WO2013086868A1

WO2013086868A1 - Hybrid structural recyclable endoluminal stent

Info

Publication number: WO2013086868A1
Application number: PCT/CN2012/080375
Authority: WO
Inventors: 陈晓丹; 陈美娟; 李玉茜; 冷德嵘
Original assignee: 南京微创医学科技有限公司
Priority date: 2011-12-14
Filing date: 2012-08-20
Publication date: 2013-06-20
Also published as: CN102488579A

Abstract

A hybrid structural recyclable endoluminal stent (1) consists of a column main body (2) and ends (3) connected to two ends of the column main body (2). The stent is characterized in that the column main body (2) is an imbricated structure which is formed by means of weaving, the top of at least one of the two ends (3) is provided with at least one circle of annular structures (4), a recycling thread (5) is penetratingly mounted in the annular structures (4), and a joint of the recycling thread (5) is knotted to form a knot (7). The stent overcomes shortcomings of a conventional stent, and has the advantages of simple and novel structure and the like.

Description

Description Hybrid structure in-tube retrievable support TECHNICAL FIELD

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a medical device, and more particularly to a stent for use in dilatation to treat a stenotic or obstructive lesion, and more particularly to a hybrid structural intraluminal retrievable stent. Background technique

At present, in the medical field, there are often diseases such as stenosis or obstruction caused by different causes in the human body. In order to alleviate the pain caused by surgery, interventional therapy has gradually developed. The therapy is a method of using a catheter to deliver a drug or surgical device to a lesion for treatment. The introduction of a highly elastic mesh stent is one of the important applications.

At present, the stents in the non-vascular lumen are mainly hand-woven diamond-shaped mesh stents. In some cases, the bending performance is not ideal, the radial support force is insufficient, and the axial shortening rate is large after implantation. More complications, and serious problems lead to secondary surgery. At the same time, the problem of recyclability of such stents has been plagued.

Initially, the stent cannot be recovered after being implanted into the human body. Once the stent is placed improperly or the patient's complications are serious, the stent cannot be removed safely and effectively in time, which will result in a serious medical accident. Therefore, the requirements for recyclability of the stent are clinically required, and the requirement for the implantation period of the stent in the human body also requires the recyclability of the stent, otherwise tissue proliferation occurs in the human body, and the silk material is broken due to corrosion and causes the official cavity. Serious consequences such as perforation and bleeding.

At present, the most retrievable aspect of the stent is threading in the mesh at the head end, but since the mesh is parallel to the surface of the stent, the friction between the wire and the wire is large when pulling the wire, so The pulling force is also large, and the head end shrinkage is not in place and the line is broken, which makes the bracket difficult to recycle, or the head end portion is not flattened when the wire is pulled, and the wall of the lumen is stimulated during the recovery process. Summary of the invention

The object of the present invention is to design a recyclable stent in a mixed structure lumen with convenient recovery and good radial strength in view of the problems of low radial strength and inconvenient recovery in the existing intraluminal stent.

The technical solution of the present invention is:

A hybrid structure intracavity retrievable stent, which is composed of a cylinder main body 2 and an end portion 3 connected at both ends thereof, characterized in that the cylindrical portion 2 has a scaly structure, and the scaly structure is woven. The formed structure, the two ends 3 At least one end portion 3 is provided with at least one annular structure 4, and the annular structure 4 is provided with a recovery wire 5, and the joint of the recovery wire 5 is knotted to form a node 7.

The end portion 3 and the cylindrical portion 2 are of a unitary structure or a separate structure. When the end portion 3 is a split structure, it is connected to the column portion 2 by welding, soft wire or film.

The number of the recovery wires 5 is one or more, and the number of the nodes is equal to the number of the recovery wires 5. The two end portions 3 have the same structure of a bell mouth, a ball head, a cup mouth shape or any two.

The inner surface and/or the outer surface of the column body 2 and the end portion 3 are partially or entirely provided with a coating film, and the coating material is a polymer material having good biocompatibility.

The annular structure 4 of the end portion 3 is an annular structure having a rotation angle formed by winding a wire, and the annular structure 4 is wound into one or more turns.

The beneficial effects of the invention:

The hybrid structural support of the present invention is processed from a wire having good biocompatibility, and is composed entirely of two ends and an intermediate portion. The middle portion and the end portions can be mixed by hand weaving and mechanical weaving, and can be selected as needed. When the middle part is woven by weaving, the stent has good compliance while enhancing the radial support strength of the whole stent. The special scaly mesh structure reduces the stimulation of the stent wall to the lumen. The axial shortening rate makes positioning more accurate. When the whole bracket and the two ends are hand-woven, the head end is composed of a ring structure with a certain rotation angle formed by winding the wire material, and the ring structure can be wound into a plurality of shapes by the wire material, and can be wound one turn or Multiple turns, in the ring structure, one or more wires with sufficient strength can be passed through, and knotted at the joint of the wire, the number of knots can be one or more, according to the actual situation, a reasonable choice, and The change in shape at both ends provides more selectivity. The invention solves the defects of the conventional stent, and has the advantages of simple and novel structure, high success rate of surgery, small pain of the patient, good curative effect, and the like, and has broad prospects in clinical application.

The head end recyclable structure of the present invention allows each mesh of the head end portion to be easily contracted together during recovery, and has a regular structure, thereby avoiding the stimulation of the lumen wall at the end of the stent head during recovery, and reducing The patient's pain, the angular design of the annular structure reduces the friction between the wire and the wire, improving the safety of the recyclable stent. At the same time, the design of the multi-junction of the recycling line improves the success rate of recyclability and the convenience of operation, so that the stent can ensure its own recyclability while treating the lesion, and prevent the stent from being implanted for too long or difficult to take out. Serious defects such as tissue hyperplasia and wire breakage due to corrosion. The invention has far-reaching significance in minimally invasive surgical equipment, and the process is simple, easy to manufacture and operate, and can be quickly extended to clinical use fields. DRAWINGS BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a schematic view showing the structure of an uncoated stent of the present invention.

Fig. 2 is a second schematic view showing the structure of the uncoated stent of the present invention.

Fig. 3 is a schematic view showing the structure of a stent of the film of the present invention.

Fig. 4 is a second schematic view showing the structure of the stent of the film of the present invention.

Fig. 5 is a schematic view showing the structure of the stent of the present invention implanted into a lesion in a human lumen.

Fig. 6 is a second schematic view showing the structure of the stent of the present invention implanted into the lumen of the human body. detailed description

The invention will now be further described with reference to the accompanying drawings and embodiments.

Embodiment 1.

As shown in Figure 1-2.

A hybrid structure tubular recoverable stent (Fig. 1, 2), the stent 1 is a tubular network composed of a cylindrical portion 2 and a distal end portion 3 of a columnar structure, and is composed of a biological phase Woven fabric with good properties. The cylindrical portion 2 and the end portions 3 can be mixed by hand weaving and mechanical weaving. The mesh shapes of the two parts can be the same or different, and the cylindrical portion 2 has a scaly structure, as shown in FIG. The cylindrical portion and the one end portion of each of the cylinders have a scaly structure, and the cylindrical portion of Fig. 2 has a scaly structure. The end portions at both ends are annular structures 4 having a certain rotation angle (which may be 45 degrees or 60 degrees, etc.). When the hand-wound monolithic stent 1 or both end portions 3 are used, the end portion 3 is an annular structure 4 having a certain rotation angle which is wound by a wire (the upper end of Fig. 1, the upper and lower ends of Fig. 2) The annular structure 4 may be wound into a plurality of shapes by a wire material, and may be wound one or more times, and one or more of the ends having sufficient strength may be passed through the outermost end of the ring structure. The wire 5 is knotted at the joint of the recovery wire 5 to form a knot 7, and the number of knots may be one or more, as needed. The cylindrical portion 2 and the end portions 3 at both ends may be a split structure or a unitary structure, and the split structures are connected together in a specific manner, and the combination of the two depends on different lesion conditions. The structure of the end portions 3 at both ends may be a plurality of shapes such as a bell mouth, a ball head, a cup mouth, or a combination of any two.

Before use, the stent is compressed and fixed in the delivery device. During use, the stent 1 is delivered to the lesion and released by the guidewire, X-ray or auxiliary monitoring of the endoscope, for example, the stenosis in the lumen. The stent is accurately fixed in the lesion in the lumen, gradually recovering the shape and expanding the lumen, and can fit the wall well (Figure 5, 6). If the head end portion 3 is hand-woven, before the recovery of the bracket, the take-out device is transported to the rack placement position by a specific means, such as a sampling pliers, etc., after the knot 7 of the recovery thread 5 is clamped, the recovery thread 5 is pulled. The end of the stent is tightened, and the state of the end of the stent is still observed under the auxiliary monitoring of the X-ray or the endoscope. After confirmation, the stent is pulled out of the lumen and the recovery is completed. Example 2.

As shown in Figures 3 and 4.

A hybrid structure tubular retrievable stent (Fig. 3, 4), the stent 1 is composed of a cylindrical portion 2 and a terminal portion 3 at both ends, and has good biocompatibility. The wire is woven. The cylindrical portion 2 and the end portions 3 at both ends may be a mixture of a hand-woven and a mechanical weaving process, and the mesh shape of the cylindrical portion 2 may be the same or different. When the hand-wound monolithic support 1 or both end portions 3 are used, the end portion 3 is composed of a ring-shaped structure 4 having a certain rotation angle formed by winding a wire material, and the annular structure 4 can be wound into a plurality of shapes by the wire material. One or more turns may be wound, and one or more recovery wires 5 having sufficient strength may be passed through the ring structure 4, and knots 7 are formed at the joint of the recovery wire 5 to form a knot 7 The number of knots can be one or more, depending on the needs. The cylindrical portion 2 and the two end portions 3 may be a split structure or a unitary structure, and the split structures are connected together in a specific manner, such as by welding, soft wire or film connection, and the combination of the two according to different lesions. And set. The structure of the both end portions 3 may be a combination of various shapes such as a bell mouth, a ball head, and a cup mouth. The biggest difference between this embodiment and the first embodiment is that the inner/outer surface of the stent 1 can be partially or completely coated, and the coating material 4 is a polymer material with good biocompatibility, and the filming manner of the two ends and the main body. The same or different, the rest are the same as in the first embodiment.

Before use, the stent is compressed and fixed in the delivery device. During use, the stent 1 is delivered to the lesion and released by the guidewire, X-ray or auxiliary monitoring of the endoscope, for example, the stenosis in the lumen. The stent is accurately fixed in the lesion in the lumen, gradually recovering the shape and expanding the lumen, and can fit the wall well (Figure 5, 6).

If the head end is hand-woven, before the recovery of the bracket, the take-out device is transported to the rack placement position by a specific means, such as a sampling clamp, etc., after clamping the knot of the recovery line 5, pull the recovery line to tighten the head end of the bracket. In the department, the state of the end of the stent is still observed under the auxiliary monitoring of the X-ray or the endoscope. After confirmation, the stent is pulled out of the lumen and the recovery is completed.

The parts not covered by the present invention are the same as the prior art or can be implemented by the prior art.

Claims

Claim

A hybrid structure intracavity retrievable stent consisting of a column body (2) and an end portion (3) connected at both ends thereof, characterized in that the column portion (2) is scaly a structure in which the scaly structure is a woven structure, and at least one end of the end portion (3) of the two end portions (3) is provided with at least one annular structure (4), the ring shape The structure (4) is fitted with a recovery thread (5), and the joint of the recovery thread (5) is knotted to form a joint.

(7).

2. The hybrid structure intraluminal retrievable support according to claim 1, wherein the end portion (3) and the cylindrical portion (2) are a unitary structure or a split structure, and the end portion (3) When it is a split structure, it is connected to the column portion (2) by welding, soft wire or film.

3. The hybrid structure intracavity retrievable support according to claim 1, wherein the number of the recovery wires (5) is one or more, the number of nodes and the recovery wire (5) The number is equal.

4. The hybrid structure intraluminal recyclable stent according to claim 1, wherein the two end portions (3) have the same structure as a bell mouth, a ball head, a cup mouth shape or any two. combination.

5. The hybrid structural intraluminal retractable stent according to claim 1, wherein the inner surface and/or the outer surface of the cylindrical body (2) and the end portion (3) are partially or completely provided. The film is made of a polymer material having good biocompatibility.

6. The hybrid structure intracavity retrievable stent according to claim 1, wherein the annular structure (4) of the end portion (3) is a ring having a rotation angle wound by a wire material. The structure, the ring structure (4) is wound into one or more turns.