Endoluminal occlusion device

Abstract

The application provides an intraluminal occluder, comprising a framework and a flow-blocking membrane formed on the framework, wherein the maximum axial length of the flow-blocking membrane is greater than or equal to the axial stretching length of the framework. The intraluminal occluder in the application has a small size after compression, can be quickly released, has good wall-adhesion performance after release, and is suitable for occluding an organ channel with a long axial direction.

Description

TECHNICAL FIELD

[0001] The present application relates to a medical device, in particular to an intraluminal occlusion device. BACKGROUND

[0002] Interventional therapy is a new treatment method between surgical and medical treatment, including intravascular intervention and nonvascular intervention. Simply speaking, interventional therapy is a minimally invasive treatment method of making a few millimeters of microchannel on blood vessels or skin, or through the original pipeline of human body, and treating the lesion locally under the guidance of imaging equipment (angiography machine, fluoroscope, etc.) without exposing the lesion by surgery. Interventional therapy has the advantages of small trauma, simplicity, safety, effectiveness, fewer complications, and significantly shorter hospitalization time.

[0003] As an implant for interventional therapy, the occlusion device can be used to occlude a defect opening, a tissue break, a lumen, or an organ channel in a human body and / or an animal body. For example, the treatment of congenital heart disease, which has been widely used in clinical practice, includes the occlusion of defect openings such as atrial septal defect, ventricular septal defect, and patent ductus arteriosus, and the main principle is to block the "leakage" between left and right atrial chambers, the "leakage" between left and right ventricles, and the channel between the aorta and the pulmonary artery by the occlusion device.

[0004] On the other hand, aortic dissection is caused by tearing of the intima and media of the aorta due to various reasons, separation of the intima and media of the aorta, blood flow into the aortic lumen, and separation of the true lumen and the false lumen. A typical aortic dissection can be seen between the true lumen and the false lumen. The true lumen and the false lumen can be connected or not connected. The conventional endovascular repair of the aorta currently used for the treatment of aortic dissection generally achieves the purpose of aortic remodeling by closing the primary break and reducing the pressure of the false lumen. However, data shows that in 7% to 20% of cases in clinical practice, the above purpose is difficult to achieve, because the false lumen of the aortic dissection is not completely thrombosed. The existence of the distal tear and the continuous perfusion (the false lumen is not thrombosed) increase the risk of continuous enlargement of the false lumen, and accordingly increase the risk of further tearing of the dissection and rupture of the dissection aneurysm, and also increase the probability of surgical re-intervention after endovascular repair. At present, a blocking auxiliary technology is used in clinical practice after the implementation of standard endovascular repair of the aorta to promote thrombosis of the false lumen.

[0005] The access route through which the occlusion device is delivered to the defect opening, the tissue break, the lumen, or the organ channel in the human body and / or the animal body by the interventional method includes the human body arteries and / or veins and / or the heart, and the lesion can be treated locally. The occlusion device requires reasonable design, such as small size after compression, rapid release, and occlusion suitable for a relatively long organ channel, etc. The existing occlusion device often cannot meet the above requirements at the same time. SUMMARY

[0006] The present application aims to provide a lumen occluder which is small in size after compression, can be released quickly, has good adhesion after release, and is suitable for occluding long axial organ channels.

[0007] To solve the above technical problems, the present application provides a lumen occluder, comprising: a framework; and a flow-blocking membrane formed on the framework; wherein the maximum axial length of the flow-blocking membrane is greater than or equal to the maximum axial stretching length of the framework.

[0008] The lumen occluder provided by the present application is small in size after compression, can be released quickly, has good adhesion after release, and is suitable for occluding long axial organ channels. BRIEF DESCRIPTION OF DRAWINGS

[0009] To more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the embodiments. Obviously, the drawings described in the following embodiments are some embodiments of the present application, and other drawings can also be obtained by those skilled in the art without any creative effort based on these drawings.

[0010] Fig. 1 is a perspective view of the lumen occluder provided by the first embodiment of the present application.

[0011] Fig. 2 is a sectional view of the lumen occluder provided by the first embodiment of the present application.

[0012] Figs. 3a to 3d is a sectional view of the lumen occluder provided by the first embodiment of the present application.

[0013] Figs. 4a to 4d is a perspective view of the shape of the framework of the lumen occluder provided by the first embodiment of the present application.

[0014] Fig. 5 is a partial sectional view of the lumen occluder provided by the first embodiment of the present application.

[0015] Fig. 6 is a partial sectional view of the lumen occluder provided by the first embodiment of the present application. Fig. 5

[0016] Fig. 7 is a partial sectional view of the lumen occluder provided by the first embodiment of the present application.

[0017] Fig. 8 is a sectional view of the lumen occluder provided by the first embodiment of the present application.

[0018] ​Fig. 9 is a cross-sectional view of a lumenal occlusion device provided by a second embodiment of the present application.

[0019] Fig. 10 is a cross-sectional view of a lumenal occlusion device provided by a third embodiment of the present application.

[0020] Fig. 11 is a cross-sectional view of a lumenal occlusion device provided by a fourth embodiment of the present application. DETAILED DESCRIPTION

[0021] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments of the present application. Based on the embodiments in the present application, all the other embodiments obtained by those skilled in the art without creative effort belong to the scope of protection of the present application.

[0022] Please refer to Figs. 1 to 9 , the first embodiment of the technical solutions provides a lumenal occlusion device 100, which can form an obstruction immediately after being implanted in a lesion area to prevent blood from flowing into the lesion area.

[0023] As shown in Figs. 1 to 2 , the lumenal occlusion device 100 includes a framework 11, a sleeve head 12, a plug head 13, and a flow-blocking membrane 14.

[0024] In an embodiment, the framework 11 is a hollow columnar structure as a whole.

[0025] In an embodiment, at least part of the framework 11 is a cylindrical structure, so that the lumenal occlusion device 100 can be closely fitted with the tissue at the release position when released, so as to have a better occlusion effect.

[0026] In an embodiment, as shown in Figs. 3a to 3d , and Figs. 4a to 4d , in the radial direction of the framework 11, the cross-sectional shape of the framework 11 can be circular (see Fig. 3a and Fig. 4a ), large semicircular (see Fig. 3b and Fig. 4b ), crescent (see Fig. 3c and Fig. 4c ), and semicircular (see Fig. 3d and Fig. 4d ).

[0027] In other embodiments, the cross-sectional shape of the framework 11 can also be other shapes, which are not limited to the above.

[0028] In one embodiment, the skeleton 11 may be a mesh structure woven from filaments. The filaments may be metal wires, metal tubes, polymer filaments or polymer tubes, etc., or may be a composite formed of at least two of metal wires, metal tubes, polymer filaments and polymer tubes.

[0029] In one embodiment, the skeleton 11 is woven from multiple wires made of shape memory alloys, such as nickel-titanium shape memory alloys, copper-nickel shape memory alloys, copper-aluminum shape memory alloys, copper-zinc shape memory alloys, iron-based shape memory alloys (Fe-Mn-Si, Fe-Pd), etc., so that it can recover its original shape after compression and release.

[0030] In one embodiment, the skeleton 11 is woven from multiple titanium-nickel wires; wherein, the nickel-titanium wires have better elasticity and memory resilience, and have a good adaptability, which can improve the sealing effect.

[0031] The filaments of the skeleton 11 converge at both axial end faces of the skeleton 11, forming a first end and a second end, respectively. For example... Fig. 2 As shown, the sleeve 12 is fitted onto the first end and connected to the first end by welding; the plug 13 is fitted onto the second end and connected to the second end by welding; the sleeve 12 and the plug 13 are preferably made of stainless steel, such as 316L stainless steel.

[0032] In one embodiment, the end of the plug 13 away from the sleeve 12 is threaded (not shown) for mating with other devices, such as a conveyor.

[0033] A flow-blocking membrane 14 is coated on the skeleton 11; wherein, the flow-blocking membrane 14 can be formed inside the skeleton 11, or outside the skeleton 11, or simultaneously inside and outside the skeleton 11.

[0034] The maximum axial length of the flow-blocking membrane 14 is greater than or equal to the maximum axial tensile length of the skeleton 11. Therefore, when the intracavitary plug 100 needs to be compressed in a delivery sheath, the skeleton 11 will not be unable to be compressed in the delivery sheath due to the inability of the flow-blocking membrane 14 to extend. That is, the flow-blocking membrane 14 and the skeleton 11 can stretch and change together, so that the flow-blocking membrane 14 bound to the skeleton 11 will not restrict the axial tensile of the skeleton 11.

[0035] In this embodiment, as Figs. 1 to 2 As shown, the flow-blocking membrane 14 covers the outside of the skeleton 11 and is in close contact with the skeleton 11. Thus, in its natural state, the shape and axial length of the flow-blocking membrane 14 are the same as those of the skeleton 11.

[0036] In this embodiment, the flow-blocking film 14 is elastic, and the maximum axial tensile length of the flow-blocking film 14 is greater than or equal to the maximum axial tensile length of the framework 11; when the framework 11 is compressed and thus elongated axially, the flow-blocking film 14 elastically deforms and is elongated axially along with the framework 11; when the intraluminal occluder 100 is released to the lesion site and the framework 11 returns to its original state, the flow-blocking film 14 also returns to its original state, that is, the shape of the flow-blocking film 14 in the stretched state is the same as the shape of the framework 11 in the stretched state.

[0037] The material of the flow-blocking film 14 can be a biocompatible material such as polytetrafluoroethylene (ePTFE) or a PET film.

[0038] In an embodiment, the thickness of the flow-blocking film 14 is 0.02 mm to 0.1 mm; preferably, the thickness of the flow-blocking film 14 is 0.04 mm to 0.08 mm; more preferably, the thickness of the flow-blocking film 14 is 0.04 mm, 0.06 mm, or 0.08 mm.

[0039] The flow-blocking film 14 can be connected to the framework 11 by suturing with a suture 15; the suturing can be single-point suturing.

[0040] The suture 15 can be sutured at any one end or both ends of the framework 11 in the axial direction, or at any position between the two ends of the framework 11.

[0041] Specifically, the suture 15 can be sutured near the sleeve head 12, near the plug head 13, or at any position of the framework 11 between the sleeve head 12 and the plug head 13, or at any two or more positions; for example, as shown in Fig. 5 and Fig. 6 the suture 15 is sutured at the sleeve head 12; as shown in Fig. 7 the suture 15 is sutured at the plug head 13; as shown in Fig. 8 the suture 15 is sutured at the sleeve head 12, the plug head 13, and the cylindrical surface of the framework 11.

[0042] The material of the suture 15 can be a biocompatible material such as polytetrafluoroethylene.

[0043] Please refer to Fig. 9The second embodiment of the technical scheme provides a cavity occlusion device 100a. The cavity occlusion device 100a in the embodiment is basically the same as the cavity occlusion device 100 in the first embodiment, and the difference is that the flow blocking film 14a is not closely attached to the framework 11a, and the shape of the flow blocking film 14a is also different from that of the framework 11a. In the embodiment, the flow blocking film 14a is wrapped on the framework 11a and is in a wave-creased shape. In a natural state, the axial length of the flow blocking film 14a is the same as that of the framework 11a. Preferably, the flow blocking film 14a is in a regular wave-creased shape, that is, the distance between the highest points of adjacent convex parts is the same, the distance between the lowest points of adjacent concave parts is also the same, and the height of each convex part is the same, and the height of each concave part is also the same, that is, the line connecting the highest points of each convex part is parallel to the axial direction of the flow blocking film 14a, and the line connecting the lowest points of each convex part is also parallel to the axial direction of the flow blocking film 14a. When the framework 11a is compressed and axially elongated, the creases of the flow blocking film 14a are gradually unfolded, so that the flow blocking film 14a is axially elongated together with the framework 11a. When the cavity occlusion device 100a is released and the framework 11a returns to the original state, the flow blocking film 14a returns to the creased shape. In the embodiment, when all the creases of the flow blocking film 14a are unfolded, the axial length of the flow blocking film 14a is greater than or equal to the maximum axial elongation length of the framework 11a. The cavity occlusion device 100a in the embodiment can increase the fitting performance with the tissue at the release position and enhance the occlusion effect.

[0044] Please refer to Fig. 10 The third embodiment of the technical scheme provides a cavity occlusion device 100b. The cavity occlusion device 100b in the embodiment is basically the same as the cavity occlusion device 100a in the second embodiment, and the difference is that the flow blocking film 14b is not in a wave-creased shape. In the embodiment, the flow blocking film 14b is wrapped outside the framework 11b and is in a zigzag-creased shape. In a natural state, the axial length of the flow blocking film 14b is the same as that of the framework 11b. That is, the creases of the flow blocking film 14a in the second embodiment are smooth, and the creases of the flow blocking film 14b in the embodiment are not smooth, and each crease is folded in a triangular shape, for example Fig. 11The flow-blocking film 14b is preferably in the shape of a regular sawtooth corrugation, i.e., the distance between the highest points of adjacent protrusions is the same, the distance between the lowest points of adjacent depressions is the same, the height of each protrusion is the same, the height of each depression is the same, the line connecting the highest points of each protrusion is parallel to the axial direction of the flow-blocking film 14b, and the line connecting the lowest points of each protrusion is also parallel to the axial direction of the flow-blocking film 14b. When the skeleton 11b is compressed and thus axially elongated, the corrugation of the flow-blocking film 14b gradually unfolds, so that the flow-blocking film 14b is axially elongated along with the skeleton 11b; when the endoluminal occlusion device 100b is released and the skeleton 11b returns to its original state, the flow-blocking film 14b returns to its corrugated shape. In this embodiment, when the corrugation of the flow-blocking film 14b is completely unfolded, the axial length of the flow-blocking film 14b is greater than or equal to the maximum axial elongation length of the skeleton 11b. The endoluminal occlusion device 100b in this embodiment can increase the conformability to the tissue at the released position and enhance the occlusion effect.

[0045] For reference Fig. 11 The fourth embodiment of the present technical solution provides an endoluminal occlusion device 100c. The endoluminal occlusion device 100c in this embodiment is basically the same as the endoluminal occlusion device 100 in the first embodiment, except that the axial length of the flow-blocking film 14c is different from the axial length of the skeleton 11c in the natural state. In this embodiment, the flow-blocking film 14c is wrapped outside the skeleton 11c, the axial length of the flow-blocking film 14c in the natural state is greater than the axial length of the skeleton 11c, and is greater than or equal to the maximum axial elongation length of the skeleton 11c, i.e., the axial cross-sectional shape of the flow-blocking film 14c is the same as that of the skeleton 11c, but in the axial direction, the flow-blocking film 14c has a certain length reserved, so that when the skeleton 11c is compressed and thus axially elongated, the skeleton 11c can be elongated in the space formed by the reserved length of the flow-blocking film 14c, so that the flow-blocking film 14c does not limit the axial elongation of the skeleton 11c. Since the flow-blocking film 14c in this embodiment is made of soft material, the reserved length of the flow-blocking film 14c does not affect the tissue at the released position when the endoluminal occlusion device 100c is released.

[0046] The intracavity occluder provided by the technical scheme has a framework and a flow blocking film, and the framework and the flow blocking film have good compressibility, so that the volume of the intracavity occluder after compression is small; the intracavity occluder provided by the technical scheme is made of the framework and the flow blocking film, and can quickly restore the original shape when released, and has good adhesion after release; further, the maximum axial length of the flow blocking film of the intracavity occluder is greater than or equal to the maximum axial length of the framework, so that the intracavity occluder can be applied to the occlusion of an organ channel with a relatively long axial length; for example, when the intracavity occluder is compressed in a delivery sheath tube, the flow blocking film can be elongated along with the elongation of the intracavity occluder in the axial direction, and after the intracavity occluder is released at a lesion position and restores the shape, the flow blocking film can also change along with the intracavity occluder and cover the intracavity occluder, so that the blood can be completely prevented from passing through the intracavity occluder into a defect opening or a tissue break, so as to complete the occlusion of the defect opening or the tissue break; because the flow blocking film does not limit the elongation of the framework, even if the occluder has a relatively long axial length, the occluder can still be compressed in the sheath tube with a small size, and is especially suitable for the interventional treatment of aortic dissection; the occluder is placed in a false lumen of the dissection, and can promote the thrombosis of the false lumen; on the other hand, the shapes of the false lumens of different individuals are different, and the occluder provided by the present application has different cross sections, such as a circular shape, a large semicircular shape, a crescent shape and a semicircular shape, so that the occluder can be selected according to the shape of the false lumen, and the adhesion of the occluder to the inside of the false lumen is improved.

[0047] The above is the implementation manner of the embodiment of the present application, and it should be noted that, for those skilled in the art, without departing from the principle of the embodiment of the present application, some improvements and refinements can be made, and these improvements and refinements are also regarded as the protection scope of the present application.

Claims

1. An endoluminal occlusion device, comprising: a skeleton, the skeleton being a hollow columnar structure, and at least a part of the skeleton being a cylindrical structure, a cross-sectional shape of the skeleton in a radial direction of the skeleton being semicircular, large semicircular or crescent, the endoluminal occlusion device being used for placement in an aortic dissection false lumen; and a flow-blocking membrane, the flow-blocking membrane being wrapped on the skeleton, the flow-blocking membrane not being closely attached to the skeleton, the flow-blocking membrane being in a wave-creped or zigzag-creped shape, in the flow-blocking membrane, a distance between highest points of adjacent convexes is the same, and a distance between lowest points of adjacent concaves is the same, and an axial length of the flow-blocking membrane in a natural state is the same as an axial length of the skeleton. the flow-blocking membrane is connected to the skeleton by sewing with a suture, the endoluminal occlusion device further comprising a sleeve head and a plug head, the suture being sewn at the sleeve head, the plug head and a columnar surface of the skeleton, wherein when all the creases of the flow-blocking membrane are flattened, a maximum axial length of the flow-blocking membrane is greater than or equal to a maximum axial stretching length of the skeleton.

2. The endoluminal occlusion device of claim 1, wherein, the skeleton is a mesh structure woven by filaments, and the filaments of the skeleton converge at two end surfaces of the skeleton in an axial direction, respectively forming a first end and a second end.

3. The endoluminal occlusion device of claim 2, wherein, the sleeve head is sleeved on the first end and connected to the first end by welding, the plug head is sleeved on the second end and connected to the second end by welding, and a thread is formed on an end of the plug head away from the sleeve head, the thread being used for cooperation with a delivery device.

4. The endoluminal occlusion device of claim 1, wherein, in the flow-blocking membrane, a height of each convex is the same, and a height of each concave is the same.

Images