CN111248953B - Patent foramen ovale occluder, patent foramen ovale occlusion system and method thereof - Google Patents
Patent foramen ovale occluder, patent foramen ovale occlusion system and method thereof Download PDFInfo
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- CN111248953B CN111248953B CN201811453078.3A CN201811453078A CN111248953B CN 111248953 B CN111248953 B CN 111248953B CN 201811453078 A CN201811453078 A CN 201811453078A CN 111248953 B CN111248953 B CN 111248953B
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- 208000008883 Patent Foramen Ovale Diseases 0.000 title claims abstract description 83
- 238000000034 method Methods 0.000 title abstract description 16
- 230000000903 blocking effect Effects 0.000 claims description 36
- 210000002837 heart atrium Anatomy 0.000 claims description 14
- 239000012528 membrane Substances 0.000 claims description 11
- 230000005540 biological transmission Effects 0.000 claims description 5
- 210000004491 foramen ovale Anatomy 0.000 abstract description 16
- 210000005246 left atrium Anatomy 0.000 abstract description 10
- 210000005245 right atrium Anatomy 0.000 abstract description 10
- 230000006378 damage Effects 0.000 abstract description 5
- 238000007789 sealing Methods 0.000 description 33
- 239000000463 material Substances 0.000 description 10
- 230000007027 foramen ovale closure Effects 0.000 description 8
- 229920000747 poly(lactic acid) Polymers 0.000 description 6
- 239000004626 polylactic acid Substances 0.000 description 6
- 238000012546 transfer Methods 0.000 description 6
- 238000010586 diagram Methods 0.000 description 5
- 230000007774 longterm Effects 0.000 description 5
- 230000002093 peripheral effect Effects 0.000 description 4
- 229920002732 Polyanhydride Polymers 0.000 description 3
- 229920000954 Polyglycolide Polymers 0.000 description 3
- 229920000331 Polyhydroxybutyrate Polymers 0.000 description 3
- 230000001746 atrial effect Effects 0.000 description 3
- 239000005015 poly(hydroxybutyrate) Substances 0.000 description 3
- 229920000515 polycarbonate Polymers 0.000 description 3
- 239000004417 polycarbonate Substances 0.000 description 3
- 239000004633 polyglycolic acid Substances 0.000 description 3
- 241000219122 Cucurbita Species 0.000 description 2
- 235000009852 Cucurbita pepo Nutrition 0.000 description 2
- 230000004308 accommodation Effects 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 229910001285 shape-memory alloy Inorganic materials 0.000 description 2
- 241001272720 Medialuna californiensis Species 0.000 description 1
- 229910000831 Steel Inorganic materials 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 230000006793 arrhythmia Effects 0.000 description 1
- 206010003119 arrhythmia Diseases 0.000 description 1
- 210000003157 atrial septum Anatomy 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 210000004060 endocardial cushion Anatomy 0.000 description 1
- 230000001605 fetal effect Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 210000001161 mammalian embryo Anatomy 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
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- 230000000087 stabilizing effect Effects 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- 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
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- 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
- A61B2017/00646—Type of implements
- A61B2017/00654—Type of implements entirely comprised between the two 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)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
Abstract
本发明公开了一种卵圆孔未闭封堵器、卵圆孔未闭封堵系统及其方法，通过第一连接部与第二连接部连接，使得第一封堵盘与第二封堵盘装设在传送件上，如此，使得第一封堵盘与第二封堵盘能够顺利放入右心房与左心房内；再通过挤压第一封堵盘与第二封堵盘，使得第一连接件与第二连接件连接，从而使得第一封堵盘与第二封堵盘分别通过无铆固定方式顺利、稳定且安全地安装在右心房与左心房内，进而有利于卵圆孔得到稳定封堵。同时，第一连接件与第二连接件分别位于第一容置腔内与第二容置腔内，有效避免第一封堵盘与第二封堵盘表面对周边组织造成损伤，如此，通过本卵圆孔未闭封堵器，使得卵圆孔进行稳定且安全封堵。
The present invention discloses a patent foramen ovale occluder, a patent foramen ovale occlusion system and a method thereof. The first connecting part is connected with the second connecting part, so that the first occluding disc and the second occluding disc are installed on a conveying member, so that the first occluding disc and the second occluding disc can be smoothly placed in the right atrium and the left atrium; then the first occluding disc and the second occluding disc are squeezed to connect the first connecting member and the second connecting member, so that the first occluding disc and the second occluding disc are respectively installed in the right atrium and the left atrium smoothly, stably and safely in a rivet-free fixing manner, thereby facilitating the stable occlusion of the foramen ovale. At the same time, the first connecting member and the second connecting member are respectively located in the first accommodating cavity and the second accommodating cavity, effectively preventing the surface of the first occluding disc and the second occluding disc from causing damage to the surrounding tissues. In this way, the patent foramen ovale occluder can stably and safely occlude the foramen ovale.
Description
Technical Field
The invention relates to the technical field of patent foramen ovale, in particular to a patent foramen ovale plugging device, a patent foramen ovale plugging system and a method thereof.
Background
Patent foramen ovale (patentovalforamen abbreviated as PFO) mainly occurs in the development process of infants, when the embryo develops to 6-7 weeks, the atrial septum emits 2 septa successively, the septa which appear first are primary septa or first septa, and the septa which appear later are secondary septa or second septa. The primary septum grows from the back side wall of the midline of the atrium in a half moon shape, grows to the atrioventricular tube, merges with the endocardial cushion, and leaves a small hole with the tail end of the atrioventricular septum, which is called a primary hole. Before the primary orifice is not closed, a hole is formed at the proximal end part of the primary septum, called a secondary orifice, which is a normal passage of blood during fetal period. At the same time, a sickle-shaped septum grows from the atrial wall at the right side of the first septum, the septum is called a secondary septum or a second septum, the septum does not continue to grow and separate the atrium to stop midway, the sickle-shaped pit is in an oval shape and called an oval fossa, and a small gap called an oval foramen is left at the oval fossa when the primary septum and the secondary septum are not adhered and fused. After birth, the pressure of the left atrium rises, so that the left primary septum is clung to the right secondary septum, and functional closure occurs, and anatomical closure is achieved within 1 year. Patent foramen ovale is known as patent foramen ovale if a child older than 3 years old does not close.
In order to seal the foramen ovale, the traditional treatment method generally adopts a PFO (pulse frequency) plugging device to plug the foramen ovale, however, because the traditional PFO plugging device adopts a rivet structure to fix, and the rivet structure protrudes out of a plugging disc, peripheral tissues are easily touched in the plugging process, so that the peripheral tissues are damaged, and complications are caused.
Disclosure of Invention
Based on this, it is necessary to provide an patent foramen ovale occluder, patent foramen ovale occlusion system and method thereof, which can stably and safely occlude the foramen ovale.
The technical scheme is as follows:
The patent foramen ovale occluder comprises a first occluding disc, wherein a first accommodating cavity and a jack are arranged on the first occluding disc, a first connecting part is arranged on the inner side wall of the first accommodating cavity, a first channel communicated with the jack is arranged on the first connecting part, a second occluding disc is connected with the first occluding disc, a second accommodating cavity is arranged on the second occluding disc, a second connecting part is arranged on the inner side wall of the second accommodating cavity, a second channel is arranged on the second connecting part, the second channel is used for being inserted into a conveying part through the jack and the first channel in sequence, a first connecting part is arranged on the inner side wall of the second channel, the first connecting part is used for being detachably connected with a second connecting part on the conveying part, and when the first occluding disc and the second occluding disc are extruded, the first connecting part is in connection fit with the second connecting part.
According to the patent foramen ovale plugging device, the first connecting part is connected with the second connecting part, so that the first plugging disc and the second plugging disc are arranged on the conveying part, the first plugging disc and the second plugging disc can be smoothly placed into the right atrium and the left atrium, and the first connecting part is connected with the second connecting part by extruding the first plugging disc and the second plugging disc, so that the first plugging disc and the second plugging disc are respectively and stably arranged in the right atrium and the left atrium, and further stable plugging of the foramen ovale is facilitated. Simultaneously, first connecting piece and second connecting piece are located first holding intracavity and second holding intracavity respectively, effectively avoid first shutoff dish and second shutoff dish surface to cause the damage to peripheral tissue, so, through this patent foramen ovale shutoff ware for the foramen ovale is stable and safe shutoff.
In one embodiment, the first connecting piece is provided with a first fastening part, and the second connecting piece is provided with a second fastening part in fastening fit with the first fastening part.
In one embodiment, the first fastening portion is a protrusion, the second fastening portion is a groove, the protrusion is disposed on an inner side wall of the first channel, the groove is disposed on a side surface of the second connecting piece, or the first fastening portion is a groove, the second fastening portion is a protrusion, the groove is disposed on a side surface of the first connecting piece, and the protrusion is disposed on an inner side wall of the second channel.
In one embodiment, the first connecting piece is provided with a first thread, the second connecting piece is provided with a second thread corresponding to the first thread, the inner side wall of the first channel is provided with a limiting piece, and the limiting piece is used for being in limiting fit with a limiting groove on the tightening piece.
In one embodiment, the first plugging disc comprises a first woven mesh and a first plugging film arranged on the first woven mesh, the first woven mesh and the first plugging film enclose a first accommodating cavity, and the socket is arranged on the first woven mesh.
In one embodiment, the second plugging disc comprises a second woven mesh and a second plugging film arranged on the second woven mesh, and the second woven mesh and the second plugging film enclose the second accommodating cavity.
In one embodiment, an end of the second connecting piece, which is far away from the second woven mesh, penetrates through the second blocking film.
In one embodiment, the patent foramen ovale occluder further comprises a third occluding membrane and a third woven mesh surrounding the third woven mesh, wherein the third occluding membrane is arranged on the inner side wall of the third woven mesh, and the first occluding plate is connected with the second occluding plate through the third woven mesh.
The patent foramen ovale plugging system comprises a conveying member, a loader, a sheath tube and the patent foramen ovale plugging device, wherein the conveying member is provided with a second connecting part which is detachably connected with the first connecting part, the loader is used for loading the patent foramen ovale plugging device into the sheath tube, and the sheath tube is used for being inserted into an atrium.
According to the patent foramen ovale plugging system, the patent foramen ovale plugging device is safely and smoothly fed into an atrium through the conveying part, the loader and the sheath tube, and the conveying part is pulled back, so that the first plugging disc and the second plugging disc can be placed, extruded and connected in the atrium, and the plugging operation of the patent foramen ovale is greatly facilitated. Meanwhile, by the patent foramen ovale plugging device, the foramen ovale is stably and safely plugged, so that complications after the foramen ovale is plugged are effectively avoided.
A method for plugging patent foramen ovale by using the patent foramen ovale plugging system comprises the steps of penetrating a conveying member into a first channel and a second channel through a socket, enabling a first connecting part to be connected with a second connecting part, loading the conveying member connected with the patent foramen ovale plugging device into a loader, inserting the conveying member into a sheath tube through the loader after the conveying member is installed, pushing the conveying member into an atrium, enabling the first plugging disc to be located in a right atrium, enabling the second plugging disc to be located in a left atrium, enabling the first plugging disc to be extruded with the second plugging disc, enabling the first connecting part to be connected with the second connecting part, and after the first connecting part is connected with the second connecting part, disconnecting the first connecting part from the second connecting part, enabling the conveying member to be disconnected from the sheath tube, and withdrawing the patent foramen ovale from the right atrium.
The patent foramen ovale blocking method adopts the patent foramen ovale blocking system, so that the patent foramen ovale is stably and safely blocked. Meanwhile, by the patent foramen ovale blocking method, operators can more conveniently block the foramen ovale, and the blocking efficiency and success rate of the foramen ovale are greatly improved.
Drawings
FIG. 1 is a cross-sectional view of a patent foramen ovale occluder in accordance with one embodiment of the present invention;
FIG. 2 is an enlarged schematic view of the structure of FIG. 1 at circle A;
FIG. 3 is an enlarged schematic view of the structure at circle B in FIG. 1;
FIG. 4 is a cross-sectional view of a closed patent foramen ovale occluder in accordance with one embodiment of the present invention;
FIG. 5 is an enlarged schematic view of the structure at circle C in FIG. 4;
FIG. 6 is a cross-sectional view of a patent foramen ovale occluder in accordance with another embodiment of the present invention;
FIG. 7 is an enlarged schematic view of the structure of FIG. 6 at circle D;
FIG. 8 is an enlarged schematic view of the structure at the circle E in FIG. 6;
FIG. 9 is a cross-sectional view of a threaded patent foramen ovale occluder in accordance with another embodiment of the present invention;
FIG. 10 is an enlarged schematic view of the structure of FIG. 9 at circle F;
FIG. 11 is a cross-sectional view of a patent foramen ovale occluder in accordance with yet another embodiment of the present invention;
FIG. 12 is a schematic diagram of a patent foramen ovale closure system with a second closure disc open according to one embodiment of the present invention;
FIG. 13 is a schematic diagram of a patent foramen ovale closure system with a first and second closure discs open in accordance with an embodiment of the present invention;
FIG. 14 is a schematic view showing the structure of a patent foramen ovale closure system when a second closure disc is squeezed according to an embodiment of the present invention;
FIG. 15 is a schematic diagram of a patent foramen ovale closure system upon squeezing a first closure disc and a second closure disc in accordance with an embodiment of the present invention;
FIG. 16 is an enlarged schematic view of the structure at circle G in FIG. 15;
FIG. 17 is a schematic diagram of a patent foramen ovale closure system upon squeezing a first closure disc and a second closure disc in accordance with another embodiment of the present invention;
FIG. 18 is an enlarged schematic view of the structure at circle H in FIG. 17;
FIG. 19 is a schematic view showing a portion of a tightening member according to an embodiment of the present invention;
Fig. 20 is a schematic structural diagram of a first connector according to an embodiment of the invention.
Reference numerals illustrate:
100. The patent foramen ovale occluder, 110, first occlusion disk, 111, first mesh, 1111, socket, 112, first occlusion membrane, 113, first accommodation chamber, 120, second occlusion disk, 121, second mesh, 122, second occlusion membrane, 123, second accommodation chamber, 130, third mesh, 131, third occlusion membrane, 140, first connector, 141, first channel, 142, first buckle, 143, first thread, 144, limiter, 150, second connector, 151, second channel, 152, first connector, 153, second buckle, 154, second thread, 200, delivery member, 210, second connector, 300, loader, 400, sheath, 500, tightening member, 510, limit slot.
Detailed Description
The present invention will be further described in detail with reference to the drawings and the detailed description, in order to make the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the detailed description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the invention.
It will be understood that when an element is referred to as being "fixed to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and the like are used herein for illustrative purposes only and are not meant to be the only embodiment.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.
The terms "first" and "second" in this specification do not denote a particular quantity or order, but rather are used for distinguishing between similar or identical items.
In one embodiment, referring to Figs. 1-12, an patent foramen ovale occluder 100, includes a first occluding disk 110 and a second occluding disk 120. The first plugging tray 110 is provided with a first accommodating cavity 113 and a socket 1111. The inner sidewall of the first receiving chamber 113 is provided with a first connection member 140. The first connector 140 is provided with a first channel 141 which is communicated with the socket 1111. The second sealing disc 120 is connected with the first sealing disc 110, and the second sealing disc 120 is provided with a first accommodating cavity 113 and a second accommodating cavity 123. The second connecting member 150 is disposed on the inner sidewall of the second accommodating chamber 123. The second connecting member 150 is provided with a second channel 151. The second channel 151 and the first channel 141 are used to insert the transfer element 200 through the receptacle 1111. The second channel 151 has a first connection 152 on an inner sidewall thereof. The first connection portion 152 is configured to be detachably connected to the second connection portion 210 of the transfer element 200. When the first sealing disc 110 and the second sealing disc 120 are pressed, the first connecting piece 140 is connected and matched with the second connecting piece 150.
The patent foramen ovale occluder 100 is connected with the second connecting part 210 through the first connecting part 152, so that the first occluding disc 110 and the second occluding disc 120 are installed on the conveying member 200, and the first occluding disc 110 and the second occluding disc 120 can be smoothly placed into the right atrium and the left atrium, and then the first connecting part 140 is connected with the second connecting part 150 by extruding the first occluding disc 110 and the second occluding disc 120, so that the first occluding disc 110 and the second occluding disc 120 are respectively and stably installed in the right atrium and the left atrium. Therefore, through ingenious structural design, the first sealing disc 110 and the second sealing disc 120 are smoothly, stably and safely installed in the atrium in a rivetless fixing mode, and long-term complications caused by the fact that the traditional rivet structure remains in the body are avoided, so that the oval foramen is stably sealed. Meanwhile, the first connecting piece 140 and the second connecting piece 150 are respectively located in the first accommodating cavity 113 and the second accommodating cavity 123, so that damage to peripheral tissues caused by the surfaces of the first plugging disc 110 and the second plugging disc 120 is effectively avoided, and the patent foramen ovale plugging device 100 is used for stabilizing and safely plugging the foramen ovale. In addition, the first receiving chamber 113 is disposed in communication with the second receiving chamber 123 for the purpose of enabling the transfer member 200 to pass from the first channel 141 into the second channel 151. In particular, in the present embodiment, the first connecting member 140 and the second connecting member 150 are degradable members, and have good biocompatibility, so as to effectively avoid long-term complications caused by residual in vivo, such as arrhythmia, valve injury, residual shunt, thrombosis, etc.
Further, referring to fig. 1 to 5, the first connecting piece 140 is provided with a first fastening portion 142. The second connecting piece 150 is provided with a second fastening portion 153 that is in fastening fit with the first fastening portion 142. Therefore, when the first sealing disc 110 and the second sealing disc 120 are respectively located in the right atrium and the left atrium, the first sealing disc 110 and the second sealing disc 120 are pressed to close the first connecting member 140 to the second connecting member 150, and the first connecting member 140 is tightly connected to the second connecting member 150 through the snap fit of the first fastening portion 142 and the second fastening portion 153, so that the patent foramen ovale occluder 100 can stably seal the patent foramen ovale in a rivetless fixation manner.
Further, the first fastening portion 142 is a protrusion. The second fastening portion 153 is a groove. The protrusions are provided on the inner sidewall of the first channel 141. Grooves are provided on the sides of the second connection member 150. In this way, the first connection member 140 is tightly connected with the second connection member 150 by the protrusion and the groove being engaged. Or the first fastening portion 142 is a groove. The second fastening portion 153 is a protrusion. The groove is provided on a side of the first connection member 140. The protrusions are provided on the inner sidewall of the second channel 151.
In one embodiment, referring to fig. 6,7,8, 9, 10, 19 and 20, the first connecting member 140 is provided with a first thread 143. The second connection member 150 is provided with a second thread 154 corresponding to the first thread 143. The inner side wall of the first channel 141 is provided with a limiting member 144. The limiting member 144 is used for limiting cooperation with a limiting groove 510 on the tightening member 500. It can be seen that when the first sealing disk 110 and the second sealing disk 120 are pressed, the first connecting member 140 approaches the second connecting member 150 and contacts the second connecting member 150. The limiting piece 144 in the first channel 141 can be screwed through the limiting groove 510 on the screwing piece 500, so that the first connecting piece 140 is in threaded connection with the second connecting piece 150, and the patent foramen ovale occluder 100 is stably installed in an atrium, so that the patent foramen ovale occluder 100 can stably occlude the patent foramen ovale. In particular, in an embodiment, the first threads 143 are disposed on an inner sidewall of the first channel 141 and the second threads 154 are disposed on a side of the second connector 150. Or the first screw thread 143 is provided on a side surface of the first connection member 140 and the second screw thread 154 is provided on an inner sidewall of the second passage 151.
In one embodiment, the first sealing disc 110 includes a first mesh 111 and a first sealing film 112 mounted on the first mesh 111. The first woven mesh 111 and the first blocking film 112 enclose a first accommodating cavity 113, and a socket 1111 is disposed on the first woven mesh 111.
Optionally, the first mesh 111 and the first blocking film 112 are degradable materials, and the materials of the first mesh 111 and the first blocking film 112 are polycarbonate, polyanhydride, polyglycolic acid, polylactic acid, polyhydroxybutyrate or other degradable materials.
Specifically, the materials of the first mesh grid 111 and the first plugging film 112 are all l-polylactic acid (PLLA), so that the whole first plugging disc 110 is degradable, has good biocompatibility, and avoids long-term complications caused by residues in human bodies.
In one embodiment, the second sealing disc 120 includes a second woven mesh 121 and a second sealing film 122 disposed on the second woven mesh 121. The second woven mesh 121 and the second blocking film 122 enclose a second accommodating cavity 123.
Optionally, the second mesh 121 and the second blocking film 122 are degradable, and the materials of the second mesh 121 and the second blocking film 122 are polycarbonate, polyanhydride, polyglycolic acid, polylactic acid, polyhydroxybutyrate or other degradable materials.
Specifically, the materials of the second mesh 121 and the second blocking film 122 are all l-polylactic acid (PLLA), so that the whole second blocking disc 120 is degradable, has good biocompatibility, and avoids long-term complications caused by residues in the human body.
Further, referring to fig. 11, an end of the second connecting member 150 away from the second mesh 121 penetrates the second blocking film 122. Therefore, when the second connecting portion 210 on the delivery member 200 is connected to the first connecting portion 152, the second connecting member 150 is disposed through the second sealing membrane 122, so that the delivery member 200 does not need to penetrate the second sealing membrane 122, thereby effectively avoiding the damage of the delivery member 200 to the second sealing membrane 122, and being beneficial to maintaining the integrity of the second sealing membrane 122, and thus improving the sealing success rate of the patent foramen ovale occluder 100.
In one embodiment, patent foramen ovale occluder 100 further comprises a third occluding film 131 and a third braided mesh 130 enclosing a tube. Third blocking film 131 is mounted on the inner sidewall of third mesh 130. The first sealing disk 110 is connected to the second sealing disk 120 via a third woven mesh 130. The first sealing disc 110, the third woven mesh 130 and the second sealing disc 120 of this embodiment are an integrated structure.
Optionally, the third mesh 130 and the third plugging film 131 are degradable, and the materials of the third mesh 130 and the third plugging film 131 are polycarbonate, polyanhydride, polyglycolic acid, polylactic acid, polyhydroxybutyrate or other degradable materials.
Specifically, the materials of the third mesh 130 and the third blocking film 131 are all l-polylactic acid (PLLA), so that the third mesh 130 and the second blocking film 131 have good biocompatibility, and long-term complications caused by residues in the human body are avoided.
In one embodiment, referring to fig. 12-20, an patent foramen ovale closure system includes a delivery member 200, a loader 300, a sheath 400, and patent foramen ovale closure 100 in any of the above embodiments. The transfer member 200 is provided with a second connection portion 210 detachably connected to the first connection portion 152. Loader 300 is used to load patent foramen ovale occluder 100 into sheath 400. Sheath 400 is for insertion into the atrium.
In the above patent foramen ovale plugging system, the patent foramen ovale plugging device 100 is safely and smoothly delivered into the atrium through the delivery member 200, the loader 300 and the sheath 400, and the first plugging disc 110 and the second plugging disc 120 are placed, extruded and connected in the atrium by pulling back the delivery member 200, so that the plugging operation of the patent foramen ovale is greatly facilitated. Meanwhile, by the patent foramen ovale plugging device 100, the patent foramen ovale is stably and safely plugged, so that complications after the patent foramen ovale is plugged are effectively avoided. In this embodiment, the transmission member 200 is a steel cable, and the first connecting portion 152 and the second connecting portion 210 are both threaded.
Further, referring to fig. 17, 18, 19 and 20, the patent foramen ovale closure system further includes a tightening member 500. The tightening member 500 is sleeved outside the transfer member 200, and the tightening member 500 is used to be fitted into the sheath 400 by the loader 300. The tightening piece 500 is provided with a limiting groove 510, and the inner side wall of the first channel 141 is provided with a limiting piece 144 in limiting fit with the limiting groove 510. When the conveying member 200 is pulled back, the first sealing disc 110 and the second sealing disc 120 are extruded, the first connecting member 140 and the second connecting member 150 are close to each other, at this time, the tightening member 500 is clamped on the first sealing disc 110 through the limit groove 510 and the limit member 144 in a matching manner, and the tightening member 500 is twisted, so that the first connecting member 140 and the second connecting member 150 are in threaded connection, and the fixation of the patent foramen ovale sealing device 100 is realized.
In one embodiment, a method of patent foramen ovale occlusion employing the patent foramen ovale occlusion system of the above embodiment includes the steps of threading a delivery member 200 through a socket 1111 into first channel 141 and second channel 151 such that first connecting portion 152 connects with second connecting portion 210, and loading delivery member 200 with patent foramen ovale occlusion device 100 connected thereto into loader 300. After the delivery member 200 is assembled, the delivery member 200 is pushed into the atrium by insertion of the cartridge 300 into the sheath 400, and the first occlusion disk 110 is positioned in the right atrium and the second occlusion disk 120 is positioned in the left atrium. By pulling back the transfer member 200, the first and second sealing discs 110, 120 are pressed and the first and second connection members 140, 150 are connected. After first connector 140 is connected to second connector 150, first connector 152 is disconnected from second connector 210, such that delivery member 200 is disconnected from patent foramen ovale occluder 100, and sheath 400 is withdrawn from the atrium.
The patent foramen ovale blocking method adopts the patent foramen ovale blocking system, so that the patent foramen ovale is stably and safely blocked. Meanwhile, by the patent foramen ovale blocking method, operators can more conveniently block the foramen ovale, and the blocking efficiency and success rate of the foramen ovale are greatly improved.
Specifically, the step of connecting the first connecting member 140 to the second connecting member 150 includes snap-connecting the first connecting member 140 to the second connecting member 150, and screwing the first connecting member 140 to the second connecting member 150. The plugging process for the first connection member 140 and the second connection member 150 by means of fastening is to pull back the transmission member 200 with the sheath 400 as an interference object, so that the second plugging tray 120 is pressed first, refer to fig. 14, and then pull back the transmission member 200 to press the first plugging tray 110, refer to fig. 15, at this time, the first connection member 140 is clamped on the second connection member 150. Since the second sealing disc 120 of the present embodiment cannot automatically recover to the shape before loading like a memory alloy, the sheath 400 will be pushed to expand to a shape like a "gourd", and therefore the second sealing disc 120 needs to be tightly molded to the final state of the atrial wall after the delivery member 140 is pulled back. The plugging process for the connection between the first connecting member 140 and the second connecting member 150 in a threaded manner is to pull back the transmitting member 200 by taking the sheath 400 as an abutting object, so that the second plugging disc 120 is extruded first, then pull back the transmitting member 200 to enable the first plugging disc 110 to be extruded, at this time, the first connecting member 140 abuts against the second connecting member 150, and, as the first plugging disc 110 of the embodiment cannot be automatically restored to the shape before loading like a memory alloy, the sheath 400 can be expanded to the shape like a "gourd" after being pushed, so that the first plugging disc 110 can be tightly shaped to be attached to the atrial wall after the transmitting member 140 is pulled back, then the tightening member 500 sleeved outside the transmitting member 200 is inserted into the sheath 400 to be matched with the limiting member 144 through the limiting groove 510, so that the tightening member 500 is clamped on the first connecting member 140, and the tightening member 500 is twisted, so that the first connecting member 140 and the second connecting member 150 are in threaded connection, as shown in fig. 18.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.
Claims (5)
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| CN201811453078.3A CN111248953B (en) | 2018-11-30 | 2018-11-30 | Patent foramen ovale occluder, patent foramen ovale occlusion system and method thereof |
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| CN201811453078.3A CN111248953B (en) | 2018-11-30 | 2018-11-30 | Patent foramen ovale occluder, patent foramen ovale occlusion system and method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111870286B (en) * | 2020-07-24 | 2024-07-16 | 广东脉搏医疗科技有限公司 | Non-riveting plugging device |
| CN114305535B (en) * | 2021-12-29 | 2024-10-11 | 武汉大学中南医院 | Device suitable for patent foramen ovale patient |
| CN115153685A (en) * | 2022-08-09 | 2022-10-11 | 花沐医疗科技(上海)有限公司 | Degradable heart plugging device for atrial septal defect without riveting points on two sides |
| CN115153684A (en) * | 2022-08-09 | 2022-10-11 | 花沐医疗科技(上海)有限公司 | Bilateral non-riveted-point patent foramen ovale degradable heart plugging device |
| CN115177309A (en) * | 2022-08-09 | 2022-10-14 | 花沐医疗科技(上海)有限公司 | Degradable heart occluder without riveting points on two sides |
| CN118717210B (en) * | 2024-07-08 | 2025-05-16 | 南京思脉德医疗科技有限公司 | Vascular occluder |
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| CN209770426U (en) * | 2018-11-30 | 2019-12-13 | 广州启骏生物科技有限公司 | Patent foramen ovale plugging device and patent foramen ovale plugging system |
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| ES2428967T3 (en) * | 2003-07-14 | 2013-11-12 | W.L. Gore & Associates, Inc. | Oval foramen tubular permeable closure device (FOP) with retention system |
| US8257389B2 (en) * | 2004-05-07 | 2012-09-04 | W.L. Gore & Associates, Inc. | Catching mechanisms for tubular septal occluder |
| US8551135B2 (en) * | 2006-03-31 | 2013-10-08 | W.L. Gore & Associates, Inc. | Screw catch mechanism for PFO occluder and method of use |
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| CN206995284U (en) * | 2015-12-31 | 2018-02-13 | 上海锦葵医疗器械有限公司 | Degradable foramen ovale of heart arteriosus occluder |
| CN209770426U (en) * | 2018-11-30 | 2019-12-13 | 广州启骏生物科技有限公司 | Patent foramen ovale plugging device and patent foramen ovale plugging system |
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