Background
The foramen ovale refers to a small hole on the left and right atrial septa, is positioned at the middle lower part of the atrial septum, is a 'valve-like' structure formed by the secondary septum lower edge and the primary septum, and is an important physiological channel through which oxygenated placental blood can reach the arterial circulation of the fetus during pregnancy. After birth, functional closure of the foramen ovale occurs with increased left atrial pressure, anatomic closure is achieved within one year, and patent foramen ovale is not closed beyond three years old, known as Patent Foramen Ovale (PFO), and the incidence of PFO in adults has been investigated to be 25% -33%.
PFO directly causes the heart to shunt from right to left, but PFO has long been thought not to have clinical consequences due to its small shunt. In recent years, more and more researches show that risks of cerebral apoplexy, migraine, peripheral arterial embolism, decompression sickness and the like of PFO patients are increased several times than those of normal people, and the pathogenic effect of PFO only attracts attention of vast experts and scholars.
At present, a catheter instrument is mainly used for conveying the occluder to the position of the foramen ovale to mechanically occlude the foramen ovale.
The existing occluder basically comprises two elastic disc-shaped parts, and when in use, the two disc-shaped parts are respectively attached to the septal walls of the left atrium and the right atrium so as to realize the occlusion of the foramen ovale. For example, chinese patent ZL202011619405.5 discloses a degradable patent foramen ovale occluder and a method for manufacturing the same, the occluder structure is composed of a flow blocking member, a tubular portion, a connecting member and two disc-shaped portions, and the tubular portion and the two disc-shaped portions are woven by elastic mesh. When the occluder is used clinically, the occluder is usually conveyed to the oval foramen area by a conveying pipe and then released, and the two disc-shaped parts are respectively attached to the septum walls of the left atrium and the right atrium by the elastic tension of the elastic net, so that the purpose of closing the oval foramen is achieved.
The existing occluder lacks a tightening part and a supporting part, and because the difference of the shapes of the oval holes of everyone is extremely large, the occluder is deformed and reset only by virtue of the elastic tension of the elastic net after being implanted, and the situation that the heart room space can be completely attached each time cannot be ensured, so that the oval holes cannot be completely blocked is avoided, and residual shunt still exists in the oval holes after operation. In addition, the occluder is a foreign body in the heart, and tissue cells gradually coat the foreign body during long-term implantation, which is called endothelialization. However, this greatly increases the time for the endothelialization process, since the occluder does not completely conform to the atrial septum after implantation. The occluder made of degradable material can be degraded after implantation for a certain time, and if the endothelialization process is not completed after degradation, the occluder is equivalent to the patent foramen ovale without occlusion, so that the operation fails.
Disclosure of Invention
In order to solve the problems of the prior occluder, the application provides a heart foramen ovale occluder, which comprises a connecting piece, a first flow blocking part, a second flow blocking part, an elastic part and a tightening part, wherein two ends of the connecting piece are respectively connected with the first flow blocking part and the second flow blocking part; the elastic part comprises a first elastic piece and a second elastic piece, the first elastic piece is paved on the first flow blocking part, the second elastic piece is paved on the second flow blocking part, the tightening part is arranged on the periphery of the connecting piece, two ends of the tightening part are respectively connected with the first elastic piece and the second elastic piece, and the tightening part is used for tightening the first flow blocking part and the second flow blocking part.
As a further improvement of the embodiment of the present application, the tightening part includes a plurality of tightening members disposed at intervals, and the plurality of tightening members are disposed at the periphery of the connection member in the direction in which the connection member extends.
As a further improvement of the embodiment of the present application, two ends of the plurality of tightening elements are also connected to the first choke and the second choke, respectively.
As a further improvement of the embodiment of the present application, two ends of the plurality of tightening members are also connected to the outer side ends of the first choke portion and the second choke portion, respectively.
As a further improvement of the embodiment of the present application, a plurality of tightening members are symmetrically disposed at the periphery of the connecting member.
As a further improvement of the embodiment of the application, the tightening member is a linear structure.
As a further improvement of the embodiment of the present application, the first flow blocking portion and the second flow blocking portion are disc-shaped structures having elasticity.
As a further improvement of the embodiment of the present application, the diameter areas of the first choke portion and the second choke portion are the same.
As a further improvement of the embodiment of the present application, the elastic portion further includes a third elastic member, the third elastic member is laid on the connecting member, and two ends of the third elastic member are respectively connected with the first elastic member and the second elastic member.
As a further improvement of the embodiment of the present application, the first elastic member, the second elastic member and the third elastic member are elastic net bodies.
As a further improvement of the embodiment of the present application, the first elastic member, the second elastic member, and the third elastic member are integrally formed.
As a further improvement of the embodiment of the present application, the connecting member has a columnar structure.
As a further improvement of the embodiment of the present application, the connecting piece is connected with the axes of the first choke portion and the second choke portion.
As a further improvement of the embodiment of the present application, the first choke part or the second choke part is provided with a connecting hole, and the connecting hole extends into the connecting piece.
As a further improvement of the embodiment of the application, the inner wall of the connecting hole is provided with internal threads.
As a further improvement of the embodiment of the present application, surfaces of the connecting piece, the elastic portion, the first flow blocking portion, the second flow blocking portion, and the tightening portion are respectively provided with an anti-hemagglutination coating and/or a development coating.
Compared with the prior art, the embodiment of the application tightens the first flow blocking part and the second flow blocking part through the tightening part under the action of the heart room partition wall, so that the first flow blocking part and the second flow blocking part can be respectively attached to corresponding heart room spaces after the occluder is implanted into a heart foramen ovale, thereby occluding the heart foramen ovale, and simultaneously, the first flow blocking part and the second flow blocking part are connected and supported through the connecting piece, so that the first flow blocking part and the second flow blocking part are not easy to shift and deform, and the problem of residual flow division of the foramen ovale is thoroughly solved.
Detailed Description
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 application belongs; the terminology used in the description of the applications herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application; the terms "comprising" and "having" and any variations thereof in the description of the application and the claims and the description of the drawings above are intended to cover a non-exclusive inclusion. The terms first, second and the like in the description and in the claims or in the above-described figures, are used for distinguishing between different objects and not necessarily for describing a sequential or chronological order.
In order to enable those skilled in the art to better understand the present application, the following description will make clear and complete descriptions of the technical solutions according to the embodiments of the present application with reference to the accompanying drawings. It will be apparent that the described embodiments are merely some, but not all embodiments of the application. All other embodiments, which can be made by those skilled in the art based on the embodiments of the present application without making any inventive effort, shall fall within the scope of the present application.
As shown in fig. 1-3, an embodiment of the present application provides a cardiac foramen ovale occluder, which includes a connecting piece 1, a first choke part 2, a second choke part 3, an elastic part and a tightening part, wherein two ends of the connecting piece 1 are respectively connected with the first choke part 2 and the second choke part 3, in order to ensure balance of the two first choke parts 2 and the second choke part 3, the connecting piece 1 is connected with axes of the first choke part 2 and the second choke part 3, the connecting piece 1 is used for supporting the first choke part 2 and the second choke part 3, after the occluder is implanted into a heart, the connecting piece 1 passes through the cardiac foramen ovale, and the first choke part 2 and the second choke part 3 are respectively located in left and right atrium; the first flow blocking part 2 and the second flow blocking part 3 are used for blocking the oval foramen and preventing overflow between the left atrium and the right atrium.
The elastic part comprises a first elastic piece 4 and a second elastic piece 5, the first elastic piece 4 is paved on the first flow blocking part 2, the first elastic piece 4 is fixedly connected with the first flow blocking part 2, the first elastic piece 4 is used for shaping the first flow blocking part 4, and when the occluder is implanted, the first elastic piece 4 can promote the first flow blocking part 2 to be quickly deformed and restored to block the oval hole. The second elastic piece 5 is paved on the second flow blocking part 3, and the second elastic piece 5 is connected with the second flow blocking part 3; the second elastic element 5 is used for shaping the second flow blocking portion 3, when the occluder is implanted, the second elastic element 5 can promote the second flow blocking portion 3 to be deformed and restored to block the oval hole rapidly, in the embodiment of the application, the first elastic element 4 is fixedly connected with the first flow blocking portion 2 in an adhesive manner, the second elastic element 5 is also fixedly connected with the second flow blocking portion 3 in an adhesive manner, the connection manner between the elastic element and the flow blocking portion is not limited, and the connection manner between the elastic element and the flow blocking portion is not limited as long as the fixation manner between the elastic element and the flow blocking portion can be achieved.
In the embodiment of the application, the first elastic piece 4 and the second elastic piece 5 are respectively paved on the surfaces of the first choke part 2 and the second choke part 3 close to the connecting piece 1; in other embodiments, the first elastic member 4 and the second elastic member 5 may be disposed in any of the following ways: the first elastic piece 4 and the second elastic piece 5 are both paved on the surfaces of the first choke part 2 and the second choke part 3 far away from the connecting piece 1, or the first elastic piece 4 is paved on the surface of the first choke part 2 near the connecting piece 1, and the second elastic piece 5 is paved on the surface of the first choke part 2 far away from the connecting piece 1; or, the second elastic piece 5 is paved on the surface of the second choke part 3 close to the connecting piece 1, the first elastic piece 4 is paved on the surface of the first choke part 2 far away from the connecting piece 1, or the first elastic piece 4 and the second elastic piece 5 are paved on all surfaces of the first choke part 2 and the second choke part 3.
The tightening part is arranged on the periphery of the connecting piece 1, two ends of the tightening part are respectively connected with the first elastic piece 4 and the second elastic piece 5, and the tightening part is used for tightening the first choke part 2 and the second choke part 3; after the occluder is implanted into the oval foramen of a heart, the tightening part can tighten the first flow blocking part 2 and the second flow blocking part 3 by pulling the first elastic piece 4 and the second elastic piece 5, so that the first flow blocking part 2 and the second flow blocking part 3 are respectively and tightly attached to the partition walls of corresponding atria, and the purpose of occluding the oval foramen is achieved.
The surfaces of the connecting piece 1, the elastic part, the first flow blocking part 2, the second flow blocking part 3 and the tightening part are respectively provided with an anti-hemagglutination coating. In the embodiment of the application, the main component of the anti-hemagglutination coating is heparin. By providing an anti-hemagglutination coating, the occluder can prevent blood coagulation in the heart after being implanted in the heart, and can prevent thrombus to a certain extent.
The surfaces of the connecting piece 1, the elastic part, the first flow blocking part 2, the second flow blocking part 3 and the tightening part are also respectively provided with a developing coating, and the developing coatings are arranged to enable the occluder to be observed under the irradiation of X rays, so that medical staff can know the deformation reset condition of the occluder after being implanted into the heart, and whether the occluder is successful in occluding an oval hole is judged.
The tightening part comprises 8 tightening members 6 of a strip-like structure, but in other embodiments the tightening members 6 may be of other numbers; the tightening member 6 is made of flexible material and can be made into the shape of wire, thread and the like; the 8 tightening members 6 are arranged at equal intervals on the periphery of the connecting piece 1 along the extending direction of the connecting piece 1; the two ends of the tightening member 1 are fixedly connected with the first elastic member 4 and the second elastic member 5, respectively.
In order to improve the tightening tension of the tightening element 6, in the embodiment of the present application, the tightening element 6 is disposed at the outer end positions of the first choke portion 2 and the second choke portion 3, respectively, so as to better tighten the first choke portion 2 and the second choke portion 6.
In order to ensure that the tightening and stretching forces of the 8 tightening members 6 on the respective areas of the first flow blocking portion 2 and the second flow blocking portion 6 are uniform, in the embodiment of the present application, the 8 tightening members are symmetrically disposed on the periphery of the connecting member 1.
When the occluder is manufactured, the tightening member 6 can be formed by winding a single wire around the first elastic member 4 and the second elastic member 5, or can be made by inserting a plurality of wires, the tightening part can be formed by inserting a single wire through the two first choke parts 2 and the second choke parts 6, and the tightening part can also be formed by inserting a plurality of tightening members 6 through the two first choke parts 2 and the second choke parts 6.
The connecting piece 1 is made of a rigid material and is in a cylindrical structure, the rigid connecting piece 1 can ensure that the connecting piece 1 can play a supporting role when the first flow blocking part 2 and the second flow blocking part 3 are stretched and deformed by the tightening piece 6 after the plugging device is implanted, and in the embodiment of the application, the connecting piece 1 is in a solid structure.
The elastic part further comprises a third elastic piece 7, the third elastic piece 7 is paved on the outer surface of the connecting piece 1, and the third elastic piece 7 is respectively connected with the first elastic piece 4 and the second elastic piece 5. The first elastic piece 4, the second elastic piece 5 and the third elastic piece 7 are all elastic net bodies, and the first elastic piece 4, the second elastic piece 5 and the third elastic piece 7 are integrally formed. The first elastic member 4, the second elastic member 5 and the third elastic member 7 may be formed by laser cutting, or may be made by weaving, etc., and the third elastic member 7 may be provided to fix the connecting member 1, and the connecting member 1 may be bonded or mechanically bound to the third elastic member 7.
The first choke part 2 and the second choke part 3 are both elastic disc-shaped structures, and the diameter areas of the first choke part 2 and the second choke part 3 are the same. When the occluder is assembled, the third elastic piece 7 is paved on the surface of the connecting piece 1, and the first elastic piece 4 and the second elastic piece 5 are paved on the corresponding surfaces of the first choked flow part and the second choked flow part 3 of the second choked flow part 2; the first elastic piece 4 and the second elastic piece 5 are pulled by the tightening part, so that the first flow blocking part and the second flow blocking part 3 are contracted towards the directions close to each other, and the first flow blocking part 2 and the second flow blocking part 3 are respectively and tightly attached to the partition walls of the corresponding atrium, thereby achieving the purpose of sealing the oval foramen. In order to facilitate the connection and fixation of the occluder with an external delivery system, a connecting hole 8 is provided in the central position of the first flow blocking part 2, the connecting hole 8 extends into the connector 1, and an internal thread 9 is provided in the connecting hole 8. When the occluder is implanted, the connecting hole 8 is in threaded connection with a conveying pipe of a conveying system, so that the occluder is fixed on the conveying pipe, and the occluder is conveyed into the oval hole of the heart through the conveying pipe; and then the connection between the connecting hole 8 and the conveying pipe is loosened, and the plugging device is left in the oval foramen of the heart so as to complete the process of plugging the oval foramen.
In other embodiments, the connecting hole 8 may also be provided on the second choke 3, and the function and use process are the same as those provided on the first choke 2.
In the embodiment of the application, all components in the plugging device can be made of one or more of the following degradable materials: polylactic acid, poly-L-lactic acid, poly-D-lactic acid, poly-ethanol, poly-caprolactone, poly-p-dioxanone, poly-hydroxybutyrate, polyanhydride, polyphosphoester, polyurethane, polycarbonate, silk fibroin. After the degradable material is implanted into a human body, the occluder can be absorbed by the human body after the endothelial speaking process is completed in the human body along with the time, so that the long-term influence of implantation foreign matters on the human body is avoided.
Of course, in other embodiments, the components in the occluder may be partially or completely made of non-degradable materials such as medical grade plastics or metals.
When the occluder is used, the connecting hole 8 of the occluder is connected and fixed with the conveying pipe of the conveying system, then the occluder is received on the conveying pipe, the occluder is conveyed to the position of the cardiac foramen ovale through the conveying pipe, then the conveying pipe is loosened from the connecting hole 8, and the conveying pipe is pulled out, so that the occluder stays on the foramen ovale.
As shown in fig. 4, after the delivery tube is drawn out, the occluder is rapidly deformed and restored under the action of the elastic tension of the elastic part and the flow blocking part; at this time, the connecting piece 1 just passes through the oval foramen, and the first flow blocking part and the second flow blocking part 3 are respectively positioned in the left atrium and the right atrium; along with the restoration and deformation process of the occluder, the tightening members 6 are respectively abutted with the side edges of the oval holes; along with the restoration deformation of the occluder, the side wall of the oval hole can press the tightening member 6, the tightening member 6 is deformed under radial pressure, and the tightening member 6 pulls the first flow blocking part 2 and the second flow blocking part 3 through the elastic part to generate bending deformation towards the oval hole, so that the two flow blocking parts are respectively attached to the septum walls of the corresponding atrium, and the occlusion of the oval hole of the heart is completed.
Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present application, and not for limiting the same; although the application has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the application.