CN109745094B - Plugging device - Google Patents

Plugging device Download PDF

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CN109745094B
CN109745094B CN201811646808.1A CN201811646808A CN109745094B CN 109745094 B CN109745094 B CN 109745094B CN 201811646808 A CN201811646808 A CN 201811646808A CN 109745094 B CN109745094 B CN 109745094B
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occlusion
plugging
blocking
aneurysm
section
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CN109745094A (en
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刘建勇
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Lifetech Scientific Shenzhen Co Ltd
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Lifetech Scientific Shenzhen Co Ltd
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Abstract

The invention belongs to the field of interventional medical instruments, and particularly relates to a plugging device for plugging an opening in a body. The occlusion device has a compressed configuration and a deployed configuration formed by self-expansion from the compressed configuration, the occlusion device comprising a support portion, an occlusion portion, and one or more connecting portions between the support portion and the occlusion portion, the connecting portions being resilient in the deployed configuration, the connecting portions urging the support portion and the occlusion portion away from each other when the support portion and the occlusion portion are subjected to an external force that causes them to move closer together. The plugging device provided by the invention can realize that the supporting part abuts against the inner wall at the far end of the aneurysm and the plugging part abuts against the inner wall near the near end opening part of the aneurysm by virtue of the resilience force of the connecting part under the unfolding configuration, thereby realizing effective plugging, not only plugging is tight, but also the plugging device is more stable to place in the aneurysm and is not easy to fall off or shift.

Description

Plugging device
Technical Field
The invention belongs to the technical field of interventional medical instruments, and particularly relates to a plugging device for plugging an opening in a body.
Background
Aneurysms are a common vascular disease, resulting in the appearance of localized or diffuse dilatation or bulging of the arterial wall due to lesions or lesions of the arterial wall. Aneurysms can occur anywhere in the arterial system, with serious consequences once the aneurysm ruptures. Taking intracranial aneurysm as an example, the intracranial aneurysm is the first cause of subarachnoid hemorrhage, is 3 rd in the cause of cerebrovascular diseases, and has a mortality rate and a disability rate which account for 22% -25% of patients who die of cerebrovascular diseases and gradually increase in tendency. The incidence rate of intracranial aneurysm is high, and investigation results show that congenital aneurysm occupies most people, is most common in 40-66 years old, about 10% of patients die before admission, the autopsy detection rate is about 1-5%, the death rate of initial bleeding of ruptured aneurysm is about 15% -20%, the death rate reaches 75% -85% in 2 years after not timely diagnosis and treatment, and more than 50% of ruptured aneurysm survivors can remain disabled to different degrees.
The main treatment methods for aneurysms are surgical clipping and interventional embolization. Interventional embolization therapy has advanced significantly over decades and is now the mainstay of treatment for bleeding from acute aneurysm ruptures. The interventional therapy of the aneurysm mainly comprises spring coil embolism, balloon-assisted spring coil embolism or stent-assisted spring coil embolism, and becomes the preferred clinical treatment scheme of many medical experts at present due to the advantages of minimally invasive, safe and effective interventional therapy. Coil spring therapy, the most common form of therapy, still has limitations such as low packing density, blood flow resulting in repeated compression against the aneurysm wall, complex procedures, and poor stability in wide-necked aneurysms, and many require multiple coils to be deployed. Another treatment is to prevent rupture of the aneurysm by placing a woven or covered stent in the blood vessel by reducing the pressure of blood flow against the inner wall of the aneurysm. Braided or stent-graft stents still have some limitations for the treatment of aneurysms, firstly because they have difficulty in having a low porosity to block blood from entering the aneurysm, and secondly they may block side branch vessels, in order to accommodate microcatheters.
In contrast, it is necessary to provide a new occlusion device for solving various problems of the conventional occlusion device, such as complicated operation, poor stability of occlusion, poor occlusion effect, and influence on the side branch vessels.
Disclosure of Invention
The invention provides a plugging device capable of effectively and stably plugging an internal opening based on the above problems of the plugging device in the prior art, which is mainly realized by the following technical scheme:
the invention provides an occlusion device having a compressed configuration and a deployed configuration formed by self-expansion from the compressed configuration, the occlusion device comprising a support portion, an occlusion portion and one or more connecting portions between the support portion and the occlusion portion, the connecting portions being resilient in the deployed configuration, the connecting portions driving the support portion and the occlusion portion away from each other when the support portion and the occlusion portion are subjected to an external force urging them towards each other.
Further, a portion of the support portion is recessed in a direction in which the blocking portion is located, the portion including at least a portion of an outer surface of the support portion corresponding to a connection point of the connection portion.
Further, the shape of the blocking part is at least one of the following or a combination thereof: spherical, cylindrical or inverted truncated cone.
Further, the plugging part comprises a first plugging piece and a second plugging piece which are connected from far to near, the first plugging piece is spherical or flat, and the second plugging piece is cylindrical.
Further, the occlusion device further comprises at least one blocking portion located between the support portion and the occlusion portion; when the blocking part is one, the connecting part comprises at least one first section and at least one second section, the blocking part and the supporting part are connected through the at least one first section, and the blocking part are connected through the at least one second section; when the blocking parts are multiple, the connecting parts comprise at least one first section, at least one second section and at least one third section, the blocking parts are connected with the supporting parts through the at least one first section, the blocking parts are connected with the blocking parts through the at least one second section, and the adjacent two blocking parts are connected through the at least one third section.
Further, in the deployed configuration, a radial length of the blocking portion is greater than or equal to a radial length of the occluding portion.
Further, the connecting portion is spirally rising or zigzag.
Further, the connecting portion includes at least one segment having a spherical shape or a fusiform shape, and when there are a plurality of the segments, a plurality of the segments are connected in series.
Further, one or more flow-blocking membranes are arranged on the supporting part and/or the blocking part.
Further, the plugging device further comprises at least one limiting member, wherein one end of each limiting member is connected with the supporting portion, and the other end of each limiting member is connected with the plugging portion.
The invention has the advantages that:
the plugging device provided by the invention, for example, for treating aneurysm, can realize that the supporting part abuts against the inner wall at the far end of the aneurysm and the plugging part abuts against the inner wall near the near end opening part of the aneurysm by virtue of the resilience force of the connecting part in a deployed configuration, thereby realizing effective plugging, not only realizing tight plugging, but also ensuring that the plugging device is more stable to place in the aneurysm and is not easy to fall off or shift. In addition, the stent does not need to be released in the blood vessel for assistance, so the operation difficulty is small, and the condition that the implantation of the stent blocks the adjacent blood vessel can be avoided.
Drawings
Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. Also, like reference numerals are used to refer to like parts throughout the drawings. In the drawings:
FIG. 1 is a schematic view of the occlusion device of example 1;
FIG. 2 is a schematic view of the occluding device of FIG. 1 being deformed when the support portion and the occluding portion are subjected to an external force;
FIG. 3 is a schematic view of the occluding device of FIG. 1 housed in a microcatheter;
FIG. 4 is a schematic illustration of the blood pressure distribution before implantation of the occluding device in an aneurysm;
FIG. 5 is a schematic view of the occlusion device of FIG. 1 deployed in an aneurysm to effect occlusion of the aneurysm;
fig. 6 is another schematic structural view of the plugging portion of the plugging device of example 1 (the plugging portion includes a first plugging member and a second plugging member);
FIG. 7 is another schematic structural view of the occluding device of example 1 (the connecting portions are spherical segments);
FIG. 8 is another schematic structural view of the occluding device of example 1 (shuttle-shaped segments are used for the connecting portions);
FIG. 9 is a schematic view of a mesh tube woven from a single or multiple braided filaments;
FIG. 10 is a schematic structural view of the plugging device formed by knitting a plurality of knitting yarns into a supporting portion, a connecting portion and a plugging portion, respectively, and then connecting and heat-setting the same;
FIG. 11 is a schematic view of the occluding device of FIG. 10 housed in a micro-catheter;
FIG. 12 is a schematic view of the occlusion device of FIG. 10 deployed in an aneurysm to effect occlusion of the aneurysm;
FIG. 13 is a schematic view of a flow-blocking membrane disposed in the occluding portion of the occluding device of FIG. 1;
FIG. 14 is a schematic structural view of the occluding device of example 2;
FIG. 15 is a schematic view of the occlusion device of FIG. 14 deployed in an aneurysm to effect occlusion of the aneurysm;
FIG. 16 is a schematic structural view of the occluding device of example 3;
fig. 17 is a schematic structural view of the occlusion device of example 4.
The reference symbols in the drawings denote the following:
1: plugging device, 101: support portion, 102: plugging portion, 1021: first block piece, 1022: second block piece, 103: connecting portion, 1031 a: segment, 1031 b: segment, 105: first fixing member, 106: second fixing member, 4: microcatheter, 41: development mark point, 5: micro-guide wire, 6: flow-blocking film, 10: aneurysm, 15: network management, 18: a proximal port portion;
1 b: plugging device, 101 b: support portion, 102 b: plugging portion, 103 b: a connecting portion;
1 c: plugging device, 101 c: support portion, 102 c: plugging portion, 103 c: connection portion, 104 c: a blocking portion;
1 d: plugging device, 101 d: support portion, 102 d: plugging portion, 103 d: a connecting portion; 104 d: and a limiting member.
Detailed Description
Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.
It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless specifically identified as an order of performance. It should also be understood that additional or alternative steps may be used.
Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.
For convenience of description, spatially relative terms, such as "inner", "outer", "lower", "below", "upper", "above", and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below … …" can include both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
In the field of interventional medical devices, the end of a medical device implanted in a human or animal body closer to an operator is generally referred to as the "proximal end", the end farther from the operator is referred to as the "distal end", and the "proximal end" and the "distal end" of any component of the medical device are defined according to this principle. "axial" generally refers to the length of the medical device as it is being delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines both "axial" and "radial" directions for any component of the medical device in accordance with this principle.
In addition, it should be noted that the occlusion device of the present invention can be used not only for aneurysm occlusion but also for application scenarios such as left atrial appendage occlusion, which are not listed here. In the following, embodiments of the occlusion device according to the invention will be described in detail, taking aneurysm occlusion as an example.
Example 1
As shown in fig. 1 and 2, the present embodiment proposes an occlusion device 1 having a compressed configuration (as shown in fig. 3) receivable within a microcatheter 4 and an original configuration in a natural state as shown in fig. 1 or a deployed configuration after implantation into body tissue as shown in fig. 2 formed by self-expansion of the compressed configuration, the axial length of the occlusion device 1 in the compressed configuration being greater than its vertical height in the deployed configuration and the original configuration. It should be noted that the occlusion device 1 is acted upon by gravity only in the original configuration, and is acted upon not only by gravity but also by the compression of the body tissue against the interior of the occlusion device 1 in the deployed configuration. The occluding device 1 comprises a supporting portion 101, an occluding portion 102 and a connecting portion 103, the connecting portion 103 being connected between the supporting portion 101 and the occluding portion 102.
In another embodiment, the occlusion device 1 may comprise a plurality of connection portions 103, and the plurality of connection portions 103 are connected between the support portion 101 and the occlusion portion 102, so that when the occlusion device 1 is compressed by an external force, the resilience provided by the connection portions 103 can be enhanced, thereby achieving effective occlusion more stably. Further, in another embodiment, the occlusion device 1 may comprise a plurality of supporting portions 101 respectively adapted to abut against the inner wall of the body tissue, each supporting portion 101 being connected to at least one connecting portion 103, so as to ensure that the connecting portions 103 provide sufficient resilience while allowing the occlusion device 1 to adapt to body tissues having different lumen configurations.
The occluding device 1 has shape memory and is thus capable of self-expanding from a compressed configuration to an expanded configuration or an original configuration in its natural state without restraint by a tubular component such as a sheath. The connection portion 103 has a resilient force in the deployed configuration, and when the supporting portion 101 and the blocking portion 102 are subjected to an external force that brings them close to each other, the connection portion 103 drives the supporting portion 101 and the blocking portion 102 away from each other due to the presence of the resilient force.
The occluding device 1 may be used to occlude in vivo tissue structures such as aneurysms, left atrial appendages, and the like, as well as other similar tissue structures having openings and lumens. Taking the example of plugging the aneurysm 10 shown in fig. 4, after the plugging device 1 is released in the aneurysm 10, the supporting portion 101 and the plugging portion 102 are respectively subjected to pressing forces of the inner wall of the aneurysm 10 at the distal end and the inner wall near the proximal port 18, so that the supporting portion 101 and the plugging portion 102 approach each other, and the connecting portion 103 drives the supporting portion 101 and the plugging portion 102 to move away from each other under the action of a resilient force, so that the supporting portion 101 abuts against the inner wall of the aneurysm 10 at the distal end, and the plugging portion 102 abuts against the inner wall near the proximal port 18 of the aneurysm 10, thereby achieving effective plugging of the proximal port 18, and the schematic structural diagram and the plugging effect after plugging refer to fig. 5.
The plugging device 1 proposed in this embodiment can realize that the supporting portion 101 abuts against the distal end inner wall of the aneurysm 10 and the plugging portion 102 abuts against the inner wall near the proximal end opening 18 of the aneurysm 10 by virtue of the resilience of the connecting portion 103 in the deployed configuration, thereby realizing effective plugging, which not only is tight in plugging, but also ensures that the plugging device 1 is more stably placed in the aneurysm 10 and is not easy to fall off or shift.
In example 1, the supporting portion 101 is in the shape of a spherical cap as shown in fig. 1 or fig. 2, and when the occluding device 1 is implanted in the aneurysm 10, the edge portion of the supporting portion 101 is folded towards the inside of the occluding device 1 to a certain extent (as shown in fig. 2), so as to be tightly attached to the inner wall of the aneurysm 10, and the support provided by the supporting portion 101 is more stable. In another embodiment, the supporting portion 101 may also be in the shape of a cylinder, a square column, a truncated cone, etc., and the inside thereof may be a hollow structure or a non-hollow structure. The plugging portion 102 is in a spherical cap shape as shown in fig. 1 or fig. 2, and when the plugging device 1 is implanted into the aneurysm 10, the edge portion of the plugging portion 102 is attached to the inner wall near the proximal port 18 of the aneurysm 10, so as to be folded towards the inside of the plugging device 1 to a certain extent (as shown in fig. 2), thereby achieving effective plugging of the site to be plugged. In another embodiment, the blocking portion 102 may also be one or a combination of a cylindrical shape, an inverted truncated cone shape, etc., which are not limited herein and should be understood to be included in the scope of the present invention, and the inside thereof may be a hollow structure or a non-hollow structure. The inverted frustum shape indicates a structure in which a frustum shape is inverted.
In another embodiment, referring to fig. 6, the blocking portion 102 includes a first blocking member 1021 and a second blocking member 1022 connected from a distal end to a proximal end, wherein the first blocking member 1021 is spherical or flat, and the second blocking member 1022 is cylindrical. When the occlusion part 102 in this embodiment occludes the proximal port 18 of the aneurysm 10, the second occluding member 1022 is occluded within the proximal port 18 to preliminarily occlude the proximal port 18; the edge portion of the first occluding member 1022 conforms to the inner wall of the aneurysm 10 near the proximal port 18 to further seal the proximal port 18 in cooperation with the second occluding member 1022, so that blood flow is more difficult to enter the aneurysm 10 and the sealing effect is better.
The connecting portion 103 is in the form of a broken line as shown in fig. 1 and 2, and in other embodiments, the connecting portion 103 may be in the form of a spring-like spiral rise or any other shape that is resilient when compressed. Further, in order to ensure that the connecting portion 103 has sufficient supporting force for the supporting portion 101 and the plugging portion 102 after the plugging device 1 is released in the aneurysm 10, and at the same time, the supporting portion 101 is not pushed out of the distal end of the aneurysm 10 due to too large resilience force to cause rupture of the aneurysm 10, and the resilience force is not too small to play a supporting role, in this embodiment, the value range of the elastic coefficient of the connecting portion 103 is 0.000125N/mm to 0.0005N/mm, and the measurement can be performed by using existing tools such as a tensile machine.
In another embodiment, as shown in fig. 7 and 8, the connecting portion 103 of the occlusion device 1 may also be of a segmented design, i.e. the connecting portion 103 comprises at least one segment 1031a (shown in fig. 7) in a spherical shape or a segment 1031b (shown in fig. 8) in a fusiform shape, when there are a plurality of segments 1031a (or 1031b), the plurality of segments 1031a (or 1031b) are connected, wherein the plurality of segments 1031a (or 1031b) may be connected end to end in sequence or may be connected by an elastic connection. By adopting the segmented design, the reaction force generated when the connecting part 103 deforms can be reduced, so that the plugging device 1 can better fit the inner wall of the aneurysm 10 and simultaneously prevent the aneurysm 10 from rupturing. Of course, the segments may take other shapes, and are not limited to spheres and shuttles.
The occluding device 1 is woven by high-strength metal (such as cobalt alloy, nickel alloy and platinum alloy) or high polymer material, or is formed by a mesh tube 15 (shown in figure 9) formed by mixing a plurality of high-strength metal and/or high polymer material with high-density metal (such as platinum), and the mesh tube can be self-expanded to an original configuration or an expanded configuration implanted in a body when not constrained. The high-strength metal or polymer material can ensure that the plugging device 1 has sufficient elasticity and radial force after being implanted into the aneurysm 10, and the high-density metal can be gold, so that the plugging device 1 can display the position of the plugging device 1 in the blood vessel under the equipment of CT angiography (CTA), Magnetic Resonance Angiography (MRA) and the like.
The occluding device 1 may be formed by weaving a single or a plurality of woven filaments into the integrally formed mesh tube 15 (as shown in fig. 9) and then heat-setting (as shown in fig. 1 or fig. 2), or may be formed by weaving a plurality of woven filaments into the supporting portion 101, the connecting portion 103 and the occluding portion 102, respectively, and then heat-setting (as shown in fig. 10 to fig. 12).
As shown in fig. 13, further, one or more layers of flow blocking films 6, which may be polymer films (e.g., PET films), are disposed on the blocking portion 102. As shown in fig. 4, before the plugging device 1 is implanted, the inner wall of the aneurysm 10 is continuously subjected to the impact force F of the blood flow, so that the inner wall of the aneurysm 10 is continuously enlarged and thinned, and finally, the inner wall is ruptured. As shown in fig. 5, the plugging device 1 of the present embodiment is used to reduce the impact of blood flow on the inner wall of the aneurysm 10 after being released in the aneurysm 10, so that the aneurysm 10 forms an approximately closed cavity to promote the formation of thrombus, thereby effectively plugging the aneurysm 10. The flow of blood into the aneurysm 10 requires penetration of the two layers of the mesh structure of the occluding portion 102 to access the aneurysm, and the presence of the flow-blocking membrane 6 therein makes it more difficult for blood to enter the lumen of the aneurysm 10.
Further, the supporting portion 101 is provided with one or more layers of flow blocking films, the flow blocking films can be polymer films (such as PET films), when blood enters the cavity of the aneurysm 10 to the supporting portion 101, kinetic energy of the blood entering the aneurysm 10 is greatly reduced, at this time, the blood still needs to penetrate through two layers of net structures to impact the aneurysm wall, and the flow blocking films arranged on the supporting portion 101 enable the blood to be more difficult to penetrate through the supporting portion 101 to impact the inner wall of the aneurysm 10. It should be noted that the present embodiment can not only perform the treatment by completely blocking the blood flow from entering the aneurysm 10, but also utilize the net-like structure such as the blocking portion 102, the supporting portion 101, etc. to reduce the flow rate and flow velocity of the blood entering the aneurysm 10 so as to coagulate the blood in the cavity of the aneurysm 10, so as to achieve multi-layer occlusion of the aneurysm 10. Of course, the lower the porosity of the plugging device 1, the better the plugging effect, the number of the woven wires of the mesh tube 15 can be 36, 42, 72, 144, etc., and the smaller the porosity can be achieved as the number of the woven wires is larger.
In the original configuration, the vertical height of the occlusion device 1 from the top to the bottom thereof is 1.5mm to 35mm, wherein the vertical height of the occlusion portion 102 from the top to the bottom thereof is 0.04mm to 30mm, the vertical height of the supporting portion 101 from the top to the bottom thereof is 0.04mm to 30mm, the vertical height of the connecting portion 103 from the top to the bottom thereof is 1.4mm to 35mm, and the length of the occlusion portion 102 in the radial direction is 0.5mm to 5mm, preferably 0.5mm to 3mm, 2mm to 4mm, 3mm to 5mm, etc. greater than the length of the proximal mouth 18 of the aneurysm 10.
The occluding device 1 further comprises a first fixing member 105 arranged at the proximal end of the occluding portion 102 and a second fixing member 106 arranged at the distal end of the supporting portion 101, wherein when a pulling force in opposite directions is applied to the first fixing member 105 and the second fixing member 106, the first fixing member 105 and the second fixing member 106 can drive the occluding device 1 to stretch in the axial direction, so that the diameter of the occluding device 1 in the radial direction is reduced, and the occluding device 1 is put into a compressed configuration for being transported in the body.
The occluding device 1 may be implanted in an aneurysm 10 (as shown in figures 3 and 11) through a microcatheter 4 and a micro-guidewire 5, with the first securing member 105 being a cannula connectable to the micro-guidewire 5. The implantation process is as follows: connecting the proximal end of the occlusion device 1 with the distal end of the micro-guide wire 5; the occluding device 1 is entered from the proximal end of the micro-catheter 4 and placed at the distal end of the micro-catheter 4, with the occluding device 1 in a compressed configuration; delivering the distal end of the microcatheter 4 into position within the aneurysm 10; fixing the micro guide wire 5, withdrawing the micro catheter 4, slowly releasing the supporting part 101 of the plugging device 1, and then expanding by self expansion and fitting with the inner wall of the far end of the aneurysm 10; simultaneously withdrawing the micro guide wire 5 and the micro catheter 4, wherein the withdrawal speed of the micro catheter 4 is faster than that of the micro guide wire 5, so that the blocking part 102 of the blocking device 1 is slowly released in the withdrawal process; when the micro-guide wire 5 and the micro-catheter 4 are withdrawn to the proximal port 18 of the aneurysm 10, the micro-guide wire 5 is fixed, and the micro-catheter 4 is continuously and slowly withdrawn, so that the blocking part 102 of the blocking device 1 is completely released, and the effective blocking of the proximal port 18 of the aneurysm 10 is realized; finally, the blocking device 1 and the micro guide wire 5 are released, and the micro catheter 4 and the micro guide wire 5 are withdrawn from the body, wherein the releasing mode can be mechanical releasing, electrical releasing, water releasing, thermal releasing or the like. Finally, the supporting part 101 of the plugging device 1 is attached to the inner wall of the distal end of the aneurysm 10, the plugging part 102 is attached to the inner wall of the aneurysm 10 near the proximal port 18, and the connecting part 103 is compressed to generate resilience, so that the stability of attaching the supporting part 101 and the plugging part 102 to the aneurysm 10 is ensured.
Further, a development marker 41 capable of imaging under a contrast apparatus may be provided at the front end of the micro-catheter 4, and the development marker 41 is a metal material (e.g., gold, platinum, thallium, tantalum, etc.) or a rare earth material having a large atomic-mass ratio.
Example 2
The same parts of the occluding device 1b of embodiment 2 as those of the occluding device 1 of embodiment 1 are not described again, and the main difference between the two parts is that in embodiment 2, as shown in fig. 14 and 15, a part of the supporting portion 101b is configured to be concave toward the direction of the occluding portion 102b, and the part described herein includes a part of the outer surface of the supporting portion 101b corresponding to the connection point of the connecting portion 103b, thereby forming an inner concave surface on the supporting portion 101b facing the inside of the occluding device 1b to prevent the distal tip of the aneurysm 10 from bearing pressure, and further ensure that the aneurysm 10 does not rupture.
In another embodiment, when there are a plurality of connecting portions 103b, the supporting portion 101b may be recessed toward the blocking portion 102b in the vicinity of the connecting portion 103b to form a plurality of recessed surfaces on the supporting portion 101 b. Further, in another embodiment, when there are a plurality of the supporting portions 101b, each supporting portion 101b may include at least one such concave surface.
Example 3
The same parts of the occlusion device 1c of embodiment 3 as the occlusion device 1 of embodiment 1 or the occlusion device 1b of embodiment 2 are not repeated here, and the main difference between the two parts is that in embodiment 3, as shown in fig. 16, the occlusion device 1c may further include a blocking portion 104c, and the blocking portion 104c is used to further reduce the flow rate of blood entering the aneurysm 10 and simultaneously achieve multiple occlusion of the in vivo tissue to be occluded. For larger aneurysms, the occlusion effect may be enhanced by providing a blocking portion 104 c. The blocking portion 104c is disposed between the supporting portion 101c and the blocking portion 102c, and may be one or a plurality thereof. When the blocking portion 104c is one, the connecting portion 103c includes a first section through which the blocking portion 104c is connected with the supporting portion 101c and a second section through which the blocking portion 104c is connected with the blocking portion 102 c. When the blocking portion 104c is plural, the connecting portion 103c includes a first section, a second section, and a third section, the blocking portion 104c and the supporting portion 101c are connected by the first section, the blocking portion 104c and the blocking portion 102c are connected by the second section, and adjacent two blocking portions 104c are connected by the third section. It can be understood that the number of the first section, the second section, and the third section may be multiple, and the positions of the first section, the second section, and the third section are the same as those of the first section, the second section, and the third section in this embodiment, and the roles of these sections are also the same, and will not be described herein again.
In the above embodiment, in the deployed configuration and the original configuration, the radial length of the blocking portion 104c is greater than or equal to the radial length of the blocking portion 102c, so as to adapt to a cavity structure with a larger diameter in the middle of a cavity such as an aneurysm and the like, increase a blocking layer, realize multiple blocking, and improve the blocking effect.
Example 4
The same parts of the occluding device 1d of embodiment 4 as those of embodiments 1 to 3 are not repeated herein, and the main difference is that in embodiment 4, as shown in fig. 17, in order to ensure the stability between the supporting portion 101d and the occluding portion 102d and prevent the large reaction force generated after the occluding device 1d is over-compressed from bursting the aneurysm, the occluding device 1d of this embodiment further includes at least one limiting member 104d, one end of the limiting member 104d is connected to the supporting portion 101d, and the other end is connected to the occluding portion 102 d. When the supporting portion 101d and the blocking portion 102d are too much moved away from each other, the stopper 104d can reduce the excessive movement of the supporting portion 101d and the blocking portion 102d toward each other, thereby preventing the aneurysm from being ruptured by the blocking device 1 d. The position-limiting member 104d may be made of a metal material, such as nitinol or cobalt-chromium alloy, or a non-metal material, such as a polymer material, such as polypropylene or poly-p-phenylene terephtalate. The limiting member 104d is a linear member with good flexibility, the limiting member 104d includes at least one section of a predetermined curved segment, the curved segment may be a spring segment or a broken line segment, and the length of the limiting member 104d provided with the curved segment may vary, so that the length of the limiting member may be consistent with the length of the occlusion device 1d in a compressed configuration, and the limiting member may limit the relative movement of the supporting portion 101d and the occlusion portion 102d in the process of expanding the occlusion device 1d into an expanded configuration, thereby not only ensuring the relative stability of the supporting portion 101d and the occlusion portion 102d, but also limiting the distance between the supporting portion 101d and the occlusion portion 102d, and preventing the aneurysm from being broken after the occlusion device 1d is implanted.
Further, the at least two limiting members 104d are respectively disposed at least on two opposite sides of the connecting portion 103d, or are uniformly distributed around the circumference of the connecting portion 103d, and preferably, the proximal ends of the at least two limiting members 104d are respectively located near the central axis of the blocking portion 102d, and the distal ends are respectively located near the distal end edge of the supporting portion 101d, or the distal ends of the at least two limiting members 104d are respectively located near the central axis of the supporting portion 101d, and the proximal ends are respectively located near the distal end edge of the blocking portion 102 d. The included angle between the straight line or plane where the single limiting member 104d is located and the central axis of the plugging device 1d ranges from 10 degrees to 60 degrees, and the sheath can be conveniently fed.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the appended claims.

Claims (8)

1. An occlusion device having a compressed configuration and a deployed configuration formed by self-expansion from the compressed configuration, the occlusion device comprising a support portion, an occlusion portion and one or more connecting portions between the support portion and the occlusion portion, wherein the connecting portions are resilient in the deployed configuration, the connecting portions drive the support portion and the occlusion portion away from each other when the support portion and the occlusion portion are subjected to an external force that causes them to approach each other, and the support portion and the occlusion portion are spaced apart in an axial direction of the occlusion device and do not have overlapping portions in a radial direction; the plugging device further comprises at least one limiting part, one end of each limiting part is connected with the supporting part, the other end of each limiting part is connected with the plugging part, the limiting parts are used for reducing excessive opposite movement between the supporting part and the plugging part, the plugging part comprises a first plugging piece and a second plugging piece which are in transition connection from far to near, the first plugging piece is spherical or flat, and the second plugging piece is cylindrical.
2. The occlusion device of claim 1, wherein a portion of the support portion is concave in a direction of the occlusion portion, the portion including at least an outer surface portion of the support portion corresponding to a connection point of the connection portion.
3. The occlusion device of claim 1 or 2, further comprising at least one blocking portion located between the support portion and the occlusion portion;
when the blocking part is one, the connecting part comprises at least one first section and at least one second section, the blocking part and the supporting part are connected through the at least one first section, and the blocking part are connected through the at least one second section;
when the blocking parts are multiple, the connecting parts comprise at least one first section, at least one second section and at least one third section, the blocking parts are connected with the supporting parts through the at least one first section, the blocking parts are connected with the blocking parts through the at least one second section, and the adjacent two blocking parts are connected through the at least one third section.
4. The occlusion device of claim 3, wherein in the deployed configuration, a radial length of the blocking portion is greater than or equal to a radial length of the occlusion portion.
5. The occlusion device of claim 1 or 2, wherein the connecting portion is in the form of a spiral rise or a fold.
6. The occlusion device of claim 1 or 2, wherein the connecting portion comprises at least one segment in the shape of a sphere or a shuttle, and when there are a plurality of the segments, a plurality of the segments are connected in series.
7. The occlusion device of claim 1 or 2, wherein one or more flow-blocking membranes are provided on the support portion and/or the occlusion portion.
8. The occlusion device of claim 1, wherein the retaining member comprises at least one predetermined curved segment, wherein the retaining member having the curved segment can vary in length.
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CN114504356B (en) * 2021-06-23 2024-03-12 上海心玮医疗科技股份有限公司 Three-dimensional self-adaptation intracranial aneurysm plugging device
CN116269600A (en) * 2023-04-24 2023-06-23 上海心瑞医疗科技有限公司 Aortic blood blocking device

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