CN116327294B - Absorbable vascular plug and absorbable vascular plug system - Google Patents

Abstract

The present invention relates to an absorbable vascular plug and an absorbable vascular plug system. The absorbable vascular plug comprises a plug body comprising at least two axially arranged plug discs. On the opposing surfaces of any two adjacent plug discs, one is provided with a first adhesive portion, and the other is provided with a second adhesive portion. The first and second adhesive portions cooperate to lock the axial distance between any two adjacent plug discs. This absorbable vascular plug can lock the axial length and has good flexibility.

Description

Absorbable vascular plug and absorbable vascular plug system

Technical Field

The invention relates to the field of medical equipment, in particular to an absorbable vascular plug and an absorbable vascular plug system.

Background

This section provides merely background information related to the present disclosure and is not necessarily prior art.

Transcatheter intervention is a treatment for diseases that has developed very rapidly in recent years, and the field in which this therapy is applicable is becoming more and more widespread. Wherein, the device and/or the medicine can be placed on the heart, the artery and vein of the human body and other parts by adopting a transcatheter interventional therapy method. The apparatus may be a heart occluder, a vascular plug, a vascular filter, etc.

The traditional devices such as the vascular plug are generally made of shape memory alloy materials, the shape memory alloy materials have good elasticity, and the devices can better recover the original shape after being released and better fit with the tissue of the defect part. However, the existing memory alloy material is generally a material which cannot be corroded or degraded in organisms, and after endothelialization is completed and complete plugging is achieved, devices such as a blood vessel plug and the like made of the shape memory alloy material are permanently kept in the body, so that long-term clinical risks can exist.

The vascular plug or other implantable devices made of absorbable polymer materials can be degraded in the organism, so that the vascular plug can be gradually degraded, and after degradation products are absorbed by the organism, no residue exists in the organism. But the polymer material is soft and is not easy to be molded. The vascular plug made of the polymer material is softer and easy to deform, and when the vascular plug is impacted by blood flow, the vascular plug is easy to lengthen and the radial dimension is reduced, so that the frictional force between the vascular plug and the vascular wall is insufficient and the vascular plug is easy to fall off. In order to avoid the above problems, in the conventional vascular plug, a locking member extending in an axial direction is provided in the plugging frame to fix an axial length of the vascular plug so as to avoid deformation due to impact of blood flow. This necessarily requires that the locking member has a certain rigidity and length.

However, the rigid locking member extends axially within the occluding frame to some extent to increase the rigidity of the occluding device after stretching, adding difficulty to delivery and being detrimental to passage through a tortuous vessel.

Disclosure of Invention

Based on this, it is necessary to provide an absorbable vascular plug that can lock the axial length and that is relatively flexible.

The utility model provides an absorbable vascular stopper, includes the cock body, the cock body includes two at least axial arrangement's stopper dish, on the relative quotation of arbitrary adjacent two stopper dishes, is provided with first paste portion on one of them, is provided with the second on the other and pastes the portion, first paste portion and second paste the portion mutually support to lock the axial distance of arbitrary adjacent two stopper dishes.

In one embodiment, the first adhesive part and the second adhesive part form an adhesive buckle, or the first adhesive part and the second adhesive part form a primary-secondary buckle.

In one embodiment, the first and second adhesive portions are each made of an absorbable material.

In one embodiment, the plug body comprises three plug discs, adjacent plug discs are connected by a waist, and the radial dimension of the waist is smaller than the radial dimension of the plug discs.

In one embodiment, the axial length of the middle plug disc is greater than the axial length of both plug discs.

In one embodiment, the absorbable vascular plug further comprises a first end socket and a second end socket, and the first end socket and the second end socket are respectively arranged at two ends of the plug body.

In one embodiment, the plug body is woven from woven filaments, or the plug body is formed by 3D printing, or the plug body is formed by cutting.

In one embodiment, the material of the plug body is at least one selected from polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoate, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphoester, polydioxanone and polycarbonate.

The absorbable vascular plug system comprises a traction piece and the absorbable vascular plug, wherein the traction piece is used for enabling the first pasting part and the second pasting part to be matched with each other so as to lock the axial distance between any two adjacent plug discs.

In one embodiment, the traction member is detachably connected with the first sealing head, and the traction member is used for pulling the first sealing head to enable the first pasting part and the second pasting part to be close to each other so as to lock the axial distance between any two adjacent plug discs.

The first pasting part and the second pasting part are arranged on the opposite disc surfaces of any two adjacent plug discs of the absorbable vascular plug, and can be matched with each other, so that the any two adjacent plug discs can be pasted together, the axial distance of the any two adjacent plug discs can be locked, and the integral axial length of the absorbable vascular plug can be locked. Moreover, the first adhesive part and the second adhesive part are adhered to be locked, so that a rigid locking piece extending along the axial direction can be avoided, and the absorbable vascular plug has better flexibility.

Drawings

FIG. 1 is a schematic diagram of an embodiment of an absorbable vascular plug system;

FIGS. 2-3 are schematic diagrams illustrating absorbable vascular plugs according to one embodiment;

Fig. 4 is a schematic structural view of the pushing member and the pulling member according to an embodiment.

Detailed Description

In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The invention may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit or scope of the invention, which is therefore not limited to the specific embodiments disclosed below.

Unless defined otherwise, 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 invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

In the field of interventional medical devices, "distal" is defined as the end of the procedure that is distal to the operator, and "proximal" is defined as the end of the procedure that is proximal to the operator. "axial" refers to a direction parallel to the line connecting the distal center and the proximal center of the medical device, and "radial" refers to a direction perpendicular to the axial direction. "circumferential" refers to the circumferential direction, i.e., the direction about the axis of the luminal device.

Referring to fig. 1, an absorbable vascular plug system 1 of an embodiment comprises an absorbable vascular plug 10 and a conveyor 20.

Referring to fig. 2, absorbable vascular plug 10 comprises plug body 100. The plug body 100 includes at least two axially aligned plug discs 110. At least two plug discs 110 are arranged at intervals, and are opposite to each other.

The plug body 100 is made of an absorbable material. In one embodiment, the material of the plug body 100 is at least one selected from polylactic acid (PLA), polyglycolic acid (PGA), polylactic acid-glycolic acid copolymer (PLGA), polyhydroxyalkanoate (PHA), polydioxanone (PDO), polycaprolactone (PCL), polygluconic acid, polyhydroxybutyrate, polyanhydride, polyphosphoester (PPE), polydioxanone, and Polycarbonate (PC). It will be appreciated that in other embodiments, the materials of the plug body 100 are not limited to those listed above, and absorbable materials that are biocompatible, degradable in an organism, and capable of being prepared into the plug tray 100 are suitable.

The plug body 100 may be formed by cutting a tube, the plug body 100 may be formed by braiding a braided wire, or the plug body 100 may be formed by 3D printing.

In one embodiment, the plug body 100 includes three plug trays 110. Adjacent trays 110 are connected by a waist 120. The radial dimension of the waist 120 is smaller than the radial dimension of the stopper disc 110. Radial dimensions such that the distance between two points of greatest distance in the radial direction is meant, e.g., diameter, side length, etc. It will be appreciated that in other embodiments, the number of trays 110 is not limited to three, but may be two, four, five, etc. In one embodiment, the plug body 100 includes three plug trays 110, and the axial length of the plug tray 110 positioned in the middle is greater than the axial length of the plug tray 110 positioned at both sides. As shown in fig. 3, in a natural state, the axial length of the plug disc 110 located in the middle is L1, the axial lengths of the plug discs 110 located at the two sides are L2 and L3, respectively, L1 is greater than L2, L1 is greater than L3, and L2 and L3 are equal or unequal. The three plug discs 110 are arranged, and the three plug discs 110 are mutually matched, so that after implantation, the contact area between the plug body 100 and the vascular wall is larger, the anchoring reliability is improved, and the impact of blood flow is resisted. Further, the axial length L1 of the plug 110 is larger, which is beneficial to further increase the contact area, improve the anchoring reliability, and adapt to individuals with longer focus. In the case of a further embodiment of the present invention, l1=l2 =l3.

In one embodiment, the plug body 100 includes four plug discs 110, the axial lengths of the four plug discs 110 being equal or unequal. Adjacent two pucks 110 are connected by a waist 120.

With continued reference to fig. 3, a first attaching portion 130 is disposed on one of the two adjacent opposing disc surfaces 110, and a second attaching portion 140 is disposed on the other of the two opposing disc surfaces. When the first attaching portion 130 and the second attaching portion 140 are close to each other, the first attaching portion 130 and the second attaching portion 140 are attached to each other, so that the adjacent two stopper discs 110 are attached to each other, thereby achieving locking of the axial length of the whole absorbable vascular stopper 10. Moreover, this locking arrangement eliminates the need for a rigid, axially extending locking member, resulting in a relatively flexible absorbable vascular plug 10.

Further, the first attaching portion 130 and the second attaching portion 140 can be provided to adjust the entire length of the absorbable vascular stopper 10, and only two stopper plates 110 may be attached together or all stopper plates 110 may be attached together according to actual needs.

Further, the adjacent two plug discs 110 are bonded together, which is advantageous in improving the radial support performance of the plug body 100, thereby improving the anchoring reliability.

The first and second adhesive parts 130 and 140 are flexible structures. In an embodiment, one of the first attaching portion 130 and the second attaching portion 140 is of a hook structure, the other is of a filament structure, and the first attaching portion 140 and the second attaching portion 140 form a hook and loop fastener or a fastening tape, so that two adjacent plug discs 110 can be attached together.

The first attaching portion 130 extends on the disk surface of the stopper 110. The second attaching portion 140 extends on the disk surface of the stopper 110. The use of flexible first and second attachment portions 130, 140 allows for better compliance of absorbable vascular plug 10 relative to rigid, axially extending locking elements.

In an embodiment, the first and second adhesive parts 130 and 140 are each ring-shaped, and the first and second adhesive parts 130 and 140 are disposed around the central axis of the tray 110.

In an embodiment, the first attaching portion 130 covers the entire disc surface of the stopper disc 110, and the opposite second attaching portion 140 covers the opposite entire disc surface of the adjacent stopper disc 110 to increase the attaching area, so that the adjacent two stopper discs 110 are reliably attached together, thereby improving the radial supporting performance.

In an embodiment, the first attaching portion 130 and the second attaching portion 140 are non-annular structures, such as regular or irregular shapes, including square, rectangle, circle, etc. A plurality of first adhesive parts 130 or a plurality of second adhesive parts 140 may be provided on one disc surface of the stopper disc 110.

It will be appreciated that the first adhesive portion 130 and the second adhesive portion 140 are disposed opposite each other on the opposite disc surfaces of any adjacent two of the plug discs 110, regardless of the shape of the first adhesive portion 130 and the second adhesive portion 140.

The first adhesive portion 130 and the second adhesive portion 140 are each made of an absorbable material. For example, the first attaching portion 130 is a hook structure made of an absorbable material, and the second attaching portion 140 is a hairline structure made of an absorbable material.

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

In another embodiment, one of the first attaching part 130 and the second attaching part 140 is a male button and the other is a female button, and the first attaching part 130 and the second attaching part 140 constitute a female button, thereby enabling to attach two adjacent plug discs 110 together. The first and second adhesive portions 130 and 140 of this construction may also be made of an absorbable polymer material.

In one embodiment, the surface of the stopper disk 110 is a flat surface. In an embodiment, the surface of the plug tray 110 is a curved surface, the surface of the plug tray 110 includes a protruding portion, and the first adhering portion 130 and the second adhering portion 140 are respectively disposed on the protruding portions of the opposing surfaces of the two adjacent plug trays 110, so as to facilitate adhesion.

With continued reference to fig. 3, the absorbable vascular plug 10 further includes a first end cap 150 and a second end cap 160, where the first end cap 150 and the second end cap 160 are disposed on two sides of the plug body 100 respectively. The first and second caps 150, 160 are provided to facilitate the delivery, release and adjustment of the absorbable vascular plug 10 in cooperation with the delivery device 20. In one embodiment, when plug body 100 is formed from braided wires, first head 150 and second head 160 also function to secure the two free ends of the braided wires.

The first closure 150 is located distally. The first end socket 150 is provided with a first through hole 152. In one embodiment, the first through hole 152 is a threaded hole. A second closure 160 is located at the proximal end. The second end socket 160 is provided with a second through hole 162, and the outer wall of the second end socket 160 is provided with external threads 164.

The materials of the first head 150 and the second head 160 are both absorbable materials. The materials of the first seal head 150 and the second seal head 160 may be the same or different. In one embodiment, the material of the first cap 150 and the second cap 160 is selected from at least one of polylactic acid (PLA), polyglycolic acid (PGA), polylactic acid-glycolic acid copolymer (PLGA), polyhydroxyalkanoate (PHA), polydioxanone (PDO), polycaprolactone (PCL), polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphoester (PPE), polydioxanone, and Polycarbonate (PC).

The second head 160, plug body 100, and first head 150 communicate to form a path.

Returning to fig. 1, the delivery device 20 includes a delivery sheath (not shown), a pusher member 210, and a retractor member 220 slidably disposed through the pusher member 210.

The pusher 210 is removably coupled to the second cap 160 to pull or push the absorbable vascular plug 10 into or out of the delivery sheath. Referring to fig. 4, the pusher 210 includes a hollow tube 212 and a connector 214 connected to the distal end of the tube 212. The connector 214 is detachably connected to the second head 160. Specifically, the joint 214 is provided with internal threads, and the joint 214 is matched with the external threads 164 of the second seal head 160 through the internal threads, so as to realize detachable connection.

The traction member 220 is an elongated rod member. The distal end of the traction member 220 is provided with external threads 222, and the traction member 220 is detachably connected with the first seal head 150 through the matching of the external threads 222 and threads in the first seal head 150. The traction member 220 is used for pulling the first sealing head 150 to enable the first pasting part 130 and the second pasting part 140 to be close to each other so as to lock the axial distance between any two adjacent plug discs 110.

During loading, the traction member 220 enters the first sealing head 150 along a path formed by the communication of the second sealing head 160, the plug body 100 and the first sealing head 150, and the external thread 222 of the traction member 220 is matched with the first through hole 152 of the first sealing head 150, so that the traction member 220 is connected with the first sealing head 150. Fitting 214 of the pushing member 210 to the external threads 164 of the second head 160 connects the pushing member 210 to the second head 160. The plug body 100 is then placed in tension by the pulling member 220, and the absorbable vascular plug 10 is then pulled into the delivery sheath.

When the delivery sheath loaded with the absorbable vascular plug 10 is implanted at the target site, the pushing member 210 is pushed distally to push the absorbable vascular plug 10 out of the delivery sheath, and after the position is adjusted (if necessary), the pulling member 220 is pulled proximally to gradually increase the radial width of the absorbable vascular plug 10 in a stretched state and gradually return to an expanded state. During proximal pulling of the pull member 220, the opposing first and second attachment portions 130, 140 are attached together, thereby locking the axial distance of the absorbable vascular plug 10.

The first adhesive portion 130 and the second adhesive portion 140 are provided on two opposing disc surfaces of any adjacent two of the stopper discs 110, respectively, to lock the axial length of the absorbable vascular stopper 10 as a whole. This locking arrangement avoids the use of a rigid, axially extending locking element, which results in better compliance of the absorbable vascular plug 10.

And, the first attaching part 130 and the second attaching part 140 attach two adjacent stopper discs 110 together, which is advantageous in improving the radial support performance of the absorbable vascular stopper 10, and in avoiding falling off, thereby improving the safety of use.

Further, the length of the rigid locking element determines the axial length of the vascular plug, and thus the presence of the locking element affects the adjustment of the length of the vascular plug, making it difficult to adapt to different individuals. By selectively adhering or not adhering the first adhering portion 130 and the second adhering portion 140, the axial length of the absorbable vascular stopper 10 is made adjustable to suit different individuals.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims (10)

1. The absorbable vascular plug is characterized by comprising a plug body, wherein the plug body comprises at least two plug discs which are axially arranged, a first pasting part is arranged on one of opposite disc surfaces of any two adjacent plug discs, a second pasting part is arranged on the other plug disc, and the first pasting part and the second pasting part are mutually matched so as to lock the axial distance between any two adjacent plug discs.

2. The absorbable vascular plug of claim 1, wherein the first and second adhesive parts constitute a buckle, or wherein the first and second adhesive parts constitute a snap buckle.

3. The absorbable vascular plug of claim 1, wherein the first and second attachment portions are each made of an absorbable material.

4. The absorbable vascular stopper according to claim 1, wherein the stopper body comprises three stopper plates, adjacent stopper plates being connected by a waist portion having a radial dimension smaller than the radial dimension of the stopper plates.

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

6. The absorbable vascular plug of claim 1, further comprising a first end cap and a second end cap, the first end cap and the second end cap being disposed at respective ends of the plug body.

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

8. The absorbable vascular plug of claim 1, wherein the plug body is made of a material selected from at least one of polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoate, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphoester, polydioxanone, and polycarbonate.

9. An absorbable vascular plug system comprising a traction element and an absorbable vascular plug as claimed in any one of claims 1 to 8, wherein the traction element is arranged to co-operate the first and second attachment portions to lock the axial distance of any adjacent two plug discs.

10. The absorbable vascular plug system of claim 9, further comprising a first end cap and a second end cap, the first end cap and the second end cap being disposed at two ends of the plug body, respectively, the traction member being detachably connected to the first end cap, the traction member being configured to pull the first end cap so that the first adhesive portion and the second adhesive portion are adjacent to each other to lock an axial distance of any two adjacent plug discs.