CN115137437A - Interlayer crevasse plugging instrument - Google Patents

Abstract

The invention provides an interlayer crevasse plugging instrument which is provided with an anchoring mechanism and a spring ring, wherein the anchoring mechanism comprises a main anchor hook body and an anchor hook body, the main anchor hook body is of a tubular structure with an inner cavity, the near end of the main anchor hook body is connected with the near end of the spring ring through the inner cavity, the far end of the anchor hook body is a free end and can be freely bounced open and compressed relative to the far end of the main anchor hook body, the spring ring is in a preset three-dimensional shape, accurate anchoring is realized through the anchoring mechanism, the spring ring is in the preset three-dimensional shape in a free state, the self-adaptability and the shape-preserving capability are realized, the spring ring cannot be displaced under the action of blood flow or gravity, accurate crevasse plugging is realized, and the interlayer crevasse plugging instrument can effectively adapt to the anatomical characteristics of interlayer far ends of most patients.

Description

Interlayer crevasse plugging instrument

Technical Field

The invention relates to the technical field of medical instruments, in particular to an interlayer laceration plugging instrument.

Background

Aortic endoluminal repair (EVAR) is currently the primary treatment for aortic dissection. Most aortic dissection patients can simultaneously have a plurality of lacerations, and the current principle of the endovascular repair treatment is to use a bare stent to seal the near-end laceration of the dissection, but the far-end laceration cannot be isolated by the bare stent due to the existence of branch blood vessels. Open placement of a distal laceration can lead to serious complications, such as poor perfusion of organ branches, formation of a dissecting aneurysm, even rupture and death.

However, the existing interlayer breach plugging device has the following defects: (1) The existing plugging disc or plugging device can not adapt to the anatomical characteristics of all the far-end crevasses of the interlayer, such as the situation that the crevasses are positioned at the edge of a membrane in the interlayer; (2) The existing spring ring is used as an occluder, the number of the spring rings is large, the spring rings are easy to fall off, the displacement risk is easy to generate, and the patient faces serious consequences such as thrombus and ischemia.

Disclosure of Invention

The invention aims to provide an interlayer crevasse plugging device which can prevent the device from shifting, has self-adaptability and shape-preserving capability and is suitable for more interlayer crevasses.

In order to achieve the aim, the invention provides an interlayer laceration plugging device which comprises an anchoring mechanism and a spring ring; the anchoring mechanism comprises an anchor hook main body and an anchor hook body, wherein the anchor hook main body is a tubular structure with an inner cavity, the proximal end of the anchor hook main body is connected with the proximal end of the spring ring, the distal end of the anchor hook main body is connected with the proximal end of the anchor hook body, the anchor hook body comprises at least 2 rod-shaped structures, and the distal end of the anchor hook body is a free end and can be freely bounced and compressed relative to the distal end of the anchor hook main body; the spring ring is connected to the anchoring mechanism in a predetermined three-dimensional shape.

Optionally, in a free state, the anchor mechanism body and an axis of the anchor main body form a predetermined included angle, and the predetermined included angle is 30 ° to 90 °.

Optionally, the proximal end of the spring ring extends into the lumen of the anchor body and is mechanically or by welding attached to the proximal end of the anchor body.

Optionally, the rod-like structure is of the same width from the proximal end to the distal end, or gradually widens, or the distal end of the rod-like structure is wider relative to other parts of the rod-like structure, and the outer periphery of the distal end is rounded.

Optionally, the spring coil includes a core wire that is a shape memory material and takes the predetermined three-dimensional shape in a free state, and a spring wire that is wound around the core wire as an axis and is spirally wound around the core wire.

Optionally, the core wire has a straight section unit and a plurality of arc-like units in a free state; the near-end of core silk does the straight section unit just the one end of straight section unit with the near-end of anchoring main part links to each other, the other end of straight section unit with one the class circular arc unit links to each other, and is a plurality of the class circular arc unit distributes on the sphere of same hemisphere or the ellipsoid of same semiellipsoid and hugs closely the sphere of hemisphere or the ellipsoid coiling of semiellipsoid is shaped, the straight section unit is located on the center pin of spring coil, so that anchoring mechanism connects between two parties the spring coil.

Optionally, the plurality of arc-like units are distributed in at least one layer on the spherical surface of the same hemisphere or the ellipsoidal surface of the same hemisphere, and at least two arc-like units in the same layer are overlapped.

Optionally, the plurality of layers of arc-like units are arranged layer by layer along a direction from the top to the bottom of the spherical surface of the semi-sphere or from the top to the bottom of the ellipsoidal surface of the semi-ellipsoid, and the top of the arc-like unit of the next layer is pressed on the bottom of the arc-like unit of the previous layer.

Optionally, the spring coil further comprises an embolic cilium, wherein the embolic cilium is fixed on the core wire or the spring wire in a knotted or winding manner and is in an untwisted state and/or a twisted state.

Optionally, the single side length of said embolic cilia is less than or equal to the spacing between adjacent said embolic cilia.

Optionally, at least part of the distal end and/or the middle part of the rod-like structure is provided with a visualization structure.

Optionally, the interlayer breach sealing device further comprises a release member connected to the distal end of the spring ring.

Optionally, the interlayer breach plugging device further comprises a bare support with a lumen, an anchor hook body of the anchoring mechanism is lapped on the inner wall of the lumen of the bare support, the spring ring connected with the anchoring mechanism is located on the outer wall of the lumen of the bare support, the bare support has a hollowed-out structure, and the anchoring mechanism is used for being inserted into the hollowed-out structure and connected with the bare support.

Compared with the prior art, the technical scheme of the invention has at least one of the following beneficial effects:

1. according to the interlayer crevasse plugging instrument, accurate anchoring can be achieved through the anchoring mechanism, the spring ring is in the preset three-dimensional shape in a free state and cannot shift under the action of blood flow or gravity, so that the problem of shifting risk of the existing interlayer crevasse plugging instrument is solved, crevasse accurate plugging is achieved, and the interlayer crevasse plugging instrument has certain self-adaptability and can effectively adapt to the anatomical characteristics of far-end crevasses of most of patients.

2. The spring coil can be in a preset three-dimensional shape in a free state, so that the use number of the spring coil is reduced and the economic burden of a patient is reduced compared with the existing interlayer breach plugging device.

3. The spring ring forms a hemispherical or semi-ellipsoidal three-dimensional structure through one layer and more than one layer of arc-like units formed by core wire lap winding and shaping, can have good plugging property, self-adaptability and shape-preserving property at the same time, can be widely applied to various crevasses and can improve crevasse plugging efficiency.

Drawings

Fig. 1 is a schematic structural diagram of a sandwich breach sealing device according to an embodiment of the present invention.

Fig. 2 is a schematic view of an anchoring mechanism of an embodiment of the present invention compressed within the lumen of a delivery catheter.

Fig. 3 is a schematic illustration of an anchoring mechanism according to an embodiment of the present invention in a free state (i.e., deployed state).

FIG. 4 is a schematic illustration of a spring coil according to an embodiment of the present invention in a straightened condition.

Fig. 5 is a schematic view of core wire winding according to an embodiment of the present invention.

Fig. 6 is a schematic view of a spring coil according to an embodiment of the present invention in a free state (i.e., after being released).

FIG. 7 is a schematic view of a interbedded breach closure device of an embodiment of the present invention preloaded into a delivery system.

FIG. 8 is a schematic view of a dissection breach occluding device according to an embodiment of the invention after being applied to a distal breach of an aortic dissection.

FIG. 9 is a schematic view of a sandwich breach occluding device of an embodiment of the present invention anchored to a bare stent.

Fig. 10 to 14 are schematic diagrams respectively illustrating different examples of the development structure provided on the fluke body in the interlayer breach sealing device according to the embodiment of the present invention.

Detailed Description

In the following description, numerous specific details are set forth in order to provide a more thorough understanding of the present invention. It will be apparent, however, to one skilled in the art, that the present invention may be practiced without one or more of these specific details. In other instances, well-known features have not been described in order to avoid obscuring the present invention. It is to be understood that the present invention may be embodied in many different forms and should not be construed as 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 invention to those skilled in the art. In the drawings, the size and relative sizes of layers and regions may be exaggerated for clarity. Like reference numerals refer to like elements throughout. It will be understood that when an element or layer is referred to as being "on" \8230 "", "connected to" other elements or layers, it can be directly on the other elements or layers, the other elements or layers can be connected, or intervening elements or layers can be present. In contrast, when an element is referred to as being "directly on" \8230 "; or" directly connected to "another element or layer, there are no intervening elements or layers present. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatial descriptors used herein interpreted accordingly. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising" are used in an inclusive sense to 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. As used herein, the term "and/or" includes any and all combinations of the associated listed items. The term "proximal" in this context is the end near the heart. Meanwhile, one side close to the true lumen of the blood vessel in the present application is the inner side, and the other side is the outer side.

The technical solution proposed by the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become more apparent from the following description. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.

Referring to fig. 1 to 7, an embodiment of the present invention provides a dissection occluding device including an anchoring mechanism 100, a spring ring 200 and a release member 300.

Alternatively, anchoring mechanism 100 is a one-piece structure, which is made of a metal tube with shape memory. As an example, the anchoring mechanism 100 may be formed from a metal tube of nitinol by laser cutting.

Referring now to fig. 2 and 3, in the present embodiment, the anchoring mechanism 100 includes a main body 101 and a hook body, the main body 101 is a tubular structure having an axially through lumen 103, and the proximal end of the spring ring 200 extends into the lumen 103 and is mechanically connected or welded to the proximal end of the main body 101. The fluke body comprises at least 2 rod-like structures 102, the number of rod-like structures 102 may also be multiple (e.g. 3 or more than 3), and the individual rod-like structures 102 are evenly spaced along the circumference of the distal end of the fluke body 101. The proximal ends of all of the rod-like structures 102 may be integrally formed structures to form the proximal end of the fluke body and connected to the distal end of the fluke body 101, the distal end of each rod-like structure 102 being free and capable of being freely sprung and compressed relative to the distal end of the fluke body 101, and in the freely sprung state (i.e., free state), each rod-like structure 102 being expanded by a predetermined angle relative to the central axis (or axial center) of the fluke body 101. Preferably, each rod-like structure 102 is deployed at the same angle relative to the central axis of the fluke body 101, so that the forces experienced by each rod-like structure 102 are the same after the interbedded breach sealing device has been implanted in the body. As an example, the predetermined included angle θ is 30 to 90, and the larger the angle, the smaller the space occupied by the anchoring mechanism 100 and the better the snap fit with the spring ring 200.

Referring specifically to fig. 3, in the embodiment of fig. 3, the fluke body has 4 rod-shaped structures 102, wherein after the 4 rod-shaped structures 102 are unfolded relative to the fluke body 101, two rod-shaped structures 102 protrude out of the paper and form an angle θ of 30 ° to 90 ° (not shown) with the central axis of the fluke body 101, and two rod-shaped structures 102 are parallel to the paper (i.e., in the paper), so that the angle θ between the rod-shaped structures 102 parallel to the paper and the central axis of the fluke body 101 is 30 ° to 90 °.

Referring to fig. 2, 3 and 7, each rod-like structure 102, when compressed to some extent, can abut against the spring coil 200, so that the anchoring mechanism 100 can be compressed within the lumen of a sized delivery catheter 400, and after the lumen of the delivery catheter 400 is removed, the distal end of each rod-like structure 102 can spring freely, so that the anchoring mechanism 100 can return to a pre-formed shape (e.g., in the shape of an umbrella frame).

Alternatively, as shown in fig. 1, the proximal end of the spring ring 200 passes through the lumen 103 of the anchor body 101 and is aligned with the proximal end of the anchor body 101 and is laser welded together, and further, the proximal end of the anchor body 101 together with the outer surface of the proximal end of the spring ring 200 welded together are laser welded to be melted into a rounded spherical surface and are closed (i.e., the proximal end of the lumen 103 is closed) so as not to damage the blood vessel; the outer edge (or outer edge) of the distal end of each rod-like structure 102 is rounded or blunt, and has a circular arc-like shape, such as a circular arc or an approximate circular arc, so as to avoid damaging the blood vessel.

The shape and width of the rod-like structure 102 are not particularly limited, and need to meet the requirements of mechanical strength and safety for implantation and occlusion.

As an example, the width of the rod-like structure 102 from the proximal end to the distal end is equal, or gradually wider, or first narrower and then wider, or the distal end of the rod-like structure 102 is wider relative to the rest of the rod-like structure 102 and the outer edge of the distal end is rounded, etc. Preferably, the width of the rod-like structure 102 gradually widens from the proximal end to the distal end, and the outer edge of the distal end is rounded, or the distal end of the rod-like structure 102 is wider and rounded relative to other parts of the rod-like structure 102, as shown in fig. 11 to 14, so that the fluke body 102 has a wider distal end, and the distal end is rounded and has a relatively larger contact area with the blood vessel, so that the pressure on the blood vessel wall can be relatively reduced, and the irritation or damage on the blood vessel wall can be reduced, and the narrower proximal end of the rod-like structure 102 can make the anchoring mechanism 100 more easily shape and push.

The spring coil 200 has a predetermined three-dimensional shape in a free state. The predetermined three-dimensional shape is, for example, a three-dimensional shape of a hemispherical crown type or a semi-ellipsoidal type. It should be understood that when the spring ring 200 is a three-dimensional structure (i.e., hemisphere) in the shape of a hemispherical crown, the structure is equivalent to the structure of a sphere that is left after being cut by a plane, and is not limited to a hemisphere that is cut by a plane where the sphere has a diameter, but may be a structure that is larger or smaller than a hemisphere. When the spring coil 200 is a semi-ellipsoidal three-dimensional structure, it is not limited to a structure in which an ellipsoid is sectioned by a plane in which the major axis or the minor axis is located, but may be a structure in which an ellipsoid is sectioned by a plane in which an arbitrary straight line is located in a direction parallel to the major axis or an arbitrary straight line is located in a direction parallel to the minor axis.

Referring with emphasis to figures 1, 4-6, a coil 200 is comprised of a core wire 201, a spring wire 202, and embolic cilia 203. The core wire 201 is a shape memory material, such as a metal material with shape memory (e.g. an elastic metal material such as nitinol), and can be made into a structure capable of assuming a predetermined three-dimensional shape in a free state by heat setting, and can be straightened after being compressed into the lumen of the delivery catheter 400 and can be restored to the predetermined three-dimensional shape after being released to a target site.

As an example, the core wire 201 is composed of straight segment units 201b and at least 3 arc-like units 201 a.

All the arc-like units 201a are distributed on the surface of the same mold 500 (which is a hemisphere or a semi-ellipsoid), and the forming method thereof is, for example: the core wire 201 is tightly attached to the surface of the mold 500 (i.e., the spherical surface of the hemisphere or the ellipsoidal surface of the semi-ellipsoid) to be wound into a plurality of circular or circular-like arc units 201a, at least one layer of circular-like arc units 201a can be wound on the surface of the mold 500 in an overlapping manner, at least two circular-like arc units 201a in two adjacent layers and/or the same layer of adjacent circular-like arc units 201a are overlapped, and the overlapping area of the corresponding circular-like arc units 201a can be adjusted according to requirements. For example, two adjacent arc-like units 201a in each layer of arc-like units 201a have approximately semicircular overlapping, and corresponding arc-like units 201a in two adjacent layers also have approximately semicircular overlapping.

In addition, the shape and the size of each arc-like unit 201a may be completely the same, or may not be completely the same, and the technical solution of the present invention is not particularly limited in this respect. As an example, all the arc-like cells 201a are the same size. As another example, the arc-like units 201a in the same layer have the same size, and the arc-like units 201a in different layers have different sizes. As yet another example, the diameters of the arc-like units 201a in the same layer are the same, the number of the arc-like units 201a in the next layer is greater than or equal to the number of the arc-like units 201a in the previous layer, and the diameter of the arc-like units 201a in the next layer is greater than the diameter of the arc-like units 201a in the previous layer.

A straight unit 201b is used to connect with the anchoring body 101, specifically, one end of the straight unit 201b is connected with the anchoring body 101 through the inner cavity 103, and the other end is connected with one of the arc-like units 201 a.

Preferably, in a natural state, the straight unit 201b extends along the central axis of the spring ring 200 in a predetermined three-dimensional shape and protrudes outward, thereby enabling the anchoring main body 101 to connect with the spring ring 200 from the central axis of the spring ring 200, so that the anchoring mechanism 100 connects with the spring ring 200 centrally, while the central axis of the anchoring mechanism 100 and the central axis of the spring ring 200 are coaxial, and after the fluke hooks are freely bounced open, the distal ends of the respective rod-shaped structures 102 are uniformly distributed on the same circle around a point on the central axis.

Further, as shown in fig. 5, the arc-like units 201a have at least two layers, and two adjacent layers of arc-like units 201a are overlapped, for example, in the two adjacent layers of arc-like units 201a, one layer relatively close to the top of the hemispherical or semi-ellipsoidal mold 500 is a first layer, and the other layer is a second layer, so that the second layer is at least partially pressed on the first layer to form an overlapped portion. As an example, the top of the second layer arc-like unit 201a is disposed near the bottom of the first layer arc-like unit 201 a. Optionally, the top of the arc-like unit 201a of the corresponding second layer is stacked on the bottom of the arc-like unit 201a of the corresponding first layer and has an approximately semicircular overlap with the arc-like unit 201a of the first layer.

It should be understood that the greater the number of layers of arc-like cells 201a, the greater the number of tops of the arc-like cells 201a in the subsequent layer is stacked at the intersections between the arc-like cells 201a in the previous layer, and thus, the smaller the blank of the permeation coil is, the better the vascular breach sealing effect is.

The spring wire 202 may be made of platinum tungsten wire, platinum gold wire, stainless steel wire, nickel titanium wire, or other metal wires, and the spring wire 202 is formed by coaxially and spirally winding the corresponding metal wires and is in a spring shape. That is, the spring wire 202 is wound around the heat-set core wire 201 after being formed, whereby the spring wire 202 is finally wound around the core wire 201 with the core wire 201 as an axis.

It should be noted that the core wire 201 is very thin, and the outer diameter of the spring of the hollow tubular-like structure formed by spirally winding the spring wire 202 on the core wire 201 is usually much larger than the diameter of the core wire 201, for example, 4 times to 5 times of the diameter of the core wire 201, so in this embodiment, when the spring wire 202 is sleeved on each arc-like unit 201a to form the corresponding arc-like spring, and the position of the corresponding arc-like spring can be adaptively adjusted under the effect of the tube diameter stacking height of the arc-like springs when the core wire is in a free state (i.e., when the spring ring is freely unfolded after being released to the broken opening), specifically, for example, the top of the second layer of arc-like spring is relatively moved upward to enclose the top of the first layer of arc-like spring, in conjunction with fig. 5, that the top of the second layer of arc-like unit 201a of the core wire 201 is moved upward along the spherical surface of the mold 500 to a degree higher than the top of the first layer of arc-like unit 201 a.

The embolic cilia 203 is a high polymer material wire which can be fixed on the core wire 201 or the spring wire 202 by knotting, embedding, winding and the like to form corresponding nodes of the embolic cilia, and the embolic cilia 203 can extend out from two sides of the core wire 201 or the spring wire 202 after being fixed on the core wire 201 or the spring wire 202.

The filaments of the cilia 203 may be in a loose state (i.e., untwisted state) and/or twisted state. That is, all the thrombogenic cilia 203 are in an untwisted state, or all the thrombogenic cilia 203 are in a twisted state, or a part of the thrombogenic cilia 203 are in an untwisted state, and a part of the thrombogenic cilia 203 are in a twisted state. The twisting is a process of winding raw material filaments into threads, one thread is composed of a plurality of filaments, the plurality of filaments are mutually wound to form a thread, and the tighter the plurality of filaments are wound, the higher the twist of the finally formed thread is, the firmer the thread is, and the fastness is good. Untwisting means that the filaments are not twisted with each other. In this embodiment, when the cilia 203 are in the untwisted state, the space filling property of the spring ring 200 is better; when the thrombolytic cilia 203 is in a twisted state, the cilia are easier to tie and fix, and the thread-off prevention performance is better, and the twisted state is preferred.

As shown in fig. 4 or fig. 6, a plurality of the embolic cilia 203 may be disposed along the axial direction of the core wire 201, and the total length of each of the embolic cilia 203 is equal to the sum of the single-side length L1 of the embolic cilia 203 protruding outwards from both sides of the core wire 201 and the length of the embolic cilia 203 used for forming the embolic cilia node. The unilateral lengths L1 of the same thrombus promoting cilia 203 respectively extending outwards from the two sides of the core wire 201 may be the same or different, the unilateral lengths L1 of the different thrombus promoting cilia 203 extending outwards from the same side of the core wire 201 may be the same or not completely the same, and the distances L2 between adjacent thrombus promoting cilia (i.e. the distances between adjacent thrombus promoting cilia nodes on the core wire) may be the same or not completely the same.

Optionally, the unilateral length L1 of the embolic cilia 203 is equal to (i.e. completely the same as or close to) the distance L2 between adjacent embolic cilia 203 (i.e. the distance between adjacent nodes of the embolic cilia on the core wire), thereby ensuring that the adjacent embolic cilia 203 are separated from each other in the same direction and do not overlap and interleave in the manufacturing process of the coil 200, and forming a good embolic effect by using the embolic cilia 203 after the interlayer laceration occlusion device is implanted into a human body, so that thrombus can be quickly formed at the laceration in practical application, and occlusion of the target laceration can be realized.

In other embodiments of the invention, the single-sided length L1 of the embolic cilia 203 may also be less than the spacing L2 between adjacent embolic cilia 203, thereby ensuring that adjacent embolic cilia 203 are separated from each other in the same direction and do not have problems with overlapping and interweaving during the coil manufacturing process.

Referring to fig. 7, the releasing member 300 is made of a metal material such as stainless steel, nitinol, platinum-iridium or a high-strength polymer material, the proximal end of the releasing member 300 is connected to the distal end of the spring wire 202 and/or the distal end of the core material 201, and when the spring ring 200 is pre-assembled in the lumen of the delivery catheter 400 in an approximately straightened state, the releasing member 300 is connected (the connection is releasable) to a similar structure on the push rod 600 in the sheath, so as to connect the spring ring 200 and the push rod 600 in the lumen of the delivery catheter 400. And when the spring ring 200 is pushed to a proper position in the human body, the releasing piece 300 can be separated from the push rod 600 through mechanical releasing, electrical releasing and the like, so that releasing and releasing of the spring ring 200 are realized.

As an example, the proximal end of the release member 300 is coupled to the distal end of the coil spring 200, and the distal end of the release member 300 is a hook that is adapted to engage the release distal end 601 of the pusher rod 600 in the delivery system, such that when the coil spring 200 is pre-loaded in a substantially straightened state in the lumen of a suitable delivery catheter 400, the release member 300 engages the release distal end 601 of the pusher rod 600 to couple the release member 300 to the pusher rod 600 within the delivery catheter 400.

In addition, the dissection treatment device of the embodiment also has a real-chamber graft, which can be a bare stent 700 with a lumen (not labeled), and the bare stent 700 can expand the real chamber through the lumen after being delivered into the real chamber of the aortic dissection. The bare bracket 700 has a hollow structure, and the anchoring mechanism 100 is inserted into the hollow structure and connected to the bare bracket 700. Wherein, after the anchoring mechanism 100 and the spring ring 200 are delivered to the aortic dissection and released, the anchoring mechanism 100 entirely passes through the hollowed structure (i.e. the mesh) of the bare stent 700 to enter the lumen of the bare stent 700 and release the spring, i.e. to be located in the lumen of the bare stent 700, the anchor hook body of the anchoring mechanism 100 is lapped on the inner wall of the lumen of the bare stent 700, the spring ring 200 connected with the anchoring mechanism 100 is located at the laceration close to the outer wall of the lumen of the bare stent 700 and takes a predetermined three-dimensional shape, and the spring ring 200 is used to fill the false lumen to realize the plugging of the aortic dissection.

With further reference to fig. 8 and 9, when aortic dissection occurs in a patient, the aortic intima tears, allowing the media to separate and form a true lumen and a false lumen in the vessel, and the true lumen and the false lumen are typically in communication through a laceration. At this time, the aortic dissection treatment can be performed by using the dissection and tear blocking device of the embodiment, and the specific process is as follows:

first, the bare stent 700 is delivered into the true lumen of a diseased vessel (e.g., a diseased aorta) and to the vicinity of the laceration site by a delivery system (e.g., a delivery catheter assembly including an inner sheath and an outer sheath), and the corresponding mechanism (e.g., the outer sheath, etc.) of the delivery system is withdrawn to release the bare stent 700, so that the true lumen of the diseased vessel can be supported by the bare stent 700.

Next, the assembled anchoring mechanism 100, spring coil 200, and release element 300 are assembled to the proximal end of the pusher rod 600 of the delivery system and pressed together into the delivery catheter 400 (e.g., an inner sheath, etc.), whereupon the anchoring mechanism 100 and spring coil 200 are approximately straightened under the compressive guidance of the delivery catheter 400. Anchoring mechanism 100, coil 200 and release member 300 are further delivered through delivery catheter 400 to the corresponding distal ostium of the diseased vessel.

Then, the releasing piece 300, the spring ring 200 and the anchoring mechanism 100 are continuously pushed together through the push rod 600, so that the anchoring mechanism 100 is released into the lumen of the bare stent 700 and freely unfolded, the anchor hook body of the anchoring mechanism 100 is anchored on the inner wall of the lumen of the bare stent 700, then the spring ring 200 is released, the spring ring 200 is deformed into a preset three-dimensional shape after being released, and the interlayer laceration is blocked, so that the laceration blocking is realized, and the problem of thrombus formation at the laceration is avoided. In the process that the anchoring mechanism 100 is gradually released, the proximal end of the anchoring main body 101 of the anchoring mechanism 100 firstly penetrates through the distal end breach and the mesh hole on the bare stent 700 to enter the lumen of the bare stent 700, then the anchoring main body 101 and the anchoring hook body all enter the lumen of the bare stent 700, the anchoring mechanism 100 is released as a whole, the anchoring hook body of the anchoring mechanism 100 is released and then freely bounces open relative to the anchoring main body 101, so that the anchoring mechanism 100 is anchored on the inner wall of the lumen of the bare stent 700 to realize the anchoring of the anchoring mechanism 100 and the bare stent 700, then after the connection between the releasing piece 300 and the push rod 600 is released, the spring ring 200 is released at the false lumen breach (namely in the false lumen) outside the lumen of the bare stent 700 and deforms into a preset three-dimensional shape, and the anchoring hook body and the spring ring 200 are in a buckling state at the inner side and the outer side of the lumen of the bare stent 700, so as to realize the plugging of the interlayer breach. And the anchoring mechanism 100 and the bare stent 700 are anchored, so that the spring ring 200 which is restored to the predetermined three-dimensional shape can be ensured to be kept at the distal end breach, and the spring ring 200 is prevented from being displaced under the impact of blood flow to influence the occlusion effect.

Thereafter, the release 300 is released from the push rod 600 according to the connection manner of the release 300 and the push rod 600. Specifically, the connection between the release member 300 and the push rod 600 may be released by a mechanical release, an electrical release, etc., which are well known to those skilled in the art and will not be described in detail herein.

In addition, in the above-mentioned method of use, the releasing member 300, the spring ring 200 and the anchoring mechanism 100 constitute a single occlusion structure at the breach, and the above-mentioned method only describes the case of using one such occlusion structure, but the technical solution of the present invention is not limited thereto, and in fact, since the anchoring mechanism 100 can be detachably connected to the bare stent 700, the number of the occlusion structures consisting of the releasing member 300, the spring ring 200 and the anchoring mechanism 100 can be reasonably selected according to the breach of the diseased blood vessel of the patient, and one occlusion structure consisting of the releasing member 300, the spring ring 200 and the anchoring mechanism 100 is provided at one distal breach, and the anchoring mechanisms 100 of these occlusion structures can all be anchored on the same bare stent 700.

That is, as shown in fig. 8 and 9, the anchoring mechanism 100 is fixed to the bare stent 700 in the true lumen in the blood vessel, and the spring coil 200 is placed at the breach in the aortic dissection prosthesis and maintains a predetermined three-dimensional shape under the supporting action of the core wire 201 without being displaced by the blood flow or gravity. The thrombus promotion cilia 203 have good thrombus promotion effect, can quickly form thrombus at the position of the interlayer laceration, and realize the plugging of the target laceration. In addition, a naked support 700 can be used with a plurality of spring coils 200 to block a plurality of lacerations, so as to realize better false lumen blocking and true lumen remodeling effects.

Further, in order to facilitate the positioning of the interlayer laceration occlusion device in the operation and improve the developability of the device, a development structure is arranged on at least one rod-shaped structure 102 of the anchor hook body, and the material (namely, development material) of the development structure is any one or a mixture of more than two of tantalum, gold, platinum and tungsten.

The developing structure may be disposed at a distal end and/or a middle portion of the rod-like structure 102, and further, the developing structure may be formed by spraying, embedding, winding, or the like, using a developing material.

Specifically, in one embodiment, the developer material is sprayed onto the distal and/or intermediate portions of rod-like structure 102 to form a developed structure;

in another embodiment, the distal end of the rod-like structure 102 is an arc-like structure, a through hole penetrating through the rod-like structure 102 or a groove not penetrating through the rod-like structure 102 is provided on the arc-like structure at the distal end, and the developing material is embedded in the through hole or the groove and blocks the through hole or the groove to form a developing structure 104a, as shown in fig. 10; or a groove is arranged in the middle of the rod-shaped structure 102, and a developing material is embedded into the groove to form a developing structure 104b, as shown in fig. 11; the distal and middle portions of rod-like structure 102 are provided with grooves extending continuously along the length of rod-like structure 102 from the middle portion of rod-like structure 102 to the distal end of rod-like structure 102, or extending along the length of rod-like structure 102, and at least one position from the middle portion of rod-like structure 102 to the distal end of rod-like structure 102 is blocked, and a developing material is inserted into the grooves to form a developing structure 104c, as shown in fig. 12. In these examples, the trenches used to form the developed structures may or may not extend through rod structures 102.

In another embodiment, referring to fig. 13, the developing material is a sheet, which circumferentially covers the middle portion of the rod-like structure 102 to form a developing structure 105. Furthermore, a developing material may be sprayed on the distal end of the rod-like structure 102 or a through hole penetrating through the rod-like structure 102 or a groove not penetrating through the rod-like structure 102 may be formed on the arc-like structure at the distal end of the rod-like structure 102, and the developing material is embedded in the through hole and blocks the through hole or the groove to form the developing structure 104a.

In another embodiment, referring to fig. 14, the developing material is a thread-like structure and is circumferentially wound around the middle portion of the rod-like structure 102 to form the developing structure 106, at this time, the developing material may be further sprayed on the distal end of the rod-like structure 102, or a through hole penetrating the rod-like structure 102 or a groove not penetrating the rod-like structure 102 is formed on the arc-like structure at the distal end of the rod-like structure 102, and the developing material is embedded in the through hole and blocks the through hole or the groove to form the developing structure 104a.

In conclusion, the interlayer laceration plugging device provided by the invention can realize accurate anchoring through the anchoring mechanism and the bare support, prevent the spring coils from displacing, reduce the number of the spring coils used and reduce the economic burden of patients, and the three-dimensional structure of the spring coils has good plugging property, self-adaptability and shape-preserving property at the same time, can effectively adapt to the anatomical characteristics of far-end lacerations of interlayers of most patients, can be more widely applied to various laceration types, can improve the laceration plugging efficiency, fills the market blank, and benefits the majority of patients in China.

The above description is only for the purpose of describing the preferred embodiment of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the present invention.

Claims (12)

1. An interlayer crevasse plugging instrument is characterized by comprising an anchoring mechanism and a spring ring; the anchoring mechanism comprises an anchor hook main body and an anchor hook body, wherein the anchor hook main body is of a tubular structure with an inner cavity, the proximal end of the anchor hook main body is connected with the proximal end of the spring ring, the distal end of the anchor hook main body is connected with the proximal end of the anchor hook body, the anchor hook body comprises at least 2 rod-shaped structures, and the distal end of the anchor hook body is a free end and can be freely bounced and compressed relative to the distal end of the anchor hook main body; the spring ring is connected with the anchoring mechanism in a preset three-dimensional shape; the spring ring comprises a core wire and a spring wire, the core wire is in the preset three-dimensional shape in a free state, and the preset three-dimensional shape is a hemispherical crown type or semi-ellipsoidal three-dimensional shape;

the core wire is provided with a plurality of arc-like units in a free state, the arc-like units are distributed on the spherical surface of the same hemisphere or the ellipsoidal surface of the same semi-ellipsoid and are tightly attached to the spherical surface of the hemisphere or the ellipsoidal surface of the semi-ellipsoid in a winding mode and are at least distributed into one layer, and at least two arc-like units in the same layer are overlapped.

2. The sandwich breach occluding device of claim 1, wherein said anchor construct is at a predetermined angle to an axis of said anchor body in a state where a distal end of said anchor body is free to spring open relative to a distal end of said anchor body, said predetermined angle being 30 ° to 90 °.

3. The sandwich breach occluding device of claim 1, wherein the proximal end of the spring coil extends into the lumen of the anchor body and is mechanically or by welding attached to the proximal end of the anchor body.

4. The sandwich breach occluding device of claim 1, wherein the rod-like structure is of uniform width from the proximal end to the distal end, or gradually widens, or the distal end of the rod-like structure is wider relative to the rest of the rod-like structure, and the outer edge of the distal end is rounded.

5. The sandwich breach occluding device of claim 1, wherein said core wire is a shape memory material and said spring wire is wound around said core wire in a spiral about said core wire.

6. The sandwich breach occluding device of claim 1, wherein the core wire further comprises straight segment units in a free state; the near end of the core wire is the straight section unit, one end of the straight section unit is connected with the near end of the anchoring main body, the other end of the straight section unit is connected with one arc-like unit, and the straight section unit is located on the central shaft of the spring ring, so that the anchoring mechanism is connected with the spring ring in the middle.

7. The interbed breach sealing device of claim 1, wherein a plurality of layers of said arc-like elements are arranged in a layer-by-layer manner in a direction from the top to the bottom of the sphere of said hemisphere or in a direction from the top to the bottom of the ellipsoid of said hemisphere, and wherein the top of a succeeding layer of said arc-like elements is pressed against the bottom of a preceding layer of said arc-like elements.

8. The sandwich breach occluding device of claim 1, wherein said spring coil further comprises embolic cilia, said embolic cilia being fixed to said core wire or spring wire by knotting or wrapping, and being in an untwisted state and/or twisted state.

9. The sandwich breach occluding device of claim 8, wherein a single side length of said embolic cilia is less than or equal to a spacing between adjacent said embolic cilia.

10. The sandwich breach occluding device of claim 1, wherein at least some of the rod-like structures are provided with visualization structures at the distal and/or intermediate portions thereof.

11. The sandwich breach occluding device of any of claims 1-10, further comprising a release member attached to the distal end of the spring coil.

12. The interlayered laceration occlusion device of any one of claims 1-10, further comprising a bare stent having a lumen, wherein the anchor hook body of the anchoring mechanism freely springs open and then overlaps the inner wall of the lumen of the bare stent, and the spring ring connected with the anchoring mechanism is positioned on the outer wall of the lumen of the bare stent, and the bare stent has a hollow structure, and the anchoring mechanism is inserted into the hollow structure and connected with the bare stent.

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