follows:

[0038] Before transfer, the occluder is compressed and loaded into the transfer catheter sheath. During surgery, the physician uses a propulsion rod to connect the occluder to the annular locking ring 4 at the tail of the occluder disc 1 and pushes the occluder along the transfer catheter sheath to the cardiac defect site. After the transfer system reaches the target position, a portion of the transfer catheter sheath is first pulled back to release the fixation disc 2. The fixation disc 2 is made of nitinol memory alloy and has self-expanding properties, automatically returning to a preset disc-shaped structure after being released from the constraints of the transfer catheter sheath. The fixing structure (fixation locking ring) on ​​the outer wall of the side of the fixation disc 2 contacts the distal tissue wall of the defect site after deployment, achieving initial fixation and preventing the occluder from moving toward the operator. The occluder disc 1 is released by continuing to pull back a portion of the transfer catheter sheath or by pushing the propulsion rod forward. The occluder disc 1 also self-expands and expands, covering the proximal side of the defect site. At this time, the closing plate 1 and the fixing plate 2 are connected via the first connecting intermediate part 3, and are located on both sides of the defect, performing initial mechanical closure on the defect and blocking blood flow.

[0039] Within the transport catheter sheath, structures such as the closure plate 1 and the fixing plate 2 are compressed and deformed, causing the spring to be in an extended state. When the structures such as the closure plate 1 and the fixing plate 2 are released from within the transport catheter sheath, the spring returns to its original shape, thereby moving the position limiting plate 501 toward the fixing plate, allowing the fixing plate 2, together with the closure plate 1, to better close the defect.

[0040] Under the sustained elastic compression of the spring, the fixing plate 2 is pushed toward the closing plate 1, causing both to adhere tightly to both sides of the area to be closed, further enhancing the closing effect. Even if the tissue at the defect site thickens or the cardiac structure changes as the child grows, the spring within the compression assembly 503 is passively compressed or extended, maintaining a constant initial tension and automatically adjusting to prevent loosening or detachment of the closure device due to tissue growth.

[0041] The foregoing description merely represents preferred specific embodiments of the present invention and does not limit the scope of protection of the present invention. To those skilled in the art, equivalent substitutions or modifications based on the technical means and ideas of the present invention within the scope of the present invention should be included in the scope of protection of the present invention. [Explanation of symbols]

[0042] 1- Closing plate; 2- Fixing plate; 3- First connecting intermediate part; 4- Annular locking ring; 5- Reinforcement device; 501- Position limiting plate; 502- Second connecting intermediate part; 503- Compression assembly; 5031- Proximal end connection part; 5032- Distal end connection part; 5033- Cushioning pad; 5034- First movable member; 5035- Second movable member.

Claims

1. A pediatric surgical intervention closure device comprising a closure plate (1) and a fixing plate (2), The fixed platen (2) is installed on one side of the closing platen (1), the closing platen (1) is connected to the fixed platen (2) via a first connecting intermediate section (3), and an annular tethering wheel (4) for connecting to a transfer device is provided at the tail end of the closing platen (1); The device further comprises a reinforcement device (5), the reinforcement device (5) having a position limiting plate (501), a second connecting intermediate part (502), and a compression assembly (503); The position limiting plate (501) is U-shaped and positioned on one side closer to the fixing plate (2); The position limiting plate (501) is connected to the fixed plate (2) using the second connecting intermediate portion (502); The compression assembly (503) is positioned between the position limiting plate (501), the fixing plate (2), and the closing plate (1); The compression assembly (503) has a proximal end connection portion (5031) and a distal end connection portion (5032), and a buffer pad (5033) is fixedly connected to both the proximal end connection portion (5031) and the distal end connection portion (5032), the proximal end connection portion (5031) is fixedly connected to the fixing plate (2) via the buffer pad (5033), and the distal end connection portion (5032) is fixedly connected to the position limiting plate (501) via the buffer pad (5033); A first movable member (5034) and a second movable member (5035) are provided between the distal end connecting portion (5032) and the proximal end connecting portion (5032), the first movable member (5034) fits with the second movable member (5035), and a spring is provided between the first movable member (5034) and the second movable member (5035). A pediatric surgical intervention closure device characterized by the following features.

2. The pediatric surgical intervention closure device according to claim 1, characterized in that a fixing structure for fixing is provided on the outer wall of the side surface of the fixing plate (2).

3. The pediatric surgical intervention closure device according to claim 1, characterized in that the bottom of the position limiting plate (501) abuts against the outer wall of the fixing plate (2).

4. The pediatric surgical intervention closure device according to claim 1, characterized in that the buffer pad (5033) is made of a medical polymer material.

5. The first movable member (5034) is tubular, the second movable member (5035) is rod-shaped, and one end of the second movable member (5035) is inserted into the internal cavity of the first movable member (5034). The pediatric surgical intervention closure device according to feature 1.

6. The pediatric surgical intervention closure device according to claim 1, characterized in that the position limiting plate (1), the fixing plate (2), and the closing plate (501) are all made of nitinol memory alloy.

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