CN115444470A - Patent foramen ovale plugging device without influence on interatrial septum puncture - Google Patents
Patent foramen ovale plugging device without influence on interatrial septum puncture Download PDFInfo
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- CN115444470A CN115444470A CN202110637075.0A CN202110637075A CN115444470A CN 115444470 A CN115444470 A CN 115444470A CN 202110637075 A CN202110637075 A CN 202110637075A CN 115444470 A CN115444470 A CN 115444470A
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- disc
- puncture
- occluder
- atrial septal
- foramen ovale
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00597—Implements comprising a membrane
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00601—Implements entirely comprised between the two sides of the opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
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- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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- Surgical Instruments (AREA)
Abstract
The invention relates to a patent foramen ovale plugging device without affecting atrial septal puncture, and belongs to the technical field of medical instruments. The puncture sheath comprises a left disc, a right disc and a waist part between the left disc and the right disc, wherein the left disc and the right disc are in long strip shapes or oval shapes, and a space for the puncture sheath to pass through the atrial septal region again is fully reserved; the left disc, the right disc and the waist are respectively provided with a flow-resisting film. The invention not only maintains the structure of the traditional occluder and ensures the safety and effectiveness of the occluder, but also fully reserves the space for the puncture sheath to pass through the interatrial space again by arranging the disk surface of the occluder into a long strip shape or an oval shape; when blocking blood flow and passing through the occluder, the reserved interatrial space is easy to puncture and expand again, so that the puncture sheath can be easily punctured and fed in again from the reserved area around the occluder, a channel is reserved for the subsequent interatrial space puncture interventional operation, and the opportunity of performing the interatrial space minimally invasive interventional operation again is reserved for a patient.
Description
Technical Field
The invention relates to a patent foramen ovale plugging device without affecting atrial septal puncture, and belongs to the technical field of medical instruments. One side of the invention close to the left atrium is the left, and one side close to the right atrium is the right.
Background
Patent Foramen Ovale (PFO) is a common congenital heart disease, and the mainstream treatment method is to use a plugging device to perform percutaneous (femoral vein) Patent Foramen ovale plugging.
The current occluder is shown in figure 1, and is of a nickel-titanium alloy woven double-disc one-waist I-shaped structure, and the safety and the effectiveness of the occluder are widely proved in clinic. Patients who perform patent foramen ovale plugging are mostly young patients, the probability of later-stage concurrent atrial fibrillation, mitral regurgitation and other diseases is high, and the concurrent diseases can be treated by adopting radio frequency ablation, left atrial appendage plugging, mitral valve clamping and other operations which enter the left atrium through femoral vein and then puncture the atrial septum for minimally invasive intervention.
However, because the current mainstream circular disc surface plugging device has larger volume and dense grids, almost occupies the whole interatrial space after being implanted into a human body, and due to the design of double discs, four layers, dense grids and small meshes (phi 2 mm), the sheath (phi 3-9 mm) cannot be sent into the left atrium if the interatrial space needs to be punctured in the subsequent operation, so that a patient loses the interatrial space, and the opportunity of minimally invasive intervention treatment on atrial fibrillation, mitral valve regurgitation and other diseases is lost.
For example, the occluder a disclosed in chinese patent No. CN201949173U (see fig. 1) has a double-disc and one-waist structure, and the disc surface of the circular occluder occupies the whole atrial septum, so that the puncture sheath cannot pass through the occluder at all in the later stage when the puncture is needed again.
The occluder disclosed in chinese patent No. CN211355623U (see fig. 2) is also of a double-disk one-waist structure, and is also of a circular disk surface, although a puncture space is reserved for future atrial septal puncture through left and right anchoring petals, when the atrial septal puncture is needed at the later stage, the difficulty of atrial septal puncture is still large through a very limited area of the petals, and a few metal wires in the petals are difficult to provide sufficient fixing force, so that the occluder has a risk of falling. Therefore, there is a need in the art for a safe and effective atrial septal occlusion device that can safely and easily perform atrial septal puncture again after implantation and maintain safe and effective atrial septal occlusion.
Disclosure of Invention
The invention aims to solve the technical problems that after implantation, the atrial septum puncture can be safely and simply carried out again, and the safe and effective atrial septum occlusion is kept.
In order to solve the problems, the technical scheme adopted by the invention is to provide a patent foramen ovale occluder which does not affect puncture of interatrial septum, namely a patent foramen ovale occluder which does not affect puncture sheath tube passing through interatrial septum, comprising a left disc, a right disc and a waist part between the left disc and the right disc, wherein the left disc and the right disc are respectively positioned at two sides of the foramen ovale on the interatrial septum; the left disc and the right disc are made into long strips or ellipses, and a space for the puncture sheath tube to pass through the atrial septal region again is fully reserved.
Preferably, the left disc, the right disc and the waist are respectively provided with a flow-blocking film.
Preferably, the flow-blocking film is provided with a sheet shape and is made of a high polymer material or a degradable material.
Preferably, the occluder is made of wires with memory through integral weaving and then heat setting.
Preferably, the left disc, the right disc and the waist are provided as an integral mesh-like structure.
Preferably, the left and right discs are provided as a double-layer mesh-like structure.
Preferably, the surface of the outer side of the right disc is provided with a conveying component for converging connection of the knitting yarns.
Preferably, the delivery member is provided as a wire-clamping steel sleeve or a coagulated ball, one end of the delivery member is connected with the braided wire, the other end of the delivery member is provided as a free end, and the free end is provided with a connecting port connected with the occluder delivery system.
Compared with the prior art, the invention has the following beneficial effects:
the invention keeps the structure and the working principle of the traditional occluder, ensures the safety and the effectiveness of the occluder, and fully reserves the space for the puncture sheath tube to pass through the interatrial space again by arranging the disk surface of the occluder into a long strip shape or an oval shape; when blocking blood flow and passing through the occluder, the reserved interatrial space is easy to puncture and expand again, so that the puncture sheath can be easily punctured and fed in again from the reserved area around the occluder, and a channel is reserved for the subsequent interatrial space puncture intervention operation.
Drawings
Fig. 1 is a schematic structural diagram of a conventional occluder.
Fig. 2 is a schematic structural diagram of a conventional occluder.
Fig. 3 is a schematic structural diagram of the occluder of the present invention.
Fig. 4 is a schematic structural view of the occluder of the present invention.
Reference numerals: 1. a left disc; 2. a right disc; 3. a waist part; 4. a flow-blocking membrane; 5. a conveying component.
Detailed Description
In order to make the invention more comprehensible, preferred embodiments are described in detail below with reference to the accompanying drawings:
as shown in fig. 3-4, the invention provides a patent foramen ovale occluder without affecting atrial septal puncture, namely an occluder which fully reserves a puncture sheath tube to pass through the atrial septal region again, comprising a left disc 1, a right disc 2 and a waist part 3 between the left disc and the right disc, wherein the left disc 1 and the right disc 2 are respectively positioned at two sides of the foramen ovale on the atrial septal; the left disc 1 and the right disc 2 are designed to be strip-shaped or oval, and the space for the puncture sheath tube to pass through the atrial septal region again is fully reserved. The left disc 1, the right disc 2 and the waist 3 are respectively provided with a flow-resisting film 4. The flow-resistant film 4 is made of high polymer material or degradable material. The left disc 1, the right disc 2 and the waist 3 are made of memory silk materials through integrated weaving and then heat setting, and are set into an integrated grid-like structure. The left disc 1 and the right disc 2 are set to a double-layer mesh-like structure. The surface of the outer side of the right disc 2 is provided with a conveying component 5 for the convergence connection of the knitting yarns. The conveying component 5 is a wire-clamping steel sleeve or a coagulated ball, one end of the conveying component 5 is connected with the braided wire, the other end of the conveying component 5 is a free end, and the free end is provided with a connecting port connected with the occluder conveying system.
As shown in figures 3-4, the invention designs an patent foramen ovale occluder without influencing atrial septal puncture, which comprises a bracket made of memory wire materials through integrated weaving and heat setting, wherein the bracket is formed by connecting a left disc 1, a right disc 2 and a waist part 3; the plugging device also comprises a flow blocking membrane 4 which blocks the left disc 1, the right disc 2 and the waist 3 from the inside to ensure that the blood flow is blocked, thereby ensuring the safety and effectiveness of the plugging of the patent foramen ovale; the knitting silk in the center of the right disc 2 is gathered and connected with the conveying component 5, so that the connection between the plugging device and a conveying system is realized, and the plugging device can be pulled into or retracted into a conveying sheath tube. The occluding device has a shape memory function and has two shapes of contraction and expansion, wherein the contraction shape is a strip-shaped conveying shape that the occluding device is compressed into a sheath, and the expansion shape is an I-shaped working shape that the occluding device presents double discs and one waist after being freely stretched. The occluding device can automatically restore from a delivery form to a working form due to the shape memory characteristic of the occluding device. The flow-blocking film 4 is sheet-shaped, is made of high polymer materials or degradable materials, has the same sheet-shaped form as the corresponding cross sections of the left disc 1, the right disc 2 and the waist 3, and is arranged inside the left disc 1, the right disc 2 and the waist 3 to achieve the purpose of blocking blood flow. Left side dish 1, right side dish 2, waist 3 formula net appearance structure as an organic whole adopt silk material integrative weaving back heat setting to make, the silk material is memory alloy material, preferred nickel titanium alloy material that is, memory alloy material has the memory function for the occluder support of making has the shape memory, can be from carrying the automatic working form that returns of form, and the net appearance of waist is woven in addition, is favorable to strengthening its holding power and memory form and resumes. The left disc 1 and the right disc 2 are both double-layer grid-like structures, the double-layer structures are beneficial to strengthening the supporting force of the disc-shaped structures, and the grid weaving is beneficial to recovering the structural memory form. The left disc 1 and the right disc 2 are in long strip shape or oval distribution, under the premise of guaranteeing effective plugging, the space for the puncture sheath tube to pass through the interatrial space is fully reserved, and the sheath tube is guaranteed to smoothly pass through the interatrial space to enter the left atrium to complete puncture. The left disc 1 is equal in size to the right disc 2 or smaller in size than the right disc 2. The conveying component 5 is a wire-clamping steel sleeve or a coagulated ball, one end of the conveying component 5 is connected with the right disc 2 braided wire, the other end of the conveying component 5 is a free end, and the free end is provided with a connecting port and is connected with a conveying system.
Examples
Referring to fig. 3, in a specific embodiment, a patent foramen ovale occluder without affecting atrial septal puncture is designed, which comprises a left disc 1, a right disc 2 and a waist portion 3 which is supported and connected with the left disc and the right disc, wherein the left disc 1 and the right disc 2 are in a long strip shape or an oval shape, a space for a puncture sheath to pass through the atrial septal region again is fully reserved, the puncture sheath can safely and easily pass through the atrial septal region to enter the left atrium, and 1-4 layers of flow blocking membranes 4 are sewn inside the left disc 1, the right disc 2 and the waist portion 3 to block blood circulation from inside; the flow-resisting film 4 can be made of any one of polyester film, polyurethane film, polytetrafluoroethylene film and other high polymer materials, or made of degradable materials, and the sheet shape of the flow-resisting film is the same as the cross section shapes of the left disc 1, the right disc 2 and the waist 3. In the embodiment, the cross sections of the left disc 1 and the right disc 2 are oval, so the flow-blocking films of the left disc 1 and the right disc 2 are also oval, and the cross section of the waist part 3 is circular, so the flow-blocking films of the waist part are also circular.
Referring to fig. 3-4, the knitting filaments in the center of the right disc 2 converge at the conveying member 5.
The left disc 1, the right disc 2 and the waist 3 are of an integrated grid-like structure and are made by heat setting after being integrally woven by adopting wire materials, the wire materials are made of memory alloy materials, and preferably nickel-titanium alloy, so that the occluder has shape memory and can be converted in two shapes of contraction and expansion, wherein the contraction shape is a strip-shaped conveying shape when the occluder is compressed into a sheath tube, and the expansion shape is an I-shaped working shape when the occluder freely extends to form a double disc and a waist. The occluding device has the shape memory characteristic, so the occluding device can automatically restore from a conveying shape to a working shape, and the grid-like weaving of the waist part is favorable for strengthening the supporting force and restoring the memory shape.
The left disc 1 and the right disc 2 are both double-layer grid-like structures, the double-layer structures are beneficial to strengthening the supporting force of the disc-shaped structures, and the grid weaving is beneficial to recovering the structural memory form.
The conveying component 5 is a wire-clamping steel sleeve or a condensation ball, one end of the conveying component 5 is connected with the braided wire, the other end of the conveying component 5 is a free end, and the free end is provided with a connecting port and is connected with a conveying system, so that the plugging device is integrally pulled in or pushed out of the conveying sheath tube.
In a specific embodiment, the waist of the occluder designed in this embodiment is a short waist, the length is only 4mm, and the diameter of the waist is about 5 mm.
The length of the long strip-shaped or oval plate surface designed by the invention is consistent with that of the prior art, but the width of the plate surface is greatly reduced. In the specific embodiment, the length of the disk surface is set to be about 25mm, and the diameter of the disk surface is basically the same as that of the disk surface of the existing plugging device, so that the safety and effectiveness of the oval hole plugging are ensured; and the width of the disk surface is reduced to about 6mm, and the space for the puncture sheath tube to pass through the interatrial septum again is fully reserved, so that the puncture sheath tube can safely and easily pass through the interatrial septum to enter the left atrium.
The occluder designed by the invention has more models, for example, the specifications are divided according to different waist diameters, and in use, the applicable model can be selected according to the patent situation of the foramen ovale. Meanwhile, the long strip-shaped or oval disc surface of the invention also obviously reduces the difficulty of the reserved puncture channel during puncture, and enhances the success rate of the subsequent interatrial puncture interventional operation.
In the specific embodiment, the invention keeps the traditional double-disk one-waist structure and the working principle, and ensures the safety and the effectiveness of the occluder; meanwhile, the occluder is designed into a strip shape or an oval shape, and the left disk surface and the right disk surface are arranged in the same size, so that when the blood flow is blocked and the blood flow passes through the occluder, the puncture sheath tube is easy to puncture and expand due to the sufficient reserved space for the puncture sheath tube to pass through the interatrial space, and the sheath tube is very easy to be sent into from the reserved area at the periphery of the occluder. The invention can safely and effectively treat the patent foramen ovale, simultaneously reserve a channel for the subsequent interventional operation of transseptal puncture, and reserve the opportunity of carrying out minimally invasive interventional operation on the interatrial for patients.
While the invention has been described with respect to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention. Those skilled in the art can make various changes, modifications and equivalent arrangements, which are equivalent to the embodiments of the present invention, without departing from the spirit and scope of the present invention, and which may be made by utilizing the techniques disclosed above; meanwhile, any changes, modifications and variations of the above-described embodiments, which are equivalent to those of the technical spirit of the present invention, are within the scope of the technical solution of the present invention.
Claims (8)
1. A patent foramen ovale plugging device which does not affect atrial septal puncture, namely a plugging device which fully reserves a puncture sheath and passes through an atrial septal region again, comprises a left disc, a right disc and a waist part between the left disc and the right disc, wherein the left disc and the right disc are respectively positioned at two sides of a foramen ovale on the atrial septal; the method is characterized in that: the left disc and the right disc are made into long strips or ellipses, and a space for the puncture sheath tube to pass through the atrial septal region again is fully reserved.
2. The patent foramen ovale occluder without affecting atrial septal puncture of claim 1, wherein: and the left disc, the right disc and the waist are respectively provided with a flow resistance film.
3. The patent foramen ovale occluder without affecting atrial septal puncture in claim 2, wherein: the flow resisting film is sheet and is made of high polymer material or degradable material.
4. The patent foramen ovale occluder without affecting atrial septal puncture of claim 3, wherein: the left disc, the right disc and the waist part of the plugging device are made of memory wire materials through integrated weaving and then heat setting.
5. The patent foramen ovale occluder without affecting atrial septal puncture of claim 4, wherein: the left disc, the right disc and the waist are of an integrated grid-like structure.
6. The patent foramen ovale occluder without affecting atrial septal puncture in claim 5, wherein: the left disc and the right disc are of double-layer grid-like structures.
7. The patent foramen ovale occluder without affecting atrial septal puncture of claim 6, wherein: and a conveying component for convergence and connection of the braided wires is arranged on the surface of the outer side of the right disc.
8. The patent foramen ovale occluder without affecting atrial septal puncture of claim 7, wherein: the conveying component is a wire-clamping steel sleeve or a coagulating sphere, one end of the conveying component is connected with the braided wire, the other end of the conveying component is a free end, and the free end is provided with a connecting port connected with the occluder conveying system.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110637075.0A CN115444470A (en) | 2021-06-08 | 2021-06-08 | Patent foramen ovale plugging device without influence on interatrial septum puncture |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110637075.0A CN115444470A (en) | 2021-06-08 | 2021-06-08 | Patent foramen ovale plugging device without influence on interatrial septum puncture |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN115444470A true CN115444470A (en) | 2022-12-09 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110637075.0A Pending CN115444470A (en) | 2021-06-08 | 2021-06-08 | Patent foramen ovale plugging device without influence on interatrial septum puncture |
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| Country | Link |
|---|---|
| CN (1) | CN115444470A (en) |
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2021
- 2021-06-08 CN CN202110637075.0A patent/CN115444470A/en active Pending
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