Oval foramen plugging device

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to an oval foramen plugging device which comprises a middle waist connecting part, a lower disc face and an upper disc face, the middle waist connecting part is arranged at the position between the lower disc face and the upper disc face, and the middle waist connecting part is fixedly connected with the lower disc face and the upper disc face. A first steel sleeve is fixed at one end, far away from the middle waist connecting part, of the lower disc surface; a second steel sleeve is fixed to the end, away from the waistline connecting part, of the upper disc face. And the inner side of the middle waist connecting part is rotationally connected with a rotary adjusting rod. Through the matched structural design of the upper disc surface, the lower disc surface, the rotary adjusting rod, the connecting assembly and the limiting assembly, the unfolding diameters of the lower disc surface and the upper disc surface can be adjusted according to the actual condition of a patient after the device is placed in the fossa; therefore, the situation that the size of the plugging device is different from the actual size of the patient and needs to be replaced can be avoided, and the practicability of the device is improved.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, in particular to a foramen ovale occluder. Background Art

[0002] The foramen ovale is an open area in the middle of the atrial septum and is a physiological passage in the atrial septum of the heart during the embryonic period. 20-25% of the population have incomplete fusion of the foramen ovale valve and the atrial septum. Studies have shown that the probability of unexplained cerebral ischemia in patients with patent foramen ovale is significantly higher than that in patients without patent foramen ovale. Many clinical observations have shown that occluding patent foramen ovale (PFO) can reduce the risk of cerebrovascular events.

[0003] Patent foramen ovale is a common congenital heart disease, and the traditional treatment method is surgery. For surgical treatment, the patient needs to undergo a surgical thoracotomy. Since the 1980s, with the development and improvement of catheter interventional diagnosis and treatment technology, my country has gradually introduced minimally invasive interventional technology to treat congenital heart disease. The method of minimally invasive interventional treatment of patent foramen ovale has developed rapidly and is now very mature. Compared with traditional surgery, minimally invasive interventional treatment is a modern high-tech minimally invasive treatment. After right-to-left shunt is confirmed by right atrial angiography, the end-hole catheter is placed in the left atrium or left upper pulmonary vein through the foramen ovale, and the exchange guide wire is sent to the left atrium or left upper pulmonary vein through the end-hole catheter, and the corresponding size of the delivery sheath is sent into the left atrium; the occluder is loaded and sent into the left atrium through the sheath. After the left atrium disc of the occluder is fully opened and the thin waist is unsheathed, the delivery rod and the long sheath are withdrawn together, so that the left atrium disc is closely attached to the left atrium wall, and the thin waist is completely stuck at the foramen ovale, and then the sheath is withdrawn to open the right atrium disc. When the position and shape of the occluder meet the requirements through fluoroscopy and echocardiography monitoring, right atrial angiography is performed again to confirm that there is no right-to-left shunt, the occluder is released, and the delivery device is withdrawn to complete the operation. This minimally invasive interventional treatment has the advantages of no surgery, less trauma, fewer complications, faster recovery, better results, a wide range of indications, and relatively low surgical costs.

[0004] The disk size of the traditional metal patent foramen ovale occluder is large, and the disk of the occluder cannot be adjusted according to the actual situation of the patient. If the defect is close to the valve or blood vessel wall, it is easy to cause tissue wear and extrusion. Replacing the occluder wastes treatment time and increases the patient's surgical safety risk. Therefore, a foramen ovale occluder is proposed to address the above problems. Summary of the invention

[0005] In order to make up for the deficiencies of the prior art and solve at least one technical problem raised in the background technology, the present invention proposes an oval foramen occluder.

[0006] The technical solution adopted by the present invention to solve its technical problem is: the foramen ovale occluder described in the present invention includes a mid-waist connection part, a lower disk surface and an upper disk surface, the mid-waist connection part is arranged at a position between the lower disk surface and the upper disk surface, and the mid-waist connection part is fixedly connected to the lower disk surface and the upper disk surface respectively: a first steel sleeve is fixed to an end of the lower disk surface away from the mid-waist connection part; a second steel sleeve is fixed to an end of the upper disk surface away from the mid-waist connection part; a rotating adjustment rod is rotatably connected to the inner side of the mid-waist connection part; the two ends of the rotating adjustment rod are respectively connected to the first steel sleeve and the second steel sleeve through a group of connecting components; a limiting component is arranged at the position of the rotating adjustment rod located on the inner side of the mid-waist connection part.

[0007] Preferably, the connecting component includes an embedding groove; the first steel sleeve and the second steel sleeve are both provided with embedding grooves at positions corresponding to the rotating adjustment rod; a plurality of connecting grooves are evenly provided on the outer sides of both ends of the rotating adjustment rod; and the first steel sleeve and the second steel sleeve are both provided with plug-in components at positions corresponding to the connecting grooves.

[0008] Preferably, both groups of the plug-in components include a connecting block; the connecting block is arranged at the position of the first steel sleeve and the second steel sleeve corresponding to the connecting groove; the connecting block is slidingly connected to the first steel sleeve or the second steel sleeve respectively; the connecting block is plug-connected to the rotating adjustment rod through the connecting groove; a first spring is fixed to one end of the connecting block away from the rotating adjustment rod; one end of the first spring away from the connecting block is fixedly connected to the first steel sleeve or the second steel sleeve respectively.

[0009] Preferably, the limiting assembly includes a plurality of limiting balls; the plurality of limiting balls are respectively arranged at the outer position of one end of the rotation adjustment rod located at the lower end of the mid-waist connecting part; the limiting ball is slidably connected to the rotation adjustment rod; a plurality of limiting grooves are evenly arranged at the positions of the mid-waist connecting part corresponding to the limiting grooves; a second spring is fixed to the side of the limiting ball close to the rotation adjustment rod; the end of the second spring away from the limiting ball is fixedly connected to the rotation adjustment rod.

[0010] Preferably, a plurality of weight-reducing grooves are evenly arranged on the middle outer side of the mid-waist connecting portion.

[0011] Preferably, the middle of the inner side of the rotating adjustment rod is set to be hollow.

[0012] Preferably, the lower disc surface, the upper disc surface and the middle waist connecting part are woven together with the first steel sleeve and the second steel sleeve through a plurality of single threads.

[0013] Preferably, the lower disk surface and the upper disk surface are both made of memory material nickel-titanium alloy.

[0014] Beneficial effects of the present invention:

[0015] The present invention provides an oval foramen occluder. Through the coordinated structural design of an upper disk, a lower disk, a rotating adjustment rod, a connecting assembly and a limiting assembly, after the device is placed in the oval foramen, the expanded diameters of the lower disk and the upper disk can be adjusted according to the actual conditions of the patient, thereby avoiding the situation where the size of the occluder is different from the actual size required by the patient and needs to be replaced, thereby improving the practicability of the device.

[0016] The present invention provides an oval foramen occluder, which, through the structural design of a limiting ball and a second spring, can limit the rotation of the rotating adjustment rod when the rotating adjustment rod is rotated to a suitable position, thereby avoiding changes in the diameter of the lower disk surface or the upper disk surface caused by the rotation of the rotating adjustment rod, and effectively improving the stability of the device. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The drawings described herein are used to provide a further understanding of the present invention and constitute a part of this application. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the drawings:

[0018] Figure 1 is a stereogram of the present invention;

[0019] Figure 2 It is a three-dimensional diagram of the lower disk surface and the upper disk surface in the present invention;

[0020] Figure 3 is a stereogram of a connection assembly in the present invention;

[0021] Figure 4 is a stereogram of the plug-in assembly of the present invention;

[0022] Figure 5 It is a three-dimensional diagram of the limiting component in the present invention.

[0023] Legend:

[0024] 1. Mid-waist connection; 2. Lower disc surface; 3. Upper disc surface; 4. First steel sleeve; 5. Second steel sleeve; 6. Rotary adjustment rod; 7. Connecting groove; 8. Connecting block; 9. First spring; 10. Weight reduction groove; 11. Limiting ball; 12. Second spring. DETAILED DESCRIPTION

[0025] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0026] Specific examples are given below.

[0027] See also Figure 1-Figure 5 The present invention provides an oval foramen occluder, comprising a middle waist connection part 1, a lower disk surface 2 and an upper disk surface 3, wherein the middle waist connection part 1 is arranged at a position between the lower disk surface 2 and the upper disk surface 3, and the middle waist connection part 1 is fixedly connected to the lower disk surface 2 and the upper disk surface 3 respectively: a first steel sleeve 4 is fixed to one end of the lower disk surface 2 away from the middle waist connection part 1; a second steel sleeve 5 is fixed to one end of the upper disk surface 3 away from the middle waist connection part 1; a rotating adjustment rod 6 is rotatably connected to the inner side of the middle waist connection part 1; two ends of the rotating adjustment rod 6 are respectively connected to the first steel sleeve 4 and the second steel sleeve 5 through a group of connecting components; a limiting component is arranged at the position of the rotating adjustment rod 6 located on the inner side of the middle waist connection part 1. During operation, first move the instrument device to the oval fossa, then retract the catheter so that the device can be moved out of the catheter from the direction of the first steel sleeve 4 to the second steel sleeve 5. When the catheter moves to the upper disk surface 3 and is located outside the catheter, it is unfolded on the upper disk surface 3. When the upper disk surface 3 is unfolded, it drives the first steel sleeve 4 to move in the direction close to the rotating adjustment rod 6, and then the rotating adjustment rod 6 is connected to the first steel sleeve 4 through the connecting assembly. Similarly, when the lower disk surface 2 is unfolded, the second steel sleeve 5 and the rotating adjustment rod 6 are unfolded at the same time, and then the second steel sleeve 5 is rotated so that the second steel sleeve 5 drives the first steel sleeve 4 to rotate through the rotating adjustment rod 6. When the first steel sleeve 4 and the second steel sleeve 5 rotate, the lower disk surface is driven 2 and one end of the upper disk surface 3 connected to the first steel sleeve 4 and the second steel sleeve 5 are contracted, so that the diameters of the lower disk surface 2 and the upper disk surface 3 are changed. At the same time, the rotation adjustment rod 6 can be rotationally limited by the limit assembly, so that the rotation adjustment rod 6 cannot be rotated without external force, thereby completing the occlusion work of the occluder. This step is designed through the matching structure of the upper disk surface 3, the lower disk surface 2, the rotation adjustment rod 6, the connecting assembly and the limit assembly, so that after the device is placed in the ovarian fossa, the expansion diameters of the lower disk surface 2 and the upper disk surface 3 can be adjusted according to the actual situation of the patient, thereby avoiding the situation where the occluder size is different from the actual size required by the patient and needs to be replaced, thereby improving the practicality of the device;

[0028] Further, such as Figure 3 and Figure 4As shown, the connection assembly includes an embedding groove; the first steel sleeve 4 and the second steel sleeve 5 are both provided with an embedding groove at positions corresponding to the rotating adjustment rod 6; a plurality of connecting grooves 7 are evenly provided on the outer sides of both ends of the rotating adjustment rod 6; and the first steel sleeve 4 and the second steel sleeve 5 are both provided with a plug-in assembly at positions corresponding to the connecting grooves 7. When the first steel sleeve 4 and the second steel sleeve 5 are moved to positions corresponding to the connecting grooves 7 during operation, the plug-in assembly is connected to the rotating adjustment rod 6 through the connecting grooves 7. This step enables the first steel sleeve 4 or the second steel sleeve 5 to be connected to the rotating adjustment rod 6 through the structural design of the plug-in assembly and the connecting groove 7, so that when the second steel sleeve 5 rotates, it is convenient to drive the first steel sleeve 4 to rotate at the same time through the rotating adjustment rod 6.

[0029] Further, such as Figure 3 and Figure 4 As shown, both groups of plug-in assemblies include a connecting block 8; the connecting block 8 is arranged at the position corresponding to the connecting groove 7 of the first steel sleeve 4 and the second steel sleeve 5; the connecting block 8 is slidably connected to the first steel sleeve 4 or the second steel sleeve 5 respectively; the connecting block 8 is plug-connected with the rotating adjustment rod 6 through the connecting groove 7; the end of the connecting block 8 away from the rotating adjustment rod 6 is fixed with a first spring 9; the end of the first spring 9 away from the connecting block 8 is fixedly connected to the first steel sleeve 4 or the second steel sleeve 5 respectively. During operation, when the first steel sleeve 4 or the second steel sleeve 5 moves to the point where the connecting block 8 contacts the rotating adjustment rod 6, the rotating adjustment rod 6 will squeeze the connecting block 8, so that the connecting block 8 moves in the direction close to the first spring 9. When the connecting block 8 moves to the position corresponding to the connecting groove 7, the connecting block 8 is pushed to the inner side of the connecting groove 7 under the elastic action of the first spring 9, so that the plug-in with the rotating adjustment rod 6 is completed. This step is achieved through the structural design of the connecting block 8 and the first spring 9, so that the connection between the first steel sleeve 4 or the second steel sleeve 5 and the rotating adjustment rod 6 can be completed through the connecting block 8.

[0030] like Figure 5As shown, the limiting assembly includes a plurality of limiting balls 11; the plurality of limiting balls 11 are respectively arranged at the outer position of one end of the rotation adjustment rod 6 located at the lower end of the middle waist connection part 1; the limiting ball 11 is slidably connected with the rotation adjustment rod 6; a plurality of limiting grooves are evenly provided at the positions of the middle waist connection part 1 corresponding to the limiting grooves 11; a second spring 12 is fixed to the side of the limiting ball 11 close to the rotation adjustment rod 6; the end of the second spring 12 away from the limiting ball 11 is fixedly connected to the rotation adjustment rod 6. During operation, when the rotation adjustment rod 6 rotates, the limiting ball 11 will be squeezed, causing the limiting ball 11 to move in the direction close to the second spring 12. When the rotation adjustment rod 6 rotates to a position where another limiting groove corresponds to the limiting ball 11, the limiting ball 11 will be pushed into the limiting groove under the elastic action of the second spring 12, thereby limiting the rotation adjustment rod 6. This step is achieved through the structural design of the limiting ball 11 and the second spring 12, so that the rotation adjustment rod 6 can be rotationally limited when it is rotated to a suitable position, thereby avoiding changes in the diameter of the lower disk surface 2 or the upper disk surface 3 due to the rotation of the rotation adjustment rod 6, and effectively improving the stability of the device.

[0031] like Figure 5 As shown, a plurality of weight-reducing grooves 10 are evenly arranged on the middle outer side of the middle waist connecting part 1. This step can effectively reduce the overall weight of the device and reduce the load on tissues and organs.

[0032] like Figure 5 As shown, the inner middle of the rotating adjustment rod 6 is set to be hollow. This step effectively reduces the overall weight of the device and reduces the load on tissues and organs.

[0033] like Figure 1 As shown, the lower disk surface 2, the upper disk surface 3 and the middle waist connecting part 1 are woven with the first steel sleeve 4 and the second steel sleeve 5 respectively through a plurality of single threads. This step can improve the plasticity of the first steel sleeve 4 and the second steel sleeve 5, so that the unfolded diameters of the upper disk surface 3 and the lower disk surface 2 change when the first steel sleeve 4 or the second steel sleeve 5 rotates.

[0034] like Figure 1 As shown, the lower plate surface 2 and the upper plate surface 3 are both made of memory material nickel-titanium alloy. This step improves the durability of the device and reduces the rejection reaction to foreign objects.

[0035] When the upper plate 3 is moved to the outside of the plate 3, the upper plate 3 is unfolded, and the first steel sleeve 4 is driven to move in the direction close to the rotating adjustment rod 6 when the upper plate 3 is unfolded, and then the rotating adjustment rod 6 is connected to the first steel sleeve 4 through the connecting assembly. Similarly, when the lower plate 2 is unfolded, the second steel sleeve 5 and the rotating adjustment rod 6 are unfolded at the same time, and then the second steel sleeve 5 is rotated so that the second steel sleeve 5 drives the first steel sleeve 4 to rotate through the rotating adjustment rod 6. When the first steel sleeve 4 and the second steel sleeve 5 rotate, the ends of the lower plate 2 and the upper plate 3 connected to the first steel sleeve 4 and the second steel sleeve 5 are contracted, thereby changing the diameters of the lower plate 2 and the upper plate 3. At the same time, the rotating adjustment rod 6 can be rotationally limited by the limiting assembly, so that in the absence of external force When the first steel sleeve 4 and the second steel sleeve 5 move to the position corresponding to the connecting groove 7, the plug-in assembly is connected to the rotating adjusting rod 6 through the connecting groove 7. When the first steel sleeve 4 or the second steel sleeve 5 moves to the connecting block 8 and contacts the rotating adjusting rod 6, the rotating adjusting rod 6 will squeeze the connecting block 8, so that the connecting block 8 moves in the direction close to the first spring 9. When the connecting block 8 moves to the position corresponding to the connecting groove 7, the connecting block 8 is pushed to the inner side of the connecting groove 7 under the elastic action of the first spring 9, so as to complete the plugging with the rotating adjusting rod 6. When the rotating adjusting rod 6 rotates, the limiting ball 11 is squeezed, so that the limiting ball 11 moves in the direction close to the second spring 12. When the rotating adjusting rod 6 rotates to the position corresponding to another limiting groove and the limiting ball 11, the limiting ball 11 is pushed into the limiting groove under the elastic action of the second spring 12, thereby limiting the rotating adjusting rod 6.

[0036] The above shows and describes the basic principles, main features and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments, and the above embodiments and descriptions are only for explaining the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, and these changes and improvements all fall within the scope of the present invention to be protected.

Claims

1. An oval foramen occluder, comprising a middle waist connection portion (1), a lower disk surface (2) and an upper disk surface (3), wherein the middle waist connection portion (1) is arranged between the lower disk surface (2) and the upper disk surface (3), and the middle waist connection portion (1) is fixedly connected to the lower disk surface (2) and the upper disk surface (3), respectively, and characterized in that: A first steel sleeve (4) is fixed to one end of the lower disk surface (2) away from the middle waist connection part (1); a second steel sleeve (5) is fixed to one end of the upper disk surface (3) away from the middle waist connection part (1); a rotary adjustment rod (6) is rotatably connected to the inner side of the middle waist connection part (1); two ends of the rotary adjustment rod (6) are respectively connected to the first steel sleeve (4) and the second steel sleeve (5) through a group of connecting components; a limit position component is provided at the position of the rotary adjustment rod (6) located inside the middle waist connection part (1).

2. The foramen ovale occluder according to claim 1, characterized in that: The connection assembly comprises an embedding groove; the first steel sleeve (4) and the second steel sleeve (5) are both provided with embedding grooves at positions corresponding to the rotating adjustment rod (6); a plurality of connection grooves (7) are evenly provided on the outer sides of both ends of the rotating adjustment rod (6); and the first steel sleeve (4) and the second steel sleeve (5) are both provided with plug-in assemblies at positions corresponding to the connection grooves (7).

3. The foramen ovale occluder according to claim 2, characterized in that: Both groups of the plug-in assemblies comprise a connecting block (8); the connecting block (8) is arranged at positions of the first steel sleeve (4) and the second steel sleeve (5) corresponding to the connecting groove (7); the connecting block (8) is slidably connected to the first steel sleeve (4) or the second steel sleeve (5); the connecting block (8) is plug-connected to the rotary adjustment rod (6) through the connecting groove (7); a first spring (9) is fixed to one end of the connecting block (8) away from the rotary adjustment rod (6); and one end of the first spring (9) away from the connecting block (8) is fixedly connected to the first steel sleeve (4) or the second steel sleeve (5).

4. The foramen ovale occluder according to claim 1, characterized in that: The limiting assembly comprises a plurality of limiting balls (11); the plurality of limiting balls (11) are respectively arranged at the outer side of one end of the rotation adjustment rod (6) located at the lower end of the middle waist connection part (1); the limiting ball (11) is slidably connected to the rotation adjustment rod (6); a plurality of limiting grooves are evenly arranged at positions corresponding to the middle waist connection part (1) and the limiting balls (11); a second spring (12) is fixed on the side of the limiting ball (11) close to the rotation adjustment rod (6); and the end of the second spring (12) away from the limiting ball (11) is fixedly connected to the rotation adjustment rod (6).

5. The foramen ovale occluder according to claim 1, characterized in that: A plurality of weight-reducing grooves (10) are evenly arranged on the middle outer side of the middle waist connecting portion (1).

6. The foramen ovale occluder according to claim 1, characterized in that: The middle of the inner side of the rotating adjustment rod (6) is arranged to be hollow.

7. The foramen ovale occluder according to claim 1, characterized in that: The lower disk surface (2), the upper disk surface (3), the middle waist connecting portion (1), the first steel sleeve (4), and the second steel sleeve (5) are respectively formed by weaving a plurality of single threads.

8. The foramen ovale occluder according to claim 1, characterized in that: The lower disk surface (2) and the upper disk surface (3) are both woven from a memory profile nickel-titanium alloy.

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