A patent foramen ovale occluder with adjustable disk

Abstract

The present invention relates to a patent foramen ovale occluder with an adjustable disk, belonging to the technical field of medical devices; the occluder with a mesh structure comprises an upper disk, a waist, a lower disk, an adjustment rod and an adjustment wire; a waist is provided between the upper disk and the lower disk; the upper disk is provided with a middle section of the same central axis and an edge section with an adjustable cross section perpendicular to the central axis; the upper disk of the occluder is designed as a splicing of the middle section and the edge section, an adjustment wire is provided between the edge section and the adjustment rod, and the size of the upper disk can be freely adjusted by rotating the adjustment rod and changing the length of the adjustment wire. The occluder with an adjustable disk reduces the probability of replacing the occluder during surgical operations; improves the fit of the occluder; the upper disk of the occluder adopts a two-section design of a middle section and an edge section, and the edge section is softer than the middle section, which is conducive to the adjustment of the disk size of the occluder and reduces the wear of the tissue fitted therewith.

Description

Technical Field

[0001] The invention relates to a patent foramen ovale occluder with an adjustable disk surface, belonging to the technical field of medical devices. Background Art

[0002] The foramen ovale is an open area in the middle of the atrial septum and a physiological passage of the atrial septum during the embryonic period. In 20-25% of the population, the fusion of the foramen ovale valve and the atrial septum is incomplete. Studies have shown that the incidence 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 cerebrovascular events.

[0003] At present, the main means of treating patent foramen ovale is to implant a patent foramen ovale occluder through minimally invasive surgery. However, the thickness of the septum at the oval fossa is lower than that of the surrounding atrial septum area, and the shape of the oval fossa is irregular. The disc size of the traditional patent foramen ovale occluder is fixed. If the size does not match, the occluder needs to be replaced and re-implanted, which prolongs the operation time. The disc size of the traditional metal patent foramen ovale occluder is large. If the patient's defect is close to the valve or blood vessel wall, it is easy to cause tissue wear and extrusion. And because the thickness of the atrial septum is greater than the thickness of the oval fossa, the edge of the occluder disc is easy to warp, and the poor tissue fit affects endothelialization. Therefore, the technical field needs to develop a patent foramen ovale occluder that can effectively reduce the chance of replacing the occluder during surgery and reduce the patient's bleeding time; it can also improve the matching degree between the occluder and the patient's heart structure, reduce tissue wear, and facilitate endothelialization. Summary of the invention

[0004] The purpose of the present invention is to solve the technical problems of reducing the probability of replacing the occluder during surgery, reducing tissue wear, improving the matching degree between the occluder and the patient's heart structure, and facilitating endothelialization.

[0005] In order to achieve the purpose of solving the above-mentioned problems, the technical solution adopted by the present invention is to provide a patent foramen ovale occluder with an adjustable disk surface. The mesh-structured occluder includes an upper disk surface, a waist, and a lower disk surface; a waist is provided between the upper disk surface and the lower disk surface; the upper disk surface is provided with a middle section with the same central axis and an edge section with an adjustable cross-section perpendicular to the central axis.

[0006] Preferably, an edge section is provided on the outer periphery of the middle section.

[0007] Preferably, a steel sleeve 1 is provided at the central opening of the upper disk surface, a steel sleeve 2 is provided at the central opening of the lower disk surface, and a mesh-structured blocker is provided between the steel sleeve 1 and the steel sleeve 2.

[0008] Preferably, an adjusting rod is provided between the first steel sleeve and the second steel sleeve, and an adjusting wire is provided on the adjusting rod, and the adjusting wire is connected to the edge segment.

[0009] Preferably, the middle section is woven from a nickel-titanium alloy mesh.

[0010] Preferably, the edge segment is woven from a degradable silk woven mesh or a nickel-titanium alloy silk woven mesh with a diameter less than or equal to 0.04 mm.

[0011] Preferably, the adjusting wire is configured as a nickel-titanium wire or a degradable wire, one end of the adjusting wire is fixed to the edge section of the upper disk surface, and the other end is fixed to the adjusting rod.

[0012] Preferably, the steel sleeve one and the steel sleeve two are provided with internal threads, and both ends of the adjustment rod are provided with external threads for connecting the steel sleeve one and the steel sleeve two and fixing the rotation angle of the adjustment rod.

[0013] Compared with the prior art, the present invention has the following beneficial effects:

[0014] The invention provides a patent foramen ovale occluder with an adjustable disk, comprising an upper disk, a waist, a lower disk, an adjusting rod and an adjusting wire. The upper disk of the patent foramen ovale occluder is designed by splicing a middle section and an edge section. The size of the upper disk can be freely adjusted by the adjusting rod and the adjusting wire.

[0015] The occluder provided by the present invention adopts an adjustable disk design, which reduces the probability of replacing the occluder during surgery and improves the fit of the occluder. The upper disk of the occluder adopts a two-section design of a middle section and an edge section. The edge section is softer than the middle section, which is conducive to adjusting the disk size of the occluder and reducing the wear of the fitted tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 It is a schematic side view of the structure of a patent foramen ovale occluder with an adjustable disk surface according to the present invention;

[0017] Figure A is a schematic side view of the structure when the regulating wire is extended; Figure B is a schematic side view of the structure when the regulating wire is shortened;

[0018] Figure 2 A schematic top view of a patent foramen ovale occluder with an adjustable disk according to the present invention;

[0019] Figure A is a schematic top view of the structure when the regulating wire is extended; Figure B is a schematic top view of the structure when the regulating wire is shortened;

[0020] Reference numerals: 1. Steel sleeve 1; 2. Middle section; 3. Edge section; 4. Adjustment wire; 5. Adjustment rod; 6. Waist; 7. Lower plate surface; 8. Steel sleeve 2; 9. Upper plate surface; DETAILED DESCRIPTION

[0021] In order to make the present invention more clearly understood, a preferred embodiment is described in detail with reference to the accompanying drawings as follows:

[0022] like Figure 1-2 As shown, the present invention provides a patent foramen ovale occluder with adjustable disk surface, and the occluder with mesh structure includes an upper disk surface 9, a waist 6, and a lower disk surface 7; a waist 6 is provided between the upper disk surface 9 and the lower disk surface 7; the upper disk surface 9 is provided with a middle section 2 with the same central axis and an edge section 3 with an adjustable cross section perpendicular to the central axis. The outer periphery of the middle section 2 is provided with an edge section 3. A steel sleeve 1 is provided at the center closing of the upper disk surface 9, a steel sleeve 2 8 is provided at the center closing of the lower disk surface 7, and a mesh structure occluder is provided between the steel sleeve 1 and the steel sleeve 2 8. An adjusting rod 5 is provided between the steel sleeve 1 and the steel sleeve 2 8, and an adjusting wire 4 is provided on the adjusting rod 5, and the adjusting wire 4 is connected to the edge section 3. The middle section 2 is woven from a nickel-titanium alloy wire mesh. The edge section 3 is woven from a degradable wire mesh or a nickel-titanium alloy wire mesh with a diameter less than or equal to 0.04 mm. The adjusting wire 4 is a nickel-titanium wire or a degradable wire, one end of which is fixed to the edge section 3 of the upper disk surface 9, and the other end is fixed to the adjusting rod 5. The steel sleeve 1 and the steel sleeve 2 8 are provided with internal threads, and both ends of the adjusting rod 5 are provided with external threads for connecting the steel sleeve 1 and the steel sleeve 2 8 and fixing the rotation angle of the adjusting rod 5.

[0023] Example

[0024] like Figure 1 The present invention shown in the figure provides a patent foramen ovale occluder with an adjustable disk surface, and the occluder structure includes an upper disk surface 9, a waist 6, a lower disk surface 7, an adjustment wire 4, and an adjustment rod 5. The nickel-titanium wire mesh is fixed in the middle of the upper and lower disk surfaces by steel sleeves 1 and 8 respectively. The upper disk surface 9 of the occluder is divided into a middle section 2 and an edge section 3. The middle section 2 is woven from a nickel-titanium alloy wire mesh, and the edge section 3 is a degradable wire woven mesh or a 0.04mm ultra-fine nickel-titanium alloy wire woven mesh. The adjustment wire 4 is a nickel-titanium wire or a degradable wire, one end of which is fixed to the edge section 3 of the upper disk surface, and the other end is fixed to the adjustment rod 5. The adjustment rod 5 is located in the middle of the waist 6 of the occluder. Rotate the adjustment rod 5, and the adjustment wire 4 is wrapped around the rod body to pull the edge section 3 of the upper disk surface 9. Adjust the size of the upper disk surface 9. The top and bottom of the adjustment rod 5 are provided with threads for connecting the steel sleeves of the upper and lower disk surfaces. When the adjusting rod 5 rotates, the thread sinks into the steel sleeve, and the rotation angle is fixed by the thread riveting structure, preventing the disk size from falling back after adjustment.

[0025] like Figure 2 As shown, after the adjusting rod 5 is twisted, the adjusting wire 4 is wound along the adjusting rod body, the length of the adjusting wire 4 is shortened, and the edge section 3 of the occluder disk is contracted, thereby adjusting the disk size.

[0026] The above is only a preferred embodiment of the present invention, and is not any formal or substantial limitation of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the present invention, and these improvements and supplements should also be regarded as the protection scope of the present invention. Any technician familiar with this profession, without departing from the spirit and scope of the present invention, can make some changes, modifications and equivalent changes made by using the technical content disclosed above, which are equivalent embodiments of the present invention; at the same time, any changes, modifications and evolutions of any equivalent changes made to the above embodiments based on the essential technology of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. A patent foramen ovale occluder with an adjustable disk, the occluder having a mesh structure comprises an upper disk, a waist, and a lower disk; a waist is provided between the upper disk and the lower disk; the characteristics are: The upper disk surface is provided with a middle section with the same central axis and an edge section perpendicular to the central axis with an adjustable cross section; The outer periphery of the middle section is provided with an edge section; The upper plate is designed by splicing the middle section and the edge section, and the edge section is softer than the middle section; A steel sleeve 1 is provided at the central closing portion of the upper disk surface, a steel sleeve 2 is provided at the central closing portion of the lower disk surface, and a mesh-structured plugger is provided between the steel sleeves 1 and 2; An adjusting rod is provided between the first steel sleeve and the second steel sleeve, and an adjusting wire is provided on the adjusting rod, and the adjusting wire is connected to the edge segment; The adjusting rod is rotated, and the adjusting wire is wound around the rod body to pull the edge section of the upper disk surface to adjust the size of the upper disk surface.

2. A patent foramen ovale occluder with an adjustable disk surface as claimed in claim 1, characterized in that: The middle section is woven from a nickel-titanium alloy wire mesh.

3. A patent foramen ovale occluder with adjustable disk surface as claimed in claim 2, characterized in that: The edge section is woven from a degradable silk woven mesh or a nickel-titanium alloy silk woven mesh with a diameter less than or equal to 0.04 mm.

4. A patent foramen ovale occluder with adjustable disk surface as claimed in claim 3, characterized in that: The regulating wire is configured as a nickel-titanium wire or a degradable wire, one end of the regulating wire is fixed to the edge section of the upper disk surface, and the other end is fixed to the regulating rod.

5. The patent foramen ovale occluder with adjustable disk surface as claimed in claim 4, characterized in that: The first steel sleeve and the second steel sleeve are provided with internal threads, and both ends of the adjusting rod are provided with external threads for connecting the first steel sleeve and the second steel sleeve and fixing the rotation angle of the adjusting rod.

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