CN118203381A - Plugging system and plugging device - Google Patents

Abstract

The present invention relates to a plugging system and a plugging device. The plugging system comprises a conveying device and a plugging device, wherein the plugging device is used for being pressed and held on a conveying rod of the conveying device so as to convey the plugging device through friction force between the conveying rod and the plugging device, the plugging device comprises a tubular support portion and a flow blocking portion, the cross sections of two ends of the tubular support portion in the axial direction are larger than those of the middle portion, the two ends of the tubular support portion in the axial direction are used for being respectively arranged on the inner side and the outer side of a target cavity opening so as to clamp the target cavity opening, and the flow blocking portion is fixed in the inside of the tubular support portion and extends along the non-axial section of the tubular support portion so as to block the target cavity opening through the flow blocking portion. The plugging device disclosed by the invention can be used for plugging an aneurysm orifice or a cavernous fistula orifice, is good in plugging effect and stability, is not easy to damage the aneurysm top, and reduces the risk of rupture of the aneurysm.

Description

Plugging system and plugging device

Technical Field

The invention relates to the field of medical instruments, in particular to a plugging system and a plugging device.

Background

Along with the rapid development of economy, the heart cerebrovascular diseases become common diseases seriously threatening the life health of people due to factors such as increasingly improved substance living standard of people, increasingly accelerated aging process of population and the like, and the aging trend is shown.

Intracranial aneurysms (INTRACRANIAL ANEURYSM, IAN) are common hemorrhagic cerebrovascular diseases, most frequently found on the wall of intracranial arterial blood vessels, are the most common cause of subarachnoid hemorrhage (Subarachnoid hemorrhage, SAH), and have a second only incidence of cerebral thrombosis and hypertensive cerebral hemorrhage. Currently intracranial arteries are commonly treated by craniotomy and intratumoral interventional embolization. Craniotomy clamping is required as the name implies, the operation risk is extremely large, the wound is large, the side effects are numerous, and the patient suffers from great pain. The intravascular interventional therapy has small wound, small operation risk and few side effects, and reduces the impact of blood flow on the wall of a tumor body blood vessel and the rupture risk by arranging a spring ring or an intratumoral turbulence device in the intracranial aneurysm body or arranging a covered stent or a dense-mesh stent in a tumor-carrying artery.

The embolism of the spring ring or the intratumoral turbulence device can promote the intratumoral thrombosis and promote the gradual healing of the aneurysm, but the packing density of the spring ring is not high enough, the neck of the aneurysm can not be completely plugged, and the recurrence rate is high. Intratumoral turbulators may later undergo device displacement resulting in recurrence of the aneurysm; the blood flow guiding devices such as the dense net stent or the covered stent have the blood flow guiding function, and form a plug at the neck of the aneurysm immediately after being placed in the parent artery, so that blood flow is prevented from entering the aneurysm, blood flow stasis and thrombus formation in the cavity of the aneurysm are promoted, and the aneurysm is gradually mechanized and contracted, so that the effect of healing is achieved. However, because the metal coverage rate of the dense-mesh stent is high, and the covered stent can form a complete seal on the wall of the blood vessel, the two treatment modes can influence the blood flow of the branch blood vessel, and ischemia is easy to cause. Thus, although having significant advantages, the method of endovascular intervention for the treatment of aneurysms has several problems, mainly including: 1) The spring ring embolism has lower efficiency, higher requirements on the skill and experience of doctors, more complex operation and easy herniation of the arterial tumor when being used alone; 2) When the blood flow guiding device is used, a patient needs to take the dual antiplatelet medicines for a long time after operation, and the risk of hemorrhagic complications exists; 3) The intra-tumor turbulent flow device is filled in the process, the top of the tumor with fragile far end can be touched, so that the aneurysm is broken in the operation, the long-term stability of the intra-tumor turbulent flow device in the tumor cavity is poor, and the risk of displacement exists.

It should be noted that the information disclosed in this background section is only for enhancement of understanding of the general background of the invention and should not be taken as an acknowledgement or any form of suggestion that this information forms the prior art already known to a person skilled in the art.

Disclosure of Invention

Therefore, the invention provides a plugging system and a plugging device, which can be used for plugging an aneurysm orifice or a cavernous fistula orifice, have good plugging effect and good stability, are not easy to damage the aneurysm top, and can reduce the risk of rupture of the aneurysm and the risk of delayed rupture.

In order to achieve the above object, the present invention provides an occlusion device having a compressed state and an expanded state and being switchable between the compressed state and the expanded state, the occlusion device comprising a tubular stent portion and a flow blocking portion; the cross section of the two ends of the tubular bracket part along the axial direction is larger than that of the middle part; the two ends of the tubular bracket part along the axial direction are respectively arranged at the inner side and the outer side of the target cavity opening so as to clamp the target cavity opening; the flow blocking portion is fixed inside the tubular stand portion and extends and spreads along a non-axial section of the tubular stand portion to block the target cavity opening by the flow blocking portion.

Optionally, the flow blocking portion is located between two ends of the tubular stand portion in the axial direction, and/or the flow blocking portion extends and spreads along a transverse cross section of the tubular stand portion.

Optionally, the choke part is a dense mesh braid or an elastic coating.

Optionally, the choke part and the tubular support part are integrally woven and formed, or the choke part and the tubular support part are integrally formed, and the choke part and the tubular support part are connected by glue, stitching or hot melting.

Optionally, the choke has a delivery hole allowing a delivery rod to pass through, the delivery hole being a mesh or a machined hole, the diameter of the delivery hole being adapted to the outer diameter of the delivery rod.

Optionally, two ends of the tubular support portion in the axial direction are arranged in a conical horn mouth shape, the middle portion is arranged in a straight tube shape, the length of the middle portion in the axial direction is adapted to the height of the target cavity opening, and the maximum diameter of the two ends of the tubular support portion in the axial direction is larger than the width of the target cavity opening.

Optionally, the tubular support part is made of a woven mesh tube, the woven mesh tube is woven by shape memory wires, or the woven mesh tube is woven by shape memory wires and developing wires in a mixed mode, or the tubular support part is cut by a tube with shape memory characteristics.

Optionally, the choke part is a dense mesh braiding body, the dense mesh braiding body is formed by braiding shape memory wires, or the dense mesh braiding body is formed by braiding shape memory wires and developing wires in a mixed mode.

To achieve the above object, the present invention also provides a plugging system comprising a conveying device and any one of the plugging devices, the conveying device comprising a conveying rod, the plugging device being for being pressed against the conveying rod to convey the plugging device by friction between the conveying rod and the plugging device.

Optionally, a pushing pad is disposed on a distal end surface of the delivery rod, the flow blocking portion has a delivery hole allowing the pushing pad to pass through, and the tubular support portion and the flow blocking portion are both configured to press-grip on the pushing pad.

Compared with the prior art, the plugging system and the plugging device have the following advantages:

The plugging device comprises a flow blocking part and a tubular bracket part; the cross section of the two ends of the tubular bracket part along the axial direction is larger than that of the middle part; the two ends of the tubular bracket part along the axial direction are respectively arranged at the inner side and the outer side of the target cavity opening so as to clamp the target cavity opening; the flow blocking portion is secured to the interior of the tubular stent portion and extends and spreads along a non-axial cross-section of the tubular stent portion to occlude the target stoma, such as an aneurysmal or spongy sinus stoma, with the flow blocking portion. By taking the aneurysm as a schematic illustration, the flow blocking part can achieve better blocking effect, can avoid the use of double-antibody medicaments, and particularly can reduce the influence on normal blood flow in blood vessels; moreover, the plugging device is only positioned at the neck of the aneurysm to avoid the top of the aneurysm, so that the top of the aneurysm is not easily damaged, and the rupture risk of the aneurysm is reduced; in addition, as only the neck of the aneurysm is plugged, the plugging device does not need to be matched with the shape of the aneurysm, and even if the shape of the aneurysm changes, the occlusion of the aneurysm can be ensured, so that the plugging device has strong adaptability to the aneurysms in various clinical forms and has wider clinical application range; furthermore, the release process of the plugging device is simplified, so that the dependence on the personal aneurysm embolism experience of an operator in the operation process can be reduced, and the operation time is shortened.

Further, the flow blocking portion is located between both ends of the tubular stand portion in the axial direction, and/or the flow blocking portion extends and spreads along the lateral cross section of the tubular stand portion. The design has the advantages that the scouring shearing force of the blood flowing in the normal direction in the blood vessel (artery) on the flow blocking part can be reduced, the stability and the firmness of the flow blocking part are improved, the flow blocking part can prevent the blood from entering the aneurysm or the cavernous fistula, the obstruction on the normal flowing blood flow in the blood vessel, especially the thinner blood vessel, is smaller, and the influence on the blood flow dynamics in the blood vessel is reduced.

Because the plugging system provided by the invention and the plugging device provided by the invention belong to the same conception, the plugging system provided by the invention has all the advantages of the plugging device provided by the invention, and the beneficial effects of the plugging system provided by the invention are not repeated here.

Drawings

The drawings provided by the invention are not necessarily to scale and some components and structures have been exaggerated for clarity. Variations of the illustrated embodiments are contemplated. Thus, the description of the various aspects and elements of the embodiments in the drawings is not intended to limit the scope of the invention. In the drawings:

FIG. 1 is a front view of an occluding device in accordance with a preferred embodiment of the present application;

FIG. 2 is a top view of an occluding device in accordance with a preferred embodiment of the present application;

FIG. 3 is a diagram showing the state of delivery of the occlusion device in a delivery catheter according to a preferred embodiment of the present application;

FIG. 4 is a diagram showing the occlusion device of the preferred embodiment of the present application being pushed out of the delivery catheter for release;

FIG. 5 is a schematic view showing the completed release of the occlusion device according to the preferred embodiment of the present application;

FIG. 6 is a bottom view of an occluding device in a plugged state in a vessel with a resistive portion being an elastic coating in accordance with a first embodiment of the present application;

Fig. 7 is a bottom view of a plugging device according to a second embodiment of the present application in a plugged state in a blood vessel, wherein the flow blocking portion is a dense mesh braid.

In the accompanying drawings:

100-plugging device; 110-a tubular stent section; 111-distal flare; 112-an intermediate portion; 113-proximal flare; 130-a choke; 131-a delivery orifice; 10-aneurysms; 11-tumor neck; 20-carrying a tumor artery; 30-a delivery catheter; 200-conveying device; 210-a conveying rod; 230-push pad.

Detailed Description

Various example embodiments are described below. These examples are non-limiting and it should be understood that they are intended to illustrate the broader application aspects of the apparatus, system, and method. The embodiments may be modified in numerous ways and equivalents without departing from the true spirit and scope of the present invention. In addition, many variations may be made to adapt a particular situation, material, composition of matter, process action or step, to the objective, spirit or scope of the present invention. All such variations are intended to be within the scope of the present invention.

Any dimensions described in the summary or detailed description are to be considered merely examples and are not limiting of the inventive subject matter unless set forth in the various example embodiments. Moreover, the various structures of the embodiments described herein will complement each other rather than be purely alternating unless so stated. In other words, structures from one embodiment may be freely combined with structures of other embodiments, as will be readily appreciated by those of ordinary skill in the art, unless such structures are described for substitution only.

In the present document, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions relative to each other from the perspective of an operator using the occlusion device or delivery device, although "proximal" and "distal" are not limiting, "proximal" generally refers to an end of the occlusion device or delivery device that is proximal to the operator during normal operation, and "distal" generally refers to an end that first enters the patient. The "distal" and "proximal" in the present document are not directed to the ends of the structure, but rather to relative positions, e.g. the distal end of the stent is not the end of the stent, but rather to a position relatively close to the end of the stent.

In the present document, "axial" generally refers to a direction along the central axis of the occlusion device or delivery device; "radial" generally refers to the diameter of the occluding device or delivery device, i.e., the direction perpendicular to the central axis; "circumferential" generally refers to a direction about the central axis of the occluding device or delivery device; "cross section" refers to a section perpendicular to the central axis of the occlusion device, the cross section of the occlusion device corresponding to the diameter of the target orifice; by "axial cross section" is meant a cross section parallel to the central axis of the occlusion device, the axial cross section being perpendicular to the cross section. Herein, "target stoma" refers primarily to the stoma of an aneurysm or the stoma of a cavernous fistula.

The core idea of the application is to provide an occlusion device and an occlusion system comprising an occlusion device; the occluding device is suitable for occlusion of intracranial aneurysms or occlusion of cavernous fistulae.

The occlusion device provided by the application has a compressed state and an expanded state, and is switchable between the compressed state and the expanded state. The plugging device comprises a tubular bracket part and a flow blocking part; the cross section of the two ends of the tubular bracket part along the axial direction is larger than that of the middle part; the two ends of the tubular bracket part along the axial direction are respectively arranged at the inner side and the outer side of the target cavity opening so as to clamp the target cavity opening; the flow blocking portion is fixed inside the tubular stand portion and extends and spreads along a non-axial section of the tubular stand portion to block the target cavity opening by the flow blocking portion.

When the plugging device is designed in such a way, the plugging device can be stably fixed at the target cavity opening through the two ends of the tubular bracket part along the axial direction, so that the plugging device is not easy to shift, the long-term stability is good, and the purpose of turbulent flow can be achieved through the flow blocking part. It is understood that the occlusion of the occlusion part against the target stoma is relatively complete, and the effect of preventing blood from entering the aneurysm or cavernous fistula is better, which is beneficial to the occlusion of the aneurysm or cavernous fistula. Moreover, the plugging device provided by the application can realize plugging treatment only at the target cavity opening, hardly enters into a blood vessel (such as an aneurysm-carrying artery), so that double-resistant medicines are not required to be taken for a long time, and the plugging device is not easy to contact and damage the top of a fragile aneurysm in the plugging process when the plugging device is particularly applied to the aneurysm embolism, thereby reducing the risk of rupture of the aneurysm. Therefore, when the plugging device provided by the application is used for plugging an aneurysm, the protection of a tumor top area is realized while the neck coverage of the aneurysm is improved, the long-term stability of the device in a tumor cavity is also improved, the recurrence risk of the aneurysm can be effectively reduced, and a better plugging effect can be achieved.

The application will be further described in connection with preferred embodiments. The following embodiments and features of the embodiments may be complemented or combined with each other without conflict. In the following description, an aneurysm occlusion is schematically illustrated, but a person skilled in the art shall be able to modify the following description to apply the occlusion device in the case of occluding a cavernous sinus stoma.

Fig. 1 and 2 show an exemplary structure of an occlusion device 100 provided in a preferred embodiment of the present application. As shown in fig. 1 and 2, the occluding device 100 includes a tubular stent section 110 and a flow blocking section 130. The tubular stent portion 110 is a mesh tube structure, and the intermediate portion 112 of the tubular stent portion 110 has a smaller cross section than the axial ends, i.e., the diameter of the axial ends of the tubular stent portion 110 is greater than the diameter of the intermediate portion 112 between the ends.

As shown in fig. 3 to 5, the tubular holder portion 110 is used in such a manner that the maximum diameter of both ends of the tubular holder portion 110 in the axial direction is larger than the width (i.e., diameter) of the neck opening 11, so that both ends of the tubular holder portion 110 in the axial direction are respectively arranged inside and outside the neck opening 11 to clamp the neck opening 11, in other words, both ends of the tubular holder portion 110 in the axial direction are respectively clamped on the aneurysm-carrying arterial side (outside) and the lumen side (inside) of the neck opening 11, thereby ensuring long-term stability of the occlusion device 100, reducing the risk of device displacement, and further reducing the risk of delayed rupture of the aneurysm 10.

Further, the two ends of the tubular support portion 110 along the axial direction are provided with conical flare shapes, and the middle portion 112 is provided with a straight tube shape, specifically, the two ends of the tubular support portion 110 along the axial direction are flare shapes, specifically, a distal flare 111 and a proximal flare 113, the distal flare 111 is clamped on the tumor cavity side of the tumor neck 11, and the proximal flare 113 is clamped on the tumor artery side of the tumor neck 11. The conical flare can better prevent the device from shifting. Further, the proximal flare 113 has a length (i.e., the length of the portion of the herniated parent artery 20) of 0.5mm to 2mm. It should be appreciated that it is acceptable for the portion of the tubular stent section 110 that herniates into the parent artery 20 to be less than 50% of the parent artery diameter. In addition, it should be understood that the stent struts at the two bell mouths of the tubular stent section 110 are sparsely distributed, so long as they serve as anchors, and thus have little effect on hemodynamics.

The tubular stent portion 110 may be made from a woven mesh tube or cut from tubing. The tubular stent portion 110 is made of a woven mesh tube. Preferably, the tubular stent portion 110 is braided and shaped from a shape memory wire, in particular a shape memory metal or shape memory plastic (conventional shape memory polymer), such that the tubular stent portion 110 assumes its final shape at normal or body temperature. Developing wires may be added during the braiding process, and the tubular stent portion 110 may be formed by mixed braiding of the shape memory wires and the developing wires to enhance the developing effect. If the tubular stent portion 110 can be formed using a braiding of DFT material, the DFT material is configured with a developed core wire plus a nitinol sleeve. The present invention does not exclude the case where the tubular stent portion 110 is not a woven mesh tube, for example, cut from a metal tube or cut from a tube having shape memory properties (primarily nitinol-based shape memory alloy). Because of the good flexibility of the woven mesh tube, the woven mesh tube is preferably used to make the tubular stent portion 110. The tubular stent portion 110 is often a self-expanding stent.

The length of the intermediate portion 112 of the tubular hanger part 110 in the axial direction is preferably configured to enable the two ends of the tubular hanger part 110 in the axial direction to firmly clamp the neck opening 11. The length of the intermediate portion 112 in the axial direction may be configured according to the height of the aneurysmal opening of different patients, e.g., different sizes of occluding device 100 may be provided clinically to accommodate different sizes of aneurysmal openings with different sizes of occluding device 100.

To achieve turbulent flow, the flow blocking portion 130 is fixed inside the tubular hanger part 110. After the choke portion 130 is fixed inside the tubular stand portion 110, the choke portion 130 is spread along a non-axial section of the tubular stand portion 110. The primary function of the flow blocking portion 130 is to occlude the neck 11 of the aneurysm 10, preventing blood from entering the aneurysm.

The choke 130 may be a tight mesh braid or an elastic coating. It can be understood that the braid with meshes smaller than 0.1mm ² is a dense-mesh braid, and the turbulent flow effect is achieved through the dense-mesh braid. The elastic coating has small gap and can play the role of turbulent flow. Therefore, the choke 130 can close the tumor neck 11 by its structure, thereby achieving better closing effect, avoiding the use of double-antibody drugs, and particularly reducing the influence on the normal blood flow in the blood vessel. It should be understood that the flow blocking portion 130 may extend along the cross section of the tubular support portion 110, that is, the flow blocking portion 130 is parallel to the cross section of the tubular support portion 110, at this time, the influence of the blood flowing in the normal direction in the parent artery 20 on the flow blocking portion 130 is smaller, so that the stability and firmness of the flow blocking portion 130 are better, and the influence on the blood flow dynamics in the blood vessel can be better reduced due to smaller obstruction on the blood flow flowing in the normal direction in the parent artery 20. However, in other embodiments, the flow blocking portion 130 may extend along an oblique cross-section that is at an angle to the cross-section of the tubular hanger part 110, so long as it does not extend along the axial cross-section of the tubular hanger part 110.

Further, the choke portion 130 is located between both ends of the tubular hanger part 110 in the axial direction instead of both ends of the tubular hanger part 110. The advantages of this design are similar to those described above, not only can the scouring shear force of the blood flowing in the normal direction in the parent artery 20 on the flow blocking portion 130 be reduced, and the stability and firmness of the flow blocking portion 130 are improved, but also because the position of the flow blocking portion 130 is in the inner middle portion 112 of the tubular support portion 110, the flow blocking portion 130 can prevent the blood from entering the aneurysm 10, and on the basis of preventing the blood from entering the aneurysm 10, the obstruction on the normal flowing blood flow in the parent artery 20, especially in the finer blood vessels, is smaller, so that the influence on the blood flow dynamics in the parent artery 20 is better reduced. In this embodiment, the choke portion 130 is located between two ends of the tubular support portion 110 in the axial direction, and the choke portion 130 spans across the cross section of the tubular support portion 110, so that the effect is better. The intermediate portion 112 of the tubular holder portion 110 should not be construed as an absolute intermediate position, but as a portion located between both axial ends of the tubular holder portion 110.

Furthermore, the occluding device 100 may have a compressed state and an expanded state, and may generally be switched between the expanded state and the compressed state. The expanded state is understood to be the filled state (i.e., the implanted state) when the occluding device 100 is filled within the aneurysm 10 after being pushed out of the delivery catheter 30, and the natural expanded state when the occluding device 100 is not in use and is not acted upon by an external force. The compressed state is generally the state of the occluding device 100 when compressed within the delivery sheath 30. The occluding device 100 may be elongated, such as by being elongated in a straight shape, with a small radial dimension in the delivery sheath 30 for delivery. It should be further appreciated that the plugging device 100 according to the preferred embodiment of the present application is only located at the neck of the aneurysm, does not fill the whole aneurysm 10, and in this way, is not easy to damage the top of the aneurysm, thus reducing the risk of rupture of the aneurysm, and since the neck 11 of the aneurysm is only plugged, the shape of the aneurysm is not required to be adapted, and even if the shape of the aneurysm changes, the occlusion of the aneurysm can be ensured, so that the plugging device 100 has strong adaptability to aneurysms of various clinical forms, and has a wide clinical application range.

Further, the preferred embodiment of the present application also provides an occlusion system comprising a delivery device 200 and an occlusion device 100, see in particular figures 3 to 5.

As shown in fig. 3 to 5, the delivery device 200 is used for delivering the occlusion device 100. The delivery device 200 comprises a delivery rod 210 and the occluding device 100 is adapted to be crimped onto the delivery rod 210 to deliver the occluding device 100 by friction between the delivery rod 210 and the occluding device 100. In practice, the delivery rod 210 passes axially through the occluding device 100 and uses friction between the tubular stent portion 110 and the delivery rod 210 to advance the occluding device 100. During delivery, the occluding device 100 is elongated and positioned within the delivery sheath 30 and the delivery rod 210 is required to pass through the flow blocking portion 130 to sheath the entire occluding device 100 over the delivery rod 210. The delivery rod 210 may advance the occluding device 100 within the delivery sheath 30 to approximate the occluding device 100 to the lesion.

Further, the choke 130 has a delivery hole 131 (see fig. 6 and 7) allowing the delivery rod 210 to pass therethrough, and the delivery hole 131 may be a mesh or a machined hole. The processing holes are holes formed by additional processing, and the mesh holes are holes of the dense mesh braiding body. The diameter of the delivery bore 131 generally adapts to the outer diameter of the delivery rod 210. The adaptation here is understood to mean that the diameter of the delivery opening 131 is slightly larger than the outer diameter of the delivery rod 210, or that the diameter of the delivery opening 131 is slightly smaller than the outer diameter of the delivery rod 210, or that the diameter of the delivery opening 131 is equal to the outer diameter of the delivery rod 210. If the choke 130 is a tight weave, the mesh may have a distance between opposite sides slightly greater than the outer diameter of the rod 210. If the choke 130 is an elastic coating, the diameter of the processing hole on the elastic coating may be smaller, equal to or larger than the outer diameter of the conveying rod 210 because the ductility of the elastic coating is good. In this embodiment, the diameter of the delivery hole 131 may be set according to the outer diameter of the conventional delivery rod 210, for example, the diameter of the delivery hole 131 is controlled to be within 0.58mm. It should also be appreciated that when the flow blocking portion 130 is a tight mesh weave, the conveying rod 210 need only traverse a certain position of the mesh, and the mesh is preferably spaced no more than 0.58mm across. The delivery orifice 131 is generally centered in the flow blocking portion 130.

It will be appreciated that since the number of delivery openings 131 is one, the delivery openings 131 do not affect the effect of the flow blocking portion 130 in blocking blood flow into the aneurysm 10 for the entire flow blocking portion 130.

The connection between the choke portion 130 and the tubular hanger portion 110 is not limited, and an appropriate connection is generally selected according to the structure of the choke portion 130.

Further, the choke part 130 and the tubular support part 110 are integrally woven, or the choke part 130 and the tubular support part 110 are formed separately, and during the separate forming, the choke part 130 and the tubular support part 110 can be connected by glue, stitching or hot melting, or multiple connection modes can be adopted at the same time. Specifically, when the choke part 130 is a dense mesh braid, the choke part 130 may be integrally woven with the tubular support part 110, or the tubular support part 110 and the choke part 130 may be woven separately, and then the choke part 130 and the tubular support part 110 may be connected by glue, stitching, hot melting, or the like. When the choke portion 130 is an elastic film, the elastic film may be connected to the tubular support portion 110 by glue, stitching, hot melting, or the like. It should be appreciated that the edge of the flow blocking portion 130 is connected to the tubular hanger part 110, which corresponds to having the flow blocking portion 130 cover the inner cavity of the tubular hanger part 110.

The specific material for preparing the choke 130 is not limited, and can be a medical material with good biocompatibility, such as a medical metal material or a medical polymer material, and the medical metal material is usually a shape memory alloy material, such as nickel-titanium alloy, and the medical polymer material can be a material with good strength and good elasticity, such as TPU, PU, silica gel, and the like, or a material PTFE, ePTFE, PLA, PLC, PLGA, PA, and the like. Further, the choke 130 is a dense mesh braid, which is woven from shape memory filaments, or a dense mesh braid, which is woven from a mixture of shape memory filaments and developing filaments, to improve the developing property. The number of the flow blocking portions 130 may be one or more, and a plurality of flow blocking portions 130 are distributed along the axial direction of the tubular stand portion 110, and in this embodiment, one flow blocking portion 130 is schematically illustrated.

Referring to fig. 3 and 4, in one embodiment, the distal end surface of the delivery rod 210 is provided with at least one push pad 230, and the tubular support portion 110 and the flow blocking portion 130 are each configured to press against the push pad 230 to deliver the occlusion device 100 by friction between the push pad 230 and the tubular support portion 110 and the flow blocking portion 130. Most of the push pad 230 is an elastic film, the push pad 230 is made of a polymer material with better elasticity, and preferably, the push pad 230 is a silica gel film. The push pad 230 should be capable of passing through the flow-blocking portion 130, such as the delivery aperture 131 on the flow-blocking portion 130 configured to be passed by the push pad 230, the maximum outer diameter of the push pad 230 not exceeding the diameter of the delivery aperture 131, such as the maximum outer diameter of the push pad 230 not exceeding 0.58mm. Further, the number of push pads 230 is plural, and the plurality of push pads 230 are disposed at intervals along the axial direction of the delivery rod 210, which makes the delivery rod 210 contact with the tubular support portion 110 and the choke portion 130 through the plurality of push pads 230, thereby increasing friction and reducing the risk of the plugging device 100 falling off. The push pad 230 is preferably disposed along the axial direction of the tubular stand portion 110, for example, the proximal end, the middle portion and the distal end of the tubular stand portion 110 are each provided with the push pad 230, and in particular, the push pad 230 may be provided in two or three.

In specific use, the preset plugging device 100 is sleeved on the position of the distal end of the conveying rod 210 with the pushing pad 230, and then the plugging device 100 is stretched into an elongated shape along the axial direction and enters the conveying catheter 30 together with the conveying rod 210, and at this time, the conveying of the plugging device 100 can be realized through friction between the pushing pad 230 and the plugging device 100.

The process of delivering the occluding device 100 will be further described.

In using the occluding device 100, the occluding device 100 which has been fabricated and shaped in vitro is first elongated into the delivery sheath 30, and then the delivery rod 210 is passed through the occluding device 100 to deliver the occluding device 100 via the delivery rod 210. The distal end of the delivery catheter 30 reaches the lesion first, then the occluding device 100 also reaches the lesion under delivery of the delivery sheath 210, after which the occluding device 100 is released from the body to the shape. During release, the tubular stent 110 of the occluding device 100 is partially within the lumen of the aneurysm and partially within the parent artery 20. The entire delivery and release procedure may be released under angiography, the position and morphology of the occluding device 100 may be indicated by the visualization points and/or visualization wires, and the delivery sheath may be retracted by adjusting the delivery rod 210 to withdraw the occluding device 100 into the delivery sheath 30 until the release position is satisfactory, and the following procedure may be performed. It will be appreciated that after the occluding device 100 has been delivered to the lesion by the delivery sheath 210, the occluding device 100 is slowly pushed out of the delivery sheath 30 and automatically opened to release the occluding device 100 to the desired expanded state due to the pre-shaped configuration of the occluding device 100. After release of the occluding device 100 is completed, the delivery rod 210 and delivery catheter 30 are withdrawn.

Fig. 5 shows the occlusion device 100 in a fully released configuration within the aneurysm 10. After release within the aneurysm 10, the distal flare 111 of the tubular stent section 110 should be located on the luminal side of the neck 11 of the aneurysm, and the proximal flare 113 of the tubular stent section 110 should be located on the aortic side of the neck of the aneurysm, with the intermediate section 112 of the tubular stent section 110 disposed within the neck 11 of the aneurysm, in such a way that the entire tubular stent section 110 is clamped against the neck 11 of the aneurysm for stable support, so that the occluding device 100 can be securely fastened to the neck of the aneurysm, effectively preventing displacement of the device, while the flow blocking section 130 at this time acts to occlude the neck of the aneurysm, preventing blood from entering the lumen of the aneurysm. Thus, the entire occluding device 100 is positioned at the neck of the aneurysm, with little impact on the walls and fragile roof of the aneurysm while effectively covering the neck 11, reducing the risk of rupture of the aneurysm.

The following describes the technical scheme of the plugging device 100 according to the present application with reference to specific embodiments.

[ Embodiment one ]

In one embodiment, as shown in fig. 6, the choke 130 may be made of a biopolymer material film with a certain strength, where the choke 130 is an elastic film, and a delivery hole 131 is left in the center of the elastic film. In delivery, the entire occluding device 100 may be sleeved over the delivery rod 210, preferably over the push pad 230, through the delivery port 131. During the filling process, the distal flare 111 of the tubular stent section 110 is formed in the tumor cavity, and then gradually pushed out of the delivery catheter 30 until the proximal end is released, and the proximal flare 113 is opened and formed in the parent artery to play a role of anchoring.

It will be appreciated that the parent artery 20 in fig. 6 is located below the aneurysm 10, the closure of the aneurysm 10 towards the parent artery 20 is achieved by an elastic coating visible from above, and the two flared ends of the tubular stent portion 110 are respectively erected on the parent artery side and the parent neck side of the parent neck 11, so that the plugging device 100 is tightly attached to the parent neck (i.e. away from the parent roof), and will not damage the fragile parent roof, and meanwhile, the stability is better because both the proximal end and the distal end of the plugging device 100 can play a limiting role. In addition, the elastic membrane provides scaffolding for cells to facilitate endothelialization of the neck of the aneurysm 10 while preventing blood from entering the aneurysm.

[ Example two ]

In one embodiment, as shown in fig. 7, the choke 130 may be formed by braiding shape memory filaments, where the choke 130 is a tight mesh braid. Because mesh openings are formed between the braided wires, a mesh opening at a more central position can be selected as the conveying hole 131. In delivery, the entire occluding device 100 is sleeved over the delivery rod 210, preferably over the push pad 230, through a mesh. During the filling process, the distal flare 111 of the tubular stent section 110 is formed in the tumor cavity, and then gradually pushed out of the delivery catheter 30 until the proximal end is released, and the proximal flare 113 is opened and formed in the parent artery to play a role of anchoring.

It will be appreciated that the parent artery 20 in fig. 7 is located below the aneurysm 10, the closure of the aneurysm 10 towards the parent artery 20 is achieved by a dense mesh braid seen from above, and the two flared ends of the tubular stent portion 110 are respectively erected on the parent artery side and the parent neck side of the parent neck 11, so that the plugging device 100 is tightly attached to the parent neck (i.e. away from the parent roof), and will not damage the fragile parent roof, and meanwhile, the stability is better because both the proximal end and the distal end of the plugging device 100 can play a limiting role. In addition, the dense mesh braid prevents blood from entering the aneurysm and provides scaffolds for cells so as to facilitate endothelialization of the neck of the aneurysm.

Compared with the prior art, the plugging device provided by the embodiment of the invention has the following advantages:

(1) The occlusion effect can be better achieved through the flow blocking part, the use of double-antibody medicines is avoided, the influence on normal blood flow in blood vessels can be reduced, and the long-term stability of the plugging device is ensured through the tubular support part, so that the plugging device is not easy to shift;

(2) The plugging device is only positioned at the neck of the aneurysm, so that the top of the aneurysm is not easily damaged, and the rupture risk of the aneurysm is reduced;

(3) The plugging device only plugs the neck of the aneurysm, does not need to adapt to the shape of the aneurysm, and can ensure the occlusion of the aneurysm even if the shape of the aneurysm changes, so that the plugging device has strong adaptability to the aneurysms with various clinical forms and has wider clinical application range;

(4) The plugging device has the advantages of simple structure, short release length and simple release process, can reduce the dependence on the personal aneurysm embolism experience of an operator in the operation process, and reduces the operation time;

(5) The flow blocking part is positioned between two ends of the tubular support part along the axial direction, and/or the flow blocking part extends and spreads along the transverse section of the tubular support part, so that the scouring shearing force of blood flowing in the normal direction in the carrying aneurysm on the flow blocking part can be reduced, the stability and firmness of the flow blocking part are improved, and the flow blocking part can prevent the blood from entering the aneurysm, so that the blocking part has smaller obstruction on the normal flowing blood flow in the carrying aneurysm artery, especially finer blood vessels, and the influence on the hemodynamics in the carrying aneurysm is reduced.

It should be further understood that, since the plugging system provided by the present invention and the plugging device provided by the present invention belong to the same inventive concept, the plugging system provided by the present invention has all the advantages of the plugging device provided by the present invention, and the beneficial effects of the plugging system provided by the present invention will not be described in detail herein

It should be noted that, although the innovation of the present invention is derived from the technical field of embolization of aneurysms, those skilled in the art can understand that the present invention can also be applied to the technical field of embolization of other vascular abnormal bleeding openings, such as sponge Dou Lou, and fistula can be formed after the sponge sinus fistula is ruptured, and the plugging device can plug the fistula according to actual needs, even can be applied to other fields in which the problems of lumen occlusion and the like need to be solved, and the technical concept of the present invention can be applied, and only structural adaptive adjustment is needed.

It should be noted that, in the present description, each embodiment is described in a progressive manner, and each embodiment is mainly described in a different manner from other embodiments, and identical and similar parts between the embodiments are all enough to refer to each other. For the system disclosed in the embodiment, the description is relatively simple because of corresponding to the method disclosed in the embodiment, and the relevant points refer to the description of the method section.

It should be further noted that although the present invention has been disclosed in the preferred embodiments, the above embodiments are not intended to limit the present invention. Many possible variations and modifications of the disclosed technology can be made by anyone skilled in the art without departing from the scope of the technology, or the technology can be modified to be equivalent. Therefore, any simple modification, equivalent variation and modification of the above embodiments according to the technical substance of the present invention still fall within the scope of the technical solution of the present invention.

It should also be understood that the terminology described herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention. It must be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, reference to "a step" or "an apparatus" means a reference to one or more steps or apparatuses, and may include sub-steps as well as sub-apparatuses. All conjunctions used should be understood in the broadest sense. And, the word "or" should be understood as having the definition of a logical "or" rather than a logical "exclusive or" unless the context clearly indicates the contrary. Furthermore, implementation of the methods and/or apparatus in embodiments of the invention may include performing selected tasks manually, automatically, or in combination.

Claims (10)

1. An occlusion device having a compressed state and an expanded state and being switchable between the compressed state and the expanded state, characterized in that the occlusion device comprises a tubular stent portion and a flow blocking portion; the cross section of the two ends of the tubular bracket part along the axial direction is larger than that of the middle part; the two ends of the tubular bracket part along the axial direction are respectively arranged at the inner side and the outer side of the target cavity opening so as to clamp the target cavity opening; the flow blocking portion is fixed inside the tubular stand portion and extends and spreads along a non-axial section of the tubular stand portion to block the target cavity opening by the flow blocking portion.

2. The occlusion device of claim 1, wherein said flow-blocking portion is located between two ends of said tubular stent portion in an axial direction and/or said flow-blocking portion extends along a transverse cross-section of said tubular stent portion.

3. The occlusion device of claim 1 or 2, wherein said flow blocking portion is a tight mesh braid or an elastic membrane.

4. The occlusion device of claim 1 or 2, wherein said flow blocking portion is integrally woven with said tubular stent portion or said flow blocking portion is integrally formed with said tubular stent portion, said flow blocking portion being glue, suture or hot melt connected to said tubular stent portion.

5. The occlusion device of claim 1 or 2, wherein said flow blocking portion has a delivery aperture allowing a delivery rod to pass therethrough, said delivery aperture being a mesh or a machined aperture, the diameter of said delivery aperture being adapted to the outer diameter of said delivery rod.

6. The plugging device according to claim 1 or 2, wherein both ends of the tubular holder portion in the axial direction are provided in a tapered horn mouth shape, and the intermediate portion is provided in a straight tubular shape, the length of the intermediate portion in the axial direction is adapted to the height of the target orifice, and the maximum diameter of both ends of the tubular holder portion in the axial direction is larger than the width of the target orifice.

7. The occlusion device according to claim 1 or 2, wherein said tubular stent portion is made of a woven mesh tube woven from shape memory filaments, or said woven mesh tube is woven from a mixture of shape memory filaments and developing filaments, or said tubular stent portion is cut from a tube having shape memory properties.

8. The plugging device of claim 1 or 2, wherein the flow blocking portion is a tight mesh braid, the tight mesh braid being braided from shape memory filaments, or the tight mesh braid being braided from a mixture of shape memory filaments and developing filaments.

9. A closure system comprising a delivery device and the closure device of any one of claims 1-8, the delivery device comprising a delivery rod, the closure device being adapted to be crimped onto the delivery rod to deliver the closure device by friction between the delivery rod and the closure device.

10. The occlusion system of claim 9, wherein said delivery rod has a push pad disposed on a distal surface thereof, said flow blocking portion having a delivery aperture therethrough allowing said push pad, said tubular support portion and said flow blocking portion each adapted to be crimped onto said push pad.