Absorbable vascular plugs and absorbable vascular plug systems

Abstract

The present application relates to a kind of absorbable vascular plug and absorbable vascular plug system.The absorbable vascular plug includes plug body, plug body includes at least two axially arranged plug disc, any two adjacent plug disc opposite disc surface, wherein one is provided with first adhesive part, and the other is provided with second adhesive part, the first adhesive part and the second adhesive part cooperate with each other, to lock the axial distance of any two adjacent plug disc.The absorbable vascular plug can lock axial length, and flexibility is better.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to an absorbable vascular plug and an absorbable vascular plug system. BACKGROUND

[0002] This section provides background information only and can not necessarily be prior art.

[0003] In recent years, transcatheter intervention therapy has developed very rapidly and is increasingly widely used. The therapy can be used to place devices and / or drugs in the heart, arteries and veins, etc. of the human body. The devices can be heart occluders, vascular plugs, vascular filters, etc.

[0004] Traditional vascular plugs and other devices are generally made of shape memory alloy materials. The shape memory alloy materials have good elasticity and can better restore the original shape after release and better fit the tissue of the defect site. However, the current shape memory alloy materials are generally materials that cannot be corroded or degraded in the body. When endothelialization is completed and complete occlusion is achieved, the vascular plugs and other devices made of shape memory alloy materials will remain permanently in the body, which may pose a long-term clinical risk.

[0005] Although the vascular plugs and other implantable devices made of absorbable polymer materials can degrade in the body, making the vascular plugs gradually degrade and the degradation products be absorbed by the body, there is no residue in the body. However, the polymer materials are relatively soft and difficult to shape. The vascular plugs made of polymer materials are relatively soft and easy to deform. When subjected to the impact of blood flow, the vascular plugs are easy to lengthen and cause the radial size to decrease, thereby causing the friction between the vascular plugs and the blood vessel wall to be insufficient and the vascular plugs to be easily detached. To avoid the above problems, the existing vascular plugs have locking members extending in the axial direction in the occlusion frame to fix the axial length of the vascular plugs and avoid deformation caused by the impact of blood flow. This necessarily requires the locking members to have a certain rigidity and length.

[0006] However, the rigid locking members extending in the axial direction in the occlusion frame increase the rigidity of the occluder after stretching to some extent, which increases the difficulty of delivery and is not conducive to passing through curved blood vessels. SUMMARY

[0007] Therefore, it is necessary to provide an absorbable vascular plug that can lock the axial length and has good flexibility.

[0008] An absorbable vascular plug comprises a plug body, the plug body comprising at least two axially arranged plug disks, wherein one of the opposite disk surfaces of any two adjacent plug disks is provided with a first adhesive portion and the other is provided with a second adhesive portion, the first adhesive portion and the second adhesive portion cooperating with each other to lock the axial distance of any two adjacent plug disks.

[0009] In one embodiment, the first adhesive portion and the second adhesive portion form a Velcro fastener; or, the first adhesive portion and the second adhesive portion form a snap fastener.

[0010] In one embodiment, the first adhesive portion and the second adhesive portion are made of absorbable material.

[0011] In one embodiment, the plug body comprises three plug disks, adjacent plug disks being connected by a waist portion, the waist portion having a radial dimension smaller than the radial dimension of the plug disks.

[0012] In one embodiment, the axial length of the middle plug disk is greater than the axial length of the two side plug disks.

[0013] In one embodiment, the absorbable vascular plug further comprises a first end cap and a second end cap, the first end cap and the second end cap being respectively arranged at the two ends of the plug body.

[0014] In one embodiment, the plug body is woven by woven wire; or, the plug body is formed by 3D printing; or, the plug body is formed by cutting.

[0015] In one embodiment, the material of the plug body is selected from at least one of polylactic acid, polyglycolic acid, poly(lactic-co-glycolic acid), polyhydroxyalkanoate, polydioxanone, polycaprolactone, polygluconate, polyhydroxybutyrate, polyanhydride, polyphosphoester, polydioxanone, and polycarbonate.

[0016] An absorbable vascular plug system comprises a traction member and the above-mentioned absorbable vascular plug, the traction member being used to make the first adhesive portion and the second adhesive portion cooperate with each other to lock the axial distance of any two adjacent plug disks.

[0017] In one embodiment, the traction member is detachably connected with the first end cap, the traction member being used to pull the first end cap to make the first adhesive portion and the second adhesive portion close to each other to lock the axial distance of any two adjacent plug disks.

[0018] The opposite disc surfaces of any two adjacent plug discs of the absorbable vascular plug are provided with a first adhesive part and a second adhesive part, the first adhesive part and the second adhesive part can cooperate with each other, so that any two adjacent plug discs can be adhered together, thereby locking the axial distance of any two adjacent plug discs, i.e. locking the axial length of the whole absorbable vascular plug. Moreover, the locking is achieved by the adhesion of the first adhesive part and the second adhesive part, which can avoid using a rigid locking member extending in the axial direction, so that the flexibility of the absorbable vascular plug is better. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 Structure schematic diagram of an embodiment of an absorbable vascular plug system;

[0020] Figures 2-3 Structure schematic diagram of an embodiment of an absorbable vascular plug;

[0021] Figure 4 Structure schematic diagram of an embodiment of a pushing member and a pulling member. DETAILED DESCRIPTION

[0022] In order to make the above objectives, characteristics and advantages of the present application more apparent and comprehensible, the specific embodiments of the present application will be described in detail below with reference to the accompanying drawings. In the following description, a large number of specific details are set forth in order to fully understand the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the scope of the present application, so the present application is not limited to the specific embodiments disclosed below.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0024] In the field of interventional medical devices, the "distal end" is defined as the end far away from the operator during the operation, and the "proximal end" is defined as the end close to the operator during the operation. The "axial direction" refers to the direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device, and the "radial direction" refers to the direction perpendicular to the above-mentioned axial direction. The "circumferential direction" refers to the circumferential direction, i.e. the direction around the axis of the lumen device.

[0025] Referring to Figure 1 , an embodiment of an absorbable vascular plug system 1, comprising an absorbable vascular plug 10 and a delivery device 20.

[0026] Referring to Figure 2The absorbable vascular plug 10 comprises a plug body 100. The plug body 100 comprises at least two axially arranged plug discs 110. The at least two plug discs 110 are spaced apart and opposite to each other.

[0027] The plug body 100 is made of an absorbable material. In an embodiment, the material of the plug body 100 is selected from at least one of polylactic acid (PLA), polyglycolic acid (PGA), poly(lactic-co-glycolic acid) (PLGA), polyhydroxyalkanoate (PHA), polydioxanone (PDO), polycaprolactone (PCL), polyglyconate, polyhydroxybutyrate, polyanhydride, polyphosphoester (PPE), polydioxanone and polycarbonate (PC). It is understood that in other embodiments, the material of the plug body 100 is not limited to the above-mentioned materials, and any absorbable material which is biocompatible, degradable in vivo and capable of being formed into the plug disc 100 is applicable.

[0028] The plug body 100 can be formed by cutting a tube, by weaving a wire or by 3D printing.

[0029] In an embodiment, the plug body 100 comprises three plug discs 110. The adjacent plug discs 110 are connected by a waist 120. The radial dimension of the waist 120 is smaller than the radial dimension of the plug disc 110. The radial dimension refers to the distance between the two points farthest apart in the radial direction, such as diameter, side length, etc. It is understood that in other embodiments, the number of plug discs 110 is not limited to three, and can be two, four, five, etc. In an embodiment, the plug body 100 comprises three plug discs 110, and the axial length of the plug disc 110 in the middle is greater than the axial length of the plug discs 110 on both sides. As shown in FIG. 1, in the natural state, the axial length of the plug disc 110 in the middle is L1, and the axial length of the plug discs 110 on both sides is L2 and L3 respectively, L1 is greater than L2, L1 is greater than L3, and L2 and L3 are equal or unequal. Figure 3 The setting of three plug discs 110, the three plug discs 110 cooperate with each other, so that when implanted, the contact area of the plug body 100 with the blood vessel wall is larger, the anchoring reliability is improved, and it is beneficial to resist the impact of blood flow. Further, the axial length L1 of the plug disc 110 in the middle is larger, which is beneficial to further increase the contact area, improve the anchoring reliability, and can adapt to individuals with longer lesion sites. In other embodiments, L1=L2=L3.

[0030] In an embodiment, the plug body 100 comprises four plug discs 110, and the axial lengths of the four plug discs 110 are equal or unequal. The adjacent two plug discs 110 are connected by a waist 120.

[0031] Please continue to refer to Figure 3, one of the two opposite disc surfaces of any two adjacent disc 110 is provided with a first adhesive part 130, and the other is provided with a second adhesive part 140. When the first adhesive part 130 and the second adhesive part 140 are close to each other, the first adhesive part 130 and the second adhesive part 140 are adhered to each other, so that the two adjacent disc 110 are adhered to each other, thereby realizing the locking of the axial length of the whole absorbable vascular plug 10. Moreover, this locking mode does not need to pass through the rigid and axially extending locking piece, so that the flexibility of the absorbable vascular plug 10 is better.

[0032] Moreover, by setting the first adhesive part 130 and the second adhesive part 140, the length of the whole absorbable vascular plug 10 can be adjusted, and the two disc 110 can be adhered together or all the disc 110 can be adhered together according to actual needs.

[0033] Further, the two adjacent disc 110 are adhered together, which is beneficial to improve the radial support performance of the plug body 100, thereby improving the anchoring reliability.

[0034] The first adhesive part 130 and the second adhesive part 140 are flexible structures. In an embodiment, one of the first adhesive part 130 and the second adhesive part 140 is a hook structure, and the other is a hair structure, and the first adhesive part 140 and the second adhesive part 140 form a magic tape or a Velcro, so that the two adjacent disc 110 can be adhered together.

[0035] The first adhesive part 130 extends on the disc surface of the disc 110. The second adhesive part 140 extends on the disc surface of the disc 110. Compared with the rigid and axially extending locking piece, the flexible first adhesive part 130 and the second adhesive part 140 can make the flexibility of the absorbable vascular plug 10 better.

[0036] In an embodiment, the first adhesive part 130 and the second adhesive part 140 are annular, and the first adhesive part 130 and the second adhesive part 140 are arranged around the central axis of the disc 110.

[0037] In an embodiment, the first adhesive part 130 covers the whole disc surface of the disc 110, and the opposite second adhesive part 140 covers the opposite whole disc surface of the adjacent disc 110, so as to improve the adhesive area and reliably adhere the two adjacent disc 110 together, thereby improving the radial support performance.

[0038] In an embodiment, the first adhesive part 130 and the second adhesive part 140 are non-annular structures, such as square, rectangular, circular and other regular or irregular shapes. One disc surface of the disc 110 can be provided with a plurality of first adhesive parts 130 or a plurality of second adhesive parts 140.

[0039] It can be understood that, regardless of the shape of the first adhesive part 130 and the second adhesive part 140, the first adhesive part 130 and the second adhesive part 140 are oppositely arranged on the opposite disc surfaces of any two adjacent plug discs 110.

[0040] The first adhesive part 130 and the second adhesive part 140 are both made of absorbable material. For example, the first adhesive part 130 is a hook structure made of absorbable material, and the second adhesive part 140 is a hair structure made of absorbable material.

[0041] In an embodiment, the material of the first adhesive part 130 and the second adhesive part 140 is selected from at least one of polylactic acid (PLA), polyglycolic acid (PGA), polylactic-glycolic acid copolymer (PLGA), polyhydroxyalkanoate (PHA), polydioxanone (PDO), polycaprolactone (PCL), polyglucanoic acid, polyhydroxybutyric acid, polyanhydride, polyphosphoester (PPE), polydioxanone, and polycarbonate (PC). The materials of the first adhesive part 130 and the second adhesive part 140 can be the same or different.

[0042] In another embodiment, one of the first adhesive part 130 and the second adhesive part 140 is a male buckle, and the other is a female buckle. The first adhesive part 130 and the second adhesive part 140 form a male-female buckle, so as to realize the adhesion of the two adjacent plug discs 110. The first adhesive part 130 and the second adhesive part 140 of this structure can also be made of absorbable polymer material.

[0043] In an embodiment, the disc surface of the plug disc 110 is a plane. In an embodiment, the disc surface of the plug disc 110 is a curved surface, and the disc surface of the plug disc 110 includes a convex part. The first adhesive part 130 and the second adhesive part 140 are arranged on the convex parts of the opposite disc surfaces of the two adjacent plug discs 110, respectively, so as to facilitate adhesion.

[0044] Please continue to refer to Figure 3 The absorbable vascular plug 10 further includes a first head 150 and a second head 160 arranged on the two sides of the plug body 100. The first head 150 and the second head 160 are arranged to facilitate cooperation with the delivery device 20, and to deliver, release and adjust the absorbable vascular plug 10. In an embodiment, when the plug body 100 is formed by braiding wires, the first head 150 and the second head 160 also function to fix the two free ends of the braided wires.

[0045] The first head 150 is located at the distal end. The first head 150 is provided with a first through hole 152. In an embodiment, the first through hole 152 is a threaded hole. The second head 160 is located at the proximal end. The second head 160 is provided with a second through hole 162, and the outer wall of the second head 160 is provided with an external thread 164.

[0046] The material of the first head 150 and the second head 160 is absorbable material. The material of the first head 150 and the second head 160 can be the same or different. In an embodiment, the material of the first head 150 and the second head 160 is selected from at least one of polylactic acid (PLA), polyglycolic acid (PGA), poly(lactic-co-glycolic acid) (PLGA), polyhydroxyalkanoate (PHA), polydioxanone (PDO), polycaprolactone (PCL), polyglyconate, polyhydroxybutyric acid, polyanhydride, polyphosphoester (PPE), polydioxanone, and polycarbonate (PC).

[0047] The second head 160, the plug body 100, and the first head 150 are in communication to form a path.

[0048] Please refer back to Figure 1 The delivery device 20 includes a delivery sheath (not shown), a pusher 210, and a puller 220 slidably disposed in the pusher 210.

[0049] The pusher 210 is detachably connected with the second head 160 to pull the absorbable vascular plug 10 into the delivery sheath or push the absorbable vascular plug 10 out of the delivery sheath. Please refer to Figure 4 The pusher 210 includes a hollow tube 212 and a connector 214 connected with a distal end of the tube 212. The connector 214 is detachably connected with the second head 160. Specifically, the connector 214 is internally threaded, and the connector 214 is detachably connected with the externally threaded 164 of the second head 160 by the internal thread.

[0050] The puller 220 is an elongated rod. The puller 220 is externally threaded 222 at a distal end thereof, and the puller 220 is detachably connected with the first head 150 by the externally threaded 222 and the thread in the first head 150. The puller 220 is used to pull the first head 150 to make the first adhesive portion 130 and the second adhesive portion 140 close to each other to lock the axial distance between any two adjacent plug disks 110.

[0051] In loading, the puller 220 is inserted into the first head 150 along the path formed by the second head 160, the plug body 100, and the first head 150, and the externally threaded 222 of the puller 220 is connected with the first head 150 by the first through hole 152 of the first head 150. The connector 214 of the pusher 210 is connected with the second head 160 by the externally threaded 164 of the second head 160. Then, the plug body 100 is in a stretched state by the puller 220, and then the absorbable vascular plug 10 is pulled into the delivery sheath.

[0052] When the delivery sheath loaded with the absorbable vascular plug 10 is implanted at the target site, the pusher 210 is pushed to the distal end to push the absorbable vascular plug 10 out of the delivery sheath, and after the position is adjusted (if necessary), the puller 220 is pulled to the proximal end, so that the radial width of the absorbable vascular plug 10 in the stretched state gradually increases and gradually recovers to the expanded state. During the pulling of the puller 220 to the proximal end, the opposite first adhesive part 130 and the second adhesive part 140 are adhered together, thereby locking the axial distance of the absorbable vascular plug 10.

[0053] By arranging the first adhesive part 130 and the second adhesive part 140 on the opposite two disc surfaces of any two adjacent plug discs 110, the axial length of the whole absorbable vascular plug 10 is locked. This locking mode can avoid using a rigid, axially extending locking member, so that the flexibility of the absorbable vascular plug 10 is better.

[0054] In addition, the first adhesive part 130 and the second adhesive part 140 adhere the two adjacent plug discs 110 together, which is beneficial to improve the radial support performance of the absorbable vascular plug 10 and avoid falling off, thereby improving the safety of use.

[0055] Further, the length of the rigid locking member determines the axial length of the vascular plug, so the presence of the locking member will affect the adjustment of the length of the vascular plug, and it is difficult to adapt to different individuals. By selectively adhering or not adhering the first adhesive part 130 and the second adhesive part 140, the axial length of the absorbable vascular plug 10 is adjustable to adapt to different individuals.

[0056] The technical features of the above-described embodiments can be combined in any manner. To make the description concise, all possible combinations of the technical features in the above-described embodiments are not described, but as long as the combinations of the technical features do not exist contradictory, they should be considered as the scope of the description.

[0057] The above-described embodiments only express several embodiments of the present application, and the description is more specific and detailed, but it should not be understood as limiting the scope of the patent. It should be pointed out that for ordinary skilled in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which are within the scope of the present application. Therefore, the scope of protection of the patent of the present application should be subject to the appended claims.

Claims

1. An absorbable vascular plug, comprising: The plug body comprises at least two axially arranged plug discs, wherein one of the opposite disc surfaces of any two adjacent plug discs is provided with a first adhesive part and the other is provided with a second adhesive part, and the first adhesive part and the second adhesive part cooperate to lock the axial distance of any two adjacent plug discs.

2. The absorbable vascular plug of claim 1, wherein, The first adhesive part and the second adhesive part constitute a buckle; or the first adhesive part and the second adhesive part constitute a male-female buckle.

3. The absorbable vascular plug of claim 1, wherein, The first adhesive part and the second adhesive part are both made of absorbable material.

4. The absorbable vascular plug of claim 1 wherein, The plug body comprises three plug discs, and adjacent plug discs are connected by a waist part, wherein the radial dimension of the waist part is smaller than the radial dimension of the plug discs.

5. The absorbable vascular plug of claim 4, wherein, The axial length of the middle plug disc is greater than the axial length of the two plug discs on both sides.

6. The absorbable vascular plug of claim 1 wherein, The absorbable vascular plug further comprises a first end cap and a second end cap, and the first end cap and the second end cap are respectively arranged at both ends of the plug body.

7. The absorbable vascular plug of claim 1 wherein, The plug body is woven by woven wire; or the plug body is formed by 3D printing; or the plug body is formed by cutting.

8. The absorbable vascular plug of claim 1 wherein, The material of the plug body is selected from at least one of polylactic acid, polyglycolic acid, poly(lactic-co-glycolic acid), polyhydroxyalkanoate, polydioxanone, polycaprolactone, polygluconate, polyhydroxybutyrate, polyanhydride, polyphosphoester, polydioxanone and polycarbonate.

9. An absorbable vascular plug system, comprising: The absorbable vascular plug comprises a traction member and the absorbable vascular plug according to any one of claims 1-8, and the traction member is used to make the first adhesive part and the second adhesive part cooperate to lock the axial distance of any two adjacent plug discs.

10. The absorbable vaso-occlusive system of claim 9, wherein, The absorbable vascular plug further comprises a first end cap and a second end cap, and the first end cap and the second end cap are respectively arranged at both ends of the plug body, the traction member is detachably connected with the first end cap, and the traction member is used to pull the first end cap to make the first adhesive part and the second adhesive part close to each other to lock the axial distance of any two adjacent plug discs.

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