CN114246631A

CN114246631A - Plugging device and plugging assembly

Info

Publication number: CN114246631A
Application number: CN202210183523.9A
Authority: CN
Inventors: 李�瑞; 汤亮; 闫伟; 龚善石
Original assignee: Shanghai Pushi Medical Equipment Co ltd; Shanghai Interventional Medical Equipment Co ltd
Current assignee: Shanghai Pushi Medical Equipment Co ltd; Shanghai Interventional Medical Equipment Co ltd
Priority date: 2022-02-28
Filing date: 2022-02-28
Publication date: 2022-03-29
Also published as: CN115969434A; CN219720755U

Abstract

The invention discloses an occluder and an occlusion assembly, wherein the occluder comprises a main body, a far end beam-closing point positioned at the far end of the main body and a near end beam-closing point positioned at the near end of the main body; the occluding device has a constrained state and a deployed state, wherein the occluding device is deployed in a radial direction with a larger dimension, the main body is bent in a direction toward the proximal end at a position near the distal end to form a distal space, and is bent in a direction toward the distal end at a position near the proximal end to form a proximal space. In the using process, the plugging device has better supporting stability and can promote the fusion of the plugging device and the tissues of a patient.

Description

Plugging device and plugging assembly

Technical Field

The invention relates to the field of medical treatment, in particular to an occluder and an occlusion assembly.

Background

The plugging device can be sent to a human body lesion part in a minimally invasive intervention mode, is widely applied to abnormal openings of blood vessels, hearts, digestive tracts and the like, and is used for blocking the circulation of blood and other liquid at the abnormal openings.

Under normal conditions, blood flow is maintained between the left atrium and the left atrial appendage in the heart. When the heart undergoes atrial fibrillation, arrhythmia causes a decrease in blood flow velocity in the left atrial appendage, and blood tends to clot around the pectinate muscle in the left atrial appendage to form a thrombus. With blood circulation, thrombi may leave the left atrial appendage and enter the aorta with the blood flow, which may cause an acute ischemic stroke. The plugging device is usually applied to the left atrial appendage in the heart to block the blood circulation between the left atrial appendage and the left atrium, and has great significance for avoiding the occurrence of acute ischemic stroke lesions.

It should be noted that the occluder, as an insertion device, is expected to remain in a desired position after being inserted into the tissue of the human body and to be completely fused with the tissue of the human body in time, i.e., the occluder should be stable and effective. When the occluder is placed between the left auricle and the left atrium of the heart of a patient, the occluder has proper support performance, and is beneficial to the performance of the occluder in stability, otherwise, certain falling risk exists, and great potential safety hazard is formed. Therefore, the stability of the occluder and the fusion with the heart tissue are worth being improved continuously.

Disclosure of Invention

In view of the above technical problems, an object of the present invention is to provide an occluder and an occlusion assembly, in which a distal space is formed near a distal constriction point of the occluder, and a proximal space is formed near a proximal constriction point, so that, in use, tissue of a patient at an implanted position can enter the distal space and the proximal space, and the occluder has good support stability and promotes fusion of the occluder and the tissue of the patient.

To achieve the above objects, the present invention provides an occluder comprising a main body, a distal pinch point at a distal end of the main body, and a proximal pinch point at a proximal end of the main body;

the occluding device has a constrained state and a deployed state, wherein the occluding device is deployed in a radial direction with a larger dimension, the main body is bent in a direction toward the proximal end at a position near the distal end to form a distal space, and is bent in a direction toward the distal end at a position near the proximal end to form a proximal space.

In some embodiments, in the deployed state, the distal pinch point is located within the distal volume and/or the proximal pinch point is located within the proximal volume.

In some embodiments, the main body has a distal connecting section and a proximal connecting section at both ends, respectively, and in the deployed state, the distal connecting section extends in the proximal direction and forms the distal space around the central axis of the occluding device, and the proximal connecting section extends in the distal direction and forms the proximal space around the central axis of the occluding device.

In some embodiments, the body has a distal neck section and a proximal neck section at each end, the distal neck section is connected to the distal pinch point and the distal connecting section at each end, the proximal neck section is connected to the proximal pinch point and the proximal connecting section at each end, and in the deployed state, the distal neck section forms a distal neck and the proximal neck section forms a proximal neck.

In some embodiments, the distal neck portion and the proximal neck portion are each located on a central axis of the occluding device.

In some embodiments, the junction of the distal neck segment and the distal connecting segment and the junction of the proximal neck segment and the proximal connecting segment have a predetermined arc.

In some embodiments, the main body further includes an intermediate connecting section, two ends of the intermediate connecting section are respectively connected to the distal end connecting section and the proximal end connecting section, and joints between the intermediate connecting section and the distal end connecting section and between the intermediate connecting section and the proximal end connecting section respectively have a preset radian.

In some embodiments, the occluder further comprises an anchoring structure located on an outer surface of the body, at least a portion of the anchoring structure being disposed to protrude radially and/or axially of the body for contact with the patient's tissue to increase stability of the body installation.

In some embodiments, the anchoring structure includes a bent elastic piece, a root of the bent elastic piece is connected to the main body, and an end of the bent elastic piece extends obliquely in a direction away from the outer surface of the main body.

In some embodiments, a half region of the intermediate connecting section near the distal beam-converging point is surrounded by at least one row of the anchoring structures, and the bent shrapnel of the at least one row of the anchoring structures extends along different directions.

In some embodiments, the predetermined position of the outer surface of the main body has a receiving space corresponding to the bent elastic piece for receiving the bent elastic piece in the constrained state.

In some embodiments, the intermediate connecting section of the body is wavy in a radial direction, the wavy intermediate connecting section forming the anchoring structure.

In some embodiments, the body includes a plurality of elongate wires, both ends of the plurality of elongate wires being respectively constricted at the distal pinch point and the proximal pinch point.

In some embodiments, the plurality of elongate filaments of the body are obliquely staggered to form a mesh structure, or the plurality of elongate filaments are sequentially arranged to form a cage structure.

In some embodiments, the plurality of elongate filaments of the main body are obliquely staggered to form a mesh structure, and in the deployed state, the angle between the elongate filaments of the distal connecting segment ranges from 20 ° to 60 °, and/or the angle between the elongate filaments of the proximal connecting segment ranges from 20 ° to 60 °.

In some embodiments, the body comprises an elastic frame and a covering layer wrapping the outer side of the elastic frame, and in the unfolded state, the elastic frame supports the covering layer to form the distal space and the proximal space.

In some embodiments, the occluding device further has an intermediate state in which a distal portion of the occluding device extends out of the catheter to form a particular shape.

According to another aspect of the present invention, the present invention further provides an occlusion assembly comprising:

an axial occlusion device, the occluder of any preceding claim, adapted to extend into a defect;

and the radial plugging device is connected with the axial plugging device and is suitable for covering the outer side of the gap.

Compared with the prior art, the plugging device and the plugging component have at least one of the following beneficial effects:

1. the far-end connecting section and the near-end connecting section of the occluder respectively extend obliquely towards the interior of the main body to form a far-end space and a near-end space, and when the middle connecting section of the main body is subjected to extrusion force, the far-end connecting section and the near-end connecting section can play a better role in elastic supporting force, so that the main body is better maintained to have a preset shape, and the installation stability of the main body is improved;

2. the far-end convergence point of the occluder is located in the far-end space, the near-end convergence point is located in the near-end space, and in the using process, the far-end convergence point and the near-end convergence point do not protrude out of the main body of the occluder, so that the far-end convergence point and the near-end convergence point can be prevented from injuring a patient;

3. a far-end space is formed near a far-end converging point of the occluder, a near-end space is formed near a near-end converging point, and in the using process, the tissue of a patient at the implanted position can enter the far-end space and the near-end space, so that the occluder and the tissue of the patient can be better fused;

4. the outer surface of the main body of the occluder is provided with an anchoring structure, so that the friction force between the main body and the tissue at the implanted position can be increased in the using process, and the installation stability of the main body is improved.

Drawings

The above features, technical features, advantages and modes of realisation of the present invention will be further described in the following detailed description of preferred embodiments thereof, which is to be read in connection with the accompanying drawings.

FIG. 1 is a schematic view of the occluding device of a preferred embodiment of the present invention in a constrained state;

FIG. 2 is a schematic view of the occluding device of the preferred embodiment of the present invention in a deployed state;

figure 3a is a schematic view of an intermediate state of the occluding device of the preferred embodiment of the present invention;

figure 3b is a schematic view of the occluding device of the preferred embodiment of the present invention as it switches from the intermediate state to the deployed state;

FIG. 4 is an enlarged view taken at a in FIG. 2;

figure 5 and figure 6 are schematic structural views of the elongate elastic wire of the occluding device of the preferred embodiment of the present invention;

figure 7 is a force diagram of the occluding device of the preferred embodiment of the present invention;

figure 8 is a schematic structural view of a variant embodiment of the occluding device of the preferred embodiment of the present invention;

FIG. 9 is a schematic structural view of a preferred embodiment of the occluding assembly of the present invention;

FIG. 10 is an enlarged, fragmentary, schematic structural view of an axial occluding device of the occluding assembly of the preferred embodiment of the present invention;

FIG. 11 is an enlarged, fragmentary, schematic view of a radial occlusion device of the occlusion assembly of the preferred embodiment of the invention;

figure 12 is a schematic view of the occluding device of the preferred embodiment of the present invention in a deployed state;

figure 13 is a schematic view of the radial occlusion device of the preferred embodiment of the invention.

The reference numbers illustrate:

the occluder comprises an occluder 100, a main body 10, a distal end 11, a proximal end 12, a distal space 21, a proximal space 22, a distal connecting section 13, a proximal connecting section 14, an inner space 15, a distal neck section 16, a proximal neck section 17, an intermediate connecting section 18, an elongated wire 19, a distal constriction point 41, a proximal constriction point 42, a constrained state 101, an expanded state 102, an anchoring structure 30, a bent elastic sheet 31, a storage space 32, an axial occluding device 201, a radial occluding device 202, a central axis 300, a delivery instrument 400, and a catheter 500.

Detailed Description

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following description will be made with reference to the accompanying drawings. It is obvious that the drawings in the following description are only some examples of the invention, and that for a person skilled in the art, other drawings and embodiments can be derived from them without inventive effort.

For the sake of simplicity, only the parts relevant to the invention are schematically shown in the drawings, and they do not represent the actual structure as a product. In addition, in order to make the drawings concise and understandable, components having the same structure or function in some of the drawings are only schematically illustrated or only labeled. In this document, "one" means not only "only one" but also a case of "more than one".

It should be further understood that the term "and/or" as used in this specification and the appended claims refers to and includes any and all possible combinations of one or more of the associated listed items.

In this context, it is to be understood that, unless otherwise explicitly stated or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In addition, in the description of the present application, the terms "first", "second", and the like are used only for distinguishing the description, and are not intended to indicate or imply relative importance.

In this application, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions with respect to each other from the perspective of a clinician using the medical device, although "proximal" and "distal" are not intended to be limiting, with "proximal" generally referring to the end of the medical device that is closer to the clinician during normal operation and "distal" generally referring to the end that is first introduced into a patient.

Referring to fig. 1-10, an occluding device 100 of a preferred embodiment provided by the present invention is illustrated, the occluding device 100 comprising a body 10, a distal pinch point 41 at a distal end 11 of the body 10 and a proximal pinch point 42 at a proximal end 12 of the body 10. The occluding device 100 has a constrained state 101, a deployed state 102 and an intermediate state 103 between the constrained state 101 and the deployed state 102.

Referring to fig. 1, the occluding device 100 is shown being constrained in a catheter 500, i.e. the occluding device 100 is in the constrained state 101. In the constrained state 101, the occluding device 100 has a small radial dimension and is elongated and suitable for placement along a body passageway into a lesion in a patient.

Referring to fig. 2, the occluding device 100 is shown in the deployed state 102. In the deployed state 102, the occluding device 100 returns to a preset shape, and the radial dimension of the occluding device 100 is large enough to block an abnormal passage. In the deployed state 102, the occluding device 100 can be effectively secured to the site of infection, such as but not limited to the opening of the left atrial appendage, by virtue of the radial support force of the body 10 itself.

In the deployed state 102, the body 10 has a larger dimension in the radial direction than in the constrained state 101. The body 10 has the distal end 11 and the proximal end 12, and also has a central axis 300 passing through the distal end 11 and the proximal end 12. In the unfolded state 102, the main body 10 is bent toward the proximal end 12 at a position near the distal end 11 to form a distal space 21, and is bent toward the distal end 11 at a position near the proximal end 12 to form a proximal space 22.

Referring to figure 3a, the occluding device 100 is shown in the intermediate state 103. In the intermediate state 103, only the distal part of the occluding device 100 extends out of the catheter 500, and the expanded volume of the extended part is within one half of the volume of the occluding device 100 in the deployed state 102, i.e. the volume of the body 10 in the intermediate state 103 is less than or equal to half the volume of the body 100 in the deployed state 102. The distal portion of the occluding device 100 expands and takes a specific shape after exiting the catheter 500. In some preferred embodiments, the main body 10 forms the distal space 21 near the distal end 11 and the main body 10 forms the proximal space 22 near the proximal end 12 when the occluding device 100 is in the deployed state 102; in the intermediate state 103, the body 10 is sectioned along the central axis 300 of the body 10, the distal end 11 of the occluding device 100 is generally triangular with the apex of the triangle near the distal end point of the catheter 500 and the base of the triangle near the distal end of the occluding device 100 and is relatively smooth, in some embodiments having a relatively small arc with no significant protrusions. In use, when the occluding device 100 is inserted into an implantation site, particularly in the left atrial appendage of the heart, the occluding device 100 has a smoother distal end in the intermediate state 103, which can reduce possible damage of the occluding device 100 to human tissue and is beneficial to improving safety performance of the occluding device 100 during use.

It will be appreciated that the occluding device 100 also has a configuration approaching the neutral state 103 during partial removal from the catheter 500, e.g., the protruding portion is formed in a generally spherical shape when less volume is removed from the catheter 500, which is also beneficial for safety of use of the occluding device 100. Thus, in the intermediate state 103, the occluding device 100 may have a spherical shape, a generally triangular shape, or the like.

Referring to figure 3b, the occluding device 100 is deployed to the deployed state 102 after being completely removed from the catheter 500. From the intermediate state 103 to the deployed state 102, the distal portion of the occluding device 100 is turned from the most distal end in the intermediate state 103 to be recessed into the main body 10 and form the distal space 21, and the tendency of the main body 10 to be drawn toward the central axis 300 is balanced, so that potential impact force which may be formed on human tissues during the deployment process of the occluding device 100 is balanced, and safety during the installation process of the occluding device 100 is improved.

In some preferred embodiments, the distal space 21 is formed near the distal end 11 of the body 10 and the proximal space 22 is formed near the proximal end 12 of the body 10, respectively, when the occluding device 100 is in the deployed state 102. After the occluding device 100 is placed in a lesion of a patient, the distal space 21 and the proximal space 22 can allow the tissue of the lesion of the patient to enter, so that the fusion of the occluding device 100 and the lesion of the patient can be accelerated, and the installation stability of the occluding device 100 is improved.

It should also be noted that, in some preferred embodiments, by providing the distal space 21 and the proximal space 22 at two ends of the main body 10, the main body 10 can have better supporting force and more stable supporting stability in the unfolded state 102.

In the deployed state 102, the distal end beam spot 41 is arranged in the vicinity of the distal end space 21; and/or the proximal beam-ending spot 42 is arranged in the vicinity of the proximal space 22. The distal pinch point 41 and/or the proximal pinch point 42 are configured such that the main body 10 is configured as a closed structure, which is more likely to generate a counter force when squeezed by human tissue, thereby further enhancing the supporting ability of the occluding device 100. The proximal pinch point 42 can also be arranged for connection with a delivery instrument 400. It will be appreciated that the distal end beam spot 41 and/or the proximal end beam spot 42 can also be disposed at other locations on the body 10, or in some other embodiments the distal end beam spot 41 and/or the proximal end beam spot 42 can also be absent. In other embodiments, other cylindrical heads can be provided instead of the distal beam-ending point 41 and/or the proximal beam-ending point 42. It is to be understood that the specific arrangement of the far end beam-ending point 41 and the near end beam-ending point 42 should not be construed as limiting the present application.

In some preferred embodiments, the distal pinch point 41 is disposed in the distal space 21, and the proximal pinch point 42 is disposed in the proximal space 22, which can reduce the axial dimension of the occluding device 100 in the deployed state 102, and reduce the potential risk to the lesion of the patient.

Referring to fig. 5 and 6, the occluding device 100 is sectioned along the central axis 300, the distal space 21 having a distal connecting segment 13 therein and the proximal space 22 having a proximal connecting segment 14 therein. In the deployed state 102, the body 10 is deployed and forms an interior space 15 therein. The distal connecting section 13 extends from the distal end 11 to the inner space 15 radially inwards and axially towards the proximal end 12 and surrounds the distal space 21. The proximal connecting section 14 extends from the proximal end 12 to the inner space 15 radially inwards and axially towards the distal end 11, and surrounds the proximal space 22. The distal connecting section 13 is bent in a radially outward direction at the distal end 11, and forms a substantially circular shape (not shown) around the central axis 300 at the distal end 11, the substantially circular shape lying in a plane substantially perpendicular to the central axis 300, that is, the distal space 21 is formed on a proximal side of the plane in which the substantially circular shape lies; at the proximal end 12, the proximal connecting segment 14 is bent in a radially outward direction, and a substantially circular second (not shown) is formed at the proximal end 12 around the central axis 300, and a plane second of the substantially circular second is substantially perpendicular to the central axis 300, i.e., the proximal space 22 is formed at a side of a distal end of the plane second of the substantially circular second. The first plane and the second plane are also referred to as a distal end surface and a proximal end surface, respectively, in the present invention.

It will be appreciated that the distal beam-ending point 41 and/or the proximal beam-ending point 42 may extend into the interior space 15. In the deployed state 102, the distal end beam-closing point 41 and/or the proximal end beam-closing point 42 can be accommodated in the internal space 15, and the distal end beam-closing point 41 and the proximal end beam-closing point 42 can be prevented from protruding, thereby improving safety during use. That is, the relative positions of the distal end beam-closing point 41 and the proximal end beam-closing point 42 with respect to the internal space 15 should not be a limitation of the present invention.

In the first modified embodiment, the distal beam-ending point 41 is arranged in the distal space 21, and the proximal beam-ending point 42 is arranged in the proximal space 22. The distal space 21 also has a distal neck section 16 therein and the proximal space 22 also has a proximal neck section 17 therein. The distal neck section 16 is connected at its both ends to the distal beam-closing point 41 and the distal connecting section 13, respectively, and the proximal neck section 17 is connected at its both ends to the proximal beam-closing point 42 and the proximal connecting section 14, respectively. In the deployed state, the distal neck segment 16 forms a distal neck and the proximal neck segment 17 forms a proximal neck.

The body 10 also includes an intermediate connecting section 18. The intermediate connecting segment 18 is connected at both ends thereof to the distal connecting segment 13 and the proximal connecting segment 14, respectively. The intermediate connecting section 18, the distal connecting section 13, the proximal connecting section 14, the distal neck section 16 and the proximal neck section 17 enclose the inner space 15. The interior space 15 is configured as a buffer space, and the shape change of the occluding device 100 in the deployed state 102 can better avoid contact of various parts of the occluding device 100 due to the interior space 15, which affects the safety and effectiveness of the installation of the occluding device 100.

The joints of the intermediate connecting section 18, the distal connecting section 13 and the proximal connecting section 14 have a predetermined radian respectively. Similarly, the junction of the distal neck segment 16 and the distal connecting segment 13 and the junction of the proximal neck segment 17 and the proximal connecting segment 14 have predetermined curvatures.

Specifically, the main body 10 is roughly divided between the distal end beam spot 41 and the proximal end beam spot 42 into: the far end beam-closing points 41 to the segment A, the segment AB, the segment BC, the segment CD, the segment DE, the segment EF, the segment FG, the segment GH, the segment HI, the segment IJ and the segment J to the near end beam-closing point 42. The section from the far end closing point 41 to the point A is the far end neck section 16, forming the far end neck; the proximal neck section 17 is formed between the proximal pinch point 42 and the J point, forming the proximal neck; the AB section and the IJ section are arc transition areas, the BC section forms the far-end connecting section 13, and the HI section forms the near-end connecting section 14; CE section and FH section are arc transition zones; the EF section is the intermediate connection section 18.

Referring to fig. 6, specifically, the neck height H1 from the distal beam point 41 to the point a, the arc radius R1 of the AB segment, the height H1 from the midpoint of the AB segment to the distal face, and the radius R1 of the distal face. h1 may range from 0-3mm, i.e. in some embodiments, the neck region may not be provided. H1 may range from 3 to 7 mm. r1 may range from 1 to 3 mm. A neck height H2 from the proximal pinch point 42 to J, an arc radius R2 of the IJ segment, a height H2 from the midpoint of the IJ segment to the proximal face, a radius R2 of the proximal face. h2 may range from 0 to 3 mm. H2 may range from 3 to 9 mm. r2 may range from 1 to 3 mm. The radius R2 of the proximal face is greater than the radius R1 of the distal face. The vertical height H, H from the distal end face to the proximal end face ranges from 12-16 mm.

Referring to fig. 2, 5 and 6, in the preferred embodiment, the included angles between the intermediate connecting section 18 and the distal connecting section 13 and the proximal connecting section 14 are acute angles, the included angle between the distal connecting section 13 and the distal neck section 16 is also acute angle, and the included angle between the proximal connecting section 14 and the proximal neck section 17 is also acute angle. When the middle connecting section 18 is subjected to extrusion force, a first-stage elastic buffer structure is formed at the joint of the middle connecting section 18, the far-end connecting section 13 and the near-end connecting section 14, and a second-stage elastic buffer structure is formed at the joint of the far-end connecting section 13 and the far-end neck section 16 and at the joint of the near-end connecting section 14 and the near-end neck section 17, so that the middle connecting section 18 can bear larger pressure, and a preset shape can be better maintained.

Referring to fig. 7, when the intermediate connecting section 18 is subjected to a radial compression force F substantially perpendicular to the central axis, the radial compression force is converted into axial thrust forces F 'and F ″ substantially parallel to the central axis, F' towards the distal pinch point 41 and F ″ towards the proximal pinch point 42, so that the occluder tends to elongate along the central axis, rather than compress, under the action of the radial compression force F. Due to the existence of the far-end space 21 and the near-end space 22, especially, the existence of the AB segment and the IJ segment, the far-end beam converging point 41 and the near-end beam converging point 42 are not easily protruded out of the far-end space 21 and the near-end space 22. So set up, the far-end beam-closing point 41 is more difficult to form the injury to the left atrial appendage tissue, the far-end space 21 and the near-end space 22 still exist after the occluder 10 is elongated, the size is greatly reduced, the tissue is more favorable to climbing on the occluder 100, and the occluder 100 is internalized in the intracardiac tissue more quickly. At the same time, under the action of the main body 10, the plugging device 100 forms a supporting force P which is approximately perpendicular to the central axis, and the directions of the P and the F are opposite.

It is noted that the radial support force of the occluding device 100 is a generally radially outwardly directed support force generated by the occluding device 100, particularly a radial compression of the proximal face radius R2 of the occluding device 100, with the radial dimension of the occluding device 100 compressed by 10% -40%, particularly 20% -30%. When the occluder 100 is applied to block the left auricle and left atrium channel, it is required to generate 2-6N radial supporting force when being compressed, and the minimum can be 2N, or 3N, 3.5N.

In some variant embodiments, the distal connecting section 13 and the proximal connecting section 14 of the main body 10 are bent to form a wave shape, so as to provide more levels of elastic buffering after the middle connecting section 18 is subjected to the compression force, further increasing the pressure that the occluder 100 can bear, and better maintaining the shape of the main body 10.

Referring to fig. 6, the distal neck portion and the proximal neck portion are respectively located on the central axis of the body 10. In some variant embodiments, the distal neck and the proximal neck can also not be arranged on the same axis, and the specific arrangement positions of the distal neck and the proximal neck should not be limiting.

Referring to fig. 2 and 4, the occluding device 100 further comprises an anchoring structure 30 located on the outer surface of the body 10. At least a portion of the anchoring structure 30 is convexly disposed along a radial and/or axial direction of the body 10 for contacting or partially extending below a tissue surface of a patient and is configured to be retrievable, i.e., to be moved away from the tissue surface of the patient, without causing irreparable damage to the tissue of the patient. The anchoring structure 30 can increase the stability of the installation of the occluding device 100 without reducing the safety of the installation of the occluding device 100.

The anchoring structure 30 is preferably formed at the intermediate connecting section 18 of the body 10. The anchoring structures 30 can be formed on the distal connecting section 13 and the proximal connecting section 14 of the main body 10, or the anchoring structures 30 are arranged on the middle connecting section 18, the distal connecting section 13 and the proximal connecting section 14 of the main body 10, and the specific arrangement position and number of the anchoring structures 30 should not be construed as limiting the application.

Referring to fig. 4, the anchoring structure 30 includes bent resilient pieces 31. The root of the bent elastic sheet 31 is connected to the main body 10, and the end of the bent elastic sheet 31 extends obliquely in a direction away from the outer surface of the main body 10. During use, after the occluder 100 is switched to the deployed state 102, the bent resilient sheet 31 can contact with the tissue surface of the patient or partially extend below the tissue surface of the patient, especially the part of the bent resilient sheet 31 away from the root; when the bent elastic sheet 31 partially extends below the tissue surface of the patient, the vertex of the bent shape plays a proper blocking role so as to control the extending depth of the bent elastic sheet 31, form no unrecoverable damage to the tissue of the patient, increase the installation stability of the occluder 100 and not reduce the installation safety of the occluder 100.

Referring to fig. 2, at least two rows of the anchoring structures 30 are circumferentially disposed on the outer surface of the main body 10 in a half area near the distal end 11, and the bent resilient pieces 31 of the at least two rows of the anchoring structures 30 may extend in different directions. By arranging at least two rows of bent elastic pieces 31 extending along different directions, the mounting position of the main body 10 can be limited in at least two directions, so that the main body 10 has more opportunities, the friction force between the main body 10 and tissues in different directions is increased, and the mounting stability of the main body 10 is further improved. The roots of the bent resilient pieces 31 of adjacent anchoring structures 30 may be aligned or not aligned, that is, the anchoring structures 30 may be arranged in order or distributed in a staggered manner.

Referring to fig. 12, at least one row of the anchoring structures 30 may be circumferentially disposed on the outer surface of the main body 10 in a half area near the distal end 11, and the bent elastic pieces 31 of the at least one row of the anchoring structures 30 may extend in different directions. In the preferred embodiment, the perpendicular distance H from the distal end face to the proximal end face is no greater than 12 mm.

Referring to fig. 4, a predetermined position of the outer surface of the main body 10 has a receiving space 32 corresponding to the bent elastic piece 31 for receiving the bent elastic piece 31. When the occluder 100 is in the constrained state 101, the bent resilient piece 31 can be accommodated in the accommodation space 32 without increasing the overall thickness of the main body 1. When the occluder 100 is in the unfolded state 102, the end points of the bent resilient pieces 31 are bent and protruded away from the main body 10. When the occluder 100 is in the constrained state 101, the catheter 500 is further sleeved outside the occluder 100, the occluder 100 is mounted in advance or the user pushes the occluder 100 into the catheter 500, after the occluder 100 is pushed out from the catheter 500, the occluder 100 is stretched from the constrained state 101 to the deployed state 102, and the bent elastic pieces 31 of the anchoring structure 30 are ejected from the accommodating space 32.

In the preferred embodiment, the thickness of the bent elastic sheet 31 is smaller than the wall thickness of the main body 10, and the groove on the outer surface of the main body 10 forms the receiving space 32. In some variant embodiments, the thickness of the bent resilient piece 31 is greater than the wall thickness of the main body 10, a hole in the main body 10 forms the receiving space 30, an outer surface of the bent resilient piece 31 is flush with an outer surface of the main body 10 in the constrained state 101, and at least a portion of the bent resilient piece 31 passes through the hole in the main body 10.

Referring to fig. 8, in some variant embodiments, the intermediate connecting section 18 of the body 10 is wavy in a radial direction, the wavy intermediate connecting section 18 forming the anchoring structure 30.

Referring to fig. 5 and 6, the main body 10 includes a plurality of elongate filaments 19, and both ends of the elongate filaments 19 are respectively converged at the distal end convergence point 41 and the proximal end convergence point 42. The plurality of elongate filaments 19 of the body 10 are preferably angularly staggered to form a mesh structure. In some variations, the plurality of elongate filaments 19 can also be arranged in series to form a cage-like structure.

One of the plurality of filaments 19 of the main body 10 rotates in one direction about the central axis, and the other of the plurality of filaments 19 rotates in the opposite direction about the central axis, so that the two filaments 19 cross each other.

The elongate wire 19 is preferably a wire having a certain elasticity, in particular an alloy having shape memory properties, such as nitinol or the like. In some variant embodiments, the elongate wire 19 can also be made of a medical-grade elastic material. In other variations, the elongate wire 19 may be a blend of different materials, such as a partially elastic metal wire, a partially degradable material; or the filaments 19 may be all filaments made of degradable material. The particular type of material of the elongate filaments 19 should not be limiting.

Referring to fig. 2, in the deployed state 102, the angle between the filaments 19 of the distal connecting section 13 of the main body 10 is in the range of 20 ° -60 °, and the angle between the filaments 19 of the proximal connecting section 14 may also be in the range of 20 ° -60 °. The acute crossing angle can have higher structural strength and play a better supporting role.

In some preferred embodiments, the main body 10 comprises an elastic frame and a covering layer (not shown) covering the elastic frame, and in the unfolded state, the elastic frame supports the covering layer to form the distal space and the proximal space. The coating layer can be made of polyester fiber, PTFE, ePTFE and the like, and the thickness can be 0.1 mm-5 mm. In the preferred embodiment, the coating layer can play a role in resisting flow and forming buffer between the outer surface of the elastic frame and human tissues, so that possible damage of the elastic frame to the human tissues is further reduced. The coating layer coats the elastic frame, and can be completely coated or partially coated, so long as the functions of flow resistance and buffer between the outer surface of the elastic frame and human tissues are achieved. The spring frame is constructed to have the same or similar structural features as the body 10.

In other preferred embodiments, the coating (not shown) may also be located within the inner space 15 of the body 10 or on the outside, in particular the outer surface, of the body 10. I.e. the relative position of the cover to the elastic frame or the body 10, does not form a limitation of the invention.

In some embodiments, the perpendicular distance H of the occluding device 100 from the distal end face to the proximal end face may be shortened to 8-12 mm. The height H1 of the distal space 21 is greatly shortened and may be 2-6mm, and the height H2 of the proximal space 22 may be 4-8 mm. The radius R2 of the proximal face coincides with the radius R1 of the distal face. When the occluding device 100 is radially compressed by 10% -40%, particularly 20% -30%, a radial supporting force of 2-6N is generated, and the minimum can be 2N, or 3N, 3.5N.

With reference to fig. 9, 10 and 11 and 13, according to another aspect of the invention, the invention further provides an occlusion assembly comprising an axial occlusion device 201 and a radial occlusion device 202. The axial occlusion device is the occlusion device 100 described above, adapted to extend into the opening; the radial occlusion device 202 is connected to the axial occlusion device 201 and is adapted to cover the outer side of the gap. The axial occlusion device 201 and the radial occlusion device 202 are preferably connected by means of a screw connection, and in some variant embodiments can also be connected by means of a snap connection, an integral connection, or the like. The radial occlusion device 202 can be deformed in different ways, and in a preferred embodiment, the distal and proximal surfaces of the radial occlusion device 202 can have a curvature, the centers of which can be equally distributed at the proximal end, i.e., the curvatures are both curved towards the proximal end. So configured, the radial stopper 202 may have a better fit at the gap, and the coverage of the gap may have a reinforcing effect.

It should be noted that the above embodiments can be freely combined as necessary. The foregoing is only a preferred embodiment of the present invention, and it should be noted that those skilled in the art can make various improvements and modifications without departing from the principle of the present invention, and these improvements and modifications should also be construed as the protection scope of the present invention.

Claims

1. An occluder comprising a body, a distal pinch point at a distal end of said body, and a proximal pinch point at a proximal end of said body;

2. The occluder of claim 1, wherein in said deployed state, said distal pinch point is located in said distal space and/or said proximal pinch point is located in said proximal space.

3. The occluder of claim 2, wherein each end of the body has a distal connecting section and a proximal connecting section, the distal connecting sections extending in the proximal direction and defining the distal space around the central axis of the occluder and the proximal connecting sections extending in the distal direction and defining the proximal space around the central axis of the occluder in the deployed state.

4. The occluder of claim 3, wherein the body has distal and proximal neck sections at opposite ends thereof, the distal neck section being connected at opposite ends thereof to the distal pinch point and the distal connecting section, the proximal neck section being connected at opposite ends thereof to the proximal pinch point and the proximal connecting section, the distal neck section forming a distal neck portion and the proximal neck section forming a proximal neck portion in the deployed state.

5. The occluder of claim 4, wherein the distal neck portion and the proximal neck portion are each located on a central axis of the occluder.

6. The occluder of claim 4, wherein the junction of the distal neck segment and the distal connecting segment and the junction of the proximal neck segment and the proximal connecting segment have a predetermined arc.

7. The occlusion device of claim 3, wherein the body further comprises an intermediate connecting section, both ends of the intermediate connecting section are connected to the distal connecting section and the proximal connecting section, respectively, and the joints of the intermediate connecting section and the distal connecting section and the proximal connecting section respectively have a predetermined radian.

8. The occluder of claim 7, further comprising an anchoring structure on an outer surface of the body, at least a portion of the anchoring structure being disposed to protrude radially and/or axially of the body for contact with the patient's tissue to increase stability of the body installation.

9. The occlusion device of claim 8, wherein the anchoring structure comprises a bent resilient tab, a root of the bent resilient tab is connected to the main body, and an end of the bent resilient tab extends obliquely away from the outer surface of the main body.

10. The occlusion device of claim 9, wherein a half of the region of the intermediate connecting section near the distal pinch point is circumferentially provided with at least one row of the anchoring structures, and wherein the bent resilient pieces of the at least one row of the anchoring structures extend in different directions.

11. The occlusion device of claim 9, wherein the predetermined location of the outer surface of the main body has a receiving space corresponding to the bent resilient piece for receiving the bent resilient piece in the constrained state.

12. The occluder of claim 7, wherein the intermediate connecting sections of the body undulate in a radial direction, the undulated intermediate connecting sections forming the anchoring structure.

13. The occluder of any one of claims 1-12, wherein said body comprises a plurality of elongate filaments having ends converging at said distal and proximal converging points, respectively.

14. The occlusion device of claim 13, wherein said plurality of elongate wires of said body are obliquely staggered to form a mesh-like structure, or wherein said plurality of elongate wires are sequentially arranged to form a cage-like structure.

15. The occluder of claim 13, wherein said plurality of elongate filaments of said main body are obliquely staggered to form a mesh configuration, wherein in said deployed state the angle between the filaments of said distal connecting segment is in the range of 20 ° -60 °, and/or wherein the angle between the filaments of said proximal connecting segment is in the range of 20 ° -60 °.

16. The occluder of any one of claims 1-12, wherein said body comprises a resilient frame and a covering surrounding said resilient frame, said resilient frame in said expanded state distracting said covering to form said distal space and said proximal space.

17. The occluder of any one of claims 1-12, further comprising an intermediate state in which a distal portion of said occluder extends out of the catheter to a specific shape.

18. The shutoff subassembly, its characterized in that includes:

an axial occlusion device being the occluder of any one of claims 1-17 adapted to extend into a defect;