CN113712606A - Special plugging device for ventricular septum perforation and treatment assembly - Google Patents
Special plugging device for ventricular septum perforation and treatment assembly Download PDFInfo
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- CN113712606A CN113712606A CN202010456754.3A CN202010456754A CN113712606A CN 113712606 A CN113712606 A CN 113712606A CN 202010456754 A CN202010456754 A CN 202010456754A CN 113712606 A CN113712606 A CN 113712606A
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- 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
- A61B2017/00632—Occluding a cavity, i.e. closing a blind opening
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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
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- A61B2017/00654—Type of implements entirely comprised between the two sides of the opening
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Abstract
本发明涉及一种室间隔穿孔专用封堵器及治疗组件，室间隔穿孔专用封堵器包括第一封堵盘和第二封堵盘，以及连接第一封堵盘和第二封堵盘的腰部；室间隔穿孔专用封堵器被配置为：腰部用于穿设在室间隔穿孔中，腰部的最大直径小于室间隔穿孔的最小直径，使得腰部与室间隔穿孔周边的病变心肌之间存在间隙；第一封堵盘和第二封堵盘分别布置在室间隔穿孔的轴向两侧，以在夹持正常心肌的同时封堵室间隔穿孔。本发明封堵器的腰部与病变心肌之间没有相互作用力，避免病变心肌受力破碎而引起残余分流。优选的治疗组件中，封堵器及其操作杆还具有供导丝穿设的内腔，输送封堵器前无需撤出导丝，操作方便，缩短手术时间并实现精准释放。
The invention relates to a special occluder for ventricular septal perforation and a treatment component. The special occluder for ventricular septal perforation comprises a first blocking disk and a second blocking disk, and a device connecting the first blocking disk and the second blocking disk Waist; the special occluder for ventricular septal perforation is configured as follows: the waist is used to be inserted into the ventricular septal perforation, and the maximum diameter of the waist is smaller than the minimum diameter of the ventricular septal perforation, so that there is a gap between the waist and the diseased myocardium around the ventricular septal perforation The first blocking disk and the second blocking disk are respectively arranged on both sides of the ventricular septal perforation in the axial direction, so as to block the ventricular septal perforation while clamping the normal myocardium. There is no interaction force between the waist of the occluder of the invention and the diseased myocardium, so as to avoid residual shunt caused by force fragmentation of the diseased myocardium. In a preferred treatment component, the occluder and its operating rod also have an inner cavity for the guide wire to pass through, and the guide wire does not need to be withdrawn before delivering the occluder, which is convenient to operate, shortens the operation time and achieves precise release.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a special plugging device for perforation of an indoor space and a treatment assembly.
Background
Ventricular septal perforation (VSR) is one of the serious complications after Acute Myocardial Infarction (AMI), accounting for approximately 1% -2% of patients with acute myocardial infarction.
Methods of treatment for ventricular septal perforation include medical drug therapy, interventional occlusion, and surgical treatment, wherein medical drug therapy is intended to improve symptoms and cardiac function, creating opportunities for further surgery or interventional therapy. Currently, no specially designed plugging device special for ventricular septal perforation exists in interventional plugging treatment, and the clinically used plugging device is a congenital ventricular septal defect plugging device which is easy to cause complications such as residual shunt.
Disclosure of Invention
The invention aims to provide a special plugging device for ventricular septal perforation and a treatment assembly, which are suitable for ventricular septal perforation caused by myocardial infarction and reduce the occurrence probability of complications such as residual shunt and the like.
In order to achieve the purpose, the special plugging device for the perforation of the room interval comprises a first plugging disc, a second plugging disc and a waist part, wherein the first plugging disc and the second plugging disc are oppositely arranged, and the waist part is connected with the first plugging disc and the second plugging disc;
the interventricular perforation dedicated occluder is configured to: the waist is used for penetrating into the ventricular septum perforation, the maximum diameter of the waist is smaller than the minimum diameter of the ventricular septum perforation, and therefore a gap exists between the waist and the diseased myocardium around the ventricular septum perforation; the first occluding disk and the second occluding disk are respectively arranged on both axial sides of the ventricular septum penetration hole to occlude the ventricular septum penetration hole while holding the normal myocardium.
Optionally, the ratio of the maximum diameter of the waist to the diameter of the first occluding disk is 1: (8-10); and/or the ratio of the maximum diameter of the waist to the diameter of the second plugging disc is 1: (7-9).
Optionally, the maximum diameter of the waist is 3mm to 4 mm.
Optionally, the axial length of the waist is 5mm to 6 mm.
Optionally, the first blocking disc includes a first clamping surface and a first blocking surface which are oppositely disposed, wherein the first clamping surface is connected with the waist portion, the first blocking surface is an arc surface, and a concave side of the first blocking surface faces the first clamping surface.
Optionally, the second plugging disc includes a second clamping surface and a second plugging surface which are oppositely disposed, wherein the second clamping surface is disposed opposite to the first clamping surface, the second plugging surface is an arc surface, and a concave side of the second plugging surface faces the second clamping surface.
Optionally, the first plugging disc and the second plugging disc are both woven by weaving yarns, and the weaving density of the first plugging disc is greater than that of the second plugging disc.
Optionally, a first inner cavity which axially penetrates through the first blocking disc, the waist and the second blocking disc is arranged on the special blocking device for perforation of the ventricular septum.
Optionally, a valve is disposed within the first lumen.
In order to achieve the above object, the present invention further provides a ventricular septal perforation therapy assembly, which comprises a delivery sheath, a control rod and the ventricular septal perforation dedicated occluder; the operating rod is provided with a near end and a far end, and the far end is detachably connected with the special plugging device for the ventricular septum perforation; the conveying sheath is provided with a second inner cavity which is axially penetrated and is used for accommodating the special plugging device for the ventricular septum perforation and the distal end of the operating rod in a compressed state.
Optionally, the special plugging device for perforation of ventricular septum has a first inner cavity axially penetrating the first plugging disc, the waist and the second plugging disc; the operating rod is provided with a third inner cavity which is axially communicated, and the third inner cavity is used for being communicated with the first inner cavity; the ventricular septum perforation treatment assembly further comprises a guide wire which is movably arranged in the third inner cavity and the first inner cavity in a penetrating mode so as to guide the conveying sheath to convey the special occlusion device for ventricular septum perforation to the ventricular septum perforation.
Optionally, a valve is disposed in the first inner cavity, when the guide wire is inserted into the first inner cavity, the valve is opened to form a through hole for the guide wire to pass through, and when the guide wire is withdrawn from the first inner cavity, the valve is closed to separate the first inner cavity into two parts which are not communicated with each other.
Optionally, the delivery sheath has opposing second proximal and distal ends, the second distal end is formed as a frustum-shaped structure, and the frustum-shaped structure tapers in cross-section in a direction from the second proximal end to the second distal end.
Optionally, the delivery sheath has opposing second proximal and distal ends; the compartmental fenestration therapy assembly further comprises a locking mechanism disposed on the second proximal end of the delivery sheath, the first proximal end of the lever being configured to selectively connect and disconnect with the locking mechanism;
the compartmental fenestration therapy assembly is configured to: the first proximal end of the lever remains relatively stationary relative to the delivery sheath when the lever is coupled to the locking mechanism; the operating rod is axially movable relative to the delivery sheath when the first proximal end of the operating rod is disconnected from the locking mechanism.
Optionally, the locking mechanism comprises a locking body removably connected with the delivery sheath; the locking main body is provided with a fourth inner cavity which is axially communicated, and an internal thread is arranged on the cavity wall of the fourth inner cavity; and the first near end of the operating rod is provided with an external thread and is used for penetrating through the fourth inner cavity and being connected with the internal thread on the cavity wall of the fourth inner cavity.
Optionally, the locking mechanism further comprises a flying wing disposed on an outer surface of the locking body.
Compared with the prior art, the special plugging device for ventricular septum perforation and the treatment assembly have the following advantages:
first, the aforesaid plugging device special for perforation in ventricular septum comprises a first plugging disc and a second plugging disc which are oppositely arranged, and a waist part connecting the first plugging disc and the second plugging disc. The interventricular perforation dedicated occluder is configured to: the waist is used for penetrating into the ventricular septum perforation, and the maximum diameter of the waist is smaller than the minimum diameter of the ventricular septum perforation, so that a gap exists between the waist and the diseased myocardium around the ventricular septum perforation; meanwhile, the first blocking disk and the second blocking disk are respectively arranged on the two axial sides of the ventricular septal perforation to clamp the normal myocardium and block the ventricular septal perforation. Because a gap exists between the waist and the diseased cardiac muscle at the perforation of the ventricular septum, the complications such as residual shunt and the like caused by the breakage of the radial acting force of the diseased cardiac muscle at the waist are avoided.
Secondly, the ratio of the maximum diameter of the waist part to the diameter of the first plugging disc is 1 (8-10), and/or the ratio of the maximum diameter of the waist part to the diameter of the second plugging disc is 1: (7-9), the special plugging device for ventricular septal perforation is designed according to the size, so that the first plugging disc and the second plugging disc are clamped on the normal cardiac muscle under the condition that a gap exists between the waist and the diseased cardiac muscle, and the ventricular septal perforation is effectively plugged.
Thirdly, the axial length of the waist part is 5mm-6mm, and the length is less than the thickness of the chamber interval, so that when the waist part is arranged in the perforation of the chamber interval in a penetrating way, the waist part is stretched and deformed to generate elastic force, the clamping force of the first plugging disc and the second plugging disc is enhanced under the action of the elastic force, and the plugging effect of the perforation of the chamber interval is improved.
Fourthly, the special plugging device for ventricular septum perforation is also provided with a first inner cavity which axially penetrates through the first plugging disc, the waist and the second plugging disc, and the first inner cavity is used for penetrating and arranging a guide wire so as to carry out positioning and be convenient for conveying the special plugging device for ventricular septum perforation. Further, a valve is arranged in the first inner cavity, when the guide wire is arranged in the first inner cavity in a penetrating mode, the valve is opened to form a through hole for the guide wire to penetrate through, when the guide wire is withdrawn from the first inner cavity, the valve is automatically closed to divide the first inner cavity into two parts which are not communicated with each other, blood flow is prevented from flowing into the right ventricle from the left ventricle through the first inner cavity, and the blocking effect is improved.
Drawings
FIG. 1 is an anatomical view of a human heart showing ventricular septum fenestrations formed therein;
FIG. 2 is a schematic illustration of a prior art use of a congenital ventricular septal defect occluder to occlude a perforation of a ventricular septum;
fig. 3 is a schematic structural diagram of a dedicated plugging device for perforation of a compartment according to an embodiment of the present invention;
fig. 4 is a schematic diagram of the plugging device for the perforation of the interventricular septum provided by the invention according to an embodiment when the plugging device is used for plugging the perforation of the interventricular septum;
figure 5 is a cross-sectional view of a specific occluding device for perforation of a compartment provided by the present invention according to one embodiment;
fig. 6 is a schematic structural diagram of a valve of a special plugging device for perforation of a compartment according to an embodiment of the invention;
fig. 7 is a schematic structural diagram of a treatment assembly dedicated to ventricular septum perforation according to an embodiment of the present invention.
[ reference numerals are described below ]:
1-left atrium, 2-left ventricle, 3-right ventricle, 4-right atrium, 5-interventricular septum, 6-interventricular septum puncture;
10-special plugging device for perforation in the ventricular septum;
100, 100' -first plugging disk;
110-a first clamping surface, 120-a first blocking surface;
200, 200' -a second plugging disc;
210-a second clamping surface, 220-a second plugging surface;
300, 300' -waist;
400-a first lumen;
500-a valve;
20-delivery sheath, 30-operation rod, 40-guide wire.
Detailed Description
The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention. It should be noted that the drawings provided in the present embodiment are only for illustrating the basic idea of the present invention, and the components related to the present invention are only shown in the drawings rather than drawn according to the number, shape and size of the components in actual implementation, and the type, quantity and proportion of the components in actual implementation may be changed freely, and the layout of the components may be more complicated.
Furthermore, each of the embodiments described below has one or more technical features, and thus, the use of the technical features of any one embodiment does not necessarily mean that all of the technical features of any one embodiment are implemented at the same time or that only some or all of the technical features of different embodiments are implemented separately. In other words, those skilled in the art can selectively implement some or all of the features of any embodiment or combinations of some or all of the features of multiple embodiments according to the disclosure of the present invention and according to design specifications or implementation requirements, thereby increasing the flexibility in implementing the invention.
As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either fixedly connected, detachably connected, or integrally connected. Either mechanically or electrically. Either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations. The same or similar reference numbers in the drawings identify the same or similar elements.
Fig. 1 shows an anatomical diagram of a human heart, which as shown in fig. 1 comprises a left atrium 1, a left ventricle 2, a right ventricle 3 and a right atrium 4, wherein the left ventricle 2 and the right ventricle 3 are separated by a ventricular septum 5, over which ventricular septum perforation 6 occurs. As described in the background, most of the current clinics use an occluder for congenital ventricular septal defects to occlude ventricular septal perforations, and fig. 2 shows a schematic diagram of occluding ventricular septal perforations with an occluder for congenital ventricular septal defects. As shown in fig. 2, the occluder for congenital ventricular septal defects comprises a first occluding disk 100 ', a second occluding disk 200' and a waist 300 ', wherein the waist 300' connects the first occluding disk 100 'and the second occluding disk 200'. Such occluders currently have a number of specifications, adapted to different defects, but are basically designed such that when the maximum diameter of the waist 300 ' is D1, the diameter of the first occluding disk 100 ' is (D1+8mm) and the diameter of the second occluding disk 200 ' is (D1+4 mm). The diameter of the first containment disc 100 ', the diameter of the second containment disc 200 ' and the diameter of the waist 300 ' do not differ much.
In practice, when plugging the ventricular septal perforation 6, the operator selects an occluder with a suitable diameter at the waist 300 'according to the size of the ventricular septal perforation 6, and plugs the defect with the waist 300' to completely close the ventricular septal perforation 6, while clamping the ventricular septum 5 with the first occluding disk 100 'and the second occluding disk 200' to achieve the positioning of the occluder. However, a large number of patients develop complications such as residual shunting after surgery. The applicant found that this is because the myocardium around the ventricular septal perforation 6 is a fragile diseased myocardium, which is significantly different from a healthy congenital myocardial defect part, and when the occlusion is performed by using an occluder for a congenital ventricular septal defect, the waist 300' completely fills the perforation and radially presses the diseased myocardium, which is very likely to cause the diseased myocardium to be broken, resulting in residual shunting. However, if the occluder with a smaller waist 300 'is selected, the diameter of the first occluding disk 100' and the diameter of the second occluding disk 200 'are not different from the diameter of the waist 300', and the interventricular septum perforation 6 cannot be completely occluded, so that the therapeutic effect cannot be achieved.
In view of this, the embodiment of the present invention provides a dedicated plugging device for perforation of a room interval, which includes a first plugging disc and a second plugging disc, and a waist portion connecting the first plugging disc and the second plugging disc. The interventricular perforation dedicated occluder is configured to: the waist is used for penetrating into the ventricular septum perforation, and the maximum diameter of the waist is smaller than the minimum diameter of the ventricular septum perforation, so that a gap exists between the waist and the diseased myocardium around the ventricular septum perforation; the first plugging disc and the second plugging disc are respectively arranged on two axial sides of the ventricular septum perforation, and the first plugging disc and the second plugging disc both extend to the normal myocardial part around the ventricular septum perforation. That is, the interventricular perforation dedicated occluder clamps normal myocardium with the first occluding disk and the second occluding disk to achieve positioning, and also occludes an interventricular perforation with the first occluding disk and the second occluding disk. Therefore, the waist part only achieves the purpose of connecting the two blocking discs, the pathological change cardiac muscle can not be broken due to the radial acting force generated on the pathological change cardiac muscle, and the probability of residual shunt is effectively reduced.
To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to the appended drawings. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.
Fig. 3 shows a schematic structural diagram of the special plugging device for ventricular septum perforation provided by the embodiment of the invention, and fig. 4 shows a schematic structural diagram of the special plugging device for ventricular septum perforation provided by the embodiment of the invention when the special plugging device for ventricular septum perforation is implanted into the heart of a patient to plug the ventricular septum perforation.
Referring to fig. 3, the interventricular perforation dedicated occluder 10 comprises a first occluding disk 100 and a second occluding disk 200, and a waist 300 connecting the first occluding disk 100 and the second occluding disk 200. Referring to fig. 4, when the interventricular septum puncture dedicated occluding device 10 is used for occluding a ventricular septum puncture, the waist portion 300 is inserted into the ventricular septum puncture, and the maximum diameter of the waist portion 300 is smaller than the minimum diameter of the ventricular septum puncture, so that a gap exists between the waist portion 300 and a diseased myocardium of the ventricular septum puncture. Meanwhile, the first blocking disk 100 and the second blocking disk 200 are respectively arranged at both axial sides of the ventricular septal perforation, and the first blocking disk 100 and the second blocking disk 200 both extend to the normal myocardial portion around the ventricular septal perforation to block the ventricular septal perforation. That is, in this embodiment, the first blocking disk 100 and the second blocking disk 200 not only play a role of positioning, but also play a role of blocking the perforation of the ventricular septum, so that the waist 300 is only used for connecting the first blocking disk 100 and the second blocking disk 200, and it is not necessary to completely block the perforation of the ventricular septum, and it does not generate radial force to the fragile diseased myocardium around the perforation of the ventricular septum, thereby avoiding the rupture of the diseased myocardium to cause complications such as residual shunt, and improving the treatment effect.
In this embodiment, the larger the gap between the waist 300 and the myocardium around the ventricular septal perforation, the better, and the first blocking disk 100 and the second blocking disk 200 need to completely cover the ventricular septal perforation and extend to the healthy myocardium around the ventricular septal perforation, so the radial dimension of the first blocking disk 100 and the second blocking disk 200 is different from the radial dimension of the waist 300. In particular, the ratio of the maximum diameter of the waist 300 to the diameter of the first plugging disc 100 may be 1: (8-10), for example, 1:8, 1:9, 1:9.5, 1:10, etc. The ratio of the maximum diameter of the waist 300 to the diameter of the second occluding disk 200 may be 1: (7-9), for example, 1:7, 1:7.5, 1:9, 1:10, etc. This ensures that the first sealing disk 100 and the second sealing disk 200 achieve the purpose of sealing the perforation of the compartment space even when the diameter of the waist 300 is as small as possible. In the actual manufacture of the interventricular perforation-dedicated occluder 10, the maximum diameter of the waist is less than or equal to 4mm, which is much smaller than the size of the interventricular perforations (the diameter of the interventricular perforations is typically tens of millimeters). Further, the maximum diameter of the waist 300 is generally greater than or equal to 3mm, subject to material and process limitations.
The thickness of the compartment 5 is typically 7mm to 8mm, so in this embodiment it is preferred that the axial length of the waist 300 is 5mm to 6mm, less than the thickness of the compartment 5. The reason for this is that the first plugging disc 100, the second plugging disc 200 and the waist portion 300 of the plugging device 10 for puncturing a hole in a ventricular septum are all woven by using woven yarns and have certain elasticity, so that when the plugging device 10 for puncturing a ventricular septum is used for plugging a ventricular septum, the waist portion 300 is inserted into the puncture hole in the ventricular septum and is stretched under the action of the ventricular septum 5 to generate elastic force, and the elastic force can enhance the clamping force of the first plugging disc 100 and the second plugging disc 200 on the ventricular septum 5, thereby improving the plugging effect.
Further, with continued reference to fig. 3, the first plugging disc 100 includes a first clamping surface 110 and a first plugging surface 120 which are oppositely disposed. The first clamping surface 110 is used for being attached to a room at intervals, the first blocking surface 120 is an arc surface, and a concave side of the arc surface is arranged towards the first clamping surface 110. Similarly, the second plugging disc 200 comprises a second clamping surface 210 and a second plugging surface 220 which are oppositely arranged, wherein the second clamping surface 210 is arranged opposite to the first clamping surface 110 and connected with the waist 300 for attaching with a room space, the second plugging surface 220 is an arc surface, and the concave side of the arc surface faces the second clamping surface 210. The centers of the first occlusion surface 110 and the second occlusion surface 210 are located on the axis of the waist 300. The advantage of this arrangement is that the clamping force of the first and second plugging discs 100 and 200 on the normal myocardium increases gradually in the direction away from the ventricular septal perforation, thereby further avoiding the rupture of the diseased myocardium while enhancing the clamping force on the normal myocardium.
In addition, the interventricular perforation dedicated occluder 10 is configured to attach the first occluding disk 100 to the surface of the ventricular septum 5 facing the left ventricle when occluding interventricular perforation, and thus the first occluding disk 100 is also referred to as a left occluding disk. Accordingly, the second occluding disk 200 is attached to the surface of the interventricular septum 5 facing the right ventricle, and the second occluding disk 200 is also referred to as the right occluding disk. Thus, the first occluding disk 100 is subjected to a greater blood flow impaction force than the second occluding disk 200. Based on this, the weaving density of the first plugging disc 100 is preferably greater than that of the second plugging disc 200, so as to improve the plugging effect and further avoid the generation of residual shunt.
Figure 5 shows a cross-sectional view of the interventricular perforation specific occluder. As shown in fig. 5, the dedicated occluder for perforation of ventricular septum 10 further has a first inner lumen 400, the first inner lumen 400 axially penetrates the first occluding disk 100, the waist 300 and the second occluding disk 200, and the first inner lumen 400 is used for passing a guide wire for delivery. Still further, a valve 500 is disposed in the first inner cavity 400, and when the first inner cavity 400 is penetrated by a guide wire, the valve 500 is opened to form a through hole for the guide wire to pass through. When the guidewire is withdrawn from the first lumen 400, the valve 500 is closed to separate the first lumen 400 into two portions that are not in communication with each other, such that blood cannot flow along the first lumen 400. In one implementation, the valve 500 may be fabricated using a multi-lobed biomaterial (as shown in fig. 6).
In addition, it should be understood that the plugging device 10 for ventricular septum perforation is provided with a connecting part (not shown) for detachably connecting an operating rod for transportation in the human body.
Further, it is another object of the embodiment of the present invention to provide a ventricular septal perforation specific therapy assembly, as shown in fig. 7, which includes a delivery sheath 20, a manipulation rod 30 and the ventricular septal perforation specific occluder 10. The operating rod 30 has opposite first proximal and distal ends for detachable connection with the interventricular perforation exclusive stopper 10. The delivery sheath 20 has a second lumen running axially therethrough for receiving the interventricular perforation specific occluding device 10 and the first distal end of the operating rod 30 in a compressed state. The operator uses the delivery sheath 20 and the operation rod 30 to deliver the special occluder for ventricular septum perforation 10 to the ventricular septum perforation and release the occluder to occlude the ventricular septum perforation. It will be understood that "proximal" and "distal" are used herein to refer to the relative orientation, relative position, and orientation of elements or actions with respect to one another from the perspective of a clinician using the medical device, and that "proximal" generally refers to the end of the medical device that is closer to the clinician during normal operation, and "distal" generally refers to the end that is first introduced into a patient's body, although "proximal" and "distal" are not intended to be limiting.
Further, when the interventricular perforation dedicated occluder 10 has the first inner cavity (not shown in fig. 7), the operating rod 30 has a third inner cavity which is axially communicated with the first inner cavity, the interventricular perforation dedicated therapeutic assembly further comprises a guide wire 40, and the guide wire 40 is movably arranged in the third inner cavity and the first inner cavity in a penetrating manner to guide the delivery sheath 20 to deliver the interventricular perforation dedicated occluder 10 to the interventricular perforation.
The occluder 10 and the operating rod 30 of the special treatment assembly for perforation at the ventricular septum can be penetrated by the guide wire 40, the guide wire 40 does not need to be withdrawn before the occluder 10 is conveyed, the operation is convenient, the operation time is further shortened, the occluder 10 is limited by the guide wire 40, and accurate release is realized.
Further, the delivery sheath 20 has a second proximal end and a second distal end that are opposite. The interventricular perforation specific therapy assembly further comprises a locking mechanism 50, said locking mechanism 50 being disposed on the second proximal end of said delivery sheath 20, said locking mechanism 50 being adapted to be selectively connected to and disconnected from the first proximal end of said operating rod 30. When the first proximal end of the operating rod 30 is connected with the locking mechanism 50, the operating rod 30 and the delivery sheath 20 are kept relatively still, so that the special occluder for ventricular septum perforation 10 can be prevented from extending out of the delivery sheath 20 in advance to cause injury to human tissues during delivery. When the first proximal end of the operating rod 30 is disconnected from the locking mechanism 50, the operating rod 30 can be axially moved relative to the delivery sheath 20 to release the interventricular septal perforation specific occluder 10.
In an alternative implementation, the locking mechanism 50 includes a locking body 51, and the locking body 51 is threadably connected to the proximal end of the delivery sheath 20. The locking body 51 has a fourth inner cavity which is axially through, and an inner thread is arranged on the cavity wall of the fourth inner cavity. The first near end of the operating rod 30 is provided with an external thread, and the first near end of the operating rod 30 can penetrate through the fourth inner cavity and is in threaded connection with the cavity wall of the fourth inner cavity. In this way, during the process of delivering the interventricular perforation occluder 10, the locking body 51 is connected to the delivery sheath 20, and the first proximal end of the operating rod 30 is connected to the wall of the fourth lumen, so as to fix the operating rod 30. After the interventricular perforation occluder 10 is delivered to the target position, the locking body 51 is detached from the proximal end of the delivery sheath 20, and the connection between the cavity wall of the fourth lumen and the first proximal end of the operating rod 30 is released, so that the operating rod 30 can move axially relative to the delivery sheath 20 to release the interventricular perforation occluder 10.
Further, the locking mechanism 50 further includes at least one flying wing 52, and the at least one flying wing 52 is disposed on an outer surface of the locking body 51 for easy holding.
Further, the distal end of the delivery sheath 20 is designed as a frustum-shaped structure that tapers in cross-section in the proximal-to-distal direction to improve the passability of the delivery sheath 20 in the human body.
Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.
Claims (16)
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| WO2024001651A1 (en) * | 2022-06-28 | 2024-01-04 | 微创投资控股有限公司 | Blocking device and blocking system |
| CN118614970A (en) * | 2024-06-20 | 2024-09-10 | 北京审谛医疗科技有限公司 | A device for treating ventricular septal defect |
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| CN113712606B (en) | 2025-02-21 |
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